Simon v. Smith & Nephew, Inc.
Filing
35
OPINION & ORDER re: 24 MOTION to Dismiss Plaintiff's Amended Complaint. filed by Smith & Nephew, Inc., 15 MOTION to Dismiss Plaintiff's Verified Complaint. filed by Smith & Nephew, Inc. For the foregoing reasons, Smith & Nephew's motion to dismiss is granted. The Clerk of Court is directed to terminate the motions at docket numbers 15 and 24, and to close this case. (Signed by Judge Paul A. Engelmayer on 12/3/2013) (djc)
UNITED STATES DISTRICT COURT
SOUTHERN DISTRICT OF NEW YORK
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:
SUSAN SIMON,
:
Plaintiff,
:
:
-v:
:
SMITH & NEPHEW, INC.,
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:
:
Defendant.
:
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13 Civ. 1909 (PAE)
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.
Background 1
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
1
The facts that form the basis of this Opinion are drawn from the Amended Complaint, Dkt. 23
(“Am. Compl.”), affidavits submitted with the parties’ briefs, and documents issued by
government agencies, of which judicial notice may be taken. See Leonard F. v. Israel Discount
Bank of N.Y., 199 F.3d 99, 107 (2d Cir. 1999) (“In adjudicating a Rule 12(b)(6) motion, a district
court must confine its consideration ‘to facts stated on the face of the complaint, in documents
appended to the complaint or incorporated in the complaint by reference, and to matters of which
judicial notice may be taken.’”) (quoting Allen v. WestPoint–Pepperell, Inc., 945 F.2d 40, 44 (2d
Cir. 1991)). On a motion to dismiss, the Court accepts all factual allegations in the Amended
Complaint as true.
2
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 (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
3
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 “substantial[] equivalen[ce]” to devices that are
already on the market. See Riegel, 552 U.S. at 317.
C.
History of the Device 2
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.
2
For the purpose of resolving the present motion, the Court takes judicial notice of public
records contained on the FDA website. See Gale v. Smith & Nephew, Inc., No. 12 CV 3614
(VB), 2013 WL 563403, at *1 n.2 (S.D.N.Y. Feb. 13, 2013).
3
FDA 510(k) Summary, number K070756, available at
http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K070756.
4
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 (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 (2009). A complaint is properly
4
The BHR System received PMA approval on May 9, 2006. See FDA Premarket Approval
Summary, PMA number P040033, available at
http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pma&id=17306.
5
Device Approvals and Clearances: Birmingham Hip Resurfacing (BHR) System - P040033,
available at
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandCleara
nces/Recently-ApprovedDevices/ucm078189.htm (last updated September 5, 2013).
6
See FDA Premarket Approval Summary, PMA number P040033, Supplement number S006,
Declaration of Glenn S. Kerner in Support of Motion to Dismiss (“Kerner Decl.”), Ex. A.
7
See FDA Premarket Approval Summary, PMA number P040033, Supplement number S013,
Kerner Decl., Ex. B.
5
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.
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. “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) (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.
Discussion
A.
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).
6
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. 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; and (2) impose standards “different from, or in
addition to” federal requirements. Id. at 323–330. However, the Riegel Court noted, “§ 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) (“Gelber II”).
Courts interpreting Riegel have held that state-law claims “parallel” federal regulations,
and thus are not preempted, only in a narrow set of circumstances: where the defendant allegedly
violated FDA regulations, but the violation is not itself the basis of the claim. See Gale v. Smith
& Nephew, No. 12 CV 3614 (VB), 2013 WL 563403, at *3 (S.D.N.Y. Feb. 13, 2013) (citing
cases and noting that “plaintiff must be suing for conduct that violates federal law, or Section
360k(a) pre-empts the claim, but the plaintiff must not be suing because the conduct violates
federal law, because he has no private right to bring such a claim”) (internal quotation marks,
citation, and alterations omitted) (emphasis in Gale). Put more plainly, “‘section 360k protects a
medical device manufacturer from liability to the extent that it has complied with federal law,’”
i.e. received PMA approval, “‘but it does not extend protection from liability where the [state
tort] claim is based on a violation of federal law,’” i.e., failure to conform to PMA-approved
device specifications, id. (quoting Bausch v. Stryker Corp., 630 F.3d 546, 552 (7th Cir. 2010))
(alteration in Gale).
