A 'Duty' to Continue Selling Medicines

Abstract

With disappointing frequency, shortages occur in the supply of prescription pharmaceuticals. Sometimes, those shortages persist for months (even years), and can implicate the only known medicine to treat a life-threatening medical condition. Sometimes, those shortages may also be due to avoidably negligent decisions in manufacture. Twice in the past two years, seriously ill patients — confronting just such medicine supply shortages — have resorted to the courts, demanding a judicial remedy for negligently caused supply interruptions to critically needed medicines. In doing so, they have asserted a bold litigating position: the law ought to impose upon drug manufacturers a legal duty to continue selling their medicines. In other words, once a pharmaceutical manufacturer enters a medicine market, it is obligated by law to remain there and preserve perpetually its medicine’s supply. This claim of compelled-access-to-pharmaceuticals pushes to the very frontier of drug law in America.

This Article begins by tracing the two cases (one in Utah, the other in Florida) that confronted these creative compelled-access-to-medicines arguments. Earlier cases, resolving a distinctive but thematically similar compelled-access argument in the context of experimental drugs, are introduced as well. The discussion explains how each claim lost in court. The Article next performs an independent survey of a wide range of legal theories — in constitutional principle, enacted law, regulatory law, and case law — that could be cited as alternative potential sources for imposing a duty on manufacturers to continue selling their drugs. It demonstrates that none is likely to be a credible source for that duty. Finally, the Article examines the competing policy considerations that would be implicated by “inventing” such a duty, finds that a judicial invention is unwise, but offers a potential statutory amendment designed to strike a sound balance between the legitimate proprietary and autonomy interests of manufacturers and the health and survival interests of critically ill patients.

Keywords: pharmaceutical; medical device; biologics; lawsuit; selling; sale; duty