Court Sides With Merck in Second Case Over Fosamax

A federal court has dismissed allegations that Merck’s osteoporosis drug Fosamax causes jaw bone destruction, two months after declaring a mistrial in a similar suit involving Fosamax liability.

In granting summary judgment, Judge John Keenan of the U.S. District Court for the Southern District of New York said an expert witness for plaintiff Bessie Flemings was unqualified and that Flemings failed to otherwise prove her case, according to the opinion. He called the lawsuit “the second of three bellwether trials in a multi-district products liability litigation concerning the osteoporosis drug Fosamax.”

Flemings was seeking damages for alleged jaw and dental problems she experienced after taking Fosamax (alendronate sodium). The drug’s labeling notes that osteonecrosis of the jaw (ONJ), typically associated with tooth extraction or local infection, has been reported in patients taking bisphosphonates such as Fosamax.

Flemings and her family physician, Walter Rose, claimed she developed ONJ in 2006 after taking the product for severe osteoporosis, according to the District Court opinion. But the judge says that Rose’s opinion is derived from a “subjective belief” rather than from scientific knowledge and that he is not qualified as an expert under Rule 702 and his opinion is inadmissible.

Specifically, the judge said Rose did not explain whether his theory that Flemings’ ONJ would heal when she stopped taking Fosamax had been tested, peer reviewed and published, and whether it was generally accepted in the scientific community.

Flemings also offered no evidence to support her claim, Paul Strain, outside counsel for Merck, says in a statement. “Unfortunately, Ms. Flemings had medical problems that cause people to develop jaw problems regardless of whether they were taking Fosamax,” he adds.

The first bellwether lawsuit to go to trial ended in to a mistrial in September after the jury failed to reach a verdict. That case, Boles v. Merck, also alleged that Fosamax caused deterioration of the plaintiff’s jaw (DID, Sept. 14). The second case was Flemings v. Merck & Co., Inc., for which the In re: Fosamax Products Liability Litigation opinion was filed Nov. 23.

The third bellwether case, Maley v. Merck, is set to go to trial April 12, 2010, according to a recent statement by Merck. As of Sept. 30, about 953 Fosamax liability cases had been filed by an estimated 1,334 plaintiff groups in state or federal courts, according to the statement. — Meg Bryant