New York Federal Court Upholds “Failure to Update” Theory

For those who follow pharmaceutical litigation, the issue of preemption – as discussed primarily by the U.S. Supreme Court in PLIVA, Inc. v. Mensing and Mutual Pharmaceutical Co. v. Bartlett, as well as in a host of other state and federal court opinions – continues to be an important battleground.  Although most courts have rejected the plaintiffs’ efforts to pursue failure-to-warn claims against generic drug manufacturers, based on the generic drug makers’ federal law “duty of sameness,” under which a warning label for a generic drug must be the same as the warning label for the branded equivalent, some plaintiffs have achieved some success in some courts by arguing that a generic drug maker can nevertheless face liability for failing to promptly update its generic drug label to match changes made to the branded drug label.  This theory has become known as the “failure to update theory.”

In what is noted to be a case of first impression in the Second Circuit, the Southern District of New York has joined what it views as “the majority of other jurisdictions in finding that ‘failure to update claims’ against [generic drug makers] are not preempted.”  The opinion was issued in response to a motion to dismiss filed by the manufacturers of the generic version of Fosamax, alendronate sodium, in the Fosamax MDL.

While the court did not discuss what length of time would be an “unreasonable” delay for a generic drug manufacturer in updating its labeling, because the generic defendants challenged the plaintiffs’ claims on a motion under Fed. R. Civ. P. 12(c), the court merely determined that the plaintiffs had adequately pled such a claim and that it was not preempted by Mensing and Bartlett.

In rejecting the generic defendants’ efforts to dismiss the plaintiffs’ “failure to update” claims, the court also rejected the argument that such a claim is also impliedly preempted by federal law that excludes private causes of action for violation of FDA regulations, finding that the plaintiffs’ “failure to update” theory was not premised on a violation of federal law, but rather on an independent state duty to provide an adequate warning (which would be the FDA-approved branded drug label).

While the plaintiffs were less successful on their other claims – indeed, the court dismissed all of the plaintiffs’ other claims, including claims that the generic manufacturers should have communicated labeling changes to physicians and consumers through so-called “Dear Doctor” letters and claims that the drug was defectively designed – this opinion represents another important decision in the ongoing battle over the extent of generic drug preemption following Mensing.  Practitioners in this area, along with their generic pharmaceutical clients, should continue to follow this active issue nationwide.

The decision is available, click here.


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