Merck wins bellwether Fosamax femur-fracture trial

The jury in the latest Fosamax trial has spoken, and it spoke for Merck ($MRK). In a federal court in New Jersey, the panel determined that plaintiff Bernadette Glynn's broken leg wasn't caused by the bone drug Fosamax. It was the first jury verdict among the more than 3,000 lawsuits claiming Fosamax caused serious femur fractures.

During the course of the trial, plaintiff's attorney Paul Pennock said Merck knew Fosamax could trigger the so-called "atypical" femur fractures, but didn't alert regulators or doctors until years later, after the drug had lost market exclusivity. The drug fell off patent in 2008 and has since lost three-fourths of its sales. In 2007, Fosamax was a $3 billion drug; in 2012, sales amounted to $676 million.

But Merck maintained that it not only kept patients and doctors apprised of Fosamax safety risks, but that early indications of a potential link to fractures were "theoretical," Bloomberg reports. The company's lawyer, Chilton Varner, contended that studies showed Fosamax patients had fewer fractures than patients on placebo.

In the end, the jury sided with Merck. "We are pleased with the jury's verdict," EVP and general counsel Bruce Kuhlik said. "The company provided appropriate and timely information about Fosamax to consumers and the medical, scientific and regulatory communities." We remain confident in the efficacy and safety profile of Fosamax and will continue to always act in the best interest of patients."

A 2010 study suggested that patients using bisphosphonate drugs--including Fosamax--were more likely to suffer that type of fracture. After reviewing the data, the FDA added warnings to the drugs' labels to caution doctors about long-term use. One of the agency's expert panels later backed warnings--perhaps even restrictions--on long-term use; by last year, the FDA had determined that the bone drugs offer limited benefit after three to 5 years of therapy.

In addition to 3,300 lawsuits filed by fracture patients, Merck has been fighting claims that Fosamax caused women's jawbone injuries. The company lost a bellwether trial in February. The jury in that case awarded $285,000 to patient Rhoda Scheinberg, saying that Merck didn't adequately warn patients about Fosamax's links to jawbone death.

- see the release from Merck
- get more from Bloomberg

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