Three Trials Scheduled in Fosamax Litigation Over Jaw Decay

Three Fosamax jaw decay lawsuits are scheduled to go to trial in 2012, including a new trial on damages in one case that resulted in an $8 million jury award in 2010.

U.S. District Judge John Keenan issued an order earlier this month calling for additional Fosamax bellwether trials to take place in May, September and November of next year. The cases will include lawsuits brought by Rosemary Spano and Shirley Boles, as well as one as-yet-unnamed case.

The jury in the Boles’ trial will only evaluate the damages that should be awarded for the plaintiff developing osteonecrosis of the jaw (ONJ) from Fosamax, as another jury already determined in October 2010 that the plaintiff’s damages were caused by Merck’s failure to adequately warn about the risk of the devastating jaw damage. However, Judge Keenan subsequently determined that the jury’s award of $8 million in damages was excessive, and Boles elected to have a new trial instead of accepting a reduced award of $1.5 million.

The Spano trial is slated to begin on May 7, the Boles damages trial is scheduled for September 10 and a third case is expected to begin on November 13. 

All of the plaintiffs claim that side effects of Fosamax caused them to suffer ONJ, where the jaw bone begins to decay and can result in bone showing through the skin. In some cases, full or partial jaw removal is required as a result of the condition.

Fosamax (alendronate sodium), is a member of a class of drugs known as bisphosphonates, which are prescribed for treatment of osteoporosis. Fosamax was approved by FDA in October 1995, and has been used by more than 20 million people. The drug generated over $3 billion in annual sales for Merck before it became available as a generic last year.

Merck faces about 1,000 other product liability suits over Fosamax that involve similar allegations that users of the drug suffered jaw damage. All federal cases are consolidated before Judge Keenan in the U.S. District Court for the Southern District of New York as part of an MDL, or multidistrict litigation.

Boles’ case was originally set to be the first of several Fosamax bellwether cases selected for an early trial to help give the parties an idea of how juries will respond to evidence that may be similar to what will be presented in other cases. Such trials are often useful in gauging the strengths and weaknesses of common claims in complex litigation, and could help lead to an eventual Fosamax settlement.

In September 2009, Judge Keenan declared a mistrial after several days of tense jury deliberations at the conclusion of Boles’ first Fosamax trial. The eight jury members were unable to reach a unanimous verdict in the case, though media reports suggested that most of the jurors were siding with Merck.

A retrial in October 2010 resulted in Boles being awarded $8 million, but Keenan reduced that monetary amount to $1.5 million, and Boles elected to have another trial for damages rather than accepting the reduced award. 

Merck has successfully defended itself in all but the Boles trial, and Keenan has assigned a settlement master in hopes of reaching an out-of-court settlement on most of the pending claims.

In addition to claims involving jaw damage, Merck also faces a growing number of lawsuits over femur fractures from Fosamax. Those complaints allege that long-term use of Fosamax can lead to atypical femur fractures, which typically occur with little or no trauma at all. Those cases are consolidated as part of a different MDL, which is centralized in the U.S. District Court for the District of New Jersey.