A New York jury has determined that a Merck & Co. osteoporosis drug did not cause an Indiana woman’s jaw to decay, resulting in a defense verdict in what was the second Fosamax trial to reach a jury, and the first case to result in a verdict.  

The federal Fosamax lawsuit, filed by Louise H. Maley, was one of three “bellwether” trials leading the way for nearly 1,000 other cases that involve similar allegations that users of the osteoporosis drug suffered jaw decay from Fosamax. Plaintiffs allege that long-term use of Fosamax has been linked to a rare and painful condition known as osteonecrosis of the jaw, which involves decay or death of the jawbone, often requiring surgery to remove portions of the jaw.

A jury in the U.S. District Court for the Southern District of New York deliberated for only 30 minutes earlier this week before determining that Maley did not suffer osteonecrosis of the jaw from Fosamax. The jury agreed with Merck’s position that multiple medical conditions suffered by Maley could have caused her jaw and dental problems, and never considered whether the drug maker failed to adequately warn about the risk of jaw problems from Fosamax.

The first Fosamax lawsuit to go to trial, filed by Shirley Boles, ended in a mistrial last year when jurors could not reach an agreement. That case is scheduled to be retried on June 2, 2010. The cases are two of three scheduled “bellwether” trials that are designed to gauge how juries will respond to evidence that is likely to be presented throughout the Fosamax litigation.

The first state court Fosamax trial is set to begin in New Jersey, with a case filed by Alison Rosenberg scheduled for trial to begin in the Atlantic County Superior Court on July 12. Like Maley and Boles, Rosenberg alleges that she developed debilitating jaw damage after taking Fosamax for a number of years to treat her osteoporosis.

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.

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.

In December 2009, Judge Keenan remanded at least one fracture Fosamax lawsuit, removing it from the federal MDL and returning it to the court where it was originally filed for seperate litigation. In his ruling, Judge Keenan stated that the evidence of general causation for the jaw decay lawsuits included in the MDL were substantially different from the case involving fractures from Fosamax.

Tags: Fosamax, Merck, ONJ, Osteonecrosis of the Jaw