Retrial of Fosamax Bellwether Case Set to Begin Next Week

A new trial is scheduled to begin next Tuesday for the Fosamax bellwether case that ended in a mistrial last fall, after a jury could not come to a decision about whether side effects from Fosamax, a Merck & Co. osteoporosis medication, caused a woman’s jaw bone to decay. 

The Fosamax lawsuit involves a claim by 71 year-old Shirley Boles, who claims that she developed osteonecrosis of the jaw in 2003 after using the drug for a number of years. Boles alleges that Merck failed to adequately warn about the risk of the jaw damage from Fosamax, which is associated with death of the bone, often resulting in infection and portions of the jaw bone becoming exposed inside the mouth.

According to a scheduling order issued earlier this month, U.S. District Court Judge John Keenan, who is overseeing the pretrial proceedings for the federal Fosamax litigation, set a retrial date for June 2 in the Boles case. The trial is expected to take about two weeks.

Fosamax (alendronate sodium), is a member of a class of drugs known as bisphosphonates, and is 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 nearly 1,000 other lawsuits against Fosamax that involve similar allegations that users of the drug suffered jaw decay. 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 the first of three 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.

Earlier this month, the second Fosamax bellwether trial, involving a claim filed by Louise H. Maley, ended in a defense verdict for Merck after the jury determined that the plaintiff did not suffer osteonecrosis of the jaw from Fosamax. That jury agreed with Merck’s position that multiple medical conditions suffered by Maley could have caused her jaw and dental problems, so they never considered whether the drug maker failed to adequately warn about the risk of Fosamax jaw problems.

A third bellwether Fosamax case in the MDL is expected to go to trial in November.

In addition to the jawbone decay claims, Merck also faces a growing number of lawsuits over Fosamax femur fractures. Although Fosamax is designed to strengthen the bones and reduce the risk of fractures associated with osteoporosis, the drug has been linked to a number of non-impact femur fractures, which are allegedly caused by Fosamax side effects weakening the ability of the bone to repair itself from microdamage.