2,104 research outputs found
A Critical Examination of the FDA’s Efforts to Preempt Failure-to-Warn Claims
This article explores the legality and wisdom of the FDA’s effort to persuade courts to find most failure-to-warn claims preempted. The article first analyzes the FDA’s justifications for reversing its long-held views to the contrary and explains why the FDA’s position cannot be reconciled with its governing statute. The article then examines why the FDA’s position, if ultimately adopted by the courts, would undermine the incentives drug manufacturers have to change labeling to respond to newly-discovered risks. The background possibility of failure-to-warn litigation provides important incentives for drug companies to ensure that drug labels reflect accurate and up-to-date safety information. The article next explains why the agency’s view that it is capable of singlehandedly regulating the safety of drugs is unrealistic. The agency does not have the resources to perform the Herculean task of monitoring the performance of every drug on the market. Both the Institute of Medicine and the Government Accountability Office have explained the shortcomings in the FDA’s recent performance, and they express doubt that the FDA is in capable of facing an increasingly challenging future.
The article then explains how state damages litigation helps uncover and assess risks that are not apparent to the agency during a drug’s approval process, and why this “feedback loop” enables the agency to better do its job. FDA approval of drugs is based on clinical trials that involve, at most, a few thousand patients and last a year or so. These trials cannot detect risks that are relatively rare, affect vulnerable sub-populations, or have long latency periods. For this reason, most serious adverse effects do not become evident until a drug is used in larger population groups for periods in excess of one year. Time and again, failure-to-warn litigation has brought to light information that would not otherwise be available to the FDA, to doctors, to other health care providers, and to consumers. And failure-to-warn litigation often has preceded and clearly influenced FDA decisions to modify labeling, and, at times, to withdraw drugs from the market
Coexistence in an inhomogeneous environment
We examine the two-dimensional extension of the model of Kessler and Sander
of competition between two species identical except for dispersion rates. In
this class of models, the spatial inhomogeneity of reproduction rates gives
rise to an implicit cost of dispersal, due to the tendency to leave favorable
locations. Then, as in the Hamilton-May model with its explicit dispersal cost,
the tradeoff between dispersal case and the beneficial role of dispersal in
limiting fluctuations, leads to an advantage of one dispersal rate over
another, and the eventual extinction of the disadvantaged species. In two
dimensions we find that while the competition leads to the elimination of one
species at high and low population density, at intermediate densities the two
species can coexist essentially indefinitely. This is a new phenomenon not
present in either the one-dimensional form of the Kessler-Sander model nor in
the totally connected Hamilton-May model, and points to the importance of
geometry in the question of dispersal
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