Jaw Damage Lawsuit Against Fosamax Dismissed Weeks Before Trial

A federal judge has dismissed a lawsuit over Fosamax, saying that the plaintiff will be unable to establish at trial that the osteoporosis drug caused her to suffer debilitating jaw damage. The case had been scheduled for trial to begin on January 12, in what was to be the second of three bellwether trials in federal court, where hundreds of Fosamax lawsuits are current pending against Merck & Co.

U.S. District Judge John Keenan issued the ruling on Monday in a case filed by 74 year-old Bessie Flemings. In the case, Flemings alleged that Fosamax side effects caused her to suffer osteonecrosis of the jaw, or ONJ, which involves progressive destruction of the jawbone.

The case was dismissed after Flemings’ dentist testified in his deposition that he did not know what caused her jaw problems. In addition, Flemings smokes, which attorneys for Merck have argued also can cause ONJ. Judge Keenan determined that it would be impossible for Flemings to meet the burden of proof necessary for a jury to conclude Fosamax use resulted in her jaw necrosis.

Dismissal of the Flemings case will not have any impact on the estimated 900 pending jaw damage lawsuits against Fosamax filed by other plaintiffs. Although many of the cases are currently pending before Judge Keenan for pretrial proceedings as part of an MDL, or multidistrict litigation, each plaintiff still has an individual burden of proof. In addition to establishing that Fosamax causes jaw damage, each plaintiff must also prove that their injury was in fact caused by side effects of Fosamax.

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 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 first Fosamax jaw damage 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 case will be retried in the spring.

The third bellwether Fosamax trial is currently scheduled for April 2010 before Judge Keenan in the U.S. District Court for the Southern District of New York.