Kathryn NIEHOFF, Appellant, v. SURGIDEV CORPORATION, Appellee.
No. 96-SC-0127-DG.
Supreme Court of Kentucky.
June 19, 1997.
Rehearing Denied Oct. 2, 1997.
All concur.
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 accept-
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,
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
The FDA imposed narrow restrictions on the reach of
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
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
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
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. Surgidev, on the contrary, characterizes the Lohr decision as a 4-1-4 plurality asserting
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
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 investigational 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 investigational 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
Congress has given the FDA a unique role in determining the scope of
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
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
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
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.
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
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
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.
ERIC L. ISON, Special Justice, dissenting.
Congress’ intent to preempt at least some state law is plain from the express language of
A state law claim is preempted if it conflicts with federal law or if federal law so thoroughly occupies the field as to make reasonable the inference that Congress left no room for state law to supplement it. See, Cipollone, 505 U.S. at 515-517, 112 S.Ct. at 2617. This Court today concludes that Niehoff‘s product liability claims of strict liability and negligence and her claims based on violation of federal regulations are not preempted. I believe that all of Niehoff‘s claims do conflict with federal law and that federal law thoroughly occupies the legislative field pertaining to the product of which Niehoff complains. I, therefore, respectfully dissent.
I.
The Intraocular lens (“IOL“) at issue in this case is a Class III medical device, regulated by the Food and Drug Administration (“FDA“) under the Medical Device Amendments of 1976 (“MDA“) to the Food, Drug and Cosmetic Act (“FDCA“).
Surgidev‘s IOL was marketed for human use from April 1978 to May 1988 under the auspices of an FDA clinical investigation. The requirements of this investigation are codified at
The [FDA] Secretary shall ... by regulation prescribe procedures and conditions under which devices intended for human use may upon application, be granted an exemption from the requirements of Section 352, 360, 360d, 360e, 360f, 360i or 379e of this title or subsection (e) or (f) of this section or from any combination of such requirements to permit the investigational use of such devices by experts qualified by scientific training and experience to investigate the safety and effectiveness of such devices.
Moreover, under
Further federal requirements relating to the safety and effectiveness of Surgidev‘s IOL are codified in
(b) Effect of exemption. (1) In general, intraocular lenses are exempted from provisions of the following sections of the act and regulations thereunder when an application for exemption applicable to the lenses is in effect under this part: Misbranding under section 502, registration and premarket notification under section 510, performance standards under section 514, premarket approval under section 515, records and reports under section 519, restricted devices under section 520(e), good manufacturing practices under section 520(f), and color additives under section 721.
During the ten year period when Surgidev‘s IOL was marketed under the IDE‘s provisions, there is nothing in the record to indicate that Surgidev had not satisfied the FDA in meeting the testing, record keeping, informed consent and other requirements of both the IDE statute and its copious accompanying regulations.
Now, however, Niehoff alleges that Surgidev‘s IOL was defective in that it was unreasonably dangerous for its intended use. She further alleges that Surgidev was negligent in the design, manufacture and sale of the IOL. In order to prevail at trial, Niehoff‘s claims require a fact finder to conclude that although Surgidev satisfied the requirements of
II.
Before this Court reaches the conclusion from which I dissent, the Majority correctly
[t]he purpose of Congress and the FDA in allowing the marketing of an investigation-al device did not imply any intention to insulate Surgidev from liability to a patient who had not assumed the risk.
As tempting as it is in deciding this case to follow the Majority in its concern that Niehoff may not have consented to the treatment at issue, this omission is not determinative of the preemption issue. If Niehoff did not give her informed consent, she is not without remedy, even if her claims before this Court, as pled, are preempted. Her action below against her approved investigational opthamologist remains. Surgidev, as the manufacturer of the IOL, was not required to obtain informed consent from patients who used its device. This is true under tort law and under the protocol that controlled the clinical investigation in this case. To begin with, manufacturers such as Surgidev have no contact with patients. Surgidev was required under the federal regulations to obtain from each approved physician investigator, a written agreement to comply with the informed consent requirements of
III.
I also respectfully disagree with the Majority‘s application of Medtronic, Inc. v. Lohr, 518 U.S. 470, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996) to this case. Again, I agree with the Majority that while the Lohr decision is not dispositive of this case, its analysis is instructive. I also agree, as discussed further below, that the method by which the pacemaker at issue in Lohr was authorized for sale in the marketplace is different from the method by which Surgidev‘s IOL was authorized for use. The Majority further provides an excellent analysis of the evolution in the law from Slater v. Optical Radiation Corp., 961 F.2d 1330 (7th Cir.1992) and its progeny, to the Supreme Court‘s decision in Lohr.
