Appeals Court Finds Fosamax Lawsuits Over Femur Fractures Are Not Preempted

Hundreds of Fosamax lawsuits will be reinstated once again, after the U.S. Court of Appeals for the Third Circuit determined that the drug maker was not prevented by federal law from independently updating label warnings about the increased risks of femur fractures associated with the osteoporosis drug.

The litigation has been pending for more than 13 years, involving product liability lawsuits filed by users who suffered sudden femur fractures that occurred with little or no trauma, allegedly due to side effects of Fosamax.

Plaintiffs have maintained that Merck knew about the bone fracture risk with Fosamax for years, but withheld information from consumers and the medical community until the U.S. Food and Drug Administration (FDA) required a label update in late 2010. However, the drug maker has repeatedly challenged the claims, maintaining that federal law prevented the company from independently updating the warning label.

Fosamax Lawsuit Dismissal History

In 2014, U.S. District Judge Joel Pisano granted a motion for summary judgment filed by Merck, dismissing all Fosamax femur fracture lawsuits involving injuries that occurred before the FDA label update, finding that the claims were preempted by federal law.

Following a lengthy appeals process, the Third Circuit Court of Appeals vacated that order in March 2017, and Merck took the case to the U.S. Supreme Court.

In a ruling issued in May 2019, 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.

The case was then remanded back to the U.S. District Court for the District of New Jersey, to determine whether there was “clear evidence” that 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.

However, after being handed the case in 2022 following those rulings, a federal judge in New Jersey again dismissed the Fosamax lawsuits, ruling that Merck had provided clear evidence that the FDA would have rejected warnings plaintiffs say should have been on the Fosamax label.

Plaintiffs appealed that ruling again, arguing that Merck could have revised the language in the proposed Fosamax femur fracture label warning to meet the agency’s requirements, but opted to go with no warning at all.

On September 20, the Third Circuit appeals court issued an opinion (PDF) ruling in favor of the plaintiffs, once again reinstating the litigation.

“With real respect for the thorough and thoughtful work the District Court did in this complex case, we nonetheless conclude that it erred in its pre-emption analysis by giving too little weight to the required presumption against pre-emption,” the opinion states. “Applying that presumption, and considering the record here, we conclude that Plaintiffs’ state law claims are not preempted. Accordingly, we will vacate the District Court’s judgment for Merck and remand for further proceedings.”

The decision means that Merck again faces hundreds of Fosamax femur fracture lawsuits, which have now been sent back to the U.S. District Court for the District of New Jersey, where they were consolidated for coordinated pretrial proceedings. It is unclear whether the drug maker will seek review again in the U.S. Supreme Court, attempt to negotiate Fosamax femur fracture settlements or push remaining claims to trial.