Thibodeau v. Cochlear Limited et al

Filing 42

ORDER granting in part and denying in part 26 Motion to Dismiss for Failure to State a Claim; granting in part and denying in part 27 Motion to Dismiss for Lack of Jurisdiction. Plaintiff shall file an amended complaint on or before 8/15/2014. This order does not dispose of the personal jurisdiction arguments set forth in Cochlear's motion to dismiss 27 . The parties shall complete briefing on that motion under the schedule previously established by the Court. Signed by Judge David G Campbell on 7/25/2014.(DGC, nvo)

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1 WO 2 3 4 5 6 IN THE UNITED STATES DISTRICT COURT 7 FOR THE DISTRICT OF ARIZONA 8 Justin Thibodeau, No. CV-13-02184-PHX-DGC Plaintiff, 9 10 v. 11 ORDER Cochlear Limited, et al., 12 Defendants. 13 14 Defendants Cochlear Limited and Cochlear Americas Corporation have filed 15 motions to dismiss under Rule 12(b)(6). Docs. 26, 27. The motions are fully briefed and 16 no party has requested oral argument. The Court will grant the motions with respect to 17 all claims other than Defendants’ alleged failure to warn the FDA. 18 I. Background. 19 Cochlear Limited (“CLTD”) is an Australian public company. Doc. 26 at 3. 20 Cochlear Americas Corporation (“CAM”) is a Delaware corporation and a subsidiary of 21 CLTD that distributes CLTD products in the United States. 22 manufacturer of the Nucleus CI512 cochlear implant device which “electrically 23 stimulates nerves inside the ear through an implanted electrode, thereby restoring a sense 24 of hearing to those with severe to profound nerve deafness.” Id. at 1-2. The CI512 is a 25 Class III medical device, approved by the Food and Drug Administration (“FDA”) 26 pursuant to its premarket approval process (“PMA”). Id. Id. CLTD is the 27 Plaintiff Justin Thibodeau alleges that he was implanted with a CI512 device at 28 Banner Desert Medical Center in Mesa, Arizona, in July 2011. Id. at 6. Plaintiff claims 1 that his implant “failed due to an electronic failure caused by a loss of hermeticity (i.e. 2 failure of the moisture impervious seal)[.]” Doc. 1, ¶ 81. Plaintiff alleges that the loss of 3 hermeticity was caused by “unintended variations in the brazing process that occurred 4 during Defendants’ manufacture” of the implant. Id. ¶ 82. “Brazing is the process that 5 joined the feed through of Plaintiff’s [implant] to its titanium chassis.” Id. ¶ 83. Plaintiff 6 alleges that “microcracks” in the braze joints of his implant allowed water molecules to 7 enter the implant and “cause the malfunction and eventual failure of the [implant]’s 8 electronic components.” Id. ¶ 86. 9 The CI512 was part of a voluntary recall initiated by CAM in September 2011. Id. 10 ¶ 70. The FDA then issued a “Class 2 Recall” of all unimplanted CI512 devices on 11 October 3, 2011. Id. ¶ 71. Plaintiff alleges that Defendants publicly released two letters 12 from the CEO of CLTD which stated that “unexpected variations in the brazing process 13 during manufacturing” led to a loss of hermeticity. Id. ¶¶ 74, 75. 14 Plaintiff asserts claims for defective manufacturing, defective design, failure to 15 warn, negligence, negligence per se, breach of express warranty, breach of implied 16 warranty of merchantability and fitness for a particular purpose, and negligent 17 misrepresentation. Id. ¶¶ 116-77. 18 II. Legal Framework. 19 Defendants argue that Plaintiff’s claims are preempted by the Medical Devices 20 Amendments (“MDA”) to the Federal Food, Drug, and Cosmetic Act (“FDCA”). 21 Doc. 26 at 7. Relying on Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), Defendants 22 argue that “state law product liability claims such as those alleged by Plaintiff in this case 23 fall squarely within the preemption provision of the [MDA].” Doc. 26 at 2. 