Slater v. Optical Radiation Corp.

• Decision Date: 20 May 1992
• Docket Number: No. 91-1544,91-1544
• Citation: 961 F.2d 1330
• Parties: Albert SLATER, Plaintiff-Appellant, v. OPTICAL RADIATION CORPORATION, Defendant-Appellee.
• Court: U.S. Court of Appeals — Seventh Circuit

Page 1330

961 F.2d 1330

60 USLW 2693

Albert SLATER, Plaintiff-Appellant, v. OPTICAL RADIATION CORPORATION, Defendant-Appellee.

No. 91-1544.

United States Court of Appeals Seventh Circuit.

Argued Dec. 2, 1991.

Decided April 22, 1992.

Rehearing and Rehearing En Banc Denied May 20, 1992.

Peter A. Nicholson, Horvath, Lieber & Quilici, Chicago, Ill. (argued), for plaintiff-appellant.

Thomas H. Fegan (argued), William V. Johnson, Brian C. Fetzer, Andrea H. Kott, Johnson & Bell, Chicago, Ill., for defendant-appellee.

Before POSNER and MANION, Circuit Judges, and FAIRCHILD, Senior Circuit Judge.

POSNER, Circuit Judge.

The district judge dismissed this diversity personal-injury suit on the pleadings, on the ground that it was preempted by an investigational-device exemption issued by the Food and Drug Administration under the Medical Device Amendments of 1976 to the Food, Drug and Cosmetic Act of 1938, et seq. (N.D.Ill.1991). He thus disagreed with (E.D.La.1988), the only other case concerning the preemptive force of an exemption for an investigational device--which makes ours a case of first impression at the appellate level.

The Amendments gave the FDA comprehensive regulatory authority over medical devices for the first time. H.R.Rep. No. 853, 94th Cong., 2d Sess. 1, 6-13 (1976). Among other things, the Amendments authorize the agency to promulgate implementing regulations, (a), and forbid states to subject a medical device to "any requirement (1) which is different from, or in addition to, any requirement applicable under the [Amendments] to the device, and (2) which relates to the safety and effectiveness of the device or to any other matter included in a requirement applicable to the device under" the Amendments. Sec. 360k(a). In regulations the validity of which neither party questions, the FDA has declared that preemption, though equally applicable whether the state is acting "by statute, ordinance, regulation, or court decision," is limited to cases in which the FDA "has established specific counterpart regulations [to the challenged state requirements] or there are other specific requirements applicable to a particular device under" the federal act. (b), (d).

In the year following the enactment of the Medical Device Amendments, the FDA issued "Investigational Device Exemption Regulations" for intraocular lenses. 21 C.F.R. pt. 813. Such exemptions, which the Amendments expressly authorize the FDA to grant upon application, (g), are intended to encourage innovation by exempting promising experimental devices from the usual requirement of establishing the safety and efficacy of a medical device before it can be sold. Cf. H.R.Rep. No. 853, supra, at 12, 42. The regulatory exemption is not total. (See (7th Cir.1984), and with specific reference to the exemption for intraocular lenses (D.C.Cir.1983), and (D.Minn.1986), aff'd, (8th Cir.1987).) A detailed application is required, describing the device and setting forth a plan for studying its use in human subjects ("clinical investigation") during the experimental period. . The application must be reviewed by an institutional review committee as well as by the FDA before it can be approved. Secs. 813.20, 813.30. After approval, the committee has a duty to monitor the clinical investigation. Sec. 813.65. Congress expected the FDA to grant an investigational-device exemption for intraocular lenses; we know this because the Medical Device Amendments contain a specific provision intended to require the FDA to make intraocular lenses "reasonably available to physicians meeting appropriate qualifications" if an investigational exemption is granted. (l )(3)(D)(iii); H.R.Conf.Rep. No. 1090, 94th Cong., 2d Sess. 63 (1976); (D.D.C.1991).

Intraocular lenses are plastic lenses implanted in the eyes of persons who have undergone surgery for the removal of cataracts. Richard B.S. Packard & Fiona C. Kinnear, Manual of Cataract and Intraocular Lens Surgery (1991). The removal of a cataract destroys the (natural) lens on which the cataract has formed, and restoration of focused vision requires either special cataract glasses, a contact lens, or an intraocular lens (behind the cornea). Alfred Mamelok, "Cataract," in 3 Roscoe N. Gray & Louise J. Gordy, Attorneys' Textbook of Medicine pp 56.45, at pp. 56-50 to 56-52 (3d ed. 1991). Now standard treatment for cataract patients, intraocular lenses were experimental back in the 1970s when the investigational-device exemption for such lenses was issued, and for some years afterward.

Optical Radiation Corporation, the defendant in this case, manufactured an intraocular lens called "Stableflex." This was an anterior-chamber intraocular lens (that is, it was installed in the anterior chamber of the eye, which is a space between the cornea and the iris), a type of lens manufactured by several other companies as well. All of these lenses, as well as intraocular lenses of different design, received investigational-device exemptions. In 1984, Slater, the plaintiff in this case, had a cataract removed and a Stableflex implanted in the eye. Before the operation he signed a form in which he consented to participate in the clinical investigation of this experimental device. After the operation, according to the allegations of the complaint, the vision in Slater's left eye deteriorated, he experienced continuous pain, the eye became infected, and eventually the implant had to be removed, leaving him with permanent damage to the eye (beyond the damage done by the cataract itself). The surgeon who performed the removal found the lens "cocooned" in the eye--which he thought due to the fact that the lens had an awkward design--and therefore difficult to remove. This model of the Stableflex was later withdrawn from the market. David J. Apple et al., Intraocular Lenses: Evolution, Designs, Complications, and Pathology 88 (1989).

The suit is for the injury to Slater's eye allegedly caused by the implantation and removal of the lens. The complaint alleges inadequate clinical testing, defective design of the intraocular lens, and failure to warn the public of the lens's dangers. The district judge dismissed the suit on the ground that the plaintiff was seeking to impose in the name of Illinois tort law requirements relating to safety or effectiveness that were different from the requirements imposed by the FDA's regulations governing the experimental use of intraocular lenses.

The plaintiff's counsel wisely conceded at argument that insofar as the complaint might be construed to allege that Illinois tort law required the defendant to do more or different clinical testing of Stableflex than required by the FDA's regulations governing the investigational exemption for intraocular lenses, the suit is indeed preempted; for it would then be unquestionably a matter of imposing in the name of state law a different requirement relating to safety and effectiveness from that imposed by federal law. If the FDA in a valid regulation under the Medical Devices Amendments requires X, and X relates to safety or effectiveness, a state cannot, whether through statute, regulation, or...