Merck's ($MRK) already won two bellwether suits over femur fractures suffered by Fosamax patients. But is that enough to get the remaining 500 or so cases tossed out?
The pharma giant is aiming to find out, the New Jersey Law Journal reports. The company filed an Aug. 15 application asking a federal court in Trenton to order plaintiffs to show why the rest of the pending claims shouldn't be dismissed.
Merck has already scored a pair of victories in suits related to use before and after a 2011 label change that warned of potential side effects. In the post-revision case, filed by Barbara Gaynor, a judge deemed the label revision adequate; the judge dismissed Bernadette Glynn's pre-revision case after finding that her New York state law claim for failure to warn was preempted by federal law.
The way Merck sees it, those two decisions should just about take care of the outstanding claims. Though the decision in the Gaynor case was based on the laws of New York, Gaynor's home state, Merck contends that it was also based on "fundamental principles that all states recognize--most notably, that a plaintiff cannot prevail for failure to warn if the warning label at issue warned of the very injury she allegedly suffered," the company said in its brief, as quoted by the Journal.
The issue dates back to 2008, when the FDA sent the New Jersey drugmaker notice that some Fosamax patients were suffering bone fractures. In September of that year, Merck asked for the FDA's permission to revise the osteoporosis med's label to include femur fracture precautions--a reference the FDA permitted only in the label's adverse reactions section.
That's a stance the agency later revised for all bisphosphonate-containing drugs, and in October 2010, Merck incorporated the warning into the label's precautions section.
Use of Fosamax, a drug that brought in $560 million for Merck last year, has brought on more than just femur-fracture litigation. Last year, in another bellwether case, a New York jury decided Merck hadn't done enough to warn patients about the possibility that the treatment could cause necrosis of the jawbone, stinging the company with a $285,000 verdict.
- read the New Jersey Law Journal story
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