Liability Considerations Presented by Human Gene Therapy

Abstract

Through the use of a hypothetical scenario, this article examines the legal liability associated with gene therapy. Basic negligence principles are applied to the factual context of a human gene therapy experiment gone awry, including its prior governmental review and its potential effect on future generations. The federal requirements, while not preempting state law damages claims, do provide a mechanism for achieving some protection from liability. The effect on future generations raises questions about the limits of liability.

Overview summary

Now that human gene therapy is into clinical trials, the question of liability is being raised. Who can be held liable if something goes wrong? How vulnerable are investigators, institutions, and the companies that provide material? Palmer, a practicing attorney with considerable knowledge of the science and practice of gene therapy, examines these questions.