The U.S. Supreme Court has agreed to hear an appeal over the reinstatement of thousands of Fosamax fracture lawsuits, in a case that could have sweeping implications for product liability claims against drug manufacturers.
The high court announced on June 28 that it granted a petition by Merck to consider a case about whether claims by Fosamax users who suffered sudden fractures should be permitted to proceed.
The drug maker is attempting to reverse a decision by the U.S. Court of Appeals for the Third Circuit, which reinstated more than 1,000 failure to warn lawsuits filed over the osteoporosis drug, which claim that Merck should have provided stronger warnings that users may experience rare and unexpected femur fractures with little or no trauma, such as falling from standing height or less.
After the trial judge dismissed the litigation, finding that the claims were pre-empted, the U.S. Court of Appeals for the Third Circuit vacated summary judgment in March 2017.
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, summary judgment was originally granted in 2014, after the judge presiding over the litigation 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.
Potentially Sweeping Drug Liability Implications
If the Supreme Court expands upon the Wyeth ruling, it could broaden or narrow the definition of pre-emption. If the definition is broadened, as Merck hopes, it would mean that many consumers who suffer serious injuries or deaths due to drug side effects would be unable to seek compensation, simply because the drug was approved by the FDA.
However, narrowing the definition prevent drug manufacturers from attempting to use pre-emption as a shield in the future, and make them more proactive regarding drug label warnings.
It is also possible that the Justices issue a ruling that is specific to the technical details of this case, leaving the bigger questions about pre-emption unanswered.
Merck argues that 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.
Plaintiffs argue 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.
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.