MEMORANDUM OPINION AND ORDER

JOHN G. HEYBURN, II, District Judge.

Breanna Sadler and her parents Michelle and Brian Sadler (collectively, "Plaintiffs") bring this action to recover for injuries Breanna incurred as a result of the malfunctioning of her cochlear implant against Advanced Bionics, the manufacturer of the device. Advanced Bionics now moves for summary judgment of most of Plaintiffs' claims on preemption grounds. Many district and circuit courts have addressed medical device preemption issues from a variety of perspectives. As yet, the Sixth Circuit has not contributed any comprehensive discussion on the precise context presented here. The Court has reviewed relevant approaches and decided upon a reasonable one. For the reasons that follow, the Court sustains the motion in part and denies the motion in part.

I.

The facts particular to this case are straightforward. Breanna Sadler suffered from permanent hearing loss until she underwent open-head surgery to receive a cochlear implant on January 16, 2006. Breanna's cochlear implant device was Advanced Bionics' HiRes 90k. With the assistance of a cochlear implant, the brain learns to decode noise, and over time, implant recipients are able to distinguish sounds such that they are able to hear again. Although the device is technologically complicated, two principal systems comprise the cochlear implant: an internal component surgically implanted in the skull and an external component that sits outside the ear. The feedthru, which must remain hermetic (waterproof) throughout the life of the device, connects these two parts.

In December 2009, a leak in the feedthru that allowed moisture into the device caused Breanna's cochlear implant to fail, and as a result, she endured an aggressive shock. As Breanna convulsed on the floor, her mother held her down. After Breanna disconnected the device, her mother reconnected it at the urging of a doctor on the telephone. The cochlear implant again shocked Breanna, and Breanna's mother allowed Breanna to once more disconnect the device. The following day, Brian Sadler took Breanna to an audiologist. While Brian held Breanna down, the doctor reconnected the external processor to Breanna's skull. For the third time, the device shocked Breanna. When Breanna underwent replacement surgery in February 2010, the Sadlers chose a competitor cochlear implant for their daughter. The lingering physical and emotional effects of the three shocks are disputed.

Breanna's cochlear implant is subject to significant federal regulation under the Federal Food, Drug, and Cosmetic Act ("FDCA"), which governs medical device manufacturing. The FDCA specifically empowers the Food and Drug Administration ("FDA") to regulate production and labeling practices of medical product manufacturers and distributors. In amending the FDCA several times since its enactment, Congress expanded the federal role in medical product regulation while preserving the applicability of state laws to the manufacture and distribution of medical products. Wyeth v. Levine, 555 U.S. 555, 566, 129 S.Ct. 1187, 173 L.Ed.2d 51 (2009).

In 1976, Congress enacted the Medical Device Amendment ("MDA") to broaden the FDCA's regulatory scope to include medical device manufacturing. Anne-Marie Dega, The Battle Over Medical Device Regulation: Do the Federal Medical Device Amendments Preempt State Tort Law Claims, 27 LOY. U. CHI. L.J. 615, 625-26 (1996). Because medical devices vary in composition and risk, Congress created three classes of these devices with corresponding varied levels of federal administrative control over the covered devices. For Class III devices, such as Advanced Bionics' cochlear implant, the FDA will grant manufacturers approval to market and distribute their products after obtaining premarket approval ("PMA").1 PMA "requires that manufacturers conduct extensive testing to obtain clinical results that demonstrate the safety and effectiveness of a device. Both FDA staff members and outside experts must approve the PMA before the FDA will approve the device for commercial use." Dega, supra, at 627. This involves over 1,000 hours of FDA review. Lohr, 518 U.S. at 478, 116 S.Ct. 2240. Once a device receives PMA approval, the manufacturer must

21 C.F.R. § 814.39(a) (emphasis added). In sum, federal regulations require Advanced Bionics to obtain PMA approval for the initial cochlear implant device and supplemental approval for any subsequent generation of the device that incorporates changes affecting device safety or effectiveness.

In 1996, Advanced Bionics obtained a PMA for its original cochlear implant, the Clarion Multi-Strategy Cochlear Implant System. Subsequently, Advanced Bionics obtained PMA Supplement #30 for a later generation of the device, called the HiRes 90k. Advanced Bionics manufactured two versions of the HiRes 90k. First, the PMA Supplement #30 approved the device using a Pacific Aerospace and Electronics, Inc. ("PA & E") manufactured feedthru ("Vendor A HiRes 90k"). In July of 2003, Advanced Bionics began commercially selling the Vendor A HiRes 90k.

Shortly thereafter, Advanced Bionics began manufacturing the second version of the HiRes 90k; this cochlear implant contained a feedthru manufactured by AstroSeal, Inc. ("Vendor B HiRes 90k"). Advanced Bionics did not seek a PMA Supplement for the Vendor B HiRes 90k. When Breanna underwent cochlear implant surgery in January of 2006, she received a Vendor B HiRes 90k, manufactured in 2005.

