By Susan Lasser, J.D.
A request by the manufacturer and the marketer of a generic drug prescribed for pain relief that the U.S. Supreme Court review a ruling by the Illinois Court of Appeals holding that they could not rely on a federal preemption defense in a state-law products liability and fraud action has been denied by the High Court. The manufacturer and marketer had argued that the appellate court's decision conflicted with the Supreme Court’s findings in Mutual Pharmaceutical Co., Inc. v. Bartlett, 133 S. Ct. 2466 (2013) (Target Corp. v. Guvenoz, Docket No. 15-1081, petition filed February 25, 2016, cert. denied June 6, 2016).
The case arose from a patient's taking the generic version of the brand name drug, Darvocet®, and subsequently becoming a spastic quadriplegic and dying. The patient's widow asserted claims against Teva Pharmaceuticals USA, Inc. (the manufacturer) and Target Corporation (the marketer) alleging that her husband’s taking the medication caused his illness and death. The patient was given a prescription for Darvocet, but when he filled his prescription at a Target pharmacy, he purchased the generic version manufactured by Teva. After ingesting the recommended dose, he suffered a cardiac arrest, which caused serious brain injury and, later, his death. Target and Teva moved to dismiss the complaint on the ground that federal law preempted the widow’s claims.
Illinois appellate court ruling. The Illinois Court of Appeals determined that the widow’s claims survived the preemption defense asserted by the manufacturer and marketer [see Products Liability Law Daily’s March 30, 2015 analysis). The defendants claimed that even though the drug was unsafe, they were operating under a safe harbor provided by federal law. The Illinois court, however, found that the marketer and manufacturer were mistaken in their readings of federal precedent. The court held that a claim against a generic manufacturer could proceed under Illinois law when the claim did not allege that the manufacturer should have altered the design or labeling of a drug in contravention of federal requirements. Therefore, the court ruled that irrespective of the Food, Drug, and Cosmetics Act’s sameness requirement, because the widow claimed that the drug should not have been sold (a “stop-selling” theory) or that Target and Teva engaged in fraud, the claims were not preempted by federal law.
Question presented. The defendants had asked the following question in their petition to the Supreme Court: “Whether the decision of the Illinois Appellate Court, which permits personal-injury plaintiffs in Illinois to proceed with the very ‘stop-selling’ theory of liability this Court rejected as ‘incompatible with our pre-emption jurisprudence’ in Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013), should be summarily reversed” [see Products Liability Law Daily’s March 1, 2016 analysis].
The case is Docket No. 15-1081.
Attorneys: Jay P. Lefkowitz (Kirkland & Ellis LLP) for Target Corp. and Teva Pharmaceuticals USA, Inc.
Companies: Target Corp.; Teva Pharmaceuticals USA, Inc.
MainStory: TopStory SupremeCourtNews PreemptionNews WarningsNews DrugsNews
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