Mistrial Declared in First Fosamax Trial Over Jaw Necrosis

A federal judge has declared a mistrial in the first Fosamax lawsuit submitted to a jury over allegations that Merck & Co.’s popular osteoporosis drug causes jaw necrosis, or painful and deforming decay of the jawbone.

U.S. District Court Judge John Keenan granted the mistrial after several days of tense jury deliberations, which ended Friday afternoon with jurors confirming that they will be unable to reach a unanimous verdict. The case, which is one of more than 900 similar lawsuits over Fosamax pending against Merck, will likely be rescheduled for trial in Spring 2010.

The Fosamax lawsuit involved a claim by 71 year-old Shirley Boles, who alleges that she developed jaw damage in 2003 after using the drug for a number of years. Formally known as osteonecrosis of the jaw or ONJ, the jaw injury is associated with irreversible death of the jaw, resulting in infection and portions of bone becoming exposed inside the mouth.

The jury was unable to reach a verdict over whether Fosamax side effects caused the painful and disfiguring jaw injury Boles suffered and whether Merck failed to adequately warn about the potential problems. News reports suggest that most of the jurors were siding with Merck, but the eight jurors were unable to reach a consensus.

The case was the first of three “bellwether” Fosamax trials scheduled for an early trial to gauge how juries will respond to the evidence against Merck. However, in the Boles case, all evidence involving the drug maker’s knowledge of this potential Fosamax side effect after September 2003, by which time Boles had already developed the jaw injury, was excluded from the trial. In the other two “bellwether” trials, which are currently scheduled for January and April 2010, post-2003 evidence may be admitted, which plaintiffs’ lawyers suggest is the most damaging evidence against the pharmaceutical company.

All federal lawsuits involving Fosamax jaw problems are consolidated before Judge Keenan in an MDL, or Multidistrict Litigation, in the U.S. District Court for the Southern District of New York.