Simon v. Smith & Nephew, Inc.

• Decision Date: 26 March 2014
• Docket Number: No. 13 Civ.1909PAE.,13 Civ.1909PAE.
• Citation: 18 F.Supp.3d 423
• Parties: Susan SIMON, Plaintiff, v. SMITH & NEPHEW, INC., Defendant.
• Court: U.S. District Court — Southern District of New York

18 F.Supp.3d 423

Susan SIMON, Plaintiff

v.SMITH & NEPHEW, INC., Defendant.

No. 13 Civ.1909PAE.

United States District Court, S.D. New York.

Signed March 26, 2014.

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:

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, 990 F.Supp.2d 395, 2013 WL 6244525, 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.

I. Background

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, 128 S.Ct. 999.

As the Supreme Court held in Riegel, PMA approval for a particular device triggers the MDA's express preemption clause¹ ; 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, 128 S.Ct. 999. 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, 128 S.Ct. 999 ; 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 Def., 395 F.Supp.2d 17, 19 (S.D.N.Y.2005) ; see also Goonan v. Fed. Reserve Bank of N.Y., No. 12 Civ. 3859(JPO), 2013 WL 1386933, at *2 (S.D.N.Y. Apr. 5, 2013) (“Simply put, courts do not tolerate such efforts to obtain a second bite at the apple.”). On a Local Rule 6.3 motion, “a party may not advance new facts, issues, or arguments, not previously presented to the Court.”Polsby v. St. Martin's Press, No. 97 Civ. 690(MBM), 2000 WL 98057, at *1 (S.D.N.Y. Jan. 18, 2000) (citation omitted). Generally, district courts will only amend or alter a judgment “to correct a clear error of law or prevent manifest injustice.” In re Assicurazioni Generali, S.P.A., 592 F.3d 113, 120 (2d Cir.2010).

III. Motion for Reconsideration

In the Amended Complaint, Simon brings strict liability, negligence, and breach of implied warranty claims under New York law against Smith & Nephew based on injuries sustained following hip replacement surgery. In her surgery, Simon was implanted with the Smith & Nephew-designed R3 Acetabular System, which had received § 510(k) approval, and was also implanted with an optional metal liner that was not part of that system, but which had received supplemental PMA approval in connection with a separate PMA-approved device, the Birmingham Hip Resurfacing (“BHR”) System. The Amended Complaint alleges that her hip prosthesis

was defective, and caused her injuries.

Familiarity with the Opinion is assumed. There, the Court concluded that Simon's state-law causes of action are preempted because the metal liner implanted during her surgery had been PMA-approved, and the Amended Complaint “does not allege that Smith & Nephew took any act to design an R3 Acetabular System to contain an optional metal liner component,” nor does it allege “that Smith & Nephew encouraged medical personnel to use the optional metal liner component from the BHR System in conjunction with the R3 Acetabular System.” Id. at 10–11. Thus, the Amended Complaint “does not allege facts that plausibly indicate that a non-PMA approved device was defective and caused [Simon's] injuries.” Id. at 14.

The Court further concluded that, to the extent Simon's claims are not preempted, they fail to state a claim. With respect to the strict products liability claim, the Court noted that the Amended Complaint fails to allege that Smith & Nephew designed or marketed the R3 Acetabular System to include the metal liner designed for the separate BHR System; thus, the “the Amended Complaint does not allege any facts that could plausibly indicate that a Smith & Nephew product, as designed, was defective and caused her injuries.” Id. at 11. Specifically, the Court noted that, in describing the alleged defect—i.e. the “metal on metal” interaction between the metal liner and components of the R3 Acetabular System—the Amended Complaint “describes the R3 Acetabular System in a manner flatly inconsistent with that system as defined and approved by the FDA”; the FDA approval papers for that system nowhere mention the metal liner from the separate BHR system that Simon alleges was implanted during her surgery; and the Amended Complaint lacks concrete allegations tying Smith & Nephew with a later decision (presumably made by on-scene medical personnel) to use the metal liner in conjunction with the R3 Acetabular System. Id. at 10. The allegation of a feasible alternative design was similarly ill-pled, the Court held: “The Amended Complaint states that Smith & Nephew could have designed a hip replacement system that did not create metal-on-metal interactions, and such a design would have been safer.... But, as explained, the R3 Acetabular System as designed did not create metal-on-metal interactions involving the optional metal liner.” Id. at 11–12.

For substantially the same reasons, the Court concluded that Simon's negligence and breach of implied warranty claims fail to state a claim: The Amended Complaint did not allege facts plausibly indicating that the R3 Acetabular System, as designed by Smith & Nephew, was defective and caused her injuries.Id. at 14, 16, 17. The boilerplate allegations in the Amended Complaint were insufficient to tie Smith & Nephew to the decision to include the metal liner from the BHR System in the separate R3 Acetabular System implanted during Simon's surgery.

In seeking reconsideration, Simon simply repeats arguments already considered and rejected by the Court. Specifically, she argues that the Court overlooked allegations in the Amended Complaint that Smith & Nephew in fact designed the R3 Acetabular System to include the metal liner component. See Memorandum of Law in Support of Motion for Reconsideration (Dkt. 43) (“Pl. Br.”) at 4–8. In the words of Judge Rakoff, however, “[t]he Court did not overlook this argument; it rejected it.” Associated Press, 395 F.Supp.2d at 19. As explained in the December 3 Opinion and recited above, the Amended Complaint does not make any specific, concrete allegation as to Smith & Nephew's ostensible role in causing the metal liner from the BHR System to be used in connection with the R3 Acetabular System during Simon's surgical procedure. Thus, Simon fails to plausibly allege that any non-PMA approved Smith & Nephew product, as designed, was defective and caused her injuries. See Opinion at 11. Simon fails to point to any facts the Court overlooked that would warrant reconsideration of this conclusion. See Goonan, 2013 WL 1386933, at *2 (denying motion for reconsideration on the ground that it “appears to be little more than an effort to re-litigate an issue that the Court has already decided”).

Even if reconsideration were warranted, however, Simon's argument is unconvincing on the merits, for several reasons. First, as already noted, the Amended Complaint lacks allegations concretely stating that Smith & Nephew designed or marketed the R3 Acetabular System so as to contemplate or encourage use of the metal liner. To be sure, the Amended Complaint states that Smith & Nephew “introduce[d]”...