The retrial of the Fosamax/osteonecrosis of the jaw (ONJ) trial that ended in a mistrial last year got under way June 7 in the U.S. District Court for the Southern District of New York.
The lawsuit involves a claim by Shirley Boles, 71, who alleges that she developed ONJ in 2003 after using the drug for several years. According to Boles, Merck -- manufacturer of Fosamax -- failed to adequately warn about the risk of the jaw damage from Fosamax.
The case was initially tried in the summer of 2009 and resulted in a mistrial after the jury was unable to reach a unanimous verdict.
The company believes the evidence will show that Fosamax did not cause the plaintiff to develop dental and jaw-related problems as Boles claims.
"Unfortunately, the plaintiff had medical problems that cause people to develop jaw problems, regardless of whether they were taking Fosamax," said Paul Strain of Venable, outside counsel for Merck, in a press release. "She had significant periodontal disease and a history of smoking up to a pack of cigarettes a day, which can result in poor wound healing. The evidence will show that the plaintiff would have experienced dental and jaw-related problems whether she took Fosamax or not."
"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," said Bruce Kuhlik, executive vice president and general counsel of Merck. "The company provided appropriate and timely information about Fosamax to consumers and to the medical, scientific, and regulatory communities."
As of March 31, 2010, approximately 1,039 Fosamax cases, which include approximately 1,417 plaintiff groups, had been filed and were pending against Merck in either federal or state court.
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