Searchable USDC Az RICO Case Statement

Robert Davidson, et al v Vivra Inc, et al
RICO CASE STATEMENT
KEY TO NAMED PARTIES TO THIS ACTION: [keyed identically to Plaintiff’s

Original Complaint]
Robert Davidson, M.D. [plaintiff A]

Vanessa Komar, R.N. [plaintiff B]
Joanne C. Wray, R.N. [involuntary co-plaintiff C]
Vivra Inc [defendant D]
Vivra Asthma Allergy Inc [defendant E]
Vivra Asthma & Allergy Care America of Arizona, P.C. [defendant F]
Vivra Holdings Inc [defendant G]
Magellan Specialty Health Inc [defendant H]
Texas Pacific Group Inc [defendant I]
IHealth Technologies Inc [defendant J]
Gambro Healthcare Inc [defendant K]
Dialysis Holdings Inc [defendant L]
Allied Specialty Care Services Inc [defendant M]
Albany Medical College [defendant N]
Jay Grossman, M.D. [defendant O]
Eudice Grossman [defendant P]
Thomas B. Edwards, M.D. [defendant Q]
Gayle F. Petrillo [defendant R]
Charles W. Ott [defendant S]
Timothy G. Wighton [defendant T]
John W. Strack [defendant U]
Lynda L. Nessinger [defendant V]
Richard Hassett, M.D. [defendant W]
James L. Sublett, M.D. [defendant X]
Leanne M. Zumwalt [defendant Y]
An undetermined number of presently unknown defendants [defendants Z]
Per an order of the Court, under local rule 1.2 (i), and the provisions of Rule 37, Fed. R.
Civ. P.:
1. State whether the alleged unlawful conduct is in violation of 18 USC Section
(a), (b), (c), and/or (d).
Response: It is alleged that the defendants (Vivra Inc; Vivra Asthma Allergy
Inc; Vivra Asthma Allergy Care America of Arizona, PC; Vivra Holdings Inc;
Magellan Specialty Health Inc; Texas Pacific Group Inc; iHealth
-1- RICO CASE STATEMENT

Technologies Inc; Gambro Healthcare Inc; Dialysis Holdings Inc; Allied
Specialty Care Services Inc; Albany Medical College; Jay Grossman; Eudice
Grossman; Thomas B. Edwards; Gayle F. Petrillo; Charles W. Ott; Timothy
G. Wighton; John W. Strack; Lynda L. Nessinger; Richard Hassett; James L.
Sublett; Leanne M. Zumwalt; and an undetermined number of presently
unnamed defendants) have violated, or conspired to violate, 18 USC Section
1962 (b), (c), and (d).
2. List each defendant and state the alleged misconduct and basis of liability of
each defendant.
Response:
Vivra Inc agreed, with conspirators or anyone else, to conduct or participate in
the violation of the substantive RICO statute, specifically 18 USC Section
1962 (b), 18 USC Section 1962 (c), and 18 USC Section 1962 (d). Vivra Inc
agreed, with conspirators or anyone else, to conduct or participate in the
affairs of an enterprise through a pattern of racketeering activity as proscribed
by 18 USC Section 1962 (c). Vivra Inc agreed to the commission of at least
two predicate acts on behalf of the conspiracy. Vivra Inc also agreed to the
commission of predicate acts of racketeering activity that in themselves are
conspiracies. Vivra Inc conspired to conspire in an overall conspiracy to
violate 18 USC Section (b), (c), and (d). Vivra Inc employed a pattern of
racketeering activity to acquire or maintain an interest in an interstate
enterprise. Vivra Inc conducted or participated in the conduct of an
enterprise’s affairs through a pattern of racketeering activity. Through the

commission of two or more of the enumerated predicate acts which constitute
a pattern of racketeering activity, Vivra Inc directly or indirectly participated
in the conduct of an enterprise the activities of which affect interstate
commerce. The plaintiffs were injured in their business or property by reason
of such conduct by Vivra Inc which was violative of the substantive RICO
statute. Plaintiffs allege the existence of an enterprise, that the enterprise
affected interstate commerce, that Vivra Inc was associated with the
enterprise, that Vivra Inc participated, either directly or indirectly, in the
conduct of the affairs of the enterprise, and that Vivra Inc participated through
a pattern of racketeering activity, through the commission of at least two
predicate acts. Vivra Inc participated in an enterprise through a pattern of
racketeering activity. Vivra Inc agreed to violate, and in concert with the
conspirators violated, the substantive RICO statute 18 USC Sections 1962 (b),
(c), and (d). Plaintiffs allege a causal connection between the injury and the
prohibited activity. Plaintiffs allege racketeering enterprise injury, substantive
RICO conspiracy injury [18 USC Section 1962 (d)], substantive RICO injury
[18 USC Section 1962 (b) and (c)], and predicate act injury, to their business
or property by reason of the prohibited conduct by Vivra Inc. Plaintiffs allege
that these injuries are on-going [even though stated in past tense], continuing
injuries to their business or property.
Defendant E [Vivra Asthma Allergy Inc] agreed, with conspirators or anyone
else, to conduct or participate in the violation of the substantive RICO statute,

specifically 18 USC Section 1962 (b), 18 USC Section 1962 (c), and 18 USC
Section 1962 (d). Defendant E agreed, with conspirators or anyone else, to
conduct or participate in the affairs of an enterprise through a pattern of
racketeering activity as proscribed by 18 USC Section 1962 (c). Defendant E
agreed to the commission of at least two predicate acts on behalf of the
conspiracy. Defendant E also agreed to the commission of predicate acts of
racketeering activity that in themselves are conspiracies. Defendant E
conspired to conspire in an overall conspiracy to violate 18 USC Section (b),
(c), and (d). Defendant E employed a pattern of racketeering activity to
acquire or maintain an interest in an interstate enterprise. Defendant E
conducted or participated in the conduct of an enterprise’s affairs through a
pattern of racketeering activity. Through the commission of two or more of
the enumerated predicate acts which constitute a pattern of racketeering
activity, Defendant E directly or indirectly participated in the conduct of an
enterprise the activities of which affect interstate commerce. The plaintiffs
were injured in their business or property by reason of such conduct by
Defendant E which was violative of the substantive RICO statute. Plaintiffs
allege the existence of an enterprise, that the enterprise affected interstate
commerce, that Defendant E was associated with the enterprise, that
Defendant E participated, either directly or indirectly, in the conduct of the
affairs of the enterprise, and that Defendant E participated through a pattern of
racketeering activity, through the commission of at least two predicate acts.
Defendant E participated in an enterprise through a pattern of racketeering

activity. Defendant E agreed to violate, and in concert with the conspirators
violated, the substantive RICO statute 18 USC Sections 1962 (b), (c), and (d).
Defendant F [Vivra Asthma Allergy Care America of Arizona, P.C.] agreed,
with conspirators or anyone else, to conduct or participate in the violation of
the substantive RICO statute, specifically 18 USC Section 1962 (b), 18 USC
Section 1962 (c), and 18 USC Section 1962 (d). Defendant F agreed, with
conspirators or anyone else, to conduct or participate in the affairs of an
enterprise through a pattern of racketeering activity as proscribed by 18 USC
Section 1962 (c). Defendant F agreed to the commission of at least two
predicate acts on behalf of the conspiracy. Defendant F also agreed to the
commission of predicate acts of racketeering activity that in themselves are
conspiracies. Defendant F conspired to conspire in an overall conspiracy to
violate 18 USC Section (b), (c), and (d). Defendant F employed a pattern of
racketeering activity to acquire or maintain an interest in an interstate
enterprise. Defendant F conducted or participated in the conduct of an
enterprise’s affairs through a pattern of racketeering activity. Through the
commission of two or more of the enumerated predicate acts which constitute
a pattern of racketeering activity, Defendant F directly or indirectly
participated in the conduct of an enterprise the activities of which affect
interstate commerce. The plaintiffs were injured in their business or property
by reason of such conduct by Defendant F which was violative of the
substantive RICO statute. Plaintiffs allege the existence of an enterprise, that

the enterprise affected interstate commerce, that Defendant F was associated
with the enterprise, that Defendant F participated, either directly or indirectly,
in the conduct of the affairs of the enterprise, and that Defendant F
participated through a pattern of racketeering activity, through the commission
of at least two predicate acts. Defendant F participated in an enterprise
through a pattern of racketeering activity. Defendant F agreed to violate, and
in concert with the conspirators violated, the substantive RICO statute 18 USC
Sections 1962 (b), (c), and (d).
The corporate liability of the corporate defendants [D, E, F, G, H, I, J, K, L, M, N, and Z]
to this cause of action is not based on a theory of respondeat superior, but rather is based
upon the misconduct of the directors or high managerial agents of the corporate entities
which were [most, if not all, still are] members of the “Vivra” association-in-fact
enterprise. While defendant F was apparently administratively dissolved by the Arizona
Corporations Commission on 1/18/2001, the directors, high managerial agents, and
beneficiaries of defendant F, are still members of the enterprise. The plaintiffs allege and
will produce evidence at trial that directors or high managerial agents of the corporate
defendants D, E, F, G, H, I, J, K, L, M, N, and Z, performed, authorized, requested,
commanded, ratified or recklessly tolerated the unlawful conduct of the agents. The
plaintiffs allege and will produce evidence at trial that the corporate defendants D, E, F,
G, H, I, J, K, L, M, N, and Z, demonstrated [and demonstrate] both legitimate and
illegitimate conduct. This dual nature of their corporate function, both legitimate and
illegitimate, was [and is] an important element of the “Vivra” association-in-fact

enterprise and was [and is] very much a regular part of the way in which enterprise
conducted [and conducts] its affairs. The legitimate corporate functions were [and are]
intended to provide an ongoing appearance of legitimacy to the numerous regulatory
entities which reviewed [and review] their conduct. The illegitimate corporate functions
were intended [and are intended] to provide an on-going source of illicit financial gain to
the enterprise, some of which was [and is] reinvested in the enterprise to grow the
enterprise, some of which was [and is] provided as incentive compensation, bonuses,
salaries, and distributions to defendants O, P, Q, R, S, T, U, V, W, X, Y, and Z, and to
directors and high managerial agents of the enterprise, and some of which was [and is]
utilized to conceal and perpetuate the [past, present, and future] illicit activities of the
enterprise. The illegitimate corporate functions of the corporate members of the “Vivra”
association-in-fact enterprise were [and are] very much a part of the regular way in which
the “Vivra” enterprise conducted [and conducts] its affairs.
3. List the alleged wrongdoers, other than the defendants listed above, and state
the alleged misconduct of each wrongdoer.
Response:
By information and belief, an unknown number of possible defendants
[defendants Z] to this complaint are presently of unknown identity [and
unknown location] to the plaintiffs because of the effectiveness of an ongoing
conspiracy of concealment. FDA officials acting in their representative
capacities will not be named as defendants in this complaint. The FDA itself
will not be named as a defendant in this complaint. However, by information

and belief, FDA officials acting in their personal capacities [defendants Z]
may possibly, though not necessarily, be named defendants in this complaint,
pending discovery. By information and belief, BIG PHARMA [corporate
pharmaceutical entity] representatives acting in their representative capacities
and/or in their personal capacities [defendants Z] will possibly, though not
necessarily, be named defendants in this complaint, pending discovery. By
information and belief, various officials [officers or directors] or employees or
associates of Albany Medical College, acting in their representative capacities
and/or in their personal capacities [defendants Z] will possibly, though not
necessarily, be named defendants in this complaint, pending discovery. By
information and belief, various officials [officers or directors] or employees or
associates of the multiple other named defendants to this complaint, acting in
their representative capacities and/or in their personal capacities [defendants
Z] will possibly, though not necessarily, be named defendants in this
complaint, pending discovery.
4. List the alleged victims and state how each victim was allegedly injured.
Response:
Plaintiff A [Robert Davidson, M.D.] in this complaint alleges direct injury in
his business or property by reason of Vivra Inc’s conduct violative of the
substantive RICO statute, specifically 18 USC Section 1962 (b), (c), and (d).

Plaintiff B [Vanessa Komar, R.N.] in this complaint alleges direct injury in
her business or property by reason of Vivra Inc’s conduct violative of the
substantive RICO statute, specifically 18 USC Section 1962 (b), (c), and (d).
Plaintiff C [Joanne Wray, R.N.] in this complaint, by compulsory joinder, is
alleged to have been injured in her business or property by reason of Vivra
Inc’s conduct violative of the substantive RICO statute, specifically 18 USC
Section 1962 (b), (c), and (d).
5. Describe in detail the pattern of racketeering activity or collection of unlawful
debts alleged for each RICO claim. A description of the pattern of
racketeering shall include the following information:
a. List the alleged predicate acts and the specific statutes which were
allegedly violated;
Response:
Plaintiff’s Original Complaint alleged multiple related instances of mail fraud in violation
of 18 USC Section 1341, multiple related instances of wire fraud in violation of 18 USC
Section 1343, multiple related instances of interference with commerce by threats or
violence in violation of 18 USC Section 1951 and 18 USC Section 2, multiple related
instances of retaliating against a witness, victim, or an informant in violation of 18 USC
Section 1513, multiple related instances of obstruction of justice in violation of 18 USC
Section 1503, obstruction of criminal investigations in violation of 18 USC Section 1510,
obstruction of state or local law enforcement in violation of 18 USC Section 1511,
tampering with a witness, victim, or an informant in violation of 18 USC Section 1512,
multiple related instances of Interstate or foreign travel or transportation or use of

interstate wire communications in aid of racketeering enterprises in violation of 18 USC
Section 1952 and 18 USC Section 2, and multiple related instances of bribery in violation
of 18 USC Section 201.
b. Provide the dates of predicate acts, the participants in the predicate acts,
and a description of the facts surrounding the predicate acts;
Response:
Obstructions of justice in violation of 18 USC Section 1503:
(1) Gayle F. Petrillo [defendant R] hand-wrote the “stay home” note at Jay Grossman,
M.D.’s [Defendant O’s] express request and faxed same to plaintiff A [at Defendant O’s
express request] on April 27, 1999, at 1609 hrs with the “Vivra” date and time stamp.
The Tucson FDA EIR report of 5/5-6/28/99, Page 13, Paragraph 11 provides the mens
rea for this act. “Also included…is a handwritten memo by Gayle Petrillo [Defendant R],
Office Manager. When I ask Ms. Petrillo where this came from she stated that Dr.
Grossman [Defendant O] had asked her to write this and present it to Dr. Davidson
[plaintiff A]. The memo states that Dr. Davidson can take two days off beginning April
28, 1999. I asked why to which she stated so Dr. Davidson would not be around during
the scheduled inspection of 4/28-30/99.”
(2) On April 27, 1999 at 698 E. Wetmore Road, Suite 100, Tucson, AZ, defendant O
(Jay Grossman, M.D.) and defendant R (Gayle F. Petrillo) corruptly endeavored, and
agreed to corruptly endeavor, to (a) influence or impede an officer (Armando Chavez,
U.S. FDA Investigator) in the discharge of his duty, and (b) influence, obstruct, or
impede, the due administration of justice. Neither defendant O nor defendant R wanted
plaintiff A to be present at the Vivra Tucson facility during the scheduled inspection of
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4/28-30/99 for fear he would “blow the whistle on them”. Defendants O and R agreed to
a scheme by which they would insure that plaintiff A was not present at the Vivra
Tucson. They agreed to give him two days off beginning on April 28, 1999.
(3) Jay Grossman, M.D. [Defendant O] criminally assaulted and battered plaintiff A
on May 11th, 1999, at the “Vivra” Tucson facility at 698 E. Wetmore Road during a
federal [FDA] investigation of defendant O’s conduct. This assault and battery took place
less than a week after defendant O had learned that he was the subject of a “for cause”
investigation of his research conduct by the FDA.
(4) Jay Grossman, M.D. [Defendant O] corruptly, by threat and by force, endeavored
to influence, obstruct, or impede the due administration of justice by committing physical
violence to plaintiff A on May 11th, 1999 at the “Vivra” Tucson, AZ, 698 E. Wetmore
Road facility.
(5) Jay Grossman, M.D. [Defendant O] attacked the nursing license of plaintiff C claiming to
the Arizona State Board of Nursing that “she exceeded the scope of her practice”. Defendant S
(Charles W. Ott, “Vivra” General Counsel) provided pro bono legal “services” to plaintiff C
(Joanne C. Wray, R.N., formerly Joanne C. Siegel, R.N.) in “defense” of her nursing license after
Defendant O (Jay Grossman, M.D.) was ostensibly terminated “for cause” by defendant D on July
30, 1999. Plaintiff C is one of several direct witnesses to allegations of upcoding and unnecessary
procedures billed to 3rd party insurance payors. Defendant O attacked her nursing license [by filing
a complaint with the Arizona State Board of Nursing], claiming that she “exceeded the scope of her
practice”, presumably often. This conditional pro bono legal representation of plaintiff C was
conditioned upon her remaining an employee of Vivra, thus constituting either bribery, extortion,
or a fraudulent inducement to keep plaintiff C from independently seeking her own legal redress.

Plaintiff C could otherwise have readily “blown the whistle” on the serial, related insurance mail
frauds and wire frauds perpetrated by Defendant O (Jay Grossman, M.D.), Defendant U (John
Strack, VP Operations, Western Region), Defendant V (Lynda Nessinger, Billings, Claims, and
Collections manager), Defendant T (Timothy G. Wighton), Defendant R (Gayle F. Petrillo),
Defendant Y (Leanne M. Zumwalt], Defendant D [Vivra Inc], Defendant E [Vivra Asthma Allergy
Inc], and Defendant F [Vivra Asthma & Allergy Care America of Arizona, P.C.], and Defendant Z
[an undetermined number of presently unnamed defendants, to be determined at discovery].
Defendant S (Charles W. Ott, “Vivra” General Counsel) was always very much aware of the
reasons why Defendant O (Jay Grossman, M.D.) attacked plaintiff C’s (Joanne C. Wray, R.N.,
formerly Joanne C. Siegel, R.N.) nursing licence. Both Defendant O’s attack upon plaintiff C’s
nursing license and Defendant S’s “defense” of her nursing license were calculated overt acts in
furtherance of the conspiracy, specifically the subsidiary conspiracy to conceal and perpetuate on-
going, parallel schemes of serial related clinical research frauds and Medicare frauds, i.e. frauds
against the United States, and serial related frauds against “Vivra” employees, specialty practice
patients, and clinical research subjects. Plaintiffs allege that defendants D, E, F, O, P, R, S, T, U, V,
W, X, Y, and Z, willfully and knowingly participated in schemes to defraud the plaintiffs.
Defendants did so with an intent to defraud and used or caused to be used the U.S. mails and
interstate wire communications for the purpose of executing the schemes to defraud.
(6) During an on-going FDA inspection of Defendant O’s regulated conduct in
Albany, NY, defendant O (Jay Grossman, M.D.) took all of the Case Report Forms
(CRFs) for a study plus the study binder and some copies of the patient files when he
moved from Albany, NY to Tucson, AZ (reference: page 3 Albany, NY FDA EIR of
1993). Carolanne Currier of the FDA gave permission to omit coverage required by the

Compliance Program 7348.811 and was told to check only the 7 CRFs received as
supporting documents to the assignment (reference: page 4 Albany, NY FDA EIR of
1993). This constitutes obstruction of justice in violation of 18 USC Section 1503 and
interstate travel in aid of racketeering enterprises in violation of 18 USC Section 1952 by
defendants O and Z. This also constitutes overt acts of conspiracy to conceal and
perpetuate ongoing schemes of clinical research fraud and insurance fraud by both
defendants O and Z.
(7) “Vivra” Tucson [defendant F] had to obtain a court order to obtain control of the
clinical research records maintained by the Defendants O and P in an off-site storage
facility, during the “for cause” Tucson FDA inspection of 5/5-6/28/99. This represents
obstruction of justice by defendants O and P in violation of 18 USC Section 1503, a
predicate of racketeering as well as an overt act of conspiracy to conceal and perpetuate
ongoing serial frauds against the United States (serial clinical research frauds and serial
insurance frauds).
Interference with commerce by threats or violence in violation of 18 USC Section
1951:
(8) Jay Grossman, M.D. [defendant O} at 698 E. Wetmore Road, Suite 100, Tucson,
AZ on multiple occasions between September 1, 1998 and May 12, 1999 obstructed,
delayed, or affected commerce by extortion [as defined in 18 USC Section 1951 (b)(2)]
or attempts or conspires so to do, or commits or threatens physical violence to plaintiff A
and to most [if not all] of the clinical research coordinators at the “Vivra” Tucson facility.
These serial acts were related and represent predicate act violations of 18 USC Section

1951 in a pattern of racketeering activity and overt acts of conspiracy to defraud, conceal,
and perpetuate on-going frauds.
(9) An unrelenting, pervasive pattern of intimidation and harassment of the clinical
research staff by defendant O [Jay Grossman, M.D., Principal Investigator at the “Vivra”
Tucson clinical facility] under color of official right, engendered an atmosphere of “don’t
ask, don’t tell” and “psychic blindness” to certain objective clinical facts, including
patient safety, out of fear of retribution, at the Vivra Tucson 698 E. Wetmore, Tucson,
AZ facility, between September 1, 1998 and May 12, 1999.
(10) According to the Tucson FDA EIR of 5/5-6/28/99 page 2, “included in the records
provided by Andrea York was a handwritten letter dated 4/17/99, Exhibit 7.03-7.05 and
signed by the majority of the staff describing their concerns about their work environment
ranging from theft…prescreens done by front office, patients with questionable
qualifying criteria being randomized anyway.
(11) Jay Grossman, M.D. [defendant O] obstructed, delayed, or affected commerce by
extortion or attempts or conspired so to do, or committed or threatened physical violence
to plaintiff A and the majority of the Vivra clinical research staff at 698 E. Wetmore
Road in furtherance of a plan or purpose to obtain property from plaintiff A and the
majority of the Vivra clinical research staff, with their consent, induced by wrongful use
of actual or threatened force, violence, or fear, or under color of official right. These acts
took place serially at 698 E. Wetmore Road, Suite #100, Tucson, AZ between April 22,
1997 and July 30, 1999.
(12) Page 3, Paragraph 5 of the FDA Tucson EIR of 5/5-6/28/99 states “He [former
Vivra Tucson Supervisory Clinical Research Coordinator, Eric Johansen] has seen Dr JG

[defendant O, Jay Grossman, M.D.] argue with Dr. RD [plaintiff A] regarding Dr. RD
informing patient (and documenting in the clinic notes) of the possible side effects of a
study. EJ stated that Dr. JG has been heard to say that type of comment would scare
patients away. Dr JG would tell patients of the benefits of the study and downplay the
risks.”
(13) Defendant O in agreement and in concert with defendants D, E, F, P, R, S, T, U,
V, W, X, Y, and Z, accomplished serial, related intentional frauds [in a pattern of
racketeering activity] upon the plaintiffs, Vivra employees, clinical research subjects,
specialty practice patients, and the United States, at 1601 N. Tucson Blvd, 3395 N.
Campbell Ave, 698 E. Wetmore Road, Tucson, AZ between April 22, 1997 and May 12,
1999. These intentional frauds were committed, or caused to be committed,or
attempted, or conspired so to do, directly or indirectly, by Defendant O through serial
acts of extortion by defendant O upon the clinical research coordinators and upon
plaintiffs A and C. Defendant O intentionally created an atmosphere of unquestioned
obedience by the clinical research staff, inspired by fear, under color of official right.
Defendant O obstructed, delayed or affected commerce by extortion or attempts or
conspires so to do, or committed or threatened physical violence to plaintiffs A and C,
and the Vivra clinical research staff, in furtherance of a plan or purpose to obtain property
from plaintiffs A and C, and the Vivra clinical research study coordinators, with their
consent, induced by wrongful use of actual or threatened force, violence, or fear, or under
color of official right.
(14) Serial acts of extortion, or attempts or conspiracy to extort, caused the obstruction
or delay of, or an effect upon, commerce by defendants O, P, D, E, F, R, S, T, U, V, W,

X, Y, and Z at 1601 N. Tucson Blvd, 3395 N. Campbell Ave, and 698 E. Wetmore Road,
Tucson, AZ prior, during, and subsequent to the time of defendant O’s employment with
defendant D [April 22, 1997 through July 30, 1999]. The victims [plaintiffs A, C, and
most of the Vivra Tucson clinical research coordinators] were fearful, the fear was
reasonable, and the defendants made use of that fear to obtain the demanded property,
within the meaning of 18 USC Section 1951. Defendants intended the natural
consequences of their acts. Defendants induced victims to part consensually with
property either through wrongful use of actual or threatened force, violence, or fear, or
under color of official right, so as to adversely affect interstate commerce. Defendant O
had a reputation for violence. Defendant O physically assaulted plaintiff A on May 11,
1999, in the workplace at 698 E. Wetmore Road, Tucson, AZ. Defendant O also made
threats to plaintiff A during conversation on May 11, 1999, which induced fear in
plaintiff A. Plaintiff A alleges that plaintiff A was fearful for his life and his physical
safety when plaintiff A made his report on May 11, 1999 to defendant R [Gayle R.
Petrillo, Vivra Tucson Practice Manager] and subsequently to the Tucson Police
Department. Plaintiff A alleges that plaintiff A made his report to the Tucson Police
Department at the express recommendation of the Vivra Tucson Practice Manager, Gayle
F. Petrillo [defendant R] on May 11, 1999. The alleged assault and battery by defendant
O upon plaintiff A took place in the workplace at 698 E. Wetmore Road during an FDA
investigation of defendant O’s regulated conduct. The alleged assault and battery took
place just 6 days after defendant O learned that he was the subject of a “for cause”
investigation of his regulated conduct by the FDA.

