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Merck wins Fosamax case

Merck has won the first US state court case to go to trial over whether the company's osteoporosis drug Fosamax (alendronate) causes serious dental and jaw problems
Merck has won the first state court case to go to trial over the issue of whether the company's much-prescribed osteoporosis drug Fosamax (alendronate) causes serious dental and jaw problems. 

A state court jury in New Jersey found in the company's favour in Rosenberg v. Merck. According to Merck's counsel, the 75-year-old plaintiff, who took Fosamax from 1999 to 2006, had other medical conditions that were likely responsible for her jaw and dental problems, including a long history of periodontal and endodontic treatments and extended use of steroid medications.

Fosamax, an oral bisphosphonate, is safe for the majority of people who take it but may pose a risk of osteonecrosis (or "bone death") of the jaw in some people, according to the US Food and Drug Administration (FDA). The reports of osteonecrosis have been primarily associated with active dental disease or a recent dental procedure. 

The trial, which took place in Superior Court for Atlantic County, New Jersey, was the fourth US Fosamax trial to reach a jury. The three others were tried in Federal court. In all, there are about 1,180 US Fosamax cases pending, which include approximately 1,560 plaintiff groups, but settlements are expected to be reached based on the early "bellweather" trials, which were selected to provide an indication of how juries are likely to respond.

The first three trials were conducted as part of the federal multidistrict litigation proceedings before Judge John F Keenan in the US District Court for the Southern District of New York. The first and third trials resulted in defense verdicts for Merck, while the second resulted in a plaintiff verdict that Merck is appealing. 

Fosamax was approved in the US in 1995 and had annual revenues of $3bn a year before generic competition began to cut into sales. The drug is cleared by the FDA for multiple indications, including the treatment and prevention of osteoporosis in postmenopausal women.

"Merck acted responsibly in researching and developing Fosamax and in monitoring the medicine ever since it has been on the market. Our clinical trials, conducted both before and following approval, have involved more than 28,000 patients, including more than 17,000 treated with Fosamax," Bruce N Kuhlik, Merck's general counsel, said in a statement. "The company provided appropriate and timely information about Fosamax to consumers and to the medical, scientific and regulatory communities."

15th February 2011

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