Case Name: Kathryn NIEHOFF, Appellant, v. SURGIDEV CORPORATION, Appellee
Court: Supreme Court of Kentucky
Jurisdiction: Kentucky
Decision Date: 1997-06-19
Citations: 950 S.W.2d 816
Docket Number: No. 96-SC-0127-DG
Parties: Kathryn NIEHOFF, Appellant, v. SURGIDEV CORPORATION, Appellee.
Judges: GRAVES, LAMBERT, STUMBO and WINTERSHEIMER, JJ., concur.
Reporter: South Western Reporter Second Series
Volume: 950
Pages: 816–832

Head Matter:
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. Pieht, Stites and Har-bison, Louisville, for Appellees.

Opinion:
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 accept able 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 Niehoffs 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 with the majority of federal circuit courts which have considered the question and based its decision on the Slater case. Slater completely barred a plaintiff from recovery under Illinois law for breach of warranty, strict liability and negligence in connection with a defective lens. The federal court conceded that the regulations imposed no requirement concerning the design of IOL devices and that there is no federal damage remedy that a plaintiff might invoke. The Slater court believed that the FDA had established procedures for determining whether the experimental design is safe and effective and these procedures sufficed as a counterpart regulation preempting any state law bearing on the safety of an IOL. All federal courts did not concur. In Kennedy v. Collagen Corp., 67 F.3d 1453 (9th Cir.1995), the Ninth Circuit held that pre-market approval is supposed to benefit consumers and not insulate manufacturers from liability. Kennedy expressed concern over the disregard by other federal courts of the long-standing narrow construction of § 360k by the Agency.
Medtronic, Inc. v. Lohr
In Lohr, the U.S. Supreme Court has now established that medical device amendments of 1976 do not preempt state law unless a specific state requirement contravenes a specific regulation. Lohr involved claims under Florida law against a manufacturer of a defective pacemaker. Lohr had sustained injury in 1990 when her pacemaker, a Class III device that Medtronic had placed on the market as the substantial equivalent device pursuant to 21 C.F.R. § 510(k), failed because of a defective lead.
The opinion of the United States Supreme Court which was authored by Justice Stevens concluded that the medical devices amendments did not preempt any of the tort claims under the common law of Florida for negligence and strict liability. Our resolution of the Kentucky case is highly influenced by the decision of Lohr and the analysis we give it. Niehoff contends that Lohr provides a corrective and authoritative view that the real objective of Congress in 1976 was to provide consumer protection and informed deference to the FDA in resolving any difference between state and federal regulatory interest. Niehoff argues that Lohr effectively abolishes any immunity running to manufacturers under the medical device amendments. Sur-gidev, on the contrary, characterizes the Lohr decision as a 4-1-4 plurality asserting that the concurring opinion of Justice Breyer disagreed with the reasoning of the plurality but concurred in the result only. Part of our task is to sort out the varying views expressed by the members of the United States Supreme Court.
Our consideration of Lohr indicates that it is not necessarily dispositive of the situation presented in -this case. However, we believe that Lohr is instructive and the result and rationale of Lohr is of considerable assistance in reviewing the matter before us. In essence, Lohr held that the state tort claims for negligence and product liability were not always preempted. The Court noted that there is a presumption against preemption which occurs only when it is the clear and manifest intent of Congress as revealed by the language of the act and the purpose and structure of the statute as a whole. The Lohr decision permitted the plaintiff to maintain an action for the manufacturer's violation of FDA regulations. In that context, the state requirement is equivalent to and not different from the federal requirement. The decision also reasoned that the state common law requirements upon which the plaintiff based her claim were not specifically developed with respect to medical devices. The court stated that it was substantially informed by the FDA interpretive regulations in reaching that conclusion. The decision went on to say these state requirements therefore escape preemption because their generality leaves them outside the category of requirements that § 360k envisioned to be with respect to specific devices such as pacemakers.
Surgidev also argues that Lohr supports a finding of preemption in this case because preemption is consistent with the express congressional intent. We disagree. The congressional purpose behind the substantially equivalent rule is distinguishable from the research and development ends of the inves-tigational device exemption. The FDA has more specific regulations regarding IOLs. Congress and the FDA clearly intended to allow Surgidev to market its IOL as an in-vestigational device, but this permission did not extend to an insulation of Surgidev from any liability to a patient who had not assumed the risk. The distinctions in Lohr do not remove this case from its larger principles. There is a presumption against preemption and a deference to the FDA interpretation of preemption.
