Gile v. Optical Radiation Corp.

• Decision Date: 03 May 1994
• Docket Number: No. 93-5555,93-5555
• Parties: , Prod.Liab.Rep. (CCH) P 13,848 Helen GILE, Appellant, v. OPTICAL RADIATION CORPORATION; XYZ Companies, # 1 through # 5; John Does, # 1 through # 5.
• Court: U.S. Court of Appeals — Third Circuit

Page 540

22 F.3d 540

62 USLW 2720, Prod.Liab.Rep. (CCH) P 13,848

Helen GILE, Appellant, v. OPTICAL RADIATION CORPORATION; XYZ Companies, # 1 through # 5; John Does, # 1 through # 5.

No. 93-5555.

United States Court of Appeals Third Circuit.

Argued March 24, 1994.

Decided May 3, 1994.

Richard Galex, (argued), Galex, Tortoreti & Tomes, East Brunswick, NJ, for appellant.

John F. Brenner, (argued), McCarter & English, Newark, NJ, for appellees.

Before: HUTCHINSON, ROTH, and ROSENN, Circuit Judges.

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. ¹ 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. Sec. 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, 106 S.Ct. 2548, 2552-57, 91 L.Ed.2d 265 (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, 106 S.Ct. 2505, 2510, 91 L.Ed.2d 202 (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. Sec. 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:

[N]o 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. Sec. 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 requirements applicable to marketed devices:

It is the purpose of this subsection to encourage, to the extent consistent with the protection of the public health and safety and with ethical standards, the discovery and development of useful devices intended for human use and to that end to maintain optimum freedom for scientific investigators in their pursuit of that purpose.

21 U.S.C. Sec. 360j(g)(1). Persons seeking an exemption from pre-market approval for a particular medical device (an "investigational device exemption" or "IDE") must apply to the FDA for permission to undertake clinical investigations. Id. at Sec. 360j(g)(2)(A).

The FDA issued specific regulations governing the development of IOLs. 21 C.F.R. Sec. 813 et seq. (the "IOL Regulations"). The regulations require a detailed application, describing the device under investigation and setting forth a plan for studying its use in human subjects, which is reviewed by both the FDA and an institutional review committee. 21 C.F.R. Secs. 813.20, 813.30. The device must be described in sufficient detail to permit "a knowledgeable judgment about the anticipated safety and effectiveness of the lens." Id. at Sec. 813.20(b)(2). After approval, the committee has a duty to monitor the clinical investigation. Id. at Sec. 813.65. The regulations detail the monitoring of the studies and set forth reporting and recordkeeping requirements, including evaluation of complaints about devices. Id. at Secs. 813.46, 813.180 et seq. Under the IOL Regulations, the FDA can refuse an exemption if it finds, inter alia, that the lens may be unsafe or ineffective, that the investigational plan is not a reasonable one, or that manufacturing, storage, and implantation methods do not assure adequate safety and effectiveness. 21 C.F.R. Sec. 813.30(c). In sum, the IOL Regulations broadly govern nearly all facets of the investigational program. See Covey v. Surgidev Corp., 815 F.Supp. 1089, 1095 (N.D.Ohio 1993) ("[t]o say that the regulations covering intraocular lenses are expansive would be an understatement").

II.

Gile first argues that Congress never intended to preempt state common law when it passed the MDA. She contends that the word "requirement" in 21 U.S.C. Sec. 360k(a) refers only to positive legislative enactments and not to state tort common law claims. This argument must be rejected, however, in light of Cipollone v. Liggett Group, Inc., --- U.S. ----, 112 S.Ct. 2608, 120 L.Ed.2d 407 (1992). The Cipollone Court addressed the Public Health Cigarette Smoking Act of 1969, which preempted certain "requirement[s] or prohibition[s] ... imposed under state law." The Court rejected the contention that the act did not extend to state tort claims:

The phrase "[n]o requirement or prohibition" sweeps broadly and suggests no distinction between positive enactments and common law; to the contrary, those words easily encompass obligations that take the form of common law rules. As we noted in another context, "[state] regulation can be as effectively exerted through an award of damages as through some form of preventive relief. The obligation to pay compensation can be, indeed is designed to be, a potent method of governing conduct and controlling policy."

Although portions of the legislative history of the 1969 Act suggest that Congress was primarily concerned with positive enactments by States and localities, the language of the Act plainly reaches beyond such enactments.

--- U.S. at ----, 112 S.Ct. at 2620; 120 L.Ed.2d at 426 (citations and footnote omitted). Thus, the Supreme Court has clearly stated that the word "requirement," in the context of an express preemption provision, includes state law claims. See also Stamps v. Collagen Corp., 984 F.2d 1416, 1421 (5th Cir.1993), cert. denied, --- U.S. ----, 114 S.Ct. 86, 126 L.Ed.2d 54 (1993); King v. Collagen Corp., 983 F.2d 1130, 1133 (1st Cir.1993) cert. denied, --- U.S. ----, 114 S.Ct. 84, 126 L.Ed.2d 52 (1993).

Gile contends that there cannot be express preemption unless Congress uses "the words 'common law' or something analogous" to indicate its intent to preempt such claims. However, the MDA, providing "no State or political subdivision of a State may establish ... any requirement ... different from, or in addition to, any requirement applicable under this chapter," is indistinguishable from the act at issue in Cipollone, which provided, "[n]o requirement or prohibition ... shall be imposed under State law with respect to the advertising ... of any cigarettes." Thus, Gile's argument that Congress needs to explicitly provide that common law claims are preempted in order to find express preemption is unpersuasive.

Gile further argues that even if her tort claims in general are preempted under Sec. 360k, her specific claims based on lack of informed consent and adulterated products are exempt from preemption. First, she relies on 21 C.F.R. Secs. 50.20 and 50.25(c) as support for her contention that her claim for failure to obtain informed consent is not preempted. Section 50.20, which addresses general requirements for informed consent, provides in part: "No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence." Section 50.25(c), which addresses elements of informed consent, provides: "[t]he informed consent requirements in these regulations are not intended to preempt any applicable Federal, State, or...