In a case of first impression, Dolin v. SmithKline Beecham Corp., 12 C 6403, 2014 WL 804458 (N.D. Ill. Feb. 28, 2014), an Illinois federal district court judge ruled that a brand name drug manufacturer could be found negligent for improper labeling of risks on its generic counterpart. This groundbreaking decision goes against numerous courts outside of Illinois that reject the notion that a brand manufacturer might owe a duty of care to a consumer of the generic version of one of its drugs. Id. at 9.
The facts in Dolin are tragic. A Chicago lawyer began taking Paxil to treat his anxiety and depression. Paxil is the name-brand version of the drug paroxetine hydrochloride (“paroxetine”) and is owned and manufactured by GSK (“SmithKline Beecham Corp”). The lawyer's prescription, however, was ultimately filled with a generic version of paroxetine.
Only six days after beginning to take paroxetine, the lawyer committed suicide at a CTA train station. All parties agreed that the lawyer had ingested the generic version of paroxetine. The lawyer’s widow and estate brought suit against both the brand name and the generic manufacturers, claiming the companies improperly labeled the paroxetine that the lawyer ingested and hid warnings about suicide risks in adults.
The U.S District Court dismissed the generic manufacturer from the suit entirely. In dismissing the generic manufacturer, the Court relied primarily on the “Hatch-Waxman Act,” under which generic manufacturers are prohibited from making material changes to the drug’s design or unilateral changes to the drug’s warning label. See 21 C.F.R. §314.40(b) (emphasis added). Further, the U.S. Supreme Court has ruled that federal law preempts design defect claims against generic drug makers.
The Court only partially granted the brand name manufacturer’s motion for summary judgment. Under Illinois’ traditional theory of products liability, only the generic version’s manufacturer could be held liable for making or labeling an unsafe product. See Hammond v. North American Asbestos Corp., 97 Ill.2d. 195, 206 (Ill. 1983). Although the brand name could not be held strictly liable for the lawyer’s suicide under a products liability claim, the Court reasoned that the brand name manufacturer could still be found negligent.
The brand name manufacturer argued that the negligence claims were really “disguised” product liability claims. The Court rejected this argument, given that Illinois law did not require the Court to construe one claim as the other. The Court further found that when plaintiffs sue brand name manufacturers for their alleged negligence in connection with a generic drug’s design and warning label, a duty of care could be owed. Thus, a brand name manufacturer could be found liable under a negligence theory for the improper labeling of drug risks that appeared on its generic version.
This unique decision thus potentially imposes brand-name maker liability for generic-drug injuries. In addition to updating their own labels, brand name manufacturers theoretically should also monitor the labeling of the generic versions of their drugs. Under this reasoning, it could be argued that a brand name manufacturer takes on the role as a de facto “insurer” for the generic industry.
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Thanks go to Q&H law clerk Marcus Morrow for his assistance in the drafting of this case note.Zoom Kobe 1 ProtroNike shoes | adidas