In the past, I've discussed the Wyeth v. Levine case and predicted that the U.S. Supreme Court would favor the drug industry by immunizing it against state court personal injury lawsuits that attack the sufficiency of FDA-approved labeling.
Well, I was wrong. In the eagerly anticipated outcome of that case, the Supreme Court decided, by a 6-3 majority, that federal drug-labeling law does not "pre-empt" personal injury lawsuits based upon state law and the alleged failure to warn.
Time for a rewind. In Levine, the Vermont Supreme Court upheld a $6.8 million verdict for a professional musician who lost her arm because a Wyeth drug was misadministered. In doing so, the Vermont Court rejected Wyeth's pre-emption argument, which said that Wyeth's drug-labeling and warnings were FDA-approved and that federal law should pre-empt any state law applicable to "failure-to-adequately-warn" personal injury claims.
The Supreme Court then accepted the case for review and has now affirmed the Vermont court's no pre-emption ruling.
The Supreme Court rejected Wyeth's two principal arguments. Wyeth first argued that it would be impossible for it to comply with both state law duties and federal labeling duties. There is an FDA "changes being affected" regulation that allows a drug manufacturer to make certain types of labeling changes that strengthen a label warning in order to improve drug safety.
Pursuant to this regulation, Wyeth could have added a more robust warning about intravenous "pushing" of the drug administered to Levine (which is meant to be administered intramuscularly). The Supreme Court said there was insufficient proof that, by unilaterally making the label warning stronger, Wyeth would have violated federal labeling laws. The Court emphasized that it is the drug manufacturer, and not the FDA, that is responsible for labeling content.
Wyeth next argued that requiring it to comply with state "failure to warn" law interferes with Congress' intent to entrust drug-labeling decisions to an expert federal agency. The Supreme Court, however, described this argument as an "overbroad view" of Congress' intent and the power of an agency to pre-empt state law.
The Court said that Wyeth failed to produce any evidence that Congress stated that specific federal labeling standards leave no room for different state law judgments. Instead, Wyeth relied upon statements by the FDA that state laws threatened the FDA's role. The Court rejected this "hoisting one's self upon one's own petard" approach.
Justice John Paul Stevens, the oldest member of the court, delivered the majority opinion, in which Justices Anthony Kennedy, David Souter, Ruth Bader Ginsburg and Stephen Breyer joined. These justices, of course, are the so-called "liberals" of the Court, with Kennedy regarded as a "swing" vote. Surprisingly, Justice Clarence Thomas agreed with the result, but he filed his own opinion. Scalia, Alito and Roberts--the Court's other "conservatives"-- dissented.
This may be a landmark case, and it is already drawing a lot of reaction. Certainly, it is positive for plaintiffs and plaintiffs' personal-injury lawyers--and negative for not only drug manufacturers but also other industries regulated by federal law. Consumer organizations are hailing the decision as a great victory, while trade organizations are bemoaning the negative effects this decision could have on healthcare costs and, in turn, public health itself.
The court left "failure to warn" defendants some wiggle room, however, recognizing that some state law claims may frustrate federal regulatory objectives. But, the court said that "this is not the case." The pre-emption argument, contrary to my previous prediction, has been dealt a heavy blow. How heavy remains to be seen as lower federal courts will now have to interpret the Levine opinion.
PHILIP G. KIRCHER
is co-chairman of the commercial litigation department at the law firm of Cozen O'Connor.
April 1, 2009
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