The proposed bill aims to establish regulatory oversight for medical, pharmaceutical, biological, or technological liability shield products in West Virginia by adding a new article to the state code. It includes definitions for key terms such as "liability shield product," "placebo-controlled study," and various safety outcome metrics. Manufacturers of these products are required to conduct placebo-controlled studies before marketing and to continuously track and publish data on adverse outcomes for a minimum of five years. The Department of Health will monitor these products, issue alerts regarding adverse consequences, and establish a public policy for data monitoring by January 1, 2026.
Additionally, the bill grants individuals the right to refuse liability shield products without coercion and allows both the Attorney General and individuals to take legal action against entities that violate the established regulations. The Attorney General can seek injunctive relief and impose civil penalties for violations, while individuals can pursue compensatory damages and attorney fees if they suffer injuries due to non-compliance. The bill sets specific deadlines for manufacturers to submit documentation and compliance reports, ensuring accountability and transparency in the use of liability shield products.
Statutes affected: Introduced Version: 55-7L-1, 55-7L-2, 55-7L-3, 55-7L-4, 55-7L-5, 55-7L-6, 55-7L-7, 55-7L-8, 55-7L-9