Opinion
Case No. 3:19-cv-01531-YY
10-05-2020
MICHAEL LAKEY, an Oregon citizen, and DONALD REED, an Oregon citizen, Plaintiffs, v. ENDOLOGIX INC., a Delaware corporation, Defendant.
FINDINGS AND RECOMMENDATIONS :
FINDINGS
Plaintiffs Michael Lakey ("Lakey") and Donald Reed ("Reed") have brought suit against defendant Endologix Inc. ("Endologix") alleging state law claims of strict products liability and negligence for defective manufacturing, design defect, and failure to warn; negligence per se; and fraud. Compl., ECF #1. Plaintiffs also alleged a claim of conscious misrepresentation, but have dismissed that claim. Joint Stipulation, ECF #37 (dismissing Claim VII). This court has diversity jurisdiction pursuant to 28 U.S.C. § 1332.
Endologix has filed a Motion to Dismiss (ECF #17) in which it asserts that (1) plaintiffs' state law claims are preempted by federal law and therefore should be dismissed under Federal Rule of Civil Procedure 12(b)(6); (2) plaintiffs have failed to allege plausible claims under Federal Rule of Civil Procedure 8(a); and (3) plaintiffs have failed to allege their fraud claim with sufficient particularity as required by Federal Rule of Civil Procedure 9(a). The motion to dismiss should be DENIED for the reasons set forth below.
Given the parties' exhaustive briefing, and plaintiffs' dismissal of their claim for conscious misrepresentation following the court's email conferral to schedule oral argument on that claim specifically, the court finds these motions suitable for decision without oral argument pursuant to LR 7-1(d)(1).
I. Plaintiffs' Allegations
Plaintiffs have each suffered an abdominal aortic aneurysm ("AAA"), a potentially fatal weakening in the wall of the aortic artery. Compl. ¶¶ 8-10, 20-25, ECF #1. AAAs are treated by endovascular repair, a common surgical technique wherein a repair graft device is inserted into the aneurysm, which allows blood to flow through the device, thus avoiding the damaged artery wall and preventing rupture. Id. ¶¶ 11-12.
Some patients experience complications known as endoleaks, where blood continues to remain in or flow into the aneurysm cavity. Id. ¶¶ 13-15. One form of endoleak, called the Type III endoleak, is attributed to device failures and occurs when there is either a separation between the graft components or a tear or hole in the graft material. Id. ¶ 18. The condition is serious and requires urgent medical attention. Id.
In 2004, Endologix secured premarket approval ("PMA") from the Food and Drug Administration ("FDA") of its PowerLink AAA System to treat AAAs. Id. ¶¶ 36-37. The approval was subject to FDA requirements, including post-approval conditions imposed by a PMA order. Id. ¶ 38; PMA Order 6-8, ECF #19-2. Endologix later developed a new repair graft device called the Endologix AFX Endovascular AAA System ("AFX System") but did not prepare a separate PMA application, and instead submitted a 180-Day Track PMA Supplement for the PowerLink AAA System. Id. ¶¶ 39-40. Endologix also developed Strata, a propriety graft material, for use in a different device that never made it to market because testing revealed a high rate of failure attributed in part to the Strata material. Id. ¶¶ 44-46. Endologix employed Strata in the AFX System. Id. ¶ 47. Endologix began marketing the new device in August 2011. Id. ¶ 41. Within two years of use, Endologix received nearly five times more reports of Type III endoleaks from the AFX System than the PowerLink AAA System. Id. ¶¶ 48-50.
Despite these reports and internal research, Endologix advertised the AFX System as having "advanced clinical performance," representing in marketing materials that its "new proprietary Strata graft materials" were a "durable highly conformable ePTFE that enhances seal." Id. ¶¶ 51-52. Endologix stopped making the AFX System with Strata graft material in 2014 but made no reference to the higher failure rate when it submitted a 30-day process change notice to the FDA. Id. ¶ 53. Endologix did not notify physicians of the change in material or of the increased risk of Type III endoleaks from the AFX System. Id. ¶ 54.
Reed underwent endovascular repair in 2013 and Lakey the same in 2014. Id. ¶¶ 20, 25. In both cases, plaintiffs' AAAs were treated with the AFX System with Strata graft material. Id. ¶¶ 21, 26. In both cases, plaintiffs required corrective surgery in 2019 because they suffered Type III endoleaks. Id. ¶¶ 24, 30. In December 2016, Endologix recalled the AFX System and notified physicians. Id. ¶ 56. The FDA classified the recall as Class I, meaning use of the device may cause serious injury or death. Id. ¶¶ 58-60. II. Rule 12(b)(6) , Rule 8(a), and Preemption Framework
Defendant contends that because federal law preempts all of plaintiffs' state law claims, they must be dismissed pursuant to Rule 12(b)(6). A motion to dismiss for failure to state a claim under Rule 12(b)(6) may be granted where there is no cognizable legal theory to support the claim or when the complaint lacks sufficient factual allegations to state a facially plausible claim for relief. Shroyer v. New Cingular Wireless Servs., Inc., 622 F.3d 1035, 1041 (9th Cir. 2010). A Rule 12(b)(6) motion is a proper vehicle to argue that a state law claim is preempted by federal law and should be dismissed. See Williamson v. Gen. Dynamics Corp., 208 F.3d 1144, 1149 (9th Cir. 2000).
In analyzing defendant's motion, it is helpful to provide some context regarding the Medical Device Act and its preemption provisions. Historically, states have regulated citizen health and safety through the exercise of their police powers. Medtronic, Inc. v. Lohr, 518 U.S. 470, 475 (1996). However, over time, "the Federal Government has played an increasingly significant role in the protection of the health of our people." Id. at 475. In 1976, "[i]n response to the mounting consumer and regulatory concern," Congress enacted the Medical Device Amendments ("MDA"), 21 U.S.C. §§ 360c et seq., to the Federal Food, Drug, and Cosmetic Act ("FDCA"), 21 U.S.C. §§ 301 et seq., to "provide for the safety and effectiveness of medical devices intended for human use." Id. at 474. The MDA "swept back some state obligations and imposed a regime of detailed federal oversight." Riegel v. Medtronic, Inc., 552 U.S. 312, 316-17 (2008).
Under the MDA, the FDA may "approve devices that present great risks if they nonetheless offer great benefits in light of available alternatives." Id. at 318. The MDA classifies medical devices into three categories based on their risk. Lohr, 518 U.S. at 476. Class III medical devices, such as the AFX System, receive the most scrutiny and are subject to a "rigorous" premarket approval process. Id. at 477. "[T]he FDA requires a device that has received premarket approval to be made with almost no deviations from the specifications in its approval application, for the reason that the FDA has determined that the approved form provides a reasonable assurance of safety and effectiveness." Riegel, 552 U.S. at 323; 21 U.S.C. § 360e(d)(6)(A)(i)).