The Majority, having observed that the “substantially equivalent” rule in Lohr is distinguishable from the research objectives of the IDE, and that the FDA regulations regarding IOL‘s are more specific, concludes that Lohr supports a finding that Niehoff‘s claims are not preempted. I do not agree with this conclusion.
My view of the difference between the Supreme Court‘s holding in Lohr, and the issue before this Court, comes in large part from the difference between the “substantially equivalent” approval process by which the pacemaker in Lohr reached the market, and the IDE approval process, by which Surgidev‘s IOL reached Niehoff here. The “substantially equivalent” requirement which controlled in Lohr
[i]mposes a limited form of review on every manufacturer intending to market the new device by requiring it to submit a “pre-market notification” to the FDA. (The process is also known as a § 510(k) process).... If the FDA concludes on the basis of the § 510(k) notification that the
device is “substantially equivalent” to a pre-existing device, it can be marketed without further regulatory analysis.
Lohr, 518 U.S. at 478, 116 S.Ct. at 2246. As the Supreme Court observed, the “substantially equivalent” inquiry is brief and simple. It imposes no federal requirements on the design, manufacture or labeling of a product. Lohr, 518 U.S. at 493, 116 S.Ct. at 2253-54. The “substantially equivalent” approval process
is focused on equivalence, not safety.... [A]s a result, substantial equivalent determination provide little protection to the public ... “Substantially equivalent” devices never been formerly reviewed under the MDA for safety or efficiency
Id. at 493, 116 S.Ct. at 2254 (emphasis added). In order not to be put at a competitive disadvantage, manufacturers such as the manufacturer in Lohr were allowed to freely market their devices because they were “substantially equivalent” to other grandfathered devices already on the market. Having been placed on the same playing field as their competitors, such manufacturers logically should also be subject to the same standard of liability. It follows that the Supreme Court in Lohr concluded that the “substantially equivalent” pre-notification process was not a federal requirement that preempted common law claims of negligence or strict liability. In contrast, the IDE process does review in great detail, devices approved under
Surgidev obtained approval to market its IOL under this exemption by submitting an application which included the following information:
(2) A description of all components, ingredients and properties and a description of the principal of the operation of the device ... in enough detail so that a scientist or a physician familiar with the general type of lens can make a knowledge judgment about the anticipated safety and effectiveness of the lens in the proposed investigational study.
(3) A description of those methods, facilities, and controls used for the manufacture, processing, packing, and storage of the device in enough detail so that a person generally informed in that area can make a knowledgeable judgment about the safety and effectiveness of the device in the proposed investigational study....
(9) A copy of all informational material, including labels and other labeling, which is to be supplied to investigators as required by § 813.47(a).
Surgidev was also required to submit an investigational plan which included,
[t]he plan for obtaining informed consent from subjects and copies of all informational materials to be given to subject, including all forms and materials to be used in obtaining such consent....
Thus, when the FDA considered whether Surgidev‘s IOL could be used by investigators on patients including Niehoff, it first made a “knowledgeable judgment about the safety and effectiveness of the device.” The FDA was also required to review and approve labeling and informed consent procedures applicable to the device during the investigatory period. This is completely distinguishable from the perfunctory “substantially equivalent” approval by which the allegedly defective pacemaker reached consumers in Lohr.
The FDA was solely responsible for the review, approval and monitoring of Surgidev‘s application to include its IOL in the investigational study. Further, the FDA was solely responsible for the determination that Surgidev‘s IOL was exempt from the statute‘s good manufacturing principles, labeling and performance requirements. The FDA might have disapproved or withdrawn Surgidev‘s right to participate in the investigation
(2) ... The report of prior investigation of the intraocular lens is inadequate to support a conclusion that it is reasonably safe to begin or continue the proposed investigational study.
(3) There is reason to believe that the lens may be unsafe or ineffective when used for the purpose or in the manner for which it is to be investigated....
(4) The investigational plan described in the application is not a reasonable plan, in full or in part, for scientific investigation to determine whether the investigation device is safe or effective.
(5) The methods, facilities, and controls used for the manufacturing, processing, packing, storage, or implantation of the lens do not assure adequately the safety and effectiveness of the lens....
(8) The proposed investigational study subjects humans subjects to undue risks.
Id. (emphasis added).
