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Gile v. Optical Radiation Corp.

argued: March 24, 1994.

HELEN GILE, APPELLANT
v.
OPTICAL RADIATION CORPORATION; XYZ COMPANIES, #1 THROUGH #5; JOHN DOES, #1 THROUGH #5



Appeal from the United States District Court for the District of New Jersey. D.C. No. 92-cv-02957.

Before: Hutchinson, Roth, and Rosenn, Circuit Judges.

Author: Rosenn

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 the natural lens of the human eye. In December 1985, Dr. Henry Scimeca, an investigator approved by the FDA, implanted in the eye of plaintiff Helen Gile, who suffered from cataracts, an ORC model UV11H intraocular lens. Prior to the surgery, Gile signed an informed consent form, which she claims that she did not read before signing. Gile subsequently had the ORC lens surgically removed from her left eye, and is now legally blind in that eye.

In May of 1992, Gile commenced this products liability and negligence action against ORC in the Superior Court of New Jersey. ORC removed the case to the United States District Court for the District of New Jersey.*fn1 Thereafter, ORC moved for summary judgment on the ground that Gile's claims were expressly preempted under the Federal Food, Drug and Cosmetic Act (FDCA or the Act), 21 U.S.C. § 301 et seq. The district court entered summary judgment in favor of ORC and dismissed the complaint with prejudice. Gile timely appealed to this court. We affirm.

I.

This court exercises plenary review over a grant of summary judgment, and we apply the same test the district court should have utilized initially. Oritani Sav. and Loan Ass'n v. Fidelity and Deposit Co., 989 F.2d 635, 637 (3d Cir. 1993). Summary judgment is appropriate only when it is demonstrated that there is no genuine issue as to any material fact and the moving party is entitled to judgment as a matter of law. Celotex Corp. v. Catrett, 477 U.S. 317, 322-32, 91 L. Ed. 2d 265, 106 S. Ct. 2548 (1986); Fed.R.Civ.P. 56(c). An issue of material fact is genuine "if the evidence is such that a reasonable jury could return a verdict for the nonmoving party." Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248, 91 L. Ed. 2d 202, 106 S. Ct. 2505 (1986). In deciding a motion for summary judgment, all reasonable inferences must be drawn in favor of the non-movant. Oritani, 989 F.2d at 638.

At the heart of this action are the Medical Device Amendments of 1976 ("MDA"), 21 U.S.C. § 360c et seq., to the FDCA. Pursuant to the FDCA, and amendments thereto, including the MDA, the FDA strictly regulates the development, marketing, and monitoring of medical devices. The MDA sets forth various requirements concerning the safety and effectiveness of medical devices and the approvals to be obtained from the FDA before bringing a device to the market. The MDA also limits entities other than the FDA from imposing requirements on the makers of medical devices and the process by which those devices are discovered, investigated, and manufactured. Section 360k(a), the focus of this appeal, provides:

No State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement--

(1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and

(2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter.

21 U.S.C. § 360k(a).

In enacting the MDA, Congress recognized the need for special treatment of investigational devices which, by their very nature, could not meet the ...


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