(15) Defendant O obstructed, delayed, or affected commerce by committing physical
violence to plaintiff A on May 11th 1999 at the “Vivra” Tucson, AZ, 698 E. Wetmore
Road facility, in furtherance of a plan or purpose to conceal and perpetuate serial
violations of 18 USC Section 1341, Section 1343, Section 1951, and Section 1952, by
defendant O at 698 E. Wetmore Road between September 1, 1998 and May 12, 1999.
Jay Grossman, M.D. [defendant O] criminally assaulted and battered plaintiff A on May
11th, 1999, at the “Vivra” Tucson facility at 698 E. Wetmore Road. These acts were
agreed upon [calculated] by defendants O, P, R, S, T, U, D, E, F, and Z to intimidate a
witness during a federal (FDA) investigation, conceal, and perpetuate an on-going
scheme of defrauding two branches of the Department of Health & Human Services
(FDA and Medicare).
(16) Plaintiff A, plaintiff C, and each of the clinical research coordinators at the Vivra
Tucson clinical facility at 698 E. Wetmore Road, Suite 100, Tucson, AZ, from September
1, 1998 through May 11, 1999, were both witnesses and victims of serial related acts of
extortion and fraud (interference with commerce by threats or violence in violation of 18
USC Section 1951, mail fraud 18 USC Section 1341, and wire fraud 18 USC Section
1343, in a pattern of racketeering activity) by defendants O, P, R, S, T, U, V, W, X, Y,
and Z.
(17) Paragraph 5, Page 3 of Tucson FDA EIR of 5/5-6/28/99 states: “EJ [Eric
Johansen, Vivra Tucson supervisory clinical research coordinator] stated that Dr JG
[Defendant O, Jay Grossman, M.D.] asked him to bring all CRF and records for this into
his office and recreated past medical histories into the clinic notes from information taken

from source document medical questionnaires. EJ stated he has seen Dr JG tear up clinic
notes and redo them because of the information on them.”
(18) Former Vivra Tucson, AZ clinical research coordinator, Linda Buer [formerly
Linda LeBlanc] was a victim of defendant O’s violations of 18 USC Section 1951
[interference with commerce by threats or violence} at 698 E. Wetmore Road. In an
email of November 13, 2000, from Linda Buer to plaintiff A, she states “It was nice to
hear from you. I’m sorry it is for this reason however. Sometimes bad pennies don’t want
to go away. I think it is terrible that Dr. Grossman [defendant O] just won’t owe up to his
personal responsibility and ethical conduct – but must continue to find scapegoats for his
misconduct, my deepest empathies.” “I just remember feeling ethically compromised and
not sleeping well there at the end of my employment.”
(19) In a letter to plaintiff A on November 28, 2000 [as an email attachment], former
Vivra Tucson, AZ, clinical research study coordinator, Linda Buer [formerly Linda
LeBlanc] wrote: “However, my professional relationship with Dr Grossman [defendant
O] during my employ contributed greatly to my decision to leave Vivra. Over a period of
several months, I found my professional ethics concerning the health and welfare of the
study patient increasingly violated by Dr. Grossman’s reversals in the approval of study
patients’ entry into a particular trial.” “As coordinator, I only facilitate his [defendant
O’s] decision by collecting the needed information. Dr Davidson [plaintiff A], as a sub-
investigator, also must defer to the decisions of the Principal Investigator.” “I can say that
there were numerous occasions where I would deem a patient ineligible for a study by
some criteria usually from the Inclusion/Exclusion list to then have Dr. Grossman reverse
my decision and admit the patient into the study.” “Dr Grossman may say to the Sponsor

that a patient’s asthma is stable, but he would neglect to tell the Sponsor that the patient
had had a number of prednisone bursts during the previous year.” “Dr Grossman
routinely pushed the envelope of acceptable criteria for entry into a study.” “I found Dr
Grossman to be more concerned with patient accrual and subsequent paid patient visits
than with the highest and best for the patient. The health interests of the patient were
secondary to Dr. Grossman. Dr Grossman continually berated Dr Davidson and myself
for making any decisions concerning the entry or early withdrawal of a study patient from
a study no matter how appropriate the basis of our decision. Dr. Grossman would
verbally “assault” us within earshot of others. Dr Grossman would continually tell us
that only he had the ability to admit a patient or not.”
(20) Page 28, Allegation #50 of plaintiff A’s second report to the Arizona State Board
of Medical Examiners states “It is alleged that Buu Dinh, a former Tucson research
coordinator of Jay Grossman’s at the 3395 N. Campbell Ave facility, resigned abruptly
after complaining bitterly about a protocol violation by Grossman prior to his
resignation. …The incident in question, occurred when Grossman is alleged to have
violated protocol, in order to qualify a potential study subject, by making this subject
consume several cups of coffee prior to spirometry….It is highly likely that Mr Dinh was
a victim of Grossman’s serial acts of extortion” [intended to inappropriately enroll or
cause to be inappropriately enrolled (intentionally endangered) clinical research subjects].
(21) Page 28, Allegation #51 of plaintiff A’s second report to the Arizona State Board
of Medical Examiners states “Donald R. Jones, C-PA, a former Albany research
coordinator of Jay Grossman’s, is alleged to have stated that “Dr Grossman was
unethical and violated drug protocols… The source of this allegation is documents

obtained from the Albany County Clerk’s office pertaining to Albany County Case #2960-
91 (Jay Grossman, M.D. et al versus Richard Ball, M.D., et al). It is higly likely that Mr
Jones was a victim of Grossman’s serial acts of extortion” [intended to inappropriately
enroll or cause to be inappropriately enrolled (intentionally endangered) clinical research
subjects].
(22) Defendant S (Charles W. Ott, “Vivra” General Counsel) provided pro bono legal
“services” to plaintiff C (Joanne C. Wray, R.N., formerly Joanne C. Siegel, R.N.) in
“defense” of her nursing license after Defendant O (Jay Grossman, M.D.) was ostensibly
terminated “for cause” by defendant D on July 30, 1999.. Plaintiff C is one of several
direct witnesses to allegations of upcoding and unnecessary procedures billed to 3rd party
insurance payors. Defendant O attacked her nursing license [by filing a complaint with
the Arizona State Board of Nursing], claiming that she “exceeded the scope of her
practice”, presumably often. This conditional legal representation of plaintiff C [as long
as she remained an employee of Vivra] constitutes either bribery, extortion, or a
fraudulent inducement to keep plaintiff C from independently seeking her own legal
redress, and represents an overt act of conspiracy, specifically, the subsidiary conspiracy
to conceal and perpetuate on-going parallel schemes of clinical research fraud and
insurance fraud. Defendant S’s knowing, willful, and intentional deception of plaintiff C
constitutes overt acts of conspiracy and predicate acts of racketeering within the meaning
of 18 USC Section 1961 (obstruction of justice, tampering with a witness, victim, or an
informant, interstate or foreign travel in aid of racketeering enterprises, mail fraud, wire
fraud, bribery, obstruction of criminal investigations, and interference with commerce by
threats or violence). Plaintiff C could otherwise have readily “blown the whistle” on the

serial, related insurance mail frauds and wire frauds perpetrated by Defendant O (Jay
Grossman, M.D.), Defendant U (John Strack, VP Operations, Western Region),
Defendant V (Lynda Nessinger, Billings, Claims, and Collections manager), Defendant T
(Timothy G. Wighton), Defendant R (Gayle F. Petrillo), Defendant V (Lynda L.
Nessinger), Defendant Y, Defendant Z, Defendant D, Defendant E, and Defendant F.
Defendant S (Charles W. Ott, “Vivra” General Counsel) was always very much aware of
the reasons why Defendant O (Jay Grossman, M.D.) attacked plaintiff C’s (Joanne C.
Wray, R.N., formerly Joanne C. Siegel, R.N.) nursing licence. Both Defendant O’s attack
upon plaintiff C’s nursing license and Defendant S’s “defense” of her nursing license
were calculated overt acts in furtherance of the conspiracy, specifically the subsidiary
conspiracy to conceal and perpetuate on-going, parallel schemes of serial related clinical
research frauds and Medicare frauds, i.e. frauds against the United States, and serial
related frauds against “Vivra” employees, specialty practice patients, and clinical
research subjects. Plaintiffs allege that defendants D, E, F, O, P, R, S, T, U, V, W, X, Y,
and Z, willfully and knowingly participated in schemes to defraud the plaintiffs.
Defendants did so with an intent to defraud and used or caused to be used the U.S. mails
and interstate wire communications for the purpose of executing the schemes to defraud.
Retaliating against witness, victim, or informant in violation of 18 USC Section 1513:
(23) Defendant O’s assault and battery upon plaintiff A on May 11, 1999 in the
workplace at 698 E. Wetmore Road, Tucson, AZ, during a “for cause” federal [FDA]
investigation of defendant O’s regulated conduct.
(24) Defendant O’s on-going civil defamation action [Pima County Superior Court
Case # 333954] against plaintiffs A and B.

(25) Defendant O’s on-going attack upon plaintiff C’s nursing license on or about
October 1, 1999 in Tucson, AZ [defendant O allegedly filed a complaint with Arizona
State Board of Nursing].
(26) Defendant O’s, R’s, D’s, E’s, F’s, and Z’s, libel and slander of plaintiff A and
Arnold Funckes, M.D. [on or about August 20, 1999 in Tucson, AZ] wherein “Dr.
Grossman [defendant O] had sent letters to all the drug companies and insurance
companies that Vivra bills printing a grey picture of you [plaintiff A] and Dr. Funckes.
Trying to put the blame on you two and how you walked out of the office and left patients
that were waiting to be seen…a copy of these letters were put in the regulatory binders
[at the Vivra Tucson facility of defendant F]”.
(27) Defendant O has shown a prior pattern of filing abusive civil defamation actions
(please reference Albany County Case # 2960-91 and Pima County Superior Court Case
# 333954) against his accusers. In Albany County Case # 2960-91, defendant O claimed
that he was defamed by Richard Ball, M.D., Scott Osur, M.D., and David Shulan, M.D.
In a Reply-Affidavit, filed on December 6, 1994, Richard Ball, M.D., Scott Osur, M.D.,
and David Shulan, M.D. alleged violence, unethical, and probably illegal conduct by
Defendant O in Albany, NY.
(28) Defendant O has shown a prior pattern of “attacking the messenger” via abusive
legal tactics and character assassination. Defendant O’s defamation action against
Richard Ball, M.D., et al and defendant O’s attack on Mr Donald R. Jones C-PA’s
research credentials, in Albany, NY [Albany County Case # 2960-91]. The parallelism
and similarity to defendant O’s on-going defamation action [Pima County Superior Court
Case # 333954] against plaintiff A and defendant O’s attack upon plaintiff C’s nursing

license in Tucson, AZ approximately 10 years later, is really quite striking, and strongly
supports the plaintiff’s allegation of pattern and relatedness in this present federal cause
of action.
Tampering with witness, victim, or informant in violation of 18 USC Section 1512:
(29) On May 11th, 1999 at the “Vivra” Tucson, AZ, 698 E. Wetmore Road facility,
defendant O knowingly used intimidation, physical force, and threats to corruptly
persuade, or to attempt to corruptly persuade plaintiff A, with intent to influence, delay,
or prevent the testimony of plaintiff A in an official proceeding, and hinder, delay, or
prevent the communication to a law enforcement officer of information relating to the
commission of serial, related violations of 18 USC Section 1341, Section 1343, Section
1951, and Section 1952 by defendant O at 698 E. Wetmore Road between September 1,
1998 and May 12, 1999. These acts were agreed upon [calculated] by defendants O, P,
R, S, T, U, D, E, F, and Z to intimidate a witness during a federal (FDA) investigation,
conceal, and perpetuate an on-going scheme of defrauding two branches of the
Department of Health & Human Services (FDA and Medicare).
(30) Defendant O attacked plaintiff C’s Arizona nursing license by filing a complaint
with the Arizona State Board of Nursing on or about October 1, 1999 wherein defendant
O alleged that plaintiff C “exceed[ed] the scope of [her] nursing practice.”. These acts
were agreed upon [calculated] by defendants O, P, R, S, T, U, D, E, F, and Z to
intimidate a witness[plaintiff C] during a federal (FDA) investigation, conceal, and
perpetuate an on-going scheme of defrauding two branches of the Department of Health
& Human Services (FDA and Medicare).

(31) Defendant O’s assault and battery upon plaintiff A in the workplace on May 11th,
1999 during an on-going “for cause” investigation by the FDA of defendant O’s
regulated conduct constitutes predicate act violations of 18 USC Section 1951
(interference with commerce by threats or violence), 18 USC Section 2, 18 USC Section
1503 (obstruction of justice), 18 USC Section 1513 (retaliating against a witness, victim,
or an informant), and 18 USC Section 1512 (tampering with a witness, victim, or an
informant). They also represent overt acts of conspiracy to conceal and perpetuate on-
going frauds against the plaintiffs, clinical research subjects, specialty practice patients,
and the United States.These acts should toll the statute of limitations under the doctrine
of equitable tolling, or equitable estoppel, or fraudulent concealment, or continuing tort.
Plaintiffs allege that defendants O, R, T, and Z conspired to violate 18 USC Section
1951, Section 1503, Section 1513, and Section 1512, on May 11th 1999, at 698 E.
Wetmore Road, Suite 100, in Tucson, AZ. They agreed to commit, or attempted to
commit, or caused to be commited, or attempted to cause to be commited, or aided and
abetted, these predicate acts through a pattern of racketeering activity. On May 11, 1999
at 698 E. Wetmore Road, in agreement and in concert with defendants R, T, and Z,
defendant O knowingly, willfully, maliciously, and wantonly, engaged in conduct
[assault and battery upon plaintiff A] which caused bodily injury to plaintiff A, or
threatened to do so, or attempted to do so, with intent to retaliate against plaintiff A for
the attendance of plaintiff A at an official proceeding, or any testimony given or any
record, document, or other object produced by plaintiff A in an official proceeding, or
any information relating to the commission or possible commission of a Federal offense,
or attempted to do so. On May 11th, 1999 at 698 E. Wetmore Road, in agreement and in

concert with defendants R, T, and Z, defendant O knowingly, willfully, maliciously, and
wantonly, obstructed, delayed, or affected commerce by extortion or attempts or
conspires so to do, or commits or threatens physical violence to plaintiff A in furtherance
of a plan or purpose to do anything in violation of 18 USC Section 1951. On May 11th,
1999 at 698 E. Wetmore Road, in agreement and in concert with defendants R, T, and Z,
defendant O knowingly, willfully, maliciously, and wantonly, used intimidation or
physical force, threatened, or corruptly persuaded plaintiff A, or attempted to do so, or
engaged in misleading conduct toward plaintiff A, with intent to influence, delay, or
prevent the testimony of plaintiff A in an official proceeding, cause or induce plaintiff A
to withhold testimony, or withhold a record, document, or other object, from an official
proceeding, hinder, delay, or prevent the communication to a law enforcement officer of
the United States of information relating to the commission or possible commission of a
Federal offense. On May 11th, 1999 at 698 E. Wetmore Road, in agreement and in
concert with defendants R, T, and Z, defendant O knowingly, willfully, maliciously, and
wantonly, corruptly, or by threats or force, or by any threatening communication,
endeavored to influence, intimidate, or impede an officer of any court of the United
States, or officer who may be serving at any examination in the discharge of his duty, or
corruptly or by threats or focrce, or by any threatening communication, influenced,
obstructed, or impeded, or endeavored to influence, obstruct, or impede, the due
administration of justice.
(32) On or about October 1, 1999, defendant S (Charles W. Ott) corruptly, or by
threats or force, or by any threatening letter or communication, endeavored to influence,
obstruct, and impede, the due administration of justice. Without the knowledge or

consent of the plaintiffs, defendants R, S, T, U, V, O, P, and Z agreed that defendant S’s
influencing, obstructing, or impeding the due administration of justice would further, for
the purpose of executing, the scheme and artifices to conceal and perpetuate the ongoing
schemes to defraud the plaintiffs, clinical research subjects, specialty practice patients,
and two branches of the US Department of Health & Human Services (FDA and
Medicare).
(33) Plaintiffs allege that on April 27, 1999 at 698 E. Wetmore Road, Suite 100,
Tucson, AZ, defendant O (Jay Grossman, M.D.) and defendant R (Gayle F. Petrillo)
corruptly endeavored to (a) influence or impede an officer (Armando Chavez, U.S. FDA
Investigator) in the discharge of his duty, and (b) influence, obstruct, or impede, the due
administration of justice. This represents a predicate act violation of 18 USC Section
1503 (influencing or injuring officer or juror generally) and an overt act of conspiracy to
conceal and perpetuate on-going frauds against the plaintiffs, clinical research subjects,
specialty practice patients, and the United States.
(34) Gayle F. Petrillo [defendant R, Vivra Tucson’s Practice Manager] wrote the “stay
home” note [at Defendant O’s express request] and faxed same to plaintiff A [at
Defendant O’s express request] on April 27, 1999 at 1609 hours with the “Vivra” date
and time stamp. The Tucson FDA EIR report of 5/5-6/28/99, Page 13, Paragraph 11
provides the mens rea for this act. “Also included…is a handwritten memo by Gayle
Petrillo [Defendant R], Office Manager. When I ask Ms. Petrillo where this came from
she stated that Dr. Grossman [Defendant O] had asked her to write this and present it to
Dr. Davidson [plaintiff A]. The memo states that Dr. Davidson can take two days off

beginning April 28, 1999. I asked why to which she stated so Dr. Davidson would not be
around during the scheduled inspection of 4/28-30/99.”
(35) Defendant O’s assault and battery upon the plaintiff A in the workplace on May
11, 1999, just 6 days after Defendant O learned that Defendant O was the subject of a for-
cause FDA audit of his research conduct, were overt-acts of conspiracy of concealment,
as well as predicate acts of racketeering within the meaning of 18 USC Section 1961
(interference with commerce by threats or violence, retaliating against a witness, victim,
or an informant, obstruction of justice, and tampering with a witness, victim, or an
informant). Defendant O’s assault and battery upon plaintiff A was intended either (a) to
provoke plaintiff A into physically defending himself, or (b) to provoke plaintiff A into
calling 911 [as plaintiff A was subsequently advised to do by Defendant R (Gayle F.
Petrillo, Practice Manager) after she “learned” of the assault and battery on May 11,
1999].
practice”, presumably often. This conditional pro bono legal representation of plaintiff
C [as long as she remained an employee of Vivra] constitutes either bribery, extortion,
or a fraudulent inducement to keep plaintiff C from independently seeking her own

legal redress, and represents an overt act of conspiracy, specifically, the subsidiary
conspiracy to conceal and perpetuate on-going parallel schemes of clinical research fraud
and insurance fraud. Defendant S’s knowing, willful, and intentional deception of
plaintiff C constitutes overt acts of conspiracy and predicate acts of racketeering within
the meaning of 18 USC Section 1961 (obstruction of justice, tampering with a witness,
victim, or an informant, interstate or foreign travel in aid of racketeering enterprises, mail
fraud, wire fraud, bribery, obstruction of criminal investigations, and interference with
commerce by threats or violence). Plaintiff C could otherwise have readily “blown the
whistle” on the serial, related insurance mail frauds and wire frauds perpetrated by
Defendant O (Jay Grossman, M.D.), Defendant U (John Strack, VP Operations, Western
Region), Defendant V (Lynda Nessinger, Billings, Claims, and Collections manager),
Defendant T (Timothy G. Wighton), Defendant R (Gayle F. Petrillo), Defendant V
(Lynda L. Nessinger), Defendant Y, Defendant Z, Defendant D, Defendant E, and
Defendant F. Defendant S (Charles W. Ott, “Vivra” General Counsel) was always very
much aware of the reasons why Defendant O (Jay Grossman, M.D.) attacked plaintiff C’s
(Joanne C. Wray, R.N., formerly Joanne C. Siegel, R.N.) nursing licence. Both Defendant
O’s attack upon plaintiff C’s nursing license and Defendant S’s “defense” of her nursing
license were calculated overt acts in furtherance of the conspiracy, specifically the
subsidiary conspiracy to conceal and perpetuate on-going, parallel schemes of serial
related clinical research frauds and Medicare frauds, i.e. frauds against the United States,
and serial related frauds against “Vivra” employees, specialty practice patients, and
clinical research subjects. Plaintiffs allege that defendants D, E, F, O, P, R, S, T, U, V,

(37) Defendants O, R, S, and T knowingly used intimidation or physical force,
threatened, or corruptly persuaded plaintiff A and plaintiff C, or attempted to do so, or
engaged in misleading conduct toward plaintiff A and plaintiff C, with intent to
influence, delay, or prevent the testimony of plaintiff A and plaintiff C in an official
proceeding; caused or induced plaintiff A and plaintiff C to withhold testimony, or
withhold a record, document, or other object, from an official proceeding; or be absent
from an official proceeding; or hindered, delayed, or prevented the communication to a
law enforcement officer or judge of the United states of information relating to the
commission or possible commission of a Federal offense; or intentionally harassed
plaintiff A and plaintiff C and thereby hindered, delayed, prevented, or dissuaded
plaintiff A and plaintiff C from attending or testifying in an official proceeding.
(38) On or about October 1, 1999 at 698 E. Wetmore Road, Suite 100, Tucson, AZ,
defendant S (Charles W. Ott) and defendants Z knowingly and corruptly persuaded
plaintiff C, or attempted to do so, or engaged in misleading conduct toward plaintiff C,
with intent to (a) influence, delay, or prevent the testimony of plaintiff C in an official
proceeding, and (b) cause or induce plaintiff C to withhold testimony, or withhold a
record, document, or other object, from an official proceeding, and (c) hinder, delay, or
prevent the communication to a law enforcement officer or judge of the United States of
information relating to the commission or possible commission of Federal offenses [serial
“upcoding” and “unnecessary procedure” insurance frauds in violation of 18 USC
Section 1341 and 18 USC Section 1343 violations at 698 E. Wetmore Road, Tucson, AZ

between on or about September 1, 1998 and May 12, 1999] by defendants O, R, U, V, Y,
D, E, and F. Without the knowledge or consent of the plaintiffs, defendants R, S, T, U, V,
W, X, Y, O, P, and Z agreed that defendant S’s provision of “pro bono” legal services in
“defense” of plaintiff C’s nursing license, conditioned up her remaining in the
employment of defendants D, E, and F, would further, for the purpose of executing, the
scheme and artifices to conceal and perpetuate the ongoing schemes to defraud the
plaintiffs, clinical research subjects, specialty practice patients, and two branches of the
US Department of Health & Human Services (FDA and Medicare). Defendant S (Charles
W. Ott, “Vivra” General Counsel) was always very much aware of the reasons why
Defendant O (Jay Grossman, M.D.) attacked plaintiff C’s (Joanne C. Wray, R.N.,
formerly Joanne C. Siegel, R.N.) nursing licence. Both Defendant O’s attack upon
plaintiff C’s nursing license and Defendant S’s “defense” of her nursing license were
calculated overt acts in furtherance of the conspiracy, specifically the subsidiary
conspiracy to conceal and perpetuate on-going, parallel schemes of serial related clinical
research frauds and Medicare frauds, i.e. frauds against the United States, and serial
related frauds against “Vivra” employees, specialty practice patients, and clinical
research subjects. Plaintiffs allege that defendants D, E, F, O, P, R, S, T, U, V, W, X, Y,
Please incorporate by reference the emails of October 1, 1999, April 22, 2000, October
11, 2000, December 15, 2000, and January 18, 2003 from plaintiff C to plaintiff A.

(39) On April 27, 1999 at 698 E. Wetmore Road, Suite 100, Tucson, AZ, defendant O
(Jay Grossman, M.D.) and defendant R (Gayle F. Petrillo) knowingly and corruptly
persuaded plaintiff A, or attempted to do so, or engaged in misleading conduct toward
plaintiff A, with intent to (a) influence, delay, or prevent the testimony of plaintiff A in
an official proceeding, and (b) cause or induce plaintiff A to withhold testimony, or
withhold a record, document, or other object, from an official proceeding, and (c) hinder,
delay, or prevent the communication to a law enforcement officer or judge of the United
States of information relating to the commission or possible commission of a Federal
offense. This represents a predicate act violation of 18 USC Section 1512 (tampering
with a witness, victim, or an informant) and an overt act of conspiracy to conceal and
perpetuate on-going frauds against the plaintiffs, clinical research subjects, specialty
practice patients, and the United States. Please reference FDA Tucson EIR of 5/5-
6/28/99, page 13, paragraph 11. Please incorporate by reference plaintiff A’s reports to
the Arizona Board of Medical Examiners on December 22, 2000 and March 5, 2001.
Please incorporate by reference the FDA Tucson EIR of 5/5-6/28/99 in its entirety. Please
incorporate by reference the facsimile transmission with defendant D’s time stamp on
April 27, 1999.
Interstate travel or transportation or use of interstate wire communications in aid of
racketeering enterprises in violation of 18 USC Section 1952 and 18 USC Section 2:
(40) Defendants Z testified on defendant O’s (Jay Grossman, M.D.) behalf in Albany
County Case # 2960-91 despite the Reply Affidavit of Richard Ball, M.D., David Shulan,
M.D., and Scott Osur, M.D., filed on December 6, 1994, wherein allegations of violence,
unethical, and possibly illegal conduct were made against defendant O. Please reference

Page 10 and Page 29 from Albany County Case # 2960-91 This constitututes overt acts of
conspiracy to conceal and perpetuate ongoing schemes of clinical research fraud and
insurance (including Medicare) fraud which made use of the United States mails and
interstate wire communications. Defendants O, N, Q, and Z agreed that falsified
testimony by defendants Z in Albany County Case #2960-91 on defendant O’s behalf
would facilitate, conceal, and perpetuate defendant O’s ongoing frauds against the United
States, clinical research subjects, and specialty practice patients.
(41) During an on-going FDA inspection of defendant O’s regulated conduct in
Albany, NY, defendant O (Jay A. Grossman, M.D.) took all of the Case Report Forms
moved from Albany, NY to Tucson, AZ (please reference page 3 of Albany, NY FDA
EIR of 1993) on or about January-July 1993. Carolanne Currier of the FDA gave
permission to omit coverage required by the Compliance Program 7348.811 and was told
to check only the 7 CRFs [Case Report Forms] received as supporting documents to the
assignment (please reference page 4 Albany, NY FDA EIR of 1993). Defendants O, N,
Q, R, T, and Z, corruptly agreed to aid and abet defendant O’s travels in interstate
commerce [from Albany, NY to Tucson, AZ on or about January-July 1993, during an
on-going lawsuit (Albany County Case # 2960-91), and during an FDA investigation of
his regulated conduct at 62 Hackett Blvd, Albany, NY]. Defendant O traveled in
interstate commerce or used the mail or any facility in interstate commerce, with intent to
otherwise promote, manage, establish, carry on, or facilitate the promotion, management,
establishment, or carrying on, of any unlawful activity, and thereafter performed or
attempted to performs the promotion, management, establishment, carrying on, or

facilitated the promotion, management, establishment, or carrying on, of unlawful
activity.
(42) The plaintiffs allege that Defendants O, S, T, and U traveled interstate frequently
in aid of the “Vivra” racketeering enterprises. Paragraph 1, Page 5 of FDA Exhibit1.05
states “After checking my calendar for 1998, I confirmed that I was at the Vivra site in
Tucson for approximately 214 days of that year.” Paragraph 4, Page 3 of FDA Exhibit
1.03 states “In addition to my work at the research site, I have worked with several drug
companies in the development of research protocols, and as a consultant.” Please also
reference the Monthly Operations Meeting Agenda of January 15, 1999. Plaintiffs allege
that defendants O, S, T, and U traveled in interstate commerce or used the mail or any
facility in interstate commerce, with intent to otherwise promote, manage, establish, carry
on, or facilitate the promotion, management, establishment, or carrying on, of any
unlawful activity and thereafter performs or attempts to perform an act described in 18
USC Section 1952, Subsection (a) (3).
(43) Plaintiffs allege serial related instances of wire fraud in violation of 18 USC
Section 1341, serial related instances mail fraud in violation of 18 USC Section 1343,
serial related instances of interference with commerce by threats or violence in violation
of 18 USC Section 1951, and serial related instances of interstate travel in aid of
racketeering enterprise in violation of 18 USC Section 1952 by defendant O (Jay
Grossman, M.D.). These serial related frauds, extortions, and interstate travel in support
of racketeering enterprise, comprise a pattern of racketeering activity within the meaning
of 18 USC Section 1962 (b), (c), and (d). This racketeering activity took place in both
Albany, NY (62 Hackett Blvd and 215 Washington Avenue Extension) and in Tucson,

AZ (1601 N. Tucson Blvd, 3395 N. Campbell Ave, 698 E. Wetmore Road, and 6261 N.
La Cholla Blvd) between about 1984 and the present, with open-ended continuity. These
multiple, related acts of racketeering, occurring within ten years of one another,
constitute a pattern of racketeering activity within the meaning of 18 USC Section 1961
(5).
(44) Documents from the Albany County Clerk from Albany County Case # 2960-91,
Page 29, state “Further, at the time of trial, plaintiffs will offer the testimony of
representatives from the drug companies for whom the studies were performed who will
testify that the studies were performed properly and that there were no protocol
violations committed by Dr Grossman [defendant O]”
practice”, presumably often. Defendant S’s knowing, willful, and intentional deception of

(46) On or about October 1, 1999, defendant S (Charles W. Ott) traveled in interstate
commerce to 698 E. Wetmore Road, Tucson, AZ or used the US mail, or any facility in
interstate commerce, with intent to promote, manage, establish, carry on, or facilitate the
promotion, management, establishment, or carrying on, of unlawful activity, and
thereafter performed or attempted to perform unlawful activity in aid of racketeering
enterprises. Without the knowledge or consent of the plaintiffs, defendants R, S, T, U, V,

W, X, Y, O, P, and Z agreed that defendant S’s interstate travel or use of the US mail, or
any facility in interstate commerce in aid of racketeering enterprises would further, for
the purpose of executing, the scheme and artifices to conceal and perpetuate the ongoing
schemes to defraud the plaintiffs, clinical research subjects, specialty practice patients,
and two branches of the US Department of Health & Human Services (FDA and
Medicare).
Obstruction of criminal investigations in violation of 18 USC Section 1510:
(47) In Albany County Case # 2960-91, defendants O, N, Q, and Z conspired to
obstruct the enforcement of criminal laws of the state of NY in violation of 18 USC
Section 1511 and federal laws of the United States in violation of 18 USC Section 1510.
In agreement with defendants O, N, and Q, defendants Z endeavored by means of
bribery to obstruct, delay, or prevent the communication of information relating to
violations of 18 USC Section 1341 and 18 USC 1343 of the United States by defendants
O and Q to federal (FDA) investigators during FDA Albany, NY EIRs of 11/12-11/22/93
and 10/26-11/14/94 at 62 Hackett Blvd. This scheme was intended by defendants O, N,
Q, and Z to conceal and perpetuate ongoing frauds. The defendants O, N, Q, and Z used
and caused to be used the US mails and interstate wire communications in furtherance
and for the purpose of executing the scheme and artifices to defraud and obtain money by
false pretenses.
(48) Plaintiffs allege that levoalbuterol (Xopenex, marketed by Sepracor) may have
gained expedited market approval by the FDA under the PDUFA II (Prescription Drug
User Fee Act) during the pendancy period of a criminal investigation of defendant O (Jay
A. Grossman, M.D.) by the criminal division of the FDA. This market approval is

believed to have been granted by FDA after completion of the FDA Tucson “for cause”
inspection of 5/5-628/99 and prior to publication of the FDA Tucson EIR report, which
was “[This inspection report was] delayed due to a PDUFA report.” Defendants Z’s
selective enforcement of the PDUFA II was and continues to be motivated by corporate
bribery by Big Pharma. Plaintiffs allege that whenever a “for cause” investigator-related
FDA investigation involves a large enough number of study drugs, defendants Z “stone-
wall” and delay their investigation under the color of official provided by selectively
enforcing the PDUFA II, motivated by the Congressionally-sanctioned corporate bribery
provided under the PDUFA II.