24 In recent years, many cases across the country have considered both the express 25 and implied preemption of claims under the MDA. Several courts have thoroughly and 26 ably summarized the legal background. See, e.g., Scovil v. Medtronic, Inc., -- F. Supp. 2d 27 --, 2014 WL 502923, at *4-8 (D. Ariz., Feb. 7, 2014); Hawkins v. Medtronic, Inc., 28 No. 1:13-CV-0049AWISKO, 2014 WL 346622, at *3-5 (E.D. Cal., Jan. 30, 2014); -2- 1 Kashani-Matts v. Medtronic, Inc., No. SACV 13-01161-CJC (RNBx), 2013 WL 2 6147032, at *3 (C.D. Cal., Nov. 22, 2013); Houston v. Medtronic, Inc., 957 F. Supp. 2d 3 1166, 1173-76 (C.D. Cal. 2013); Ramirez v. Medtronic Inc., 961 F. Supp. 2d 977, 985-87 4 (D. Ariz. 2013). Section 360k of the MDA includes this preemption clause: 5 6 7 8 9 10 Except as provided in subsection (b) of this section, no State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement (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. 11 12 21 U.S.C. § 360k. 13 The Supreme Court has considered § 360k and preemption in Medtronic, Inc. v. 14 Lohr, 518 U.S. 470 (1996), Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 15 (2001), and Riegel. In Lohr, the Supreme Court held that state-law claims that “parallel” 16 federal requirements are not preempted by § 360k. 518 U.S. at 495-96. 17 In Buckman, the court held that claims that a device manufacturer had made 18 fraudulent representations to the FDA were “inherently federal in nature” because the 19 relationship between the manufacturer and the FDA “originates from, is governed by, and 20 terminates according to federal law.” 531 U.S. at 347-48. The court held that such 21 “fraud-on-the-FDA” claims were impliedly preempted. Id. at 348. 22 Riegel is the Supreme Court’s most recent consideration of the MDA’s preemption 23 provision. 552 U.S. at 315. The medical device at issue in Riegel was a balloon catheter, 24 which was used during the plaintiff’s heart surgery in a manner inconsistent with its 25 FDA-approved labeling. Id. at 320. In discussing the rigor of the PMA process, the court 26 noted that the FDA “spends an average of 1,200 hours reviewing each application” and 27 “grants premarket approval only if it finds there is a ‘reasonable assurance’ of the 28 device’s ‘safety and effectiveness[.]’” Id. at 318 (citing § 360e(d)). The court noted that -3- 1 the FDA “may thus approve devices that present great risks if they nonetheless offer great 2 benefits in light of available alternatives.” 3 determine whether state law claims are preempted under § 360k: courts must determine 4 (1) whether the federal government established “requirements” applicable to the device 5 in question, and, if so, (2) whether the state common law claims are based on state law 6 requirements “that are different from, or in addition to the federal ones” and “relate to 7 safety and effectiveness.” Id. at 321-22 (citing § 360k(a)). Id. The court used a two-part test to 8 Riegel found that the PMA imposes “requirements” applicable to each specific 9 device and that “common-law causes of action for negligence and strict liability do 10 impose ‘requirements’ and would be preempted by federal requirements specific to a 11 medical device.” Id. at 323-24. Riegel affirmed the earlier holding in Lohr that § 360k 12 “does not prevent a State from providing a damages remedy for claims premised on a 13 violation of FDA regulations; the state duties in such a case ‘parallel,’ rather than add to, 14 federal requirements.” Id. at 330. The Ninth Circuit has considered § 360k twice since 15 Riegel and has confirmed that “the MDA does not preempt a state-law claim for violating 16 a state-law duty that parallels a federal-law duty under the MDA.” Perez v. Nidek Co., 17 711 F.3d 1109, 1117 (9th Cir. 2013) (quoting Stengel v. Medtronic, Inc., 704 F.3d 1224, 18 1228 (9th Cir. 2013) (en banc), cert. denied by Medtronic Inc. v. Stengel, -- S. Ct. --, 19 2014 WL 2807193 (June 23, 2014)). 20 III. Analysis. 21 Plaintiff does not dispute Defendants’ reading of Riegel or the subsequently issued 22 Ninth Circuit authority. Nor does Plaintiff dispute that the first element of the Riegel test 23 is satisfied here: through the PMA process, the federal government has established 24 “requirements” applicable to the CI512 device. Plaintiff instead argues that his claims 25 are based on state law duties that “parallel” federal law duties and therefore are not 26 preempted. 