The MDA "expressly preempts state law regulation of medical devices." Weber v. Allergan, Inc., 940 F.3d 1106, 1110 (9th Cir. 2019), cert. denied, No. 19-869, 2020 WL 1326110 (U.S. Mar. 23, 2020) (citing 21 U.S.C. § 360k(a)). The pertinent portion of the MDA, § 360(k)(a), provides:
"[N]o State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement—
21 U.S.C. § 360k(a) (emphasis added).(1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and
(2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter.
Thus, to be preempted, "[s]tate requirements must be 'with respect to' medical devices and 'different from, or in addition to,' federal requirements." Lohr, 518 U.S. at 500. "[T]he MDA does not preempt state law requirements that ''parallel,' rather than add to, federal requirements.'" Weber, 940 F.3d at 1111 (quoting Riegel, 552 U.S. at 330); see also Stengel v. Medtronic Inc., 704 F.3d 1224, 1228 (9th Cir. 2013) (en banc) (holding that "the MDA does not preempt a state-law claim for violating a state-law duty that parallels a federal-law duty under the MDA"); Perez v. Nidek Co., 711 F.3d 1109, 1120 (9th Cir. 2013) (recognizing the "'narrow gap'" through which a state-law claim must fit to escape preemption by the FDCA"). "State requirements must also relate 'to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device. . . .'" Lohr, 518 U.S. at 500. "Moreover, federal requirements must be 'applicable to the device' in question, and, according to the regulations, pre-empt state law only if they are 'specific counterpart regulations' or 'specific' to a 'particular device.'" Id. "The statute and regulations, therefore, require a careful comparison between the allegedly pre-empting federal requirement and the allegedly pre-empted state requirement to determine whether they fall within the intended pre-emptive scope of the statute and regulations." Id.
"[T]he regulations provide that state requirements of 'general applicability' are not pre-empted except where they have 'the effect of establishing a substantive requirement for a specific device.'" Lohr, 518 U.S. at 500. Examples of requirements of "general applicability" include "general electrical codes, and the Uniform Commercial Code (warranty of fitness)), or to unfair trade practices in which the requirements are not limited to devices." Id. at 500 n.18 (citing 21 C.F.R. § 808.1(d) (1995)).
Importantly, there is "a presumption against federal preemption of state laws that operate in traditional state domains." Stengel, 704 F.3d at 1227 (en banc). "Parties seeking to invalidate a state law based on preemption 'bear the considerable burden of overcoming the starting presumption that Congress does not intend to supplant state law.'" Id. at 1227-28 (quoting De Buono v. NYSA-ILA Med. & Clinical Servs. Fund, 520 U.S. 806, 814 (1997)).
"In Riegel, the Supreme Court held that § 360k preempted state law claims challenging the safety and effectiveness of a Class III medical device that had received pre-market approval from the FDA." Weber, 940 F.3d at 1111 (citing Riegel, 552 U.S. at 321-25). Premarket approval imposes requirements under the MDA and is specific to individual devices. Riegel, 552 U.S. at 322-23.
The Supreme Court also held that all claims, including those sounding in tort, are subject to preemption if the "claims are based upon [state] requirements with respect to the device that are 'different from, or in addition to,' the federal [requirements], and that relate to safety and effectiveness." Id. at 322 (quoting 21 U.S.C. § 360k(a)). Moreover, "[n]othing in the statutory text suggests that the pre-empted state requirement must apply only to the relevant device, or only to medical devices and not to all products and all actions in general." Id. at 328 (emphasis in original). The Supreme Court reiterated that "[t]he MDA provides that no State 'may establish or continue in effect with respect to a device . . . any requirement' relating to safety or effectiveness that is different from, or in addition to, federal requirements." Id. at 328 (quoting 21 U.S.C. § 360(k)(a)) (emphasis in original).
"Since the MDA expressly pre-empts only state requirements 'different from, or in addition to, any requirement applicable . . . to the device' under federal law, . . . [the court] must determine whether the Federal Government has established requirements applicable to" the AFX System. Riegel, 552 U.S. at 321. "If so, [the court] must then determine whether the [plaintiffs'] common-law claims are based upon [state] 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.
In addition to preemption, defendant contends that plaintiffs' complaint fails to comply with the pleading standards required by Rule 8(a). Pursuant to Rule 8(a), a complaint must contain sufficient factual allegations to "plausibly suggest an entitlement to relief, such that it is not unfair to require the opposing party to be subjected to the expense of discovery and continued litigation." Starr v. Baca, 652 F.3d 1202, 1216 (9th Cir. 2011). "A claim has facial plausibility when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged." Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (citing Bell Atl. Corp. v. Twombly, 550 U.S. 544, 556 (2007)). Nevertheless, the plausibility standard does not create a "probability requirement at the pleading stage; it simply calls for enough fact to raise a reasonable expectation that discovery will reveal evidence of illegal [conduct]." Twombly, 550 U.S. at 556. In evaluating the sufficiency of a complaint's factual allegations, the court must accept as true all well-pleaded material facts alleged in the complaint and construe them in the light most favorable to the nonmoving party. Wilson v. Hewlett-Packard Co., 668 F.3d 1136, 1140 (9th Cir. 2012); Daniels-Hall v. Nat'l Educ. Ass'n, 629 F.3d 992, 998 (9th Cir. 2010).
III. Analysis
Consistent with the above legal framework, the court examines each of plaintiffs' claims in turn, specifically asking:
(1) whether the claim is preempted, i.e., it is based on state requirements relating to safety and effectiveness of the device that are different from, or in addition to, the federal requirements; and
(2) whether the claim meets Rule 8(a) plausibility standards in that it alleges sufficient facts showing a violation of FDA regulations or requirements related to the device and a causal nexus between the alleged injury and the violation.
A. Strict Liability/Negligence: Defective Manufacturing (Claims I & IV)
In Claim I, plaintiffs allege that defendant is strictly liable for "selling and distributing medical devices in an unsafe, defective, unreasonably dangerous, and/or improperly manufactured condition." Compl. ¶ 143, ECF #1. In Claim IV, plaintiffs allege that defendant acted negligently by failing to "exercise ordinary care in the . . . manufacture, sale, testing, quality assurance, quality control . . . and distribution of the Endologix AFX system" even though it knew or should have known that the product was unsafe. Id. ¶¶ 168-69.
