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Civitas Outlook
Topic
Economic Dynamism
Published on
Feb 5, 2025
Contributors
Richard Epstein
Benjamin Flowers
"Research Chemist in Lab" U.S. Department of Agriculture, Public Domain, via Wikimedia Commons.

Why Failure-to-Market Claims Are Preempted Under Federal Law

Contributors
Richard Epstein
Richard Epstein
Senior Research Fellow
Richard Epstein
Benjamin Flowers
Benjamin Flowers
Benjamin Flowers
Summary
This short white paper addresses preemption arguments relevant to “failure to market” claims, which cover those cases in which plaintiffs allege that drug companies may be held liable for failing to bring to market, as quickly as possible, drugs that present (allegedly) fewer side effects than other, FDA-approved drugs already on the market.
Summary
This short white paper addresses preemption arguments relevant to “failure to market” claims, which cover those cases in which plaintiffs allege that drug companies may be held liable for failing to bring to market, as quickly as possible, drugs that present (allegedly) fewer side effects than other, FDA-approved drugs already on the market.
Listen to this article

A California appellate court invented out of whole cloth a new and troubling theory of tort liability. Specifically, the court held that drug companies have a duty to develop and bring to market drugs that are supposedly safer and more effective than another, FDA-approved drug the company sells already. The claim rested on factual premises contradicted by all publicly available information, the acceptance of which could seriously disrupt the FDA approval process. This disruption gives rise to an issue the parties did not raise on appeal and that the appeals court never addressed, notwithstanding the complex, comprehensive statutes governing drug approval: these state tort law claims are preempted under theories of both field and conflict (including obstacle) preemption. This White Paper explains why it is imperative for the federal government and private parties to advance these preemption arguments, and why the courts should accept them.

Read the Issue Brief

This white paper was originally published by the Pacific Research Institute's Center for Medical Economics and Innovation.

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