27 The Court finds that Plaintiff has failed to provide sufficient factual detail to plead 28 parallel state claims, and thereby avoid preemption, for all claims other than his -4- 1 allegation that Defendants failed to warn the FDA. The Court will address the various 2 categories of Plaintiff’s claims individually. 3 A. Defective Manufacturing. 4 An introductory section of Plaintiff’s complaint specifically states that he is 5 pleading only parallel state law claims. Doc. 1, ¶¶ 9-15. The complaint attempts to do so 6 by alleging that his state tort claims are premised solely on Defendants’ failure to comply 7 with the PMA and other federal requirements. 8 “Defendants’ manufacture of Plaintiff’s Cochlear Implant deviated in a material way 9 from the PMA, CGMP, Defendants’ approved product specifications, approved 10 manufacturing performance standards and/or other applicable federal law and federal 11 regulations[.]” 12 Defendants purportedly failed to follow. Id. ¶ 114. These allegations – such as “Failed 13 to comply with the MIL-STD-883 Test Method 2009 and/or JEDEC Standard 9 in the 14 manufacture of the Cochlear Implant” – include no factual explanation of the failure. 15 Plaintiff further alleges that Defendants’ conduct “rendered the [CI512] defective, 16 adulterated, and more dangerous than a reasonably prudent consumer would expect[.]” 17 Id., ¶ 119. Doc. 1, ¶ 118. Plaintiff alleges, for example, that The complaint lists 30 PMA or federal standards 18 Although these allegations attempt to follow the form of parallel state claims, they 19 are wholly conclusory. They include virtually no facts. Plaintiff therefore has failed to 20 plead claims that are not preempted. As numerous cases have recognized, “Plaintiffs 21 cannot simply incant the magic words ‘[Defendants] violated FDA regulations’ in order 22 to avoid preemption.” In re Medtronic Inc., 592 F. Supp. 2d 1147, 1158 (D. Minn. 23 2009). “Parallel claims must be specifically stated in the initial pleadings.” Wolicki- 24 Gables v. Arrow Int’l, Inc., 634 F.3d 1296, 1301 (11th Cir. 2011). “To properly allege 25 parallel claims, the complaint must set forth facts” pointing to specific PMA 26 requirements that have been violated. Parker v. Stryker Corp., 584 F. Supp. 2d 1298, 27 1301 (D. Colo. 2008). An allegation that “the manufacturing processes for the device . . . 28 did not satisfy the [PMA] standards” is insufficient to plead a parallel claim if it fails to -5- 1 “provide any factual detail to substantiate that crucial allegation.” Id. at 1302; see also 2 Williamson v. Medtronic, Inc., No. 2:13-CV-02433, 2014 WL 2042004, at *7 (W.D. La., 3 May 15, 2014) (“Mere assertions that a defendant is liable because a given product 4 deviated from federal specifications and regulations without any more specificity are 5 precisely the types of legal conclusions of which Rule 12(b)(6) motions are designed to 6 dispose.”); Kashani-Matts, 2014 WL 819392 at *3 (“Simply adding the ‘magic words’ 7 that the device deviated from FDA-approved labeling and design, without any factual 8 support, is not sufficient to save Plaintiff’s claims from preemption.”); Hawkins, 2014 9 WL 346622 at * 5 (“To properly plead parallel claims that survive preemption, a plaintiff 10 must allege facts (1) showing an alleged violation of FDA regulations or requirements 11 related to [the device], and (2) establishing a causal nexus between the alleged injury and 12 the violation.”) (emphasis added); Houston, 2013 WL 3927839 at *5 (same); Erickson v. 13 Boston Scientific Corp., 846 F. Supp. 2d 1085, 1092 (C.D. Cal. 2011) (same); In re 14 Medtronic, Inc., Sprint Fidelis Leads Prods. Liab. Litig., 623 F.3d 1200, 1206 (8th 15 Cir.2010) (“Absent concrete allegations that the product sold by [defendant] was not the 16 product design approved in the PMA Supplement, these are not parallel claims.”). 17 B. Defective Design. 