Thursday, July 4, 2013

Federal Judge dismisses lawsuit against manufacturer of Fosamax on pre-emption grounds

In recent years, increasing evidence has linked the popular drug Fosamax (manufactured by Merck) to spontaneous breaks of the thigh bone after little or no trauma.  As lawsuits began to mount, more than 1,000 Fosamax femur fracture cases have been consolidated in the federal court system as part of a multidistrict litigation.  Many of those cases may now be threatened by a recent ruling by the federal judge presiding over the litigation granting summary judgement in favor of the defendant.

About Lawsuits is reporting (here) that the judge has ruled that one of the many claims that allege that Merck failed to adequately warn about the risk of sudden femur fractures is preempted by federal law because the FDA rejected a request to update the warning label.  

In his order, the judge (available here), the failure to warn claim is pre-empted by federal law because the FDA decided not to strengthen the Fosamax label in 2009, the year Glynn’s femur fractured. 

I am not sure, however, that this ruling is consistent with the US Supreme Court decision n Wyeth v. Levine, in which the Court held that a failure-to-warn claim related to a branded pharmaceutical was not preempted because the manufacturer was free to update the warning label at its discretion.

As I understand it, the state of the law is that if the manufacturer is not required to get FDA approval to update the label and can, therefore, decide to update the warning, then the claim would not be preempted.  If the manufacturer can't do that - if it needs to get FDA approval to update - then the claim would be preempted.  This was the holding in last year's PLIVA, Inc. v. Mensing (followedd last Monday in Mutual Pharmaceutical Co. v. Bartlett).

It is not clear to me that Merck was required to seek permission from the FDA in this case and, thus, that the clam must be preempted. 

What is different in this case is that regardless of whether Merck was required to seek permission from the FDA, it did ask the FDA and the FDA replied that there was not enough evidence to warrant a change in the warning.

So, the question for me is, what happens if a manufacturer decides it has enough evidence to change a warning and it wants to change the warning, but relies on the FDA's decision?  Should the court allow a claim against the manufacturer because it was not careful enough in reaching its own conclusions, or should it be excused from liability because it relied on the FDA?

Personally, I think that if the evidence shows the manufacturer had enough evidence to justify the change in the warning and that it had decided it should change it, the cause of action should be allowed. 

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