Source: https://docs.justia.com/cases/federal/district-courts/arizona/azdce/2:2013cv02184/815890/42
Timestamp: 2017-05-25 03:35:58
Document Index: 67657057

Matched Legal Cases: ['art 26', 'art 27', 'art 26', 'art 27', '§ 360', '§ 360', '§ 360', '§ 360', '§ 360', '§ 360', '§ 360', '§ 803', '§ 360', '§ 360', '§ 360']

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