7
To avoid preemption and satisfy the Twombly and Iqbal pleading standards, plaintiffs
suing with regard to a PMA-approved device cannot simply make the conclusory allegation that
defendant’s conduct violated FDA regulations. See id. at *4; see also Gelber II, 788 F. Supp. 2d
at 155. “Rather, to state a parallel claim plaintiff must ‘set forth facts pointing to specific
[premarket approval] requirements that have been violated,’ and link those violations to his
injuries.” Gale, 2013 WL 563403, at *4 (quoting Wolicki–Gables v. Arrow Int’l, Inc., 634 F.3d
1296, 1301 (11th Cir. 2011)) (alteration in Gale); see also Gelber II, 788 F. Supp. 2d at 155.
B.
Simon’s Claims
The Amended Complaint alleges three theories of liability under New York common law:
strict liability, negligence, and breach of implied warranty. Each is premised on the theory that
Smith & Nephew defectively designed the prosthesis implanted during her hip replacement, and
that the defective design of that device caused her injuries. Simon argues that those claims are
not preempted by the MDA because they do not relate to the safety and effectiveness of a PMAapproved device: The R3 Acetabular system she alleges to have caused her injuries was
approved via the § 510(k) process, not the PMA process, and § 510(k) approval does not have
the same preemptive force as PMA approval. Pl. Br. 11−14.
Smith & Nephew responds by noting that each of the state-law claims in the Amended
Complaint challenges the safety and effectiveness of the optional metal liner; and the R3 metal
liner was indeed PMA-approved, albeit in connection with the separate BHR System. Def. Br.
7−11. Further, Smith & Nephew states, Simon’s physician independently chose to use the R3
metal liner, which was PMA-approved for use with the BHR System, with another system for
which it was not PMA-approved; that choice does not defeat preemption of claims against the
8
manufacturer. Def. Reply Br. 3−4. Smith & Nephew also argues that, for each cause of action,
the Amended Complaint fails to state a claim. Def. Br. 11−18.
Importantly, the parties, although differing as to whether Simon’s state common-law
claims are preempted, do not dispute that those claims relate to the safety and effectiveness of
the Smith & Nephew device implanted during her hip replacement surgery. Nor do they appear
to dispute that Simon’s claims would impose requirements “different from, or in addition to”
federal requirements. The parties’ only dispute with respect to preemption, therefore, is whether
the claims in the Amended Complaint concern a device that received PMA approval, in which
case those claims are preempted. In addition to the preemption analysis, the Court also must
address Smith & Nephew’s argument, as to each claim, that Simon has otherwise failed to allege
facts that state a claim for relief. Because Simon’s characterizations of the device that caused
her harm subtly differ among her claims, the Court addresses each of Simon’s three common-law
claims separately, addressing preemption analysis in the course of addressing each claim.
1.
Strict Products Liability
To state a claim for strict products liability under a design defect theory, a plaintiff must
allege that “(1) the product as designed posed a substantial likelihood of harm; (2) it was feasible
to design the product in a safer manner; and (3) the defective design was a substantial factor in
causing plaintiff’s injury.” Colon v. BIC USA, Inc., 199 F. Supp. 2d 53, 83 (S.D.N.Y. 2001).
In its claim for strict products liability, the Amended Complaint states that “the R3
Acetabular System and relevant components as designed, posed a substantial likelihood of harm,
specifically, its propensity to deteriorate prematurely and release cobalt and chromium into the
human body” as a result of the “metal on metal components . . . grind[ing] against each other.”
Am. Compl. ¶ 62. The Amended Complaint makes clear that the focus of the strict liability
9
design defect claim is its theory of “metal-on-metal” contact, id. ¶ 63, i.e., in which the “optional
metal liner component” of the R3 Acetabular System, id. ¶ 65, grinded against the metallic
femoral head component of the same system. To this end, the Amended Complaint alleges, “[i]t
was feasible for Smith & Nephew to design the R3 Acetabular System and its relevant
components, including the liner component, in a safer manner. Defendant was able to quickly
withdraw the optional metal liner component from the R3 Acetabular System and continue to
offer nonmetal liner options, such as plastic and ceramic, for the R3 Acetabular System.” Id.
