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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
The Price of Stagnation: Britain’s Retreat from Dynamism
We face a basic issue: we do not let cities or communities grow or die.
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London and the Architecture of Creative Growth
Preserving London's creative dynamism will require humility from policymakers and a commitment to keeping the city liveable.
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Is Economics a Failure?
Rather than ending with “economics is broken,” Alexander Rosenberg’s deliberately provocative book 'Blunt Instrument' argues that “economics is useful for a different reason than economists often say.” That is a serious and worthwhile thesis.
Locke, Meet Claude
The concern is not regulation per se. It is a regulation that outruns its justification by arriving before the evidence, foreclosing the technology before its benefits are understood, and insulating the powerful from competition that would otherwise discipline them. That is the pattern worth resisting.
