By Susan Engstrom
Under West Virginia law, the brand-name drug maker was not required to provide warnings for generic medications produced by other companies.
A patient who allegedly developed acute respiratory distress syndrome after taking a generic antibiotic could not sustain failure-to-warn claims against the manufacturer of the brand-name drug, the U.S. Court of Appeals for the Fourth Circuit ruled in an unpublished opinion, affirming the district court after receiving an answer to a question certified to West Virginia’s high court. According to the state court, West Virginia law does not permit failure-to-warn and negligent misrepresentation claims against a brand-name drug manufacturer when the drug ingested was produced by a generic drug maker (McNair v. Johnson & Johnson, July 18, 2019, per curiam).
Patent. Janssen Pharmaceuticals, Inc. held the patent for the drug levofloxacin under the trade name Levaquin® and produced the warnings that accompanied the medication. When Janssen’s patent expired, other companies began manufacturing generic versions of levofloxacin using the same warnings Janssen produced, as required by federal law.
Complaint. In the case at bar, a patient filed a complaint in West Virginia state court against Janssen alleging that she developed acute respiratory distress syndrome after taking generic levofloxacin, which had warning information prepared by Janssen. According to the complaint, Janssen was aware that the syndrome had been linked to the use of levofloxacin but failed to include this fact in its warnings. Even though the patient took a generic version manufactured by a different company, she argued that Janssen had exclusive control of the content of the warnings for both the name-brand drug and the generic forms.
District court decision. The case was removed to federal court on diversity grounds, and the district court granted summary judgment in favor of Janssen. The court concluded that West Virginia law does not permit a plaintiff who consumes a generic drug to instead sue the brand-name manufacturer that produced the original formula of the drug and the warning label. Every other court of appeals has arrived at the same conclusion, the district court said, and there was no reason to think the outcome would be any different under West Virginia law [see Products Liability Law Daily’s June 29, 2015 analysis].
Certified question and answer. On appeal, the Fourth Circuit sought guidance on this issue from West Virginia’s highest court, presenting it with the following certified question: "Whether West Virginia law permits a claim of failure to warn and negligent misrepresentation against a branded drug manufacturer when the drug ingested was produced by a generic manufacturer" [see Products Liability Law Daily’s May 31, 2017 analysis]. The state high court answered the question in the negative, holding that "there is no cause of action in West Virginia for failure to warn and negligent misrepresentation against a brand-name drug manufacturer when the drug ingested was produced by a generic drug manufacturer" [see Products Liability Law Daily’s May 14, 2018 analysis].
The state supreme court explained that when products liability cases are premised on strict liability, the plaintiff must bring his or her claim against the manufacturer or seller of the allegedly injury-causing product. The basis of strict liability is that a manufacturer impliedly represents that its product is reasonably suitable, safe, and fit for the purposes for which it is being sold. A plaintiff cannot recover damages in a strict liability action against the defendant in the absence of a showing that the defendant either manufactured or sold the product that allegedly injured the patient.
The state court concluded that its products liability law is abundantly clear: liability is premised on the defendant being the manufacturer or seller of the product in question. Accordingly, when a brand manufacturer neither manufactures nor sells the generic drug, it cannot impliedly represent that the generic drug is free of defects. While West Virginia law provides that manufacturers are subject to the duty to warn about the risks of their products, the generic drug in this case was not a product of the brand manufacturer. Therefore, the brand manufacturer could not be held strictly liable for failure to warn of another manufacturer’s product.
Likewise, the state court found that a negligent misrepresentation claim against a brand manufacturer for injuries allegedly caused by a generic drug is not viable under West Virginia products liability law. Finally, the court stated that allowing a generic drug consumer to bring an action against the brand manufacturer for an injury allegedly arising out of the generic drug would be at odds with public policy, which limits the scope of products liability actions to manufacturers and, while now statutorily limited, to sellers. The court determined that the proper remedy for consumers harmed by generic drugs rests with Congress or the U.S. Food and Drug Administration.
Disposition. Because the parties agreed that the state supreme court’s ruling was dispositive and that no viable claims remained, the Fourth Circuit affirmed the district court’s judgment in favor of Janssen.
The case is No.15-1806.
Attorneys: Richard David Lindsay (Tabor Lindsay & Associates) for Kimmy McNair. Philip Combs (Thomas Combs & Spann, PLLC) for Johnson & Johnson and Janssen Pharmaceuticals, Inc.
Companies: Johnson & Johnson; Janssen Pharmaceuticals, Inc.
MainStory: TopStory WarningsNews DrugsNews MarylandNews NorthCarolinaNews SouthCarolinaNews VirginiaNews WestVirginiaNews
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