SCOTUS Will Hear Preemption Case Appeal
The Supreme Court has agreed to hear Merck’s appeal of a controversial 3rd Circuit Court of Appeals ruling that a jury should be allowed to “speculate” about how FDA might have responded to a hypothetical Merck application to add to its Fosamax label a warning about atypical femur fracture. Attorney Joe Hollingsworth (Hollingsworth) writes in a Washington Legal Foundation Legal Pulse that the 3rd Court made its ruling despite the fact that Merck had submitted an actual application to FDA to change the Fosamax labeling and FDA refused to permit it.
“The 3rd Circuit effectively imposed an insurmountable hurdle to pharmaceutical defendants seeking summary judgment on preemption grounds (despite the court’s protestations to the contrary),” Hollingsworth says.
Until the Fosamax case, he says, FDA rejection of an actual proposed warning had been considered the gold standard for determining whether there was “clear evidence” of preemption as required by the Supreme Court in Wyeth v. Levine. But, he says, the 3rd Circuit read “clear evidence” to require an extremely heightened burden in which the evidence is examined to see whether it is “highly probable” that FDA would have rejected a proposed warning.
Further, he writes, although the construction of the scope and impact of regulatory actions traditionally is a question of law, the 3rd Circuit held that speculation about whether it was “highly probable” the FDA would have rejected a proposed warning was a question of fact for the jury.
Hollingsworth says the Solicitor General filed a strong brief supporting Merck’s request that the high court hear its appeal. The government brief says that the scope and import of regulatory action is a question of law for the court, not a question of fact for the jury, and that where the manufacturer actually proposed to warn about the adverse event at issue and FDA declined, that should end the inquiry.
“That approach is a sensible one that the Supreme Court should adopt, as forecast in Wyeth,” Hollingsworth concludes. “Even better, though, we would have thought unnecessary at one time, the Supreme Court should clarify that its ‘clear evidence’ language in Wyeth was not intended to establish an impossibly high evidentiary burden on defendants asserting preemption.”