The Amended Complaint goes on to allege that “[a]t all times herein mentioned, the
R3Acetabular System, including when utilized with the metal liner, was in a defective condition
and unsafe, and defendant knew, or had reason to know, that said product was defective and
unsafe, especially when used in the form and manner as designed, manufactured, marketed and
distributed by the defendant.” Id. ¶ 66.
The Amended Complaint’s strict liability theory, however, suffers from a fundamental
flaw. In making these allegations, 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 the R3 Acetabular System nowhere mention an optional metal liner
component. And, indeed, the Amended Complaint elsewhere alleges that the optional metal liner
was approved by the FDA for use with another Smith & Nephew system altogether: the BHR
System, a hip resurfacing system. See id. ¶ 26.
Under these circumstances, Simon’s claim for strict products liability based on a design
defect theory must fail. Simon does not allege that Smith & Nephew took any act to design an
R3 Acetabular System to contain an optional metal liner component. Nor does her Amended
Complaint allege even that Smith & Nephew encouraged medical personnel to use the optional
10
metal liner component from the BHR System in conjunction with the R3 Acetabular System. Put
differently, 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. Instead, the
Amended Complaint appears to intimate that the use of the BHR System’s optional metal liner
component in conjunction with the R3 Acetabular System caused Simon injury. Without
concrete allegations tying Smith & Nephew to the decision to make such use of the optional
metal liner component, however, this conduct does not state a claim for strict products liability,
let alone on a design defect theory.
The Amended Complaint does allege that Smith & Nephew voluntarily recalled the
optional metal liner. See id. ¶¶ 44, 65. However, that allegation does not support Simon’s claim
of a design defect with respect to the R3 Acetabular System, which, as noted, did not include
such a liner. 8 In any event, “[t]he bare fact of the voluntary recall does not suffice to prove a
design defect.” Goldin, 2013 WL 1759575, at *4. And Simon does not allege any facts
indicating that the Smith & Nephew R3 Acetabular System as designed was defective or created
an unreasonable risk of harm. Merely pleading the legal conclusion is insufficient. See id.
(allegation that the product posed a “risk of harm because of its propensity to dislocate” fails to
“identify any particular problem in the design of the product,” and thus fails to support design
defect claim).
Independently, the Amended Complaint fails to allege facts that would indicate the
existence of a feasible alternative design that could have prevented Simon’s injuries. 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. See
8
Even if the Amended Complaint had so alleged, a design defect claim made with respect to the
liner itself would be preempted, as discussed in greater length below.
11
Am. Compl. ¶ 62 (“other hip replacement manufacturers . . . manufactured total hip replacement
systems which were not metal-on-metal and that do not deteriorate prematurely and do not
release cobalt and chromium into the human body”); see also id. ¶¶ 63, 65, 73. But, as
explained, the R3 Acetabular System as designed did not create metal-on-metal interactions
involving the optional metal liner. In any event, an allegation that Smith & Nephew could have
manufactured a different product altogether, or that others have done so, does not itself make out
a plausible claim of a design defect. See In re Fosamax Prods. Liab. Litig., 924 F. Supp. 2d 477,
485 (S.D.N.Y. 2013) (a claim for design defect requires a “‘showing that an alternative design
was feasible and safer’”) (quoting Urena v. Biro Manu. Co., 114 F.3d 359, 365 (2d Cir. 1997));
cf. Goldin, 2013 WL 1759575, at *5 (“the question is whether a safer alternative design for this
product existed”) (emphasis in original). 9
Pressed at argument about the fact that the R3 Acetabular System does not contain an
option metal liner, Simon’s counsel changed tack, arguing that the optional metal liner alone,
rather than the interaction of the liner with components of the R3 Acetabular System, was the
source of Simon’s injury. A plaintiff may not, of course, amend her theory of liability by means
of statements during argument. See Chauvet v. Local 1199, Drug, Hosp. & Health Care Empls.
Union, et al., Nos. 96 CV 2934 (SS), 96 CV 4622 (SS), 1996 WL 665610, at *6 (S.D.N.Y. Nov.