There is no evidence in this case that the FDA made any such finding. On the contrary, when the FDA approved Surgidev‘s IOL for marketing under the IDE, it concluded that Surgidev‘s IOL was safe and effective to be used for the purpose and manner for which it was to be investigated.1 It further concluded that Surgidev‘s method for manufacturing and processing the lens assured adequately the safety and effectiveness of the device. Finally the FDA approved the proposed investigational study of the device finding it did not subject humans to undue risk. However misguided one may argue that these approvals may have been in retrospect, Niehoff may not be heard to collaterally attack the FDA‘s findings and attempt to reverse them in filing its state court action. Unlike the Petitioner‘s common law claims in Lohr, Niehoff‘s strict liability and negligence claims in this case collide directly with the federal requirements that applied to the subject device. Niehoff alleges requirements that are different than and in addition to the federal law which controlled the use of Surgidev‘s device and therefore her claims should be preempted.
IV.
Congressional intent is the touchstone of all preemption analysis. See, Lohr, 518 U.S. at 485, 116 S.Ct. at 2250, (quoting Retail Clerks v. Schermerhorn, 375 U.S. 96, 84 S.Ct. 219, 11 L.Ed.2d 179 (1963)). Congress and the FDA intended to insulate manufacturers from liability to individuals asserting common law strict liability and negligence claims such as Niehoff‘s claims in this case because they interfere with and threaten the federal interest which is plain on the face of the statute:
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.
Exposing a manufacturer to tort liability after it has qualified for and is involved in a clinical investigation of its device, is wholly inconsistent with the objective of maintaining “optimum freedom for scientific investigators.” That is why the FDA expressly exempts manufacturers from the pre-marketing approval process, and perhaps most importantly from general good manufacturing, labeling and performance standards under the MDA during the investigation of that device. The fact that Surgidev‘s IOL was exempt from following the good manufacturing practice requirements under the FDCA, as well as labeling or “misbranding” requirements, and performance standards under the statute is convincing evidence of Congress’ intent to preempt state common law actions against manufacturers based upon similar theories of liability. Notably, these federal requirements from which in-
The Majority insists that Niehoff‘s claims are not preempted because they rest upon state laws of “general applicability.” However, the Majority‘s conclusion is contravened by the Supreme Court‘s acknowledgment that there are general state laws which are preempted by conflicting federal requirements.
[W]e do not believe that this statutory and regulatory language necessarily precludes general federal requirements from ever preempting state requirements, or general state requirements from ever being preempted....
Lohr, 518 U.S. at 500, 116 S.Ct. at 2257 (emphasis added, quotations omitted); see also Chambers v. Osteonics, 109 F.3d 1243 (7th Cir.1997).
The Court in Lohr could not ignore the “overarching” concern that only particular state requirements were preempted in that case, but even there, the Court acknowledged that general state requirements were subject to preemption where they threaten to interfere with a specific federal interest. Id. This is such a case. Here, not only do Niehoff‘s state law claims threaten the express federal interest in “maintaining optimum freedom for scientific investigators,” but Niehoff‘s claims threaten the federal interest encouraging “the discovery and development of useful devices intended for human use.” Niehoff‘s state law claims further threaten federal interest in exempting IDE devices from the general requirements of good manufacturing, misbranding, and performance. Niehoff‘s general state law claims threaten the federal interest in permitting the investigational use of devices to determine their safety and effectiveness. Finally, Niehoff‘s state law claims threaten the federal interest in “so thoroughly occupy[ing] a legislative field ... as to make reasonable the inference that Congress left no room for the states to supplement it.” Cipollone, 505 U.S. at 516, 112 S.Ct. at 2617.
This is certainly an instance in which the legislative field has been thoroughly occupied by Congress. Here, Congress has authorized the FDA to exempt an IOL from its pre-market approval process, allowing the device to be implanted by a federally approved physician investigator, under the authority of a federally monitored clinical investigation, pursuant to the federal requirements contained in
V.
As indicated by the Majority, the analysis by Justice Breyer in his concurring opinion is critical to the U.S. Supreme Court‘s decision
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.
