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. Continue reading