A number of issues relating to the HiRes 90k arose prior to Breanna's implantation surgery. In 2004, Advanced Bionics thoroughly tested failed, explanted cochlear implant devices, and concluded that the devices failed due to excessive moisture concentration in the feedthrus. In September of 2004, Advanced Bionics issued a recall of its unimplanted cochlear implant devices including the HiRes 90k, claiming that moisture sealed into the device during its manufacture caused issues with the proper functioning of the device. After implementing some changes to the device manufacturing process, Advanced Bionics resumed manufacturing and distributing the HiRes 90k. Nevertheless, Advanced Bionics received a warning letter the next year from the FDA informing it of insufficiencies in its operating structure. Because some devices continued to fail, Advanced Bionics issued another recall in March of 2006, which included a recall of unimplanted Vendor B HiRes 90ks. This time, Advanced Bionics concluded that a leak in the feedthru, rather than moisture being sealed in the device during manufacture, caused the excessive moisture levels.

After the 2006 recall, the FDA conducted an on-site investigation of Advanced Bionics' operations related to the recall. In 2007, apparently as a result of the inspection, the FDA filed a civil complaint against Advanced Bionics and its president and CEO, Jeffrey Grenier, seeking administrative penalties related to Advanced Bionics' violation of the FDCA and its corresponding regulations. The parties agreed to settle the case, and Advanced Bionics and Grenier paid the maximum FDCA fine.

II.

Plaintiffs brought suit arising from the failure of Breanna's Vendor B HiRes 90k in August of 2011, alleging negligence, products liability, negligence per se, breach of implied warranty, common law fraud, and punitive damages claims. Plaintiffs have agreed to withdraw their breach of implied warranty claim. Additionally, the parties do not discern the punitive damages. Therefore, the Court's preemption analysis addresses the remaining four claims separately.

Advanced Bionics moves for summary judgment under Federal Rule of Civil Procedure 56 on these four claims. Summary judgment is appropriate where "there is no genuine dispute as to any material fact." FED.R.CIV.P. 56(c). Initially, the moving party bears the burden of proving that no genuine issues of material fact are extant. Matsushita Electric Indus. Co., Ltd. v. Zenith Radio Corp., 475 U.S. 574, 585-86, 106 S.Ct. 1348, 89 L.Ed.2d 538 (1986). The Court will view the facts in a light most favorable to the nonmoving party. Id. Once the moving party satisfies its burden, the nonmoving party may overcome summary judgment only by designating "specific facts showing that there is a genuine issue for trial." Celotex Corp. v. Catrett, 477 U.S. 317, 324, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986).

III.

Advanced Bionics' primary argument is that express and implied medical device preemption void the four claims. The Court will attempt to navigate the murky waters of medical device preemption, relying on controlling precedent and applying relevant and persuasive decisions to the case sub judice. As a threshold matter, though, the Supreme Court affirmatively recognizes

Wyeth, 555 U.S. at 565, 129 S.Ct. 1187 (internal citations omitted).

The purpose of the MDA is to provide a comprehensive legislative regime regulating medical device production to protect consumers from the potentially fatal effects of defective medical devices. Prior to enacting the MDA, the FDA maintained an enormous role in ensuring the safety of medical products for consumers. Dega, supra, at 624-25. With the inclusion of the MDA in the FDCA, this role is even more pronounced as applied to medical devices, because in certain circumstances, the FDA is the only party entitled to reign in unlawful medical device manufacturing practices. See 21 U.S.C. § 337(a) (vesting sole power for enforcement of some FDA violations with the federal government, as explained below). With congressional intent in mind, the Court turns to the state of medical device claim preemption.

A.

Federal courts recognize three varieties of preemption: express, implied, and field. Fadel v. Nationwide Mut. Fire Ins. Co., 2012 WL 5878728, at *4 (W.D.Ky. Nov. 21, 2012). Medical device preemption includes both the express and implied varieties. Congress provided an express preemption statute for medical devices in the MDA, codified at 21 U.S.C. § 360k(a). This provision states,

21 U.S.C. § 360k(a).

The Supreme Court has decided two major express preemption cases that help define the preemptive scope of § 360k. In Medtronic v. Lohr, the Supreme Court addressed "whether [the MDA] pre-empts a state common-law negligence action against the manufacturer of an allegedly defective medical device." 518 U.S. at 474, 116 S.Ct. 2240.2 In holding that § 360k did not preempt the plaintiffs' state law negligence claims as a matter of law, the plurality reasoned that

Id. at 495, 116 S.Ct. 2240. The Court maintained that "pre-emption [can] occur only where a particular state requirement threatens to interfere with a specific federal interest." Id. at 500, 116 S.Ct. 2240. Justice Stevens explained that "the use of the term `requirement,' rather than the term `remedy,' indicated that Congress intended to preempt `device-specific enactments of positive law by legislative or administrative bodies, not the application of general rules of common law by judges and juries.'" Kemp v. Medtronic, Inc., 231 F.3d 216, 223 (6th Cir.2000) (quoting Lohr, 518 U.S. at 489, 116 S.Ct. 2240). In so holding, the Supreme Court declared that the FDCA did not preempt any of the claims at issue. Lohr, 518 U.S. at 503, 116 S.Ct. 2240.