1. Preemption
In identifying the applicable federal requirements, plaintiffs contend that defendant failed "to manufacture the device in accordance with FDA's imposed specification and regulations [and that this] rendered the AFX device adulterated under 21 U.S.C. § 351(a)(2)(B) and 21 U.S.C. § 351(h)." Pls.' Resp. Mem. Opp'n Def.'s Mot. Dismiss ("Pls.' Resp.") 8, ECF #19. Section 351(a)(2)(B) pertains to the strength, quality, and purity of "drugs," and its relevance to this case is unclear. See 21 U.S.C. § 321(g)(1) (defining "drug"); 21 U.S.C. § 321(h) (defining "device"). Nevertheless, § 351(h) speaks specifically to the "manufacture . . . of [a] device not in conformity with applicable requirements or conditions of section § 360j(f)." Under § 360j(f)(1)(A):
The Secretary may, in accordance with subparagraph (B), prescribe regulations requiring that the methods used in, and the facilities and controls used for, the manufacture, pre-production design validation (including a process to assess the performance of a device but not including an evaluation of the safety or effectiveness of a device), packing, storage, and installation of a device conform to current good manufacturing practice, as prescribed in such regulations, to assure that the device will be safe and effective and otherwise in compliance with this chapter.The regulations, i.e., current good manufacturing practices ("CGMP"), are codified at 21 C.F.R. Pt. 820. See 21 C.F.R. § 820.1 ("[t]he failure to comply with any applicable provision in this part renders a device adulterated"). Plaintiffs also allege several violations of CGMPs in support of their manufacturing defect claim, including inter alia a failure to test product under "actual or simulated use conditions" with proper "risk analysis" as required by 21 C.F.R. § 820.30(g), as well as a failure to "establish and maintain procedures for implementing corrective and preventive action," including the use of "appropriate statistical methodology," required by 21 C.F.R. § 820.100(a)(1). Pls.' Resp. 6-7, ECF #19. Plaintiffs assert that their state law claims parallel these violations of federal law and therefore are not preempted. Id. at 8.
a. CGMPs
As an initial matter, defendants argue the CGMPs are too vague to serve as the basis of a parallel claim. Def.'s Mot.14, ECF #14; Def.'s Reply 3, ECF #21. The Ninth Circuit recently noted the "intercircuit disagreement regarding whether a parallel claim demands that the federal 'requirement' must be 'device-specific' (such as FDA premarket approval for a particular medical device) or may be a general FDA regulation applicable to all medical devices (such as the Current Good Manufacturing Practices)." Weber, 940 F.3d at 1114. Although the Ninth Circuit has not said one way or the other whether parallel claims may be premised on general federal regulations or requirements, the weight of authority from other circuits holds that they may:
Mink v. Smith & Nephew, Inc., 860 F.3d 1319, 1331 n.3 (11th Cir. 2017) (agreeing "with our sister circuits that there is no 'sound legal basis' to distinguish these federal requirements because the plain text of § 360k refers to 'any requirement'");
Bass v. Stryker Corp., 669 F.3d 501, 511-13 (5th Cir. 2012) (holding allegations based on a CGMP were sufficient at the pleading stage because at trial the plaintiff "will have to prove violations of the more specific, FDA-approved PMA process for this device");
Bausch v. Stryker Corp., 630 F.3d 546, 554-55 (7th Cir. 2010) (rejecting the approach of some federal courts that have held that "the Quality System Regulations and Current Good Manufacturing Practices are too general to allow juries to enforce them");
Howard v. Sulzer Orthopedics, Inc., 382 F. App'x 436, 440 (6th Cir. 2010) (noting there may be instances when "the particular GMP that [a plaintiff] cites is not so vague as to be incapable of enforcement") (cited pursuant to 6th Cir. R. 32.1).
Moreover, it is telling that the Supreme Court eschewed adoption of a per se rule regarding the kinds of federal regulations or requirements that trigger preemption under the MDA, favoring a "careful comparison between the state and federal duties at issue" instead. Riegel, 552 U.S. at 322 (citing Lohr, 518 U.S. at 500-01). Thus, plaintiffs' reliance on the CGMPs as the basis for a parallel claim should not be categorially rejected.
b. Parallel State Law Claims
Oregon statutory law supplies the basis for plaintiffs' negligent and strict liability manufacturing defect claims. Under O.R.S. 30.900, a "'product liability civil action' means a civil action brought against a manufacturer, distributor, seller or lessor of a product for damages for personal injury, death or property damage arising out of: (1) Any . . . manufacturing or other defect in a product. . . ." (emphasis added). O.R.S. 30.920(1) provides that "[o]ne who sells or leases any product in a defective condition unreasonably dangerous to the user or consumer . . . is subject to liability for physical harm or damage to property caused by that condition . . . ." (emphasis added).
These statutes apply generally to manufacturing defects in all products, not specifically medical devices, and do not have the effect of establishing an additional substantive requirement for the AFX System. These statutes provide a damages remedy. However, "§ 360k does not prevent a State from providing a damages remedy for claims premised on a violation of FDA regulations; the state duties in such a case 'parallel,' rather than add to, federal requirements." Riegel, 552 U.S. at 330 (quoting Lohr, 518 U.S. at 495). As such, plaintiffs have alleged parallel state law manufacturing defect claims and the claims are not preempted.
2. Plausibility
Plaintiffs allege that the AFX System "deviated from product specifications" and "was manufactured in a manner violative of the [FDCA] and applicable FDA regulations," thus violating 21 U.S.C. § 351(h). Compl. ¶¶ 140-41, ECF #1. However, plaintiffs do not offer facts illustrating how the AFX System deviated from approved specifications or how it was manufactured in violation of the FDCA. Rather, plaintiffs merely "recite the elements of a cause of action" without providing sufficient "underlying facts to give fair notice and to enable the opposing party to defend itself effectively." Starr, 652 F.3d at 1216.
