Merck Settles on Fosamax Damage Award in First Jaw Decay Case

After three years, two jury trials and appeals involving a number of issues, Merck has reportedly agreed to stipulate to a damage award in the first Fosamax “bellwether” case involving claims that their popular osteoporosis drug caused a woman to suffer debilitating decay of her jaw bone. 

A Fosamax jaw decay lawsuit brought by Shirley Boles was the first of several hundred similar claims to be presented to a jury in September 2009, resulting in a mistrial after jurors were unable to agree on a verdict.

Following re-trial in June 2010, Boles obtained the first successful Fosamax verdict, after a jury found that Merck failed to adequately warn about the risk of users developing osteonecrosis of the jaw, a rare condition where the jaw bone begins to decay and rot, often resulting in the need for surgery to remove portions of the jaw.

Boles was awarded $8 million in damages from Fosamax by a federal jury, but the judge that presided over the case subsequently ruled that the verdict was excessive. Rather than accepting a reduced of $1.5 million, Boles opted for a third trial to determine the among of damages she would receive for her Fosamax jaw injury.

The case was set to be presented to another jury this month to determine the amount of damages that would be awarded to the Estate of Shirley Boles, who died since the second trial. However, a confidential Fosamax settlement agreement has reportedly been reached, involving a stipulation on the amount of damages.

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 currently faces about 1,000 Fosamax cases involving jaw damage that was allegedly caused by long-term use of the osteoporosis drug. In the federal court system, the cases have been consolidated as part of a multidistict litigation, or MDL, which is centralized before U.S. District Judge John F. Keenan in the Southern District of New York.

Besides the Boles case, Merck has successfully defended each of the other Fosamax bellwether trials that have reached a jury.

Judge Keenan previously indicated that at least two more “bellwether” trials will be held in the Fosamax jaw damage MDL, to help the parties gauge how juries are likely to respond to certain testimony and evidence that may be repeated throughout many cases. In addition, a well-respected law professor was appointed late last year to oversee potential Fosamax settlement negotiations before Judge Keenan starts remanding cases back to the U.S. District Courts throughout the country where they were filed for individual trial dates.

In addition to claims involving jaw damage, Merck faces an even greater number of Fosamax lawsuits over atypical femur fractures, which can occur with little or no trauma at all. In the federal court system, 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.