The U.S. Supreme Court is considering whether to hear an appeal filed by Merck, which is attempting to reverse a decision by the U.S. Court of Appeals for the Third Circuit, which reinstated more than 1,000 Fosamax femur fracture lawsuits pending in the federal court system last year.
A petition has been filed asking the Supreme Court to overturn a decision that restored the lawsuits after they were originally thrown out by the trial judge. The move has sparked a series of briefs between Merck and plaintiffs, who are urging the high court to reject the company’s petition.
In March 2017, the U.S. Court of Appeals for the Third Circuit vacated 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.
Each of the cases raise similar allegations against Merck, involving claims brought by individuals who suffered a sudden thigh fracture following long-term use of the osteoporosis drug.
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 atypical femur fractures, which may occur with 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 in 2014, 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 opinion 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 move that could have broad implications for product liability lawsuits involving medication side effects, Merck wants the court to revisit its ruling and better define what pre-emption means, in hopes of overturning the Third Circuit ruling and having the Fosamax claims dismissed again. The U.S. Solicitor General filed a brief (PDF) last month supporting Merck.
Merck says preemption applies in this case, because it attempted to update Fosamax labels to include a fracture warning, but the request was denied by the FDA. The Solicitor General states that the FDA’s decision clearly supported preemption.
On June 5, plaintiffs filed a supplemental brief (PDF) with the Supreme Court, saying that a review of the ruling is unwarranted, saying that Merck is basing its entire argument on an internal memo that talks about one employee’s phone conversation with the agency. The brief argues that the unusual nature of the case means that a ruling would be very limited in scope, and thus not worth the court’s consideration.
“Respondents are aware of no other preemption case in which the manufacturer relied on hearsay accounts of informal FDA communications to contradict the plain language of an official regulatory action,” the brief states. “The Third Circuit’s holding that factual disputes remained for the jury is thus unlikely to have significant influence beyond the case’s unusual facts.”
Merck issued a response (PDF) to the brief on June 7, arguing that if the FDA had found scientific grounds for a label change, it would have ordered the company to do so.
If the Third Circuit’s ruling is upheld, or the Supreme Court decides not to hear the case, hundreds of cases would be reinstated, and the issue may go before a jury, unless the manufacturer reaches agreements to settle or otherwise resolves the litigation.