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From Health Law Daily, March 3, 2014

Liability of generic-drug related death might fall on brand-name manufacturer

By Greg Hammond, JD

Negligence claims were properly brought against a brand-name drug manufacturer, resulting from the death of a patient that took the generic version of the medication. The Northern District of Illinois reasoned that although the brand-name company did not manufacture the generic version, it was the only party with the ability to alter or amend the drug label. As such, a duty of reasonable care could be properly imposed on the manufacturer (Dolin v Smithkline Beecham Corporation, February 28, 2014, Zagel, J).

Background. Stewart Dolin suffered from anxiety and depression, and was prescribed paroxetine, a generic version of the depression treating prescription drug Paxil®. Smithkline Beecham Corporation (SBC) manufactured Paxil, and Mylan, Inc. manufactured paroxetine. After taking the generic drug for six days, Mr. Dolin jumped in front of a train to his death. His wife, Wendy Dolin, brought a wrongful death action against both SBC and Mylan, alleging negligence, misrepresentation, and product liability claims. Specifically, Mrs. Doris claimed that paroxetine can cause restlessness and agitation associated with suicidal behavior, both SBC and Mylan new or should have known of the greater risk of such behavior, the generic drug label failed to disclose the risk, and SBC manipulated adverse event data by including previous suicide attempts by placebo patients in clinical trial results. The case was before the Northern District of Illinois on SBC’s motion for summary judgment and Mylan’s motion to dismiss.

Negligence. SBC primarily argued that because it did not manufacture the generic drug, it was entitled to judgment as a matter of law. However, the court determined that under the Hatch Waxman Act (P.L. 98-417), SBC was responsible for the generic product’s design and warning label, and was the only entity legally permitted to fix any warning label defects. Consequently, the court found that Mrs. Dolin properly alleged a genuine issue of material fact that SBC violated its duty of reasonable conduct with regard to the drug’s label. In addition, the court found that because SBC intended to induce physicians to trust its data regarding the depression treating drug, the company knew that patients would, in turn, rely on their physicians as intermediaries. As such, the court found that Dolin alleged a genuine issue of material fact regarding her negligent misrepresentation claims, and dismissed SBC’s motion for summary judgment as it related to these claims.

Strict Liability. According to the court, strict liability may be imposed on people or entities in the “distributive chain,” including manufacturers, suppliers, distributors, wholesalers, and retailers. However, because SBC did not benefit from the sale of paroxetine and did not manufacture the generic drug, the court found that the company was outside the chain of distribution. SBC’s motion for summary judgment was therefore granted with regard to these claims.

Dolin conceded that her claims against Mylan were preempted by federal law, because SBC was the only entity allowed to alter the label. Consequently, the court granted Mylan’s motion to dismiss.

The case number is 12 C 6403.

Attorneys: Bijan Esfandiari (Baum Hedlund Aristei & Goldman, PC) for Wendy B. Dolin. Alan Scott Gilbert (Dentons US LLP ) for SmithKline Beecham Corp. Clement C. Trischler , Jr. (Pietragallo Gordon Alfano Bosick & Raspanti, LLP) and Robert E. Haley (Swanson, Martin & Bell, LLP ) for Mylan, Inc.

Companies: SmithKline Beecham Corp.; Mylan, Inc.

MainStory: TopStory CaseDecisions HatchWaxmanNews DrugBiologicalNews GenericDrugNews LabelingNews PrescriptionDrugNews PreemptionNews PLDrugNews IllinoisNews

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