Twelve years later, the Supreme Court retreated from Lohr's relatively broad reading of the scope of § 360k preemption. In Riegel v. Medtronic, Inc., 552 U.S. 312, 128 S.Ct. 999, 169 L.Ed.2d 892 (2008), the Supreme Court established a two-part test to determine whether § 360k preempts a state common law claim. First, the Court "must determine whether the Federal Government has established requirements applicable to the" medical device at issue. Id. at 321, 128 S.Ct. 999. "If so, [the Court] must then determine whether the [plaintiffs'] common-law claims are based upon [state law] requirements with respect to the device that are `different from, or in addition to' the federal ones, and that relate to safety and effectiveness." Id. at 321-22, 128 S.Ct. 999 (quoting 21 U.S.C. § 360k(a)).

As to the first step, Justice Scalia explained that general federal requirements applicable across the board to almost all medical devices "did not pre-empt the common-law claims of negligence and strict liability at issue in Lohr." Riegel, 552 U.S. at 322, 128 S.Ct. 999. To preempt state law, the federal law violations must be somewhat specific to a particular medical device. For example, and germane to this case, the Supreme Court determined that premarket approval "imposes [federal] `requirements' under the MDA," id. at 322, 128 S.Ct. 999, because "devices that receive FDA premarket approval must be manufactured with `almost no deviations from the specifications' in the approval application.... [A]ny changes to a device's design specifications, manufacturing process, labeling, or other attribute that would affect safety require FDA approval." Cooley v. Medtronic, Inc., 2012 WL 1380265, at *3 (E.D.Ky. Apr. 20, 2012).

As for the state law analysis, Justice Scalia commented on each of the three elements that comprise the second step of the Riegel test, which are: (1) the existence of state law requirements applicable to the device, (2) that are different from or in addition to federal requirements, and (3) that relate to safety and effectiveness. Writing for the majority, Justice Scalia determined that plaintiffs' state law claims invariably deal with safety and effectiveness. Riegel, 552 U.S. at 323, 128 S.Ct. 999. Therefore, "the first critical issue is whether [the state's] tort duties constitute `requirements' under the MDA." Id. Adhering to Lohr, Justice Scalia concluded that the plaintiffs' "common-law causes of action for negligence and strict liability do impose `requirement[s]' and would be pre-empted by federal requirements specific to a medical device." Id. at 323-24, 128 S.Ct. 999.

Most importantly, Justice Scalia did not to continue his analysis to the final element of the second step regarding whether the state common law requirements were "different from, or in addition to" federal requirements, as the parties did not raise this argument in the proceedings below. Instead, he wrote,

Id. at 330, 128 S.Ct. 999. Thus, the Supreme Court allows for parallel state law claims to survive express preemption. For the duration of this Opinion where express preemption is raised, this Court will examine whether the federal law cited establishes requirements for the medical device at issue and whether the state law claim imposes additional or different requirements upon the device manufacturers that impact the device's safety or effectiveness.

B.

Turning to implied preemption, Congress included a right of action provision in the FDCA, stating, "Except as provided in subsection (b) of this section [permitting states to bring certain actions], all such proceedings for the enforcement, or to restrain violations, of this chapter shall be by and in the name of the United States." 21 U.S.C. § 337(a). The Supreme Court has interpreted this provision to impliedly preempt private litigants from asserting claims that directly enforce FDCA provisions against a manufacturer. See Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341, 349 n. 4, 121 S.Ct. 1012, 148 L.Ed.2d 854 (2001) ("The FDCA leaves no doubt that it is the Federal Government rather than private litigants who are authorized to file suit for noncompliance with the medical device provisions."). Therefore, private plaintiffs have no right of action to directly enforce the MDA.