Plaintiffs do, however, allege facts showing a plausible claim for relief based on alleged violations of the CGMPs. In support of their claim that defendant failed to conduct adequate testing in violation of 21 C.F.R. § 820.30(g), plaintiffs point to a statement made during defendant's Q2 2010 earnings call in which President and CEO John McDermott specifically stated he hoped "studies would not even be required for the AFX System so that it could enter the market in Europe and the U.S. in 2011." Compl. ¶ 129, ECF #1 (emphasis added). In fact, the AFX System launched less than a year later in August 2011. Id. ¶ 41. Plaintiffs also refer to the method in which defendant reported the rate of Type III endoleaks. Pls.' Resp. 6, ECF #19. Defendant combined reports of Type III endoleaks from the PowerLink AAA system with those from the AFX System—despite their different designs and graft materials. Compl. ¶ 74, ECF #1. Defendant's decision to disclose only this collective reporting rate allegedly "diluted the data and concealed the increased risk for Type III endoleaks for the AFX device." Id. Furthermore, plaintiffs alleged that defendant further concealed the degree of the AFX System's failure rate by calculating the rate of endoleaks based on all devices distributed versus only those implanted. Id. ¶¶ 75, 84. Plaintiffs argue this violated the "risk analysis" requirement of 21 C.F.R. § 820.30(g), as well as the requirement that manufacturers employ "appropriate statistical methodology" under 21 C.F.R. § 820.100(a)(1). Pls.' Resp. 7, ECF #19.
To support their contention that defendant failed under 21 C.F.R. § 820.100(a) to "establish and maintain procedures for implementing corrective and preventive action," plaintiffs allege that defendant stopped manufacturing the AFX System with the faulty Strata graft material in 2014 but did not at that time notify physicians or patients of the change, the reason for the change, or the increased risk of Type III endoleaks. Compl. ¶¶ 53-54, ECF #1. Instead, plaintiffs claim that defendant waited two years, until 2016, to notify physicians it was recalling all AFX System made with Strata. Id. ¶ 56. Plaintiffs argue this contravenes the federal requirement that manufacturers ensure "information related to quality problems or nonconforming product is disseminated to those directly responsible for assuring the quality of such product." 21 C.F.R. § 820.100(a)(6). Thus, plaintiffs have pleaded enough facts to state their manufacturing defect claims.
As to causation, plaintiffs have sufficiently pleaded facts that support a causal nexus between the alleged violations of the CGMPs and plaintiffs' alleged injuries. Iqbal, 556 U.S. at 678; Twombly, 550 U.S. at 556. Plaintiffs assert that "[a]s a result of the defendant's failure to test and validate the safety of its AFX device, the devices were distributed in unreasonably dangerous condition and thus defective under state law." Pls.' Resp. 6, ECF #19; see Compl. ¶¶ 73-88, ECF #1. Plaintiffs further allege that if defendant had conducted adequate testing, reported the AFX system's failure rate in a less misleading way, or notified physicians as soon as it took corrective measures, plaintiffs' physicians would have chosen not to implant the devices. See Pls.' Resp. 6-7, ECF #19; Compl. ¶¶ 101, 132, ECF #1. Granted, Reed cannot establish causation for defendant's alleged failure to notify physicians that it was ceasing the manufacture of the AFX System made with Strata in 2014 because he had already been implanted with the device by that time. See Connelly v. St. Jude Med., Inc., 5:17-CV-02006-EJD, 2018 WL 732734, at *3 (N.D. Cal. Feb. 6, 2018) (finding plaintiff failed to "allege any facts that plausibly establish a causal nexus" where his "allegations . . . refer to adverse events that occurred after the [devices] were implanted in him"). However, plaintiffs also allege that their injuries were a direct and proximate result of defendant's failure to properly recall the device or notify physicians sooner of the risks even though defendant was aware that the AFX system had a significant failure rate within the first two years it was on the market. Compl. ¶¶ 48-51, 63, ECF #1. While it is not clear that taking these actions would have certainly prevented plaintiffs' injuries, plaintiffs need only plead facts that state a plausible claim for relief. Shroyer, 622 F.3d at 1041.
Moreover,
[a] special relationship exists between a doctor and a drug manufacturer. The doctor, in treating and prescribing drugs for patients, must rely on the drug company to inform him about the efficacy and use of various drugs. He expects to be told of any limits on their use and of any known harmful side effects. . . . This duty is a necessary one. Doctors are not capable of testing and studying the effects of the various drugs they use; they must rely on the manufacturers.Oksenholt v. Lederle Labs., 51 Or. App. 419, 425 (1981). While the "purchaser's doctor is a learned intermediary between the purchaser and the manufacturer," and "the duty of the ethical drug manufacturer is to warn the doctor, rather than the patient, the manufacturer is directly liable to the patient for a breach of such duty." Id. at 424 (citing McEwen v. Ortho Pharm. Corp., 270 Or. 375, 386-87 (1974)); see also Alton v. Medtronic, Inc., 970 F. Supp. 2d 1069, 1098 (D. Or. 2013) (recognizing a manufacturer's "general obligation to avoid affirmative misrepresentations regarding the risks associated with such applications [of a device] with the intent that members of the public rely on those misrepresentations to their detriment).
For these reasons, plaintiffs have pleaded plausible strict liability and negligent manufacturing defect claims.
B. Strict Liability/Negligence: Design Defect (Claims II & IV)
In Claim II, plaintiffs allege that defendant "is strictly liable for selling and distributing medical devices in an unsafe, defective, unreasonably dangerous, and/or improper condition in violation of Oregon law and parallel federal requirements." Compl. ¶ 154, ECF #1. In Claim IV, plaintiffs allege that defendant is liable for negligently failing to "exercise ordinary care in the design [and]. . . labeling . . . of the Endologix AFX system" even though defendant knew the device was not safe for use by consumers. Id. ¶¶ 168-69.
1. Preemption
For the federal requirement, plaintiffs rely on 21 U.S.C. § 331(a), which prohibits "[t]he introduction or delivery for introduction into interstate commerce of any food, drug, device, tobacco product, or cosmetic that is adulterated or misbranded." Pls.' Resp. 9, ECF #19. Plaintiffs also cite 21 U.S.C. § 352(j), which provides that "[a] drug or device shall be deemed to be misbranded . . . [i]f it is dangerous to health when used in the dosage or manner, or with the frequency or duration prescribed, recommended, or suggested in the labeling thereof."
Like their manufacturing defect claims, plaintiffs cite Oregon statutes as the basis for their strict liability and negligent design defect claims. See O.R.S. 30.900; O.R.S. 30.920(1). As noted above, these statutes are generally applicable to all products and do not add anything more than a damages remedy to the federal requirements. See Mears v. Marshall, 149 Or. App. 641, 659 (1997) (holding that plaintiff's design defect was not preempted where claims asserted were "not specific state requirements that have been developed 'with respect to' medical devices" and were instead concerning "general duties that are equally applicable to manufacturers of virtually any type of product"); but cf. Alton, 970 F. Supp. 2d at 1102 (holding a design defect claim was preempted where it "would constitute imposition of requirements on the design of the device in addition to those mandated by the FDA through PMA approval").
