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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
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This paper studies the response of household inflation expectations to television news coverage of inflation.
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The Rise of Inflation Targeting
This paper discusses the interactions between politics and economic ideas leading to the adoption of inflation targeting in the United States.
Do We Still Really Need the Bureau of Labor Statistics?
It is time for the monthly story of the labor market to be told more clearly, and more reliably, through data from other sources.
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Creating Affordable Housing Requires Just One Simple Legislative Change
For nearly 50 years, federal, state, and local governments have tried to improve housing affordability without addressing the core issue of high construction costs.
Will California Reform Its Broken Housing Policies?
California's reforms could lead to a more diverse mix of housing developments, particularly in the middle and lower-price segments.
