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Burkett v. Smith & Nephew Gmbh

United States District Court, E.D. New York

March 31, 2014

SMITH & NEPHEW Gmbh, et al., Defendants.


LEONARD D. WEXLER, District Judge.

Plaintiff Theresa Burkett ("Burkett") brings this products liability action against defendant Smith & Nephew, Inc. ("Smith & Nephew")[1] for personal injuries allegedly resulting from a defectively manufactured and designed medical device. Smith & Nephew moves to dismiss pursuant to Rule 12(b)(6) of the Federal Rules of Civil Procedure. Burkett opposes the motion.


A. Statutory Background and Preemption

1. The Medical Device Amendments

In 1976, the Food, Drug, and Cosmetic Act ("FDCA"), 21 U.S.C. § 301 et seq., was amended by the Medical Device Amendments of 1976 ("MDA") to give the Food and Drug Administration ("FDA") the authority to regulate medical devices. See generally 21 U.S.C. § 360c et seq. The MDA's statutory scheme "imposed a regime of detailed federal oversight, " Riegel v. Medtronic, Inc., 128 S.Ct. 999, 1003 (2008), creating three levels of scrutiny to be applied to various medical devices before premarket approval ("PMA") may be granted, see 21 U.S.C. § 360c(a)(1). The highest level of scrutiny is applied to a device that is "purported or represented to be for a use in supporting human life or for a use which is of substantial importance in preventing impairment of human health, or presents a potential unreasonable risk of illness or injury...." Id. § 360c(a)(1)(C)(ii). Such devices, deemed "Class III" medical devices, are subject to the MDA's PMA process, which is designed to "provide reasonable assurance" of the device's safety and efficacy. See id. The PMA process for a Class III medical device is a "rigorous" process that typically requires submission of a multivolume application that includes reports of safety and efficacy studies, an explanation of the device's components, and details regarding its manufacturing, packaging, and installation. See id. generally § 360e; Riegel, 128 S.Ct. at 1004. After the FDA grants PMA to a device, the manufacturer continues to have various reporting and post-approval obligations. For instance, the MDA prohibits the manufacturer from making changes in the design specifications, manufacturing processes or labeling of the medical device that would affect safety or effectiveness of the device, absent the FDA's further review and approval. Riegel, 128 S.Ct. at 1005 (citing § 360e(d)(6)(A)(i)). "If the applicant wishes to make such a change, it must submit, and the FDA must approve, an application for supplemental premarket approval, to be evaluated under largely the same criteria as an initial application." Id. (citing § 360e(d)(6); 21 C.F.R. § 814.39(c)). The reporting requirements include an obligation to inform the FDA of new clinical investigations or scientific studies, incidents of the device causing or contributing to death or serious injury, and malfunctions that would likely cause or contribute to death or serious injury. Id. (citing § 360i; 21 C.F.R. 830.50(a)). The FDA has the power to withdraw approval based on newly reported data or existing information. Id. (citing § 360e(e)(1)).

2. Preemption

The MDA was passed in response to the introduction of sophisticated medical devices, the risks of which were not properly managed by state common-law tort systems. See Riegel, 128 S.Ct. at 1003. The MDA's comprehensive review process ensures the safety and efficacy of medical devices that were previously subject to a patchwork of state tort law. See id. To ensure uniformity in the safety and efficacy standards for such medical devices, the MDA includes an express preemption provision that provides:

[N]o State or political subdivision of a State may establish or continue in effect with respect to [medical devices covered by the MDA] any requirement -
(1) which is different from, or in addition to, any requirement applicable under [the MDA] to the device, and
(2) which relates to the safety or effectiveness of the device or any other matter included in a requirement applicable to the device.

21 U.S.C. § 360k(a).

The Supreme Court in Riegel held that a plaintiff's state-law claims for strict products liability, breach of implied warranty, and negligence in the design, testing, inspection, distribution, labeling, marketing, and sale of an FDA-approved medical device were preempted by the MDA. Riegel, 128 S.Ct. at 107-10. In its analysis, the Court focused on the MDA preemption provision barring the imposition of requirements that "are different from, or in addition to, " requirements imposed by federal law. See id. at 1011. The Court observed that the MDA preemption provision does not bar a state from providing a damages remedy for claims premised on the violation of FDA regulations, because "the state duties in such a case parallel, ' rather than add to, federal requirements." Id. Thus, the Court left open a narrow class of state law claims, so-called "parallel" claims, for injuries alleged to have been caused by federally-regulated medical devices. See In re Medtronic, Inc. Sprint Fidelis Leads Prods. Liab. Litig., 592 F.Supp.2d 1147, 1152 (D. Minn. 2009) (referring to narrow "back door" left open by Riegel ), aff'd, 623 F.3d 1200 (8th Cir. 2010).

To determine whether a claim is preempted by the MDA, a court must first find that federal requirements are imposed on the particular medical device. Riegel, 128 S.Ct. at 1006. If so, the court must then determine whether the plaintiff's claim is based on a state requirement that "relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device." Id. Should that be case, the claim is preempted if the state requirement is "different from, or in addition to, " the federal requirements. Id.

B. The Complaint

For purposes of this decision, the allegations of the complaint can be summarized as follows. On October 1, 2010, Burkett was implanted with an artificial hip containing an "R3 ceramic acetabular hip liner" ("R3 liner") manufactured by Smith & Nephew. Complaint ¶ 19. Three months earlier, the FDA determined that R3 liners manufactured at Smith & Nephew GmbH's plant in Tuttlingen, Germany were adulterated and were not being produced in conformity with Current Good Manufacturing Practices ("CGMPs") outlined in 21 C.F.R. § 820. Id. ¶ 24. The FDA specifically found that there was no process validation study to support the minimum and maximum settings being used to press titanium rings into the R3 liners. Id. ¶ 24. Smith & Nephew maintained that the R3 liners were suitable for use despite this shortcoming, and claimed that the problem had been corrected. Id. ¶ 26. On December 21, 2010, the FDA issued a warning letter that rejected Smith & Nephew's response. Id. ¶ 28. Since then, Smith & Nephew has acknowledged that titanium rings in R3 liners were incorrectly installed due to inadequate quality controls, leading to increased risk of a liner fracture, and at a higher rate than expected. Id. ¶ 25. On March 10, 2011, Smith & Nephew issued a recall of R3 liners (including the liner ...

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