Although the Ninth Circuit has not specifically addressed the issue, the Sixth Circuit has suggested that a parallel design defect claim based on information not originally before the FDA may survive a motion to dismiss if it
(1) allege[s] a cause of action for misbranding under state law,In re Darvocet, Darvon, & Propoxyphene Products Liab. Litig., 756 F.3d 917, 929 (6th Cir. 2014) (citations and quotation marks omitted). Even though the Six Circuit's analysis in Darvocet pertained to a drug, it would likely also pertain to a misbranding claim for a device since the federal premise for misbranding refers to both "misbranded drugs and devices." 21 U.S.C. § 352(j) (emphasis added).
(2) identif[ies] the new and scientifically significant information that was not before the FDA, and
(3) demonstrate[s] that the FDA would have found the drug [or device] to be misbranded in light of this new information in order to appropriately account for the FDA's role under the FDCA.
Applying the Darvocet standard, plaintiffs have established the state law basis for their design defect claims, and plaintiffs have alleged facts showing that the FDA did not have the benefit of several findings when it approved the AFX System. Specifically, plaintiffs claim that post-approval, defendant received a Type III endoleak reporting rate for the AFX System multiple times higher than the previous device design and other similar devices. Compl. ¶¶ 48-50, ECF #1. The fact that the AFX System was later recalled and characterized by the FDA as a Class I recall goes to show that the FDA would have found the device to be misbranded if it had the benefit of these failure rate findings during the PMA process. Id. ¶¶ 57, 60.
2. Plausibility
Moreover, plaintiffs have pleaded sufficient facts to show that defendant's failure to comply with federal requirements caused plaintiffs' injuries. Again, plaintiffs allege that defendants concealed the risk of Type III endoleaks to physicians, failed to submit adverse event reports to the FDA, and failed to submit a written report specifying a description of the events giving rise to correction or removal of the Strata material from the AFX System. Compl. ¶¶ 73-95. Plaintiffs point to the fact that in 2014, defendant submitted a 30-day process change notice to the FDA that made no reference to the high failure rate of its Strata grafts, and that after this notice, defendant stopped making the AFX System with Strata material and began making it with Duraply graft material. Compl. ¶ 53. Plaintiffs claim that "had Endologix followed the required removal/corrective action notification and communication regulations" that required them to describe events giving rise to corrective action to the FDA, "plaintiffs would not have been implanted with the defective device that resulted in their injuries." Id. ¶ 101.
As noted above, this line of reasoning does not help plaintiff Reed because he was implanted with the device in 2013 before this alleged duty arose. See id. ¶ 25. Still, plaintiffs also allege that their injuries were a direct and proximate result of defendant's failure to adhere to the requirements of 21 U.S.C. §§ 352(a) and (f) by properly recalling a device with a "false or misleading label" or updating labeling to provide "adequate warnings" for physicians despite the fact defendant knew of the risks as early as the first year the AFX system was on the market. Id. ¶¶ 48-51, 63. Again, the standard at this stage is not certainty as to whether these actions would have prevented plaintiffs' injuries, but plausibility. Shroyer, 622 F.3d at 1041. These allegations sufficiently establish causation between the alleged design defect violations and of plaintiffs' injuries.
It is for all these reasons defendant's reliance on the Ninth Circuit's recent decision Ebrahimi v. Mentor Worldwide LLC, No. 19-55103, 2020 WL 2510760 (9th Cir. May 15, 2020) is misplaced. There, the Ninth Circuit affirmed the dismissal of a state design defect claim as expressly preempted when the plaintiff merely contended that the court could "plausibly infer" the manufacturer violated "at least one" CGMP because her particular device was defective. Id. at *1. The Ebrahimi court applied the rule that "to survive MDA preemption, a plaintiff cannot simply demonstrate a defect or a malfunction and rely on res ipsa loquitur to suggest only 'that the thing speaks for itself.'" Weber, 940 F.3d at 1112 (quoting Funk v. Stryker Corp., 631 F.3d 777, 782 (5th Cir. 2011)). Instead, "a plaintiff must show that the defendant deviated from a particular pre-market approval or other FDA requirement applicable to the Class III medical device." Id. (quoting Weber, 940 F.3d at 1112). Plaintiffs have made this showing.
C. Strict Liability/Negligence: Failure to Warn (Claims III & IV)
In Claim III, plaintiffs allege that defendant is strictly liable for "fail[ing] to provide adequate warnings and instructions for use" and for the fact that the AFX System "remained on the market due to [defendant's] failure to comply with federal requirements." Compl. ¶ 162, ECF #1. Relatedly, in Claim IV, plaintiffs allege that defendant is liable for negligently failing to "provide adequate warnings and instructions for use." Id. ¶ 173.
1. Preemption
Plaintiffs cite federal requirements that prohibit misbranded devices and mandate that corrective or removal actions be timely communicated to plaintiffs and their physicians. See 21 U.S.C. § 352(a)(1) (prohibiting labeling that is "false or misleading in any particular"); id. § 352(f) ("A drug or device shall be deemed to be misbranded unless its labeling bears (1) adequate directions for use; and (2) such adequate warnings against . . . unsafe . . . application, in such manner and form, as are necessary for the protection of users . . . ."); 21 C.F.R. § 806.10 (requiring that "[e]ach device manufacturer or importer shall submit a written report to FDA of any correction or removal of a device" including "[a] description of the event(s) giving rise to the information reported . . ."); id. § 7.49(a) (requiring a device manufacturer to "promptly notify[] each of its affected direct accounts about [a] recall"); id. § 820.100 (requiring the use of "[a]ppropriate statistical methodology" and "[e]nsuring that information related to quality problems or nonconforming product is disseminated to those directly responsible for assuring the quality of" product subject to corrective action).
Plaintiffs cite the same Oregon statutes as the basis for their failure to warn strict liability and negligence claims. See O.R.S. 30.900; O.R.S. 30.920(1). Plaintiffs' state-law failure to warn claims are also grounded in Oregon case law. See Alton, 970 F. Supp. 2d at 1100 (noting Oregon law provides that when a manufacturer "has reason to anticipate that danger may result from a particular use, [the seller] may be required to give adequate warning of the danger . . . and a product sold without such warning is in a defective condition") (quoting RESTATEMENT (SECOND) OF TORTS § 402A cmt. h (1965)) (original alterations omitted); see also McEwen, 270 Or. at 386 ("[T]he drug manufacturer is treated as an expert in its particular field, and is under a continuous duty . . . to keep abreast of scientific developments touching upon the manufacturer's product and to notify the medical profession of any additional side effects discovered from its use.").
