Solicitor General speaks out against Vermont's FDA pre-emption ruling

WASHINGTON U.S. Solicitor General Paul Clement has issued an opinion to the Supreme Court supporting preemption, saying that the Food and Drug Administration’s approval of a drug label preempts state law.

Clement recently disagreed with the Vermont Supreme Court’s ruling that a patient could sue Wyeth over the labeling of its anti-nausea drug phenergan. In the case Wyeth v. Diana Levine, the Vermont Supreme Court “erroneously interpreted” the law by saying the FDA’s approval of drug labels is only a “first step,” according to the solicitor general. The drug’s labeling recommends deep intramuscular injection and describes how to avoid intra-arterial injection, which can cause serious adverse events.

At issue is whether patients can sue a drug maker over a product they believe caused them harm at the state level if the FDA has approved a drug. The U.S. Supreme Court has agreed to review a case involving drug preemption in February involving Rezulin, a diabetes drug made by Parke-Davis/Warner-Lambert.

The Wyeth case has been appealed to the U.S. Supreme Court, but the justices have not decided whether to accept it.