dissenting.
Congress’ intent to preempt at least some state law is plain from the express language of 21 U.S.C. § 360k(a). The United States Supreme Court has made clear that some state common law damage claims are preempted by federal law. See, Cipollone v. Liggett Group, Inc., 505 U.S. 504, 511-519, 112 S.Ct. 2608, 2615-2618, 120 L.Ed.2d 407 (1992). The first task before this Court is to decide whether NiehofPs state product liability claims are within the scope of those claims Congress intended to preempt. The second inquiry is whether claims for violation of federal regulations are properly before this Court, and if so treated, whether they also are preempted.
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 Nie-hofPs 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 NiehofPs 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”). 21 U.S.C. § 360c et seq. Under the MDA, Congress provided that no state may establish any requirement which is different from, or in addition to, any requirement applicable to the IOL under the MDA, and which relates to the safety or effectiveness or any other matter included in the MDA which applies to the device. 21 U.S.C. § 360k(a). Pursuant to the MDA, the United States Congress has enacted numerous requirements which relate to the safety or effectiveness of Surgidev’s IOL. The first such statute, essential to the resolution of this ease is the Investigational Device Exemption (“IDE”). 21 U.S.C. § 360j(g).
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 21 U.S.C. § 360j. This statute controlled the marketing and use of the device, and controlled the conditions under which the device reached Niehoff. Under Section (g) of that statute, Surgidev’s IOL was granted an exemption from having to meet several requirements under the FDCA.
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 investiga-tional use of such devices by experts qualified by scientific training and experience to investigate the safety and effectiveness of such devices.
21 U.S.C. § 360j(g)(2)(A) (emphasis added).
Moreover, under 21 U.S.C. § 360j(g), the Congress delegated authority to the FDA to require
*824the establishment and maintenance of such records and the making of such reports ... of data obtained as a result of the investigational use of the device during the exemption, as the [FDA] determines will enable [it] to assure compliance with such conditions, review the progress of the investigation, and evaluate the safety and effectiveness of the device.
21 U.S.C. § 360j(g)(2)(B)(ii).
Further federal requirements relating to the safety and effectiveness of Surgidev’s IOL are codified in 21 C.F.R. § 813. These regulations contain extensive requirements which apply specifically and exclusively to IOL’s such as the one at issue in this case. The regulations painstakingly detail the controls and standards an IOL must meet to qualify for the IDE. The IDE regulations require a detailed application and plan for the clinical investigation, 21 C.F.R. §§ 813.20 — 813.25, and approval of the application by an institutional review committee in addition to the FDA. §§ 813.20, 813.30— 813.42. These provisions further regulate virtually every aspect of the IOL’s use during the investigation, from promotion and sale of the lens, committee monitoring of its performance, selecting investigators qualified to conduct the controlled investigation, outlining the parameters and protocol for that investigation, maintaining reports and records throughout the duration of the investigation, and ultimately the withdrawing of the exemption under certain conditions, §§ 813.65, 813.30(c)(5). Section 813.1(b) sets forth the general effect of the IOL exemption:
(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: Misbrand-ing 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 Surgi-dev’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, Niehoffs claims require a fact finder to conclude that although Surgidev satisfied the requirements of 21 U.S.C. § 360j and 21 C.F.R. § 813, Surgidev sold the IOL in a defective condition that was unreasonably dangerous for human use. See Dealers Transp. Co., Inc. v. Battery Distrib. Co., Inc., Ky., 402 S.W.2d 441, 446-447 (1965). Further, Niehoff asserts in her negligence claims that although Surgidev was permitted by the FDA’s regulations to market the IOL as designed, manufactured, and labeled, it fell short of Kentucky’s requirements to exercise the reasonable care required of an ordinarily prudent manufacturer. See, C.D. Herme v. R.C. Tway Co., Inc., Ky., 294 S.W.2d 534, 537 (1956). Herein lies the actual conflict between Niehoffs state product liability claims and the federal requirements that controlled the investigational use of Surgidev’s IOL. A comparison between the federal IDE and IOL requirements, and the elements of Niehoffs strict liability and negligence claims under Kentucky law, compels the conclusion that the state requirements Niehoff alleges fall squarely within the intended preemptive scope of the federal IDE statute and IOL regulations. Therefore, I cannot agree with the Majority’s conclusion that Niehoffs state product liability claims of strict liability and negligence are not preempted.
II.
Before this Court reaches the conclusion from which I dissent, the Majority correctly *825states many principles of law with which I agree. As an initial proposition, I agree with the Majority’s review of the seminal legal principles which guide the analysis in this case. The Majority ably describes the supremacy of federal law based on McCulloch v. Maryland, 17 U.S. (4 Wheat) 316, 4 L.Ed. 579 (1819) and the sovereignty of states where historic police powers are concerned. Further, I believe the Majority is correct in describing the settled methods of determining Congressional intent where state and federal law collide. In my view, the Majority’s analysis breaks down when it comes to the weight it gives to the alleged failure to obtain informed consent for Niehoffs surgical procedure. The Court appears determined to provide a remedy for this apparent omission through the tort process, concluding
[t]he 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.
