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Nagel v. Smith & Nephew, Inc.

United States District Court, D. Connecticut

July 28, 2016

SMITH & NEPHEW, INC., Defendant.


          Jeffrey Alker Meyer United States District Judge

         This is a products liability case involving an artificial hip-replacement device that was implanted in plaintiff Randall Nagel and manufactured by defendant Smith & Nephew, Inc. The device included a metal liner that allegedly harmed plaintiff. Because of severe medical complications stemming from the failure of the metal liner, plaintiff had to undergo surgery to have the metal liner removed.

         The legal issue before me is whether plaintiff and his spouse may seek state law tort relief against the defendant device manufacturer. I conclude that federal law largely preempts plaintiffs state law claims and that to the extent his claims are not preempted by federal law, plaintiff has failed to plausibly allege sufficient facts that would give rise to grounds for relief. Accordingly, I will grant defendant's motion to dismiss.


         The following facts are taken from those alleged in the complaint. In 2010, plaintiff Randall Nagel underwent surgery to have an artificial hip implanted in his body. The hip device and its components were manufactured by defendant Smith & Nephew, Inc. Plaintiffs hip socket and ball joint were replaced by a titanium alloy ball-and-socket prosthetic known as the REFLECTION 3 Acetabular System ("R3 System"). Part of the system required the use of a liner component. With plaintiffs consent, plaintiffs surgeon chose to use a metal liner (the "R3 metal liner") rather than a polymer plastic liner that was part of the original R3 system.

         Plaintiff developed severe medical complications from the hip replacement device, including the growth of a pseudotumor and significant pain. Blood testing indicated abnormal amount of metal content in his blood, consistent with failure of the metal liner. In early 2015, plaintiff underwent surgery to have the metal liner removed.

         Medical devices like those implanted in plaintiff are subject to federal regulatory requirements as overseen by the Food and Drug Administration (FDA). A company that seeks regulatory approval for a medical device may ordinarily seek approval in one of two ways. First, the company may pursue a rigorous premarket approval (PMA) process that entails scrupulous evaluation of the device's safety and effectiveness. Alternatively (and far more commonly), if the device in question is substantially similar to another PMA-approved product that is already in use, then the company may instead pursue a more streamlined approval process known as § 510(k) clearance that involves premarket notification to the FDA. See Medtronic v. Lohr, 518 U.S. 470, 477-79 (1996); Phillip G. Palmer, Jr., Medical Device Immunity: Should Promotion of Off-Label Uses Leave Medical Device Manufacturers Vulnerable to UnlimitedLiability?', 35 J. Legal Med. 553, 558-60 (2014).

         The R3 system that plaintiff received was approved by the FDA in 2006 using the streamlined § 510(k) clearance process. But it was approved with the use of a plastic polymer liner, not the metal liner that was eventually implanted in plaintiff. The R3 metal liner was originally approved by the FDA in 2008 as part of a different hip replacement system known as the Birmingham Hip Resurfacing (BFIR) system, which contained all-metal components. In contrast to the streamlined § 510(k) clearance process by which the R3 system (with its use of a polymer liner) was approved, the BHR system (with its use of the R3 metal liner) was subject to the demanding PMA approval process.

         Several months after the approval of the R3 metal liner with the BHR system, defendant issued a press release in 2009 indicating that the R3 metal liner could be used by hip replacement surgeons in conjunction with the R3 system. But beginning in 2008, studies showed that "metal-on-metal" hip replacement systems with metal liners similar to the R3 metal liner had higher revision rates (meaning that the patient had to have the implant removed) than with plastic liners. In 2010, two unrelated metal-on-metal hip replacement systems underwent voluntary recalls by the manufacturers. In May 2011, the FDA instructed manufacturers of metal-on-metal systems to conduct postmarket surveillance. From January 2008 through May 2014, the FDA received 317 adverse event reports regarding the R3 system and the R3 metal liner.[1]In June 2012, defendant voluntarily recalled all R3 metal liners from the market after finding a higher than expected number of revision surgeries on patients with those liners. After 2012, studies across the world continued to show higher revision rates for metal-on-metal systems.

         In 2014, plaintiff began having discomfort in his implanted hip. Examination showed that the implant was failing, that plaintiff had developed a pseudotumor, and that plaintiff had elevated metal levels in his blood. In February 2015, plaintiff had surgery to remove the R3 metal liner and the pseudotumor.

         Plaintiff now brings a number of claims based on the harm caused to him by the R3 metal liner used with his R3 system. According to plaintiff, "[t]he Liner was in an unsafe and unreasonably dangerous condition, was inherently unsafe, and could not be used without subjecting [him] to an unreasonable risk of injury" because the "R3 metal acetabular liner has been linked to the accelerated release of metal debris and ions into the body and/or blood stream from articular abrasion with the femoral head, excessive liner wear, liner breakage, corrosion, or a combination of these elements, " which he himself experienced. Doc. #17 at 6.

         Through the PMA process, plaintiff claims, the FDA approved the R3 metal liner "for use only with Smith & Nephew's [BHR] System" and "did not receive FDA approval to be used with the R3 System or with any other total hip replacement system." Doc. #17 at 5. Any commercial marketing or sale of the R3 metal liner that did not conform to the conditions described by the FDA in its PMA approval was a violation of the Food, Drug, and Cosmetics Act (FDCA), plaintiff contends. At the time plaintiff received his hip replacement, defendant was marketing the R3 metal liner for use with the R3 system.

         Plaintiff alleges that defendant failed to warn him of the R3 metal liner's defects, because it did not test the R3 metal liners, report adverse events, or warn the FDA often or well enough to comply with FDA requirements for devices that have received premarket approval, and it also failed to comply with the FDA's postmarket surveillance obligations. Plaintiff further alleges that defendant was negligent in not testing the R3 metal liners with enough sufficiency and care as required by the FDA, and that defendant misrepresented information to the FDA that resulted in inadequate warnings being approved by the FDA for the R3 metal liner.

         Plaintiff now brings this lawsuit alleging one count with multiple theories of liability.[2] He alleges strict liability for the product's manufacture, design, and inadequate warning; negligence in manufacture, design, and warning; and breach of implied warranty. Plaintiff also complains that defendant negligently misrepresented the safe use of the R3 metal liner with the R3 system in violation of state and federal law. Defendant has moved to dismiss the complaint in its entirety, contending that plaintiffs claims are either preempted by federal law or that plaintiff has failed to allege sufficient facts to establish plausible grounds for relief. Doc. #21.


         The principles governing this Court's consideration of a Rule 12(b)(6) motion are well established. First, the Court must accept as true all factual matter alleged in a complaint and draw all reasonable inferences in the plaintiffs favor. See Johnson v., Inc., 711 F.3d 271, 275 (2d Cir. 2013). But, '"[t]o survive a motion to dismiss, a complaint must contain sufficient factual matter, accepted as true, to state a claim to relief that is plausible on its face.'" TechnoMarine SA v. Giftports, Inc., 758 F.3d 493, 505 (2d Cir. 2014) (quoting Ashcroft v. Iqbal, 556 U.S. 662, 678(2009)).


         It is well established that Congress may preempt state law, whether expressly or impliedly, if state law is in conflict or otherwise inconsistent with federal law in a manner that defeats the federal purpose. See Arizona v. United States,132 S.Ct. 2492, 2500-01 (2012). But a federal statute will not be found to preempt claims arising under state law unless the express or implied ...

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