Expanding the Doctrine of Innovator Liability: Using Tort Liability to Create a Viable Follow-On Biologic Regime

Abstract

Advances in biotechnology are ushering in a new class of medicines called biologic drugs. Because of their unique abilities to treat diseases, the demand for biological therapies is becoming increasingly inelastic. The upcoming decade is particularly critical for the pharmaceutical market, as blockbuster biologic drugs are scheduled to go off patent, opening the floodgates for subsequent, less expensive versions of the same drugs known, in the United States, as follow-on biologics.

Because of a biologic drug’s higher propensity to result in adverse side effects, policymakers need to prophylactically address the problem of how to compensate an injured plaintiff in tort liability. In the chemical drug context, the Supreme Court has already categorically denied relief for injured plaintiffs who sue generic drug manufacturers for injuries via failure-to-warn claims, under the cloak of federal preemption. It is only a matter of time before courts are plagued with the problem of how to compensate consumers who have been injured by follow-on biological products, i.e., the “generic” versions of brand-name biologic drugs. This Note contends that the Biologic Drug Revolution brings with it a nuanced set of descriptive and normative concerns that warrant a critical reevaluation of the Supreme Court’s current approach to allocating tort liability in the chemical drug context. In doing so, I argue for a straightforward application of the doctrinal principles underlying tort law, and for the expansion of the innovator liability doctrine into the biologics realm.

Keywords: biotechnology, biological therapies, federal preemption, failure to warn, tort liability, innovator liability, generic, biosimilar, bioequivalent