Fosamax Jaw Damage Trial Will Not Result in Punitive Damages

According to a pretrial order, Merck & Co. will not face the possibility of punitive damages in the first Fosamax trial scheduled to begin next month in New York. The case involves allegations that the drug maker failed to warn that their popular osteoporosis drug Fosamax increases the risk of debilitating jaw damage, known as jaw necrosis or osteonecrosis of the jaw (ONJ).

U.S. District Judge John Keenan, who is presiding over the consolidated federal Fosamax litigation in Southern District of New York, announced this week that the first of three “bellwether” cases set for trial to start August 11 will go forward as planned, as Merck’s motion to have the case dismissed on liability was denied. However, Bloomberg News reports that Judge Keenan indicated that the jury will not be able to consider the possibility of punitive damages as a result of Merck’s action, even if they find for the plaintiff.

The Fosamax lawsuit involves a claim filed by plaintiff Shirley Boles, who alleges that she developed permanent jaw damage as a result of using Merck’s drug from January 1997 to March 2006. The case is one of more than 850 lawsuits pending against Merck over the alleged Fosamax jaw damage, with about 700 of the cases pending in a federal MDL, or Multidistrict Litigation, before Judge Keenan.

Fosamax (alendronate sodium), is a member of a class of drugs known as bisphosphonates. Approved by the FDA in October 1995, it generated more than $3 billion in sales annually for Merck before it became available as a generic last year and more than 20 million people have used the drug.

The Fosamax jaw damage lawsuits allege that Merck failed to adequately warn about the risk of osteonecrosis of the jaw and made false and misleading misrepresentations about the drug’s safety, preventing patients and doctors from avoiding the painful and potentially disfiguring condition.

Osteonecrosis of the jaw symptoms can cause swelling or infection of the gums, loose teeth or tooth aches, pain in the jaw and exposed areas of bone inside the mouth. There is no cure or effective treatment for the painful and debilitating condition, and many people who suffer from jaw necrosis ultimately require surgery to remove portions of their jaw.

Judge Keenan’s rulings clear the way for jury selection and opening statements to begin on August 11. If Merck is found liable for Boles jaw damage, the jury will only be able to award compensatory damages.

Following the Boles case, a second trial is scheduled to begin on December 1, 2009 for plaintiff Bessie Fleming, and a third filed by Karen Greene is scheduled to begin January 11, 2010.

In addition to the federal MDL cases, there are about 130 state cases consolidated before Judge Carol Higbee in New Jersey.