Bribery in violation of 18 USC Section 1952 and 18 USC Section 2:

false pretenses.
(51) Defendants Z’s selective enforcement of the PDUFA II was and continues to be
motivated by corporate bribery by Big Pharma. Plaintiffs allege that whenever a “for
cause” investigator-related FDA investigation involves a large enough number of study
drugs, defendants Z “stone-wall” and delay their investigation under the color of official
right provided by selectively enforcing the PDUFA II, motivated by the Congressionally-
sanctioned corporate bribery provided under the PDUFA II.
(52) On or about October 1, 1999 at 698 E. Wetmore Road, Suite 100, Tucson, AZ,
defendant S (Charles W. Ott) and defendant Z, directly or indirectly, corruptly gave,
offered, or promised something of value [pro bono legal “assistance” in defense of her
nursing license] to plaintiff C, with intent to influence the testimony under oath or

affirmation of plaintiff C as a witness upon a trial, or other proceeding, before any court,
or with intent to influence plaintiff C to absent herself therefrom.
(53) On or about October 1, 1999, defendant S (Charles W. Ott) and defendant Z
willfully endeavored by means of bribery [provision of “pro bono” legal services in
defense of plaintiff C’s nursing license] to obstruct, delay, or prevent the communication
of information by plaintiff C relating to serial violations of 18 USC Section 1341 and
Section 1343 by defendant O at the “Vivra” Tucson, AZ, 698 E. Wetmore Road facility
between on or about September 1, 1998 through May 12, 1999, to a criminal investigator.
Without the knowledge or consent of the plaintiffs, defendants R, S, T, U, V, O, P, and Z
agreed that defendant S’s bribery to obstruct, delay, or prevent the communication of
information by plaintiff C would further, for the purpose of executing, the scheme and
artifices to conceal and perpetuate the ongoing schemes to defraud the plaintiffs, clinical
research subjects, specialty practice patients, and two branches of the US Department of
Health & Human Services (FDA and Medicare). Please incorporate by reference the
emails of October 1, 1999, April 22, 2000, October 11, 2000, December 15, 2000, and
January 18, 2003 from plaintiff C to plaintiff A.
(54) The Prescription Drug User Fee Act (PDUFA) is a renewable congressional
enactment under which fees are paid by Big Pharma corporate entities to gain
“expedited” review of their New Drug Applications for marketing approval. The use of
the PDUFA (enactments I, II, and III) to gain expedited FDA review and market
approvals for Big Pharma corporate entities represents bribery in violation of 18 USC
Section 201.

(55) Plaintiffs allege a recurring pattern of expedited market “approvals” of New Drug
Applications by the FDA while both routine and “for cause” investigations of clinical
research establishments are often selectively “delayed” [intentionally “stone-walled”]
under the auspices of the PDUFA I and II (and now under the PDUFA III). These
expedited market approvals have occurred from 1992 (upon initial enactment by
Congress of the PDUFA) until the present and have a very real threat of continuing into
the future under the PDUFA III. The plaintiffs allege that this represents a pattern of
serial corporate bribery of FDA officials acting in both their personal and representative
capacity in violation of 18 USC Section 201 which caused direct racketeering injury,
racketeering enterprise injury, and conspiracy injury to the plaintiffs business and
property [arising out of the pattern of racketeering activity].
(56) The plaintiffs allege direct and continuing injury to their business and property,
arising out of a pattern of racketeering activity, by reason of selective enforcement of the
PDUFA II [now the PDUFA III]. The plaintiffs allege that the FDA [and OIG] criminal
investigations of defendant O’s conduct have been knowingly and willfully “stone-
walled” so as to conceal “expedited” FDA market approvals of New Drug Applications
which are based upon research by defendant O [1601 N. Tucson Blvd, 3395 N. Campbell
Ave, and 698 E. Wetmore Road, Tucson, AZ between April 22, 1997 and July 30, 1999]
and defendant Q [at 62 Hackett Blvd and 215 Washington Avenue Extension] which was
falsified, flawed, or seriously unreliable. Plaintiffs allege that similar regulatory
malfeasance by defendants Z [acting in both their personal and official capacities], has
resulted in expedited market approvals of New Drug Approvals, during or even after the
pendency of FDA investigations of other clinical investigators.

(57) FDA officials acting in both their personal and their representative capacity
(defendants Z) and the PDUFA (Prescription Drug User Fee Act, enactments II and III)
play essential roles in the on-going conspiracy by providing an appearance of legitimacy
which is virtually invisible to the public. The PDUFA also provides a statutory vehicle
for corporate bribery of the FDA by Big Pharma corporate entities. The statutory
“advantages” provided to Big Pharma corporate entities and the FDA by the PDUFA II
(recently completed its third enactment) allow them to “hide in plain sight” under color of
official right.
(58) These “expedited” market approvals represent a conflict of interest by the FDA
which, to this day, remains virtually “invisible” to the public at large. This conflict of
interest is afforded by the PDUFA II, a temporary, renewable congressional enactment,
which the plaintiffs contend is unconstitutional. This statutory enactment proximately
deprived the plaintiffs of liberty and property without the Due Process and Equal
Protection of law guaranteed by the Fifth Amendment of the U.S. Constitution.
(59) Inappropriate clinical study subject enrollment is, by definition, “reckless
endangerment”. More often than not, this endangerment is intentional, rather than simply
negligent, motivated by corporate bribery, e.g. recruitment bonuses, stock options,
“consulting” fees, ghost-written research publications, additional research studies, etc.
Reckless conduct constitutes scienter when a highly unreasonable omission, such as a
faulty informed consent or intentionally failing to disclose conflicts of interest, involving
not merely simple, or even inexcusable negligence, but an extreme departure from the
standards of ordinary care, and which presents a danger of misleading prospective

clinical research subjects that is either known to defendant O or is so obvious that
defendant O must have been aware of it.
fraud, wire fraud, obstruction of criminal investigations, bribery, and interference with
commerce by threats or violence). Defendant S (Charles W. Ott, “Vivra” General
Counsel) was always very much aware of the reasons why Defendant O (Jay Grossman,
M.D.) attacked plaintiff C’s (Joanne C. Wray, R.N., formerly Joanne C. Siegel, R.N.)
nursing licence. Both Defendant O’s attack upon plaintiff C’s nursing license and

Defendant S’s “defense” of her nursing license were calculated overt acts in furtherance
of the conspiracy, specifically the subsidiary conspiracy to conceal and perpetuate on-
going, parallel schemes of serial related clinical research frauds and Medicare frauds, i.e.
frauds against the United States, and serial related frauds against “Vivra” employees,
specialty practice patients, and clinical research subjects. Plaintiffs allege that defendants
D, E, F, O, P, R, S, T, U, V, W, X, Y, and Z, willfully and knowingly participated in
schemes to defraud the plaintiffs. Defendants did so with an intent to defraud and used or
caused to be used the U.S. mails and interstate wire communications for the purpose of
executing the schemes to defraud.
(61) During an on-going FDA inspection of Defendant O’s regulated conduct in
Albany, NY, defendant O (Jay Grossman, M.D.) took all of the Case Report Forms
moved from Albany, NY to Tucson, AZ (reference: page 3 Albany, NY FDA EIR of
1993). Carolanne Currier of the FDA gave permission to omit coverage required by the
Compliance Program 7348.811 and was told to check only the 7 CRFs received as
supporting documents to the assignment (reference: page 4 Albany, NY FDA EIR of
1993). This constitutes obstruction of justice in violation of 18 USC Section 1503 and
interstate travel in aid of racketeering enterprises in violation of 18 USC Section 1952 by
defendants O and Z. This also constitutes overt acts of conspiracy to conceal and
perpetuate ongoing schemes of clinical research fraud and insurance fraud by both
defendants O and Z. The continuity of the serial clinical research frauds and insurance
frauds was, thus, virtually seamless. There was virtually no interruption from the initial
frauds in Albany, NY in about 1984 under the name Albany Allergy and Asthma

Services at 62 Hackett Blvd to the subsequent frauds in Tucson, AZ. This smooth
transition by defendant O (Jay Grossman, M.D.) from Albany, NY to Tucson, AZ in
about January 1993, was actively (intentionally) facilitated by Big Pharma corporate
representatives [defendants Z], the FDA [defendants Z], and defendant N [Albany
Medical College]. These predicate acts of racketeering and overt acts of conspiracy to
defraud the United States caused direct conspiracy injury to the plaintiffs. Defendant O’s,
D’s, E’s, and F’s fraudulent hiring inducements (fraudulent omissions) of plaintiff A and
plaintiff C could not have occurred had they not been facilitated by defendant N [Albany
Medical College], defendant Z [Big Pharma representatives], and defendant Z [FDA
officials acting in their personal and their representative capacity], quite possibly
facilitated by the PDUFA II status of the index study drug, whose NDA (New Drug
Application) the FDA had no intention of interrupting, either “for-cause” or otherwise.
This represents an example of corporate bribery in violation of 18 USC Section 201 by
Big Pharma corporate entities of the FDA under the PDUFA II. It represents just a single
example of Congressionally-sanctioned (tolerated) corporate bribery of the FDA by Big
Pharma corporate entities. There are many such examples which are readily subject to
discovery.
(62) defendants Z [an unknown number of FDA officials acting in their personal
capacities] played a very significant role in the operation of the “Vivra” enterprise.
Importantly, defendants Z actively facilitated defendant O’s (Jay Grossman, M.D.)
relocation from Albany, NY to Tucson, AZ during an ongoing FDA investigation of
defendant O’s clinical research conduct in about January 1993. Additionally, the FDA
sponsorship and promulgation of the PDUFA I, II, and III represents willful, knowing,

intentional fraudulent commissions in support of the “Vivra” enterprise, and a willingness
(some would say eagerness) of the FDA to continue to be the recipient of corporate
bribery from their Big Pharma corporate clients.
Obstruction of state or local law enforcement in violation of 18 USC Section 1511:
false pretenses.
(64) Documents from the Albany County Clerk from Albany County Case # 2960-91,
Page 29, state “Further, at the time of trial, plaintiffs will offer the testimony of
representatives from the drug companies for whom the studies were performed who will
testify that the studies were performed properly and that there were no protocol
violations committed by Dr Grossman [defendant O]” Please reference the Reply-
Affidavit filed on December 6, 1994 by Richard Ball, M.D., Scott Osur, M.D., and David

Shulan, M.D. in Albany County Case #2960-91, Pages 10 and 11 of “Exhibit H”. Please
reference pages 28 and 29 from Albany County Case #2960-91.
c. If the RICO claim is based in the predicate offenses of wire fraud, mail
fraud, or fraud in the sale of securities, the “circumstances constituting
fraud or mistake shall be stated with particularity.” Identify the time,
place and contents of the alleged misrepresentations, and the identiy of
persons to whom and by whom the alleged misrepresentations were made;
Response:
Mail fraud in violation of 18 USC Section 1341:
(65) Serial, related fraudulent reimbursement claims [for up-coded E&M and
unnecessary procedure claims] at the “Vivra” Tucson clinical facility are believed to have
been customarily [by custom] communicated by defendants O, R, and V to (a) fiscal
intermediaries and 3rd party payors, (b) “Vivra” corporate entities [defendants D, E, F,
and J], (c) “Vivra” persons [defendants U, W, X, Y, and Z], and ultimately to (d) the U.S.
Department of Health and Human Services [including Medicare], by use of the US mails
and interstate wire communications, for the purpose of executing the scheme to defraud.
This use of the US mails and interstate wire communications for the purpose of
executing the scheme to defraud occurred at the “Vivra” Tucson facility [3395 N.
Campbell Avenue and 698 E. Wetmore Road, Suite 100 locations] from on or about
September 1, 1998 through on or about July 29, 1999. The exact dates of these serial
related frauds are presently unknown to plaintiffs A and B because of the defendant’s
fraudulent concealment and conspiracy to conceal and perpetuate the on-going frauds.

(65) Defendants O, P, D, E, F, R, S, T, U, V, W, X, Y, and Z made various untrue
statements of material fact and omitted to state other material facts, by use of the United
States mails and interstate wire communications, which they had a fiduciary duty to
disclose, necessary in order to make the statements made, in light of the circumstances
under which they were made, not misleading to plaintiffs, all in violation of 18 USC
Section 1341 (wire fraud) and 18 USC Section 1343 (mail fraud), the purpose and effect
of which was to cause plaintiff A and plaintiff C to enter into an employment relationship
with the defendants, and subsequently to cause plaintiff A and plaintiff C to retain their
employment relationship with defendants O, D, E, and F. These various untrue
statements of material fact and omissions of material facts were made with the intent to
deceive plaintiffs A and C. Plaintiffs A, B, and C relied on these misrepresentations and
omissions, and plaintiffs A, B, and C were justified in their reliance. As a direct result of
these fraudulent misrepresentations and omissions, through a pattern of racketeering
activity, plaintiffs A, B, and C have suffered damages to their business and property
arising out of the pattern of racketeering activity.
(66) The ZERO TOLERANCE POLICY memo and Employee Handbook which were
mailed by defendant D to plaintiff A during the recruitment and hiring process on or
about July through September 1998 were intentional misrepresentations, fraudulent
concealments, constructive fraud, as well as mail fraud in violation of 18 USC Section
1341, which was intended by the defendants O, R, S, T, U, W, X, Y, D, E, F, and Z to
mislead plaintiff A, and which was reasonably relied upon by plaintiff A, and directly
resulted in injury to plaintiff A’s business and property, which arose out of the pattern of
racketeering activity.. Defendants O, R, S, T, U, D, E, F, W, X, Y, and Z made false

representations of material facts to plaintiff A when they mailed him the ZERO
TOLERANCE POLICY memo and the Employee Handbook. Defendants knew that the
representations of a safe and ethical workplace were false, or the representations were
made with such reckless disregard for the truth that knowledge of the falsity of the
statements can be imputed to the defendants. Defendants willfully and knowingly made
the false representations for the purpose and with the intent of defrauding the plaintiffs.
Plaintiffs relied with justification upon the misrepresentation. Plaintiffs suffered damages
as a direct result of the reliance upon the misrepresentations. Plaintiffs allege the
existence of a legal or equitable duty owed by the defendants to the plaintiffs. Plaintiffs
reallege that a fiduciary duty existed between the plaintiffs and the defendants. Plaintiffs
allege a duty to disclose material facts by the defendants. Plaintiffs allege a failure to
disclose material facts by the defendants, by conduct which deceives or violates a
confidence or injures the public interest. The defendants intended to deceive the
plaintiffs, knowing that the plaintiffs would act in a different manner had plaintiffs
known of the existence of the undisclosed facts. The plaintiffs acted in justifiable reliance
upon the concealments. The plaintiffs suffered damages as a direct result of the
concealments.
(67) Defendant S’s letter to plaintiff A of May 28, 1999 is categorically false when it
states “Contrary to allegations in your May 17 letter to Joe Mello, you did not
communicate any concerns to Vivra management until Pamela Gaard conducted the audit
of the Practice. It is unfortunate that, if you had concerns prior to such date, you did not
bring them to our attention.” Plaintiff A affirms that he brought his concerns to the

attention of “Vivra” Tucson management on at least three separate occasions prior to Ms.
Gaard’s audit.
(68) Defendant S (Charles W. Ott, “Vivra” General Counsel) perjured himself by
signing “NO” to question re: any >20% shareholder having been subject to sanctions by
regulatory or federal body (see Arizona Corporate Commission Annual Report filing for
1999). This overt act represents a predicate act violation within the meaning of 18 USC
Section 1961 (mail fraud) which had a “lulling” effect on both prospective and current
“Vivra” employees, prospective and current clinical research subjects, prospective and
current specialty practice patients, prospective and current Big Pharma corporate research
sponsors, and the U.S. Department of Health and Human Services, including Medicare.
Defendant S willfully and knowingly participated in schemes to defraud the plaintiffs.
Defendant S did so with an intent to defraud and used or caused to be used the U.S. mails
Plaintiffs allege that defendant S has committed two or more predicate acts including
violations of the mail fraud and wire fraud statutes.
(69) The plaintiffs allege that integral to the central conspiracy to defraud [involving
ongoing parallel schemes of clinical research fraud, insurance fraud, and concealment]
were the many fraudulent hiring and retention inducements by defendants D, E, F, R, S,
T, U, V, W, X, Y, O, P, and Z upon plaintiff A, plaintiff C, and the “Vivra” clinical
research staff. These fraudulent hiring and retention inducements were accomplished by
fraudulent omissions, fraudulent concealments, breaches of fiduciary duty, constructive
frauds, internet frauds, wire frauds, and mail frauds. The defendants allege that
defendants D, E, F, R, S, T, U, V, W, X, Y, O, P, and Z, willfully and knowingly

participated in schemes to defraud the plaintiffs. Defendants did so with an intent to
defraud and used or caused to be used the U.S. mails and interstate wire communications
for the purpose of executing the schemes to defraud.
(70) Plaintiff A, plaintiff C, and each of the clinical research coordinators at the Vivra
Tucson clinical facility at 698 E. Wetmore Road, Suite 100, Tucson, AZ, from September
1, 1998 through May 11, 1999, were both witnesses and victims of serial related acts of
extortion and fraud (interference with commerce by threats or violence in violation of 18
USC Section 1951, mail fraud 18 USC Section 1341, and wire fraud 18 USC Section
1343, in a pattern of racketeering activity) by defendants O, P, R, S, T, U, V, W, X, Y,
and Z. Please incorporate by reference plaintiff A’s first and second reports to the
Arizona State Board of Medical Examiners of December 22, 2000 and March 5, 2001.
(71) Defendants O and Q are alleged by information and belief to have been involved in a sister
study to the Sepracor 051 study in Albany, NY. Please reference allegation #49 in plaintiff A’s
report of March 5, 2001 to the AZ BOMEX. A series of 6 chest radiographs came to the attention of
a PPD study auditor wherein each of the chest radiographs had a particular surgical clip in the
shoulder region of each radiograph. These radiographs were allegedly misrepresented as being the
radiographs of 6 different research subjects. The plaintiffs allege an agreement to defraud and a
scheme to defraud by defendants O and Q. Their intent was to inappropriately enroll additional
clinical research subjects for their personal financial gain. Big Pharma corporate sponsors provide
large financial incentives for achieving study subject enrollment “milestones”. Their intent can be
inferred from the scheme itself. Please reference FDA Albany, NY EIR of 10/22-12/23/97, pages 1
and 2. Plaintiffs allege that the data upon which the FDA based the expedited market approvalsof
levoalbuterol on 3/25/99 and 1/30/02 was falsified, flawed, or seriously unreliable. The plaintiffs

allege that the findings presented by the FDA in the FDA Albany, NY EIR of 10/22-12/23/97, are
grounds for a criminal fraud indictment. Plaintiffs allege that defendants O, Q, and Z, agreed to
commit, or cause to be committed, or attempt, or aid and abet this falsification of research data in
order to increase their study subject enrollment so as to please their corporate research sponsor. By
practice and custom, one may assume the defendants O, Q, and Z, employed, cause to be employed,
or attempted, or aided and abetted, the U.S. mails or interstate wire communications in furtherance
of this scheme to defraud.
(72) There was considerable cross-over between specialty practice patients, many of
whom were Medicare beneficiaries, and clinical study subjects at the “Vivra” Tucson
facility. The plaintiffs allege that multiple instances of unnecessary procedures (to wit,
prescreens for study participation) and upcoding of E&M (evaluation and management)
claims submitted to 3rd party payors (including Medicare) took place at the “Vivra”
Tucson facility at 698 E. Wetmore Road, Suite 100, Tucson, AZ from September 1, 1998
through May 12, 1999 by defendants D, E, F, O, P, R, T, U, and V. These two parallel
schemes or artifices to defraud (upcoding and unnecessary procedures) took place serially
and made routine use [as is customary] of the mails and interstate wire communications
in furtherance of the schemes, in violation of 18 USC Section 1341 and Section 1343.
(73) Plaintiffs allege that most of defendant O’s clinical research publications were
“ghost-written” by his Big Pharma corporate sponsors. These multiple “ghost-written”
publications constitute serial related mail frauds promulgated by defendants O, D, E, F,
and Z (including Big Pharma corporate entities, presently unnamed by plaintiffs) in
violation of 18 USC Section 1341. These fraudulently “written” publications also
constitute fraudulent hiring and retention inducements, as well as fraudulent omissions

for failure to disclose [their true authorship] where there was a duty to disclose. The
plaintiffs suffered direct injury to their business and property [arising out of the pattern of
racketeering activity] due to these fraudulent inducements and these fraudulent
omissions.
(74) The plaintiffs allege numerous fraudulent hiring and retention inducements
representing fraudulent omissions (fraudulent concealment) and fraud in the inducement
of contract by defendants D, E, F, O, P, R, S, T, U, V, W, X, Y, and Z, which caused
direct injury to the plaintiffs business and property, arising out of the pattern of
racketeering activity. Plaintiffs allege that defendants D, E, F, O, P, R, S, T, U, V, W, X,
Y, and Z, willfully and knowingly participated in schemes to defraud the plaintiffs.
Defendants did so with an intent to defraud and defendants used or caused to be used the
U.S. mails and interstate wire communications for the purpose of executing the schemes
to defraud. These many related, constructive frauds, fraudulent omissions, fraudulent
concealments, fraudulent inducements of “Vivra” employees, clinical research staff, and
specialty practice patients represent a pattern of racketeering activity within the meaning
of 18 USC Section 1961 et seq, in violation of 18 USC Section 1341 (mail fraud) and
Section 1343 (wire fraud). Most of them occurred at 698 E. Wetmore Road, Suite 100,
Tucson, AZ between on or about May 11, 1998 and on or about February 5, 2001.
(75) Plaintiffs allege that defendant O serially upcoded E&M claims and coded for
unnecessary procedures which were submitted to 3rd party payors, including Medicare, by
defendants D, E, F, R, U, V, J, and Z at 698 E. Wetmore Road between September 1,
1998 and May 12, 1999.

