United States District Court, S.D. New York
[Copyrighted Material Omitted]
[Copyrighted Material Omitted]
For Susan Simon, Plaintiff: Michael Scott Schlesinger, Michelle Lynn Pomerantz, Julien & Schlesinger, P.C., New York, NY.
For Smith & Nephew, Inc., Defendant: Carla Rose Karp, Goodwin Procter LLP, New York, NY; Glenn Stuart Kerner, Nilda M. Isidro, Goodwin Procter, LLP(NYC), New York, NY.
OPINION & ORDER
Paul A. Engelmayer, United States 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.
A. 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. 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. See 21 U.S.C. § § 360c(a)(1)(C), 360e. The process is " rigorous" and takes years to complete. Riegel, 552 U.S. at 318. Even following approval, any incidents involving serious injury caused by the device must be reported to the FDA. See id. at 319-20. 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 (citing 21 U.S.C. § 360e(d)(6)(A)(i)). The FDA may withdraw PMA approval at any time. See id. at 319-20.
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. More often, devices come to market through the § 510(k) process, by which the FDA grants approval based on " ...