In Buckman, the Supreme Court broadened the scope of implied preemption to bar some state law claims, holding that "the plaintiffs' state-law fraud-on-the-FDA claims conflict with, and are therefore impliedly pre-empted by, federal law." Id. at 348, 121 S.Ct. 1012. The Sixth Circuit has read Buckman to proscribe prosecuting medical device manufacturers for fraud against the FDA through state law tort actions. Garcia v. Wyeth-Ayerst Labs., 385 F.3d 961, 966 (6th Cir.2004) (holding that Buckman "teaches that state tort remedies requiring proof of fraud committed against the FDA are foreclosed since federal law preempts such claims")(quoting Garcia v. Wyeth-Ayerst Labs., 265 F.Supp.2d 825, 832 (E.D.Mich.2003)).3

Combining Buckman and a plain reading of § 337(a), medical device implied preemption bars state law claims that do not exist independent of FDA statutes and regulations, because "we have clear evidence that Congress intended that the MDA be enforced exclusively by the Federal Government." Buckman, 531 U.S. at 352, 121 S.Ct. 1012 (citing 21 U.S.C. § 337(a)); Cupek v. Medtronic, Inc., 405 F.3d 421, 424 (6th Cir.2005) (quoting Buckman for this proposition).

C.

Construing Lohr, Riegel, and Buckman together, Advanced Bionics quotes the District Court for the District of Minnesota in holding that these cases

Riley v. Cordis Corp., 625 F.Supp.2d 769, 776 (D.Minn.2009). The Court agrees with this conclusion as a general matter. However, the parallel claims that the Riegel Court determined could survive preemption may have widespread applicability, as evidenced in the large number of District Court and Court of Appeals decisions on the issue.4 The instant case provides yet another example of how some claims may fall within the gap between express and implied preemption.

Two other federal district courts have considered this preemption gap as it applies specifically to the Vendor B HiRes 90k devices, albeit with different plaintiffs. In Purcel v. Advanced Bionics Corp., 2008 WL 3874713 (N.D.Tex. Aug. 13, 2008) ("Purcel I"), District Judge Barbara Lynn held that the MDA did not preempt Plaintiffs' claims under strict liability or for breach of implied warranty. Id. at *11-12. Judge Lynn read the Riegel and Lohr opinions quite literally, explaining that "the MDA does not preempt state law claims which are premised solely on violations of federal law."5 Id. at *4.

Nearly two years later, she determined that most of the remaining claims presented proper parallel state law claims that survive preemption, except for those alleging fraud on the FDA and those where the plaintiffs did not indicate a federal requirement obligating Advanced Bionics to act in a particular way. Purcel v. Advanced Bionics Corp., 2010 WL 2679988 (N.D.Tex. June 30, 2010) ("Purcel II"). The former are impliedly preempted, and the latter are expressly preempted. Id. at *6.

Judge Jon McCalla of the District Court for the Western District of Tennessee read the scope of medical device preemption more broadly. Purchase v. Advanced Bionics, LLC, 896 F.Supp.2d 694 (W.D.Tenn.2011). First, he held that "[t]o the extent that Plaintiffs' claims are based on Advanced Bionics' purported failure to submit a PMA Supplement Application and obtain PMA approval," this "is an administrative requirement, not a substantive safety requirement." Id. at 696. Therefore, claims premised on these failures were impliedly preempted. Id. at 696-97.6

However, Judge McCalla held that claims based on Advanced Bionics' deviation from the PMA Supplement #30 requirements are parallel. Id. at 697. He determined that once the HiRes 90k was approved, "the design, manufacturing process, and labels may not be modified without further FDA approval, unless the modifications do not affect the device's safety or effectiveness." Id. (quoting Kemp, 231 F.3d at 228). He then found that using the AstroSeal feedthru was a change that affected safety and effectiveness, and accordingly, Advanced Bionics' deviation from the PMA Supplement #30 "is a parallel claim that survives preemption." Id. He also found that claims based on Advanced Bionics' failure to perform qualification testing under actual or simulated use conditions, in violation of federal regulations that require manufacturers to comply with Current Good Manufacturing Practices ("CGMPs"), are not preempted. Id. at 698.7

While Purcel I, Purcel II, and Purchase are not binding decisions on this Court, they are certainly instructive on the present issues.8

IV.

As an initial matter, Plaintiffs assert that because Advanced Bionics never obtained a PMA Supplement for the Vendor B HiRes 90k, it is not a PMA-approved device, and the preemption provisions of the MDA, and specifically § 360k, are inapplicable to this case. However, § 360k preempts claims "with respect to a device intended for human use." 21 U.S.C. § 360k(a). Under the FDCA, a device need not be PMA-approved to satisfy the definition of device. 21 U.S.C. § 321(h).9 Therefore, § 360k preemption applies to a medical device regardless of its status as PMA-approved or not. Moreover, Advanced Bionics did obtain supplemental approval for the HiRes 90k itself. Therefore, this argument fails, and the Court finds that the MDA preemption provisions apply to the Vendor B HiRes 90k.

