Niehoff v. Surgidev Corp., 96-SC-0127-DG

• Decision Date: 19 June 1997
• Docket Number: No. 96-SC-0127-DG,96-SC-0127-DG
• Citation: 950 S.W.2d 816
• Parties: Prod.Liab.Rep. (CCH) P 15,004 Kathryn NIEHOFF, Appellant, v. SURGIDEV CORPORATION, Appellee.
• Court: United States State Supreme Court — District of Kentucky

Page 816

950 S.W.2d 816

Prod.Liab.Rep. (CCH) P 15,004

Kathryn NIEHOFF, Appellant, v. SURGIDEV CORPORATION, Appellee.

No. 96-SC-0127-DG.

Supreme Court of Kentucky.

June 19, 1997.

Rehearing Denied Oct. 2, 1997.

Roy Kimberly Snell, LaGrange, for Appellant.

William Kennedy Simpson, Carol Dan Browning, Jeanne M. Picht, Stites and Harbison, Louisville, for Appellees.

WINTERSHEIMER, Justice.

This appeal is from a decision of the Court of Appeals which affirmed a summary judgment by the circuit court determining that the claim for compensatory and punitive damages was properly dismissed because federal law preempted any claim for state tort relief.

The issue is whether the tort claim under Kentucky common law is in conflict with or divergence from any specific federal regulation applicable to the medical device which allegedly ultimately resulted in the loss of the patient's eye.

Facts of this Case

The product involved in this appeal is the Style 10 intraocular lens (IOL) manufactured by Surgidev. The IOL is an artificial lens which replaces the natural crystalline lens in the human eye following cataract surgery. It is a prescription medical device which is surgically implanted in the patient's eye in order to replace the diseased natural lens of the eye. The Style 10 was a particular type of IOL known as a "closed-loop anterior chamber" IOL because it was specifically designed for implantation in the anterior chamber of the eye which is the space between the cornea and the iris. The Style 10 lens was provided to physicians who were ophthalmologists and served as clinical investigators pursuant to an investigational device exemption which was granted by the Federal Food and Drug Administration in April of 1978.

Niehoff, whose vision had been significantly impaired by cataracts, had a cataract removed from her left eye by her ophthalmologist, Dr. John Hafer, in September of 1983. Dr. Hafer used a surgical technique known as "extracapsular cataract extraction." The doctor was an approved clinical investigator for the Style 10 lens and had signed an agreement with Surgidev which required him to obtain written informed consent from all Style 10 patients. Niehoff claims she did not know at the time of her surgery that the Surgidev Style 10 was an investigational device which had not yet been approved by the FDA as safe and effective. Dr. Hafer had explained to her that there was some risk involved in the procedure, but he allegedly did not tell her that the lens was experimental or investigational. Federal law requires that manufacturers and physicians obtain informed consent from a patient regarding an implantation of an investigational IOL and have a signed form of informed consent. The form explains specific complications of the procedure and advises the patient that her surgery will be part of a clinical investigation required by the FDA. There is no signed consent form in the record for the 1983 surgery. This Court recognizes that Dr. Hafer is not a party to this appeal and any claims against him will proceed following the resolution of this appeal regardless of the result.

Niehoff developed complications from the cataract surgery in 1989 and the Style 10 lens was surgically removed in September of 1990. She suffered a surgical infection which resulted in the ultimate loss of her eye. In 1991, she filed a civil action alleging product liability claims based on strict liability and negligence against Surgidev and alleging medical malpractice negligence against the physician in a separate suit. Surgidev obtained summary judgment on the grounds that the product liability claims were preempted by federal law. The Court of Appeals affirmed the reasoning that a court decision in a products liability or negligence suit may be established or define an acceptable standard and serve to compel a manufacturer to alter the design of a specific investigational device. It therefore imposes a different or additional requirement relative to the safety and effectiveness of the device, and consequently, the Court of Appeals concluded that it can be said to be of limited or specific applicability rather than of general applicability. Following the Court of Appeals decision, the United States Supreme Court rendered Medtronic, Inc. v. Lohr, --- U.S. ----, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996), which held that state law claims for negligence and product liability are not automatically preempted. This Court accepted discretionary review.

