Following a recent U.S. Supreme Court ruling, the Third Circuit Court of Appeals has remanded hundreds of Fosamax bone fracture lawsuits for a U.S. District Judge to decide whether the failure to warn cases are pre-empted by federal law.
Merck faces about 500 product liability lawsuits filed by users who suffered sudden femur fractures allegedly caused by side effects of Fosamax, typically occurring with little or no trauma.
Plaintiffs have alleged the drug maker knew about the bone fracture risk with Fosamax, but withheld information from consumers and the medical community until the FDA required a label update in late 2010.
Merck has attempted to defend the litigation by arguing the failure to warn claims are preempted by federal law, maintaining that the FDA would not have allowed an earlier warning update, since the agency previously rejected a proposed label update about the risk of “stress fractures”.
In 2014, the U.S. District Judge Joel Pisano granted the drug makers motion for summary judgment, dismissing all Fosamax fracture claims involving injuries that occurred before a label update in September 2010.
After the Third Circuit vacated that order in March 2017, Merck appealed the issue to the U.S. Supreme Court.
In a ruling issued in May, the Supreme Court outlined the standard for a federal preemption defense in drug warning claims, indicating that it is a question for a judge, not a jury, to determine that there is “clear evidence” federal regulators were fully informed about the justifications for adding a warning, and the FDA, in turn, informed the drug maker the agency would not approve a label change to include that warning.
While the Supreme Court justices remanded the case to the Court of Appeals for further proceedings consistent with the opinion, Justice Clarence Thomas suggested in a concurring opinion that the Court should have rejected Merck’s preemption defense as a matter of law, indicating that Merck has been unable to point to any statute, regulation or other agency action that provides the force of federal law necessary to prohibit the drug maker from adding warning.
Following reconsideration of the case in light of the Supreme Court ruling, the Third Circuit issued an order (PDF) on November 25, remanding the claims back to the U.S. District Court for the District of New Jersey, where a judge will decide whether there is evidence to support the drug makers argument that they should not be held liable for failure to warn about the bone fracture risk.
“Following our review of the Supreme Court’s opinion and the supplemental briefing, we conclude and hereby order that these cases shall be remanded to the District Court in order to allow that court to determine in the first instance whether the plaintiffs’ state law claims are preempted by federal law under the standards described by the Supreme Court in its opinion,” the Third Circuit’s order states. “On remand, the District Court is instructed to determine the effect of the FDA’s Complete Response Letter and other communications with Merck on the issue of whether such agency actions are sufficient to give rise to preemption.”
Judge Pisano, who previously presided over the consolidated pretrial proceedings in the Fosamax bone fracture litigation, retired in February 2015. The federal multidistrict litigation (MDL) has since been reassigned to U.S. District Judge Fedea L. Wolfson.