PHILADELPHIA (CN) – In a sweeping reversal against the drugmaker Merck, the Third Circuit revived hundreds of class actions by people whose thigh bones shattered while they were taking the osteoporosis drug Fosamax.
The multidistrict litigation turns on whether Merck Sharp & Dohme had a duty to include a warning on Fosamax labels about the drug’s risk of femoral fractures.
Merck nearly dodged the case altogether, however, thanks to a 2009 decision in the case Wyeth v. Levine. In that case, the Supreme Court found that federal law pre-empts consumers from bringing failure-to-warn claims under state law when there is “clear evidence” that the Food and Drug Administration would not have approved the warning that a plaintiff claims was necessary.
Though a federal judge in New Jersey granted Merck summary judgment on the remaining Fosamax cases based on Wyeth, the Third Circuit overturned that ruling in an 89-page opinion on March 22.
“Preemption is an affirmative defense, and Merck has not carried its burden to prove that it is entitled to that defense as a matter of law,” Judge Julio Fuentes wrote for a three-person panel. “The Wyeth ‘clear evidence’ standard is demanding and fact-sensitive. It requires the factfinder to predict a highly probable outcome in a counterfactual world and, therefore, requires a court sitting in summary judgment to anticipate both the range of conclusions that a reasonable juror might reach and the certainty with which the juror would reach them.”
Merck contended that the law was on its side since it had in fact proposed a revision to the Fosamax label that would have included a warning about the risk of bone fractures.
Though the FDA rejected the proposal in 2009, Fuentes said this does not put Merck in the clear.
“The burden and the responsibility to correct a drug label rests with the manufacturer, not the FDA,” he wrote. Once the FDA rejected Merck’s proposal, the ball was back in Merck’s court to submit a revised, corrected proposal.”
For the appeals court, the award of summary judgment to Merck was premature.
“Here, plaintiffs have produced sufficient evidence for a reasonable jury to conclude that the FDA would have approved a properly worded warning about the risk of thigh fractures — or at the very least, to conclude that the odds of FDA rejection were less than highly probable,” Fuentes wrote.