Retrial of Fosamax Suit Results in $8M in Award for Jaw Damage

The retrial of a Fosamax suit that ended in a mistrial last year has resulted in an $8 million verdict in favor of a plaintiff who claimed that the osteoporosis drug caused her to develop severe jaw damage. 

A federal court jury in New York City sided with the plaintiff, Shirley Boles, who alleged that she suffered jaw decay after using the drug for a number of years. Formally known as osteonecrosis of the jaw or ONJ, the painful and disfiguring jaw injury is associated with irreversible death of the jaw bone, resulting in infection and portions of bone becoming exposed inside the mouth.

Fosamax (alendronate sodium), is a member of a class of drugs known as bisphosphonates, which 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 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 John 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 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.

Merck said in a press release that it will attempt to have the most recent decision in favor of Boles overturned in post-trial motions or by an appeal.

In May, the second Fosamax bellwether case, 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.

The third bellwether case in the Fosamax litigation is expected to go to trial in November.