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Indian Journal of Anaesthesia, Dec 2008


Pain Management:Medico-Legal Issues
Gaurab Maitra
1
, A Rudra
2
, Saikat Sengupta
3
Summary
Freedom from pain has now emerged as a fundamental human right. Pain has long been under treated and
physicians have been accused for poor pain management. There are many reasons for failure pf physicians to
properly manage pain. Joint Commission on Accreditation of Health Care Organizations (JCAHO) made pain assess-
ment and proper management mandatory. Many statutory regimens have evolved over the time demanding proper
pain management and focusing it as a legal right. Standards of care for pain management have evolved and are well
established. Websites have also proliferated to help physicians gain user friendly access to these guidelines. Physi-
cians are now bound with legal responsibilities to follow pain practice as per the guidelines and to document every-
thing in medical records. Not only the physicians, the hospitals are also liable to it patients if it fails to uphold the
standard of care to ensure patients safety. Though pain management has been slow to progress, a convergence of
forces have now made it possible to incorporate quality pain management in medical practice.
Key words Pain management, Medico-legal, Guidelines
1,3.Consultant, 2.Hony Consultant, Dept of Anaesthesiology, Perioperative Medicine & Pain, Apollo Gleaneagles Hospitals,
Kolkata., Correspondence to: Gaurab Maitra, 63B, Chakraberia Road (North), Kolkata 700 020,
E-mail:drgaurabmaitra2002@yahoo.co.in Accepted for publication on: 9.7.08
Introduction
Pain is defined as an unpleasant sensory and
emotional experience arising from actual or potential
tissue damage or described in terms of such damage.
Pain is always subjective. Each individual learns the
application of the word through experiences related to
in early life. It is questionably a sensation in a part or
parts of the body but it is also always unpleasant and
therefore an emotional experience
1
.
Pain is under treated at all levels : physician of-
fices , hospitals and long term care facilities
2
resulting
in needless suffering for patients, complications that
cause further injury or death and added costs in treat-
ment overall.
Physicians have long been accused of poor pain
management for their patients
3,4
. The term
Opiophobia has been coined to describe this remark-
able clinical aversion to the proper use of opioids to
control pain
5
. Physicians are falling far short in treating
pain by accepting myths about the use of opioids in the
face of evidence to the contrary.
6
There are many reasons for failure of physicians
to properly manage pain. First physicians are poorly
educated in medical school about narcotic and proper
pain management and also remain ignorant about the
treatment choices for pain management in practice
7
.
Second uncertainty about legitimate opioid use, coupled
with a regulatory system that threatens sanctions intimi-
dates physicians
8
. Third patients, worried about toler-
ance and addiction to the opioids receive little adequate
information or education by providers
9
. Fourth lack of
insurance coverage may deny patients access to costly
long term pain management with its multiple modalities
of treatment
10
.
Categories of pain
Pain is traditionally divided into acute or chronic
pain. Acute pain and its associated psychological, au-
tonomous and behavioral responses are provoked by
noxious stimulation of injury or disease that does not
produce actual tissue damage. Effective treatment may
abolish it in days or weeks but improper or ineffective
therapy may result in persistent or chronic pain. Chronic
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769
pain imposes several physical, emotional or socio-eco-
nomic stresses on the patient, family and society. This
type of pain is prevalent and very difficult to treat
11
.
Cancer pain is one of the largest categories of
pain. One estimate is that more than 90 percent of can-
cer pain can be controlled with available treatment op-
tions
12
. The elderly particularly in nursing homes, suffer
high levels of pain chronic and non-malignant in most
cases that is poorly managed up to 70 percent of the
time. As there are many differences in what may be
regarded as chronic pain, the definition remains flexible
and related to specific diagnoses or cases
13
.
Proper pain management
Pain management is defined in the Joint Commis-
sion on Accreditation of Health Care Organizations
(JCAHO) guidelines as a comprehensive approach
to the needs of patients, residents, clients or other indi-
viduals served who experience problems associated
with acute or chronic pain
14
.
Joranson and colleagues stated that the use of
opioids in the class of morphine is the cornerstone of
pain management yet health professionals are reluctant
to prescribe, administer, dispense or stock controlled
substances for fear of causing addiction or contributing
to drug abuse problem
15
.Failure to properly manage
pain to assess treat and manage it is professional neg-
ligence
16
.
According to Brenan et al , the relief of pain is a
core ethical duty in medicine
17
. Unrelieved pain blocks
enjoyment of all other human goods and values. In the
words of an oncology nurse who herself suffered from
chronic pain,. This malady has been the most frighten-
ing, the most humiliating and the most difficult ordeal of
my life. I became withdrawn, completely disabled
by my terrible, relentless pain. I was unable to function
professionally. I was unable to be much of a wife or a
mother, a daughter or a friend
18
.
