Merck must face renewed Fosamax warning claims: U.S. appeals court

A federal appeals court on Wednesday revived claims by several hundred plaintiffs who accused Merck & Co of failing to adequately warn about the risks of thigh bone fractures associated with its osteoporosis drug Fosamax.

In a 3-0 decision, the 3rd U.S. Circuit Court of Appeals in Philadelphia said the plaintiffs may proceed to trial on their failure-to-warn claims, and a lower court judge erred in finding the claims pre-empted by federal law.

Merck said it is reviewing its options, and that a judge, not a jury, should decide the pre-emption question. It also said it remains “confident” in Fosamax’s safety and effectiveness.

David Frederick, a lawyer for the plaintiffs, did not immediately respond to requests for comment.

Fosamax, whose chemical name is alendronate sodium, has been prescribed to treat or prevent bone loss in post-menopausal women since 1995.

But the plaintiffs claimed to suffer atypical femur fractures from long-term use, and said Merck knew about the risk for more than a decade before adding it to the Fosamax warning label in January 2011.

The Kenilworth, New Jersey-based company changed the label four months after an outside task force hired by the U.S. Food and Drug Administration published a report associating Fosamax with the fractures.

In March 2014, U.S. District Judge Joel Pisano in Trenton, New Jersey, dismissed all claims by plaintiffs injured before Sept. 14, 2010, the date of the task force report, leaving only about 20 active cases.

Merck agrees to proposed $27.7 million settlement over Fosamax lawsuits

Merck & Co Inc said on Monday that it was prepared to pay $27.7 million to settle lawsuits by hundreds of people who sued the company over allegations that its osteoporosis drug Fosamax caused bones in the jaw to deteriorate.

Lawyers for Merck and plaintiffs disclosed the proposed settlement at a court hearing in New York to resolve 1,140 lawsuits pending in federal and state courts. Any settlement would need to be approved by a judge.

Merck, which confirmed the agreement later on Monday, said the accord requires a 100 percent participation rate and evidence that the claimants satisfy eligibility requirements. The deal covers about 1,200 people, the company said.

“We hope to bring this to a successful conclusion,” Paul Strain, a lawyer for Merck, said at the hearing in U.S. District Court in Manhattan before Judge John Keenan, who has presided over federal litigation by plaintiffs claiming that they developed osteonecrosis of the jaw from taking Fosamax.

The condition is a disease that causes bones in the jaw to deteriorate or die.

The settlement would resolve a large portion of the 5,255 product liability cases facing Merck over Fosamax, a one-time blockbuster drug with $3 billion in sales in 2007.

Scroll to Top