Note by Justin P. Quin
Under the “duty of sameness,” manufacturers of generic drugs are required by federal law to design and label their products “the same at all times as the corresponding brand-name drug[s].” Federal law thus requires the composition of metoclopramide, a generic drug used to treat digestive issues, to be identical to that of Reglan, its brand-name counterpart. Likewise, any warning labels associated with metoclopramide (including “Dear Doctor” warning letters and the Physicians’ Desk Reference) must strictly mirror those disseminated in association with Reglan. Considering that approximately 80% of all prescriptions filled in the United States are filled with generic drugs,and that under current United States Court of Appeals for the Fifth Circuit precedent, brand-name manufacturers cannot be liable for injuries caused by generic versions of their drugs that they did not manufacture, the duty of sameness has the potential effect of placing a significant population of plaintiffs injured by the use of a generic drug up against two immunized defendants. If a generic manufacturer is “not at liberty” to alter the composition or labeling of a potentially dangerous or inadequately labeled drug, and the brand-name manufacturer who created the drug (and its warning labels) “owes no legal duty to the consumer of a generic equivalent of its drug,” then where may an injured plaintiff turn for relief?
Citation
89 Tul. L. Rev. 959 (2015)