The Hippocratic Oath states, I will keep them
from harm, the American Medical Association states
that Physicians have an obligation to relieve pain and
suffering and the American Nurses Associations po-
sition is that nursing encompasses the alleviation of
suffering A virtuous doctor would place the recog-
nition, monitoring and treatment plan as a high priority
and also inquire regularly about pain, respond appro-
priately and refer wisely if unable to control it. More-
over, Pain management should be promoted as a legal
right providing constitutional guarantees and statutory
regulations that span negligence law, criminal law and
elder abuse. Pain management should be a fundamen-
tal human right and failure to provide pain relief be con-
sidered as professional misconduct. Guidelines and
standards of practice should be issued by professional
bodies to enforce proper pain management
17
.
Functions of tort(law on civil wrong) liability
The rules developed by courts in malpractice suits
serve a range of functions in altering medical practice.
First tort rules reinforce good medical practice. Sec-
ond, tort rules give voice to patients who have been
ignored, actively manipulated or cruelly treated by phy-
sicians. Third, malpractice litigation drives institutional
practice towards convergence on validated standards
of practice. Fourth, tort law often articulates new du-
ties of care for providers. Physicians not only must pay
attention to emerging practices but must also disclose
risks, candidly make a referral to more skilled special-
ist, be honest with the patient and watch out for patients
interests over those of the providers
19
.
Physicians clearly perceive a threat from the sys-
tem, judging their risk of being sued as much higher
than actually is. The Harvard new York Study, survey-
ing New York Physicians, found that physicians who
had been sued were more likely to explain risk to pa-
tients, to restrict their scope of practice and to order
more tests and procedures
20
. Hospitals have instituted
risk management offices and quality assurance pro-
grams, informed consent forms have become ubiqui-
tous, medical record keeping with an eye toward es-
tablishing proof of care at trial has become a rule
19
.
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Indian Journal of Anaesthesia, Dec 2008
Pain management as a legal right
Statutory Regimens
The Medical Treatment Act of 1994 from the
Australian Capital Territory states a patient under the
care of a health professional has a right to receive relief
from pain and suffering to the maximum extent that is
reasonable in the circumstances
21
.
An example of statutory prohibition for doctors is
contained in the South Australian Consent to Medical
Treatment and Palliative Care Act of 1995 which pro-
tects medical practitioners, in their care of terminally ill
patients from clinical or civil liability if they administer
treatment with the intention of relieving pain, providing
such treatment is given with consent, in good faith with-
out negligence and in accordance with proper profes-
sional standards of palliative care
22
. A California Stat-
ute imposed three obligations. First is a duty for doc-
tors who refuse to prescribe opioids to a patient with
severe, chronic intractable pain, to inform the patient
that there are physicians who specialize in treatment of
such pain. Second is a duty of all doctors to complete
mandatory continuing education in pain management
and treatment of terminally ill. Third is the requirement
of California Medical Board to develop a protocol for
investigation of complaints concerning the under treat-
ment of pain
23
.
Negligence
Unreasonable failure to provide adequate pain
relief constitutes negligence. Doctors may potentially
breach standard of care as an unreasonable failure to
take an adequate history of pain from the patient, an
unreasonable failure to adequately treat pain in the con-
text of uncontrolled pain, an unreasonable failure to
consult an expert in pain management
17
.
Public interest litigation
In 1998 in India on behalf of nations cancer pa-
tients, Drs SR and RB Ghooi and the All India Law-
yers Forum for Civil Liberties filed a public interest suit
in Delhi High Court requesting a court order to state
governments to simplify the procedures for the supply
of morphine for cancer patients. Court ordered appli-
cation for licenses and supplies of morphine must be
attended to expeditiously and to allot morphine with-
out delay and that aggrieved persons were granted
freedom to approach court if dissatisfied.
Criminal Law
Is it possible for a health professional to be crimi-
nally culpable in giving analgesia ? Criminal Law con-
centrates on intention so that if the intention of the doc-
tor is to relieve pain and not to shorten the life of the
patient then the act of prescribing and dispensing anal-
gesia is not a criminal act
17
.
Professional Misconduct
Professional misconduct includes conduct that
offends against the traditions of the profession
24
, and
is more than mere negligence
25
. Negligent misman-
agement of pain alone is not sufficient. More likely, poor
pain management may fall under unprofessional con-
duct. This has occurred twice in United States , State
medical boards of Oregon (in 1999) and California (in
2003) have disciplined individual doctors for unpro-
fessional conduct related to inadequate pain manage-
ment
17
. The most recent update of the US Federation
of State Medical Boards Model Policy for the use of
Controlled Substances for the Treatment of Pain ad-
dresses the balance between patients rights and pa-
tient responsibilities with respect to pain management,
principally opioid therapy
26
.
