Risk and Reward in Stem Cell Products: A New Model for Stem Cell Product Liability
48 Pages Posted: 7 Jun 2012
Date Written: June 6, 2012
Stem cell products have the potential to give patients access to treatments and cures for diseases and conditions that are currently beyond the scope of modern medicine. There are not yet many stem cell products on the market in the United States, but soon there will be. It therefore makes sense to explore how we should deal with policy issues concerning these products now. This Article examines the problem of how best to handle legal liability for any harm that stem cell products cause. At present, a complex patchwork of federal and state statutes and legal precedents determines whether makers of drugs, biologics, medical devices and combination products are liable for defects. None of these legal materials specifically addresses stem cell products. Because stem cell product development is in its infancy, and because the risks of stem cell products are largely unknown, it is critical that the correct legal regime be in force. Too much legal liability could inhibit research into stem cell product development. Not enough legal liability could unnecessarily harm patients and hinder the use of stem cell products.
This Article crafts a proposal for what the legal rules ought to be for stem cell products to best benefit all parties involved. Far from indulging in standard neoclassical economic analysis, I employ work on bounded rationality, game theory, and other developments to come up with a proposal that has a better chance of working in the real world and with actual, non-maximizing individuals who have inadequate information. In brief, the proposal is a qualified system of strict liability for stem cell products in which patients and manufacturers contribute on a per-product basis to a compensation fund and the federal government acts as an insurer of last resort. Unlike most writing in this area, the liability proposal takes the ethics of risk imposition seriously.
Keywords: biological products, biologics, combination products, economics of risk, ethics of risk, FDA, foundations of welfare economics, game theory, insurance, economic theory, product liability, risk, risk management, stem cells, stem cell products, tort law, uncertainty, welfare economics
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