Justice Breyer‘s concurring opinion answered two questions. First, Justice Breyer agreed that the MDA‘s preemption of state requirements easily reached to preempt state tort actions for damages. Second, Justice Breyer answered the question of whether the MDA preempted the particular state tort claims at issue in that case. Justice Breyer‘s preemption analysis in Lohr focused primarily on the requisite degree of specificity of the federal requirement, not the state requirement raised by the Petitioner in that case. For example, Justice Breyer observed that federal administrative agencies have leeway to determine which regulations will have preemptive effect. 518 U.S. at 505-506, 116 S.Ct. at 2260. Also, Justice Breyer looked at the methods federal agencies can use to communicate their preemptive intent. Notably, Justice Breyer‘s quote from the FDA‘s preemption regulation was edited to exclude all of the references that described the specificity required for a state statute to be preempted by that section. Instead, Justice Breyer focused on the fact that the federal regulations in Lohr were not specific enough to have the preemptive effect that the Respondent manufacturer in that case urged upon the court. Nonetheless, the Majority in this Court has read Justice Breyer‘s opinion to imply that a certain degree of specificity is required for state requirements to be preempted by the MDA. In my view, the Majority reads into Justice Breyer‘s words a view that is not expressed by his language, and it results in a conclusion on the preemptive effect of the MDA which is incorrect in the instant case.
VI.
The conclusion that Niehoff‘s state common law product liability claims and negligence claims are preempted by the MDA, is supported by all the reported federal court decisions rendered since the Supreme Court‘s decision in Lohr.
The Majority dismisses the decision in Berish v. Richards Medical Co., 937 F.Supp. 181 (N.D.N.Y.1996) without discussion as being “without merit.”2 Although the device in Berish was an IDE hip implant, and not an IOL, the court found that the general IDE regulations (
This Court reads nothing in Lohr that compels a different conclusion. Unlike the § 510(k) devices that so troubled the Lohr court, IDEs are subject to regulations that “... set forth detailed procedures for determining whether [IDEs] are safe and effective.” Id. Moreover, IDEs are subject to specific regulations promulgated for application, not generally to all devices, but to IDEs specifically. Finally, Congress has expressly exempted IDEs from certain regulations, as set forth above. Based on the foregoing, the Court can see no reason to reconsider its findings that the plaintiff‘s state common law claims sounding in negligence and strict products liability are preempted.
The Majority did not discuss the Sixth Circuit case of Martin v. Telectronics Pacing Sys., Inc., 105 F.3d 1090 (6th Cir.1997), applying Ohio law. On remand from the United States Supreme Court in light of the Lohr decision, the Sixth Circuit in Martin held that all of Plaintiff‘s state common-law product liability claims against a pacemaker manufacturer were preempted. The Martin case contains an apt description of the distinction between the 20 hour process required to obtain “substantially equivalent” approval for devices to be marketed under the § 510(k) process, and the set of complex and comprehensive regulations which govern the IDE process. Declining the Plaintiff‘s invitation to re-characterize the approval process pertaining to the device at issue in Martin, the Court viewed the IDE process as dispositive in its determination that the Plaintiff‘s claims were preempted in that case. The Sixth Circuit‘s reasoning in Martin applies here.
The Majority also did not make reference to the Ninth Circuit‘s most recent post Lohr decision, Papike v. Tambrands, Inc., 107 F.3d 737 (9th Cir.1997). The Papike opinion is significant for at least three reasons. First, it sheds further light on the question of whether state laws of “general applicability” can be preempted by the MDA. The Papike Court acknowledges that
[i]n Section V [of Lohr], the Court evaluates the specificity of the general state common-law requirements, but only after concluding that the federal labeling and manufacturing requirements at issue were not specific to pacemakers.... [I]t is clear enough that the Court found no preemption of the common-law claims largely because the pacemaker was not subject to any device-specific FDA regulations. In addition, Section V acknowledges that the statutory and regulatory preemption language does not necessarily preclude “general” statements from ever being preempted.
The same analysis applies to this case. The federal labeling and manufacturing requirements at issue in Lohr were not specific to the device whereas the federal requirements at issue in this case, as in Papike, are highly specific to the IOL device. This distinction places Niehoff‘s claims in that category of general state requirements which are well inside the category of preempted state requirements despite their apparent generality.
Papike is also significant because it is a Ninth Circuit case. After Slater, and before Lohr, when virtually every jurisdiction held state law claims were preempted, Niehoff points out in her Brief that the Ninth Circuit “buck[ed] the preemption tide” in Kennedy v. Collagen Corp., 67 F.3d 1453 (9th Cir.1995). Now, in Papike, the Ninth Circuit is again among the first courts to analyze Lohr‘s findings and holds that general state law claims, which actually conflict with specific and pervasive federal requirements, are preempted.
