Simon v. Smith & Nephew, Inc.

Citation990 F.Supp.2d 395
Decision Date03 December 2013
Docket NumberNo. 13 Civ. 1909(PAE).,13 Civ. 1909(PAE).
CourtU.S. District Court — Southern District of New York
PartiesSusan SIMON, Plaintiff v. SMITH & NEPHEW, INC., Defendant.

OPINION TEXT STARTS HERE

Michael Scott Schlesinger, Michelle Lynn Pomerantz, Julien & Schlesinger, P.C., New York, NY, for Plaintiff.

Carla Rose Karp, Glenn Stuart Kerner, Nilda M. Isidro, Goodwin Procter, LLP, New York, NY, for Defendant.

OPINION & ORDER

PAUL A. ENGELMAYER, District Judge:

Plaintiff Susan Simon (Simon) brings this action sounding in negligence, strict products liability, and breach of implied warranty, against medical device manufacturer Smith & Nephew, Inc. (Smith & Nephew). Simon alleges that Smith & Nephew designed, manufactured, and distributed the “R3 Acetabular System” used in her hip replacement surgery, that the device was defective, and that it caused her injury. Smith & Nephew now moves to dismiss pursuant to Federal Rule of Civil Procedure 12(b)(6), arguing that Simon's state-law claims are preempted, and to the extent they are not preempted, fail to state a claim upon which relief can be granted. For the reasons that follow, Smith & Nephew's motion to dismiss is granted.

I. Background1A. Facts of this Case

On February 16, 2010, Plaintiff Susan Simon received a total hip replacement of her left hip. Am. Compl. ¶ 1. The physician performing Simon's surgery utilized the Smith & Nephew R3 Acetabular System, including a 50mm outer diameter acetabular shell with three holes, a 38mm inside diameter optional metal liner (“optional metal liner” or “R3 metal liner”), and a 38mm femoral head. Id. ¶ 32. An x-ray following surgery showed that the prosthesis was properly implanted. Id. ¶ 33.

Following the surgery, as early as March 2011, Simon developed “clicking, locking, and radiating pain down her groin area,” and experienced elevated serum chromium and cobalt levels. Id. ¶¶ 34, 35. By early 2013, Simon's symptoms had worsened; her doctor concluded that her hip pain and the clicking sensation she was experiencing were the result of corrosion and metal wear of the prosthesis, and recommended that she undergo revision surgery. Id. ¶¶ 38–40. On May 29, 2013, Simon underwent revision surgery; the R3 metal liner and femoral head were removed, and were replaced with a Smith & Nephew R3 ultra-high molecular weight polyethylene acetabular liner and oxinium femoral head. Id. ¶ 43.

On February 15, 2013, Simon filed suit against Smith & Nephew in the Supreme Court of the State of New York. On March 21, 2013, Smith & Nephew filed a notice of removal to this Court, and, on April 29, 2013, filed a motion to dismiss the Complaint as inadequately pled. Dkt. 1, 15. On July 9, 2013, Simon filed an Amended Complaint alleging negligence, strict products liability (design defect), and breach of implied warranty, arising out of the implantation, during her 2010 hip replacement surgery, of the Smith & Nephew R3 Acetabular System, including the optional metal liner component and the femoral head component. Dkt. 23. On July 29, 2013, Smith & Nephew filed the present motion to dismiss the Amended Complaint, Dkt. 24, and a supporting memorandum of law, Dkt. 25 (“Def. Br.”). On September 4, 2013, Simon filed a memorandum of law in opposition to the motion to dismiss. Dkt. 30 (“Pl. Br.”). On September 18, 2013, Smith & Nephew filed a reply. Dkt. 31 (“Def. Reply Br.”).

B. Regulatory Framework

The Medical Devices Amendments of 1976 (“MDA”), 21 U.S.C. § 360c et seq., establishes “various levels of oversight for medical devices, depending on the risks they present.” Riegel v. Medtronic, 552 U.S. 312, 316, 128 S.Ct. 999, 169 L.Ed.2d 892 (2008). Devices that are primarily used for “supporting or sustaining human life” or that “present[ ] a potential unreasonable risk of illness or injury” are designated Class III devices. 21 U.S.C. § 360c(a)(1)(C). Class III devices are subjected to the highest level of government oversight, and must receive premarket approval (“PMA”) from the Food & Drug Administration (“FDA”) before being placed on the market. See id. To obtain PMA approval, applicants must submit to the FDA extensive records as to clinical trials, design specifications, manufacturing processes, quality controls, and proposed labeling, and advertising for review. See id. § 360e; see also Riegel, 552 U.S. at 318, 128 S.Ct. 999. The FDA will grant approval to a device only if it determines, on the basis of these submissions, that there is reasonable assurance of the device's safety and effectiveness. See21 U.S.C. §§ 360c(a)(1)(C), 360e. The process is “rigorous” and takes years to complete. Riegel, 552 U.S. at 318, 128 S.Ct. 999. Even following approval, any incidents involving serious injury caused by the device must be reported to the FDA. See id. at 319–20, 128 S.Ct. 999. Manufacturers must also obtain supplemental PMA approval for any change to “design specifications, manufacturing processes, labeling, or any other attribute, that would affect safety or effectiveness.” Id. at 319, 128 S.Ct. 999 (citing 21 U.S.C. § 360e(d)(6)(A)(i)). The FDA may withdraw PMA approval at any time. See id. at 319–20, 128 S.Ct. 999.

