Legal Topics

Medical Devices

Related cases on Drug Liability, Products Liability, and Federal Preemption of State Law.

Guident Criminal Case - EndoVascular Technologies, Inc., a subsidiary of medical device manufacturer Guidant Corporation, has pled guilty to 10 felony counts and agreed to pay more than $92 million in civil and criminal penalties over allegations that it covered up malfunctions in one of its devices used to treat aortic aneurysms. DOJ Press Release describing the case. Criminal information in the case. Guilty plea.

Supreme Court strengthens federal preemption of state products liability law in medical device cases - Riegel v. Medtronic, Inc., No. 06-179 (2008)

FDA warning label on joint cement preempts tort claim - Brooks v. Howmedica, Inc., 273 F.3d 785 (8th Cir. 2001)

FDA Labeling Requirements Trump Copyright Infringement - SmithKline Beecham Consumer Healthcare, L.P. v. Watson Pharmaceuticals, Inc., 211 F.3d 21 (2nd Cir. 2000)

Brief - When Do New Medical Devices Render Old Ones Defective? - Hansen v. Baxter Healthcare Corp., 2002 WL 93106 (Ill. 2002)

Brief - Clinical Trial Issues Result in Criminal Prosecution - U.S. v. Prigmore, 243 F.3d 1 (1st Cir. 2001)

Brief - Medical Device Liability in Louisiana - Grenier v. Medical Engineering Corp., 243 F.3d 200 (Cir5 2001)

Brief - Federal courts split over whether PMA approval triggers federal preemption under the MDA - Kemp v. Medtronic, Inc., 231 F.3d 216 (6th Cir. 2000)

Brief - Supreme Court Rejects State Law Fraud on the FDA Claim - Buckman Co. v. Plantiffs' Legal Committee, 121 S.Ct. 1012, 148 L.Ed.2d 854 (U.S. 2001)

Brief - Does PMA approval trigger federal preemption of state lawsuits against a medical device supplier? - Haidak v. Collagen Corp., 67 F.Supp.2d 21 (D.Mass. 1999) and Weiland v. Telectronics Pacing Systems, Inc., 721 N.E.2d 1149 (Ill. 1999)

Can plaintiffs sue medical device manufacturers for defrauding the FDA? - In re Orthopedic Bone Screw Products Liability Litigation, 193 F.3d 781 (3rd Cir. 1999)

Supreme Court Finds Medical Device Amendments do not Preempt State Tort Law - Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996)

Court finds that FDA regulations preempt state regulation of hearing aid sales - Com. of Mass. v. Hayes, 691 F.2d 57 (1st Cir.(Mass.) 1982)

Hospital's as Sellors of Medical Devices

Hospitals as products sellers I - Cafazzo v. Central Medical Health Services, Inc., 668 A.2d 521 (Pa. 1995) (Majority view - no liability for devices)

Hospitals as products seller II - Mulligan v. Truman Medical Center, 950 S.W.2d 576 (Mo.App. W.D., 1997) (Missouri finds liability)

Hospitals as sellers III - Budding v. SSM Healthcare System, 19 S.W.3d 678 (Mo. 2000) (Missouri Supreme Court rejects hospital liability)