Merck defeats 500 lawsuits over Fosamax bone-fracture risk warnings

(Reuters) - Following a trip to the U.S. Supreme Court, Merck & Co has convinced a judge to toss more than 500 lawsuits alleging it failed to warn Fosamax users about the risks of developing thigh bone fractures associated with the osteoporosis drug.

U.S. District Judge Freda Wolfson in Trenton, New Jersey, said because the U.S. Food and Drug Administration rejected Merck's proposal to add a warning to Fosamax's label about fracture risk, federal law preempted the plaintiffs' state-law claims.

The ruling Wednesday followed more than 14 years of litigation and marked the second time Merck had won the dismissal of the cases on preemption grounds, after now-deceased U.S. District Judge Joel Pisano ruled in its favor in 2013 following a trial.

The 3rd U.S. Circuit Court of Appeals overturned that ruling in 2017, concluding that the issue of whether federal law preempted the cases presented a factual question that a jury needed to decide, not a question of law for the judge.

But the U.S. Supreme Court in 2019 ordered the issue be reconsidered, saying the question of federal law preempts state-law failure-to-warn claims is "a legal one for the judge, not a jury."

In an 87-page ruling, Wolfson said a 2009 letter by the FDA rejecting a warning Merck proposed concerning atypical femoral fractures demonstrated the drugmaker was not allowed to make the type of warning the plaintiffs desired.

While the plaintiffs' lawyers argued the letter did not mean the FDA would have rejected any and all warnings, Wolfson said "it is clear that the agency would not have approved a differently worded warning about such a risk."

James Cecchi, co-liaison counsel to the plaintiffs at Carella Byrne Cecchi Olstein Brody & Agnello, did not respond to requests for comment, and neither did Merck or defense lawyer Karen Confoy of Fox Rothschild.

The plaintiffs in the multidistrict litigation alleged they suffered atypical femur fractures from long-term use of Fosamax from 1999 to 2010 and said Merck knew about the risk before finally adding it to the warning label in January 2011.

It did so after the FDA reached a new conclusion in 2010 and ordered all manufacturers of bisphosphonate drugs like Fosamax to revise their warning labels after a task force further studied the issue.

Merck in a Feb. 25 quarterly report said it faced 3,470 product liability lawsuits in federal or state court involving Fosamax. In 2013, it settled lawsuits by around 1,200 people alleging the drug caused bones in the jaw to deteriorate for more than $27 million.

The case is In re Fosamax (alendronate sodium) Products Liability Litigation, 3rd U.S. Circuit Court of Appeals, No. 14-1900.

For the plaintiffs: James Cecchi of Carella Byrne Cecchi Olstein Brody & Agnello; Christopher A. Seeger of Seeger Weiss; Paul Pennock of Weitz & Luxenberg; Timothy O'Brien of Levin, Papantonio, Thomas, Mitchell, Rafferty & Proctor; and David Frederick of Kellogg Hansen Todd Figel & Frederick

For Merck: Karen A. Confoy of Fox Rothschild and Stephen Marshall of Venable

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Supreme Court gives Merck another shot to avoid Fosamax lawsuits

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