Advanced Bionics argues that the remaining claims for negligence per se, fraud, strict liability, and negligence are expressly or impliedly preempted, each of which the Court will address in successive sections. However, Plaintiffs' negligence per se claims are void for a different reason. Under Kentucky law, plaintiffs must bring negligence per se claims under KRS § 446.070, which codified the common law negligence per se tort.10 St. Luke Hosp., Inc. v. Straub, 354 S.W.3d 529, 534 (Ky. 2011). The Kentucky Supreme Court determined that the General Assembly did not intend KRS § 446.070 "to embrace the whole of federal laws and the laws of other states and thereby confer a private civil remedy for such a vast array of violations." T & M Jewelry, Inc. v. Hicks ex rel. Hicks, 189 S.W.3d 526, 530 (Ky.2006). Therefore, violations of federal law do not support negligence per se claims under Kentucky law. See St. Luke Hosp., 354 S.W.3d at 534 (holding that "[v]iolations of federal laws and regulations and the laws of other states do not create cause of action based on KRS 446.070.").11 Plaintiffs' negligence per se claims, which are premised upon violations of federal law, are not cognizable as a matter of Kentucky law and must be dismissed.

V.

Plaintiffs allege that Advanced Bionics committed fraud by misrepresentation and omission. Kentucky courts established that plaintiffs must prove different elements to sustain fraud by omission and fraud by misrepresentation claims.12 Giddings & Lewis, Inc. v. Indus. Risk Insurers, 348 S.W.3d 729, 747 (Ky.2011).

Id. (internal citations omitted).

A.

To the extent Plaintiffs are alleging that Advanced Bionics' labels contained false or misleading representations or failed to disclose material information, Plaintiffs are asking the Court to find that FDA-approved labels were in fact unlawful. To sustain such an argument would require the Court to find one of two facts to be true: first, that Advanced Bionics lied to the FDA during its label-approval process, a claim impliedly preempted under Buckman; or second, that the labels must include some information in addition to or different from what the FDA and the FDCA prescribe. The latter is expressly preempted under the second step of the Riegel analysis. See Purcel II, 2010 WL 2679988, at *7 ("§ 360k(a) [] preempt[s] fraud claims based on statements that were approved or required by the FDA, and § 337(a) and Buckman preempt claims based on fraud to the FDA."). In sum, Plaintiffs' claims based on labeling improprieties are preempted.

B.

The FDA also contains a comprehensive scheme regulating disclosures. Marsh, 693 F.3d at 551. To the extent Plaintiffs are alleging fraudulent misrepresentations or omissions in Advanced Bionics' disclosures to the FDA, Buckman preempts these claims as fraud-on-the-FDA. Id. Insofar as Plaintiffs are alleging that Advanced Bionics' disclosures were misleading to the public, these claims as pled in the Complaint are really asserting that Advanced Bionics failed to warn the public of certain material facts.13 According to Sixth Circuit precedent, these claims are either impliedly or expressly preempted.

In Kemp, the Court held that the scope of implied preemption under Buckman encompasses some failure-to-warn claims. 231 F.3d at 236-37. A failure-to-warn claim "could be read as asserting that the warnings found in the label and literature approved by the FDA ... were inadequate under [state] law.... [T]o the extent that plaintiffs' claim is premised on the adequacy of the warnings reviewed and approved by the FDA, our analysis of the `fraud on the FDA' claim applies equally to the failure to warn claim, and the claim is similarly preempted." Id. Therefore, to the extent Plaintiffs are asserting that Advanced Bionics' FDA-approved disclosures are inadequate, these claims are impliedly preempted.14

Additionally, recognizing that "the FDA requires continuous updates as part of the pre-market approval application and supplement process ... [that] specifically address warnings and recalls associated with medical devices", the Sixth Circuit also held that state law failure to warn claims based on fraudulent omissions can be expressly preempted. Cupek, 405 F.3d at 424 ("Any claim, under state law, then, that Defendant failed to warn patients beyond warnings required by the FDA ... would constitute state requirements `different from' or `in addition to' the requirements of the federal PMA application and supplement process.").15

Applying Kentucky law for fraudulent omissions to these preemption doctrines under the second step of the Riegel express preemption test further supports this conclusion. Kentucky law requires that the defendant have a duty to disclose information. See CertainTeed Corp. v. Dexter, 330 S.W.3d 64, 79 (Ky.2010) (noting that product manufacturers can be held to a duty to warn). Plaintiffs cite no federal duty to disclose to the public or to patients the omitted information.16 Therefore, to the extent Plaintiffs assert that Advanced Bionics was under some state law duty to disclose, this amounts to an additional requirement, which § 360k expressly preempts. See Purcel II, 2010 WL 2679988, at *6 ("Plaintiffs cite no federal requirement obligating Bionics to warn them that devices were adulterated. These claims ... impose a requirement in addition to those approved by the FDA — the duty to warn consumers if devices are adulterated — and are therefore preempted by § 360k."). Accordingly, all of Plaintiffs' common law fraud claims are preempted.

