Supreme Court Knocks Down FDA Preemption

Today, the U.S. Supreme Court held that FDA drug regulation does not preempt common law claims in state courts. This is a huge victory for consumers! The Court's decision in Wyeth v. Levine allows consumers to move forward with lawsuits against drug companies that sell defective drugs. I am happily surprised at the 6-3 outcome, and the Court in its wisdom found that Congress never intended for FDA labeling rules to preempt lawsuits in state courts.

The American Association of Justice has more:

Writing for the Court, Justice Stevens said:

“If Congress thought state-law suits posed an obstacle to its objectives, it surely would have enacted an express preemption provision at some point during the Food, Drug and Cosmetic Act’s 70 year history…Its silence on the issue, coupled with its certain awareness of the prevalence of state tort litigation, is powerful evidence that Congress did not intend FDA oversight to be the exclusive means of ensuring drug safety and effectiveness.”

Justice Thomas, in a concurring opinion, also dismissed the Wyeth preemption argument, calling it unconstitutional:

“Because such a sweeping approach to pre-emption leads to the illegitimate – and thus, unconstitutional – invalidation of state laws, I can no longer assent to a doctrine that preempts state laws merely because they ‘stand as an obstacle to the accomplishment and execution of the full purposes and objectives’ of federal law.”

The Plaintiff in the case, Ms. Levine, was a musician who lost her arm and her livelihood due to the failure of Wyeth to warn about the dangers of Phenergan...more from the NYT:

Ms. Levine’s suffering began in the spring of 2000 when, suffering from a migraine, she visited a local clinic for a treatment she had received many times: Demerol for pain and Phenergan for nausea.

If Phenergan is exposed to arterial blood, it causes swift and irreversible gangrene. Therefore, it is typically administered by intramuscular injection. Ms. Levine’s lawyers said an intravenous drip is also quite safe.

But a physician’s assistant used a third method, injecting the drug into what she thought was a vein, using a technique known as “IV push.” The assistant apparently missed a vein and hit an artery instead, causing Ms. Levine’s right hand and forearm to turn purple and black in the following weeks, leading to amputation of much of her arm.

The F.D.A.-approved label warned that “inadvertent intra-arterial injection” can cause gangrene requiring amputation, but it did not rule out administering the drug by the “IV push” method. The Vermont trial judge instructed the jury that compliance with F.D.A. requirements did not establish that the warnings on the labels were adequate.

Justice Stevens noted that the trial record contained evidence of at least 20 reports of amputations similar to Ms. Levine’s since the 1960’s. Phenergan was first approved in 1955.The justices who sided with Ms. Levine on Wednesday said that “Wyeth could have unilaterally added a stronger warning about IV-push administration” without running afoul of federal regulations. Justices Anthony M. Kennedy, David H. Souter, Ruth Bader Ginsburg and Stephen G. Breyer joined Justice Stevens, while Justice Clarence Thomas filed an opinion concurring in the overall judgment.