Alendronate Atypical Fractures Back In Court Save

Reuters reports that a U.S. appeals court on Friday revived more than 500 lawsuits alleging that Merck failed to warn that patients taking alendronate for osteoporosis may be at increased the risk of atypical femoral fractures.

 

The Philadelphia-based 3rd U.S. Circuit Court of Appeals unanimously ruled federal law did not block the plaintiffs' state law claims over the drug. Fosamax was acquired in 2021 by Organon, which agreed to indemnify Merck against liability from the lawsuits.

 

This ruling gives Fosamax victims an opportunity to seek legal compensation from Merck. Merck and Organon, have stated they "remains confident in the efficacy and safety profile of Fosamax."

 

About 3,115 lawsuits over Fosamax were pending against Merck in both federal and state courts. The federal litigation on this started in 2008, and has since been dismissed and revived twice. These 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.

 

In 2009 Merck proposed adding a femur fractures warning but was rejected by the FDA. That warning was eventually added in 2011.

 

This issue has volleyed in US courts since and was recently covered in a JAMA editorial. The 3rd Circuit on Friday, 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.

 

The case is In re Fosamax (alendronate sodium) Products Liability Litigation, 3rd U.S. Circuit Court of Appeals, No. 22-3412.