Risk, Responsibility, and Generic Drugs

From the New England Journal of Medicine

By Aaron S. Kesselheim, MD, JD, MPH; Jerry Avorn, MD; Jeremy A. Greene, MD, PhD

SUMMARY: This NEJM Perspective by Kesselheim, Avorn, and Greene examines the legal and regulatory framework governing generic drug safety, with particular focus on the question of who bears responsibility when a generic drug causes harm. The piece engages the then-contested legal question of whether generic manufacturers could be held liable for inadequate labeling under state tort law, given a Supreme Court decision holding that federal law preempted such claims. The authors examine the implications for patient safety of a liability framework that leaves injured patients without legal recourse against generic drug makers. (Note: Full text paywalled; summary based on publicly available title, description, and field context.)

BACKGROUND: Generic drugs account for the majority of prescriptions dispensed in the United States. A Supreme Court ruling found that federal law preempted state tort liability claims against generic drug manufacturers for inadequate safety labeling.

KEY FINDINGS: Not fully retrievable from publicly available text; article is paywalled. The piece examines the legal and policy implications of limiting liability for generic drug manufacturers in cases of inadequate safety information.

IMPLICATIONS: The legal framework governing generic drug liability has significant implications for patient safety, particularly regarding manufacturers' incentives to update safety labeling as new risk information emerges.