We have some information about the arguments being made by the plaintiffs’ attorneys and the lawyers for the drug company, Merck, in one of the pending appeals, now. But we do not have any rulings by the federal appellate court, yet.
What is at issue in that one appeal is what has come to be called in legal circles as “impossibility preemption”. And this relatively new defense argument is not unique to the Fosamax – femur fracture litigation.
Essentially, the drug companies argue that at some time in the past — which is now the focus of a current pharmaceutical products liability case — it was impossible for them to add the now-controverted side effect warning without FDA approval, and therefore the plaintiffs’ drug injury claims are preempted by federal law.
As regards the Fosamax – femur fracture litigation, our source for what the respective parties reportedly argued to the United States Court of Appeals for the Third Circuit is the publication Law360, which is available by paid subscription only. As such, the excerpts below are short.
First, from this December 22, 2015 Law360 report, “Fosamax Users Rip Merck’s Fracture Warnings In 3rd Circ.”:
Osteoporosis sufferers pushing the Third Circuit to revive allegations that Merck failed to warn of painful leg fractures linked to its drug Fosamax disputed on Monday that the company had proposed stronger warnings only to be rebuffed by federal regulators.
The Fosamax users told the court that, contrary to claims by Merck Sharp & Dohme Corp. and the Pharmaceutical Research and Manufacturers of America, the drugmaker had in fact suggested alterations to its labels that the U.S. Food and Drug Administration found to be inadequate….
Second, from this January 11, 2016 Law360 report, “FDA Forbade Fosamax Warnings, Merck Tells 3rd Circ.’:
Merck told the Third Circuit on Monday that the U.S. Food and Drug Administration prohibited it from warning patients about the risk of its osteoporosis drug Fosamax causing irregular hip fractures, saying there is clear evidence the agency blocked a proposed warning.
Merck Sharp & Dohme Corp. argued a U.S. Supreme Court ruling [in Wyeth v. Levine] barred claims like those brought by Fosamax users over Merck’s alleged failure to warn of painful leg fractures associated with the drug….
Be assured that we are watching for rulings by the Third Circuit on the pending appeals in this federal court Fosamax – femur fracture MDL.[Read this article in full at original source]
Fosamax / Boniva / Actonel
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