Heath took Ortho-Novum oral contraceptives from 1967 to 1974, when, at age 28, she suffered kidney failure that required a kidney transplant.
She sued, claiming the kidney failure was caused by Ortho-Novum, which did not warn physicians to monitor blood pressure or watch for signs of kidney problems. Ortho defended that it was in compliance with FDA regulations in marketing the product, so it should not be subject to common-law strict liability or negligence.
Could the case go to the jury, or did federal regulation of the drug remove commonlaw liability? [Ortho Pharmaceutical v. Heath, 722 P.2d 410, Colo. Sup. Ct. (1986)]