(76) Please reference Allegation # 8 and #9 on page 13 and 14 from plaintiff A’s
second report to the Arizona State Board of Medical Examiners of 3/5/2001 which states
on Paragraph 3, Page 13 “…Subject stated to SI [sub-investigator, plaintiff A] on clinic
visit 3/26/99 that she had ‘never been informed by PI [principal investigator, defendant
O] of any abnormal EKG’s’ Subject’s prior EKG of 5/30/98 shows T abnormality in
inferior leads to have been crossed-out by PI and WNL (within normal limits) written.
PI continued to screen subject at several subsequent visits even after subject’s EKG
abnormalities (both present and prior EKG’s) were brought to the PI’s attention AND
despite safety concerns having been expressed to the PI by the SI.”
(77) Plaintiffs allege that there existed a legal or equitable duty between study subject Mary H.
Joyce DOB 5-23-53 and defendant O. Defendant O breached that duty by conduct which deceived
or violated a confidence or injures the public interest, when defendant O crossed out T abnormality
in inferior leads and wrote WNL (within normal limits) on study subject’s EKG of 5/30/98,
motivated by his desire to personally profit (substantial and direct financial reward) by serially
enrolling her in clinically research studies, despite clear knowledge that her EKG was abnormal.
Plaintiffs allege that this scheme or artifice to defraud was employed serially by defendant O to
enroll this study subject in the Glaxo-Wellcome FLTA 4039 study on or about 2-10-99, and again
when defendant O enrolled her in Pfizer 264-101 on or about 3/26/99 at the “Vivra” 698 E.
Wetmore Road, Suite 100, Tucson, AZ facility. Thus, defendant O’s motive, methods, and type of
victim were similar [identical] for these two frauds. Plaintiffs allege that it is routine and customary
for EKG data, such as that obtained on 5/30/98 and on 3/15/99 to be placed, directly or indirectly,
into the US mail and interstate wire communications. Plaintiffs allege that defendant O knowingly

and willfully made use of the US mails and interstate wire communications for the purpose of the
alleged crimes.
(78) Please reference Allegation # 13 on Paragraph 3, Page 16 of plaintiff A’s second
report to the Arizona State Board of Medical Examiners on 3/5/2001. Plaintiff A alleges
that these acts by defendant O represent intentional endangerment of a clinical research
subject, motivated by defendant O’s desire for personal financial gain, constructive fraud,
mail fraud, and wire fraud. Plaintiffs allege that defendant O had a fiduciary relationship
with plaintiff A arising out of a relationship of confidence and trust. Defendant O
breached that duty, by conduct which deceives or violates a confidence or injures the
public interest. Plaintiffs allege that defendant O, in agreement and in concert with
defendants D, E, F, P, R, S, T, U, V, W, X, Y, and Z, willfully and knowingly
participated in a scheme to defraud the plaintiffs and clinical research subjects.
Defendants did so with an intent to defraud and used the U.S. mails or interstate wire
communications for the purpose of executing the scheme to defraud, motivated by desire
for personal financial gain.
(79) Plaintiff A alleges that study subject Sylvia M. Lancaster was intentionally
endangered by defendant O for direct financial gain by means of fraudulently inducing
her to participate in Hoechst Marion Roussel acute sinusitis study. Please reference
Allegation #15 on pages 17 and 18 of plaintiff A’s second report to the Arizona State
Board of Medical Examiners of 3/5/2001. Please reference Paragraph 4, Page 2 and
Paragraph 1, Page 3 of the 3-page affirmation of former Vivra Tucson clinical research
coordinator, Linda (LeBlanc) Buer on November 28, 2000. Plaintiffs allege that
defendant O, in agreement and in concert with defendants P, R, S, T, U, V, W, X, Y, D,

E, F, and Z, willfully and knowingly participated in a scheme to defraud the plaintiffs.
Defendants did so with an intent to defraud and used the U.S. mails and interstate wire
communications for the purpose of executing the scheme to defraud.
(80) The Affidavit from “Exhibit H” by Drs. Ball, Shulan, and Osur in Albany County
Case # 2960-91 was filed on December 6, 1994. This Affidavit alleges that defendant O
has employed fraud, intentional endangerment of clinical research subjects, and violence
in Albany, NY [from from a date in the 1980’s presently unknown to the plaintiffs
through on or about December 6, 1994] at 62 Hackett Blvd. to achieve his objectives,
motivated by avarice.
(81) Defendants O, R, D, E, F, and Z libeled and slandered plaintiff A and Arnold
Funckes, M.D. on or about August 1999 in Tucson, AZ by use of the US mails and
interstate wire communications in connection with the scheme or artifice to defraud by
libel and slander, when “Dr. Grossman [defendant O] had sent letters to all the drug
companies and insurance companies that Vivra bills printing a grey picture of you
[plaintiff A] and Dr. Funckes. Trying to put the blame on you two and how you walked
out of the office and left patients that were waiting to be seen…a copy of these letters
were put in the regulatory binders [at the Vivra Tucson facility of defendant F]”. These
acts attempted to shift blame, and did in fact shift blame, from defendants O, P, R, D, E,
F, J, K, L, S, T, U, V, W, X, Y, and Z to plaintiff A and Arnold Funckes, M.D., enabling
the defendants to rehabilitate defendant O’s reputation at the expense of his victims, and
enabling the defendants O, P, R, S, T, U, V, W, X, Y, D, E, F, J, K, L, and Z to continue
in their parallel schemes of insurance fraud and clinical research fraud. These schemes
are on-going. The plaintiffs allege that defendants D, E, F, O, P, R, S, T, U, V, W, X, Y,

(82) Defendants O, P, D, E, F, R, S, T, U, V, W, X, Y, and Z fraudulently concealed
from plaintiffs material facts giving rise to the cause of action by plaintiffs. Please
reference the Second and Third Counts of this complaint. As a result, plaintiffs have not
yet discovered the true state of affairs. Under the circumstances, plaintiff's ignorance of
his cause of action prior to about February 20, 2001 is reasonable in that plaintiff A did
not have a copy of the FDA Tucson EIR of 5/5-6/28/99 until on or about February 20,
2001. Please reference Paragraph 1, Page 1 of the FDA Tucson EIR or 5/5-6/28/99
which states “This inspection report was delayed due to a PDUFA report.”
(83) The plaintiffs allege that integral to the subsidiary conspiracy to conceal and perpetuate
ongoing parallel schemes of clinical research fraud and insurance fraud, were many fraudulent
hiring and retention inducements by defendants D, E, F, W, X, Y, O, R, S, T, and U, upon plaintiffs
A and C between on or about July 15, 1998 and on or about May 17, 1999 at 698 E. Wetmore Road,
Suite 100, in Tucson, AZ. These fraudulent hiring and retention inducements were accomplished
with constructive frauds, fraudulent omissions, fraudulent concealments, breaches of fiduciary duty,
internet frauds, wire frauds, and mail frauds. The plaintiffs allege that defendants D, E, F, W, X, Y,
O, R, S, T, U, and Z, willfully and knowingly participated in schemes to defraud the plaintiffs [as
described above], the defendants did so with an intent to defraud, and used or caused to be used the
U.S. mails and interstate wire communications for the purpose of executing the schemes to defraud.

false pretenses.
(85) Plaintiffs A and B allege injury to their business and property [arising out of the
pattern of racketeering activity which violates the substantive RICO statute 18 USC
Section 1962 (c)] as a direct result of defendant’s numerous fraudulent hiring and
retention inducements (e.g., multiple frauds in the inducement and retention of contract
by use of the mails and wire), constructive frauds, fraudulent omissions, fraudulent
concealments, wire frauds, mails frauds, and internet frauds between on or about 5/11/98
until on or about 2/5/01. Please incorporate by reference the Arizona Corporation
Commission Annual Report filings of May 11, 1998, June 5, 1998, April 14, 1999, April
23, 1999, November 30, 2000, February 5, 2001 wherein defendants S, W, X, and Y
signed “NO” to certificate of disclosure # 10 (3), which represent some, but not all, of the
fraudulent inducements. Plaintiffs A and B relied to their substantial detriment on the
Certificates of Disclosures found in these Arizona Corporation Commission filings.
Plaintiffs allege that defendants D, E, and F, adopted, as a regular way of doing the

enterprise’s business, the routine use of perjured Certificates of Disclosures to the
Arizona Corporation Commission. Defendants D, E, and F, regularly employed the use of
the U.S. mails to further the scheme or artifice to defraud plaintiff A.
(86) Plaintiffs A and B allege numerous uses of the U.S. mails and interstate wire
communications by Aaron Risen, Maylene Nafrada, and various other representatives of
Vivra Inc [defendant D] to recruit plaintiff A from on or about July 15, 1998 until on or
about September 1, 1998. Plaintiffs allege that these mailings and interstate wire
communications were fraudulent misrepresentations [fraudulent omissions] intended to
induce the contract of plaintiff A with defendant D. Plaintiffs A and B relied to their
substantial detriment on these fraudulent hiring inducements. Plaintiffs allege that
defendants O, D, E, and F had adopted, as a regular way of doing the enterprise’s
business, the routine use of fraudulent hiring and retention inducements in order that they
might induce the contract of highly qualified employees to fill certain key positions.
Defendants D, E, F, and O made regular use of the U.S. mails and interstate wire
communications to further their scheme or artifice to defraud plaintiff A. The fraudulent
hiring and retention of plaintiff A was a critical part of the scheme to defraud clinical
research subjects, specialty practice patients, and the United States Department of Health
and Human Services. A sub-investigator of plaintiff A’s experience and qualifications
lended luster and credibility to the operation of the Tucson branch of the “Vivra”
enterprise. Moreover, having a sub-investigator experienced in both clinical research and
in the medical care of patients, provided the practical means by which defendant O could
regularly travel interstate in aid of the “Vivra” racketeering enterprise between
September 1, 1998 and May 12, 1999.

(87) Plaintiffs A and B allege that the July 15, 1998 issue of the Tucson Citizen
contained the initial fraudulent hiring inducements that “led plaintiff A to defendant O’s,
D’s, E’s, and F’s door”. Plaintiffs allege that this newspaper ad was one of several initial
fraudulent inducements [fraudulent misrepresentations and omissions] intended by
defendants D, E, F, and O, to be relied upon by plaintiff A. Plaintiffs A and B relied to
their substantial detriment on these fraudulent hiring inducements. Plaintiffs re-allege that
defendants O, D, E, and F had adopted, as a regular way of doing the enterprise’s
business, the routine use of fraudulent hiring and retention inducements in order that they
might induce the contract of highly qualified employees to fill certain key positions.
(88) From Tucson FDA-483 (Inspectional Observations) of 6/28/99: “Regarding study
subject MMD [Marlys Mae Duchene DOB 1-8-44 in Forest Labs 01 study], study subject
was enrolled in study by PI despite subject having history of multiple prior abnormal
EKG’s, loud murmur, history of RBBB, and rheumatic fever. Subject’s medical history
questionnaire shows subject history of rheumatic fever to be crossed-out and PI assertion
on 11/25/98 that subject now states that she did have rheumatic fever as a child.” This
clinical research subject was, thus, intentionally endangered by defendant O, motivated
by personal financial gain. Defendant O had [apparently] crossed-out this subject’s
history of rheumatic fever, realizing that rheumatic fever was an exclusion criteria for
nearly all asthma studies. Defendant O did not make the written assertion that “subject
now states that she did have rheumatic fever as a child” until after defendant O had
learned that plaintiff A had become aware of this research subject’s loud heart murmur,
abnormal EKG’s, and her history of rheumatic fever.

(89) Page 1, Allegation #7 from plaintiff A’s second report to the Arizona State Board
of Medical Examiners states “Study subject MMD [Marlys Mae Duchene DOB 1-8-44]
was improperly enrolled by the PI into the Novartis E25 asthma study on 10/6/98. Not
only did this subject have history of rheumatic fever (a clear study exclusion for nearly
any asthma study), but she also had a history of pulmonary embolism (another clear
study exclusion for nearly any asthma study).” This clinical research subject was, thus,
serially intentionally endangered by defendant O, motivated by personal financial gain.
Ms Duchene was a so-called “study buddy” of defendant O’s. A “study buddy” is
typically a former specialty practice patient who is enrolled serially by defendant O in
one clinical research study afer another.
(90) From Tucson FDA-483 (Inspectional Observations) of 6/28/99: “Regarding
subject MHJ [Mary H. Joyce DOB 5-23-53 in the Pfizer 264-101 study], subject was
enrolled in study by PI despite subject having multiple CAD risk factors (45 y/o BF with
HTN, hyperlipidemia, family hx MI) and prior abnormal EKG’s. Subject stated to SI on
clinic visit 3/26/99 that she had “never been informed by PI of any abnormal EKG’s”.
Subject’s prior EKG of 5/30/98 shows T abnormality in inferior leads to have been
crossed-out by PI and WNL written. PI continued to screen subject at several subsequent
visits even after subject’s EKG abnormalities (both present and prior EKG’s) were
brought to the PI’s attention AND despite safety concerns having been expressed to the
PI by the SI.” This clinical research subject was, thus, intentionally endangered by
defendant O, motivated by personal financial gain.
(91) Page 2, Allegation #9 from plaintiff A’s second report to the Arizona State Board
of Medical Examiners states “Study subject MHJ [Mary H. Joyce DOB 5-23-53] was

improperly enrolled by the PI into the Glaxo-Wellcome FLTA 4039 study on 2-10-99.
Since she was never informed by the PI of her inferior T wave abnormality (recall that
the PI had crossed-out the inferior T wave abnormality and written WNL on her EKG of
5-30-98), she could not have been consented properly relative to the possibility of
increased safety risk in participating in the FLTA 4039 study on 2-10-99.” This clinical
research subject was, thus, serially intentionally endangered by defendant O, motivated
by personal financial gain. Ms Joyce was another so-called “study buddy” of defendant
O’s.
(92) From Tucson FDA-483 (Inspectional Observations) of 6/28/99: “PI enrolled
subject SML [Sylvia M. Lancaster DOB 5-7-44 into Hoechst Marion Roussel 3647A/3005
acute sinusitis study] despite subject having a clear study exclusion (maintenance inhaled
corticosteroid therapy). Subject subsequently experience SAE (Serious Adverse Event:
hospitalized) while in the study. Moreover, this subject had recently participated in a
prior asthma study [Zeneca 088] during which she required multiple prednisone bursts
and multiple courses of antibiotic therapy for several bouts of acute sinusitis with asthma
exacerbation.” This clinical research subject was, thus, intentionally endangered by
defendant O, motivated by personal financial gain. Ms Lancaster was another so-called
“study buddy” of defendant O’s.
(93) From Tucson FDA EIR (Establishment Inspection Report) of 5/5-6/28/99: Page 3:
Paragraph 7: “Included as Exhibit 11.00-11.07 are signed affidavits from coordinator EJ
[Eric Johansen], LH [Laura Hulse], and MC [Myra Coffman]. All three affiants stated
that they have seen Dr JG postdate records.”

(94) From Tucson FDA EIR (Establishment Inspection Report ) of 5/5-6/28/99: Page
3, Paragraph 6: “Two coordinators in their affidavits stated that they saw the diary card
of patient [probably Kathleen Mauro in the SKB 006 study] with the missing values prior
to patient and Dr JG going into examination room.” This clinical research subject was,
thus, intentionally endangered by defendant O, motivated by personal financial gain.
(95) From Tucson FDA EIR (Establishment Inspection Report) of 5/5-6/28/99: Page 3,
Paragraph 7: “Coordinator LH [Laura Hulse] stated that in regard to patient [probably
Juliet Cristina Granger DOB 5-22-73] in the [Glaxo Wellcome 40003] study the diary
card was observed to have values recorded. After the exam Dr JG called the Sponsor to
ask for a deviation to allow patient to change scores on the diary card. Permission was
given.” This clinical research subject was, thus, intentionally endangered by defendant
O, motivated by personal financial gain. Defendant O was known by the Vivra Tucson
clinical research staff to often call the Big Pharma corporate sponsors asking for, and
being granted, “exemptions” for study subjects who would otherwise be disqualified.
Defendant O was rarely, if ever, denied his requests for “exemptions” by the Big Pharma
corporate research sponsor..
(96) From Tucson FDA-483 (Inspectional Observations) of 6/28/99: Item #39:
“Coordinator [Laura Hulse] stated that subject BJD [redacted] called to say she could
not participate in a 12-hour a day study due to her schedule. P.I. called the subject’s
estranged husband to say that they had to get the disease under control. Coordinator
says the doctor then called subject BJD [ ] who agreed to complete the screening visit.”
This clinical research subject was, thus, intentionally endangered by defendant O,
motivated by personal financial gain.

(97) From Tucson FDA EIR (Establishment Inspection Report) of 5/5-6/28/99: Page
13: Paragraph 8: “Dr Grossman stated that he called the patient and the husband
answered at which time he instilled the need for his wife to be part of this study. The
patient later agreed to participate.”
Wire fraud in violation of 18 USC Section 1343:
(98) Plaintiffs allege fraudulent hiring and retention inducements previously found at
each of three “Vivra” internet websites on January 4, 2001 at 7:41 AM, on January 19,
2001 at 5:35 PM, and January 19th, 2001 at 5:49 PM (www.vaaca.com, www.vaai.com,
and www.vivra.com, respectively). These three internet websites are presently defunct or
non-existent. Each of these internet-based hiring inducements by defendants D, E, F, and
Z fraudulently misrepresented defendant O in the inducement [as though he were still
with the practice] even though defendant O had been terminated “for cause” by
defendant D on July 30, 1999. These internet-based hiring and retention inducements also
fraudulently misrepresented a long since defunct Arizona corporate entity by the name of
Allergy Care Consultants, Ltd. Thus, for nearly two years after defendant O’s termination
“for cause” by defendant D on July 30, 1999, defendants D, E, F and Z continued to
promote defendant O’s Tucson practice. Each of these inducements state “Allergy Care
Consultants, Ltd, located in the beautiful city of Tucson, AZ, one of the busiest clinical
research practices in the west, desires to add a physician…” [as though the practice was
still in existence]. Plaintiffs allege that these fraudulent inducements at the various
“Vivra” websites (defendants D, E, and F, each had its own website) were accessible to
the plaintiffs, the general public, including prospective and current employees,
prospective and current research subjects, prospective and current specialty practice

patients, prospective and current corporate research sponsors, and prospective and current
3rd party payors, such as Medicare. The defendants D, E, F, and Z intended for these
long-standing fraudulent hiring and retention inducements to have, and they did in fact
have, a “lulling” effect on the plaintiffs, clinical research subjects, specialty practice
patients, “Vivra” employees, and 3rd party insurance payors. Please reference the
Arizona Corporation Commission filings which show that Allergy Care Consultants, Ltd
changed its name to Allergy Care Consultants, Inc on April 22, 1997 and Allergy Care
Consultants, Inc was administratively dissolved on April 9, 1999. Please reference the
Notice of Termination letter of July 29, 1999 from defendant D to defendant O.
(99) Serial, related fraudulent reimbursement claims [for up-coded E&M and
unnecessary procedure claims] at the “Vivra” Tucson clinical facility are believed to have
been customarily [by custom] communicated by defendants O, R, and V to (a) fiscal
intermediaries and 3rd party payors, (b) “Vivra” corporate entities [defendants D, E, F,
and J], (c) “Vivra” persons [defendants U, W, X, Y, and Z], and ultimately to (d) the U.S.
Department of Health and Human Services [including Medicare], by use of the US mails
and interstate wire communications, for the purpose of executing the scheme to defraud.
This use of the US mails and interstate wire communications for the purpose of
executing the scheme to defraud occurred at the “Vivra” Tucson facility [3395 N.
Campbell Avenue and 698 E. Wetmore Road, Suite 100 locations] from on or about
September 1, 1998 through on or about July 29, 1999. The exact dates of these serial
related frauds are presently unknown to plaintiffs A and B because of the defendant’s
fraudulent concealment and conspiracy to conceal and perpetuate the on-going frauds.

(100) Please incorporate by reference the email of December 15, 2000 from plaintiff C
to plaintiff A, wherein she states “As for the upcoding, it’s a fact for anyone to see. All
office visits were billed exactly the same, without exception.” “As for unnecessary
procedures,…did I think that every person needed a PFT [pulmonary function test] every
visit? No.” Plaintiffs allege that Jack Pinnas, M.D. (Tucson, AZ) and David Shulan, M.D.
(Albany, NY) are witnesses of unnecessary procedures by defendant O in Albany, NY
and Tucson, AZ. Please also incorporate by reference emails of October 1, 1999, April
22, 2000, October 11, 2000, and January 18, 2003 from plaintiff C to plaintiff A.
(101) Defendants O, P, D, E, F, R, S, T, U, V, W, X, Y, and Z made various untrue
statements of material fact and omitted to state other material facts, by use of the United
States mails and interstate wire communications, which they had a fiduciary duty to
disclose, necessary in order to make the statements made, in light of the circumstances
under which they were made, not misleading to plaintiffs, all in violation of 18 USC
Section 1341 (wire fraud) and 18 USC Section 1343 (mail fraud), the purpose and effect
of which was to cause plaintiff A and plaintiff C to enter into an employment relationship
with the defendants, and subsequently to cause plaintiff A and plaintiff C to retain their
employment relationship with defendants O, D, E, and F. These various untrue
statements of material fact and omissions of material facts were made with the intent to
deceive plaintiffs A and C. Plaintiffs A, B, and C relied on these misrepresentations and
omissions, and plaintiffs A, B, and C were justified in their reliance. As a direct result of
these fraudulent misrepresentations and omissions, through a pattern of racketeering
activity, plaintiffs A, B, and C have suffered damages to their business and property
arising out of the pattern of racketeering activity. Please incorporate by reference the

fraudulent hiring and retention inducements found at each of three “Vivra” internet
websites (www.vaaca.com, www.vaai.com, and www.vivra.com) on January 4, 2001 at
7:41 AM, on January 19, 2001 at 5:35 PM, and January 19th, 2001 at 5:49 PM.
(102) Please reference internet website download from defendant D’s website on April
2, 2001 which indicates that “Vivra” physicians are credentialed in accordance with
NCQA standards. This represents a material misrepresentation, fraudulent
misrepresentation, constructive fraud, and wire fraud in violation of 18 USC Section
1343. The agreement by defendants N, Q, O, P, T, S, U, D, E, F, W, X, Y, and Z to
“hire” defendant O was based on considerations totally independent of NQCA standards.
Please incorporate by reference the Notice of Termination letter of July 29, 1999 from
defendant D to defendant O.
(103) At all relevant times and in furtherance of and for the purposes of executing the
scheme and artifices to defraud and to obtain money by false pretenses, defendants D, E,
F, and Z on numerous occasions, used and caused to be used wire communications in
interstate commerce, by both making and causing to be made wire communications, each
such use of a wire communication in connection with the schemes and artifices to defraud
and obtain money by means of false pretenses constituting a separate and distinct
violation of 18 USC Section 1343 (wire fraud). The defendants D, E, F, and Z intended
for long-standing, internet-based fraudulent hiring and retention inducements to have, and
they did in fact have, a “lulling” effect on the plaintiffs, various other “Vivra”
employees, clinical research subjects, and specialty practice patients. Please reference
the fraudulent hiring and retention inducements found at each of three “Vivra” internet
websites (www.vaaca.com, www.vaai.com, and www.vivra.com) on January 4, 2001 at

7:41 AM, on January 19, 2001 at 5:35 PM, and January 19th, 2001 at 5:49 PM. Please
reference the Arizona Corporation Commission filings which show that Allergy Care
Consultants, Ltd changed its name to Allergy Care Consultants, Inc on April 22, 1997
and Allergy Care Consultants, Inc was administratively dissolved on April 9, 1999.
Please reference the Notice of Termination letter of July 29, 1999 from defendant D to
defendant O.
(104) The long-standing fraudulent inducements at three different “Vivra” internet
websites (www.vaaca.com, www.vaai.com, and www.vivra.com) had a “lulling” effect
on prospective and current “Vivra” employees, prospective and current specialty practice
patients, prospective and current clinical research subjects, prospective and current Big
Pharma corporate research sponsors, and prospective and current 3rd party payors such as
Medicare. These internet-based fraudulent inducements constitute overt acts of the
central RICO conspiracy to defraud the United States [via parallel schemes of clinical
research fraud and Medicare fraud], and defraud “Vivra” employees, specialty practice
patients, and clinical research subjects. These fraudulent inducements also constitute
predicate acts of racketeering (wire fraud) within the meaning of 18 USC Section 1961.
(105) Plaintiffs allege that defendant O serially upcoded E&M claims and coded for
unnecessary procedures which were submitted to 3rd party payors, including Medicare, by
defendants D, E, F, R, U, V, J, and Z at 698 E. Wetmore Road between September 1,
1998 and May 12, 1999. These acts represent represent mail fraud, wire fraud, fraudulent
misrepresentation, constructive fraud, and breach of fiduciary duty. Plaintiffs had a
relationship of confidence and trust [i.e., a fiduciary relationship] with defendants O, P,
D, E, F, J, R, S, T, U, V, W, X, Y, and Z at 698 E. Wetmore Road from on or about

September 1, 1998 through on or about May 11, 1999. Plaintiffs allege the existence of a
legal or equitable duty arising out of a relationship where trust and confidence exist
between defendants O, D, E, F, J, P, R, S, T, U, V, W, X, Y, and Z and the plaintiffs.
Plaintiffs allege a breach of that duty, by conduct which deceives or violates a confidence
or injures the public interest. Plaintiffs allege that defendants O, P, D, E, F, J, R, S, T, U,
V, W, X, Y, and Z willfully and knowingly participated in a scheme to defraud the
plaintiffs, Vivra employees, clinical research subjects, specialty practice patients, and the
United States. Defendants did so with an intent to defraud, and used the U.S. mails or
interstate wire communications for the purpose of executing the scheme to defraud.
Plaintiffs allege that defendants O, D, E, F, J, P, R, S, T, U, V, W, X, Y, and Z conspired
to commit, or agreed to commit, or attempted to commit, or conspired to cause to be
committed, or aided and abetted, directly or indirectly, this scheme of serial mail and
wire frauds, through a pattern of racketeering activity.
(106) Page 13, Paragraph 8 of the Tucson FDA EIR of 5/5-6/28/99 states “Dr Grossman
[defendant O] stated that he called the patient and the husband answered at which time he
instilled the need for his wife to be part of this study. The patient later agreed to
participate.” However, Page 13, Paragraph 7 of the Tucson FDA EIR of 5/5-6/28/99
states “Coordinator [Laura Hulse, former Vivra Tucson clinical research study
coordinator] stated that subject [redacted by FDA] called to say she could not participate
in a 12-hour a day study due to her schedule. P.I. [principal investigator, defendant O]
called the subjects estranged husband to say that they had to get the disease under control.
Coordinator says the doctor then called subject [redacted by FDA] who agreed to
complete the screening visit. See affidavit of LH [Laura Hulse] for this record.”

(107) Page 13, Paragraph 8 of the Tucson FDA EIR of 5/5-6/28/99 states “Dr Grossman
[defendant O] stated that he called the patient and the husband answered at which time he
instilled the need for his wife to be part of this study. The patient later agreed to
participate.” However, Page 13, Paragraph 7 of the Tucson FDA EIR of 5/5-6/28/99
states “Coordinator [Laura Hulse, former Vivra Tucson clinical research study
coordinator] stated that subject [redacted by FDA] called to say she could not participate
in a 12-hour a day study due to her schedule. P.I. [principal investigator, defendant O]
called the subjects estranged husband to say that they had to get the disease under control.
Coordinator says the doctor then called subject [redacted by FDA] who agreed to
complete the screening visit. See affidavit of LH [Laura Hulse] for this record.” These
acts represent wire fraud in violation of 18 USC Section 1343, constructive fraud, and
fraudulent inducement of a clinical research subject by defendant O.
(108) Plaintiffs allege that there existed a legal or equitable duty between study subject Mary H.
Joyce DOB 5-23-53 and defendant O. Defendant O breached that duty by conduct which deceived
or violated a confidence or injures the public interest, when defendant O crossed out T abnormality
in inferior leads and wrote WNL (within normal limits) on study subject’s EKG of 5/30/98,
motivated by his desire to personally profit (substantial and direct financial reward) by serially
enrolling her in clinically research studies, despite clear knowledge that her EKG was abnormal.
Plaintiffs allege that this scheme or artifice to defraud was employed serially by defendant O to
enroll this study subject in the Glaxo-Wellcome FLTA 4039 study on or about 2-10-99, and again
when defendant O enrolled her in Pfizer 264-101 on or about 3/26/99 at the “Vivra” 698 E.
Wetmore Road, Suite 100, Tucson, AZ facility. Thus, defendant O’s motive, methods, and type of
victim were similar [identical] for these two frauds. Plaintiffs allege that it is routine and customary

for EKG data, such as that obtained on 5/30/98 and on 3/15/99 to be placed, directly or indirectly,
into the US mail and interstate wire communications. Plaintiffs allege that defendant O knowingly
and willfully made use of the US mails and interstate wire communications for the purpose of the
alleged crimes.
(109) In Paragraph 5, Page 8 of FDA Exhibit 1.08 [defendant O’s letter of July 9, 1999
to Armando Chavez, Investigator, U.S. Food and Drug Administration], defendant O
intentionally failed to point out that this study subject [Sylvia M. Lancaster] had recently
participated in a prior asthma study [Zeneca 088] during which she required multiple
prednisone bursts and multiple courses of antibiotic therapy for several bouts of acute
sinusitis with asthma exacerbation. This constitutes a fraudulent omission (fraudulent
concealment), breach of fiduciary duty were there was a legal duty to disclose, and
constructive fraud, mail fraud, and wire fraud. Further, defendant O failed to point out
that he [defendant O] performed the informed consent on this study subject. Further,
defendant O fails to mention in his [defendant O’s] discussion with the sponsor and CRO
[Contract Research Organization] on 1/12/99, whether he informed the sponsor and CRO
had recently participated in a prior asthma study during which she required multiple
prednisone bursts and multiple courses of antibiotic therapy for several bouts of acute
sinusitis with asthma exacerbation. Plaintiffs allege that defendant O corruptly
influenced, obstructed, or impeded, the due administration of justice in his letter of July
9, 1999 to Armando Chavez, Investigator, U.S. Food and Drug Administration.
(110) Plaintiffs allege that defendant O having devised or intending to devise a scheme
or artifice to defraud, or for obtaining money by means of false or fraudulent pretenses,
representations, or promises, transmitted or caused to be transmitted by means of the US

mails and interstate wire communications letters, sounds, and electronic facsimiles for the
purpose of executing such scheme or artifice, at 698 E. Wetmore Road, Suite 100,
Tucson, AZ on a date (between September 1, 1998 and June 28, 1999) which is presently
unknown to the plaintiffs. The name of the specific clinical research subject (with initials
BJD), and her estranged husband, who was defrauded [by telephone] is presently
unknown to the plaintiffs because it was redacted by the FDA from the copy of the
Tucson FDA EIR 5/5-6/28/99 obtained by plaintiff A by means of an FOI request. These
acts, the phone call to the clinical research subject and to her estranged husband,
represent predicate act violations of 18 USC Section 1343 in a pattern of racketeering
activity. It is also customary for information on subjects enrolled in clinical studies to be
placed or caused to be placed into the U.S. mails for the purpose of executing the scheme
to defraud. This activity is believed to have been witnessed by former Vivra Tucson
clinical research coordinator, Laura Hulse. Plaintiff O’s intent was not to “get the disease
under control” as defendant O indicated to her estranged husband. Defendant O’s intent
was to enroll clinical study subject [with initials BJD] in a clinical research study for
defendant O’s personal financial gain. According to Laura Hulse, “[defendant O] then
called subject [redacted] who agreed to complete the screening visit”.
d. State whether there has been a criminal conviction for violation of each
predicate act;
Response:
Plaintiffs are not aware of any criminal convictions for violation of any of the predicate
acts.

