Cases
We present these various legal decisions which we feel are important in the area of Food and Drug law:
Case #01:
Combination product case:
Bracco Diagnostics, Inc, v. Shalala, 963 F. Supp. 20
(DC District April 21, 1997)
Case #02:
FDA and Free Speech #01:
Washington Legal Foundation v. Henney
(202 F. 2d 331, US Ct. Appeals, DC cir. Feb 11, 2000)
Case #03:
Patents and investigational use:
Nexell Therapeutics v. AmCell Corp.
(2002 US Dist. Lexis 7308, April 2002, 143 F. Supp. 2d 401, 2001)
Case #04:
Management Responsibility:
“The Boss is Only Guilty if He’s Really in Charge” US v. Park
(421 U.S. 65, JUNE 1975)
Case #05:
FDA and Free Speech #02:
Thompson v. Western States
(US Supreme Court, Slip Op No. 01-344, 535 US, 2002)
Case #06:
Here’s a Bad Tip From Bard:
Don’t Ask, Don’t Tell FDA
U.S. v. C.R. Bard, Inc. 848 F. Supp. 287 (Mass. 1994)
Case #07:
United States of America v. Barr Labs, Inc.
812 F. Supp 458, 3/30/93
GMP Lessons From a Federal Judge
Case #08:
Defining the Domain of Medical Device Preemption
(Medtronic V. Lohr 518 U.S. 470, 1996)
Case #09:
FDA has only the Authority Congress Grants
(Association of American, Physicians and Surgeons, Inc. V. FDA 2002 U.S. Dist Lexis 19689)
Case #10:
Drug Development an IP Wasteland?
Merck KGaA v Integra Life Sciences Ltd., 545 US __(2005) Slip Op. 03-1237
Case #11:
Many Roads Lead to Rome – FDA is Not Sole Arbiter of What QSR Compliance Requires
United States of America v Utah Medical Products
