Stem Msj FDA

  • View
    139

  • Download
    1

Embed Size (px)

Text of Stem Msj FDA

Case 1:10-cv-01327-RMC Document 19

Filed 01/07/11 Page 1 of 64

IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA

UNITED STATES OF AMERICA, Plaintiff, v. REGENERATIVE SCIENCES, LLC, et al., Defendants.

) Civil Action No. 1:10-CV-01327-RMC ) ) ) ) ) ) ) )

PLAINTIFFS MOTION FOR SUMMARY JUDGMENT Plaintiff, the United States of America, pursuant to Fed. R. Civ. P. 56 and LCivR 7(h), hereby moves for summary judgment in the above-captioned matter on the ground that there is no genuine dispute as to any material fact and plaintiff is entitled to judgment as a matter of law. In support of this motion, plaintiff relies upon its Memorandum of Law in Support of Summary Judgment, its supporting Declarations, and Plaintiffs Statement of Material Facts, attached to this motion. Wherefore, Plaintiff respectfully request that its motion be granted and summary judgment be entered in its favor. DATED this 7th day of January, 2011.

Respectfully submitted,

TONY WEST Assistant Attorney General ANN M. RAVEL Deputy Assistant Attorney General

Case 1:10-cv-01327-RMC Document 19

Filed 01/07/11 Page 2 of 64

Of Counsel: MARK B. CHILDRESS Acting General Counsel RALPH S. TYLER Associate General Counsel Food and Drug Division ERIC M. BLUMBERG Deputy Chief Counsel, Litigation PAIGE H. TAYLOR Senior Counsel Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993-0002 301-796-8720

EUGENE M. THIROLF Director

/s/ PERHAM GORJI Trial Attorney Office of Consumer Litigation Civil Division U.S. Department of Justice 450 Fifth Street, N.W. Washington, D.C. 20001 Phone: 202-353-3881 Fax: 202-514-8742 Perham.Gorji@usdoj.gov

2

Case 1:10-cv-01327-RMC Document 19

Filed 01/07/11 Page 3 of 64

IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA UNITED STATES OF AMERICA, Plaintiff, v. REGENERATIVE SCIENCES, LLC, et al., Defendants. ) Civil Action No. 1:10-CV-01327-RMC ) ) ) ) ) ) ) )

MEMORANDUM OF LAW IN SUPPORT OF PLAINTIFFS MOTION FOR SUMMARY JUDGMENT

Case 1:10-cv-01327-RMC Document 19

Filed 01/07/11 Page 4 of 64

TABLE OF CONTENTS

Page(s) TABLE OF AUTHORITIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iii INTRODUCTION. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 STATUTORY AND REGULATORY FRAMEWORK. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 I. II. III. THE FDCA. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 THE PUBLIC HEALTH SERVICE ACT. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 THE HCT/P RULE: 21 C.F.R. PART 1271. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

STATEMENT OF FACTS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 I. II. III. THE DEFENDANTS.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 DEFENDANTS CULTURED CELL PRODUCT. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 PRIOR WARNINGS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

ARGUMENT.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 I. II. STANDARD FOR SUMMARY JUDGMENT.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 DEFENDANTS ARE VIOLATING THE FDCA BY CAUSING THE ADULTERATION OF THE CULTURED CELL PRODUCT. . . . . . . . . . . . . . . . 17 A. Defendants Cultured Cell Product is a Drug Subject to the FDCA. . . . . . . . . . . 18 1. The Cultured Cell Product is Intended to Treat Disease and to Affect the Structure and Function of the Body. . . . . . . . . . . . . . . . 18 The Cultured Cell Product Cannot Qualify for Regulation Solely Under 21 C.F.R. Part 1271 . . . . . . . . . . . . . . . . . . 20

2.

B.

Defendants Cultured Cell Product is Held for Sale After Shipment of One or More of its Components In Interstate Commerce. . . . . . . . . . . . . . . . . 22

i

Case 1:10-cv-01327-RMC Document 19

Filed 01/07/11 Page 5 of 64

C. III.

Defendants Adulterate Their Cultured Cell Product. . . . . . . . . . . . . . . . . . . . . . . 24

DEFENDANTS CULTURED CELL PRODUCT IS MISBRANDED. . . . . . . . . . . . . . 28 A. The Cultured Cell Product Is Misbranded Because It Is a Prescription Drug and Its Label Fails to Bear the Symbol Rx only. . . . . . . . . . 28 The Cultured Cell Product is Misbranded Because Its Labeling Fails to Bear Adequate Directions for Use. . . . . . . . . . . . . . . . . . . . . . . 29

B.