e. State whether civil litigation has resulted in a judgment in regard to each
predicate act;
Response:
Civil litigation has not resulted in a judgment in regard to each predicate act.
f. Describe how the predicate acts form a “pattern of racketeering activity”;
Response:
During an on-going FDA inspection of defendant O’s regulated conduct in Albany, NY,
defendant O (Jay A. Grossman, M.D.) took all of the Case Report Forms (CRFs) for a
study plus the study binder and some copies of the patient files when he moved from
Albany, NY to Tucson, AZ (please reference page 3 of Albany, NY FDA EIR of 1993)
on or about January-July 1993. Carolanne Currier of the FDA gave permission to omit
coverage required by the Compliance Program 7348.811 and was told to check only the 7
CRFs [Case Report Forms] received as supporting documents to the assignment (please
reference page 4 Albany, NY FDA EIR of 1993). Defendants O, N, Q, R, T, and Z, [and
possibly also defendants D and M, pending discovery], corruptly agreed to aid and abet
defendant O’s travels in interstate commerce [from Albany, NY to Tucson, AZ on or
about January-July 1993, during an on-going lawsuit (Albany County Case # 2960-91),
and during an FDA investigation of his regulated conduct at 62 Hackett Blvd, Albany,
NY]. Defendant O traveled in interstate commerce or used the mail or any facility in
interstate commerce, with intent to otherwise promote, manage, establish, carry on, or
facilitate the promotion, management, establishment, or carrying on, of any unlawful
activity, and thereafter performed or attempted to performs the promotion, management,
establishment, carrying on, or facilitated the promotion, management, establishment, or

carrying on, of unlawful activity. Defendants O, N, Q, R, T, and Z, [and possibly also
defendants D and M, pending discovery], corruptly agreed to influence, obstruct or
impede, or endeavored to influence, obstruct, or impede, or influenced, obstructed, or
impeded, the due administration of law. This also constitutes overt acts of conspiracy to
conceal and perpetuate ongoing schemes of clinical research fraud and insurance
(including Medicare) fraud.
David Shulan, M.D. alleged “unnecessary procedures” by defendant O in Albany, NY at
62 Hackett Blvd with the NY entity, Albany Allergy & Asthma Services. Jack Pinnas,
M.D. alleged “unnecessary procedures” by defendant O in Tucson, AZ at 1601 N.
Tucson Blvd with the AZ entity, Allergy Care Consultants, Ltd. Plaintiffs A and C have
alleged “unnecessary procedures” by defendant O at 698 E. Wetmore Road, Tucson, AZ
between September 1, 1998 and May 12, 1999. Plaintiff C is one of several direct
witnesses to allegations of upcoding of E&M claims and claims for unnecessary
procedures submitted to 3rd party payors, including Medicare. These “unnecessary
procedures” are alleged by the plaintiffs to have included spirometry and skin testing on
potential clinical study subjects, and are believed to have been billed by customary
practice to 3rd party payors, including Medicare. Most [if not all] of these “unnecessary
procedures” are believed to have actually represented “prescreens” for participation in
clinical research studies. Plaintiffs allege that most [if not all] of these “prescreens” were
performed on potential clinical research subjects, many of whom were specialty practice
patients or “study buddies”, without informing the patient prospectively that they were
being “prescreened” for possibly study participation, and without prospectively

performing a formal informed consent for participation in a specific clinical research
study. Plaintiffs allege that these fraudulent “prescreens” were performed serially by, or
at the request of defendant O, in concert and agreement with defendants D, E, F, P, R, S,
T, U, V, W, X, Y, and Z, at no cost [either in time or money] to Big Pharma corporate
research sponsors, at the Vivra Tucson 698 E. Wetmore Road facility between September
1, 1998 and May 12, 1999. Plaintiffs allege that the object of the aforementioned
agreement was to obtain “prescreens” at no cost, either in time or money, to the Big
Pharma corporate members [defendants Z acting in their representative capacities] of the
“Vivra” association-in-fact enterprise, motivated by their desire for personal and
corporate financial gain.
Prior to defendant O’s abrupt relocation to Tucson, AZ, defendants O and Q were
principals in a NY entity, Albany Medical College Allergy Division at 62 Hackett Blvd,
which is believed to have been closely affiliated with defendant N, Albany Medical
College. Defendant O was involved in an on-going lawsuit, Albany County Case # 2960-
91 with three physicians, Richard Ball, M.D., David Shulan, M.D., and Scott Osur, M.D.
[wherein there were allegations of violence, unethical, and probably illegal conduct],
when he relocated to Tucson, AZ. Defendant O relocated to Tucson, AZ during an on-
going FDA inspection of his regulated conduct [FDA Albany, NY EIR of 11/12-22/93].
Defendant O is believed to relocated from Albany, NY to Tucson, AZ in about January-
July 1993. The AZ entity Allergy Care Consultants, Ltd was incorporated in AZ on
07/09/1993. Defendant O subsequently became involved in a lawsuit with Jack Pinnas,
M.D. in Tucson, AZ [reportedly settled out of court, the details of which are presently

unknown to plaintiffs A and B], who is believed to have been affiliated [possibly a
principal] with the AZ entity Allergy Care Consultants, Ltd. The continuity of serial
clinical research frauds and insurance (including Medicare) frauds was, thus, virtually
seamless. There was virtually no interruption from the initial frauds in Albany, NY to the
subsequent frauds in Tucson, AZ. This smooth transition by defendant O (Jay Grossman,
M.D.) from NY to AZ on or about January-July 1993 was intentionally, knowingly, and
willingly facilitated by defendants Z (Big Pharma officials in their representative capacity
and various FDA officials in their personal capacity, presently unknown to plaintiffs),
defendant Q (Thomas B. Edwards, M.D.), and defendant N (Albany Medical College),
motivated by their desire to conceal and perpetuate frauds, and thereby continue to derive
personal and corporate financial gain. Because defendants T, R, M, and D, can also be
placed in Albany, NY, it is believed likely that pending discover, one or more of these
defendants will be shown to have aided and abetted in defendant O’s relocation from
Albany, NY to Tucson, AZ, also motivated by defendant’s [T, R, M, and D] desire to
conceal and perpetuate frauds, and thereby partake of personal and corporate financial
gain.
There is striking similarity between the allegations of violence, unethical, and probably
illegal conduct in the Affidavit filed by Richard Ball, M.D. in Albany County Case #
2960-91 on December 6, 1994, and the allegations of violence, unethical, and probably
illegal conduct found in the letter from plaintiff A to Dr Antoine El Hage of FDA on April
14, 1999 and the Affidavit filed by plaintiff A with FDA investigator, Armando Chavez,
on May 21, 1999. Please reference “Exhibit H” from Albany County Case #2960-91.

Please reference the former NY entity, Albany Allergy & Asthma Services, of which
defendant O was a principal. Please reference the former NY entity, Albany Medical
College Allergy Division, of which both defendants O and Q were principals. Please also
reference the former NY entity, Allergy & Asthma Center of Albany Medical College, of
which defendant Q was a principal.
The plaintiffs allege that Defendants O, S, T, and U traveled interstate frequently in aid of
the “Vivra” racketeering enterprises. Paragraph 1, Page 5 of FDA Exhibit1.05 states
“After checking my calendar for 1998, I confirmed that I was at the Vivra site in Tucson
for approximately 214 days of that year.” Paragraph 4, Page 3 of FDA Exhibit 1.03 states
“In addition to my work at the research site, I have worked with several drug companies
in the development of research protocols, and as a consultant.” Please also reference the
Monthly Operations Meeting Agenda of January 15, 1999. Plaintiffs allege that
defendants O, S, T, and U traveled in interstate commerce or used the mail or any facility
in interstate commerce, with intent to otherwise promote, manage, establish, carry on, or
facilitate the promotion, management, establishment, or carrying on, of any unlawful
activity and thereafter performs or attempts to perform an act described in 18 USC
Section 1952, Subsection (a) (3).
Three previous FDA EIR inspections of Defendant O’s research conduct were completed in 1990,
1993, and 1994, heavily redacted copies of which were obtained thru FOI by plaintiff A. These
documents establish a prior pattern of FDA inspection reports which use the following language:
“appeared suspicious in terms of the possibility of record falsification”, “there are suspicious

changes, however…”, “another suspicious example involves…”, and “the records appear suspicious
in terms of possible falsification.” These documents also establish a relationship between Defendant
O (Jay Grossman, M.D.) and Defendant Q (Thomas B. Edwards, M.D.) who was subsequent to
Defendant O’s leaving Albany, N.Y. (to take up residence in Tucson, AZ) placed on the FDA’s List
of Restricted Clinical Investigators. Defendant Q (Thomas B. Edwards, M.D.) was a Co-
Investigator of Defendant O’s (Jay Grossman, M.D.) at Albany Medical College Allergy Division,
apparently affiliated with the Department of Medicine at Albany Medical College, where Defendant
O and Defendant Q are thought to have had faculty positions prior to Defendant O’s somewhat
abrupt departure from N.Y. in about January 1993, when he took a one-year leave of absence from
N.Y. (to take up new residence in Tucson, AZ).
During an on-going FDA inspection of Defendant O’s regulated conduct in Albany, NY, defendant
O (Jay Grossman, M.D.) took all of the Case Report Forms (CRFs) for a study plus the study binder
and some copies of the patient files when he moved from Albany, NY to Tucson, AZ (reference:
page 3 Albany, NY FDA EIR of 1993). Carolanne Currier of the FDA, gave permission to omit
coverage required by the Compliance Program 7348.811 and was told to check only the 7 CRFs
received as supporting documents to the assignment (reference: page 4 Albany, NY FDA EIR of
1993). Plaintiffs allege that defendants O and Z corruptly endeavored to influence or impede an
officer who may be serving at an examination or other proceeding, in the discharge of his duty
during the FDA Albany, NY EIR of 1993 at 62 Hackett Blvd from 11/12-11/22/93.
Plaintiffs allege that defendants O, P, R, S, T, U, V, W, X, Y, and Z, in concert and in agreement,
traveled frequently in interstate commerce and frequently used the mail or any facility in interstate

commerce, with intent to promote, manage, establish, carry on, or facilitate the promotion,
management, establishment, or carrying on, of any unlawful activity, and thereafter performed or
attempted to perform obstruction of justice in violation of 18 USC Section 1503 and interstate travel
and use of the mails in aid of racketeering enterprises in violation of 18 USC Section 1952. These
acts also constitute overt acts of both the central conspiracy to defraud the United States and the
subsidiary conspiracy to conceal and perpetuate past, present, and future frauds against the United
States. Please reference Exhibit 1.05 of defendant O’s letter to FDA Investigator Armando Chavez
of July 9, 1999. Please incorporate by reference the Monthly Operations Meeting agenda from
January 15, 1999. Please incorporate by reference the Arizona Corporation Commission Annual
Report filings of May 11, 1998, June 5, 1998, April 14, 1999, April 23, 1999, November 30, 2000,
February 5, 2001 wherein defendants S, W, X, and Y signed “NO” to certificate of disclosure # 10
(3).
The FDA routinely “grants” its Big Pharma corporate client’s communications
“privileged” [protected from discovery] status, much the same way that a physician-
patient communication is protected from discovery. However, the FDA’s Big Pharma
corporate “clients” are not patients. Clinical research subjects are not patients. They are
subjected to a different standard of care from the general public, once they sign an
informed consent. Clinical research subjects are often victims of fraudulently-
administered informed consents. A myriad of conflicts of interests on the part of the
principal investigator, defendant O (Jay Grossman, M.D.), defendant P (Eudice
Grossman), the “Vivra” Tucson clinical facility , and the medical center [defendant N,

Albany Medical College, Department of Medicine], are rarely if ever disclosed to
prospective research subjects.
Plaintiffs allege that an unrelenting, pervasive pattern of intimidation and harassment of
the clinical research staff by defendant O (Jay Grossman, M.D., Principal Investigator at
the “Vivra” Tucson clinical facility), under color of official right, engendered an
atmosphere of “don’t ask, don’t tell” and “psychic blindness” to certain objective clinical
facts, including patient safety, out of fear of retribution. Please incorporate by reference
3-page affirmation by former Vivra Tucson clinical research coordinator Linda (LeBlanc)
Buer.
Plaintiffs allege a recurring pattern of expedited market “approvals” of New Drug
Applications by the FDA while both routine and “for cause” investigations of clinical
research establishments are often selectively “delayed” [intentionally “stone-walled”]
under the auspices of the PDUFA I and II (and soon to follow under the PDUFA III).
These expedited market approvals have occurred from 1992 (upon initial enactment by
Congress of the PDUFA) until the present and have a very real threat of continuing into
the future under the PDUFA III. The plaintiffs allege that this represents a pattern of
serial corporate bribery of FDA officials acting in both their personal and representative
capacity in violation of 18 USC Section 201 which caused direct racketeering injury,
racketeering enterprise injury, and conspiracy injury to the plaintiffs business and
property [arising out of the pattern of racketeering activity].

Plaintiffs allege serial related instances of wire fraud in violation of 18 USC Section
1343, serial related instances mail fraud in violation of 18 USC Section 1341, serial
related instances of interference with commerce by threats or violence in violation of 18
USC Section 1951, and serial related instances of interstate travel in aid of racketeering
enterprise in violation of 18 USC Section 1952 by defendant O (Jay Grossman, M.D.) at
698 E. Wetmore Road between September 1, 1998 and May 12, 1999. These serial
related frauds, extortions, and interstate travel in support of racketeering enterprises,
comprise a pattern of racketeering activity within the meaning of 18 USC Section 1962
(b), (c), and (d). This pattern of racketeering activity by defendant O also took place in
Albany, NY (62 Hackett Blvd and 215 Washington Avenue Extension) and in Tucson,
AZ (1601 N. Tucson Blvd, 3395 N. Campbell Ave, 698 E. Wetmore Road, and 6261 N.
La Cholla Blvd) between about 1984 and the present, with open-ended continuity. These
multiple, related acts of racketeering, occurring within ten years of one another,
constitute a pattern of racketeering activity within the meaning of 18 USC Section 1961
(5). Please incorporate by reference plaintiff C’s email to plaintiff A of December 15,
2000. Please incorporate by reference the Reply Affidavit from Albany County Case #
2960-91 filed by Richard Ball, M.D., Scott Osur, M.D., and David Shulan, M.D. Please
incorporate by reference plaintiffs A’s affidavit to FDA Investigator Armando Chavez on
May 21, 1999. Please incorporate by reference plaintiff A’s complaint to the Arizona
State Board of Medical Examiners.
Paragraph 4, Page 3 of Tucson FDA EIR of 5/5-6/28/99 states: “All three affiants stated
that they have seen Dr. JG [Defendant O, Jay Grossman, M.D.] postdate records.”

Paragraph 5, Page 3 of Tucson FDA EIR of 5/5-6/28/99 states: “EJ [Eric Johansen,
Vivra Tucson supervisory clinical research coordinator] stated that Dr JG [Defendant O,
Jay Grossman, M.D.] asked him to bring all CRF and records for this into his office and
recreated past medical histories into the clinic notes from information taken from source
document medical questionnaires. EJ stated he has seen Dr JG tear up clinic notes and
redo them because of the information on them.”
Plaintiff A alleges that defendant O intentionally, willfully, knowingly, and with bad
intent, serially created a temporal discordance between the date upon which clinical
research subjects were administered a formal informed consent for study participation,
and the date upon which “prescreens” were obtained for possible study participation at
the “Vivra” Tucson facility at 698 E. Wetmore Road, Suite 100, between September 1,
1998 and May 12, 1999. The motive for this scheme and artifice to serially defraud was
to effectively enroll research subjects for study participation at no or minimal cost [either
in time or money] to Big Pharma without having to take the time to prospectively
administer a formal informed consent for participation in a specific clinical study.
Plaintiff A alleges that defendant O has shown a prior pattern of fraudulent “prescreens”
of prospective clinical research subjects. During a telephone conversation with plaintiff
A, David Shulan, M.D. described numerous “unnecessary procedures” by defendant O at
62 Hackett Blvd in Albany, NY. During a telephone conversation with plaintiff A, Jack

Pinnas, M.D. described numerous “unnecessary procedures” by defendant O at 1601 N.
Tucson Blvd in Tucson, AZ.
Plaintiff A alleges that because of defendant O’s frequent habit of utilizing “study
buddies” and the high frequency of crossing-over from specialty practice patient to
clinical research subject at the Vivra Tucson facility between September 1, 1998 and May
12, 1999 at 698 E. Wetmore Road, Tucson, AZ, it was necessary that their documented
clinical histories remain very “lean” so as to afford the largest possible number of serial
clinical study enrollments, and thereby minimize the likelihood of documenting a
potentially disqualifying feature in their clinical histories. Plaintiff A alleges that
defendant O expressly counseled him that his documentation of clinical notes, for both
prospective and current clinical research subjects, was far too detailed and to “make them
shorter” [leaner]. Defendant O’s clinical notes were typically very short, tersely worded,
and only minimally informative. Plaintiff A does not recall ever seeing a clinical progress
note on one of defendant O’s specialty practice patients which ever documented a
complete review of systems, past medical, social and family History, and a physical exam
to warrant a high level E&M code (that is, a level 4 or level 5 E&M code). Plaintiff A,
therefore, supports plaintiff C in the allegations of up-coding and unnecessary procedures
by defendant O found in her email to plaintiff A on December 15, 2000 at 12:53:09 EST.
Moreover, it is illogical to expect that defendant O could succeed in keeping his clinical
notes “lean” and “terse” as he had counseled plaintiff A to do, while at the same time
submitting high level E&M (level 4 or 5) reimbursement codes to 3rd party payers,
including Medicare.

Plaintiff A alleges that cross-over between specialty practice patients and clinical
research subjects was a frequent occurrence at the “Vivra” Tucson facility at 698 E.
Wetmore Road between September 1, 1998 and May 12, 1999. Plaintiff A alleges that
many of the specialty practice patients and clinical research subjects at the “Vivra”
Tucson facility were Medicare [beneficiaries] recipients or the recipients [beneficiaries]
of commercial health insurance. By information and belief and the “totality of the
circumstances”, plaintiff A alleges that defendants O, D, E, F, P, R, S, T, U, V, W, X, Y,
and Z, agreed that it was financially advantageous to intentionally “blur” the temporal
distinction between the clinical research subjects and specialty practice patients, and the
documentation of this distinction, in regard to billing 3rd party payers.
Plaintiff A alleges “by the totality of the circumstances” intentional, willful, knowing
“temporal blurring” of the distinction between specialty practice patients and clinical
research subjects at 698 E. Wetmore Road, Tucson, AZ, between September 1, 1998 and
May 12, 1999, by defendants O, D, E, F, R, S, T, U, V, W, X, Y, and Z. Plaintiff A
alleges “by the totality of the circumstances” that this illegitimate practice occurred [and
occurs] serially, enterprise-wide, having received the authorization, ratification, or
reckless tolerance, by directors or high managerial agents of the corporate members D, E,
F, G, H, I, J, K, L, M, N, and Z, of the “Vivra” association-in-fact enterprise.

Defendant D’s SEC 10-K filings from February 27, 1996 and February 28, 1997, describe
capitated contracts covering approximately 2.5 million lives, of which approximately
850,000 are covered asthma & allergy lives.
Since “time-to-drug-approval equates to money” for the “Vivra” enterprise’s many Big
Pharma clients, the alleged intentional discordance between the date of the actual
informed consent for study participation, study “enrollment”, and study “prescreens”,
cannot be understated. Big Pharma can certainly afford to “pay” for “prescreens” of
Medicare and other 3rd party insurance beneficiaries. Big Pharma cannot, however, afford
delays in drug approvals by the FDA due to slow study subject enrollment. Plaintiff A
alleges that “by the totality of the circumstances” Big Pharma officials acting in their
representative capacities often “paid” [or rewarded] defendants O, D, E, F for
inappropriate study subject enrollments at the “Vivra” Tucson facility at 698 E. Wetmore
Road between September 1, 1998 and May 12, 1999, by means which included both
monetary and non-monetary compensation. To wit, non-monetary incentive
compensation [ghost-written publications, additional research studies, favorable
testimony in lawsuits, waivers of study subject inclusion/exclusion violations] and
pecuniary incentive compensation [honoraria, hotel accommodations, travel expenses,
“consulting” fees], are [and were] routinely provided by Big Pharma [defendants Z acting
in their representative capacities] to “high enrollers” including defendant O. Defendants
Q, M, N, D, E, F, and Z, are believed to have serially received both legitimate and
illegitimate forms of compensation [both monetary and non-monetary] from Big Pharma.
The outsourced clinical research overhead provided by defendants O, Q, D, E, F, M, N,

and Z, is [and was] extremely valuable to Big Pharma by providing a vast source of
specialty practice patients and “study buddies”, the potential of “prescreens” at no “cost”
[neither cost in time nor cost in money] to Big Pharma, expedited turn-around time for
study subject enrollment, and specialty practice physicians with equity positions in
“Vivra” and productivity incentives from “Vivra”. The serial receipt from Big Pharma
[defendants Z acting in their official capacities] of illegitimate forms of incentive
compensation by defendants O, P, Q, D, E, F, M, N, and Z, between September 1, 1998
and May 12, 1999, is alleged by plaintiff A to have directly enriched the “Vivra”
enterprise, and represents corporate bribery by Big Pharma. These serial, on-going,
infusions of illegitimate forms of incentive compensation from Big Pharma [defendants Z
acting in their official capacities] to defendants O, P, Q, D, E, F, M, N, and Z, enriched
[and enrich], sustained [and sustain] and grew [and grow] the “Vivra” enterprise. The
serial receipt of illegitimate incentive compensation [corporate bribes] is [and was] a
regular part of the way in which the “Vivra” enterprise conducts its daily activities.
Plaintiffs A, B, and C, allege direct racketeering enterprise injury in their business or
property by reason of the conduct or participation in, and the agreement to conduct or
participate in, by defendants D, E, F, G, H, I, J, K, L, M, N, O, P, Q, R, S, T, U, V, W, X,
Y, and Z, the “Vivra” enterprise, in violation of substantive RICO provisions, 18 USC
Sections (b), (c), and (d), through a pattern of racketeering activity, which includes the
commission of at least two predicate acts within the meaning of 18 USC Section 1961 (1)
and (5).

Plaintiff A alleges that defendant O frequently requested and was routinely granted by
defendants Z [Big Pharma representatives acting in their representative capacities]
“waivers” for study subject inclusion/exclusion criteria violations. Plaintiff A alleges that
these “waivers” by defendants Z, intentionally, knowingly, and willingly, endangered or
authorized the endangerment by defendant O of clinical research subjects at the Vivra
Tucson facility at 698 E. Wetmore Road, Tucson, AZ, between September 1, 1998 and
May 12, 1999. Plaintiff A alleges that these “waivers” were a usual way of doing
business and routine daily activities of the “Vivra” enterprise, motivated by the desire for
personal and corporate financial gain of the co-conspirators. Plaintiff A alleges that the
“granting” of these “waivers” by Big Pharma to clinical investigators, especially to
clinical investigators who are well-known to be “high-enrollers” within the industry, is
routinely used to facilitate and expedite study subject enrollment, particularly in clinical
research studies which may overall be experiencing slow study subject enrollment, for
any of a variety of reasons, including a relative paucity of study subjects with all of the
study inclusion criteria and none of the exclusion criteria. Many times these “waivers”
are never disclosed to the study subjects, either before, during, or after their signing of the
informed consent.
Plaintiff A alleges that numerous intentional inappropriate study subject enrollments and
retentions by defendant O, or caused by defendant O, in combination and agreement with
defendants D, E, F, P, R, S, T, U, V, W, X, Y, and Z, took place at the Vivra Tucson
facility at 698 E. Wetmore Road between September 1, 1998 and May 12, 1999, which
intentionally endangered clinical research subjects. Plaintiff A alleges that these serial

intentional inappropriate study subject enrollments and retentions by defendant O
constitute a pattern of racketeering activity. Plaintiff A alleges that serial intentional
inappropriate study subject enrollments and retentions by defendant O were [and are] a
regular part of the way in which the “Vivra” enterprise conducted [and conducts] its daily
activities. Plaintiff A alleges that these numerous intentional inappropriate study subjects
enrollments and retentions by defendant O could not have taken place as readily without
the serial use of extortion [within the meaning of 18 USC Section 1951] by defendant O
upon most [if not all] of the “Vivra” Tucson clinical research staff at 698 E. Wetmore
Road, Tucson, AZ between September 1, 1998 and May 12, 1999.
Plaintiff A alleges that defendant O’s serial use of extortion [within the meaning of 18
USC Section 1951] upon most [if not all] of the clinical research staff at the 698 E.
Wetmore Road between September 1, 1998 and May 12, 1999, took place in combination
with, and in agreement with, defendants D, E, F, P, R, S, T, U, V, W, X, Y, and Z.
Plaintiff A alleges that these serial [Hobb’s Act] extortions upon the clinical research
staff constitute a pattern of racketeering activity and were [and are] a regular part of the
way in which the “Vivra” enterprise conducted [and conducts] its affairs.
Defendant O is known to have received payments from Big Pharma for “consulting”
between September 1, 1998 and May 12, 1999. Defendant O has asserted to the FDA that
he does not have to solicit corporate research sponsors…they come to him. Page 3 of
FDA Albany, NY EIR of 1990 states “[defendant O] as President of the corporation, is
responsible for its overall operation. Dr Grossman indicated he does not attempt to

recruit drug manufacturers, since he is well known in the industry as a clinical
researcher, and the manufacturers take the initiative to contact him.” Per telephone
conversation between plaintiff A and FDA [Carolanne Currier], “corporate pharma
sponsors usually tell Contract Research Organizations which clinical investigators they
may and may not use for the conduct of research studies.”
In an email to plaintiff A on December 15, 2000 at 12:53 EST, plaintiff C described
numerous “unnecessary procedures” by defendant O at 3395 N. Campbell Ave and 698
E. Wetmore Road in Tucson, AZ, which involved “EVERY” person…[at] “EVERY”
visit. [bold, underline, and italics have been added for emphasis]. Plaintiffs allege that
these “unnecessary procedures” actually represented “prescreens” for potential study
participation. Plaintiffs allege that many [if not most] of these unnecessary procedures
were performed without formal informed consent for study participation. Plaintiffs allege
that defendants O, D, E, F, J, P, R, S, T, U, V, W, X, Y, and Z, never disclosed their
numerous conflicts of interest to potential study subjects, despite the fact that many of
these conflicts of interest carried an extremely high risk of exposing potential study
subjects to added clinical safety risks should they become enrolled in a research study.
Plaintiffs allege that neither defendants D, E, F, P, J, R, S, T, U, V, W, X, Y, Z, O, nor
Big Pharma paid for [or were billed for] these “unnecessary procedures”. Plaintiffs allege
that cross-over between specialty practice patients [some of whom were Medicare
recipients], and clinical research subjects, was common at the Vivra Tucson, AZ facility.
Plaintiffs allege that a fiduciary duty existed between the plaintiffs and defendants O, P,
R, S, T, U, V, W, X, Y, Z, D, E, F, and J, arising out of a relationship of confidence and

trust. This duty was breached by the aforementioned conduct which deceives or violates a
confidence or injures the public interest, motivated by the defendants desire for personal
and corporate financial gain, at the 1601 N. Tucson Blvd, 3395 N. Campbell Ave, and
698 E. Wetmore Road facility between on or about April 22, 1997 and on or about July
30, 1999.
In her email to plaintiff A on December 15, 2000 at 12:53 EST, plaintiff C described
“upcoding” of E&M claims by defendant O at the Vivra Tucson facility, stating “As for
the upcoding, it’s a fact for anyone to see. All office visits were billed exactly the same,
without exception.”…”I will sign something that says all office visits were billed the
same.”
With respect to the pattern of racketeering activity alleged by the plaintiffs to this cause
of action, the plaintiffs allege open-ended continuity of misconduct by defendants D, E,
F, G, H, I, J, K, L, M, N, O, P, Q, R, S, T, U, V, W, X, Y, and Z, and a distinct threat of
continued misconduct by defendants D, E, F, G, H, I, J, K, L, M, N, O, P, Q, R, S, T, U,
V, W, X, Y, and Z, in the future. To date, with the exception of defendants Q, D, K, and
L, [based upon present information and belief] none of the named defendants to this
cause of action are believed to have been sanctioned [fined, penalized, or otherwise
restricted] by the FDA or by Medicare. To date, neither the criminal division of the FDA
nor the OIG of the Department of Health & Human Services have been able to discover
the existence of [and prosecute] the conspiracy. This is in spite of the fact that defendants
D, K, and L settled a conspiracy to defraud Medicare Qui Tam action with the U.S.

