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Why Failure-to-Market Claims Are Preempted Under Federal Law
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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.
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.
Economic Dynamism
Unlocking Public Value: A Proposal for AI Opportunity Zones
Governments often regulate AI’s risks without measuring its rewards—AI Opportunity Zones would flip the script by granting public institutions open access to advanced systems in exchange for transparent, real-world testing that proves their value on society’s toughest challenges.
The Causal Effect of News on Inflation Expectations
This paper studies the response of household inflation expectations to television news coverage of inflation.
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Downtowns are dying, but we know how to save them
Even those who yearn to visit or live in a walkable, dense neighborhood are not going to flock to a place surrounded by a grim urban dystopia.
The Housing Crisis
Soaring housing costs are driving young people towards socialism—only dispersed development and expanded property ownership can preserve liberal democracy.
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California’s Proposed Billionaire Tax and Its Portents for Normal People
The deeper significance of California's billionaire tax is in how it redefines what it means to own property in the United States.
The Civitas Outlook Energy Symposium
Energy policy in America has become, over the past few decades, one of the most fraught debates in American politics.
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