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The first in a series of Fosamax lawsuits are scheduled to begin next month in federal court over allegations that the popular osteoporosis drug causes permanent decay of the jawbone, known as osteonecrosis of the jaw.
Fosamax (alendronate sodium), which is manufactured by Merck, has been used by over 20 million people since the FDA approved it in October 1995. Before the medication became available as a generic last year, Fosamax sales generated over $3 billion annually for Merck.
Over 600 lawsuits have been filed against Merck by former users of the drug who allege that Fosamax side effects increase the risk of osteonecrosis of the jaw or ONJ, which can include 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.
All of the federal suits over Fosamax are centralized and consolidated in the U.S. District Court for the Southern District of New York before Judge John F. Keenan as part of an MDL, or Multidistrict Litigation. As part of the pretrial litigation, three “bellwether” cases were selected for early trials, designed to be representative of the issues that will come up throughout many cases in the litigation.
The first Fosamax lawsuit is scheduled for trial to begin on August 11, involving a case brought by plaintiff Shirley Boyles, who took Fosamax from approximately January 1997 to March 2006 for the treatment of pain and inflammation due to osteoporosis. Boyles alleges that she developed osteonecrosis of the jaw as a side effect of her Fosamax use.
According to an order issued earlier this month by Judge Keenan, jury selections and opening statements will begin on August 11 for the Boyles case. The presentation of evidence is expected to conclude by September 1, with summations and jury charges scheduled for September 2.
The Boles Fosamax lawsuit will be followed by a second trial scheduled to begin on December 1, 2009 for a claim filed by Bessie Fleming, and a third filed by Karen Greene, scheduled to begin January 11, 2010.