Attorney in 1998, and in spite of the fact that defendant K has subsequently signed a
corporate integrity agreement with the U.S. Attorney. This is also in spite of the fact that
ever since his letter to Dr Antoine El Hage of FDA on April 14, 1999, plaintiff A has
been trying to gain the attention of officials with regulatory oversight for the type of
misconduct alleged against defendant O. To wit, plaintiff A has subsequently filed reports
with the Tucson Police Department, with the Arizona State Board of Medical Examiners,
with the criminal division of the FDA, and with the Office of the Inspector General of the
U.S. Department of Health & Human Services, apparently to no avail. As of this date,
plaintiffs are not aware of any restrictions or limitations, by the FDA or any other
regulatory body, upon defendant O’s conduct of clinical research studies or upon his
medical license. While defendant Q was placed on the FDA’s List of Restricted Clinical
Investigators, he has since been removed from the list, now apparently able to resume
clinical research studies without any limitation or restriction whatsoever. Finally,
Congress has recently re-enacted the PDUFA II as the PDUFA III. Thus, there is truly a
very distinct of continued misconduct by the defendants in the future.
g. State whether the alleged predicate acts relate to each other as part of a
common plan. If so, describe in detail.
Response:
The alleged predicate acts are very much related to each other as part of a common plan.
The clinical research frauds are serial intentional endangerments [inappropriate study
subject enrollments and retentions], initially in Albany, NY and then in Tucson, AZ, with
extortion of the clinical research staff and the PDUFA II as the vehicle and statutory link

for bribery of the FDA by Big Pharma. The insurance frauds are serial upcoded E&M and
unnecessary procedure claims, initially in Albany, NY and then in Tucson,, AZ. “Vivra”
provides out-sourced overhead including billing, benefits, profiling, and incentive
compensation functions for the specialty practice physicians; and a constant source of
fraudulently induced and retained “study buddies”, specialty practice patients, and
clinical research staff, upon whom to ply their frauds. A unique feature of the “Vivra”
enterprise is that by virtue of the propinquity of the conspirators, prescreens can take
place a virtually no cost to Big Pharma, and expedited market approvals can be based
upon research which is falsified, flawed, or seriously unreliable, under the ruse and tactic
of selective enforcement, selective redaction, and selective delay of FDA investigations
afforded to the conspirators by the PDUFA II. Because the “Vivra” enterprise provides
that specialty practice patients [including Medicare recipients] often cross-over into
clinical research studies, and because specialty practice patients may often have
unnecessary procedures performed, and upcoded reimbursement claims, it is relatively
facile to allocate the “cost” of prescreens to the health insurance paying public including
Medicare. Moreover, the “Vivra” enterprise facilitates study “enrollment” via
“prescreen” without the need to expend time on a formal informed consent, which can
often be obtained posthoc, with a pre-dated informed consent. This arrangement invites
temporal discordance between obtaining the formal informed consent for study
participation and obtaining the prescreen result for study qualification. Further, this
arrangement invites denial of appropriate care to specialty practice patients without their
consent, so as to qualify them by “prescreen” for study participation. At the Vivra Tucson
facility, defendant O would regularly adjust his patient’s dosages of inhaled

corticosteroids, not based on their clinical well-being, but rather based on a dosage that
would give a desired “prescreen” result for study enrollment.
Evidence to support the view that Vivra Inc [defendant D] is co-conspirator is found in
their SEC filings which describe an employee stock option plan for specialty practice
physicians, their bonus compensation for specialty practice physicians [referred to as an
agenda item for the Monthly Operations Meeting], and strict reservation in the
Physician’s Employment Contract of setting fees, billings, and collections to Vivra Inc
[defendant D] and its subsidiaries, such as iHealth Technologies Inc [defendant J].
6. Describe in detail the alleged enterprise for each RICO claim. A description
of the enterprise shall include the following information:
a. State the names of the individuals, partnerships, corporations, associations,
or other legal entities, which allegedly constitute the enterprise;
Response:
Defendants D (Vivra Inc), E (Vivra Asthma Allergy Inc), F (Vivra Asthma & Allergy
Care America of Arizona, P.C.), G (Vivra Holdings Inc), H (Magellan Specialty Health
Inc), I (Texas Pacific Group Inc), J (iHealth Technologies Inc), K (Gambro Healthcare
Inc), L (Dialysis Holdings Inc), M (Allied Specialty Care Services Inc), N (Albany
Medical College), O (Jay Grossman), P (Eudice Grossman), Q (Thomas B. Edwards,
M.D.), R (Gayle F. Petrillo), S (Charles W. Ott), T (Timothy G. Wighton), U (John
Strack), V (Lynda L. Nessinger), W (Richard Hassett, M.D.), X (James L. Sublett, M.D.),
Y (Leanne M. Zumwalt), and Z (other defendants presently unknown to plaintiffs) were

an association in fact, sharing common purpose, unity, and identifiable structure. Each
defendant listed above was an owner of, was employed by, or was associated with an
enterprise [that is “Vivra”] engaged in, or the activities of which affected interstate
commerce, within the meaning of 18 USC Section 1962 (b) and (c).
b. Describe the structure, purpose, function and course of conduct of the
enterprise;
Response:
The pattern of racketeering activity comprised [and comprises] a substantial portion of
the “Vivra” enterprise’s regular way of doing business. The individual “persons” of the
“Vivra” enterprise, defendants O, P, Q, R, S, T, U, V, W, X, Y, and Z, authorized,
requested, commanded, ratified, or recklessly tolerated, the unlawful conduct of each
other. Directors or high managerial agents of the corporate members D, E, F, G, H, I, J,
K, L, M, N, and Z, of the “Vivra” enterprise performed, authorized, requested,
commanded, ratified, or recklessly tolerated, the unlawful conduct of the agents. The
corporate “persons” of the “Vivra” enterprise, defendants D, E, F, G, H, I, J, K, L, M, N,
and Z, were the businesses that authorized, requested, commanded, ratified, recklessly
tolerated, enabled, or agreed to enable, the individual “persons” of the “Vivra” enterprise,
defendants O, P, Q, R, S, T, U, V, W, X, Y, and Z, [acting in their personal capacities], to
conspire to commit, cause to be committed, or actually commit serial related predicate
acts through a pattern of racketeering activity within the meaning of 18 USC Section
1961 (5) for personal financial gain. Defendants D, E, F, G, H, I, J, K, L, M, N, O, P, Q,
R, S, T, U, V, W, X, Y, and Z, agreed to violate, or cause to be violated, substantive
RICO provisions, 18 USC Section (b), (c), and (d), through the commission of, order to

commit, order to cause to be committed, authorization of, or enabling of, at least two
predicate acts through a pattern of racketeering activity. Plaintiffs allege and will produce
evidence at trial that these predicate acts of racketeering activity include predicate acts
which in themselves are conspiracies.
The corporate liability of the corporate defendants [D, E, F, G, H, I, J, K, L, M, N, and Z]
to this cause of action is not based on a theory of respondeat superior, but rather is based
upon the misconduct of the directors or high managerial agents of the corporate entities
which were [most, if not all, still are] members of the “Vivra” association-in-fact
enterprise. While defendant F was apparently administratively dissolved by the Arizona
Corporations Commission on 1/18/2001, the directors, high managerial agents, and
beneficiaries of defendant F, are still members of the enterprise. The plaintiffs allege and
will produce evidence at trial that directors or high managerial agents of the corporate
defendants D, E, F, G, H, I, J, K, L, M, N, and Z, performed, authorized, requested,
plaintiffs allege and will produce evidence at trial that the corporate defendants D, E, F,
G, H, I, J, K, L, M, N, and Z, demonstrated [and demonstrate] both legitimate and
illegitimate conduct. This dual nature of their corporate function, both legitimate and
illegitimate, was [and is] an important element of the “Vivra” association-in-fact
enterprise and was [and is] very much a regular part of the way in which enterprise
conducted [and conducts] its affairs. The legitimate corporate functions were [and are]
intended to provide an ongoing appearance of legitimacy to the numerous regulatory
entities which reviewed [and review] their conduct. The illegitimate corporate functions

were intended [and are intended] to provide an on-going source of illicit financial gain to
the enterprise, some of which was [and is] reinvested in the enterprise to grow the
enterprise, some of which was [and is] provided as incentive compensation, bonuses,
salaries, and distributions to defendants O, P, Q, R, S, T, U, V, W, X, Y, and Z, and to
directors and high managerial agents of the enterprise, and some of which was [and is]
utilized to conceal and perpetuate the [past, present, and future] illicit activities of the
enterprise. The illegitimate corporate functions of the corporate members of the “Vivra”
association-in-fact enterprise were [and are] very much a part of the regular way in which
the “Vivra” enterprise conducted [and conducts] its affairs.
The association-in-fact enterprise, herein referred to as “Vivra”, was [and is] thus an
“enterprise” within the meaning of 18 USC Section 1961(4) and 1962 (b) and (c). The
participants [defendants D, E, F, G, H, I, J, K, L, M, N, O, P, Q, R, S, T, U, V, W, X, Y,
and Z] in the “Vivra” enterprise shared [and share] the common purpose of benefiting
from personal and corporate financial gains derived from their conspiracy to violate, and
the actual violation of, substantive provisions of the RICO statute [specifically, 18 USC
Sections 1962 (b), (c), and (d)] and to commit, or cause to be committed, or agree to
commit, or agree to cause to be committed, and the actual commission of, serial related
predicate acts through a pattern of racketeering activity within the meaning of 18 USC
Section 1961 (4) and (5) and 1962 (b), (c), and (d).
Some corporate elements of the enterprise focused [and focus] on analysis of “Vivra”
specialty physician coding of reimbursement claims (i.e. specialty physician profiling),

billing and collections of claims submitted to 3rd party payors including Medicare,
[defendant J (iHealth Technologies Inc)]. Other operational and coordinating elements
focused [and focus] on asthma and allergy physician practice management, [defendant F
(Vivra Asthma Allergy Inc) and defendant G (Vivra Asthma & Allergy Care America of
Arizona P.C.)]. Some corporate elements focused [and focus] on coordinating and
operating their national specialty physician network and management, [defendant D
(Vivra Inc) and defendant H (Magellan Specialty Health Inc.)]. Other corporate
elements served [and serve] to disperse legal liability, shield corporate assets, shield stock
ownership, and shield ownership of corporate stock options. These elements are presently
believed to have provided a holding function [for corporate assets] protected by the
corporate shield, [defendant E (Vivra Holdings Inc), defendant I (Texas Pacific Group
Inc), defendant K (Gambro Healthcare Inc), defendant L (Dialysis Holdings Inc), and
defendant M (Allied Specialty Care Services Inc)]. For reasons already discussed in the
Plaintiff’s Original Complaint and in this Case Statement, defendants M and N are
presently, based upon present information and belief, believed to have been active
perpetrators, less so passive instruments, of the alleged racketeering activity.
The corporate holding elements of the “Vivra” enterprise “freed up” [and “free up”] the
operational and coordinating corporate elements to aid and abet, or conspire to
accomplish, or actually accomplish, or cause to be accomplished, the commission of
serial frauds, obstructions of justice, extortions, bribery, and interstate travel in aid of
racketeering enterprises through a pattern of racketeering activity. This pattern of
racketeering activity comprised [and comprises] a substantial portion of the “Vivra”

enterprise’s regular way of doing business. The actual field operatives of the “Vivra”
enterprise were [and are] the Vice Presidents, defendant T (Timothy G. Wighton, V.P.
Clinical Research) and defendant U (John W. Strack, VP Operations), the specialty
practice physicians, [defendant O (Jay A. Grossman, M.D.) and defendant Q (Thomas B.
Edwards, M.D.)], the General Counsel, [defendant S (Charles W. Ott)], the accountants,
[defendant V (Lynda L. Nessinger)], and the Practice Managers, [defendant R (Gayle F.
Petrillo)]. These field operatives often traveled interstate in aid of “Vivra’s” racketeering
enterprise, [defendant O (Jay A. Grossman, M.D.), defendant T (Timothy G. Wighton),
defendant U (John W. Strack), and defendant S (Charles W. Ott)].
The field operatives of the “Vivra” enterprise actually accomplished, or aided and
abetted, or conspired to accomplish, or caused to be accomplished, the actual predicate
acts (alleged in paragraphs 33 through 376 of this complaint) through a pattern of
racketeering activity. Other elements of the “Vivra” enterprise, [defendants Z] facilitated
the enterprise by providing the color of official right (under the PDUFA II) to the
enterprise, effectively making the conspiracy to commit serial related frauds, extortions,
bribes, and concealment appear virtually “invisible” to the United States, “Vivra”
employees, clinical research subjects, and specialty practice patients. These defendants Z
[FDA officials acting their personal capacity and Big Pharma representatives acting in
their representative capacity] directly contributed to the “Vivra” enterprise by facilitating
the receipt by the FDA of corporate bribes from Big Pharma corporate “clients” (under
the PDUFA II) and by numerous fraudulent omissions and fraudulent concealments in
support of expedited FDA review and market approvals for their Big Pharma corporate

clients. These FDA officials made (and continue to make) the decisions as to when to
stall, hamper, and hinder routine FDA inspections, “for cause” FDA inspections, and
FDA criminal investigations, via selective enforcement of the PDUFA II, in order that
their Big Pharma “clients” gain expedited FDA market approvals of their NDA’s,
relatively unsullied by the “taint” of drug approvals which were in fact based upon data
which was falsified, erroneous, or seriously unreliable. Of course, once an NDA gains
market approval, these FDA officials are extremely unlikely to aggressively pursue
ongoing investigations of the clinical investigators upon which their “expedited” market
approvals were based, because to do so is tantamount to acknowledging the possibility an
FDA-approved product would have to be removed from the marketplace because its
approval was based upon fraudulent clinical research.
A unique and important operational element of the “Vivra” enterprise was defendant N
(Albany Medical College) which directly contributed to the operation of the enterprise by
facilitating defendant O’s abrupt departure from Albany, NY in about January 1993,
during an ongoing lawsuit (Albany County Case # 2960-91) and during an on-going FDA
investigation of his clinical research conduct. Defendant O is believed to have had a
faculty position and/or a contractual relationship with defendant N (Albany Medical
College). Defendant O (Jay Grossman, M.D.) and defendant Q (Thomas B. Edwards,
M.D.) were Co-Investigators in a corporate entity called Albany Medical College Allergy
Division, which is believed to have been closely affiliated with defendant N (Albany
Medical College). By aiding and abetting defendant O’s relocation to Tucson, AZ,
defendant N (Albany Medical College) and defendants Z (other defendants presently

unknown to the plaintiffs) facilitated the [subsequent or prior] “hiring of” or “agreement
to hire” defendant O by “Vivra” and enabled defendant O to continue unimpeded in
Tucson, AZ his serial clinical research frauds, insurance frauds, extortions, retaliations,
obstructions of justice, and interstate travel in aid of racketeering enterprise. It is
presently unknown exactly when and where the decision was made by “Vivra” to hire
both defendant O (Jay Grossman, M.D.) and defendant T (Timothy G. Wighton). It is
also presently unknown who made the decision to hire defendant O. What was the exact
relationship between defendants M, N, O, P, Q, R, T, and the business entities Albany
Medical College Allergy Division, Albany Allergy & Asthma Services, Allergy &
Asthma Center of Albany Medical College, in Albany, NY? When, why, and how was
this entity dissolved? What was defendant T’s (Timothy G. Wighton) relationship to
defendant O (Jay Grossman, M.D.), defendant Q (Thomas B. Edwards, M.D.), and
defendant R (Gayle F. Petrillo) in Albany, NY? What was the exact relationship between
Albany Medical College, Albany Allergy & Asthma Services, Albany Medical College
Allergy Division, and Allergy & Asthma Center of Albany Medical College? The
plaintiffs pray for discovery on these questions.
As cited above, defendants Z [an unknown number of FDA officials acting in their
personal capacities] played a very significant role in the operation of the “Vivra”
enterprise. Importantly, defendants Z actively facilitated defendant O’s (Jay Grossman,
M.D.) relocation from Albany, NY to Tucson, AZ during an ongoing FDA investigation
of defendant O’s clinical research conduct in about January 1993. Additionally, the FDA
sponsorship and promulgation of the PDUFA I, II, and III represents willful, knowing,

intentional fraudulent commissions in support of the “Vivra” enterprise, and a willingness
(some would say eagerness) of the FDA to continue to be the recipient of corporate
bribery from their Big Pharma corporate clients.
c. State whether any defendants are employees, officers or directors of the
alleged enterprise;
Response:
Many of the individual defendants [O, P, Q, R, S, T, U, V, W, X, Y, and Z] are [or were]
employees, officers or directors of the “Vivra” enterprise. Directors or high managerial
agents of the corporate members D, E, F, G, H, I, J, K, L, M, and N, of the “Vivra”
enterprise performed, authorized, requested, commanded, ratified or recklessly tolerated
the unlawful conduct of the agents. Defendants O, P, Q, R, S, T, U, V, W, X, Y, and Z,
authorized, requested, commanded, ratified or recklessly tolerated the unlawful conduct
of each other.
d. State whether any defendants are associated with the alleged enterprise;
Response:
Each of the named defendants and defendants Z are [or were] associated with the “Vivra”
enterprise.
e. State whether the claimant is alleging that the defendants are individuals
or entities separate from the alleged enterprise, or that the defendants are
the enterprise itself, or members of the enterprise; and
Response:
The defendants are [or were] members of the association-in-fact “Vivra” enterprise.

f. If any defendants are alleged to be the enterprise itself, or members of the
enterprise, explain whether such defendants are perpetrators, passive
instruments, or victims of the alleged racketeering activity.
Response:
Claimants allege, based on presently available information, that with the possible
exception of the holding company entities [defendants G, H, I, K, and L], the defendants
are all perpetrators. The holding company entities [defendants G, H, I, K, and L] may be
passive instruments, depending on the conduct of their Officers and Directors. Corporate
defendant M can be placed in Albany, NY since its date of incorporation on 10/23/1986,
as can defendants N, O, P, Q, R, and T. It is therefore believed, based on presently
available information, that defendant M was a perpetrator. Claimants do not allege that
any of the named defendants, or unnamed defendants Z, are victims of the alleged
racketeering activity. Claimants do not allege that any defendants to this action are the
enterprise itself. While there is some overlap, none of the individual or corporate
defendants acting alone, could or can achieve what the individual and corporate
defendants have achieved [and continue to achieve] acting in concert. To wit, the objects
of the conspiracies alleged in this cause of action continue to be achieved. The “Vivra”
enterprise has adopted illegitimate practices which were [and are] a regular part of the
“Vivra” enterprise’s regular way of doing business. These illegitimate practices have
been described in the Plaintiff’s Original Complaint, and include an enterprise-wide
pattern of (a) fraudulent omissions and misrepresentations in the hiring and retention of
key “Vivra” employees, (b) fraudulent omissions and misrepresentations to prospective
and current clinical research subjects, (c) fraudulent omissions and misrepresentations to

specialty practice patients, (d) fraudulent omissions and misrepresentations to federal
regulators [acting in their “official” capacities], fraudulent omissions and
misrepresentations to 3rd party insurance payors [both commercial and federal], (e)
depriving “Vivra” employees of their intangible right to the good and honest services of
the defendants, and (f) depriving “Vivra” employees of their intangible right freely to
conduct one’s lawful business. The conspiracies and conspiracies to conspire are on-
going.
7. State and describe in detail whether the claimant is alleging that the pattern of
racketeering activity and the enterprise are separate or have merged into one
entity.
Response:
Claimants allege that the pattern of racketeering activity and the enterprise substantially
overlap, but are not identical and, therefore, cannot be said to have merged into one
entity.
8. Describe the alleged relationship between the activities of the enterprise and
the pattern of racketeering activity. Discuss how the racketeering activity
differs from the usual and daily activities of the enterprise, if at all.
Response:
The pattern of racketeering activity comprised [and comprises] a substantial portion of
the “Vivra” enterprise’s regular way of doing business. The individual “persons” of the
“Vivra” enterprise, defendants O, P, Q, R, S, T, U, V, W, X, Y, and Z, authorized,
requested, commanded, ratified or recklessly tolerated the unlawful conduct of each
other. Directors or high managerial agents of the corporate members D, E, F, G, H, I, J,

K, L, M, N, and Z, of the “Vivra” enterprise performed, authorized, requested,
corporate “persons” of the “Vivra” enterprise, defendants D, E, F, G, H, I, J, K, L, M, N,
and Z, were the businesses that authorized, requested, commanded, ratified, recklessly
tolerated, enabled, or agreed to enable, the individual “persons” of the “Vivra” enterprise,
defendants O, P, Q, R, S, T, U, V, W, X, Y, and Z, [acting in their personal capacities], to
conspire to commit, and to actually commit serial related predicate acts through a pattern
of racketeering activity within the meaning of 18 USC Section 1961 (5) for personal
financial gain. Defendants D, E, F, G, H, I, J, K, L, M, N, O, P, Q, R, S, T, U, V, W, X,
Y, and Z, agreed to violate, or cause to be violated, substantive RICO provisions, 18 USC
Section (b), (c), and (d), through the commission of, or enabling of, at least two predicate
acts through a pattern of racketeering activity. Plaintiffs allege and will produce evidence
at trial that these predicate acts of racketeering activity include predicate acts which in
themselves are conspiracies.
9. Describe what benefits, if any, the alleged enterprise receives from the alleged
pattern of racketeering.
Response:
Plaintiffs allege that the enterprise receives benefit from the enterprise-wide practice and
pattern of providing special practice physicians with equity positions in the “Vivra”
enterprise. This is a form of incentive compensation which is employed to acquire or
maintain an interest in the enterprise through a pattern of racketeering activity. Plaintiffs
allege that the enterprise receives benefit from the enterprise-wide practice and pattern of
reserving unto “Vivra” the responsibility to set fees, submit claims to 3rd party payers,

and accept collections. Plaintiffs allege that the enterprise receives benefit from the
enterprise-wide practice and pattern of profiling specialty practice physicians and
offering billing and collection services to specialty practice physicians by defendant J.
The serial receipt from Big Pharma [defendants Z acting in their official capacities] of
illegitimate forms of incentive compensation by defendants O, P, Q, D, E, F, M, N, and
Z, between September 1, 1998 and May 12, 1999, is alleged by plaintiff A to have
directly enriched the “Vivra” enterprise, and represents corporate bribery by Big Pharma.
These serial, on-going, infusions of illegitimate forms [both monetary and non-monetary]
of incentive compensation from Big Pharma [defendants Z acting in their official
capacities] to defendants O, P, Q, D, E, F, M, N, and Z, enriched [and enrich], sustained
[and sustain] and grew [and grow] the “Vivra” enterprise. The serial receipt of
illegitimate incentive compensation [corporate bribes] is [and was] a regular part of the
way in which the “Vivra” enterprise conducts its daily activities.
10. Describe the effect of the activities of the enterprise on interstate or foreign
commerce.
Response:
Both the legitimate and the illegitimate aspects of the “Vivra” enterprise effect interstate
commerce. The “Vivra” enterprise is involved in managing the delivery of medical
specialty care and drug development. Both of these activities are taking place nationwide,
and make substantial use of interstate commerce.
11. If the complaint alleges a violation of 18 USC Section 1962 (a), provide the
following information:

Response:
The plaintiffs do not allege a violation of 18 USC Section 1962 (a).
12. If the complaint alleges a violation of 18 USC Section 1962 (b), describe in
detail the acquisition or maintenance of any interest in or control of the
alleged enterprise.
Response:
Stock ownership and stock options in the “Vivra” enterprise are two of the methods
employed by the defendants to acquire or maintain, directly or indirectly, through a
pattern of racketeering activity, an interest in or control of an enterprise [that is, “Vivra”]
which is engaged in, or the activities of which affect, interstate commerce, in violation of
18 USC Section 1962 (b). Holding a position of leadership, such as an officer or director,
of one of the corporate entities belonging to the “Vivra” enterprise would be another
method for acquiring or maintaining an interest in or control of the “Vivra” enterprise.
Defendant D (Vivra Inc) and defendant E (Vivra Asthma Allergy Inc) are thought to have
had a beneficial interest and greater than a 20% stock ownership in defendant F (Vivra
Asthma Allergy Care America of Arizona, P.C.). defendant G (Vivra Holdings Inc) is
thought to be a successor in interest to defendant D (Vivra Inc). defendant H (Magellan
Specialty Health Inc) is believed to be a successor in interest to defendant E. Defendant I
(Texas Pacific Group Inc) is believed to be a successor in interest to defendant E. An
Officer of defendant I (Jim Williams) is a Director of defendant E. Defendant K (Gambro
Healthcare Inc) is believed to be a successor in interest to defendant D. Defendant L
(Dialysis Holdings Inc) is believed to have a beneficial interest in defendant D.
Defendant M (Allied Specialty Care Services Inc) is believed to be a successor in interest

to defendant E. Defendant N (Albany Medical College) is believed to have had an
employment relationship with defendants O and Q. Defendant O is thought to have had
stock options in defendant D. The SEC filings of defendant D describe an employee stock
option plan for specialty physicians. Defendant O was an Officer and a Director of
defendant F. Defendant P has a community property interest in defendant O. Gayle F.
Petrillo was Practice Manager for defendant F and a regular attendee of the Monthly
Operations Meeting. Defendant S (Charles W. Ott) was Secretary of defendant E,
Assistant Secretary of defendantF, and General Counsel for both defendant D and
defendant E. Defendant T (Timothy G. Wighton) was Vice President Clinical Research of
defendant E and a regular attendee of the Monthly Operations Meeting. Defendant U
(John W. Strack) was Vice President Operations of defendant E, Director of defendant F,
and a regular attendee of the Monthly Operations Meeting. Defendant V (Lynda L.
Nessinger) was responsible for preparing reimbursement claims for defendant O and
defendant F. Defendant W (Richard Hassett, M.D.) is CEO for defendant E. Defendant X
(James L. Sublett, M.D.) is National Medical Director for defendant E. Defendant Y
(Leanne M. Zumwalt) is Chief Financial Officer and Director of defendant D.
13. If the complaint alleges a violation of 18 USC Section 1962 (c), provide the
following information:
a. State who is employed by or associated with the enterprise; and
Response:
Defendants D (Vivra Inc), E (Vivra Asthma Allergy Inc), F (Vivra Asthma & Allergy

Medical College), O (Jay Grossman), P (Eudice Grossman), Q (Thomas B. Edwards,
M.D.), R (Gayle F. Petrillo), S (Charles W. Ott), T (Timothy G. Wighton), U (John
Strack), V (Lynda L. Nessinger), W (Richard Hassett, M.D.), X (James L. Sublett, M.D.),
Y (Leanne M. Zumwalt), and Z (other defendants presently unknown to plaintiffs) were
an association in fact, sharing common purpose, unity, and identifiable structure. Each
defendant listed above was an owner of, was employed by, or was associated with an
enterprise [that is “Vivra”] engaged in, or the activities of which affected interstate
commerce, within the meaning of 18 USC Section 1962 (b) and (c).
b. State whether the same entity is both the liable “person” and the
“enterprise” under Section 1962 (c).
Response:
The same entity is NOT both the liable “person” and the “enterprise” under Section 1962
(c).
14. If the complaint alleges a violation of 18 USC Section 1962 (d), describe in
detail the alleged conspiracy.
Response:
The defendants D (Vivra Inc), E (Vivra Asthma Allergy Inc), F (Vivra
Asthma Allergy Care America of Arizona, P.C.), G (Vivra Holdings Inc), H
(Magellan Specialty Health Inc), I (Texas Pacific Group Inc), J (iHealth
Technologies Inc), K (Gambro Healthcare Inc), L (Dialysis Holdings Inc), M
(Allied Specialty Care Services Inc), N (Albany Medical College), O (Jay
Grossman, M.D.), P (Eudice Grossman), Q (Thomas B. Edwards, M.D.), R

(Gayle F. Petrillo), S (Charles W. Ott), T (Timothy G. Wighton), U (John W.
Strack), V (Lynda L. Nessinger), W (Richard Hassett, M.D.), X (James L.
Sublett, M.D.), Y (Leanne M. Zumwalt), and Z (other defendants presently
unknown to plaintiffs), agreed, with conspirators or anyone else, to conduct or
participate in the violation of the substantive RICO statute, specifically 18
USC Section 1962 (b), 18 USC Section 1962 (c), and 18 USC Section 1962
(d). The defendants agreed, with conspirators or anyone else, to conduct or
participate in the affairs of an enterprise through a pattern of racketeering
activity as proscribed by 18 USC Section 1962 (c). The defendants agreed to
the commission of at least two predicate acts on behalf of the conspiracy. The
defendants also agreed to the commission of predicate acts of racketeering
activity that in themselves are conspiracies. Thus, the defendants conspired to
conspire in an overall conspiracy to violate 18 USC Section (b), (c), and (d).
The defendants employed a pattern of racketeering activity to acquire or
maintain an interest in an interstate enterprise. The defendants conducted or
participated in the conduct of an enterprise’s affairs through a pattern of
racketeering activity. Through the commission of two or more of the
enumerated predicate acts which constitute a pattern of racketeering activity,
the defendants directly or indirectly participated in the conduct of an
enterprise the activities of which affect interstate commerce. The plaintiffs
were injured in their business or property by reason of such conduct by the
defendants which was violative of the substantive RICO statute.

