The fourth bellwether trial for claims that side effects of Fosamax cause jaw necrosis has been scheduled to begin on May 9, 2011.
The Fosamax lawsuit alleges that Carolyn Hester, of Florida, was prescribed Fosamax in 1999 and suffered osteonecrosis of the jaw (ONJ), which causes portions of the jaw bone to decay. The painful and debilitating condition often causes bone to become exposed inside the mouth, sometimes resulting in full or partial jaw removal. Hester, 75, claims to have suffered severe and permanent injury and will have life-long complications.
In a Pretrial Scheduling Order issued on December 2, U.S. District Judge John F. Keenan announced that jury selection and opening statements will begin on May 9, 2011, in Hester’s claim. Her case will be the fourth Fosamax jaw necrosis lawsuit to see the inside of a courtroom, and it is expected to take at least two and a half weeks for the parties to present their cases to the jury.
Judge Keenan is presiding over pretrial litigation for the federal Fosamax MDL (multidistrict litigation), which has been centralized in the U.S. District Court for the Southern District of New York. There are currently about 1,000 cases pending against Merck, the manufacturer of Fosamax. All of the claims involve similar allegations that the drug maker failed to adequately warn about the risk of jaw problems from Fosamax.
Originally only three cases were selected for early trials in the Fosamax litigation, known as bellwether trials. However, in September, Judge Keenan indicated that at least two more Fosamax bellwether trials will be held in his court before he decides whether to remand cases to courts throughout the United States for individual trials.
Bellwether trials are used as test cases, to help the parties measure how juries are likely to respond to evidence, witness testimony and arguments that could will be presented throughout other cases in the litigation. The Fosamax trials that have reached a jury so far have not given the parties much guidance, or done much to promote a possible Fosamax settlement agreement.
The first bellwether trial, involving a lawsuit brought by Shirley Boles, ended in a mistrial in September 2009, after jurors failed to come to an agreement about whether Fosamax caused ONJ suffered by the plaintiff. Boles’ case was later retried and resulted in an $8 million verdict that Keenan later ruled was excessive. Boles has elected to have another trial rather than accepting Keenan’s reduced award of $1.5 million.
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.
Fosamax was approved by the 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.