New Product Liability Regime for Stem Cell Products?

By Hyeongsu Park

In May 2012, Health Canada granted market authorization for Prochymal. This decision is the world’s first regulatory approval of a stem cell drug (as well as the first therapy for acute graft-vs-host disease, a serious complication of bone marrow transplantation that kills up to 80% of children affected). Like Prochymal, many stem cell products have exciting therapeutic potential, such as bone regeneration and cartilage formation. And the global stem cell product market is estimated to reach $6.6 billion by 2016. However, side-effects remain unknown, and the regulations for such products are largely non-existent. So what should happen if a patient gets hurt?

Stephen R. Munzer (UCLA School of Law) discusses this question in his latest article in the Boston University Journal of Science and Technology Law, and recommends that qualified strict liability should govern product liability for stem cell products. A negligence regime is not appropriate, he argues, because it is particularly hard to determine the sources of any harm caused by stem cell products. However, strict liability needs to be qualified by limitations on damages, FDA approval as a rebuttable presumption of product safety, and a learned intermediary rule in order to provide the designers and manufacturers of stem cell products an incentive to determine their risks and take reasonable precautions.

Munzer also suggests establishing a compensation fund based on contributions from both manufacturing firms and patients. His proposal is similar to the National Vaccine Injury Compensation Program (VICP), but Munzer introduces a more comprehensive method to determine the amount of contributions from companies in which a firm’s market share, efforts to improve safety and effectiveness, success in securing FDA approval, and compliance with post-market regulations should all be taken into account to determine the amount of contributions to the fund.

Take a look at Munzer’s scheme and see what you think.  Are stem cell therapies really so much different from other biologics?  What role should the administrator of stem cell therapies play in the liability scheme?

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