Because the process is so rigorous and time-consuming, most devices are not actually submitted for PMA approval. See Gelber v. Stryker, 752 F.Supp.2d 328, 331 (S.D.N.Y.2010) (Gelber I ) (“Very few devices undergo the much more demanding PMA process—for example, in 2005, only 1% of Class III medical devices were subject to the PMA process.”); see also Riegel, 552 U.S. at 317, 128 S.Ct. 999. More often, devices come to market through the § 510(k) process, by which the FDA grants approval based on “substantial[ ] equivalen [ce] to devices that are already on the market. See Riegel, 552 U.S. at 317, 128 S.Ct. 999.C. History of the Device2

On June 6, 2007, Smith & Nephew received § 510(k) approval for the REFLECTION 3 Acetabular System (“R3 Acetabular System”). The R3 Acetabular System as described in the 510(k) summary is a cementless hip replacement prosthesis “consist[ing] of Acetabular shells and liner,” specifically “R3 shells ... manufactured from titanium alloy” and “liners ... manufactured from cross-linked polyethylene.” 3 Cross-linked polyethylene is not a metal, and the 510(k) summary contains no mention of an optional metal liner.

Smith & Nephew later introduced the R3 metal liner that Simon alleges was implanted during her surgery. See Am. Compl. ¶ 26. The R3 metal liner was designed for use with the Birmingham Hip Resurfacing (“BHR”) System, id. ¶¶ 26–29, a separate PMA-approved device 4 described in the FDA approval papers as a “metal on metal resurfacing artificial hip replacement system, surgically implanted to replace a hip joint.” 5 Smith & Nephew submitted the R3 metal liner for FDA review, as required by federal regulations; the FDA granted supplemental PMA approval on November 13, 2008, 6 and again on December 31, 2009.7

On June 1, 2012, Smith & Nephew released an urgent field safety notice regarding the optional metal liner component and issued a voluntary withdrawal of the device component. Am. Compl. ¶ 44.

II. Applicable Legal Standards

To survive a motion to dismiss under Rule 12(b)(6), a complaint must plead “enough facts to state a claim to relief that is plausible on its face.” Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007). A claim will only have “facial plausibility when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged.” Ashcroft v. Iqbal, 556 U.S. 662, 663, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009). A complaint is properly dismissed, where, as a matter of law, “the allegations in a complaint, however true, could not raise a claim of entitlement to relief.” Twombly, 550 U.S. at 558, 127 S.Ct. 1955.

In considering a motion to dismiss, a district court “must accept as true all well-pleaded factual allegations in the complaint, and ‘draw[ ] all inferences in the plaintiff's favor.’ Allaire Corp. v. Okumus, 433 F.3d 248, 249–50 (2d Cir.2006); see also Famous Horse Inc. v. 5th Ave. Photo Inc., 624 F.3d 106, 108 (2d Cir.2010) (We review the district court's grant of a Rule 12(b)(6) motion to dismiss de novo, accepting all factual claims in the complaint as true, and drawing all reasonable inferences in the plaintiff's favor.”). However, “the tenet that a court must accept as true all of the allegations contained in a complaint is inapplicable to legal conclusions.” Iqbal, 556 U.S. at 678, 129 S.Ct. 1937. “Threadbare recitals of the elements of a cause of action, supported by mere conclusory statements, do not suffice.” Id. [R]ather, the complaint's factual allegations must be enough to raise a right to relief above the speculative level, i.e., enough to make the claim plausible.” Arista Records, LLC v. Doe 3, 604 F.3d 110, 120 (2d Cir.2010) (citing Twombly, 550 U.S. at 555, 570, 127 S.Ct. 1955) (internal quotation marks omitted) (emphasis in Arista Records ); accord Goldin v. Smith & Nephew, Inc., No. 12 CV 9217(JPO), 2013 WL 1759575, at *2 (S.D.N.Y. April 24, 2013).

III. DiscussionA. Federal Preemption of State–Law Claims Under the MDA

The MDA expressly preempts any state requirement “which is different from, or in addition to, any requirement applicable ... to the device [under federal law],” and “which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device [under federal law].” 21 U.S.C. § 360k(a).

In Riegel v. Medtronic, Inc., the Supreme Court held that PMA approval for a particular device constitutes a requirement applicable to the device under federal law within the meaning of the MDA's express preemption clause. See 552 U.S. at 321–23, 128 S.Ct. 999. State common-law tort claims are expressly preempted, the Court explained, to the extent that they (1) relate to the safety and effectiveness of a PMA-approved device;...

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