Merck denies Fosamax caused woman's ONJ

Aug 10, 2009

Merck said it will "vigorously defend itself" in the first of what is expected to be several liability trials involving the company's osteoporosis drug Fosamax.

In a statement issued August 11 -- the day the trial began in the U.S. District Court for the Southern District of New York -- Merck said it believes "the evidence will show that Fosamax did not cause Shirley Boles to develop dental and jaw-related problems as she claims and that Merck provided appropriate and timely information about Fosamax to the medical, scientific, and regulatory communities."

In Shirley Boles v. Merck & Co., Inc., the plaintiff alleges she used Fosamax from 1997 to 2006. She further alleges that she suffered various jaw problems and complications, such as osteonecrosis of the jaw (ONJ), following two tooth extractions in June 2002, including a several-day hospitalization in 2004 to treat her condition.

"Unfortunately, Ms. Boles had medical problems that cause people to develop jaw problems, regardless of whether they were taking Fosamax," said Paul Strain of Venable LLP, 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 Ms. Boles would have experienced dental and jaw-related problems whether she took Fosamax or not."

Bruce Kuhlik, executive vice president and general counsel of Merck, said that Merck acted responsibly in researching and developing Fosamax, as well as 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," Kuhlik said. "The company provided appropriate and timely information about Fosamax to consumers and to the medical, scientific and regulatory communities."

Fosamax was granted U.S. FDA clearance in September 1995 and is still on the market today.

As of June 30, 2009, approximately 899 Fosamax cases had been filed and were pending against Merck in either federal or state court, the company noted.