Reference no: EM133809542

Question

In 1990 the ABC Drug Company began marketing a drug called Retinex, approved for prescription by doctors by the federal Food and Drug Administration (FDA). Extensive testing had shown that the drug caused positive results for people suffering various degenerative diseases of the retina, the light-sensitive area at the back of the eye. In 1991 and 1992 a puzzling pattern appeared. There were many reports of very positive results for Retinex users, involving the halting of retinal degeneration and improvement of vision. But a significant number of cases involved dramatic increase in degeneration leading to loss of vision. Then in 1993 ABC scientists determined that the negative results overwhelmingly occurred among people who had both retinal disease and also had diabetes, and that few positive results occurred among this group. ABC promptly proposed, and the FDA agreed, that Retinex should not be prescribed for any eye patient who has diabetes. Victor Vronsky's doctor prescribed Retinex for Vronsky's retinal disease in 1991. At that time Vronsky was known to be diabetic, but the special risk posed by the drug for diabetics was unknown. Soon after starting to take the drug Vronsky lost his eyesight completely and irreversibly. Strict products liability.