18, 1996). But even if the Amended Complaint were fairly read to assert a claim of design
defect based solely on the optional metal liner, any such claim would be preempted. That is
9
Although the point is arguably implicit, the Amended Complaint also does not concretely
claim, as required to state a claim for design defect, that a differently-designed hip replacement
device (one without metal-on-metal interactions) could have been used during Simon’s surgery
and would have prevented her injuries. See Bertini v. Smith & Nephew, Inc., No. 13 CV 0079
(BMC), slip op. (E.D.N.Y. July 15, 2013), Kerner Decl., Ex. D, at 6 (rejecting claim of feasible
alternative design because “[t]here is no way to tell whether other R3 liners would have been
appropriate for implantation in plaintiff”).
12
because the optional metal liner received supplemental PMA approval in conjunction with the
BHR System. As noted, design defect claims regarding a PMA-approved device are squarely
preempted by the MDA. See Riegel, 552 U.S. at 323, 327−30. Such preemption extends to a
component of a PMA-approved device. See Lewkut v. Stryker Corp., 724 F. Supp. 2d 648, 656
(S.D. Tex. 2010) (“To require that a distinction be drawn between the approval process of the
individual components of a system and the system itself, would, it seems, add a level of
complication to the medical device approval process not anticipated by Congress, the FDA, or
medical device manufacturers.”); Riley v. Cordis Corp., 625 F. Supp. 2d 769, 780 (D. Minn.
2009) (separating components of PMA-approved device to apply different preemption analysis
“makes no sense”).
For these reasons, Simon’s strict liability claim, based on a claim of a design defect, must
be dismissed for failure to state a claim upon which relief can be granted.
2.
Negligence
“‘New York courts generally consider strict products liability and negligence claims to be
functionally synonymous.’” Goldin, 2013 WL 1759575, at *6 (quoting Pinello v. Andreas Stihl
Ag & Co. KG, No. 08 CV 452 (LEK) (RFT), 2011 WL 1302223, at *16 (N.D.N.Y. Mar. 31,
2011)); see also Colon, 199 F. Supp. 2d at 83 (“for the purposes of analyzing a design defect
claim, the theories of strict liability and negligence are virtually identical”). “To make out a
prima facie case for negligence in New York, a plaintiff must show (1) that the manufacturer
owed plaintiff a duty to exercise reasonable care; (2) a breach of that duty by failure to use
reasonable care so that a product is rendered defective, i.e. reasonably certain to be dangerous;
(3) that the defect was the proximate cause of the plaintiff’s injury; and (4) loss or damage.”
Colon, 199 F. Supp. at 82.
13
Simon’s negligence claim is flawed for the same reason as her strict products liability
claim: Her Amended Complaint does not allege facts that plausibly indicate that a non-PMA
approved device was defective and caused her injuries. See Gelber II, 788 F. Supp. 2d at 155
(“Under New York law, in order ‘[t]o plead and prove a manufacturing flaw under either
negligence or strict liability, the plaintiff must show that a specific product unit was defective . . .
and that the defect was the cause of plaintiff’s injury.’”) (quoting Colon, 199 F. Supp. 2d at 85)
(first alteration in Gelber II). In claiming negligence, Simon alleges that Smith & Nephew
“failed to exercise ordinary care in the designing, researching, manufacturing, marketing,
supplying, promoting, packaging, sale, testing, quality assurance, quality control, and/or
distribution of the R3 Acetabular System, and its components, specifically the optional metal
liner component and femoral head component.” Am. Compl. ¶ 49 (emphasis added). But, as
noted above, the optional metal liner (which was part of the BHR system) received PMA
approval, and claims of negligent manufacture with respect to PMA-approved devices are
preempted. See Part III.B.1, supra. Thus, to the extent that Simon means to claim negligence on
the ground that the optional metal liner was defective, her negligence claim is preempted.
