Appeals court ruling resurrects 5,000 lawsuits tied to Merck & Co. Fosamax dangers

A federal appeals court ruling has resurrected about 5,000 cases against Merck & Co. tied to osteoporosis drug Fosamax.

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. 


Simplify and Accelerate Drug R&D With the MarkLogic Data Hub Service for Pharma R&D

Researchers are often unable to access the information they need. And, even when data does get consolidated, researchers find it difficult to sift through it all and make sense of it in order to confidently draw the right conclusions and share the right results. Discover how to quickly and easily find, synthesize, and share information—accelerating and improving R&D.

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.

Suggested Articles

With a brand new approval for Adakveo under its belt, Novartis Sunday flaunted an analysis showing the drug could cut patient hospitalizations by 40%.

BeiGene only just won its first Brukinsa nod in MCL. But it’s already pushing to join the CLL field, and Sunday it rolled out more data.

How long can one infusion of CAR-T drug Yescarta continue helping patients with refractory large B-cell lymphoma? Pretty long, Gilead showed Saturday.