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Will High Court Provide Clarity On 'Clear Evidence'?
By Erin Bosman, Julie Park and Samuel Cortina
(March 8, 2018, 11:49 AM EST)
The U.S. Supreme Court may soon revisit one of its seminal decisions defining
products liability law for pharmaceutical manufacturers. That decision — Wyeth v.
Levine — addressed whether a branded manufacturer could be held liable for state-
law failure-to-warn claims even though federal law regulates the contents of its
drug’s label.
Lower courts have struggled to apply Levine’s "clear evidence" standard, and the
Third Circuit, in In re: Fosamax, arguably gutted it altogether. Merck & Co.’s petition
for a writ of certiorari in In re: Fosamax is pending before the Supreme Court,
where it awaits the views of the Solicitor General. If the Supreme Court grants
certiorari, it could signal that In re: Fosamax will be overturned and lower courts (as
well as branded manufacturers) will finally receive guidance on Levine’s “clear
evidence” standard.
Wyeth v. Levine — The "Clear Evidence" Preemption Standard
The Supreme Court’s 2009 decision in Wyeth v. Levine set the stage for the current
dispute over pharmaceutical preemption. In 2001, a musician named Diana Levine
won a jury verdict on her state-law failure-to-warn claims against branded
manufacturer Wyeth. Levine’s injury occurred when she visited her local clinic to
seek treatment for nausea and a migraine headache.
The physician’s assistant administered Phenergan for her nausea via the IV-push
method. Levine developed gangrene after the drug entered her artery, requiring
the amputation of her entire forearm—a devastating result for a musician. Levine
sued Wyeth, the manufacturer of Phenergan, for failure to sufficiently warn
clinicians that the IV-push method was contraindicated. The Vermont jury found in
favor of Levine and awarded her over seven million dollars.
Wyeth appealed, arguing that Levine’s state-law failure-to-warn claim was
preempted by federal law because it was impossible for Wyeth to comply with both
simultaneously. Federal law, said Wyeth, generally requires any label changes to be
approved by the U.S. Food and Drug Administration, whereas state law would have required Wyeth to
Erin Bosman
Julie Park
Samuel Cortina
