The United States Supreme Court has granted certiorari to hear two cases to determine whether the manufacturer of a medical device approved for sale by the Food and Drug Administration (FDA) can be sued for damages under state law if the device injures a patient. In particular, the Court will determine whether the express preemption provision of the Federal Food, Drug and Cosmetic Act (FDCA) preempts state-law claims seeking damages for injuries caused by medical devices with FDA premarket approval (PMA). The New York Times reports that the last time the Court heard a medical device case was in 1996, "when it ruled that devices approved by the FDA under a different, more expedited process were not shielded from state liability."
The first case before the Court, Riegel v. Medtronic Inc., was brought by the family of a New York man who suffered severe medical complications when a balloon catheter burst during a procedure to clear his arteries. The second case, involving claims for injuries allegedly caused by Rezulin, a now-withdrawn drug used to treat diabetes, will be heard in February.
Continuing coverage:
- Los Angeles Times (12/4)
- Minneapolis Star-Tribune (12/4)
- Minnesota Public Radio (12/4)
- Wall Street Journal (12/5)
- Financial Times (12/5)
- Law.com (12/5)
- PharmExec.com (12/12)