In our analysis of the decision rendered by the United States Supreme Court, we must examine the concurring opinion of Justice Breyer who joined with the author of the majority opinion, Justice Stevens, and three other justices for Parts I, II, III, VI and VII of the decision. Accordingly, these parts of the Lohr opinion constitute the majority view.
The doctrine of federal preemption is derived from the supremacy clause of the United States Constitution, Article VI. McCulloch v. Maryland, 17 U.S. (4 Wheat.) 316, 4 L.Ed. 579 (1819), determined that a state law that conflicts with federal law is without effect. The historic police powers of the state are not preempted in the absence of "the clear and manifest purpose of Congress" to do so. Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 67 S.Ct. 1146, 91 L.Ed. 1447 (1947). The United States Supreme Court has stated that it is reluctant to interpret a federal statute in such a way as to find preemption of subjects traditionally governed by state law. CSX Transportation v. Easterwood, 507 U.S. 658, 113 S.Ct. 1732, 123 L.Ed.2d 387 (1993). Determination of whether a federal statute preempts a state cause of action depends on the purpose of Congress in enacting the federal statute. Malone v. White Motor Corp., 435 U.S. 497, 98 S.Ct. 1185, 55 L.Ed.2d 443 (1978).
The congressional purpose to preempt a state remedy may be determined in either of two ways. The first is whether the preemption is found in the express language of the statute, Cipollone v. Liggett Group, Inc., 505 U.S. 504, 112 S.Ct. 2608, 120 L.Ed.2d 407 (1992). The second is to find preemption implied from the structure and purpose of the statute. Implied preemption occurs when the state law actually conflicts with federal law or where the federal law so thoroughly occupies the legislative field that it may be reasonably inferred that Congress left no room for the state to supplement it. Where a statute, such as the one we are considering, has a provision explicitly addressing preemption, that provision provides a reliable indicator of the congressional intent with respect to state authority. In Ci-pollone, the preemption statute in question provided that no requirement or prohibition based on smoking and health shall be imposed under state law with respect to advertising or promotion of any cigarettes.
Congress has given the FDA a unique role in determining the scope of § 360k's preemptive effect. In most cases a state law will be preempted only to the extent that the FDA has promulgated a relevant federal requirement.
The Lohr decision reaffirms the concept that there is a presumption against the preemption of state regulations and recognizes the historic primacy of state regulation of matters of health and safety. The decision also recognizes that deference is due to the FDA's own interpretation of the medical device amendments, including § 360k. The decision endorses the narrow interpretation of preemption and agrees that § 360k does not preempt state or local requirements that are equal to or substantially identical to requirements imposed by or under the federal act. The decision in Lohr clearly cautioned that future decisions on the scope of preemption under the federal act must focus on a comparison between specific federal and state regulations. Earlier decisions such as Slater had relied on the general FDA safety regulations to preempt any state common law theory challenging the design of a medical device, even though the federal regulations had not considered any specifics for the design of a particular device.
In reviewing the decision in Lohr, we are obliged to consider both the plurality analysis of Justice Stevens and the concurring opinion by Justice Breyer. The plurality opinion indicates that the term "requirements" has a narrower meaning in § 360k than in the statute at issue in Cipollone. Justice Breyer disagrees with the plurality on two grounds. First, he believes that some common law actions are preempted by § 360k, and second, he disagrees with the plurality dicta that preemption of common law claims would be few and rare. He establishes a standard of his own in which there must be a conflict with federal regulations and regulations must be so pervasive as to preempt the field of state common law actions. Justice O'Connor wrote a concurring opinion in which she disagreed with the analysis of the majority plurality and parts of the Breyer analysis. She did concur in finding that the common law defective design claims were not preempted. However, she believed that federal regulations relating to manufacturing and labeling were so comprehensive as to preempt common law claims based on negligent manufacturing or labeling. Three justices joined her opinion. Justice Breyer refrained from joining only Part IV, which contained a detailed distinction between the previous analysis of preemption under a different statute regulating warnings on cigarettes and its analysis under the medical device amendments and Part VI, in which Justices Stevens, Kennedy, Souter and Ginsberg declined to resolve the contention by Lohr that common law duties are never requirements within the meaning of § 360k and that the statute therefore never preempts common law actions. In his concurring opinion, Justice Breyer was explicit in providing his reasons for not joining IV and VI because he believed Part IV emphasized the difference between the medical device amendments and the preemption statute at issue in Cipollone v. Liggett Group, Inc., supra, because those differences are not relevant to this case. Justice Breyer did not join Part VI because he was not convinced that future incidents of medical device amendments preemption of common law claims will be few or rare.
