The Supreme Court of Alabama recently held that “[u]nder Alabama law, a brand-name drug company may be held liable for fraud or misrepresentation (by misstatement or omission), based on statements it made in connection with the manufacture of a brand-name prescription drug, by a plaintiff claiming physical injury caused by a generic drug manufactured by a different company.” Wyeth, Inc. v. Weeks, No. 1101397, at 50-51 (Ala. Jan. 11, 2013).
The Court reasoned that “it is not fundamentally unfair to hold the brand-name manufacturer liable for warnings on a product it did not produce … when [the] alleged misrepresentations were drafted by the brand-name manufacturer and merely repeated by the generic manufacturer.” Id. at 52.
Weeks is contrary to numerous decisions refusing to impose liability on brand-name manufacturers for harm allegedly caused by a product that they did not manufacture, as even the Alabama Supreme Court acknowledged. However, Weeks was heavily influenced by the Alabama Supreme Court’s interpretation of a recent decision of the United States Supreme Court that held that claims against manufacturers of generic drugs for failure to warn are preempted by federal law which requires the generic manufacturer’s label to be identical to the brand-name labeling. PLIVA, Inc. v. Mensing, __ U.S. __, 131 S. Ct. 2567 (2011).
PLIVA, Inc. v. Mensing: Federal Law Preempts State Law Failure to Warn Claims Against Generic Drug Manufacturers
To understand the decision in Weeks, it is necessary to understand the Supreme Court’s decision in Mensing, which held that state law claims against generic drug manufacturers based on a failure to warn theory are preempted by federal law. The plaintiffs in Mensing alleged that the generic drug manufacturers “knew or should have known of the high risk of tardive dyskinesia inherent in the long-term use of their product [metoclopramide]” and that they “knew or should have known that their labels did not adequately warn of that risk.” Mensing, 131 S. Ct. at 2574. “The parties [did] not dispute that, if these allegations [were] true, state law required the [generic manufacturers] to use a different, safer label.” Id. (emphasis added). The generic manufacturers, however, contended that federal law prevented them from using labels different from those used by the brand-name and thus
preempted the state law claims.
The Court noted that while a “brand-name manufacturer seeking new drug approval is responsible for the accuracy and adequacy of its label . . . , [a] manufacturer seeking generic drug approval, on the other hand, is responsible for ensuring that its warning label is the same as the brand name’s.” Mensing, 131 S. Ct. at 2574. This “sameness” finding was critical to the Alabama Supreme Court’s holding in Weeks.
With respect to whether, and to what extent, generic manufacturers could change their labels after initial FDA approval, the Supreme Court in Mensing deferred to FDA’s determinations that (unlike brand-name manufacturers) generics cannot unilaterally strengthen the generic drug’s warning label and that Dear Doctor letters qualify as “labeling” and, therefore, could not be used by generic manufacturers to send additional warnings to prescribing physicians and other healthcare professionals. Id. at 2575-76. The Court assumed, without deciding, that FDA was correct that generic manufacturers “could have proposed—indeed, were required to propose—stronger warning labels to the agency if they believed such warnings were needed.” Id. at 2576-77.
As summarized by the Court, “State tort law places a duty directly on all drug manufacturers to adequately and safely label their products…. Federal drug regulations, as interpreted by the FDA, prevented the [generic manufacturers] from independently changing their generic drugs’ safety labels. But, we assume, federal law also required the [generic manufacturers] to ask for FDA assistance in convincing the brand-name manufacturer to adopt a stronger label, so that all corresponding generic drug manufacturers could do so as well.” Id. at 2577. The Court thus concluded that it was impossible for the generic manufacturers to do what state law required and that even if they had asked FDA for assistance in changing their labels, this would have fallen short of their state law obligations. Id. at 2577-78. Rejecting plaintiffs’ argument that their claims should not be preempted to the extent that the generic manufacturers did not do all that they were permitted to do under federal law (i.e., to ask FDA for assistance in changing the label) to comply with state law, the Court concluded “that when a party cannot satisfy its state duties without the Federal Government’s special permission and assistance, which is dependent on the exercise of judgment by a federal agency, that party cannot independently satisfy those state duties for preemption purposes.” Id. at 2580-81.
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