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SLATER v. OPTICAL RADIATION CORP.

January 30, 1991

ALBERT SLATER, Plaintiff,
v.
OPTICAL RADIATION CORPORATION, Defendant



The opinion of the court was delivered by: PLUNKETT

 PAUL E. PLUNKETT, UNITED STATES DISTRICT JUDGE

 Plaintiff Albert Slater ("Slater") has filed an amended complaint ("complaint") against defendant Optical Radiation Corporation ("ORC") for injuries allegedly sustained as a result of the implantation of a device manufactured by ORC, known as the Stableflex anterior intraocular lens. Plaintiff's complaint sounds in negligence, strict liability, and breach of an implied warranty and seeks punitive damages. Before us today is (1) ORC's motion to dismiss all counts of the complaint on the ground that Slater's claims are preempted by federal law, and (2) ORC's motion for summary judgment *fn1" on Count Four, the count which seeks an award of punitive damages. For the reasons set out below, we grant ORC's motion to dismiss all counts of the complaint on the ground that plaintiff's claims are expressly preempted by federal law. We do not reach ORC's motion for summary judgment on Count Four.

 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. ยง 813 et seq.2 (See discussion, infra). *fn3"

 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;
 
2. Distributed and sold its Stableflex intraocular lens in the market for implantation in the human eye knowing that it was not properly clinically tested and that it may cause damage to the human eye;
 
3. Failed to adequately warn the consuming public that its Stableflex intraocular lens had not been clinically tested for implantation in the human eye and that it could cause damage to the human eye;
 
4. Failed to inspect and discover that its Stableflex intraocular lens's design was defective and not fit for implantation in the human eye;
 
5. Failed to give adequate warnings as to the dangers of its Stableflex intraocular lens after its distribution and sale of the lens in July of 1984;
 
6. Knew or should have known that its Stableflex intraocular lens was designed improperly and was not fit for implantation in the human eye, and failed to warn ...

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