The defendants D (Vivra Inc), E (Vivra Asthma Allergy Inc), F (Vivra Asthma Allergy
Medical College), O (Jay Grossman, M.D.), P (Eudice Grossman), Q (Thomas B.
Edwards, M.D.), R (Gayle F. Petrillo), S (Charles W. Ott), T (Timothy G. Wighton), U
(John W. Strack), V (Lynda L. Nessinger), W (Richard Hassett, M.D.), X (James L.
Sublett, M.D.), Y (Leanne M. Zumwalt), and Z (other defendants presently unknown to
plaintiffs), conducted or participated, directly or indirectly, in the conduct of the
enterprise’s affairs and conspired so to do, through a pattern of racketeering activity
within the meaning of 18 USC Section 1961 (5), that is,
a. Multiple instances of Mail fraud in violation of 18 USC Section 1341,
b. Multiple instances of Wire fraud in violation of 18 USC Section 1343
c. Multiple instances of Interference with commerce by threats or violence in
violation of 18 USC Section 1951 and 18 USC Section 2
d. Multiple instances of Retaliating against a witness, victim, or an informant in
violation of 18 USC Section 1513
e. Multiple instances of Obstruction of justice in violation of 18 USC Section 1503
f. Obstruction of criminal investigations in violation of 18 USC Section 1510
g. Obstruction of State or local law enforcement in violation of 18 USC Section
1511
h. Tampering with a witness, victim, or an informant in violation of 18 USC
Section 1512

i. Multiple instances of Interstate and foreign travel or transportation or use of
interstate wire communications in aid of racketeering enterprises in violation of
18 USC Section 1952 and 18 USC Section 2
j. Multiple instances of Bribery in violation of 18 USC Section 201
The defendants D (Vivra Inc), E (Vivra Asthma Allergy Inc), F (Vivra Asthma Allergy
Medical College), O (Jay Grossman, M.D.), P (Eudice Grossman), Q (Thomas B.
Edwards, M.D.), R (Gayle F. Petrillo), S (Charles W. Ott), T (Timothy G. Wighton), U
(John W. Strack), V (Lynda L. Nessinger), W (Richard Hassett, M.D.), X (James L.
Sublett, M.D.), Y (Leanne M. Zumwalt), and Z (other defendants presently unknown to
plaintiffs), conspired to violate 18 USC Section 1962 (c) by agreeing to conduct or
participate, directly or indirectly, in the conduct of the enterprise’s [enterprise detailed in
paragraphs through above] affairs and conspired so to do, through a pattern of
racketeering activity within the meaning of 18 USC Section 1961 (5), that is,
a. Multiple instances of Mail fraud in violation of 18 USC Section 1341,
b. Multiple instances of Wire fraud in violation of 18 USC Section 1343
c. Multiple instances of Interference with commerce by threats or violence in
violation of 18 USC Section 1951 and 18 USC Section 2
d. Multiple instances of Retaliating against a witness, victim, or an informant in
violation of 18 USC Section 1513

e. Multiple instances of Obstruction of justice in violation of 18 USC Section
1503
f. Obstruction of criminal investigations in violation of 18 USC Section 1510
g. Obstruction of State or local law enforcement in violation of 18 USC Section
1511
h. Tampering with a witness, victim, or an informant in violation of 18 USC
Section 1512
i. Multiple instances of Interstate and foreign travel or transportation or use of
interstate wire communications in aid of racketeering enterprises in violation
of 18 USC Section 1952 and 18 USC Section 2
j. Multiple instances of Bribery in violation of 18 USC Section 201
The plaintiffs were injured by the defendants D (Vivra Inc), E (Vivra Asthma
Allergy Inc), F (Vivra Asthma Allergy Care America of Arizona, P.C.), G
(Vivra Holdings Inc), H (Magellan Specialty Health Inc), I (Texas Pacific
Group Inc), J (iHealth Technologies Inc), K (Gambro Healthcare Inc), L
(Dialysis Holdings Inc), M (Allied Specialty Care Services Inc), N (Albany
Medical College), O (Jay Grossman), P (Eudice Grossman), Q (Thomas B.
Edwards, M.D.), R (Gayle F. Petrillo), S (Charles W. Ott), T (Timothy G.
Wighton), U (John W. Strack), V (Lynda L. Nessinger), W (Richard B.
Hassett, M.D.), X (James L. Sublett, M.D.), Y (Leanne M. Zumwalt), and Z
(other defendants presently unknown to plaintiffs), in their business and
property, arising out of the pattern of racketeering activity, in an undetermined

amount by reason of violations of 18 USC Section 1962 (b), (c), and (d),
committed by the aforesaid defendants within the meaning of 18 USC Section
1964 (c) and (d).
Plaintiffs allege that a conspiracy existed from which the plaintiffs sustained
damage prior to February 20, 2001. Defendants took affirmative steps to
conceal the existence of the conspiracy, and, the plaintiffs did not know of the
existence of the conspiracy and could not have discovered it by the exercise of
due diligence.
Without the knowledge or consent of Plaintiffs, defendants D (Vivra Inc), E
(Vivra Asthma Allergy Inc), F (Vivra Asthma & Allergy Care America of
Arizona, P.C.), J (iHealth Technologies Inc), N (Albany Medical College), O
(Jay Grossman, M.D.), P (Eudice Grossman), Q (Thomas B. Edwards, M.D.),
R (Gayle F. Petrillo), S (Charles W. Ott), T (Timothy G. Wighton), U (John
W. Strack), V (Lynda L. Nessinger), W (Richard B. Hassett), X (James L.
Sublett), Y (Leanne Zumwalt), and Z (an undetermined number of defendants
presently unknown to the plaintiffs), agreed, combined, and conspired among
themselves and with others unknown to plaintiffs to devise, intend to devise,
and participate in—and did devise, intend to devise and participate in—a
scheme and artifice to serially defraud for obtaining money and property by
means of false and fraudulent pretenses, representations, and to conceal the
serial frauds by false and fraudulent pretenses, representations, false

declarations, threats, violence, retaliations, obstructions of justice, bribery,
perjury, and interstate travel, all as more fully described in paragraphs 33
through 376, infra. Please incorporate by reference Exhibit A (Schematic of
Conspiracy to Defraud the United States) to this complaint.
During the period from 1984 through the present, the exact dates being
unknown to plaintiffs because of defendant’s (D, E, F, G, H, I, J, K, L, M, N,
O, P, Q, R, S, T, U, V, W, X, Y, and Z) fraudulent concealment, defendants
engaged in an unlawful combination and conspiracy, pursuant to which
defendants reached an agreement to engage in, and did in fact engage in acts,
transactions, practices and courses of business that operated and are operating
as a fraud and deceit on plaintiffs. Please reference the First, Second, and
Third Counts to this complaint and paragraphs 1 through 376 of this
complaint.
The object of the central RICO conspiracy was to serially defraud the clinical
staff (employees and coworkers), the United States (the U.S. public and the
US Department of Health & Human Services), specialty practice patients, and
clinical research subjects, motivated by each Co-Conspirator’s desire for
personal profit. Both schemes, the research fraud scheme and insurance fraud
scheme, were accomplished through serial predicate act violations, including
wire fraud, mail fraud, interference with commerce by threats or violence,
retaliating against a witness, victim, or an informant, obstruction of justice,

obstruction of criminal investigations, obstruction of State or local law
enforcement, tampering with a witness, victim, or an informant, interstate or
foreign travel or transportation in aid of racketeering enterprises, and bribery.
The schemes are on-going.
Plaintiffs allege by the totality of the circumstances an agreement between
defendants O, P, Q, R, N, T, and Z in Albany, NY at some time prior to
January-July 1993 to commit or cause to be committed, or to aid and abet,
directly or indirectly, predicate acts through a pattern of racketeering activity,
in violation of substantive portions of 18 USC Section 1962 [please reference
the First, Second, and Third Counts to this complaint]. Defendants O, P, Q, R,
N, T, and Z all knew that those acts were part of a pattern of racketeering
activity in violation of substantive portions of 18 USC Section 1962 [please
reference the First, Second, and Third Counts to this complaint]. These
defendants were associated with or employed by New York entities by the
names of Albany Medical College, Albany Medical College Allergy Division,
Albany Allergy & Asthma Services, and Albany Medical College Allergy &
Asthma Center. This activity continued [aided and abetted by defendants Q,
R, N, T, and Z] when defendants O and P relocated to Tucson, NY on or about
January-July 1993 during an on-going federal [FDA] investigation of
defendant O’s research conduct. At some time subsequent to January-July
1993 (the exact date is presently unknown to the plaintiffs), defendants R and
T re-established contact with defendants O and P in Tucson, AZ in order to

commit, or cause to be committed, or attempt, or aid and abet, predicate acts
through a pattern of racketeering activity in violation of substantive portions
of 18 USC Section 1962 [please reference the First, Second, and Third Counts
to this complaint] in Tucson, AZ from July 9, 1993 until the present at 1601
N. Tucson Blvd, 3395, N. Campbell Ave, 698 E. Wetmore Road #100, and
6261 N. La Cholla Blvd #101.
At some time subsequent to January-July 1993 (exact date presently unknown
to the plaintiffs), defendants D, E, F, G, H, I, J, K, L, M, S, U, V, and Z
established association with defendants O, P, R, and T in Tucson, AZ and
agreed to commit, cause to be committed, attempt, aid and abet, and continue
committing predicate acts through a pattern of racketeering activity in
violation of substantive portion of 18 USC Section 1962 [please reference the
First, Second, and Third Counts to this complaint], in Tucson, AZ from July 9,
1993 until the present at 1601 N. Tucson Blvd, 3395, N. Campbell Ave, 698
E. Wetmore Road, and 6261 N. La Cholla Blvd.
The agreement to hire specialty practice physicians across the nation, provide
them with equity interests in “Vivra”, and pursue a RICO conspiracy
involving the commission of serial RICO predicate acts through a pattern of
racketeering activity, in violation of substantive provisions of 18 USC Section
1962, constitutes the central agreement of the RICO conspiracy to defraud the
plaintiffs, “Vivra” employees, research subjects, practice patients, and the

United States (FDA and Medicare). Strong support for defendants D, E, F, G,
J, K, and L participation in this conspiracy to defraud is provided by the
settlement in 1998 between defendants D, K, and L, with the U.S. Attorney of
a lawsuit [U.S. District Court – Massachusetts (Boston), Case # 97-CV-
10400] for conspiracy to defraud Medicare and entry into a Corporate
Integrity Agreement. Further support for defendants D, E, F, G, J, K, and L
participation in this conspiracy to defraud is found in SEC filings for
defendant D, which firmly establish the existence of an Employee Stock
Option Plan for specialty practice physicians. Further support for defendants
D, E, F, G, J, K, and L participation in this conspiracy is found in the
Physician Employment Agreement between defendant D and defendant O on
April 22, 1997 which reserved the setting of fees, billing, and collection
exclusively to defendant D. Defendant J’s role in the conspiracy includes
profiling the E&M coding of specialty physicians [including Defendant O]
and provision of integrated claims management, wherein Defendant J purports
to “save” 3-7% on professional claims (sometimes more). Plaintiffs allege that
“Vivra’s” conspiracy to defraud the United States is on-going, despite the
settlement in 1998 with the United States and entry into a Corporate Integrity
Agreement.
The agreement to hire specialty practice plysicians across the nation,
provide them with equity interests in “Vivra”, and pursue a conspiracy
involving the commission of serial related RICO predicate acts, to

accomplish on-going parallel schemes of serial insurance frauds and serial
clinical research frauds, constitutes the central agreement of RICO
conspiracy to defraud the United States [via parallel schemes of clinical
research fraud and Medicare fraud], and defraud clinical research subjects,
specialty practice patients, and “Vivra” employees. The subsidiary agreement
to specifically hire Defendant O (Jay Grossman, M.D.), provide him with an
equity interest in “Vivra”, and pursue RICO conspiracy may have occurred in
Albany, NY between Defendant O (Jay Grossman, M.D.) and Defendant T
(Timothy G. Wighton). Alternatively, the decision to hire Defendant O and
many other specialty practice physicians across the nation, provide them with
equity interests in “Vivra”, and pursue a RICO conspiracy to defraud the
United States, may have been made at much higher levels within the “Vivra”
corporate structure.
The subsidiary agreement to specifically hire defendant O (Jay Grossman,
M.D.), provide him with an equity interest in “Vivra”, and pursue RICO
conspiracy may have occurred in Albany, NY between defendants O and T.
Alternatively, the decision to hire defendant O and many other specialty
practice physicians across the nation, and pursue a conspiracy to defraud the
United States, may have been made at much higher levels within the “Vivra”
corporate structure. The existence of the agreement can be inferred from the
totality of the circumstances: (a) the subsequent “hiring” of defendant O by
defendant D to be Medical Director as well as officer and a director of

defendant F in Tucson, AZ on April 22, 1997, (b) defendant T’s
acknowledgment to multiple members of the clinical staff in Tucson, AZ of
his prior affiliation with defendant O in Albany, NY, (c) defendant T’s
knowledge of defendant O’s FDA EIR findings from Albany, NY, (d) the
“tolerance” by “Vivra” and defendants Z (certain individuals with FDA in
their personal capacity and Big Pharma in their representative capacity) to
allow defendant P (Eudice Grossman) to own complete responsibility for
Regulatory Affairs at the Vivra Tucson, AZ facility, (e) the “tolerance” by
“Vivra” to allow the defendants O and P to maintain control of clinical source
documents in an offsite storage facility, (f) the provision of stock options by
“Vivra” to defendant O, (g) productivity-based bonus incentives for defendant
O, (h) the “tolerance” by defendants Z (including certain individuals within
FDA in their personal capacity and Big Pharma in their representative
capacity) to “allow” defendant O to conduct additional clinical research
studies, long after the FDA published the FDA Tucson, AZ EIR of 5/5-
6/28/99, (i) the “tolerance” by defendants Z (FDA officials and Big Pharma
representatives) to “allow” defendant O to conduct additional clinical research
studies, long after defendant O was terminated (on July 30, 1999) “for cause”
by defendant D, (j) the “tolerance” by defendants D, E, F, K, L, J, R, S, T, U,
V, W, X, Y, and Z to “allow” defendant O to conduct additional clinical
research studies in Tucson, AZ, after a lawsuit in Albany, NY wherein there
were allegations of violence, unethical, and probably illegal conduct, (k) the
“tolerance” by defendants D, E, F, K, L, J, R, S, T, U, V, W, X, Y, and Z to

“allow” defendant O to conduct clinical research studies in Tucson, AZ
between April 22, 1997 and July 30, 1999 at 1601 N. Tucson Blvd, 3395 N.
Campbell Ave, and 698 E. Wetmore Road, despite numerous conflicts of
interest, and (l) the “tolerance” by defendants D, E, F, K, L, J, R, S, T, U, V,
W, X, Y, and Z to “allow” defendant O to “upcode” all E&M claims and
perform numerous “unnecessary procedures” on every patient in Tucson, AZ
between April 22, 1997 and July 30, 1999 at 1601 N. Tucson Blvd, 3395 N.
Campbell Ave, and 698 E. Wetmore Road.
The agreement to hire specialty practice physicians across the nation, provide
them equity interests in defendant D, and commit, or cause to be committed,
or attempt, or aid and abet, serial violations of 18 USC Section 1341, Section
1341, Section 1951, Section 1952, Section 1503, Section 1512, Section 1510,
and Section 1511 in a pattern of racketeering activity, constitutes the central
agreement of the RICO conspiracy to defraud the plaintiffs, clinical research
subjects, specialty practice patients, and the United States. This conspiracy is
on-going despite the settlement in 1998 by defendants D, K, and L with the
United States Attorney for conspiracy to defraud Medicare and entry into a
Corporate Integrity Agreement. Please reference defendant D’s SEC 10-K
filings from February 27, 1996 and February 28, 1997. Please reference USA,
et al v. Quest Diagnostics, et al, U.S. District Court - Massachusetts (Boston),
Civil Docket Case # 97-CV-10400 wherein defendants D, K, and L were
sanctioned by the US Attorney for conspiracy to defraud the United States.

The existence of an agreement by defendants D, E, F, O, P, R, S, T, and Z to
hire defendant O can be inferred from the totality of the circumstances: (a) the
subsequent “hiring” of defendant O by “Vivra” to be Medical Director of
defendant F, as well as an officer and a director of defendant F, (b) defendant
T’s acknowledgment to multiple members of the “Vivra” Tucson clinical staff
of his prior affiliation with defendant O in Albany, NY, (c) defendant T’s
knowledge of defendant O’s FDA EIR findings (1990, 1993, 1994) in Albany,
NY at 62 Hackett Blvd, (d) defendant T’s knowledge of defendant O’s five
year long lawsuit in Albany, NY with Richard Ball, M.D., Scott Osur, M.D.,
and David Shulan, M.D., (e) the tolerance by “Vivra” to allow defendant P to
own complete responsibility for Regulatory Affairs at the “Vivra” Tucson
facility, (f) the tolerance by “Vivra” and defendants R, T, and U to allow
defendant O and defendant P to maintain control of clinical source documents
in an off-site storage facility, (g) the provision of stock options by “Vivra” to
defendant O, (h) productivity-based incentive compensation for defendant O,
(i) the tolerance by defendants Z [individuals within the FDA and within Big
Pharma, acting in their personal and official capacities] to “allow” defendant
O to conduct clinical research studies, long after the FDA published their
Tucson FDA EIR report of 5/5-6/28/99, (j) defendant T can be placed in
Albany, NY at about the same time that defendants O, P, N and Q can be
placed in Albany, NY, (k) defendant R can be placed in NY at about the same
time that defendants O, P, N, Q, and T were residents of Albany, NY, and (l)

defendant N (Albany Medical College, Department of Medicine) and
Carolanne Currier [FDA] facilitated defendant O’s relocation on or about
January 1993, from Albany, NY to Tucson, AZ during an on-going FDA
investigation of his research conduct. Please incorporate by reference FDA
Albany, NY EIR of 11/12-11/22/93 at 62 Hackett Blvd.
The object of the central RICO conspiracy was to serially defraud the
plaintiffs, the United States, clinical research subjects, and specialty practice
patients. The object of the subsidiary RICO conspiracy of concealment is to
perpetuate an on-going scheme of serially defrauding the plaintiffs, the United
States, clinical research subjects, and specialty practice patients. Both the
central conspiracy to defraud, and the subsidiary conspiracy to conceal and
perpetuate, are on-going. Both the central conspiracy to defraud, and the
subsidiary conspiracy to conceal and perpetuate, are motivated by each
defendant’s desire for personal financial gain. The frauds are being
accomplished through serial predicate act violations through a pattern of
racketeering activity. The frauds are on-going. Please reference the predicate
act violations and overt acts of conspiracy detailed in paragraphs 1 through
376 of this complaint, and the First, Second, and Third Counts to this
complaint.
15. Describe the alleged injury to business or property.

Response:
The plaintiffs were injured by the defendants D (Vivra Inc), E (Vivra Asthma Allergy
Inc), F (Vivra Asthma Allergy Care America of Arizona, P.C.), G (Vivra Holdings
Inc), H (Magellan Specialty Health Inc), I (Texas Pacific Group Inc), J (iHealth
Technologies Inc), K (Gambro Healthcare Inc), L (Dialysis Holdings Inc), M (Allied
Specialty Care Services Inc), N (Albany Medical College), O (Jay Grossman, M.D.),
P (Eudice Grossman), Q (Thomas B. Edwards, M.D.), R (Gayle F. Petrillo), S
(Charles W. Ott), T (Timothy G. Wighton), U (John W. Strack), V (Lynda L.
Nessinger), W (Richard Hassett, M.D.), X (James L. Sublett, M.D.), Y (Leanne M.
Zumwalt), and Z (other defendants presently unknown to plaintiffs), in their business
and property, arising out the pattern of racketeering activity, in an undetermined
amount by reason of violations of 18 USC Section 1962 (b), (c), and (d), committed
by the aforesaid defendants within the meaning of 18 USC Section 1964 (c) and (d).
16. Describe the direct causal relationship between the alleged injury and the
violation of the RICO statute.
Response:
Exhibit CC to this Case Statement is a letter of December 19, 2000 from the
Arkansas State Medical Board to plaintiff A, which states “Upon review of
your application for licensure and your request for a Temporary permit, our
Chairman, W. Ray Jouett, M.D. has denied your request. However, Dr. Jouett
has requested that you appear before the full Board at the Fedruary Board
Meeting to explain the details of your application and pending suit of Jay

Grossman and Eudice Grossman Vs Robert Micahel Davidson and Vanessa
Davidson”. Plaintiffs allege that but for the on-going conspiracy to conceal
and perpetuate on-going frauds, of which defendants, O, P, D, E, F, R, S, T,
U, V, W, X, Y, and Z, were perpetrators, plaintiff A would not have been
effectively denied an already fully contract of employment with Bates
Medical Center in Bentonville, AR [please reference Exhibit III]. Plaintiffs A
and B were not only denied the benefit of the bargain for both plaintiff A’s
existing employment contract with Bates Medical Center, but also the
commercial lease agreement for office space, and promissory note with
Arkansas State Bank for the purchase of office equipment. Instead, these
potential assets [office space and office equipment] became dramatic financial
liabilities once it became necessary to request release from the employment
contract in Bentonville. Not only did the Arkansas State Medical Board deny
plaintiff A a medical license, but plaintiff A was also denied liability
insurance from several insurance carriers for the first time in his life. Plaintiff
A had previously passed up an attractive offer of employment in Texas at
comparable salary, with the anticipation of starting employment in
Bentonville. Thus plaintiff A denied any employment at all for a substantial
and quite damaging length of time, after he resigned his employment “for
cause” with defendant F on May 17, 1999, as a direct and foreseeable
consequence of the tortuous misconduct of the co-conspirators. Plaintiff A
was constructively terminated by the misconduct of defendants co-
conspirators. Plaintiffs allege that they have suffered direct injury to business

or property by reason of the defendant’s violations of the substantive RICO
statute. Plaintiffs allege multiple direct injuries to their business or property
due to enterprise injuries at the hands of the RICO conspirators.
Plaintiffs allege direct fraudulent hiring injury at the hands of the RICO
conspirators, defendants D, E, F, G, H, I, J, K, L, M, N, O, P, Q, R, S, T, U, V,
W, X, Y, and Z. But for plaintiff A’s reasonable and intended reliance upon
the fraudulent misrepresentations and omissions during his recruitment and
inducement of contract by defendants D, E, F, and O, plaintiff A would never
entered into employment agreement with defendant F, and would not have (a)
been denied the benefit of legitimate employment, (b) the benefit of legitimate
employment opportunities, (c) sustained damage to his professional
reputation, (d) sustained damage to his professional practice of medicine, (e)
sustained damage to his professional association [Dominion Health Services,
P.A., a Texas professional association], (f) would not have sustained damage
to plaintiff B’s professional practice of nursing, (g) would not suffered lost
wages, (h) would not have been denied the intangible right to the good and
honest services of the defendants, (i) would not have been deprived of
plaintiff A’s intangible right freely to conduct his lawful business, (j) would
not have been subjected to the full force of the conspirator’s subsidiary
conspiracy to conceal and perpetuate frauds, which employed retaliations
against plaintiff A, including physical violence in the workplace, abuse of
process, libel, and intentional infliction of emotional distress.

The plaintiff’s allege direct enterprise injury to their business or property
because the defendants had adopted a practice and pattern of fraudulent
inducement and retention of contracts as a regular part of the usual way in
which the enterprise conducted it’s affairs. Plaintiffs have alleged a fiduciary
relationship between the plaintiffs and various named defendants. Plaintiffs
have alleged both serial constructive frauds, intentional material
misrepresentations, concealments, and serial breaches of fiduciary duty by the
conspirators upon the plaintiffs. Plaintiffs allege that defendants O, D, E, and
F, adopted, as a regular way of doing the enterprise’s business, the routine use
of fraudulent hiring and retention inducements in order that they might induce
the contract of highly qualified employees to fill certain key positions.
Plaintiffs have alleged direct enterprise injury to their business or property due
to the conspirators adoption of a practice and pattern of serial, on-going,
receipt of illegitimate incentive compensation [corporate bribes] from Big
Pharma [defendants Z acting in their official capacities] as a regular part of
the way in which the “Vivra” enterprise conducts its daily activities.
Plaintiffs allege direct enterprise injury to their business or property due to the
conspirators adoption of a practice and pattern of serial intentional inappropriate
study subject enrollments and retentions by defendant O. These inappropriate
study subject enrollments and retentions were [and are] a regular part of the way
in which the “Vivra” enterprise conducted [and conducts] its daily activities.