As tempting as it is in deciding this case to follow the Majority in its concern that Nie-hoff 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 investiga-tional 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. Sur-gidev was required under the federal regulations to obtain from each approved physician investigator, a written agreement to comply with the informed consent requirements of 21 C.F.R. § 50. There is no dispute that Surgi-dev complied with this regulatory duty by obtaining such a signed agreement from the physician who implanted the IOL in Niehoffs eye. Several eases addressing the issue spend little time in concluding that the duty to obtain informed consent lies with the physician and not the manufacturer. See, Gile v. Optical Radiation Corp., 22 F.3d 540, 543 (3rd Cir.), cert. denied 513 U.S. 965, 115 S.Ct. 429, 130 L.Ed.2d 342 (1994); Lewis v. Intermedies Intraocular, Inc., 56 F.3d 703, 707 (5th Cir.1995): Anderson v. George H. Lanier Memorial Hosp., 982 F.2d 1513, 1520 (11th Cir.1993).
III.
I also respectfully disagree with the Majority’s application of Medtronic, Inc. v. Lohr, - U.S. -, 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 Niehoffs 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 Surgi-dev’s IOL reached Niehoff here. The “substantially equivalent” requirement which controlled in Lohr
[ijmposes 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 *826device is “substantially equivalent” to a pre-existing device, it can be marketed without further regulatory analysis.
Lohr, — U.S. at -, 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, — U.S. at -, 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. (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 21 U.S.C. § 360j for safety and efficiency. This distinction is critical because while the FDA has not examined or approved the safety and efficiency of “substantially equivalent” devices such as the pacemaker in Lohr, the FDA has clearly reviewed and approved the Surgidev IOL device marketed pursuant to the IDE as sufficiently safe and effective for investigative use on human beings.
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 in-vestigational 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).
21 C.F.R. § 813.20.
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....
21 C.F.R. § 813.25.
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 Surgi-dev’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 Surgi-dev’s right to participate in the investigation *827under 21 C.F.R. § 813.30(c) if it made any of the following findings:
(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, Niehoffs 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, — U.S. at -, 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 Niehoffs 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.
21 U.S.C. § 360j(g)(l) (emphasis added).
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-mar-keting 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-*828vestigational devices are exempt, are also the standards the Supreme Court decided in Lohr were requirements of “general enforcement” with no preemptive effect in that ease. Lohr, — U.S. at -, 116 S.Ct. at 2256. Logically then, if the Supreme Court found these general federal requirements were identical with the common law manufacturing and labeling claims in Lohr, they are similarly coincident to Niehoffs general common law claims in this case. Thus, the FDA’s decision to exempt IDE devices from the general federal requirements for good manufacturing, performance and labeling, instructs that IDE devices are also exempt from state common law claims brought on the same grounds.
The Majority insists that Niehoffs 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, — U.S. at -, 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 Niehoffs state law claims threaten the express federal interest in “maintaining optimum freedom for scientific investigators,” but Niehoffs claims threaten the federal interest encouraging “the discovery and development of useful devices intended for human use.” Niehoffs state law claims further threaten federal interest in exempting IDE devices from the general requirements of good manufacturing, misbranding, and performance. Niehoffs general state law claims threaten the federal interest in permitting the investigational use of devices to determine their safety and effectiveness. Finally, Niehoffs 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 21 U.S.C. § 360j and 21 C.F.R. § 813. Courts may infer Congress’ intent to occupy a legislative field to the exclusion of state law “where the pervasiveness of the federal regulation precludes supplementation by the State, where the federal interest in the field is sufficiently dominant, or where ‘the object sought to be obtained by the federal law and the character of obligations imposed by it ... reveal the same purpose.’ ” Schneidewind v. ANR Pipeline Co., 485 U.S. 293, 300, 108 S.Ct. 1145, 1150, 99 L.Ed.2d 316 (1988), (quoting Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 229-31, 67 S.Ct. 1146, 1152, 91 L.Ed. 1447 (1947)). The pervasiveness of the federal regulations pertaining to the IOL, as well as the dominant express federal interest in protecting scientific freedom in order to encourage the development of medically sound devices, confirms Congress’ intent to occupy the legislative field. Thus, only to the extent that Niehoffs state law claims are consistent with or substantially identical to the copious federal regulations that govern investigational IOL’s may they coexist with federal requirements in this field.
Y.
