Three years after a federal judge dismissed about 5,000 lawsuits by patients claiming Merck & Co.’s osteoporosis drug Fosamax was responsible for their femur fractures, a higher court says Merck will have to deal with them after all.
A federal appeals court in New Jersey has overturned the 2014 dismissal of the cases by a lower federal court, the New Jersey Law Journal reports (reg. req.). That dismissal centered on whether claims in state court were preempted by “clear evidence” that the Food and Drug Administration would not have approved a warning label that a plaintiff claims was needed to protect them from harm.
In its 89-page decision, the appeals court said it is not evident that Merck was entitled to the preemption and that was a decision for a jury to make, not a judge.
It says that it is undisputed that the FDA was aware of the possible link between Fosamax and so-called atypical fractures well before a 2010 study pointed them out and the dangers were included in a label change in December 2011. The court said Merck did not prove that a reasonable jury could find it “highly probable” that the FDA would have rejected a warning that a plaintiff claimed would have kept a doctor from prescribing the drug.
A Merck spokesperson said today in an email that the company remains “confident in the efficacy and safety profile of Fosamax,” and that it believes the question of “preemption” should be made by a judge and not a jury. The statement says the company remains “fully committed to defending these cases."
The litigation history of Fosamax has been lengthy and full of twists and turns. Merck won two bellwether suits over femur fractures suffered by Fosamax patients. But in 2013, Merck reached a separate settlement of $27 million with approximately 1,200 Fosamax users who suffered necrosis of the jawbone.