Plaintiff A alleges that these numerous intentional inappropriate study subjects
enrollments and retentions by defendant O could not have taken place as readily
without the serial use of extortion [within the meaning of 18 USC Section 1951]
by defendant O upon most [if not all] of the “Vivra” Tucson clinical research staff
at 698 E. Wetmore Road, Tucson, AZ between September 1, 1998 and May 12,
1999. Plaintiff A alleges direct enterprise injury to his business or property due an
enterprise-wide practice of inappropriate study enrollments and retentions. This
practice directly deprived plaintiff A of the intangible right to the good and honest
services of the defendants. Plaintiff A alleges direct enterprise injury to his
business or property due to the ratification and reckless tolerance by directors and
high managerial agents of the corporate members [defendants D, E, and F] of the
enterprise of defendant O’s serial acts of extortion upon the clinical research staff,
including plaintiffs A and C. This deprived plaintiffs A and C of the intangible
right freely to conduct their lawful business.
17. List the damages sustained for which each defendant is allegedly liable.
Response:

The plaintiffs allege that they were injured in their business or property by
reason of violations of 18 USC Section 1962. The plaintiffs allege that they
suffered proximately a racketeering enterprise injury and commercial harm,
i.e. business loss, at the hands of the defendants. The plaintiffs allege that they
suffered distinct RICO injuries, i.e. that the plaintiff’s injuries derived from
the pattern of racketeering activity which violates 18 USC Section 1962.
The plaintiffs have been delayed and hindered in their business and
occupation, and have lost a great deal of time from it, and have been deprived
of gains and profits which they otherwise would have acquired, had they not
been injured as stated. The plaintiffs have sustained direct injury to their
business and property arising out of defendant’s [D, E, F, G, H, I, J, K, L, M,
N, O, P, Q, R, S, T, U, V, W, X, Y, and Z] pattern of racketeering activity and
overt acts of conspiracy [detailed in the first three counts of this complaint and
in paragraphs 1 through 376 of this complaint]. The direct injury to plaintiff’s
business and property, arising out of the pattern of racketeering activity,
includes [in part] lost wages, lost legitimate employment opportunities,
damage to reputation, damage to presently-enjoyed business relationships,
damage to prospective business relationships, inability to obtain liability
insurance, inability to obtain new state medical licensures, loss of
investments, loss of investment income, loss of liberty, loss of the plaintiff’s
intangible right to the good and honest services of the defendants, and loss of
the plaintiff’s intangible right freely to conduct one’s lawful business. The

plaintiffs allege conspiracy injury, racketeering injury, enterprise injury, and
predicate act injury, to their business and property, arising out of the pattern of
racketeering activity, by reason of the defendant’s agreement to commit, cause
to be committed, or actual commission of, acts, including overt acts and
predicate acts, to conceal, and perpetuate serial violations of 18 USC Section
1341, Section 1343, Section 1951, Section 1952, Section 1503, Section 1510,
Section 1511, Section 1512, and Section 1513, in order that they would realize
personal financial gain, through a pattern of racketeering activity. Please
incorporate by reference Paragraph 2, Page 1 of the FDA Tucson, AZ EIR of
5/5-6/28/99 which states “This inspection report was delayed due to a PDUFA
[Prescription Drug User Fee Act] report.” Clearly, therefore, the PDUFA
status of at least one of the index clinical research studies inspected by the
FDA at the Vivra Tucson, AZ 698 E. Wetmore Road facility was a very
substantial cause of direct injury to the plaintiffs. By delaying the publication
of the FDA Tucson, AZ EIR of 5/5-6/28/99, the PDUFA II substantially
delayed the time at which the plaintiffs could begin to seek a legal remedy
against the defendants. This inured greatly to the direct benefit of the
defendants, Big Pharma (defendants Z), “Vivra”, and the FDA (defendants Z),
while inuring greatly to the detriment of the plaintiffs. Please incorporate by
reference the letter of February 19, 2002 from the Arizona State Board of
Medical Examiners to plaintiff A. Please incorporate by reference the letter of
October 17, 2001 from James A. Kopf [Director, Program Investigations
Branch, Office of Inspector General] to plaintiff A. Please incorporate by

reference the letter of December 19, 2000 from the Arkansas State Medical
Board to plaintiff A. Please incorporate by reference the letter of February 12,
2001 from plaintiff A to Dale Thompson re: Office Space Lease. Please
incorporate by reference the promissory note between Arkansas State Bank
and plaintiff A on October 12, 2000. Please incorporate by reference the
Physician Relocation Agreement on October 18, 2000 between QHG of
Springdale, Inc, d.b.a. Bates Medical Center and Dominion Health Services
P.A. d.b.a. Robert M. Davidson, M.D. Please incorporate by reference the
Motion to Withdraw as Counsel of Record and to Continue Trial in Pima
County Superior Court Case # 333954 on December 17, 2001. Please
incorporate by reference the Response to Motion to Withdraw as Counsel of
Record and to Continue Trial in Pima County Superior Court Case # 333954
on December 26, 2001, by defendants O, P, and their counsel of record, Karp,
Heurlin, & Weiss, P.C. Please incorporate by reference the Order by the Trial
Judge Jane L. Eikleberry on January 11, 2002 in Pima County Superior Court
Case # 333954, which bears the letterhead of defendant O’s and defendant P’s
counsel of record, Karp, Heurlin, & Weiss P.C. Please incorporate by
reference plaintiff A’s Notice of Appearance on February 5th, 2002 in Pima
County Superior Court Case # 333954. Please incorporate by reference
plaintiff A’s Notice of Appeal on February 11, 2002 in Pima County Superior
Court Case # 333954.

The aforementioned fraudulent misrepresentations and omissions (fraudulent
concealments) by US mails and interstate wire communications, in a pattern of
racketeering activity, were relied upon by the plaintiffs and caused direct injury in fact to
the plaintiffs, in part, (a) by denying them the benefit of legitimate employment, (b) by
causing loss of employment income, (c) by permanently injuring their professional
reputations, (d) by causing loss of employment opportunities, (e) by causing loss of
employment via constructive termination, (e) by causing injury to plaintiff A’s medical
practice, (f) by causing injury to plaintiff A’s professional association, (g) by causing
injury to plaintiff B’s nursing practice, (h) by causing injury to plaintiff C’s nursing
practice, (i) by interfering with prospective business contracts (relations), (i) by
interfering with existing business contracts (relations), (j) by causing inability to obtain
liability insurance, (k) by causing inability to obtain new state medical licensures, (l) by
causing loss of investment income, (m) by causing loss of liberty, (n) by denying the
plaintiffs their right to the defendant’s good and honest services, and (o) by denying the
plaintiffs their intangible right freely to conduct one’s lawful business. Please incorporate
by reference defendant D’s SEC 10-K filings from February 28, 1997 and February 27,
1996. Please incorporate by reference the case file including transcripts of testimony and
depositions, affidavits, and exhibits from defendant O’s lawsuit (Albany County Case #
2960-91) in Albany, NY from 1991 to January 10, 1996. Please incorporate by reference
the case file and terms of settlement from defendants (D, K, and L) lawsuit with the
United States [Civil Case # 97-CV-10400, US District Court, Massachusetts (Boston)
USA, et al v. Quest Diagnostics, et al] for conspiracy to defraud Medicare. Please
incorporate by reference the Corporate Integrity Agreement entered into between

defendants (D, K, and L) and the United States Attorney in 1998. Please incorporate by
reference the Notice of Termination letter of July 29, 1999 from defendant D to
defendant O.
This conspiracy to conceal and perpetuate violations of 18 USC Section 1962
(b) and (c) , so as to continue to derive personal financial gain, is ongoing,
and the plaintiffs have alleged ongoing direct injury to their business and
property by reason of this conspiracy to conceal.
Because the defendant’s conspiracy to conceal and perpetuate frauds against
the plaintiffs, the United States, “Vivra” employees, clinical research subjects,
and specialty practice patients [through use of the United States mails and
interstate wire communications in violation of 18 USC Section 1341 and 18
USC Section 1343, respectively] is presently on-going, and because the
plaintiffs have alleged on-going direct injury to their business and property by
reason of this conspiracy, defendants D, E, F, G, H, I, J, K, L, M, N, O, P, Q,
R, S, T, U, V, W, X, Y, and Z
Because defendant O’s assault and battery upon plaintiff A on May 11, 1999
in the workplace at 698 E. Wetmore Road, Tucson, AZ, during a “for cause”
federal [FDA] investigation of defendant O’s regulated conduct, defendant
O’s on-going civil defamation action [Pima County Superior Court Case #
333954] against plaintiffs A and B, defendant O’s on-going attack upon

plaintiff C’s nursing license on or about October 1, 1999 in Tucson, AZ
[defendant O allegedly filed a complaint with Arizona State Board of
Nursing], defendant S’s, D’s, E’s, F’s, and Z’s “pro bono” legal services in
“defense” of plaintiff C’s nursing license on or about October 1, 1999 in
Tucson, AZ, and defendant O’s, R’s, D’s, E’s, F’s, and Z’s, libel and slander
of plaintiff A and Arnold Funckes, M.D. [on or about August 20, 1999 in
Tucson, AZ], represent overt acts of conspiracy to conceal and perpetuate on-
going frauds against the plaintiffs, “Vivra” employees, clinical research
subjects, specialty practice patients, and the United States, the defendants are
again estopped from asserting the statute of limitations, in both the substantive
RICO counts and pendant state law counts to this complaint, under the
doctrines of fraudulent concealment and continuing tort. These acts also
represent predicate acts [obstruction of justice in violation of 18 USC Section
1503, obstruction of criminal investigations in violation of 18 USC Section
1510, obstruction of state and local law enforcement in violation of 18 USC
Section 1511, tampering with a witness, victim, or an informant in violation
of 18 USC Section 1512, retaliation against a witness, victim, or an informant
in violation of 18 USC Section 1513, interference with commerce by threats
or violence in violation of 18 USC Section 1951, interstate travel or wire
communications in aid of racketeering enterprises in violation of 18 USC
Section 1952, and bribery in violation of 18 USC Section 201] in a pattern of
racketeering of activity, which caused and continues to cause direct injury to
plaintiff’s business and property. This direct conspiracy injury to plaintiff’s

business and property, arising out of the pattern of racketeering activity,
caused by the defendant’s conduct is on-going, cumulative, projects into the
future with a distinct threat of continued criminal activity, and has collateral
consequences.
The plaintiffs assert that defendants D, E, F, G, H, I, J, K, L, M, N, O, P, Q, R,
S, T, U, V, W, X, Y, and Z are estopped under the doctrine of regulatory
estoppel from asserting the statute of limitations, as a defense to this action.
The plaintiffs allege that the defendants made false or misleading
representations that the defendants knew were false or misleading that the
plaintiffs believed to be true, upon which the plaintiffs relied to their
detriment, and that the defendants could reasonably have expected to induce
reliance by the plaintiffs. Further, the plaintiffs allege some “affirmative
misconduct” by defendants Z, an unknown number of presently unknown
officers within the government [FDA and OIG] acting in both their
representative and personal capacities, in support of the conspiracy to defraud
and the conspiracy to conceal. The plaintiffs allege direct conspiracy injury to
their business and property, arising out of the pattern of racketeering activity.
The plaintiffs allege that both the conspiracy to defraud and the conspiracy to
conceal are on-going.
The injuries to the plaintiffs [and to other victims] by defendants O, R, S, T,
U, V, D, E, F, W, X, Y, and Z, under the PDUFA II are on-going and capable

of repetition. The PDUFA II is a renewable congressional enactment. In the
present case and controversy, the FDA has a strong disincentive to seriously
investigate the allegations raised by plaintiff A in his initial letter to FDA of
April 14, 1999, or to seriously investigate the evidence of fraud, extortion, and
endangerments found in the Tucson FDA EIR report of May 5-June 28, 1999
and the complaint (#MD-01-0004) filed with the Arizona State Board of
Medical Examiners on December 22, 2000 and March 5, 2001.
Plaintiffs allege a recurring pattern of expedited market “approvals” of New
Drug Applications by the FDA while both routine and “for cause”
investigations of clinical research establishments are often selectively
“delayed” [intentionally “stone-walled”] under the auspices of the PDUFA I
and II (and soon to follow under the PDUFA III). These expedited market
approvals have occurred from 1992 (upon initial enactment by Congress of
the PDUFA) until the present and have a very real threat of continuing into the
future under the PDUFA III. The plaintiffs allege that this represents a pattern
of serial corporate bribery of FDA officials acting in both their personal and
representative capacity in violation of 18 USC Section 201 which caused
direct racketeering injury, racketeering enterprise injury, and conspiracy
injury to the plaintiffs business and property [arising out of the pattern of
racketeering activity].

The plaintiffs allege direct and continuing injury to their business and
property, arising out of a pattern of racketeering activity, by reason of
selective enforcement of the PDUFA II [now the PDUFA III]. The plaintiffs
allege that the FDA [and OIG] criminal investigations of defendant O’s
conduct have been knowingly and willfully “stone-walled” so as to conceal
“expedited” FDA market approvals of New Drug Applications which are
based upon research by defendant O [1601 N. Tucson Blvd, 3395 N.
Campbell Ave, and 698 E. Wetmore Road, Tucson, AZ between April 22,
1997 and July 30, 1999] and defendant Q [at 62 Hackett Blvd and 215
Washington Avenue Extension] which was falsified, flawed, or seriously
unreliable. Plaintiffs allege that similar regulatory malfeasance by defendants
Z [acting in both their personal and official capacities], has resulted in
expedited market approvals of New Drug Approvals, during or even after the
pendency of FDA investigations of other clinical investigators.
Officials of the FDA (defendants Z, acting in their personal capacity and in their
representative capacity) under color of the PDUFA II [now under the PDUFA III] caused
proximate injury to the plaintiffs business and property, arising out of the
pattern of racketeering activity, by delaying publication of the FDA Tucson,
AZ EIR of 5/5-6/28/99 and the FDA Albany, NY EIR of 10/22-12/23/97. The
substantial delay in publication and heavy redaction of the FDA Tucson, AZ
EIR of 5/5-6/28/99 [and subsequent reports pertaining to defendant O] and the
similar redaction and substantial “delay” in providing [through FOI] copies of

the FDA Albany, NY EIR of 4/29-5/2 & 8/96 and 10/22-12/23/97 (defendant
Q), under the color of official right provided by the PDUFA II, motivated by
defendant Z’s eagerness to please its Big Pharma corporate clients, in
exchange for “user fees” [and possibly other gratuities, as well], have greatly
impaired the plaintiff’s ability to discover their injury. As a result, the
plaintiffs have not yet discovered the true state of affairs. Plaintiff A did not
have a copy of the FDA Tucson EIR of 5/5-6/28/99 until on or about February
20, 2001. Paragraph 1 of Page 1 of the 5/5-6/28/99 Tucson FDA EIR states
“This inspection report was delayed due to a PDUFA report”. Plaintiff A did
not obtain heavily redacted copies of the FDA Albany, NY EIR of 4/29-5/2 &
8/96 (Thomas B. Edwards, M.D.) and FDA Albany, NY EIR of 10/22-
12/23/97 (Thomas B. Edwards, M.D.) until on or about July 26, 2002, despite
having originally requested these reports through FOI on or about 12/20/2000.
Since then, defendant Q has apparently been removed from the FDA CDER
Restricted List of Clinical Investigators, and is apparently conducting clinical
research again without restrictions, as is [apparently] defendant O in Tucson,
AZ.
The plaintiffs have sustained direct injury to their business and property,
arising out of the pattern of racketeering activity, because of defendant’s (D,
E, F, G, H, I, J, K, L, M, N, O, P, Q, R, S, T, U, V, W, X, Y, and Z)
violations of 18 USC Section 1962 (b), (c), and (d).

Defendant O’s serial predicate act violations of 18 USC Section 1343 (mail
fraud), and 18 USC Section 1341 (wire fraud) in Albany, NY and Tucson, AZ
are related (they have similar victims and methods), comprise a pattern of
racketeering activity, which is causally-related to injury-in-fact sustained by
the plaintiffs.
The plaintiffs have alleged direct conspiracy injury to their business and
property, arising out of the pattern of racketeering activity, because of
selective enforcement by defendants Z (presently unknown to the plaintiffs) of
the PDUFA II, which deprived the plaintiffs of 5th Amendment Due Process
and Equal Protection under the U.S. Constitution. Plaintiffs also allege direct
conspiracy injury to their business and property, arising out of the pattern of
racketeering activity, because of the ongoing conspiracy by defendants O, P,
D, E, F, N, Q, R, S, T, U, V, W, X, Y, and Z to conceal and perpetuate
ongoing frauds against the plaintiffs, the United States, clinical research
subjects, and specialty practice patients.
The success of the defendant’s on-going conspiracy to conceal and perpetuate
their scheme to serially defraud the plaintiffs, the United States, clinical
research subjects, and specialty practice patients, is reflected in a subsequent
FDA EIR at the “Vivra” Tucson facility on 7/6-10/00, a redacted copy of
which was obtained by the plaintiffs through FOI. Paragraph 1, Page 1 states:
“This was a High Priority CDER User Fee NDA Pre-Approval Study-

Oriented Clinical Investigator Data Validation Inspection assigned by HFD-
46 to audit,…under CP 7348.811. Review of records found no deviations and
no FD-483 was issued.” The principal investigator [defendant O] had been
previously terminated “for cause” on July 30, 1999 by “Vivra”, yet the FDA’s
report states “Review of records found no deviations…”. Thus, the FDA
Tucson, AZ EIRs of 5/5-6/28/99 and 7/6-10/00 made no findings which in any
way deterred the Big Pharma corporate sponsor from proceeding under the
PDUFA II to gain expedited “review” and market approval of their product.
These schemes to defraud the United States and to conceal and perpetuate
continue unabated. These schemes caused substantial proximate injury to
business and property of the plaintiffs, arising out of the pattern of
racketeering activity. The plaintiffs allege conspiracy injury to their business
and property, arising out of the pattern of racketeering activity, proximately
caused by an on-going pattern of racketeering activity engaged in by the
conspirators.
Plaintiffs allege that wrongful conduct by the defendants is presently being
inflicted upon the plaintiffs over a prolonged period of time. To wit, defendant
O’s defamation action against plaintiffs A and B [Pima County Superior Court
Case # 333954] is still in progress. To wit, defendant O’s attack [complaint to
the Arizona State Board of Nursing] upon plaintiff C’s nursing license is still
believed to be active. Plaintiffs allege that the subsidiary conspiracy to
conceal and perpetuate frauds is on-going. Plaintiffs allege direct injury to

their business and property, arising out of the pattern of racketeering activity,
from the on-going conspiracy to conceal and perpetuate frauds.
The plaintiffs were injured by the defendants D (Vivra Inc), E (Vivra Asthma
Allergy Inc), F (Vivra Asthma & Allergy Care America of Arizona, P.C.), G
(Vivra Holdings Inc), H (Magellan Specialty Health Inc), I (Texas Pacific
Group Inc), J (iHealth Technologies Inc), K (Gambro Healthcare Inc), L
(Dialysis Holdings Inc), M (Allied Specialty Care Services Inc), N (Albany
Medical College), O (Jay Grossman), P (Eudice Grossman), Q (Thomas B.
Edwards, M.D.), R (Gayle F. Petrillo), S (Charles W. Ott), T (Timothy G.
Wighton), U (John W. Strack), V (Lynda L. Nessinger), W (Richard B.
Hassett, M.D.), X (James L. Sublett, M.D.), Y (Leanne M. Zumwalt), and Z
(an undetermined number of defendants presently unknown to the plaintiffs),
in their business and property, arising out of the pattern of racketeering
activity, in an undetermined amount by reason of violations of 18 USC
Sections 1962 (b), (c), and (d). The plaintiffs allege injury to their business
and property, arising out of the pattern of racketeering activity, by reason of
the Defendants acquisition of an interest in or control of the “enterprise”. The
stock options provided by “Vivra” to defendant O (Jay Grossman, M.D.) and
defendants Z (other defendants presently unknown to plaintiffs) served as
incentive compensation by which “Vivra” induced defendant O and
defendants Z to perform further illegal predicate acts (these predicate acts are
detailed in the plaintiffs second count and in paragraphs 33 through 376 of

this complaint) through a pattern of racketeering activity which generated
additional illegal income to the benefit of both defendant O and the “Vivra”
enterprise.
The plaintiffs suffered injury in fact which is causally related to the conduct of the
defendants complained of, and which [the injury in fact] may be redressed by a favorable
decision from this court. Each defendant listed above conspired to violate 18 USC
Section 1962 (c) by agreeing to conduct or participate, directly or indirectly, in the
conduct of the enterprise’s [enterprise detailed in paragraphs through above] affairs
and conspired so to do, through a pattern of racketeering activity within the meaning of
18 USC Section 1961 (5).
The plaintiffs were injured by the defendants D (Vivra Inc), E (Vivra Asthma Allergy
Inc), F (Vivra Asthma Allergy Care America of Arizona, P.C.), G (Vivra Holdings Inc),
H (Magellan Specialty Health Inc), I (Texas Pacific Group Inc), J (iHealth Technologies
Inc), K (Gambro Healthcare Inc), L (Dialysis Holdings Inc), M (Allied Specialty Care
Services Inc), N (Albany Medical College), O (Jay Grossman), P (Eudice Grossman), Q
(Thomas B. Edwards, M.D.), R (Gayle F. Petrillo), S (Charles W. Ott), T (Timothy G.
Wighton), U (John W. Strack), V (Lynda L. Nessinger), W (Richard Hassett, M.D.), X
(James L. Sublett, M.D.), Y (Leanne M. Zumwalt), and Z (other defendants presently
unknown to plaintiffs), in their business and property, arising out of the pattern of
racketeering activity, in an undetermined amount by reason of violations of 18 USC

Section 1962 (b), (c), and (d), committed by the aforesaid defendants within the meaning
of 18 USC Section 1964 (c) and (d).
The plaintiffs suffered injury in fact which is causally related to the conduct of the
defendants complained of, and which [the injury in fact] may be redressed by a favorable
decision from this court. Each defendant listed above conducted or participated, directly
or indirectly, in the conduct of the enterprise’s affairs and conspired so to do, through a
pattern of racketeering activity within the meaning of 18 USC Section 1961 (5)The
plaintiffs were injured by the defendants D (Vivra Inc), E (Vivra Asthma Allergy Inc), F
(Vivra Asthma Allergy Care America of Arizona, P.C.), G (Vivra Holdings Inc), H
(Magellan Specialty Health Inc), I (Texas Pacific Group Inc), J (iHealth Technologies
Inc), K (Gambro Healthcare Inc), L (Dialysis Holdings Inc), M (Allied Specialty Care
Services Inc), N (Albany Medical College), O (Jay Grossman, M.D.), P (Eudice
Grossman), Q (Thomas B. Edwards, M.D.), R (Gayle F. Petrillo), S (Charles W. Ott), T
(Timothy G. Wighton), U (John W. Strack), V (Lynda L. Nessinger), W (Richard B.
Hassett, M.D.), X (James L. Sublett, M.D.), Y (Leanne M. Zumwalt), and Z (other
defendants presently unknown to plaintiffs), in their business and property, arising out
the pattern of racketeering activity, in an undetermined amount by reason of violations of
18 USC Section 1962 (b), (c), and (d), committed by the aforesaid defendants within the
meaning of 18 USC Section 1964 (c) and (d).
18. List all other federal causes of action, if any, and provide the relevant statute
numbers.

Response: There are presently no other federal causes of action to this
complaint.
19. List all supplemental state claims, if any.
Response:
Supplemental state claims have been included as the Fourth through Twenty-first
counts to this complaint. These counts include negligent hiring, negligent supervision,
negligent training, negligent retention, common law fraud, constructive fraud, breach
of fiduciary duty, fraudulent concealment, fraudulent misrepresentation, civil
conspiracy, abuse of process, tortuous interference with existing contract, tortuous
interference with existing contract, libel, libel per se, slander, slander per se,
intentional infliction of emotional distress, scheme and artifice to defraud, and
racketeering.
20. Provide any additional information that you feel would be helpful to the Court
in processing your RICO claim.
Response:
Please find attached to this Case Statement an Appendix of Exhibits which the
plaintiffs feel will be helpful to the Court in processing this RICO claim.
___________________________________ Date: ______________________

Robert M. Davidson
PO Box 1785
Kilgore, TX 75663-1785

903-235-0731

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Robert Davidson, et al v Vivra Inc, et al

RICO CASE STATEMENT

KEY TO NAMED PARTIES TO THIS ACTION: [keyed identically to Plaintiff’s

Robert Davidson, M.D. [plaintiff A]

1. State whether the alleged unlawful conduct is in violation of 18 USC Section

(a), (b), (c), and/or (d).

Magellan Specialty Health Inc; Texas Pacific Group Inc; iHealth

-1- RICO CASE STATEMENT

Technologies Inc; Gambro Healthcare Inc; Dialysis Holdings Inc; Allied

Grossman; Thomas B. Edwards; Gayle F. Petrillo; Charles W. Ott; Timothy

G. Wighton; John W. Strack; Lynda L. Nessinger; Richard Hassett; James L.

Sublett; Leanne M. Zumwalt; and an undetermined number of presently

unnamed defendants) have violated, or conspired to violate, 18 USC Section

1962 (b), (c), and (d).

Vivra Inc agreed, with conspirators or anyone else, to conduct or participate in

the violation of the substantive RICO statute, specifically 18 USC Section

agreed, with conspirators or anyone else, to conduct or participate in the

affairs of an enterprise through a pattern of racketeering activity as proscribed

commission of predicate acts of racketeering activity that in themselves are

conspiracies. Vivra Inc conspired to conspire in an overall conspiracy to

racketeering activity to acquire or maintain an interest in an interstate

enterprise. Vivra Inc conducted or participated in the conduct of an

enterprise’s affairs through a pattern of racketeering activity. Through the

-2- RICO CASE STATEMENT

commission of two or more of the enumerated predicate acts which constitute

a pattern of racketeering activity, Vivra Inc directly or indirectly participated

in the conduct of an enterprise the activities of which affect interstate

commerce. The plaintiffs were injured in their business or property by reason

statute. Plaintiffs allege the existence of an enterprise, that the enterprise

enterprise, that Vivra Inc participated, either directly or indirectly, in the

a pattern of racketeering activity, through the commission of at least two

predicate acts. Vivra Inc participated in an enterprise through a pattern of

prohibited activity. Plaintiffs allege racketeering enterprise injury, substantive

or property by reason of the prohibited conduct by Vivra Inc. Plaintiffs allege

injuries to their business or property.

Defendant E [Vivra Asthma Allergy Inc] agreed, with conspirators or anyone

else, to conduct or participate in the violation of the substantive RICO statute,

-3- RICO CASE STATEMENT

Section 1962 (d). Defendant E agreed, with conspirators or anyone else, to

conduct or participate in the affairs of an enterprise through a pattern of

racketeering activity as proscribed by 18 USC Section 1962 (c). Defendant E

agreed to the commission of at least two predicate acts on behalf of the

conspiracy. Defendant E also agreed to the commission of predicate acts of

racketeering activity that in themselves are conspiracies. Defendant E

conspired to conspire in an overall conspiracy to violate 18 USC Section (b),

(c), and (d). Defendant E employed a pattern of racketeering activity to

acquire or maintain an interest in an interstate enterprise. Defendant E

conducted or participated in the conduct of an enterprise’s affairs through a

pattern of racketeering activity. Through the commission of two or more of

the enumerated predicate acts which constitute a pattern of racketeering

activity, Defendant E directly or indirectly participated in the conduct of an

enterprise the activities of which affect interstate commerce. The plaintiffs

were injured in their business or property by reason of such conduct by

Defendant E which was violative of the substantive RICO statute. Plaintiffs

allege the existence of an enterprise, that the enterprise affected interstate

commerce, that Defendant E was associated with the enterprise, that

Defendant E participated, either directly or indirectly, in the conduct of the

affairs of the enterprise, and that Defendant E participated through a pattern of

racketeering activity, through the commission of at least two predicate acts.

Defendant E participated in an enterprise through a pattern of racketeering

-4- RICO CASE STATEMENT

activity. Defendant E agreed to violate, and in concert with the conspirators

Defendant F [Vivra Asthma Allergy Care America of Arizona, P.C.] agreed,

with conspirators or anyone else, to conduct or participate in the violation of