A firm trial date of January 12 has been scheduled for a Fosamax lawsuit against Merck & Co. over their popular osteoporosis drug, which alleges that the drug caused a woman to suffer severe and debilitating deterioration of the jaw, known as osteonecrosis of the jaw (ONJ).
The trial will be the second Fosamax case to be submitted to a jury out of more than 900 lawsuits against the drug manufacturer over the drug. The case was selected as a bellwether trial in the consolidated federal Fosamax litigation to evaluate how juries will respond to similar evidence that will be presented in the cases.
The first Fosamax trial, involving a claim filed by Shirley Boles, ended in a mistrial in September, after the jury was unable to reach a unanimous decision. It is anticipated that the Boles case will be retried in the spring after this second trial and a third that is currently scheduled for April 2010.
The lawsuits over Fosamax all involve similar allegations that side effects of the drug caused plaintiffs to suffer decay of the jawbone, resulting in infection and portions of exposed bone inside the mouth. Osteonecrosis of the jaw is a painful and irreversible condition, often requiring surgery to have portions of the jaw surgically removed.
According to an order issued this week by U.S. District Judge John F. Keenan, who is presiding over the consolidated Fosamax cases in federal court, the trial for a case brought by Bessie Flemings will begin on January 12, 2010. Following jury selection, each side will have five days to present their case, meaning the case is expected to conclude by the end of the month.
Bessie Flemings, who originally filed her case in Mississippi before it was transferred to the U.S. District Court for the Southern District of New York as part of the multidistrict litigation (MDL), alleges that she was diagnosed with Fosamax jaw necrosis in May 2006. The complaint alleges that Merck knew about the risk of jaw damage from Fosamax as early as 2002, but failed to adequately warn physicians and dentists.
Fosamax (alendronate sodium) is a member of a class of drugs known as bisphosphonates, which have been associated with decay of the jawbone when taken long-term or at high doses. With a very long half-life of 10 years, most of the Fosamax claims argue that dose accumulation over time increases the risk of ONJ. However, some research has indicated the potential Fosamax side effect can occur after use as short as one year.
Fosamax was approved by FDA in October 1995, and has been used by more than 20 million people. Before the medication became available as a generic last year, Fosamax sales generated more than $3 billion annually for Merck.