United States District Court, D. Arizona
DAVID G. CAMPBELL, District Judge.
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. Id. CLTD is the 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.
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.
II. Legal Framework.
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.
21 U.S.C. § 360k.
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" ...