Posted: 7 Jan 2013 Last revised: 17 Apr 2013
Date Written: January 7, 2013
This article offers a proposal for the regulation of stem cell products by the Food and Drug Administration (“FDA”) that corresponds to a specialized product liability scheme. It shows how product liability and administrative law can be successfully integrated to create a comprehensive legal and regulatory system that will promote the safety and efficiency of stem cell products both before and after market entry. The article first scrutinizes some suggested regulatory solutions and offers a way to improve them. It then builds on a scheme, articulated and defended elsewhere, for handling legal liability for harm caused by defective stem cell products.
The article’s larger point is that the effective regulation of stem cell products is intimately connected to the best legal regime for stem cell product liability. Although there are not yet many stem cell products on the market in the United States, this current paucity is likely temporary. Vigorous FDA oversight will be necessary once applications to approve these products and place them on the market arrive in large numbers. Because stem cell products differ from other FDA-approved products, effective oversight of stem cell products requires a revamping of administrative law and a specialized regime of product liability. Owing to the interrelated nature of the administrative revamping and the product liability scheme, each must take account of the other as part of a larger legal and regulatory framework. The regulatory and product liability proposals that I articulate here accomplish this objective because they are complementary, well-suited to each other, and are mutually reinforcing.
Although the solutions I propose in this article are narrowly tailored to the unique problems of stem cell products, their broad reform of administrative and product liability law reveals them to be applicable to other fields, such as toxic substances and nanotechnology. Thus, the solutions advanced here provide an object lesson in how to integrate administrative law with areas of tort law beyond the realm of defective stem cell products. My solutions achieve this ambitious aim without stifling the scientific innovation crucial to this emerging field.
Keywords: CBER, CDER, CDRH, combination products, embryonic stem cells, FDA, integration of tort and administrative law, post-market regulation, product liability, regenerative medicine, regulatory proposal, risk, risk management, risk reduction, stem cells, stem cell products, stem cell treatments
JEL Classification: D11, D12, D18, D52, D61, D63, D81, D83, G18, G38, I11, I12, I18, K23, L51, O31, O32, O33, O38
Suggested Citation: Suggested Citation
Munzer, Stephen R., How to Integrate Administrative Law and Tort Law: The Regulation of Stem Cell Products (January 7, 2013). 64 Administrative Law Review 743 (2012); UCLA School of Law Research Paper No. 12-29. Available at SSRN: https://ssrn.com/abstract=2197530
By Paul Miller