Gile v. Optical Radiation Corporation

OPINION OF THE COURT

ROSENN, Circuit Judge.

This case raises an interesting question of liability which has its origin in the coordinated efforts of the Government and manufacturers of optical medical devices to advance the cause of medical treatment through research, experimentation, and optimum freedom for scientific investigation in the pursuit of that purpose.

In 1981, the Food and Drug Administration (FDA) approved for clinical investigation an intraocular lens manufactured by defendant Optical Radiation Corporation (ORC). An intraocular lens (IOL) is a lens intended to replace surgically…