Role of World Health Organization (WHO)
The constitution of WHO defines health as a state
of complete physical mental and social well being and
not merely the absence of disease or infirmity. Adequate
provision of pain management falls comfortably within
this definition The WHO has been involved with pain
in three overlapping areas ; the promotion and dissemi-
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771
nation of guidelines on pain management, advocacy of
improved access to opioid analgesics and national pro-
grams of palliative care and pain relief
17
.
Deregulation of Medical Opioid Availability
As narcotics, opioids are subject to both interna-
tional and domestic control. The Single Convention on
Narcotic Drugs (1961) is the international treaty that
regulates the production , manufacture, import, export
and distribution of opioids for medical use. It emphasises
the importance of a balanced approach to opioid con-
trol to ensure availability for medical purposes while
preventing abuse and diversion. At the domestic level
many countries have restrictive regulatory policies for
opioid use. In the United States in recent years there
have been concerted efforts to reform. Federally the
Drug Enforcement Administration (DEA) has moved
to actively pursue a more balanced approach to the
use of controlled substances
17
. In 2001, it issued a joint
statement with dozens of professional organizations
expressly stating that, while vigilance to prevent illicit
diversion of opioid is important, it must be balanced
with the reality that effective pain management is an
integral and important aspect of quality medical care
and pain should be treated aggressively
27
. In 2006, the
DEA issued an informational outline of the Controlled
Substances Act that while acknowledging the appro-
priateness of prescribing controlled substances for le-
gitimate medical purposes devoted far more attention
to articulating an array of regulatory requirements for
doing so and penalties for non-compliance
28
.
Negligent infliction of mental distress
Can a patient or family sue for infliction of emo-
tional distress because of the patients tangible suffering
unrelieved by proper pain management ? Courts have
allowed plaintiffs(person who initiates a law suit) to sue
health care providers for the negligent infliction of emo-
tional distress under particularly egregious circum-
stances. One example is Oswald v Legrand
29
.
Referral to pain specialists
It is necessary for the primary care physician and
other specialists to be familiar with the existence and
expertise of a pain specialist. This is more than a state-
ment of medical necessity for the patient, established
tort principles require a physician to make a referral to
the appropriate specialist when the physician lacks the
knowledge or experience to properly treat the patient
(Johnson v Kokemoor)
30
.
Guidelines and Standards of Practice
Malpractice is usually defined as an unskillful prac-
tice resulting in injury to the patient, constituting a fail-
ure to exercise the required degree of care, skill and
diligence under the circumstances (Bardessono v
Michels)
31
. What a minimally competent practitioner
must know has not been derived from an external au-
thority like government standard, but rather from medi-
cal standards developed through interaction of leaders
in the profession, professional journals and meetings.
Over a period of time, a clinical policy takes shape
from series of interactions and if it becomes generally
accepted, it becomes standard of care
32
.
The guidelines developed by national medical or-
ganizations provide a source of standards against which
to judge the conduct of the defendant physician. A
widely accepted clinical standard may be a presump-
tive evidence of due care but expert testimony would
still be required to introduce the standard and establish
its source and relevancy. Standards of care for pain
management are increasingly well established. Organi-
zations such as the Agency for Health Care Policy and
Research, Agency for Health Care Research and Qual-
ity, American Pain Society, American Academy of Pain
Medicine and American Society of Anesthesiologists
have promulgated pain control standards
19
. Websites
have proliferated to help physicians gain efficient and
user friendly access to this even greater proliferation
of guidelines and medical information
33
.
A physician who displays ignorance of current
treatment guidelines may be attacked by the plaintiff
using the results of a computer search to display these
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772
Indian Journal of Anaesthesia, Dec 2008
guidelines and their relative ease of access (Warrick v
Giron)
34
.
Physicians legal responsibilities
The doctrine of informed consent
Physicians are required to disclose alternative
methods of treatment along with their risks and conse-
quences and their probability of success. Physicians are
obligated to discuss with patients the side effects of
drug treatments where driving or other life activities
might be impaired. Failure to discuss pain management
options and the possibility of referral or transfer might
well appear as a count in the patients malpractice com-
plaint for pain management
19
.