18 Plaintiff’s design defect allegations suffer from the same shortcoming. 19 complaint alleges that the CI512 he received was “defective in design or formulation” 20 and was “more dangerous than an ordinary consumer would expect because it failed to 21 comply with federal requirements for such medical devices[.]” Doc. 1, ¶ 125. Plaintiff 22 contends that the “unexpected variations in the brazing process violated the PMA’s 23 requirements, federal law and rendered the design of Plaintiff’s Cochlear Implant to be 24 something other than the design approved by the FDA.” Doc. 40 at 13 (emphasis in 25 original). As discussed above, Plaintiff must do more than simply state that Defendants’ 26 design violated federal law. Plaintiff has not pled facts supporting the allegation that the 27 design of his CI512 was different than that approved in the PMA. 28 -6- The 1 C. Failure to Warn. 2 Plaintiff contends that “Defendants violated a state law duty of care by failing to 3 report known risks . . . to the FDA.” Doc. 1, ¶ 130. He alleges that “Defendants failed to 4 adequately warn healthcare professionals and the public, including Plaintiff and his 5 physician, of the true risks of Plaintiff’s Cochlear Implant[.]” Id., ¶ 131. Plaintiff also 6 alleges that Defendants failed to report to the FDA that the CI512 may have “caused or 7 contributed to a serious injury or malfunctioned and that any recurring malfunction would 8 be likely to cause or contribute to death or serious injury” in violation of 21 C.F.R. 9 § 803.50(a) and 21 U.S.C. § 360i(a). Id., ¶¶ 102, 114. 10 Plaintiff’s claim that Defendants failed to warn healthcare professionals and the 11 public is clearly preempted. Such a duty to warn is not imposed by federal law, and the 12 state law claim would therefore impose a duty different from or in addition to those 13 imposed by the FDCA, contrary to the preemption provision in § 360k. See Stengel, 705 14 F.3d at 1234 (Watford, J., concurring, joined by six judges) (“[A]ny attempt to predicate 15 the [claim] on an alleged state law duty to warn doctors directly would have been 16 expressly preempted under [§ 360k][.]”); see also Kashani-Matts, 2013 WL 6147032, at 17 *4 (“[R]equiring warnings to doctors would be in addition to FDA requirements and thus 18 expressly preempted by the MDA.”). 19 Plaintiff’s claim that Defendants failed to warn the FDA is not preempted. In 20 Stengel, the Ninth Circuit specifically held that an Arizona-law claim for failure to warn 21 the FDA is not preempted. 704 F.3d at 1233. Plaintiff provides little factual detail 22 concerning the alleged failure to warn, but little factual detail is necessary or available 23 when a plaintiff is alleging that the defendant failed to act. It is the absence of action that 24 gives rise to the claim. The Court finds Plaintiff’s failure-to-warn-the-FDA claim to be 25 sufficiently pled to defeat preemption.1 26 1 27 28 As Judge Watford noted, however, this claim could have difficulty at the causation stage because Plaintiff must show that had Defendants timely notified the FDA, the FDA would have passed the information along to Plaintiff’s doctor in time to prevent his harm, and Plaintiff’s doctor would have timely heeded the FDA warning. Stengel, 705 F.3d at 1234 (Watford, J., concurring, joined by six judges). -7- 1 D. Negligence and Negligence Per Se. 2 Plaintiff alleges that Defendants “failed to exercise ordinary care in following the 3 PMA, CGMP, federal law, and federal regulations in the design, formulation, testing, 4 quality, assurance, quality control, labeling, manufacture, marketing, promotion, sale 5 and/or distribution of Plaintiff’s Cochlear Implant[.]” Doc. 1, ¶ 137. Plaintiff also makes 6 several allegations that Defendants “had a duty to warn Plaintiff or his physician of the 7 dangers associated with the Cochlear Implant resulting from Defendants’ failure to 8 comply with” federal law and federal regulations. Id., ¶¶ 139-40. Plaintiff argues that he 9 has identified the “specific conduct that violated the duty” (Doc. 40 at 14), but the Court 10 does not agree. As discussed above, Plaintiff’s claim that Defendants failed to warn him 11 or his doctor is expressly preempted, and Plaintiff’s other negligence claims cannot 12 simply put forth a laundry list of PMA or federal law provisions Defendants failed to 13 follow without some factual allegations in support. 