_(7184104335).webp)
Why Failure-to-Market Claims Are Preempted Under Federal Law
.png)
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
The American Dream Is Not a Coin Flip, and Wages Have Not Stagnated
This paper challenges the prevailing narrative that stagnant wages are causing the American dream to fade. It contrasts subjective public opinion with revised objective intergenerational mobility measures.
Political Economy and the Rise of Commercial Humanism
Western attitudes toward commerce have transformed from early moral condemnation to a modern appreciation that sees trade as socially beneficial.
.webp)
ESG Would Rain on Spring Break
Americans have access to abundant, reliable energy, unlike Europeans under strict climate mandates.
These Mayors Understand How to Run a City
Armed with common sense policies, three urban leaders are fighting a patient battle against chaos.
.webp)
Transatlantic Trade War Produces No Winners
The EU should end its competition policy vendetta. Trump should drop his tariffs.
.webp)
The Nadir of the Climate Change Movement
The Climate Change movement might be nearing the end of its political lifespan.
