Because we are only ruling on ORC's motion to dismiss, for today's purposes we assume all facts alleged in the complaint are true along with all reasonable inferences therefrom in the light most favorable to Slater, the plaintiff. Powe v. City of Chicago, 664 F.2d 639, 642 (7th Cir. 1981). On July 19, 1984, Slater was admitted into the Hinsdale Hospital in Hinsdale, Illinois to have a cataract removed from his left eye and to have an implant placed therein. The surgery was performed by Dr. David Whitsel, who is now deceased. Dr. Whitsel performed the extracapsular cataract extraction and inserted an anterior chamber intraocular lens in Slater's left eye. The lens was a Stableflex Model #UV-11-H, a product manufactured, designed, marketed, promoted, sold and distributed by ORC. At the time of Slater's lens implant, the Stableflex Model #UV-11-H intraocular lens was part of a clinical investigation conducted pursuant to 21 C.F.R. § 813 et seq.2 (See discussion, infra).
Over the next three years, Slater's left eye problems became worse. On January 8, 1986, Slater went to the Mayo Clinic in Rochester, Minnesota to receive treatment for his left eye. His left eye caused him great physical pain and had become infected. Slater was told that he was suffering from cestoid muscular edema. The doctors at the Mayo Clinic told him that there was no treatment available for his ailment, and told him to return in one year.
In January of 1987, Slater returned to the Mayo Clinic and was treated by two new doctors, Dr. R.R. Waller and Dr. Leo Maguire. Dr. Maguire recommended that the lens implant be removed because the pressure in Slater's left eye was dangerously low and because the tissue in his left eye was very soft. The operation to remove the lens implant was conducted on June 4, 1987.
On April 7, 1989, Slater filed the amended complaint in this action for injuries he sustained as a result of the insertion of the Stableflex intraocular lens manufactured by ORC. Count One alleges a cause of action for negligence. Specifically, Slater alleges that ORC was negligent in the performance or omission of seven acts:
1. Failed to engage in proper clinical testing in order to detect the effect of its Stableflex intraocular lens upon the human eye;