Hundreds of previously dismissed Fosamax femur fracture lawsuits will be reinstated, after an appeals court determined that a jury should determine whether the FDA would have approved a prior warning label change.
Last week, the U.S. Court of Appeals for the Third Circuit issued a ruling (PDF), which vacates summary judgment granted in product liability lawsuits over Fosamax, which alleged that Merck failed to adequately warn consumers and the medical community that the popular osteoporosis drug may increase the risk of femur fractures.
Merck previously faced more than 1,100 cases brought throughout the federal court system by individuals who suffered a sudden thigh fracture following long-term use of the medication.
While Fosamax is designed to strengthen bones and reduce the risk of fractures associated with osteoporosis, studies have linked the drug to an increased risk of femur fractures, often involving little or no trauma, such as falling from standing height or less.
Given the similar questions of fact and law presented in the claims, the Fosamax fracture litigation was consolidated in the federal court system as part of an MDL, or multidistrict litigation, with all cases centralized before U.S. District Judge Joel A. Pisano in the District of New Jersey for discovery and pretrial proceedings.
Following several years of litigation, Judge Pisano granted summary judgment after deciding that there was evidence the FDA would have rejected any request by the drug maker to strengthen the Fosamax warning label. However, the appeals court disagreed.
The lower court decision was based on an interpretation of the Supreme Court’s decision in Wyeth v. Levine, which found that state law “failure to warn” claims are pre-empted by federal law. However, the appeals court pointed out that pre-emption only applies if the drug manufacturer can establish that there is “clear evidence” the FDA would have rejected a warning label change.
In a 78 page opinion, a panel of three judges in the U.S. Court of Appeals for the Third Circuit explained that plaintiffs have produced sufficient evidence for a reasonable jury to determine the FDA would have approved a properly-worded Fosamax fracture warning.
“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,” the Third Circuit determined. “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.”
Hundreds of cases can now be reinstated, and the issue may go before a jury, unless the manufacturer reaches Fosamax settlement agreements or another resolution for the litigation.