Thursday, November 06, 2008

Wyeth v. Levine – Supreme Court Oral Argument

The U.S. Supreme recently heard oral arguments on Wyeth v. Levine. The case is being watched closely by those interested in FDA preemption law. CNBC called it the “business case of the century.”

Diana Levine brought a common-law negligence claim against Wyeth, claiming that Wyeth should have revised a drug’s FDA-approved label to bar IV push administration. Wyeth argued that Ms. Levine’s state tort suit was preempted by federal law. The jury returned a verdict in favor of Ms. Levine, and the court opinion held that the jury’s state law based judgment presented no obstacle to FDA’s regulatory objectives. Wyeth appealed to the state supreme court.

In a divided opinion, the Vermont Supreme Court upheld the trial court’s ruling. The Court found that FDA approval is not required to strengthen label warnings, so Wyeth could have complied with both state and federal law. The court also held that FDA labeling regulations create minimum requirements, and that state tort liability for FDA-approved labels would not frustrate the objective of promoting the public health that led Congress to enact the FD&C Act. The Vermont Supreme Court did not afford any deference to recent FDA statements claiming that “FDA approval of labeling under the [FD&C Act] . . . preempts conflicting or contrary State law,” and that “FDA interprets the [FD&C Act] to establish both a ‘floor’ and a ‘ceiling,’ such that additional disclosures of risk information can expose a manufacturer to liability under the act if the additional statement is unsubstantiated or otherwise false or misleading.” Wyeth appealed the Vermont Supreme Court decision to the U.S. Supreme Court.

For additional information on this case and the issues:
· An excellent overview of the case is provided by Kurt R. Karst in the FDA Law Blog.
· Additional background on the case is available at the Drug & Device Law Blog.
· The briefs filed in the case and other background materials are available via the SCOTUS Wiki.
· A transcript of the oral argument is available here.
· Ed Silverman has predicted that the new President and a Democratic Congress will erase any preemption protection won in the last eight years.
· The American Association for Justice, the trial lawyers’ group, issued a preemption report last week, “Get Out Of Jail Free: How the Bush Administration Helps Corporations Escape Accountability.”
· A report prepared for Rep. Henry Waxman as Chair of the House Committee on Oversight and Government Reform found that some FDA career officials objected to Bush Administration drug labeling preemption policy. The senior officials viewed justifications for labeling preemption as “false and misleading,” based on “false assumption,” “naïve to what actually occurs in practice,” and relied on “gross overstatement.”

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