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Drug / Device Law BlogLegal updates, news, and commentary from the attorneys of Baker Sterchi Cowden & Rice LLC

Failure-to-Update Claims Against Generic Manufacturers Remain Viable

October 16, 2014

In Franzman v. Wyeth, Inc., et al., case number ED100312, the Missouri Court of Appeals for the Eastern District recently reversed the trial court’s judgment in favor of the manufacturers of the generic form of Reglan (the “Generic Defendants”) on the portion of Franzman’s failure-to-warn claim relating to the Generic Defendants’ failure to update their warning labels to reflect the 2004 brand-name label revision. Importantly, the Missouri Court of Appeals held that this failure-to-warn claim was not pre-empted under the United States Supreme Court’s decision in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011).

In 2004, the brand-name Reglan manufacturer requested, and the FDA approved, a labeling change to add a bold-face warning that: “Therapy should not exceed 12 weeks in duration.” After this change was made to the brand-name label, various generic manufacturers (including, Franzman alleges, the Generic Defendants) failed to update the warning label on their products to match the new FDA approved warning.

The Generic Defendants argued that all state law failure-to-warn suits against manufacturers of generic drugs may be summarily dismissed under Mensing. However, the Court determined that Mensing does not provide blanket immunity. Instead, the Court stated that the proper analysis was to consider whether a conflict exists between the relevant state law and federal law in order to determine if simultaneous compliance by the Generic Defendants was possible or impossible.

Under the relevant state law (Kentucky), drug manufacturers have a duty to adequately warn of the foreseeable risks associated with the use of their product. Kentucky courts have defined an adequate warning as one “sufficient to apprise the general practitioner as well as the ‘unusually sophisticated medical man’ of the dangerous propensities of the drug.” Larkin v. Pfizer, Inc., 153 S.W.3d 758, 764 (Ky. 2004). Franzman alleged that the Generic Defendants failed to adequately warn of the dangers of long-term use of metoclopramide (the generic form of Reglan) by failing to update their label to conform to the Reglan label revision approved by the FDA in 2004. Thus, the warning label on the generic drug ingested by Franzman did not include the same bold-face warning language. The Court reasoned that while the Generic Defendants were limited with respect to the warnings they could provide by their “federal duty of sameness”, as described in Mensing, federal law did not prohibit the Generic Defendants from updating their label to conform to the 2004 Reglan label revision. Put another way, the Court determined that it was not impossible for the Generic Defendants to comply with their duties under Kentucky state law and fulfill their duty under the FDCA by updating their label to conform to the 2004 revision. The Court concluded that Franzman’s state law failure-to-warn claim was not preempted by federal law to the extent her claim is limited to the Generic Defendants’ failure to adopt the additional warning language approved in 2004. The Court affirmed the trial court’s judgment in favor of the Generic Defendants in all other respects.

The take-away from this decision is that despite the preemption principles set forth in Mensing, one must analyze whether it is possible or impossible to comply with both state and federal law with regards to warning labels.

Also of interest, the Court of Appeals affirmed the trial court’s grant of summary judgment in favor of the Brand Defendants because under Kentucky product liability law, the Brand Defendants’ product was not the legal cause of Franzman’s injuries. Franzman admitted that she only ingested generic metoclopramide, and innovator liability is not the law in Kentucky.

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The BSCR Drug / Device Law Blog examines topics and legal developments of interest to the drug and device industry. Learn more about the editor, Angela Higgins, and our Drug and Device practice.


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