Finally, the Papike opinion is significant because it sheds significant light on Justice Breyer‘s separate opinion. Disposing of any remaining inclination to use Justice Breyer‘s
it makes little sense to argue that Justice Breyer would write separately to make clear his position that duties arising under state common-law can constitute state law “requirements” which can be preempted by the MDA, and then agree that because tort law consists of generally applicable principles, it is always preempted, even in the face of specific federal requirements. Instead, in Medtronic, Justice Breyer found “no actual conflict between any federal requirement and any of the liability-creating-premises of the Plaintiffs’ state law tort suit....” Here, there would be such a conflict.
Id. Here, as in Papike, there is conflict between specific federal requirements and the Appellant‘s state law tort suit.
In the most recently decided case of Chambers v. Osteonics, 109 F.3d 1243 (7th Cir.1997), the Seventh Circuit Court of Appeals held that
claims for strict liability of breach of the implied warranty of merchantability “set up a direct collision with federal policy” because the FDA has already decided, rightly or wrongly, that a particular device can be sold, subject only a requirements, procedural in character and designed to assure that this experimental distribution was in fact a worthwhile experiment. Thus, these claims are preempted by the MDA because they impose requirements on Osteonics that are different from or greater than FDA requirements.
In so holding, the Court noted what many other courts have found that to allow state product liability claims would defeat the purpose of the investigational device exemption and impose liability on a manufacturer for an experimental device that meets all FDA standards and requirements.
Each of these post-Lohr decisions in my view persuasively support a conclusion that preemption of Niehoff‘s product liability claims is appropriate.
VII.
There remains the issue whether Niehoff has negligence claims alleging that Surgidev violated the federal statute and regulations controlling its device which survive preemption. If she does, those claims solely would escape preemption because
[t]he regulations promulgated by the FDA expressly support the conclusion that § 360k does not preempt state or local requirements that are equal to or substantially identical to, requirements imposed by or under the act.
Lohr, 518 U.S. at 495, 116 S.Ct. at 2255 (quotations omitted). In addressing this issue, two questions are presented: (1) whether such claims have been properly preserved for review by this Court, and (2) whether such claims, if properly preserved, would impose requirements different from and in addition to federal law.
First, Niehoff‘s Complaint in Jefferson Circuit Court does not allege that Surgidev violated any specific federal law, whether it be a claim involving failure to warn, labeling or informed consent. Despite the absence in her Complaint of any such allegations, Niehoff‘s claims of Surgidev‘s violation of federal regulations were addressed by the Jefferson Circuit Court in its Opinion granting Partial Summary Judgment to Surgidev. In this Opinion, the lower court dismissed Niehoff‘s strict liability claim, her claim for punitive damages, and some but not all negligence claims that contended Surgidev violated federal regulations. Limited discovery followed, after which the trial court granted Summary Judgment, dismissing all of Niehoff‘s claims.
Niehoff appealed to the Kentucky Court of Appeals. With respect to the claimed violations of FDA regulations, the one and only claim addressed by the Court of Appeals was Niehoff‘s claim “that Surgidev failed to warn its investigators ... of data indicating that high complication rates accompanied the use of Style 10 lenses.” The Court of Appeals held this claim to be preempted as it would “impose a separate and additional duty on manufacturers to notify investigators of any problems which accompany implantation.”
Niehoff then filed a Petition for Discretionary Review before this Court. That Petition made no mention whatsoever to any alleged
Surgidev asserts in its Brief that Niehoff‘s claims based on violation of the FDA regulations are not properly before this Court. Niehoff‘s Brief before this Court contains no statement with reference to the record showing whether the issue of Surgidev‘s violation of federal laws was properly preserved for review and, if so, in what manner as called for under
The fact that Niehoff‘s Complaint contained no allegations that Surgidev violated any federal regulations, that her Petition for Discretionary Review did not raise any such issue, and that the requirements of
VIII.
Niehoff‘s state product liability and negligence claims would impose requirements on Surgidev that are different from or in addition to the requirements imposed by the MDA and the accompanying FDA regulations. For the reasons discussed, I believe all of Niehoff‘s state law claims are preempted, and I would affirm the decision of the Court of Appeals.
KENTUCKY BAR ASSOCIATION, Complainant,
v.
Richard K. JACOB, Respondent.
No. 96-SC-1097-KB.
Supreme Court of Kentucky.
Sept. 4, 1997.
Bruce K. Davis, Executive Director, Jay R. Garrett, Deputy Bar Counsel, Kentucky Bar Association, Frankfort, for Complainant.
James M. Clements, Louisville, for Respondent.
OPINION AND ORDER
The Kentucky Bar Association charged Richard K. Jacob of Louisville, Kentucky, with two counts of unethical conduct for violating SCR 3.130-3.3(a)(1) and (3): knowing-