Although jurors have indicated that they will not be able to reach an agreement in the first Fosamax trial over whether a 71 year old woman woman suffered debilitating jaw necrosis as a side effect of the osteoporosis drug, U.S. District Judge John Keenan has ordered them to continue deliberations in hopes of reaching a verdict.
The case is one of nearly 1,000 Fosamax lawsuits pending against Merck & Co. with similar allegations that the drug can cause decay or “death” of the jaw bone. It is the first of three scheduled “bellwether” trials, which were selected for early trials to gauge the jury’s response to issues that will be common to many cases throughout the Fosamax litigation.
Following the first nine hours of deliberations after closing arguments concluded on September 2, several notes were sent to the judge stating that at least some jurors believe an agreement cannot be reached. According to a report by Bloomberg News, the jurors met for a few more hours yesterday after being told to continue working, and they are scheduled to resume deliberations today.
The jury got the case after a three-week trial in the U.S. District Court for the Southern District of New York in Manhattan. The case involves allegations by Shirley Boles, who says that she developed severe jaw damage after using Fosamax between 1997 and 2006.
The condition, known as osteonecrosis of the jaw or ONJ, involves irreversible decay of the jawbone, which is painful and potentially disfiguring. It is associated with jaw infection and portions of the jawbone becoming exposed inside the mouth, potentially requiring surgery to remove parts of the jaw.
Lawsuits against Merck allege that Fosamax side effects increase the risk of ONJ when the drug is taken over long periods of time, and claim that the drug maker failed to adequately research their popular product or warn about the risk.
Fosamax (alendronate sodium) 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. The company faces more than 900 state and federal lawsuits over the ONJ claims.
According to the initial scheduling order, the Boles case will be followed by a second Fosamax bellwether trial on December 1, 2009 and a third scheduled to begin January 11, 2010.