We hold that the claims of Niehoff for negligence and product liability for the injury caused by this particular experimental medical device are not preempted in state court by federal law. Recovery under a Kentucky claim does not rest on a specific finding that any particular claim would conflict with the enforcement of any specific federal regulation. Lohr, supra, is not necessarily dispositive here. The congressional purpose behind the substantially equivalent rule discussed in Lohr is distinguishable from the research and development goal of the investigational device exemption. The FDA has a more specific regulation regarding IOLs. The result and rationale of Lohr is instructive in our disposing of this case.

The Federal Regulations

The purpose of Congress and the FDA in allowing the marketing of an investigational device did not imply any intention to insulate Surgidev from liability to a patient who had not assumed the risk. The reasoning of the Court of Appeals in transforming general products liability law into a requirement of limited or specific applicability, rather than general applicability, is unconvincing.

In 1976, Congress amended the Food, Drug and Cosmetic Act, 21 USCA §§ 301-393 (1982) so as to give the FDA regulatory authority over all medical devices. An IOL is a Class III device which means it potentially presents an unreasonable risk of injury to patients. Class III devices are ordinarily subject to a FDA pre-market approval process, including a determination that the product is safe and effective, before marketing is permitted. However, in order to encourage research and development, Congress created an investigational device exemption under which the FDA may permit marketing for clinical investigation trial without pre-market approval.

21 U.S.C. § 360k(a) provides that no state may establish with respect to a medical device any requirement which is different from or in addition to any applicable federal requirement. FDA regulations interpret the term "requirement," as used in the federal statute, as including state court decisions. A state requirement is preempted only when the FDA has established counterpart regulations or there are other specific requirements applicable to the particular device under the act. Moreover, according to the FDA, the act does not preempt state requirements of general applicability when the purpose of the requirement relates to other products in addition to devices. Examples of Class III devices are pacemakers, intrauterine devices, heart valves and IOLs.

The FDA had not acted on the PMA application of Surgidev at the time the IOL was implanted in Niehoff's eye. In addition, the FDA never acted on the application before May of 1988, when Surgidev voluntarily suspended the clinical investigation of Style 10 lenses with notice to all clinical investigative physicians.

Congress provided for the investigational device exemption as a means for collecting enough data to enable the FDA to make an informed decision on pre-market approval. A review of the legislative history indicates that Congress did not believe the exemption was a means for enabling a manufacturer to market an experimental device without a determination of its safety and effectiveness. The congressional act places no time limit on exemptions, however, the FDA expressed concern that investigational exemptions should not be used as a subterfuge for commercial distribution of lenses and that the investigational study should not be unduly prolonged. 42 Fed.Reg. at 58875. In the situation presented by this appeal, it appears that Surgidev sold the Style 10 lens as an investigational device for ten years without ever obtaining pre-market approval of the lens.

The FDA imposed narrow restrictions on the reach of § 360k. In June of 1977, the agency announced that the regulation was intended to preempt only those state or local laws that directly and specifically relate to devices. 42 Fed.Reg. at 30383-84. The regulation subsequently promulgated by the FDA confirmed the narrow construction of § 360k. In addition the agency also conditioned the use of the investigational exemption of any medical device upon the requirement of informed consent to be obtained from each human subject or a representative.

Surgidev argues that this case presents a purely legal question involving federal constitutional law and its application to state tort claims. They contend that every federal court which addressed the issue prior to Lohr found that state common law product liability claims involving IOLs were preempted. To support their argument they rely on Slater v. Optical Radiation Corp., 961 F.2d 1330 (7th Cir.1992), cert. denied 506 U.S. 917, 113 S.Ct. 327, 121 L.Ed.2d 246, which involved an investigational IOL with a design similar to that of the Style 10 IOL. The reasoning of Slater, supra, was adopted by every other federal appellate court which considered the issue until the United States Supreme Court rendered Lohr in 1996, which involved a cardiac pacemaker, also a Class III medical device. The device in Lohr was never subjected to the PMA and IDA procedures but was authorized under 21 U.S.C. § 360(k) substantial equivalents. The pacemaker in Lohr was not an investigational device and consequently the investigational device exemption would not apply in any event. Pre-market approval was postponed pursuant to § 510(k).

The Kentucky Court of Appeals, in reaching its decision, agreed...