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From Health Law Daily, December 3, 2013

Court notes unfairness of decision barring consumers recovery in failure-to-warn suit

By Patricia K. Ruiz, JD

The United States Court of Appeals for the Sixth Circuit called its own decision to bar injured consumers of a generic drug from recovery in a misbranding suit “unfair.” The suit, which alleged that the consumers of a generic drug developed serious a neurological disorder because of deficient labeling, named both the generic and brand-name manufacturers as defendants. However, the court determined that any claim against the generic manufacturers was barred by federal preemption, and any claim against the brand-name manufacturers was barred by state law. Judge Jane B. Stranch issued a dissenting opinion, holding that the plaintiff’s should be permitted to pursue the failure-to-conform claim against the generic manufacturers and state law tort claims against the brand name manufacturer (Strayhorn, et al. v Wyeth Pharmaceuticals, Inc., et al., December 2, 2013, Gilman, R).

Backround. Plaintiffs, end consumers of generic version of Reglan® (metoclopramide), filed suit against the generic and brand-name manufacturers of the drug, alleging that because of deficient labeling, the users of the drug developed the neurological disorder tardive dyskinesia. The drugs, which are labeled for use as short-term therapies for heartburn and bloating, are often prescribed by physicians for long-term use, which presents an “unreasonably dangerous increased risk of developing one or more severe and permanent neurological movement disorders,” plaintiffs alleged. The plaintiff consumers alleged a variety of products liability claims against the manufacturers, ultimately boiling down to the claim that the generic manufacturers failed to provide adequate warnings to medical professionals about the risks involved in long-term use of metoclopramide.

The district court granted the generic manufacturers summary judgment, citing PLIVA, Inc. v Mensing, which held that failure-to-warn claims against generic manufacturers are preempted by federal law. The brand name manufacturers were also granted summary judgment on the basis that the plaintiffs only consumed the generic drug and that the Tennessee Products Liability Act (TPLA) (Tenn. Code Ann. sec. 29-28-101) only allows recovery against the manufacturers or seller of the product that caused the harm. The Sixth Circuit affirmed the district court’s judgment.

Preemption.Under the Hatch Waxman Act, manufacturers of generic drugs must use only the exact same labeling approved for the brand-name drug by the FDA. However, the Louisiana and Minnesota tort laws require drug manufacturers who are aware of dangers associated with their products label the drug in a way that renders the drug reasonably safe. The Mensing court held that, in the event that a brand-name manufacturers did not provide adequate warning of a drug’s dangers, it is impossible for generic drug manufacturers to simultaneously comply with both state and federal labeling laws. Thus, federal law preempted state law design-defect claims in which the adequacy of a drug’s warnings are at issue, and the generic manufacturers are not permitted to unilaterally change its labeling.

In the instant case, the TPLA governs the plaintiff’s personal injury claims, which are based on the design, warning, instruction, marketing, packaging, and labeling of the generic drug metoclopramide. The plaintiffs argued that, despite the fact that the brand-name Reglan lacked any warning on its labels, the generic manufacturers should have warned consumers of the drug’s dangers through additional advertising and promotional materials. However, under the FDC Act, “labeling” includes “all labels and other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article.” Because the federal statute applies under Mensing, the generic manufacturers would not be permitted to present information not provided by the brand-name manufacturer. Thus, the Sixth Circuit affirmed the district court’s dismissal of all plaintiffs’ claims against the generic manufacturer.

Claims against brand-name manufacturer. The Sixth Circuit also affirmed the dismissal of the plaintiffs’ claims against the manufacturers of the brand-name Reglan. Because Mensing only preempts claims against generic manufacturers, the TPLA applies to the plaintiffs’ claims against the brand-name manufacturers. Under the TPLA, plaintiff must assert that the defendant’s product caused the alleged injury. However, none of the plaintiffs took Reglan—they all used the generic metoclopramide. Because the manufacturer of a brand-name drug has no duty to patients who ingest the generic version of the drug, the Sixth Circuit determined that the district court properly dismissed the claims against the brand-name manufacturers.

Unfair result. The majority in this case, as well as the one dissenting judge, noted the unfairness of the result. However, the majority stated that any resolution rests with Congress—or with the Tennessee General Assembly, who could revise the TPLA to allow claims against the brand-name manufacturers whose labels “the generic manufacturers are compelled by federal law to duplicate.”

The case numbers are 12-6195, 12-6198, 12-6200, 12-6203, 12-6208, 12-6209, and 12-6210.

Attorneys: Collyn A Peddie (Law Offices of Collyn Peddie) for Gloria Strayhorn, et al. Henninger S. Bullock (Mayer Brown LLP) for Schwarz and Alaven. Jeffrey F. Peck (Ulmer & Berne LLP) for Watson Laboratories, Duramed Pharmaceuticals, Inc., PLIVA, Inc., and Barr Pharmaceuticals. Richard A. Oetheimer (Goodwin Procter LLP) for Teva Pharmaceuticals.

Companies: Schwarz and Alaven; Watson Laboratories; Duramed Pharmaceuticals, Inc.; PLIVA, Inc.; Barr Pharmaceuticals; Teva Pharmaceuticals

MainStory: TopStory LabelingNews MisbrandingNews PreemptionNews HatchWaxmanNews PLDrugNews DrugBiologicalNews GenericDrugNews KentuckyNews MichiganNews OhioNews TennesseeNews

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