PHILADELPHIA (Legal Newsline) - State law claims were wrongly tossed from plaintiffs in a multidistrict litigation proceeding over the drug Fosamax, the Third Circuit has found.
The Sept. 20 decision helps hundreds of lawsuits against Merck & Co. being heard in New Jersey federal court. Plaintiffs there allege they would not have taken Fosamax, an osteoporosis drug linked bone injuries like stress fractures and complete breaks, had the label appropriately warned them.
Merck, for its part, proposed a drug label that would have included that information, but the Food and Drug Administration rejected that change. It faces suit from more than 500 plaintiffs who suffer femoral fractures between 1999-2010.
The New Jersey MDL judge then, now-retired Freda Wolfson, found state law claims were preempted by the FDA's rejection of Merck's proposed label change. Merck issued a safety update in 2008 that plaintiffs claim included misleading risk factors (stress fractures vs. atypical fractures) but Wolfson said showed Merck warned the FDA about femoral fractures.
Twenty-three states supported the plaintiffs' appeal to the Third Circuit.
"We are not unsympathetic to the pressures Merck faced from the competing demands of a possible state law requirement and FDA action, but there is no escaping the consequences of Albrecht," Judge Kent Jordan wrote.
"The Supreme Court has established a very high bar to show impossibility preemption in drug labeling cases. It is Merck's burden to show that 'federal law (including appropriate FDA actions) prohibited the drug manufacturer from adding any and all warnings to the drug label that would satisfy state law.'"
The FDA didn't explicitly reject the label change, the Third Circuit found, as it instead responded that it needed more time to investigate its reasonableness.
"To support the conclusion that there was preemption, the FDA, acting with the force of law, must have clearly rejected Merck's label in a manner that made it evident that no label about atypical femoral fractures would have been appropriate at the time of Merck's prior approval settlement," the ruling says.
"That did not happen here. For that reason, Merck has not shown that the FDA would have rejected any and all labels that would have satisfied state law. In addition, the availability of a label change via a CBE supplement is problematic for Merck, as will very often be the case for pharmaceutical companies raising an impossibility defense."