Supreme Court to hear FDA preemption case

WASHINGTON Last week, the U.S. solicitor general issued an opinion regarding the U.S. Supreme Court supporting preemption, saying the Food and Drug Administration approval of drug labeling preempts state law, now this matter will be handled directly by the Supreme Court in an upcoming case due to be heard on February 25.

The case, which brought out the views of the solicitor general, is Wyeth v. Diana, which concerns the Vermont Supreme Court’s interpretation of FDA law over the labeling of the antinausea drug Phenergan. This case has been appealed to the Supreme Court, which is deciding whether or not to accept it.

The case that is headed to the Supreme Court concerns the Warner-Lambert/Pfizer drug Rezulin, which is a Type 2 diabetes drug. The case, Warner-Lambert v. Kent is about how patients who claimed to have suffered personal harm from the drug alleged that Warner-Lambert concealed safety information from the FDA. The drug was removed from the market in 2000 and had liver risks described in the labeling.

After a district court ruled in favor of Warner-Lambert, the Second Circuit reversed on appeal, concluding that the previous Supreme Court ruling could not be applied to this case. In that case, the Supreme Court decided that federal law preempts claims of manufacturer liability for alleged misrepresentations made to the FDA. Warner-Lambert requested that the appeals court ruling be reversed and the respondents’ claims be dismissed.