VI.

Plaintiffs advance manufacturing and design defect claims under both strict liability and negligence. These are related but distinct inquiries, because in Kentucky, products liability focuses on the strict liability of the defendant for inadequacies in the quality of the product, whereas negligence liability focuses on the conduct of the actor. Montgomery Elevator Co. v. McCullough by McCullough, 676 S.W.2d 776, 780 (Ky.1984). Further,

C & S Fuel, Inc. v. Clark Equip. Co., 552 F.Supp. 340, 343-44 (E.D.Ky.1982).17 For this reason, it is easier to prove a claim based on strict liability than one based on negligence, and Plaintiffs tend to focus on this claim. In any event, and due to this distinction, the Court will address strict liability recovery first.

A.

Advanced Bionics argues that Plaintiffs' strict liability claims for the Vendor B HiRes 90k are both expressly and impliedly preempted. To determine express preemption according to the Riegel test, this Court must first determine whether federal regulations provide requirements applicable to this device that caused the device's defective condition.18 Second, the Court will determine whether the state law strict liability claim imposes an additional or different requirement.

Under the first step, the defect must be premised on a violation of the FDCA or corresponding regulations. See Purcel I, 2008 WL 3874713, at *10-11 ("[T]he MDA does not preempt Plaintiffs' claims under strict liability, which are predicated solely on violations of federal law.").19 Here, the Court finds that Plaintiffs have presented enough evidence for a reasonable juror to determine that the product was defective due to violations of two federal requirements.

First, according to Plaintiffs, Advanced Bionics failed to manufacture the Vendor B HiRes 90k in conformity with its PMA Supplement, which only approved the device using the PA & E feedthru.20 The Sixth Circuit has held that the PMA Supplement imposes federal requirements under the MDA. See Kemp, 231 F.3d at 228 (holding that "it is the totality of the design, manufacturing processes, and labeling — when coupled with the prohibition against modifying them — that represents the specific federal requirement `applicable [under the MDA] to the device'") (quoting 21 U.S.C. § 360k(a)(1)). The PMA Supplement obligates the device manufacturer to comply with its provisions. By substituting the AstroSeal feedthru in noncompliance with the PMA Supplement, Advanced Bionics appears to have evaded the FDA's rigorous investigation and testing of the AstroSeal feedthru's safety and effectiveness. A reasonable juror could conclude deviating from the PMA Supplement requirement caused this device to be defective.21

Second, Plaintiffs argue that Advanced Bionics' design and manufacture of the Vendor B HiRes 90k violated certain CGMPs, which rendered the device defective. CGMPs are FDA regulations setting standards for manufacturing practices, which are incorporated by reference into the PMA.22 Most of these CGMPs impose only administrative standards or flexible guidelines rather than mandate manufacturing requirements. However, the Sixth Circuit recognized that some CGMPs may be specific enough to constitute a valid federal requirement. Howard v. Sulzer Orthopedics, Inc., 382 Fed.Appx. 436, 440-41 (6th Cir.2010); see also Lohr, 518 U.S. at 499-501, 116 S.Ct. 2240. In such a case, the CGMP may impose obligations beyond those specifically approved for that device by the FDA in its PMA, Howard, 382 Fed.Appx. at 441, and still impose a federal requirement under Riegel. The CGMP provision cannot be "so vague as to be incapable of enforcement." Howard, 382 Fed.Appx. at 440. Rather, the CGMP must "impose a concrete requirement on a manufacturer that embodies a standard of care related to the safety and effectiveness of the device." Purchase, 896 F.Supp.2d at 698. The Court finds that the CGMP requiring Advanced Bionics to test products under actual or simulated use conditions is specific enough to support a parallel claim.23 21 C.F.R. § 820.30(g).

Even though Advanced Bionics argues that it complied with testing mandated in the PMA Supplement, Plaintiffs have presented sufficient evidence that Advanced Bionics did not conduct testing under actual or simulated use conditions, as 21 C.F.R. § 820.30(g) requires. These testing failures could have caused the implant to be defective and unreasonably dangerous. Other CGMPs cited in the Complaint are too general to impose a federal requirement on medical device manufacturers, such that enforcing a state law claim based on violations of those CGMPs would impose an additional requirement on manufacturers, which is preempted under 21 U.S.C. § 360k.24

B.

