'Brand' New Law: Illinois Court Holds Brand Manufacturers Owe Duty Of Care To Generic Users

Last week, a federal district court in Illinois held that GlaxoSmithKline (GSK), a branded drug manufacturer, owed a duty of care to a patient who took the generic version of its drug. Dolin v. SmithKline Beecham Corp., No. 1:12-cv-06403, slip op. (N.D. Ill. Feb. 28, 2014). This holding is a surprising deviation from the current trend, as most courts have held that "innovator liability" does not apply where plaintiff claimed injury from taking the generic product.

BACKGROUND

The plaintiff, Wendy Dolin, is the widow of Stewart Dolin, who was an M&A partner at Reed Smith at the time of his death. Mr. Dolin was prescribed Paxil in 2010 for work-related anxiety and depression and, under Illinois' substitution law, his prescription was ultimately filled with generic paroxetine manufactured by Mylan. Six days after he began to take paroxetine, Mr. Dolin died after jumping in front of a train in Chicago.

Mrs. Dolin brought suit alleging that the paroxetine caused akathisia, a condition characterized by agitation and restlessness, and that akathisia is associated with suicidal behavior. She further alleged that GSK failed to warn that paroxetine was associated with an increased risk of suicide in adults. In fact, the complaint alleged egregious conduct—specifically, that GSK manipulated adverse event data in clinical trials. Plaintiff alleged that in comparing suicidal behavior among paroxetine, a placebo, or a comparator drug, GSK counted suicide attempts in placebo patients that occurred prior to the clinical trial.

Plaintiff brought claims for negligence and negligent misrepresentation, as well as product liability claims under theories of negligence and strict liability. The court denied GSK's motion for summary judgment on all counts except strict product liability.

THE COURT'S REASONING

The court evaluated at great length whether plaintiff's claim was common law negligence or a product liability claim as argued by GSK. The answer lay in the state's product liability law. While some states provide for exclusive remedies for injuries caused by the design or warning of a product to product liability actions against a party in the chain of distribution, Illinois law has no such limitation. The court saw "no reason why all suits brought against GSK must be brought against GSK qua manufacturer." Instead, GSK was responsible for the design and warning label of not just Paxil, but also paroxetine.

Concluding that the negligence claims need not be...