The first of three “bellwether” Fosamax trials has begun in the U.S. District Court for the Southern District of New York in Manhattan. The case, which involves allegations that the popular osteoporosis drug Fosamax caused a painful and disfiguring jaw injury, will likely be an indicator of how juries will respond to evidence in the other 900 Fosamax lawsuits waiting to go to trial.

Merck & Co. faces claims that they failed to adequately warn that a side effect of Fosamax increases the risk of jawbone decay, known as osteonecrosis of the jaw or ONJ. The irreversible condition is associated with jaw infection and portions of the jawbone becoming exposed inside the mouth. In many cases it results in surgery to remove portions of the jaw and results in permanent disability.

The first Fosamax trial involves a case filed by Shirley Boles, who alleges that she developed jaw necrosis from Fosamax after using the drug between 1997 and 2006. After two tooth extractions in 2002, Boles began to experience serious jaw problems which ultimately were diagnosed as osteonecrosis of the jaw.

The case is one of three scheduled for trials between now and early 2010, which were selected by the parties and the court to gauge the issues that will be presented throughout the litigation and how jurors will absorb the information.

According to a press release issued by Merck this morning, they intend to “vigorously defend” the case and indicate that they believe the evidence will show that Fosamax side effects did not cause Boles’ jaw problems.

“Unfortunately, Ms. Boles had medical problems that cause people to develop jaw problems, regardless of whether they were taking Fosamax,” said attorney Paul Strain, who is the outside counsel for Merck.

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

Plaintiffs argue that long-term use of Fosamax greatly increases the risk of jaw necrosis, and that Merck minimized the risk and failed to adequately warn users. Had the side effects of Fosamax been known to users and their doctors, preventative actions could have been taken to reduce the risk of osteonecrosis of the jaw, such as avoiding tooth extractions.

All of the federal Fosamax lawsuits are consolidated under U.S. District Judge John F. Keenan, in the Southern District of New York, as part of a Multidistrict Litigation (MDL) for pretrial litigation. After the trials of the bellwether cases, 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.

Opening statements and jury selections in the Boles Fosamax trial begin today. The presentation of evidence is expected to conclude by September 1, with summations and jury charges scheduled for September 2.

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

Tags: Alendronate Sodium, Fosamax, Jaw Necrosis, New York, ONJ, Osteonecrosis of the Jaw