Medical Records
Medical files play an important role in any legal
case because they represent observations, opinions and
suggestions and are generally the first item lawyers at-
tempt to obtain and review. In recording patient histo-
ries, a good pain history is strongly recommended. At-
tention to prior pain symptoms is of significance in legal
medical process. Lack of prior pain symptoms is typi-
cally used by plaintiffs attorney to support casual rela-
tionship between a compensable condition and a le-
gally significant event. The destruction or strategic loss
of medical records is absolutely wrong and may result
in significant legal liability for the doctor. It is important
that the doctor co-operate with a patients legal repre-
sentative to the extent ethically permissible. In legal
medical matters, accuracy and thoroughness in record
keeping are critically important for the doctor as well
as the patient
35
.
Medical Report
Not infrequently, a doctors first encounter with
the lawyer is a written request for a copy of the doctors
medical records on the patient and a medical report
setting out the course of treatment and the doctors
opinion. The accuracy of the medical report is directly
dependent on the accuracy and the completeness of
the medical records. The medical report should indi-
cate history, treatment, diagnosis, causation and
progress. The legal system requires that such opinions
be offered within the realm of reasonable medical cer-
tainty or probability. Every doctor is advised to consult
with a respected lawyer with litigation expertise to learn
the meaning of reasonable medical certainty or reason-
able medical probability because these terms may be
used in the legal jurisdiction where the doctor practices
medicine
35
.
Institutional legal responsibilities
General Duty
The evidence as to under treatment suggests that
while physicians may often be at fault, it is primarily the
system of care that has failed to reorganize its resources
to address the problem. The hospital system has not
been designed to recognize pain as a valid indicator of
suffering and track and treat it with the intensity with
which a fever is treated in a hospital. A health care in-
stitution whether a hospital, nursing home or clinic is
liable to its patients for negligence in maintaining its fa-
cilities, providing and maintaining medical equipment,
hiring, supervising and retaining nurses and other em-
ployees. Hospitals must have minimum facilities and
support systems to treat the range of problems and side
effects that accompany the procedures they offer.
Equipments must be adequate for services offered, al-
though it need not be state of art
19
.
Corporate negligence
A hospital is directly liable for the failure of ad-
ministrators and staff to properly monitor and super-
vise the delivery of health care within the hospital. The
liability arises from the hospitals action or inaction re-
garding its policies, rather than the specific negligent
acts of one of its employees (Moser v. Heistand)
36
. In
Thompson v. Nason, the Pennsylvania Supreme Court
held that corporate negligence is a doctrine imposing
liability on a hospital if it fails to upload the standard of
care to ensure the patients safety and well being while
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773
at the hospital
37
. Most jurisdictions have held hospitals
to a duty to take reasonable steps to ensure the com-
petence of its medical staff
38
. A failure to provide train-
ing and feedback and to detect physician reluctance to
use proper techniques provides an argument of corpo-
rate negligence
19
.
Rules and Policies to ensure quality care
The regular charting of pain should be treated as
a fifth vital sign along with the other vital sign of tem-
perature, pulse, respiration and blood pressure
39
. In
1991, Joint Commission on Accreditation of Health
Care Organizations (JCAHO) mandated pain be rou-
tinely assessed and outcomes of care be routinely docu-
mented for terminally ill patients. By 1995, JCAHO
had written pain management into its guidelines. Finally
with 2000 and 2001 editions of JCAHO accreditation
manuals, JCAHO now require surveyors inspecting
hospitals to include in their surveys a systematic look at
pain assessment and management. Failure to follow new
JCAHO standards for pain management can lead to
liability, with such standards being admissible as evi-
dence of the standard of care once they are implemented
for the hospitals accreditation
19
. The Emergency Medi-
cal Treatment and Labor Act (EMTALA) requires cov-
ered hospitals to provide a medical screening exami-
nation to any patients coming into the emergency de-
partment of the hospital
40
. Severe physical pain that
could have been avoided with appropriate medical care
is arguably a material deterioration of a patients con-
dition (Wey v. Evangelical Community Hospital)
41
EMTALA offers a statutory basis for suit in emergency
admissions when patients are not properly screened or
stabilized for pain
19
.
Progress in pain management has been slow- the
result of continued uncertainty by providers as to ap-
propriate opioid use, lack of institutional attention to
pain management and in attention by medical schools.
A convergence of forces is now building pressure on
health care providers to incorporate pain management
into their practices. First JCAHOs Statement of Pain
Assessment and Management establishes a new stan-
dard of pain as the fifth vital sign which must be moni-
tored and treated by hospitals for continued accredita-
tion. Second, pain management clinical practice guide-
lines are now readily found through the Internet for easy
access by health care providers. One can only hope
that medical school education will also incorporate a
contemporary version of pain management in to its cur-
riculum
19
.
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