Having found that Plaintiffs presented two federal requirements that Advanced Bionics allegedly violated in satisfaction of the first Riegel step, the Court now examines whether the state law cause of action presents a parallel claim. For strict liability claims, Kentucky courts adopted the Restatement (Second) of Torts § 402A definition for manufacturing defects, under which "the defendant is held strictly liable if the plaintiff proves the product was `in a defective condition unreasonably dangerous to the user or consumer.'" Greene v. B.F. Goodrich Avionics Sys., Inc., 409 F.3d 784, 788 (6th Cir.2005) (quoting Montgomery Elevator Co., 676 S.W.2d at 780).25 Kentucky law considers several factors to determine whether a defect is unreasonably dangerous, including the presence of warnings, the expectations and knowledge of the ordinary consumer, the obviousness of the danger, industry standards, the feasibility of alternative designs, subsequent maintenance and repair, and consumer misuse. Jordan, 100 F.3d 956, at *2. Moreover, the plaintiff must prove that the defendant's conduct was a substantial factor in causing the plaintiff's injury, but need not prove that the manufacturer was at fault. Greene, 409 F.3d at 788.

In analyzing defective design claims, Kentucky courts inquire into "whether the manufacturer that placed in commerce the product made according to an intended design acted prudently, i.e., was the design a defective condition which was unreasonably dangerous." Nichols, 602 S.W.2d at 433. The plaintiff must show that the "`design itself selected by the manufacturer' — the plan, structure, choice of materials, and specifications — was unreasonably dangerous." Low v. Lowe's Home Centers, Inc., 771 F.Supp.2d 739, 741 (E.D.Ky. 2011) (quoting Jones, 502 S.W.2d at 69). Kentucky law allows a risk-utility analysis in design defect cases, which "thereby implicitly require[s] proof of a reasonable alternative design without explicitly doing so." Toyota Motor Corp. v. Gregory, 136 S.W.3d 35, 42 (Ky.2004); see also Low, 771 F.Supp.2d at 741.

The PMA approval process and the CGMPs, like state law strict liability claims, are designed to prevent manufacturers from introducing unreasonably dangerous products into the stream of commerce. Considering all of this, the Court concludes that, as a general matter, Plaintiff's claims under Kentucky common law strict liability do not impose requirements in addition to or different from those mandated under federal law.26 However, this does not mean that every strict liability claim escapes preemption. The Court finds that Plaintiffs have alleged only two viable parallel claims that are not expressly preempted: (1) that Advanced Bionics violated the FDCA by deviating from the PMA Supplement, and (2) that Advanced Bionics failed to comply with the CGMP mandating actual or simulated use testing.

C.

Finally, the Court must consider whether strict liability under either of these theories may be impliedly preempted. Strict liability arising from a defect caused by the failure to properly test the Vendor B HiRes 90k exists under Kentucky law regardless of whether the FDA enacted 21 C.F.R. § 820.30(g). This theory of strict liability is not impliedly preempted. However, the argument that Kentucky law allows for recovery under strict liability for a defect caused by the failure to adhere to the PMA Supplement independent of the federal law requirement is a bit more attenuated.

According to the medical device implied preemption doctrine, plaintiffs have no private right of action to directly enforce federal regulations. Plaintiffs cannot allege state law causes of action that are in reality veiled attempts to directly enforce federal regulations. Therefore, for a state law cause of action to survive implied preemption, the state law claim must exist regardless of whether the FDA promulgated these regulations. In other words,

Riley, 625 F.Supp.2d at 776-77 (internal citations omitted).

Without the FDCA, corresponding federal regulations, and the PMA Supplement itself all requiring companies to follow the PMA Supplement, this claim, when considered quite literally, may fail. However, the PMA Supplement process involves rigorous investigation and testing. Approval of the PMA Supplement reflects the federal government's determination that the manufacturer had indeed designed a product and established a manufacturing system that ensures the medical device's safety and effectiveness. In essence, like 21 C.F.R. § 820.30(g), the requirement to follow the PMA Supplement provides that manufacturers have undergone certain processes to ensure that the product is not unreasonably dangerous when it enters the stream of commerce. The failure to subject the device to this safety and effectiveness assurance procedure may well have led to the dangerous condition at issue here. State law provides recovery under strict liability for unreasonably dangerous products, and would likely allow plaintiffs to premise the defect upon evidence that the manufacturer failed to submit its product to proper safety and effectiveness testing.

Therefore, the Court concludes that the strict liability claim based upon deviation from the PMA Supplement is not impliedly preempted, because this claim would have existed under state law absent the federal regulations requiring compliance with the PMA Supplement.

VII.

Advanced Bionics next argues that it is entitled to summary judgment as to Plaintiffs' negligence claims for two reasons: 1) Plaintiffs did not allege sufficient factual or legal support for their claims, and 2) these claims are expressly preempted.

A.

