Merck Unhappy with Fosamax ONJ Jury Verdict

New York, NYMerck & Co., the manufacturer of the pharmaceutical drug designed to treat osteoporosis, is challenging the decision of a New York jury in the retrial of a case involving a Florida woman who claimed that Fosamax fostered the onset of Fosamax osteonecrosis.


In this particular case, the plaintiff alleged that she used Fosamax from 1997 through 2006, and reported various problems with her jaw as well as other complications following a pair of tooth extractions in June 2002. In 2004 the plaintiff was in hospital for several days to treat her condition.

The original trial of Boles v. Merck ended in a hung jury last year, so they tried again. This time, a jury in a federal court in New York found in favor of Boles.

Merck, possibly buoyed by a defense verdict for the manufacturer a month ago in Maley v. Merck, announced it was not happy with the outcome of the trial and is challenging the jury verdict. In a statement published on 6/25/10 in Business Wire, one of the lawyers representing the defendant indicated that the jury verdict stemmed from the plaintiff counsel's inflammatory and prejudicial remarks.

The executive vice president of Merck & Co. also weighed in. "Both the finding and the amount of the compensatory damages are against the weight of the evidence," said Bruce N. Kuhlik, who also serves as general counsel for Merck. "We believe the evidence showed that Fosamax did not cause the plaintiff's injury and that it is a safe and effective medication that was properly designed. While this is not the outcome we had hoped for, we remain fully committed to defending these cases."

Merck stands behind Fosamax (alendronate sodium) and claims to have acted responsibly in researching and developing Fosamax, as well as in the ongoing monitoring of the drug once it was approved and available on the market. Clinical trials conducted pre- and post-approval involved 28,000 patients, 17,000 of whom took Fosamax, the manufacturer claims. Merck reportedly provided evidence supporting the company's provision of timely and appropriate information to the medical, scientific, regulatory and consumer communities.

At trial the defendant noted the plaintiff presented with medical problems known for causing difficulties with the jaw, regardless of whether Fosamax was used at all. In addition, the defendants asserted the plaintiff was suffering from periodontal disease and had a smoking habit. Merck alleged that smoking up to a full pack of cigarettes in a day could lead to poor wound healing.

Having won the first trial and currently digging in on this one, Merck is gearing up for the scores of trials still in the pipeline. Business Wire reports there were about 1,039 Fosamax cases at the end of March. That figure involves 1,417 plaintiff groups not at all happy with various Fosamax side effects.