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Merck, Sharp & Dohme Corp. wants the U.S. Supreme Court to reverse an appeals court decision reinstating hundreds of suits over the bone-building drug Fosamax while making it nearly impossible for drugmakers to win preemption arguments ( Merck, Sharp & Dohme Corp. v. Albrecht , U.S., No. 17-, certiorari petition 8/22/17 ).
The U.S. Court of Appeals for the Third Circuit said warning claims involving a branded drug are preempted, or barred by federal law, only if a jury finds it “highly probable” the Food and Drug Administration would have rejected the warning a plaintiff sought.
Fosamax is prescribed to treat osteoporosis in post-menopausal women. The appeals court in March reinstated 516 product liability suits by plaintiffs who allege Merck didn’t adequately warn that Fosamax could cause atypical femur fractures, or breaks to the thigh bone that happen without impact.
Its ruling is the latest in a series of plaintiff-friendly decisions that misconstrued the Supreme Court’s landmark 2009 ruling in Wyeth Inc. v. Levine and gutted the pharmaceutical industry’s critical preemption defense, Merck says in an Aug. 22 petition for certiorari, or Supreme Court review.
Levine said failure-to-warn claims are blocked by federal law if a drug company can show “clear evidence” the FDA would have nixed a proposed warning.
Levine illustrates when a manufacturer didn’t prove the FDA would have rejected a label change, but offers little help in determining when a drug maker met the burden.
Merck says there was no evidence the FDA had considered the risk at issue in that case.
Since Levine, courts essentially require manufacturers to show that the FDA had denied a request for a virtually identical label, because it disagreed with the request as a matter of policy or science, Merck argues.
But here, Merck submitted data and analysis to the FDA suggesting that Fosamax may be associated with certain bone fractures, and proposed a warning. The FDA rejected the proposed addition, saying it wasn’t supported by the data, Merck says.
The Third Circuit, though, said a jury could find the FDA might have allowed a differently phrased warning.
That decision displaces the court as the gatekeeper applying the rule of law, and invites a lay jury to speculate about why an expert federal agency did what it did, Merck argues.
And the court inappropriately applied a heightened standard of proof on drugmakers, equating “high probability” with “clear and convincing,” Merck argues.
This case, with facts that establish preemption, is the ideal vehicle to mark the opposite of Levine, Merck says.
Jones Day filed the petition for Merck.
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