Defendant argues that plaintiffs' claims are preempted because "Oregon law may require informing the physician of risks, but federal law requires warning [only] the FDA of newly discovered risks." Def.'s Reply 17, ECF #21. Defendant further contends there is no "case law to support that a failure to report corrective/removal actions to [the] FDA is a parallel claim that would be recognized by Oregon law," id. at 17, there is "no state law proscribing Endologix a duty to provide an 'annual report' to physicians," id. at 14, and "[t]here is no state-law duty generally equivalent to the federal requirement that a device manufacturer report adverse events to the FDA, as is required to state a parallel claim." Mot. Dismiss 16, ECF #17.
In Stengel, the Ninth Circuit held that under Supreme Court case law, a state law failure to warn claim is "not preempted, either expressly or impliedly, by the MDA." 704 F.3d at 1233. The court found that the plaintiff's claim "rests on a state-law duty that parallels a federal-law duty under the MDA, as in Lohr," and "join[ed] the Fifth and Seventh Circuits, which reached the same conclusion[.]" Id.; see also Lohr, 518 U.S. at 501-02 (noting "the predicate for the failure to warn claim is the general duty to inform users and purchasers of potentially dangerous items of the risks involved in their use" and that such general state obligations "escape preemption, not because the source of the duty is a judge-made common-law rule, but rather because their generality leaves them outside the category of requirements that § 360k envisioned to be 'with respect to' specific devices").
Defendant's argument that federal law only requires warning the FDA of risks associated with the medical device ignores the plain language of 21 C.F.R. § 7.49(a), which requires a device manufacturer to "promptly notify[] each of its affected direct accounts about [a] recall." Defendant also ignores 21 C.F.R. § 820.100(a)(6), which requires a device manufacturer to "establish and maintain procedures for implementing corrective and preventive action," including "[e]nsuring that information related to quality problems or nonconforming product is disseminated to those directly responsible for assuring the quality of such product." Additionally, defendant overlooks the language in the PMA order requiring it to provide "a clinical update to physician users at least annually." PMA Order 3, ECF #19-2. Collectively, this language shows there is a duty for device manufacturers to report defects not only to the FDA (as required in 21 C.F.R. § 806.10), but also to the physicians directly responsible for complications arising from defective devices.
As noted above, the addition of a damages remedy under a state law failure to warn claim does not add to or vary federal requirements in a way that would defeat plaintiffs' parallel-claim exception to preemption. Riegel, 552 U.S. at 330 (quoting Lohr, 518 U.S. at 495). Thus, plaintiffs have properly alleged parallel claims for a failure to warn and their claims are not preempted.
2. Plausibility
The facts supporting plaintiffs' failure to warn claims are like those underlying plaintiffs' design defect claims. Both sets of claims share a federal regulatory premise—the prohibition on misbranded devices under 21 U.S.C. § 352. Plaintiffs allege that defendant had an obligation to maintain its labeling to provide adequate warning of potential risks, but failed to do so in violation of the conditions of its PMA order. Compl. ¶¶ 69-70, ECF #1. The PMA order provides that "[a] PMA supplement must be submitted when unanticipated adverse effects, increases in the incidence of anticipated adverse effects, or device failures necessitate a labeling, manufacturing, or device modification." PMA Order 6, ECF #19-2. Plaintiffs further claim defendant attempted to conceal the true failure rate of the AFX system in its annual clinical update to physicians in violation of one of the conditions of approval in its PMA order. Compl. ¶ 73, ECF #1; see also PMA Order 3, ECF #19-2 (noting defendant must provide "a clinical update to physician users at least annually"). To show a violation of 21 C.F.R. § 806.10, plaintiffs allege that, in 2014, defendants submitted a 30-day process change notice to the FDA that made no reference to the high failure rate of its Strata graft material even though it was required to provide "[a] description of the event(s) giving rise to the information reported." Compl. ¶ 53, ECF #1; 21 C.F.R. § 806.10(c)(7). Lastly, in support of their claim defendant violated 21 C.F.R. §§ 7.49(a) and 820.100, plaintiffs note that even though defendant was aware of the AFX System's high failure rate and even though defendant in fact ceased production of the AFX System with Strata in 2014, it was only in December 2016 that defendant first notified physicians of the corrective measures taken. Compl. ¶¶ 53, 61, 63, ECF #1. This is despite the fact that defendant was required to "promptly notify[] each of its affected direct accounts about [a] recall" and ensure "that information related to quality problems or nonconforming product is disseminated to those directly responsible for assuring the quality of" product subject to corrective action. 21 C.F.R. §§ 7.49(a), 820.100.
Regarding causation, plaintiffs allege that their injuries were a direct and proximate result of defendant's failure to warn physicians of this risk and the availability of alternative device options. Compl. ¶ 63, ECF #1. More specifically, plaintiffs allege that if their physicians were provided with an adequate warning or instruction of the risks of the AFX system, their physicians would not have chosen the device, but would have pursued a safer alternative to treat their AAAs. Id. ¶ 31. Importantly, Oregon courts have recognized that "where warning is given, the seller may reasonably assume that it will be read and heeded." Alton, 970 F. Supp. 2d at 1100 (citing RESTATEMENT (SECOND) OF TORTS § 402A cmt. j (1965)). These facts illustrate a plausible claim for relief and a connection between the alleged violations and plaintiffs' injuries.
For these reasons, plaintiffs have pleaded plausible strict liability and negligent failure to warn claims.
D. Preemption Based on PMA
Defendant argues that "[w]hether the claim sounds in strict liability or negligence, to sustain either, Plaintiffs must prove that the device should have been designed, tested, manufactured, labeled, or marketed differently from the manner approved by the FDA in its PMA." Mot. Dismiss 10-11, ECF #17 (emphasis in original). Essentially, defendant contends that, if a device complies with the PMA order, preemption applies. Defendant relies on Riegel, in which the Supreme Court found that the plaintiffs' claims were preempted because the device adhered to the standards contained in the premarket approval. Id. at 11 (citing Riegel, 552 U.S. at 320-21). The Court held that "[p]remarket approval . . . imposes 'requirements' under the MDA" and constitutes "federal safety review." 552 U.S. at 322-23. Thus, "[s]tate tort law that requires a [device] to be safer, but hence less effective, than the model the FDA has approved disrupts the federal scheme no less than state regulatory law to the same effect." 552 U.S. at 325. However, defendant overlooks the conditional nature of the FDA's PMA order in this case. That order expressly provides that continued approval is contingent upon defendant's ongoing monitoring, reporting, and submission of supplemental PMAs "when unanticipated adverse effects, increases in the incidence of anticipated adverse effects, or device failures necessitate a labeling, manufacturing, or device modification." PMA Order 6-8, ECF #19-2. Moreover, the order specifically imposes "postapproval requirements" where "failure to comply with the conditions of approval invalidates this approval order." Id. at 3-4. As the Supreme Court stated in Lohr, "when Congress enacted § 360k, it was primarily concerned with the problem of specific, conflicting state statutes and regulations." Lohr, 518 U.S. at 489 (emphasis added). Here, as discussed above , no such conflict exists. Plaintiffs' state claims merely provide a damages remedy for the federal requirements mandating continued compliance with labeling, manufacturing, or device modification requirements.
