Case 2:12-cv-01312-WJ-SMV Document 1

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IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF NEW MEXICO UNITED STATES OF AMERICA, Plaintiff, v. SUNLAND, INC., a corporation, and JIMMIE D. SHEARER, an individual, Defendants. ) ) ) ) ) ) ) ) ) ) ) )

CIVIL ACTION NO. 12-cv-1312

COMPLAINT FOR PERMANENT INJUNCTION

Plaintiff, the United States of America, by its undersigned counsel, respectfully states as follows: INTRODUCTION 1. The United States of America brings this action under the Federal Food, Drug,

and Cosmetic Act (the Act), 21 U.S.C. 332(a), and the inherent equitable authority of this Court, to permanently enjoin and restrain Sunland, Inc. and Jimmie D. Shearer, (collectively, Defendants), from violating: (A) 21 U.S.C. 331(a), by introducing and causing to be introduced into interstate commerce, and delivering and causing to be delivered for introduction into interstate commerce, food that is adulterated within the meaning of 21 U.S.C. 342(a)(1) and (4); and (B) 21 U.S.C. 331(k), by causing food to become adulterated within the meaning of 21 U.S.C. 342(a)(1) and (4), while such food is held for sale after shipment of one or more components in interstate commerce. JURISDICTION AND VENUE 2. This Court has jurisdiction over this matter under 21 U.S.C. 332(a) and

28 U.S.C. 1331, 1337, and 1345.

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3.

Venue in this District is proper pursuant to 28 U.S.C. 1391(b) and (c). DEFENDANTS

4.

Defendant Sunland, Inc. (Sunland) is a New Mexico corporation with its

principal place of business at 42593 U.S. Highway 70, Portales, New Mexico (Defendants facility), within the jurisdiction of this Court. 5. Defendant Jimmie D. Shearer is the President and Chief Executive Officer of

Sunland. He has overall responsibility for Sunlands operations. He performs his duties at Defendants facility, within the jurisdiction of this Court. 6. Defendants manufacture, process, prepare, pack, hold, and distribute articles of

food, within the meaning of 21 U.S.C. 321(f), including, but not limited to, roasted nuts and nut butters (collectively, nut products). 7. Defendants nut products are made from ingredients that have been shipped in

interstate commerce and Defendants deliver their nut products to customers located outside the state of New Mexico. For example, Defendants receive raw peanuts from Georgia and ship finished nut products to California. DEFENDANTS VIOLATIONS 8. Defendants violate 21 U.S.C. 331(a) by introducing, and delivering for

introduction, into interstate commerce articles of food that are adulterated within the meaning of 21 U.S.C. 342(a)(1) and (4). 9. Defendants violate 21 U.S.C. 331(k) by causing food held for sale after

shipment of one or more components in interstate commerce to become adulterated within the meaning of 21 U.S.C. 342(a)(1) and (4).

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10.

Defendants food is adulterated within the meaning of 21 U.S.C. 342(a)(1) in

that it bears or contains a poisonous or deleterious substance, Salmonella Bredeney, which may render it injurious to health. 11. Defendants food is adulterated within the meaning of 21 U.S.C. 342(a)(4) in

that it has been prepared, packed, and held under insanitary conditions whereby it may have become contaminated with filth or been rendered injurious to health. The insanitary conditions include, but are not limited to, the widespread presence of Salmonella Bredeney at Defendants facility. 12. Salmonella Bredeney is a pathogenic organism that has a reasonable probability

of causing serious adverse health consequences or death to humans. 13. The United States Food and Drug Administration (FDA) conducted an

inspection of Defendants facility from September 9 to October 16, 2012. 14. FDA analyses of samples collected during the 2012 inspection confirmed that

certain of Defendants nut products are contaminated with Salmonella Bredeney and established the widespread presence of Salmonella Bredeney in Defendants facility. 15. On November 26, 2012, FDA suspended Defendants facilitys registration under

21 U.S.C. 350d(b), based on FDAs determination that food manufactured, processed, packed, received, and/or held at Defendants facility has a reasonable probability of causing serious adverse health consequences or death to humans and that Defendants created, caused or were otherwise responsible for such reasonable probability. WHEREFORE, Plaintiff respectfully requests that this Court: I. Permanently restrain and enjoin, under 21 U.S.C. 332(a), Defendants and each

and all of their directors, officers, agents, representatives, employees, attorneys, successors,

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assigns, and any and all persons in active concert or participation with any of them (including individuals, directors, partnerships, corporations, subsidiaries, and affiliates), who receive notice of the Courts order from, directly or indirectly: A. violating 21 U.S.C. 331(a), by introducing, delivering, and causing the

introduction and delivery for introduction into interstate commerce any article of food that is adulterated within the meaning of 21 U.S.C. 342(a)(1) or (4); and B. violating 21 U.S.C. 331(k), by doing and causing to be done any act that

causes any article of food to become adulterated within the meaning of 21 U.S.C. 342(a)(1) or (4), while such article is held for sale after shipment of one or more of its components in interstate commerce; II. Order Defendants and each and all of their directors, officers, agents,

representatives, employees, attorneys, successors, assigns, and any and all persons in active concert or participation with any of them (including individuals, directors, partnerships, corporations, subsidiaries, and affiliates), who receive notice of the Courts order to cease, directly or indirectly, receiving, processing, manufacturing, preparing, packaging, holding, and distributing any article of food within the meaning of 21 U.S.C. 321(f), at or from Defendants facility (and any other or new location at or from which Defendants receive, process, manufacture, prepare, pack, hold, or distribute food), unless and until Defendants bring their operations into compliance with the Act and its implementing regulations to the satisfaction of FDA; and III. Award the United States its costs herein, including the costs of investigation to

date, and such other relief as the Court may deem just and proper. Dated this 20th day of December, 2012.

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Respectfully submitted, KENNETH J. GONZALES United States Attorney District of New Mexico MICHAEL H. HOSES Assistant United States Attorney P.O. Box 607 Albuquerque, NM 87103 (505) 346-7274 (505) 346-7205 (fax) STUART F. DELERY Principal Deputy Assistant Attorney General MAAME EWUSI-MENSAH FRIMPONG Deputy Assistant Attorney General MICHAEL S. BLUME Director Of Counsel: WILLIAM B. SCHULTZ Acting General Counsel ELIZABETH H. DICKINSON Chief Counsel Food and Drug Division ERIC M. BLUMBERG Deputy Chief Counsel, Litigation SCOTT A. KAPLAN Associate Chief Counsel United States Department of Health and Human Services Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993-0002 /s/ Roger Gural ROGER J. GURAL Trial Attorney Consumer Protection Branch U.S. Department of Justice Civil Division P.O. Box 386 Washington, D.C. 20044 (202) 307-0174 (phone) (202) 514-8742 (fax) Roger.Gural@usdoj.gov