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Merck Wins Lawsuit Brought By Fosamax Patient

From Associated Press (February 14, 2011)

NEW YORK -- Merck & Co. said Monday it won a third lawsuit brought by a patient who said the company’s former blockbuster osteoporosis drug Fosamax caused dental and jaw problems.

The company faces more than a thousand lawsuits brought by patients who say they developed jaw and dental problems including osteonecrosis of the jaw -- or rotting of the jawbone -- after using Fosamax. Merck has now won three of the four lawsuits that have gone to trial.

On Monday the company said a jury in the Superior Court for Atlantic County, N.J., found that Fosamax did not cause the patient’s dental and jaw problems. The patient used Fosamax from 1999 to 2006, and suffered jaw problems after having a tooth removed in December 2005. Merck said the woman’s history of dental problems and use of steroid medications contributed to those problems.

In the fourth Fosamax case that has gone to trial, a jury awarded the plaintiff $8 million. That amount was later reduced to $1.5 million, and Merck is appealing the verdict. The Whitehouse Station, N.J., company said about 1,180 lawsuit related to Fosamax have been filed, including about 1,560 plaintiff groups. The three other cases are being held in federal court; Monday’s verdict comes from a state level proceeding.

Separately, the Kaiser Permanente Center for Health Research said Monday a study published in a medical journal links Fosamax to osteonecrosis of the jaw -- but says the risk is "extremely low," occurring in less than a tenth of 1 percent of patients. Osteonecrosis of the jaw occurs when blood flow to the bone is reduced for an extended period of time, generally more than six to eight weeks.

A study published in the Journal of Dental Research found oral bisphosphonate drugs like Fosamax can cause osteonecrosis of the jaw. The results were based on a review of records of 572,606 patients. The review was conducted by Kaiser and the HealthPartners Research Foundation. It was funded by grants from the National Institutes of Health.

The lead author of the study said previous research indicated that about 1 percent of patients who take oral bisphosphonates develop osteonecrosis of the jaw. The study found 23 cases of the condition, with the majority found in patients who had other risk factors, like cancer, osteoporosis, or radiation treatment targeting the head and neck. A total of 21,164 patients were prescribed oral bisphosphonates, and six of them developed osteonecrosis of the jaw. Patients who took oral bisphosphonates were more likely to develop the condition than patients who did not.

Merck has said that there were no cases of osteonecrosis of the jaw in any clinical trials of Fosamax.

Kaiser Permanente said about 4.7 million Americans are taking oral bisphosphonate drugs. Generic versions of Fosamax, or alendronate, reached the market in February 2008. Before that, the drug was a multi-billion-seller for Merck.

Shares of Merck fell 23 cents to $32.84 in afternoon trading.

Posted: February 2011