The United States Court of Appeals for the Third Circuit recently issued this opinion, In re: Fosamax (alendronate sodium) Products Liability Litigation, No. 22-3412, (3d Cir. Sept. 20, 2024), ruling that there is no federal preemption for more than 500 Fosamax MDL femur fracture lawsuits that had been dismissed previously and therefore, should now be reinstated.
A September 20, 2024, Reuters news report, “Court revives more than 500 lawsuits over Fosamax femur fracture risk”, provides a history of prior rulings on the legal defense of federal preemption for the Fosamax MDL femur fracture lawsuits:
The federal litigation stretches back to 2008, and has now been dismissed and revived twice. All of those decisions have hinged on the issue of federal preemption – whether the federal law governing what pharmaceutical companies are required to put on drug labels overrides, or preempts, state law claims that the label fails to warn consumers.
Merck has argued that it does, saying that in 2009 it proposed adding a warning about femur fractures but was initially rejected by the FDA. The warning was eventually added in 2011.
Now-deceased U.S. District Judge Joel Pisano in Trenton, New Jersey, ruled in Merck’s favor on the preemption issue in 2013, but the 3rd Circuit overturned that ruling in 2017, concluding that issue should have been decided by a jury.
The U.S. Supreme Court in 2019 ordered the issue reconsidered once again, saying it was a legal issue for a judge, not a jury.
In 2022, U.S. District Judge Freda Wolfson, who had taken over the case, again sided with Merck on preemption.
The 3rd Circuit on [September 20, 2024], however, again reversed. It said that, even though the FDA had not approved the specific warning proposed by Merck in 2009, it would not necessarily have rejected any warning about femur fractures….
Wolfson has since retired, and the case is now assigned in the trial court to U.S. District Judge Karen Williams. The litigation will return to that court for potential future trials.
We will continue to monitor legal developments for the Fosamax MDL femur fracture lawsuits.
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