Personal Injury Law

Supreme Court rejects Pharma giant Wyeth's FDA pre-emption claims in Wyeth v. Levine

By Brian F. LaBovick, Esq.

Interesting turn of events today in the U.S. Supreme Court.  The Supreme Court issued a decision  regarding pre-emption in  the Wyeth v. Levine, product liability case. This was an overwhelming victory for Americans. The 6-3 decision explicitly upheld the ruling that FDA  approvals do not provide a defense to pharmaceutical manufacturer Wyeth in product liability tort claims, in the Wyeth v. Levine, No. 06-1249 (slip op., 03/04/09).

According to the 80 page decision that was delivered by Justice Stevens,

Directly injecting the drug Phenergan into a patient'vein creates a significant risk of catastrophic consequences-quences. A Vermont jury found that petitioner Wyeth, the manufacturer of the drug, had failed to provide an Adequate-quate warning of that risk and awarded damages to re-spondent Diana Levine to compensate her for the amputation of her arm. The warnings on Phenergan's label had been deemed sufficient by the federal Food and Drug Administration (FDA) when it approved Wyeth's new drug application in 1955 and when it later approved changes in the drug's labeling .The question we must decide is whether the FDA's approvals provide Wyeth with a complete defense to Levine's tort claims. We conclude that they do not.

The majority decision, authored by Justice Stevens, unequivocally rejected the pharmaceutical defendant's arguments that the FDA regulatory scheme preempted state law failure-to-warn claims and outlined the real world limitations of FDA powers. This decision will have implications in pharmaceutical product liability claims for decades to come. Also joining Justice Stevens were Supreme Kennedy, Sorter, Ginsberg, Beyer, and Thomas. It was not surprising that the three dissenters included, Chief Justice Roberts, Ali to and Scalar. 

It is important to note that this Br yer and Thomas clarified their vote by also writing an opinion in addition to Justice Stevens.  This solidified their strong belief in their sentiments that manufacturers can't hide behind the FDA approval and not be vigilant in issuing necessary warnings and safety precautions. The Supreme Court held: (1) the FDA's regulatory scheme exists in harmony with state law failure-to-warn claims; (2) the controversial 2006 FDA preamble regarding preemption is entitled to no deference; and (3) it is the manufacturer, not the FDA, which has the duty to warn consumers about side effects. As the Supreme Court reasoned, 'State tort suits uncover unknown drug hazards and provide incentives for drug manufacturers to disclose safety risks promptly.' (Slip op., at 23.)

One does not have wonder too long as to whose side C.J. Roberts and Alito are  on after reading the dissenting opinion.  Alito states in his dissenting opinion that :

This case illustrates that tragic facts make bad law. The Court holds that a state tort jury, rather than the Food and Drug Administration (FDA), is ultimately responsible for regulating warning labels for prescription drugs. That result cannot be reconciled with Geier v. American Honda Motor Co., 529 U. S. 861 (2000), or general principles of conflict pre-emption.

Alito goes on to pose the hypothetical question:  "is it the FDA or a jury in Vermont— that has the authority and responsibility for determining the 'adequacy' of Phenergan's warnings?"

There is so much to discuss in this 80 page decision.   Over the next few days we will go into the decision more on this blog, to highlight more important points in this opinion. As Civil Justice Prosecutors, we are pleased with the Court's decision in Wyeth v. Levine.

Full post as published by LaBovick Injury Law Blog on March 04, 2009 (boomark / email).