E. Negligence Per Se (Claim V)
In this claim, plaintiffs allege that "defendant's acts . . . constitute an adulteration, misbranding, or both, as defined by the Federal Code 21 U.S.C. § 351, 21 U.S.C. § 352, and [a violation of] other applicable FDA regulations, and [therefore] constitute a breach of duty subjecting defendant to civil liability for all damages arising therefrom under the theory of negligence per se." Compl. ¶ 179, ECF #1.
1. Preemption
Defendant contends that plaintiffs' negligence per se claim is impliedly preempted under Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341 (2001), because "there is no private cause of action under the FDCA." Mot. Dismiss 12, ECF #17. In Buckman, the plaintiffs alleged "state-law fraud-on-the-FDA claims," asserting that the defendant had made fraudulent representations to the FDA and, as a result, devices were improperly given market clearance and subsequently used to the plaintiffs' detriment. 531 U.S. at 346-47. The Supreme Court noted that "[p]olicing fraud against federal agencies is hardly 'a field which the States have traditionally occupied,' . . . such as to warrant a presumption against finding federal pre-emption of a state-law cause of action." Id. Accordingly, the Supreme Court held that "the plaintiffs' state-law fraud-on-the-FDA claims conflict with, and are therefore impliedly pre-empted by, federal law." Id. at 348. "[T]he federal statutory scheme amply empowers the FDA to punish and deter fraud against the Administration[.]" Id. There is clear evidence that Congress intended that the MDA be enforced exclusively by the Federal Government." Id. at 352.
Here, unlike Buckman, plaintiffs do not allege any fraud on the FDA. Instead, as established above, plaintiffs assert parallel state law claims of manufacturing defect, design defect, and failure to warn. The Ninth Circuit reached the same conclusion in McClellan v. I-Flow Corp., 776 F.3d 1035 (9th Cir. 2015), in which it found the district court erred in refusing to give a negligence per se instruction. McClellan had alleged failure-to-warn theories that were clearly concerned with the labeling and regulation of medical devices. Id. at 1040. Because "[t]he regulation of medical devices prior to the MDA 'was left largely to the States to supervise as they saw fit,'" the court applied "the presumption against preemption" and concluded the case was not controlled by Buckman. Id. at 1040. The same result is compelled here.
2. Plausibility
To establish a negligence per se claim under Oregon law, a plaintiff must demonstrate that
(1) defendants violated a statute [or rule];Buoy v. Soo Hee Kim, 232 Or. App. 189, 204 (2009) (emphasis in original).
(2) that plaintiff was injured as a result of that violation;
(3) that plaintiff was a member of the class of persons meant to be protected by the statute [or rule]; and
(4) that the injury plaintiff suffered is of a type that the statute [or rule] was enacted to prevent.
Applying these elements, plaintiffs have alleged a cognizable claim of negligence per se. First, plaintiffs have alleged that defendant negligently violated state statutes related to manufacturing defect, design defect, and failure to warn. The FDCA provisions and implementing regulations upon which plaintiffs premise their state law claims supply evidentiary support of defendant's duty of care. Oregon law recognizes a negligence claim for the breach of a standard of care based on a violation of federal regulations:
In other words, evidence that AHP had violated the regulations would be evidence that AHP had breached a standard of care established by those regulations. If that breach could be shown to have caused Douglas Axen's injuries, then AHP could be liable under a common-law theory of negligence.Axen v. Am. Home Prod. Corp. ex rel. Wyeth-Ayerst Labs., 158 Or. App. 292, 307, opinion adhered to as modified on reconsideration sub nom. Axen v. Am. Home Prod. Corp., 160 Or. App. 19 (1999). Second, and as noted above, plaintiffs have pleaded sufficient facts to show they were injured as a result of each of these alleged violations. Third, the FDCA statutes are "designed primarily to protect the health and safety of the public at large." POM Wonderful LLC v. Coca-Cola Co., 573 U.S. 102, 108 (2014). In particular, the FDCA provisions plaintiffs cite as proof of defendant's duty of care are meant to protect medical device recipients like plaintiffs from injuries related to, inter alia, the misbranding or adulteration of medical devices. Plaintiffs are part of that class of individuals.
For these reasons, plaintiffs have plausibly alleged a negligence per se claim.
F. Fraud (Claim VI)
In Claim VI, plaintiffs allege fraud based on defendant's "representations (or omissions) to plaintiffs and/or their physicians" regarding the efficacy of the AFX System prior to the device being implanted into plaintiffs. Compl. ¶ 187, ECF #1.
1. Particularity
As an initial matter, defendant contends that plaintiffs have failed to plead their fraud claim with the particularity required by Rule 9(b). Mot. Dismiss 1, 3, 23, ECF #17. Rule 9(b) requires that a party alleging fraud or mistake "must state with particularity the circumstances constituting fraud or mistake." At a minimum, a plaintiff must allege "the time, place and nature of the alleged fraudulent activities." Ave. Lofts Condominiums Owners' Ass'n v. Victaulic Co., 24 F. Supp. 3d 1010, 1020 (D. Or. 2014) (quoting Tok Cha Kim v. CB Richard Ellis Haw., Inc., 288 F. App'x 312, 315 (9th Cir. 2008)). In essence, "[a] pleading is sufficient under rule 9(b) if it identifies the circumstances constituting fraud so that a defendant can prepare an adequate answer from the allegations." Moore v. Kayport Package Exp., Inc., 885 F.2d 531, 540 (9th Cir. 1989). Moreover, "the rule may be relaxed as to matters within the opposing party's knowledge." Id.; Rubenstein v. Neiman Marcus Grp. Ltd. Liab. Co., 687 F. App'x 564, 567-68 (9th Cir. 2017) ("Rule 9(b) only requires that plaintiffs specifically plead those facts surrounding alleged acts of fraud to which they can reasonably be expected to have access.") (cited pursuant to Ninth Circuit Rule 36-3(b)).
