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From Health Law Daily, October 19, 2016

Seventh Circuit dodges preemption question on failure-to-update drug label claim

By Robert B. Barnett Jr., J.D.

The Seventh Circuit chose not to resolve a question that has split other circuits—whether the federal Food, Drug, and Cosmetic Act (FDC Act) preempts a state law claim based on a drug manufacturer’s alleged failure to update a generic drug label—deciding instead that the claim could not proceed because it was pleaded too late and lacked the necessary factual allegations. The Seventh Circuit also ruled that the FDC Act did preempt state law claims that pharmaceutical companies sold dangerous products in Wisconsin and failed to adequately warn of the risks. (Wagner v. Teva Pharmaceuticals USA, Inc., October 18, 2016, Blakey, R.).

Case history. A woman who took brand-name and generic hormone therapy drugs to treat post-menopausal endometrial hyperplasia developed breast cancer. She sued several pharmaceutical companies, including the only three companies that sold the generic form of the drugs: Teva Pharmaceuticals USA, Barr Pharmaceuticals, and Barr Laboratories. The complaint alleged numerous state law-based tort claims, all involving allegations that the pharmaceutical companies sold the drugs in Wisconsin and failed to adequately warn of the risks.

The pharmaceutical companies filed a motion for judgment on the pleadings. In response, the woman raised for the first time a contention that the three makers of the generic drugs failed to update their generic brand labels to match the stricter labels on the brand-name drugs. The trial court granted the motion for judgment on the pleadings, ruling that the FDC Act preempted the state law claims and that the failure-to-update claim was pleaded too late and would not have prevailed in any event. The woman appealed, raising two issues: (1) her original state law tort claims were not preempted because of passage of the Food and Drug Administration Amendments Act of 2007 (FDAAA) and (2) the FDC Act does not preempt failure-to-update claims.

Preemption. In two cases (PLIVA, Inc, v. Mensing, 564 U.S. 604 (2011) and Mutual Pharmaceutical Co. Inc. v. Bartlett, 133 S. Ct. 2466 (2013)), the Supreme Court has ruled that generic drug makers are required to maintain labels that are the same as the brand-name labels. As a result, any state law that might alter that obligation or impose additional labeling requirements on generic drug makers are preempted. Over the years, state law claims based on failure to warn, design defects, breach of implied warranties, breach of express warranties, and strict liability have all been deemed preempted.

The original state law tort claims alleged in this case, therefore, were all preempted. The woman’s argument that the two Supreme Court cases were outdated because they did not consider the FDAAA had been rejected by several courts, including previously by the Seventh Circuit. The FDAAA imposed obligations on generic drug manufacturers that propose labeling changes but it did not alter the requirement that generic labels had to match the brand-name labels.

Failure-to-update claim. The woman’s failure-to-update claim presented an interesting question because some circuits (the Sixth and possibly the Eighth, but not the Fifth) have ruled that the FDC Act would not preempt a state law claim based on a drug manufacturer’s failure to update a generic label. The Seventh Circuit had not previously addressed the question.

In this case, the Seventh Circuit agreed with the lower court that, by raising the issue for the first time in response to the motion for judgment on the pleadings, the woman raised the issue too late. She never sought permission to amend the complaint before the district court, waiting until the case was before the Seventh Circuit to ask permission. Even if the woman had been granted leave to amend in the lower court, the Seventh Circuit said, the allegations she made in response to the motion for judgment on the pleadings were insufficient to support a failure-to-update claim because she asserted that both the generic labels and the brand-name labels were deficient. Thus, the Seventh Circuit denied her the right to proceed on her failure-to-update claim while leaving for another day whether the FDC Act would preempt such a state law claim in its circuit.

As a result, the Seventh Circuit affirmed the district court’s judgment granting the pharmaceutical companies’ motion for judgment on the pleadings.

This case is No. 15-2294.

Attorneys: Kathleen A. Wagner, pro se. Jeffrey F. Peck (Ulmer & Berne LLP) and Bruce Arthur Schultz (Coyne, Schultz, Becker & Bauer, SC) for Teva Pharmaceuticals USA, Inc., Barr Pharmaceuticals, LLC f/k/a Barr Pharmaceuticals, Inc., and Barr Laboratories, Inc.

Companies: Teva Pharmaceuticals USA, Inc.; Barr Pharmaceuticals, LLC f/k/a Barr Pharmaceuticals, Inc.; Barr Laboratories, Inc.

MainStory: TopStory CaseDecisions FDCActNews DrugBiologicNews GenericDrugNews LabelingNews PreemptionNews PrescriptionDrugNews

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