As indicated by the Majority, the analysis by Justice Breyer in his concurring opinion is critical to the U.S. Supreme Court’s decision *829in Lohr, and helpful in disposing of this case. Justice Breyer joined the plurality in Parts I, II, III, V and VII of the Court’s Opinion. Lohr, — U.S. at -, 116 S.Ct. at 2261. I agree with the Majority’s reiteration of Justice Breyer’s reasons for not joining Parts IV and VI of the Majority Opinion. I further agree that Justice Breyer reads 21 C.F.R. § 808.1(d) to require specific federal requirements in order to displace divergent state requirements by preemption. However, I cannot find any support in Justice Breyer’s Opinion that would lead to the Majority’s conclusion 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.
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. — U.S. at -, 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 ease.
VI.
The conclusion that Niehoffs 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., 987 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 (21 C.F.R. § 812) “largely mirror” the IDE regulations relating to IOLs (21 C.F.R. § 813). The court cited the case of Becker v. Optical Radiation Corp., 66 F.3d 18 (2nd Cir.1995), for its holding that state tort claims involving an investigational closed loop anterior chamber IOL were preempted because the MDA and the IOL regulations specifically exempt experimental IOLs from the safety and effectiveness standards usually imposed on medical devices. Applying the same reasoning to the investigational hip implant, the Berish court held that plaintiffs claims for defective design, warning and testing were preempted. The Berish court fur*830ther found that this result was consistent with Medtronic, stating:
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 plaintiffs state common law claims sounding in negligence and strict products liability are preempted.
Berish, 937 F.Supp. at 185.
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 Plaintiffs 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 Plaintiffs invitation to re-charaeterize the approval process pertaining to the device at issue in Martin, the Court viewed the IDE process as dispositive in its determination that the Plaintiffs 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 fight on the question of whether state laws of “general applicability” can be preempted by the MDA. The Papike Court acknowledges that § 360k preempts state common law requirements that are developed “with respect to” medical devices, and not those which merely describe a general duty. The plaintiff in Papike relies upon language from Part V of Lohr to argue that the generality of her tort claims leaves them outside the preemptive reach of § 360k. The Ninth Circuit Court explains, however, 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.
Papike, 107 F.3d at 742.
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 Niehoffs 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 “buckfed] 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 fight on Justice Breyer’s separate opinion. Disposing of any remaining inclination to use Justice Breyer’s *831opinion as support for the view that state common-law actions of “general applicability” cannot be preempted, the Papike Court reasoned,
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 ease 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 Niehoffs 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, — U.S. at -, 116 S.Ct. at 2256 (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, Niehoffs 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, Nie-hoffs 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 Niehoffs 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 Niehoffs 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 Niehoffs 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 *832failure by Niehoff to comply with any federal regulations. It was on the basis of that Petition that this Court granted her Discretionary Review.
Surgidev asserts in its Brief that Niehoffs claims based on violation of the FDA regulations are not properly before this Court. Niehoffs 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 CR 76.12(4) (c) (iv).
The fact that Niehoffs 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 CR 76.12(4) (c) (iv) have not been followed, when taken together support the correctness of Surgidev’s position that such claims are not properly before this Court. It is unnecessary, however, to reach or to decide this potentially fatal procedural deficiency because I agree with the Court of Appeals’ decision that Niehoffs failure to warn claims seek to impose a separate and additional duty on manufacturers to notify investigators and that this duty would impermissibly add to the existing notification and recall requirements under the applicable federal law. The same rationale would apply to dispose of Niehoffs informed consent and other negligence claims based on violations of the FDA regulations as presented in Appellant’s Brief. As such, Niehoffs negligence claims based on Surgidev’s alleged failure to comply with federal regulations would also be preempted.
VIII.
Niehoffs 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 Niehoffs state law claims are preempted, and I would affirm the decision of the Court of Appeals.
. Certainly, Niehoff is correct that the FDA never approved Surgidev IOL as safe and effective for commercial distribution but this fact proves nothing in support of her claim. The entire purpose of the clinical investigation approved by the FDA was to determine the safety and effectiveness of the IOL prior to its approval for commercial distribution.
. The majority states without elaboration that it is more persuaded by the Missouri Supreme Court's decision in Connelly v. Iolab Corp., 927 S.W.2d 848 (Mo.1996). The Court in Connelly cites Part IV of the Lohr plurality's opinion, which was specifically disapproved by Justice Breyer, and it does so incorrectly. The Missouri Supreme Court incorrectly indicates that the Lohr plurality decided the § 360k exemption is “limited " to device specific enactments of positive law. In reality, the plurality in Lohr said that it read the language of § 360k to “suggest ... that its focus is device specific enactments of positive law....'' The plurality also said that
the legislative history also confirms our understanding that § 360k simply was not intended to preempt most, let alone all, general common-law duties enforced by damages actions.
Lohr, — U.S. at -, 116 S.Ct. at 2253.