Pre-emption preempted by Justice Thomas

The decision in Wyeth vs. Levine allows patients to sue in state court for harmful side-effects of drugs that are not properly disclosed.
Written by Dana Blankenhorn, Inactive

The path to pre-emption of state lawsuits by patients taking prescribed drugs was blocked by the Supreme Court 6-3 yesterday, with Justice Clarence Thomas writing an important concurring opinion.

The decision in Wyeth vs. Levine allows patients to sue in state court for harmful side-effects of drugs that are not properly disclosed.

Justice John Paul Stevens wrote the majority opinion, with Justice Stephen Breyer writing a separate concurrence.

Thomas seldom votes differently than Justice Antonin Scalia on business issues, and is known for never speaking during arguments, so this split is historically important.

He grounded his concurrence in strict construction, writing that "congressional and agency musings" are no substitute for clearly written law on such matters.

In Wyeth vs. Levine a former violinist, Diane Levine, sued Wyeth Pharmaceuticals after being given Phenergan intravenously and losing an arm to gangrene.

What makes Justice Thomas' opinion noteworthy is that he went beyond the liberal majority in attacking the whole idea of preemption.

I have become increasingly skeptical of this Court’s “purposes and objectives” pre-emption jurisprudence. Under this approach, the Court routinely invalidates state laws based on perceived conflicts with broad federal policy objectives, legislative history, or generalized notions of congressional purposes that are not embodied within the text of federal law. Because implied pre-emption doctrines that wander far from the statutory text are inconsistent with the Constitution, I concur only in the judgment. 

Only when acting under power granted by the Constitution can even the Congress pre-empt state law, he wrote, citing the 10th Amendment. He also quoted the Federalist Papers to the effect that federal powers are "few and defined," those remaining with the states "numerous and indefinite."

Both the case and the way it was decided will have big implications. The only way for industry to win full protection from state suits is through Congress, and even then it may be challenged.

This might seem to contradict last year's finding in Riegel vs. Medtronic that FDA approvals pre-empt state suits on medical devices. But the plaintiff in this case argued that Wyeth could have changed its warnings on the drug in light of evidence and was negligent in not doing so.

The protection from suits found in FDA approvals is thus limited to the specific letter of the warnings. Even though they may be hard to change, drug companies need to change them based on evidence found after they are on the market.

Editorial standards