Based on this standard, plaintiffs have pleaded their fraud claim with sufficient particularity. Plaintiffs have specified the time and place of each alleged misrepresentation, noting that they occurred in defendant's annual update and within its website and marketing materials prior to plaintiffs' endovascular repair. Plaintiffs also indicate the nature of these alleged misrepresentations by quoting specific content within each source. This is sufficient to put defendant on notice such that it can prepare an adequate answer to the allegations.
2. Preemption
Plaintiffs primarily premise their fraud claim on 21 U.S.C. § 352(a), which provides that "[a] drug or device shall be deemed to be misbranded . . . [i]f its labeling is false or misleading in any particular." However, the facts plaintiffs allege in support of their fraud claim go beyond representations made on labeling, and encompass representations made in advertising and marketing materials targeting plaintiffs and their physicians. Compl. ¶¶ 187-91, ECF #1. There is no comparable FDCA regulation prohibiting this specific conduct. Rather, plaintiffs' "fraud claim falls instead into the second category of parallel claims contemplated in Lohr and its progeny, as a claim premised on conduct that contravenes state-law duties of such generality as not to present any risk of interference with the federal medical-device regulatory scheme." Alton, 970 F. Supp. 2d at 1098.
As in Alton, plaintiffs base their fraud claim on the common law elements of fraud under Oregon law and assert that: defendant intentionally misrepresented material health and safety risk information to the public, plaintiffs, and their physicians in the course of affirmatively marketing the device; defendant and its agents understood that their representations regarding the health and safety risks of such applications of the device were false at the time they were made; defendant intended plaintiffs and their physicians to rely on those misrepresentations; plaintiffs and their physicians were unaware of the falsity of defendant's representations; and plaintiffs and their physicians reasonably relied on defendant's misrepresentations in reaching the decision to subject plaintiffs to implantation of the device, with resultant injury to plaintiffs. Alton, 970 F. Supp. 2d at 1097-98 (stating elements of fraud under Oregon law). Like Alton, plaintiffs' fraud claim is a parallel claim that is not preempted under § 360k(a). See id. at 1099.
3. Plausibility
Turning to the sufficiency of the allegations, plaintiffs have pleaded enough facts to allege fraud. Specially, plaintiffs allege that before they were implanted with the devices, defendant "failed to disclose in its labeling, advertisements, and/or promotions that the AFX devices had an increased risk of Type III endoleak failures, particularly as compared to other AAA repair devices." Compl. ¶¶ 187-88, ECF #1. Plaintiffs also point to language used in defendant's 2012 and 2013 annual reports to physicians that described the AFX System's performance as "safe and effective" and noting "stent graft integrity has been excellent," as well as advertising used by defendant that described the "advanced clinical performance" of the device. Id. ¶¶ 52, 190 (emphasis added). This is despite the fact that defendants allegedly knew of the high failure rate associated with the AFX System within the first year on the market, which would have been before the release of the 2012 and 2013 annual reports to physicians. Id. ¶¶ 41, 48-50. Plaintiffs also note that defendant represented in its marketing materials and website that the Strata graft material had "exceptional strength and impermeability" and "provide[d] both strength and seal." Id. ¶ 191.
Regarding causation, plaintiffs claim that "[a]s a direct and proximate result of defendant's fraud plaintiffs were implanted with defendant's AFX system and . . . suffered serious physical injury, harm, damages and economic loss." Id. ¶ 198. Viewing the facts in the light most favorable to plaintiffs and accepting the factual allegations above as true, plaintiffs have stated a plausible claim for relief and plausible connection between the alleged violations and plaintiffs' injuries.
As additional support, plaintiffs call attention to Hayes v. Endologix, Inc., No. CV 19-37-HRW, 2020 WL 1624022 (E.D. Ky. Mar. 26, 2020), a recent decision from the Eastern District of Kentucky that also involved questions of federal preemption under the FDCA relating to the AFX system. There, the court found that the plaintiff's claims for negligent misrepresentation, manufacturing defect, design defect, failure to warn, and negligence survived preemption. 2020 WL 1624022, at *4. The court noted that, for a plaintiff's parallel claims to avoid preemption in the context of a 12(b)(6) motion, the plaintiff must make "specific allegations" that show "how the device violated a particular regulation." Id. at *3 (emphasis in original). Mindful that the parties had not yet engaged in discovery, the court found it was enough that the plaintiff cited to "pertinent federal regulations and how, specifically, the device at issue deviated from or violated" them. Id.
This court's findings and recommendations are consistent with the decision in Hayes. As explained in detail above, this court similarly finds that plaintiffs have pleaded specific allegations to support their state law claims that parallel pertinent federal regulations. Thus, plaintiff's claims survive preemption.
Notably, unlike this court, the E.D. Kentucky found that the plaintiff's negligence per se claim did not survive preemption. Id. (noting "[t]he law of Kentucky is clear that [v]iolations of federal laws and regulations and the law of other states do not create a cause of action" under Kentucky's negligence per se statute) (internal quotation marks omitted). However, as noted above, both the Ninth Circuit and Oregon courts recognize that plaintiffs may bring a negligence per se claim premised on a violation of a federal regulation without triggering MDA preemption if the claim relies on an independent state law duty and merely incorporates the standard of care from federal law. See McClellan, 776 F.3d at 1041; Axen, 158 Or. App. at 306. Thus, Hayes, which examined Kentucky law, is neither controlling nor persuasive as to negligence per se.
Finally, defendant motion to dismiss for failure to comply with Rule 8's short and plain statement requirement should be summarily denied. See Mot. Dismiss 1, 3, ECF #17. As the Eastern District of Kentucky put it in Hayes, "[w]hat Defendant blithely refers to as 'flotsam and jetsam' are actually detailed allegations of violation of the MDA's regulations." 2020 WL 1624022 at *8; see Def.'s Reply 2, ECF #21.
RECOMMENDATIONS
For the reasons stated above, defendant's motion to dismiss (ECF #17) should be DENIED.
SCHEDULING ORDER
These Findings and Recommendations will be referred to a district judge. Objections, if any, are due Monday, October 19, 2020. If no objections are filed, then the Findings and Recommendations will go under advisement on that date.
If objections are filed, then a response is due within 14 days after being served with a copy of the objections. When the response is due or filed, whichever date is earlier, the Findings and Recommendations will go under advisement.
NOTICE
These Findings and Recommendations are not an order that is immediately appealable to the Ninth Circuit Court of Appeals. Any Notice of Appeal pursuant to Rule 4(a)(1), Federal Rules of Appellate Procedure, should not be filed until entry of a judgment.
DATED October 5, 2020.
/s/ Youlee Yim You
Youlee Yim You
United States Magistrate Judge