2021 California Code
Health and Safety Code - HSC
DIVISION 105 - COMMUNICABLE DISEASE PREVENTION AND CONTROL
PART 4 - HUMAN IMMUNODEFICIENCY VIRUS (HIV)
CHAPTER 14 - Acquired Immune Deficiency Syndrome (AIDS) Clinical Trial Grant Award for the Prevention of Maternal Transmission of Human Immunodeficiency Virus (HIV) Infection
Section 121315.
(a) A manufacturer, research institution, or researcher shall not be strictly liable for personal injury or wrongful death resulting from the administration of any AIDS vaccine to a research subject participating in the clinical trials described in this chapter.
(b) It is the intent of the Legislature in enacting this section to confer upon manufacturers, research institutions, and researchers participating in the clinical trials described in this chapter an immunity from liability to the same extent as conferred upon specified pharmaceutical manufacturers under Brown v. Superior Court, 44 Cal. 3d 1049.
(c) No immunity shall be conferred to the extent that the injury or death was caused by the negligence, gross negligence, or reckless, willful, or wanton misconduct of the manufacturer, research institution, or researcher or the manufacturer, research institution, or the researcher has failed to comply with Section 121310.
(d) The immunity provided by this section shall not apply to a manufacturer, research institution, or researcher who intentionally provided false information to the FDA in connection with an IND application.
(e) Notwithstanding the immunity provided by this section, nothing in this section shall be construed to affect the inapplicability or applicability of the holding in Brown v. Superior Court, 44 Cal. 3d 1049 to other situations involving the same or similar conduct.
(Added by Stats. 1995, Ch. 415, Sec. 7. Effective January 1, 1996.)