United States District Court, S.D. New York
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.
In her Amended Complaint, plaintiff Susan Simon alleges that defendant medical device manufacturer Smith & Nephew, Inc. (" Smith & Nephew" ) designed, manufactured, and distributed the REFLECTION 3 Acetabular System (" R3 Acetabular System" ) and the optional metal liner component used in her hip replacement surgery, that the devices were defective, and that they caused her injury. Dkt. 23 (" Am. Compl." ). On December 3, 2013, this Court issued an Opinion & Order, granting Smith & Nephew's motion to dismiss the
Amended Complaint in its entirety. See Dkt. 35 (" December 3 Opinion" or " Opinion" ). The Court assumes familiarity with the Opinion. Relevant here, the Court dismissed Simon's negligence, strict products liability, and breach of implied warranty claims against Smith & Nephew on the grounds that they are preempted and otherwise fail to state a claim upon which relief can be granted. See Opinion 9-17. On December 19, 2013, Simon moved for reconsideration of that decision. See Dkt. 41. For the reasons that follow, Simon's motion for reconsideration is denied.
For purposes of addressing this motion, the Court briefly reviews the relevant regulatory framework and history, subjects which the December 3 Opinion addresses in greater detail.
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 oversight, and must receive premarket approval (" PMA" ) from the Food & Drug Administration (" FDA" ) before being placed on the market. See id. Most devices are not submitted for PMA approval. Instead, most 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.
As the Supreme Court held in Riegel, PMA approval for a particular device triggers the MDA's express preemption clause; thus, state common-law tort claims are expressly preempted to the extent that they (1) relate to the safety and effectiveness of a PMA-approved device; and (2) impose standards " different from, or in addition to" federal requirements. See Riegel, 552 U.S. at 321-30. However, " § 360k does not prevent a State from providing a damages remedy for claims premised on a violation of FDA regulations; the state duties in such a case 'parallel,' rather than add to, federal requirements." Id. at 330; see Gelber v. Stryker Corp., 788 F.Supp.2d 145, 153 (S.D.N.Y. 2011).
II. Legal Standards
The standard governing motions for reconsideration under S.D.N.Y. Local Civil Rule 6.3 " is strict, and reconsideration will generally be denied unless the moving party can point to controlling decisions or data that the court overlooked--matters, in other words, that might reasonably be expected to alter the conclusion reached by the court." Shrader v. CSX Transp. Inc., 70 F.3d 255, 257 (2d Cir. 1995). Such a motion is " neither an occasion for repeating old arguments previously rejected nor an opportunity for making new arguments that could have previously been made." Associated Press v. U.S. Dep't of ...