Fosamax Osteonecrosis Suit Submitted to Jury After Three Week Trial

A New York jury has begun deliberations over whether the osteoporosis drug Fosamax caused a 71 year old woman to suffer debilitating osteonecrosis of the jaw, in the first of nearly 1,000 similar Fosamax suits pending against Merck to go to trial.

Following a three-week trial, the jury heard closing arguments Wednesday in a case filed by Shirley Boles, who alleged that she developed severe jaw damage as a result of using Fosamax between 1997 and 2006. Boles alleged that Merck failed to properly research their popular drug and warn about the risk of users suffering Fosamax osteonecrosis, which involves irreversible decay of the jaw bone.

Merck & Co. faces more than 900 similar lawsuits involving the alleged Fosamax jaw side effects. Osteonecrosis of the jaw is associated with jaw infection and portions of the jawbone becoming exposed inside the mouth. The jaw decay is irreversible, and in many cases portions of the jaw must be surgically removed.

Boles’s Fosamax suit is one of three “Bellwether” trials that were selected for early trials to gauge issues common to many cases throughout the litigation and how jurors will receive the information. During trial, both sides presented expert witnesses who gave conflicting testimony over whether Fosamax causes ONJ, and, if it did, whether Merck could have known about it before 2003, by which time Boles had developed the disease.

Fosamax (alendronate sodium) was approved by FDA in October 1995, and has been used by more than 20 million people. Before the medication became available as a generic last year, Fosamax sales generated more than $3 billion annually for Merck.

All of the federal Fosamax osteonecrosis lawsuits are consolidated before U.S. District Judge John F. Keenan, in the Southern District of New York, as part of an MDL, or Multidistrict Litigation, for pretrial litigation.

After the Fosamax bellwether trials are concluded, if there is not a Fosamax settlement or other resolution of the claims, it is anticipated that Judge Keenan will begin remanding cases back to the original courts where they were filed as they become ready for trial.

The Boles case will be followed by a second Fosamax trial scheduled to begin on December 1, 2009 and a third to begin January 11, 2010.