Examining the sufficiency of the negligence claim, to the best of the Court's understanding, Plaintiffs' Complaint alleges that Advanced Bionics was negligent in the following ways:

Plaintiffs do not allude to specific federal regulations in the negligence section of their Complaint. However, the Complaint presents applicable federal requirements in enough detail to specify which acts of negligence violate specific federal laws.27 Moreover, Plaintiffs provide a wide array of factual evidence to support a reasonable juror's conclusion that Advanced Bionics indeed violated some these regulations.28 This Court has previously found a complaint inadequate to assert state law claims for violations of the FDCA where the complaint did not "identify any particular design flaw, manufacturing impropriety or product defect" and failed to assert the violation of a PMA-specific standard or CGMP regulation. White v. Stryker Corp., 818 F.Supp.2d 1032, 1039 (W.D.Ky.2011). The Complaint here is not subject to these same errors. Accordingly, the Court finds that Plaintiffs alleged sufficient factual and legal support to satisfy their obligations in asserting negligence claims.29

B.

Nevertheless, a few of these negligence theories are decidedly preempted. Plaintiffs' negligence claims based on allegations that Advanced Bionics made misrepresentations or material omissions to the FDA, Plaintiffs or the public, are preempted for the reasons stated above. Plaintiffs' negligence claim based on Advanced Bionics' failure to conduct life cycle testing is preempted, because Plaintiffs do not cite any federal regulations that require life cycle testing. To impose an obligation to perform life cycle testing would require an additional duty under state law, which is expressly preempted under § 360k. The remaining claims can be broken down into four categories: negligent design, negligent manufacturing, failure to comply with PMA and FDCA requirements, and failure to test under actual or simulated use conditions.

Beginning with the negligent design and manufacturing claims, according to the first step in the Riegel test, the defect must arise from violations of federal law. As best this Court can conceive from the briefs, Complaint, and lengthy telephonic conferences, Plaintiffs' negligent manufacturing and design claims are based on the failure to test under actual or simulated use conditions and failure to comply with PMA and FDA requirements, which are themselves asserted as distinct theories of negligence.

As this Court has already explained, the obligations to follow the PMA Supplement and to test under actual or simulated use conditions pursuant to 21 C.F.R. § 820.30(g) are viable federal requirements under Riegel. Negligence claims based on a violation of these requirements also satisfy the second step in the Riegel test. In Kentucky, a negligence case requires proof that "(1) the defendant owed the plaintiff a duty of care, (2) the defendant breached the standard by which his or her duty is measured, and (3) consequent injury." Pathways, Inc. v. Hammons, 113 S.W.3d 85, 88 (Ky.2003). Here, the duty of care owed and breach of that duty derive from federal law violations, and therefore, the negligence claims do not impose different or additional requirements. Based on the four remaining and interwoven negligence theories, the Court finds that Plaintiffs' negligence claims survive preemption.30

VIII.

Finally, Advanced Bionics argues that Michelle and Brian Sadler cannot recover noneconomic damages sustained as a result of the malfunctioning of Breanna's cochlear implant, because Kentucky subscribes to the physical impact rule. Under this rule, plaintiffs are unable to recover for emotional damages unless the plaintiffs sustained some level of physical contact with the source of the injury. Osborne v. Keeney, 399 S.W.3d 1, 13-14, 2012 WL 6634129, at *7 (Ky.2012). The Kentucky Supreme Court recently abrogated the physical impact rule in favor of a more relaxed rule allowing for recovery irrespective of contact, so long as the plaintiff satisfies the elements of the negligence claim. Id. at 15-16, at *8. Still, Plaintiffs must prove "serious" or "severe" emotional injuries, "where a reasonable person, normally constituted, would not be expected to endure the mental stress engendered by the circumstances of the case." Id. at 17, at *9. Because the Kentucky Supreme Court published its opinion after both parties briefed this motion, the Court will refrain from deciding whether Plaintiffs have alleged sufficient facts to constitute severe emotional injuries as imagined in Osborne. Nevertheless, the Osborne decision effectively nullifies Advanced Bionics' argument, and accordingly, the Court will deny the motion for summary judgment on Michelle and Brian Sadlers' claims for emotional damages.

Being otherwise sufficiently advised,

IT IS HEREBY ORDERED that Advanced Bionics' motion for summary judgment as to Plaintiffs' claims of fraud, negligence per se and breach of implied warranty are SUSTAINED and those claims are DISMISSED.

IT IS FURTHER ORDERED that Advanced Bionics' motion for summary judgment as to Plaintiffs' strict liability claims is DENIED as to those theories discussed within this opinion.

IT IS FURTHER ORDERED that Advanced Bionics' motion for summary judgment as to Plaintiffs' negligence claims is SUSTAINED for those claims based on fraudulent misrepresentations, fraudulent omissions, and failure to conduct life cycle testing, and DENIED as to all other grounds as discussed within this opinion.

IT IS FURTHER ORDERED that Advanced Bionics' motion for summary judgment on Michelle and Brian Sadler's emotional damages claims is DENIED.