14 As to Plaintiff’s negligence per se claim, Plaintiff alleges that Defendants 15 breached their duty of ordinary care by introducing Plaintiff’s CI512 into the stream of 16 commerce when they knew it “had a propensity to fail and cause bodily harm and was not 17 safe for use by consumers . . . because Defendants failed to comply with the PMA 18 CGMP, federal law, or federal regulations.” Doc. 1, ¶ 149. This claim lacks the same 19 factual foundation as the allegations discussed above. 20 allegations regarding how Defendants failed to comply with the PMA and federal law. 21 This claim also appears to be impliedly preempted because it is based directly on a 22 violation of federal law. Perez, 711 F.3d at 1120; see also Ramirez, 961 F. Supp. 2d. at 23 1000 (finding the plaintiff’s negligence per se claim impliedly preempted because it was 24 “premised wholly on violations of the FDCA and the MDA”). Plaintiff provides no factual 25 E. Express and Implied Warranties. 26 Claims for breach of express and implied warranties are widely held to be 27 preempted. See, e.g., Kitchen v. Biomet, Inc., No. 13-18-HRW, 2014 WL 694226, at *6- 28 7 (E.D. Ky., Feb. 21, 2014) (“[T]he representations a manufacturer may make with -8- 1 respect to a PMA device are limited to those approved by the FDA, and express warranty 2 claims are therefore preempted.”); Enlow v. St. Jude Medical, Inc., 210 F. Supp. 2d 853, 3 862 (W.D. Ky. 2001) (noting that implied warranty claims are “based on the accepted 4 standards of design and manufacture of the products,” which are set by the FDA “[i]n the 5 case of a product that has gone through the PMA process,” and concluding that “[a] state 6 judgment for breach of implied warranty that rested on allegations about standards other 7 than those permitted by the FDA would necessarily interfere with the PMA process and, 8 indeed, supplant it”) (internal citation and quotation marks omitted); see also Poll v. 9 Stryker Sustainability Solutions, Inc., No. CIV 13-440-TUC-CKJ, 2014 WL 199150, at 10 *6 (D. Ariz. Jan., 17, 2014) (warranty claims preempted). In addition, Plaintiff’s briefing 11 in support of the warranty claims cites law from outside this circuit that pre-dates Riegel. 12 See Doc. 40 at 15. 13 F. Negligent Misrepresentation. 14 Plaintiff alleges that Defendants “negligently misrepresented to Plaintiff and/or 15 Plaintiff’s physicians that the Cochlear Implant’s manufacture complied with the PMA 16 CGMP, federal law and federal regulations,” and that Plaintiff and his physicians relied 17 on those representations. Doc. 1, ¶ 175. Plaintiff presents essentially no arguments in 18 support of this claim, and Plaintiff’s complaint pleads no facts to support the allegation 19 that Defendants made any representations, let alone misrepresentations, to him or his 20 doctors. 21 IV. Leave to Amend. 22 Plaintiff seeks leave to amend his complaint. Doc. 40 at 17. Rule 15 makes clear 23 that the Court “should freely give leave [to amend] when justice so requires.” Fed. R. 24 Civ. P. 15(a)(2). The Court will therefore grant Plaintiff’s request for leave to amend. 25 IT IS ORDERED: 26 1. 27 28 Defendants’ motions to dismiss based on preemption (Docs. 26, 27) are granted in part and denied in as set forth above. 2. Plaintiff shall file an amended complaint on or before August 15, 2014. -9- 1 3. This order does not dispose of the personal jurisdiction arguments set forth 2 in Cochlear Limited’s motion to dismiss. Doc. 27. The parties shall complete briefing on 3 that motion under the schedule previously established by the Court. 4 Dated this 25th day of July, 2014. 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 - 10 -

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