Merck’s Fosmax® On Trial, In New York — Beginning August 11, 2009


[UPDATED 08.11.09 @ Noon EDT — Right here.]

I’ll only mention this in passing (as I don’t intend to start covering all of Merck’s products-liability cases, here), but starting Tuesday morning, Merck will defend the first of what may be nearly a thousand Fosamax® (alendronate sodium) products-liability cases. The plaintiffs allege that Merck failed to adequately warn about jaw-bone side effects, including bone death, experienced by some patients, allegedly as a result of taking Fosamax. Here is a representative snippet, on the topic, from the wire services — this one is from Reuters’ version:

. . . .Some 1,280 plaintiff groups, involving almost 900 cases, have alleged jaw problems due to Fosamax, a one-time blockbuster product that recently began facing generic competition in the United States.

U.S. District Judge John Keenan of the Manhattan District Court will hear arguments from attorneys for Shirley Boles, a 71-year-old plaintiff from Walton Beach, Florida, who claims to have suffered dental and jaw problems as a consequence of taking Fosamax from 1997 to 2006.

“Unfortunately, Ms. Boles had medical problems that cause people to develop jaw problems, regardless of whether they were taking Fosamax,” Merck said in a statement late Monday.

Fosamax, approved in the United States in 1995, belongs to the bisphosphonate family of osteoporosis drugs that include Procter & Gamble’s Actonel and Roche Holding AG’s Boniva. The pills prevent bone fractures — particularly in postmenopausal women — by helping to increase bone mineral density.

In 2003, reports first surfaced linking intravenous bisphosphonate treatments with jaw osteonecrosis, meaning death of jawbone tissue that can include symptoms such as pain, swelling or infection of the gums and jaw, gums that don’t heal, and loose teeth. . . .

As ever, we shall see.

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