We find the analysis by Justice Breyer to be critical to the decision of the U.S. Supreme Court and helpful in disposing of this case. His view was based on the proposition that § 360k would not preempt a state court decision based on a finding by a jury under the common law, unless it directly contravened a specific federal regulation applicable to a specific device. Both Justice Stevens in his plurality and Justice Breyer determined that the courts must look to the FDA for responsibility in administering the medical devices amendments. Justice Breyer pointed out that the FDA had already promulgat ed a specific regulation designed to help. The regulation in question is 21 C.F.R. § 808.1(d) which states in pertinent part that state requirements are preempted only when there are specific federal requirements applicable to a particular device, thereby making any existing divergent state requirements applicable to the device different from or in addition to the specific federal requirements. Justice Breyer and the plurality opinion agreed that none of the state tort claims presented by Lohr were preempted.
The claims presented by Niehoff against Surgidev are similar to those presented by Lohr against Medtronic and are not precluded by the narrow specific approach to preemption referenced by the Lohr case.
The tort claims under Kentucky common law are not divergent from or in conflict with any specific FDA regulations applicable to the Style 10 IOL. Niehoff alleges that the Surgidev Style 10 was a defective and unreasonably dangerous product under Kentucky's common law strict liability. She further claims that Surgidev negligently designed, marketed and monitored the device and that her strict liability and negligence claims include allegations of failure to warn or to obtain her informed consent to the use of the experimental device.
The medical device amendments do not preempt her claim that Surgidev is strictly liable for the defective Style 10 IOL. Kentucky has adopted Section 402A of the Restatement (Second) of Torts which imposes strict liability on one who sells any product in a defective condition unreasonably dangerous to the user or consumer, even though the seller has exercised all possible care in the preparation and sale of the products. KRS 411.300 et. seq. and Dealers Transport Company v. Battery Distributing Company, Ky., 402 S.W.2d 441 (1966), in regard to the federal preemption concern, state that defective design and failure to warn are separate aspects of the same cause of action, strict liability. See Montgomery Elevator Co. v. McCullough, Ky., 676 S.W.2d 776 (1984).
Kentucky's strict liability case law and statutes are laws of general applicability to all products and fall beyond the scope of the federal preemption under § 360k. The claim by Surgidev of preemption to the defective design allegation fails because there is no specific federal requirement which addresses or contradicts the specific opinions of her own expert which are in turn based upon a criticism of the Style 10 that appears in medical literature. There is no specific counterpart regulation that can preempt a Kentucky common law judgment based on a potential jury finding that the Style 10 IOL was defective or unreasonably dangerous because of its design. The claim by Niehoff that she never received any even basic instruction or warning as required by federal law is not in conflict with the applicable federal regulations. The federal amendments do not preempt her claim that Surgidev was negligent in its design, its failure to warn and its violation of federal regulations. A judgment by a Kentucky court or a potential jury verdict that Surgidev failed to use ordinary care in its design or in its failure to report its data to its investigators or any possible violation of federal regulations would not diverge from any specific federal regulation. Obviously, it would assist in enforcing them. The medical device amendments does not preempt state punitive damage remedies. There is no contradiction or conflict in any of these concepts should any of them become viable in a proper common law tort action in Kentucky.
Surgidev's many authorities presented to support its position are unpersuasive. We believe the citation by Surgidev to the Federal District Court decision in Berish v. Richards Medical Co., 937 F.Supp. 181 (N.D.N.Y.1996), which was rendered after Lohr, is without merit. We are more persuaded by the decision of the Missouri Supreme Court in Connelly v. Iolab Corp., 927 S.W.2d 848 (Mo.1996), which held that the medical device amendments did not preempt any of the state court claims of a plaintiff arising from the defective design of an IOL or the manufacturer's misconduct in failing to warn physicians of its high rate of complication. See also Montoya v. Mentor Corp., 122 N.M. 2, 919 P.2d 410 (App.1996).
Conclusion
It is the holding of this Court that the medical device amendments of 1976 do not preempt Kentucky law because there is no specific state requirement which contravenes, contradicts or conflicts with a specific federal regulation. The tort claims presented under Kentucky common law are not divergent from or in conflict with any specific federal regulation applicable to the Style 10 IOL.
The decision of the Court of Appeals is reversed and this matter is remanded to the circuit court for trial on the merits.
GRAVES, LAMBERT, STUMBO and WINTERSHEIMER, JJ., concur.
ERIC L. ISON, Special Justice, dissents by separate opinion in which STEPHENS, C.J., and COOPER, J., join.
JOHNSTONE, J., not sitting.