The US Supreme Court announced it will decide a case regarding whether federal regulation of pharmaceutical companies preempts state law. The case the Court will decide arises from a products liaiblity lawsuit against Pfizer’s Warner-Lamber unit involving its Rezulin diabetes drug. The FDA ordered Rezzulin off the market in March 2000 because it was linked to hundreds of deaths and cases of liver failure.
The original case was brought by a group of Michigan plaintiffs. A federal district court dismissed the case stating Michigan law shields FDA approved drugs from liability lawsuits. The 2nd U.S. Circuit Court of Appeals reinstated the suit and ruled that an exception in the Michigan law for cases involving fraud agaisnt the FDA by the pharmaceutical company was pre-empted by federal law. This decision conflicted with other appellate rulings. Such conflicts in federal cases are one criteria the Supreme Court justices consider when deciding whether to take a case. The justices have also decided to hear a similar case which focusing on whether the federal approval of a medical device protects the device from lawsuits under state law.