- Supreme Court Pre-empts State Medical Device Litigation
- March 17, 2008
- Law Firm: Holland & Hart LLP - Denver Office
The U.S. Supreme Court issued its long awaited opinion in Riegel v. Medtronic, Inc. ____U.S.___ (2008) as to whether the Medical Device Amendments of 1976 passed by Congress to provide federal oversight for medical devices pre-empted state product liability tort actions. It does. The Plaintiff, Charles Riegel suffered a myocardial infarction in 1996 and underwent a coronary angioplasty. His right coronary artery was diffusely diseased and heavily calcified. When his physician inserted the Evergreen Balloon Catheter into the artery it ruptured and Riegel developed a heart block requiring emergency coronary bypass surgery. The use of the catheter was contraindicated for the artery according to label warnings and the catheter was over inflated during installation.
There is no explicit pre-emption of state tort law in the statute. The Statute reads:
Except as provided in subsection (b) of this section, no State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement –
- which is different from or in addition to, any requirement applicable under this chapter to the device, and
- which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable t the device under
Does “any requirement” mean any tort standard? Apparently yes. Yet Congress gave no explicit expression of intent to wipe out this class of torts. Wouldn't’t you think that it would have discussed that or mentioned it if that was its intent? That is Justice Ginsberg’s point in her dissent.
Justice’s Scalia, Alito and Roberts seem to abandon their abhorrence and contempt for judicial activism and strict constructionism when ideology intervenes. Go figure. Stay tuned for when when state drug tort litigation is teed up on this track