Brand Name Drug Makers Owe a Duty of Care for Generic Drugs

Many people currently take the general version of a prescribed drug in order to treat various medical conditions, but several issues continue to circulate regarding liability for injuries caused by generic drugs.

In a departure from the majority of courts, a federal district court in Illinois recently held in Dolin v. SmithKline Beecham Corp., No. 1:12-cv-06403, slip op. (N.D. Ill. Feb. 28, 2014) that GlaxoSmithKline (GSK), a manufacturer of brand name drugs, owed a duty of care to a patient who took the generic version of its drug.

In Dolin, the plaintiff’s husband had been prescribed Paxil for work-related anxiety and depression and, under Illinois’ substitution law, his prescription was filled with generic paroxetine manufactured by Mylan. Six days later, he committed suicide. The plaintiff brought a wrongful death lawsuit against GSK, alleging that the generic drug paroxetine had caused a condition associated with suicidal behavior and that GSK had failed to warn that paroxetine was associated with an increased risk of suicide in adults. In fact, the plaintiff in bringing negligence and product liability claims alleged that GSK had committed egregious negligence by manipulating adverse event data in clinical trials.

Unlike some other jurisdictions, Illinois does not 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. Whereas most courts have held that brand manufacturers do not owe a duty of care to those who take a generic drug, the Dolin court evaluated the issue in light of Illinois standards, namely whether the plaintiff and defendant had a relationship such that the defendant had an obligation of reasonable conduct for the benefit of the plaintiff.

To determine whether this “relationship” existed, the court looked at the following four factors: (1) the reasonable foreseeability of the injury; (2) the likelihood of the injury; (3) the magnitude of the burden of guarding against the injury; and (4) the consequences of placing that burden on the defendant. Based on its evaluation, the court concluded that even though the relationship between plaintiff and defendant was not direct, it was sufficient to impose a duty of care on GSK.

The court’s holding is particularly noteworthy since it reaches the opposite conclusion as most jurisdictions regarding the issue of “innovator liability,” which most courts have held does not apply to those situations in which a plaintiff is injured by taking the generic version of the defendant’s product. The concept of innovator liability has arisen because current federal law requires generic labels to mimic brand name drugs in content and warning labels. But last November, the U.S. Food and Drug Administration (FDA) proposed a new rule that would allow generic drug makers to update their labels with new information in the same way that brand name drug makers can update their labels, thereby opening generic manufacturers up for liability when their drugs injure patients.

Contact an Unsafe Drug Lawyer

At Cogan & Power, P.C., we are dedicated to protecting patients from unsafe pharmaceuticals. We will continue to monitor legal developments regarding innovator liability and the Dolin decision. We advocate for injured adults and children, as well as the family members of deceased victims, throughout Illinois. If you have been injured or a loved one died as a result of unsafe drugs, contact our office at (312) 477-2500 to schedule a free consultation with one of our Chicago unsafe drug attorneys.