To the extent the Amended Complaint’s negligence claim takes aim at the overall R3
Acetabular System and not just the optional metal liner, which the Amended Complaint wrongly
treats as part of that system, it fails to state a claim. The Amended Complaint contains a long list
of conclusory allegations as to the ways in which Smith & Nephew was purportedly negligent in
designing the R3 Acetabular system. These include: “designing and manufacturing the R3
Acetabular System without thorough and proper testing”; “not conducting sufficient testing
programs to determine whether the aforesaid R3 Acetabular System was safe for use”;
“negligently failing to adequately and correctly warn . . . of the danger of the R3 Acetabular
14
System”; “negligently failing to recall its dangerous and defective R3 Acetabular System at the
earliest date that it became known to Smith & Nephew that said R3 Acetabular System was, in
fact, dangerous and defective”; “failing to provide adequate instructions regarding safety
precautions to be observed by users, handlers, and persons who would reasonably foreseeably
come into contact with and use the R3 Acetabular System”; “negligently advertising and
recommending the use of the R3 Acetabular System without sufficient knowledge as to its
dangerous propensities”; “negligently representing that the R3 Acetabular System was safe for
use for its intended purpose”; “negligently representing that the R3 Acetabular System had
equivalent safety and efficacy as other, non-defective total hip replacement systems”;
“negligently designing the R3 Acetabular System in a manner which was dangerous to its
recipients.” Am. Compl. ¶ 50. But the Amended Complaint does not contain any concrete
factual allegations to back up these legal conclusions. In short, there are not specific allegations
plausibly indicating that the R3 Acetabular System was defective or that Smith & Nephew
breached a duty of care; the Amended Complaint instead is limited to rote incantations of the
elements of negligent manufacture.
For these reasons, the Amended Complaint fails to state a claim for negligence. See
Bertini, Kerner Decl., Ex. D, at 9 (dismissing similar allegations as “boilerplate” because
“[p]laintiffs fail to support them with any facts”); see also Goldin, 2013 WL 1759575, at *6
(dismissing negligence claim premised on the allegation that Smith & Nephew “knew or should
have known about the risks associated with the R3 Constrained Acetabular Liner” because the
plaintiff did “not offer factual allegations to support this legal conclusion”).
15
3.
Breach of Implied Warranty
Under New York law, “[a] breach of implied warranty claim requires proof of the
following three elements: (1) that the product was defectively designed or manufactured; (2) that
the defect existed when the manufacturer delivered it to the purchaser or user; and (3) that the
defect is the proximate cause of the accident.” Plemmons v. Steelcase Inc., No. 04 CV 4023
(LAP), 2007 WL 950137, at *3 (S.D.N.Y. Mar. 29, 2007) (internal quotation marks and citation
omitted).
For much the same reasons as reviewed above, the Amended Complaint fails to allege
that a non-PMA approved device was defectively designed. It thus fails to state a claim for
breach of implied warranty. See Lewis v. Abbott Labs., No. 08 CV 7480 (SCR) (GAY), 2009
WL 2231701, at *6 (S.D.N.Y. July 24, 2009) (holding that where “plaintiff has not pleaded
necessary elements to support a design . . . defect claim,” “plaintiff has failed to plead an
essential element of her breach of implied warranty claim”). The Amended Complaint alleges
generically that Smith & Nephew “impliedly represented and warranted . . . that the R3
Acetabular System was safe and of merchantable quality,” Am. Compl. ¶ 82, and that these
“representations and warranties were false, misleading, and inaccurate in that the R3 Acetabular
System, including the optional metal liner, was unsafe, unreasonably dangerous, and improper,
not of merchantable quality and otherwise defective,” id. ¶ 83. This barebones allegation,
however, is conclusory. There are no concrete factual allegations to support the claim that the
R3 Acetabular System was defective as designed. To the extent that the Amended Complaint
implies that the inclusion of an optional metal liner in that system rendered it defective, that
claim is defeated by the fact that the R3 Acetabular System, as reviewed and approved by the
FDA, did not contain any such liner. And, to the extent that the Amended Complaint may be
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read to allege that the optional metal liner itself was defective and Smith & Nephew breached an
implied warranty with respect to that liner, that claim is preempted, for the reasons reviewed
above. Simon's breach of implied warranty claim must be dismissed.
In sum, the three claims in the Amended Complaint, all of which are premised on
theories of a design defect, fail to state a claim against Smith & Nephew upon which relief can
be granted. To the extent Simon's theory is that the interplay between an optional metal liner
from the BHR system caused harm to her when used in tandem with the separate R3 Acetabular
System, Simon may wish to explore whether any timely claim for relief can be made against the
person or entities responsible for the decision, in connection with her hip procedure, to use the
metal liner from the BHR system in connection with the R3 Acetabular System.
CONCLUSION
For the foregoing reasons, Smith & Nephew's motion to dismiss is granted. The Clerk of
Court is directed to terminate the motions at docket numbers 15 and 24, and to close this case.
SO ORDERED.
WA~
Paul A. Engelmayer
United States District Judge
Dated: December 3, 2013
New York, New York
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