Processing Magazine

Feds Back Wyeth in Supreme Court Case

June 9, 2008
According to the Wall Street Journal, in what’s likely to be the biggest court case of the year for the drug industry, the federal government has filed a brief with the Supreme Court backing Wyeth.

The case, Wyeth v. Levine, asks whether a patient who has been harmed by a drug can sue under state law if the drug was produced and marketed under terms approved by the FDA. The broader legal question is called “preemption,” and refers to the question of whether federal law preempts state law.

Some lawyers on the WSL website emphasize the feds’ argument that the FDA considers the balance of risks and benefits when approving a drug’s label, and that there are only very narrow circumstances in which a drugmaker can change a drug’s label without prior approval from the agency.

The balance of risks and benefits weighed by the FDA is central to the feds’ argument. Filing on behalf of the FDA, the Department of Justice wrote in its brief: “Because FDA’s approval strikes a balance between competing considerations, state laws that strike a different balance conflict with FDA’s determination and are impliedly preempted.”

The Supreme Court will hear the case later this year.