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Dolin v. GlaxoSmithKline LLC

The issue presented in this appeal is whether brand-name drug manufacturers can be held liable under Illinois law for injuries caused by inadequately labeled generic drugs. Following passage of the Drug Price Competition and Patent Term Restoration Act of 1984, commonly referred to as the Hatch-Waxman Amendments, sales of generic drugs have grown dramatically, fundamentally reshaping the pharmaceutical market. The increased availability of generic drugs has made many prescription drugs more affordable for patients. And a majority of prescriptions are now filled with generics. Despite these market changes, the law places responsibility for labeling firmly on brand-name manufacturers. Generic drug manufacturers cannot initiate labeling updates; the labeling of generic drugs must mirror that of the brand-name products. A patient’s reliance on the brand-name labeling, regardless of whether the patient took the branded or the generic version of the drug, is thus intended by the regulatory scheme. In light of this unusual fact—that one manufacturer is required to copy the safety information provided by another—patients should be able to hold brand-name drug manufacturers accountable for injuries resulting from misrepresentations about the safety of their drugs, even if those injuries are caused by a generic version of the drug.

Public Citizen filed an amicus brief to explain that allowing patients to hold the brand-name manufacturer accountable for inadequate labeling, even when the patient took the generic form of the drug, makes sense under traditional tort law principles and as a matter of policy. The court of appeals did not reach that issue, however, holding instead that the claim against the brand-name company would be preempted because the evidence showed that the Food and Drug Administration would not have allowed the company to make the labeling change that the plaintiff alleged was lacking here.