III.

DEFENDANTS VIOLATIONS ARE NOT EXCUSED BY THEIR CLAIM THAT THEY ARE ENGAGED IN THE PRACTICE OF MEDICINE. . . . . . . . . . . . . . 34 THIS COURT SHOULD ISSUE A PERMANENT INJUNCTION RESTRAINING DEFENDANTS FROM FURTHER VIOLATIONS OF THE FDCA. . . . . . . . . . . . . . . 36 A. B. Legal Standard. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36 Defendants Will Continue to Violate the FDCA Unless Enjoined. . . . . . . . . . . . 39

IV.

CONCLUSION. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

ii

Case 1:10-cv-01327-RMC Document 19

Filed 01/07/11 Page 6 of 64

TABLE OF AUTHORITIES FEDERAL CASES Page(s) *Abigail Alliance for Better Access to Developmental Drugs v. Eschenbach, 495 F.3d 695 (D.C. Cir. 2007). .............................................................................................. 36 Actavis Elizabeth LLC v. FDA, 625 F.3d 760 (D.C. Cir. 2010). ................................................................................................ 4 *Action on Smoking and Health v. Harris, 655 F.2d 236 (D.C. Cir. 1980). .......................................................................................... 4, 19 Alberty Food Prods. Co. v. United States, 194 F.2d 463 (9th Cir. 1952). ................................................................................................ 31 *Anderson v. Liberty Lobby, Inc., 477 U.S. 242 (1986)............................................................................................................... 17 *Baker v. United States, 932 F.2d 813 (9th Cir. 1991). ................................................................................................ 24 CareToLive v. von Eschenbach, 525 F. Supp. 2d 952 (S.D. Ohio 2007). ................................................................................... 5 Cason v. District of Columbia, 580 F. Supp. 2d 76 (D.D.C. 2008). ........................................................................................ 18 Cowan v. United States, 5 F. Supp. 2d 1235 (N.D. Okla. 1998)................................................................................... 36 *Estee Lauder, Inc. v. FDA, 727 F. Supp. 1 (D.D.C. 1989). ................................................................................................. 4 *FTC v. Morton Salt Co., 334 U.S. 37 (1948)................................................................................................................. 20 *Harry C. Crooker & Sons, Inc. v. Occupational Safety and Health Review Comm'n, 537 F.3d 79 (1st Cir. 2008).................................................................................................... 21

*Authorities upon which we chiefly rely are marked with asterisks iii

Case 1:10-cv-01327-RMC Document 19

Filed 01/07/11 Page 7 of 64

Hecht Co. v. Bowles, 321 U.S. 321 (1944)............................................................................................................... 38 John D. Copanos and Sons, Inc. v. FDA, 854 F.2d 510 (D.C. Cir. 1988). .............................................................................................. 26 Kordel v. United States, 335 U.S. 345 (1948)............................................................................................................... 37 Lambert v. Yellowley, 272 U.S. 582 (1926)......................................................................................................... 36 Nat'l Nutritional Foods Ass'n v. Mathews, 557 F.2d 325 (2d Cir. 1977)................................................................................................. 3, 4 National Ass'n of Pharm. Mfrs. v. FDA, 637 F.2d 877 (2d Cir. 1981)................................................................................................... 25 Nature Food Centres, Inc. v. United States, 310 F.2d 67 (1st Cir. 1962).................................................................................................... 30 *Novartis Pharms. Corp. v. Leavitt, 435 F.3d 344 (D.C. Cir. 2006). .............................................................................................. 22 Regenerative Sciences, Inc. v. FDA, Civ. No. 1:09-cv-00411-WYD (D. Colo. 2009). ............................................................. 15, 20 Regenerative Sciences, Inc. v. FDA, Civ. No. 1:10-cv-01055-RMC (D.D.C. 2010) . ...................................................................... 15 *Thomas Jefferson University v. Shalala, 512 U.S. 504 (1994)............................................................................................................... 22 *United States Air Tour Ass'n v. FAA, 298 F.3d 997 (D.C. Cir. 2002). .............................................................................................. 22 United States v. 9/1 Kg. Containers, 854 F.2d 173 (7th