Cordova et al v. Smith & Nephew, Inc.
Filing
21
ORDER granting 14 Motion to Dismiss for Failure to State a Claim. For the reasons set forth herein, the Court grants the motion to dismiss in its entirety. Sarah Cordova's design defect, failure to warn, and breach of express warranty claims are dismissed. Moreover, Sarah Cordova's breach of implied warranty and negligence claims are dismissed to the extent they rely on a theory of design defect or failure to warn; however, they are not dismissed to the extent they rely on a theory of manufacturing defect. Glen Cordova's loss of consortium claim may proceed to the extent it is derivative of Sarah Cordova's remaining claims. Finally, plaintiffs shall file a second amended complaint no later than thirty days from the date of this Order if Sarah Cordova wishes to amend her breach of express warranty claim. SO ORDERED. Ordered by Judge Joseph F. Bianco on 7/30/2014. (Gibaldi, Michael)
UNITED STATES DISTRICT COURT
EASTERN DISTRICT OF NEW YORK
_____________________
No 14-CV-351 (JFB)(ARL)
_____________________
SARAH CORDOVA AND GLEN CORDOVA,
Plaintiffs,
VERSUS
SMITH & NEPHEW, INC.,
Defendant.
___________________
MEMORANDUM AND ORDER
July 30, 2014
___________________
JOSEPH F. BIANCO, District Judge:
Pursuant to Federal Rule of Civil
Procedure 12(b)(6), defendant moves to
dismiss all claims except the strict liability,
breach of implied warranty, negligence, and
loss of consortium claims to the extent they
are premised on an alleged manufacturing
defect. For the reasons set forth infra, the
Court grants the motion. In particular, the
Medical Device Amendments (“MDA”), 21
U.S.C. §§ 360c et seq., to the Food, Drug,
and Cosmetic Act (“FDCA”), 21 U.S.C.
§§ 301 et seq., preempt the design defect
and failure to warn claims because the R3
Ceramic System is a Class III medical
device that received premarket approval by
the U.S. Food and Drug Administration
(“FDA”). The Court need not decide
whether the MDA preempts the breach of
express warranty claim because the Court
concludes that the allegations supporting
this claim are too conclusory to survive a
motion made under Rule 12(b)(6). Finally,
the negligence, breach of implied warranty,
and loss of consortium claims are dismissed
This products liability case arises out of
alleged defects in an artificial hip
replacement manufactured and sold by
defendant Smith & Nephew, Inc.
(“defendant” or “Smith & Nephew”).
Plaintiff Sarah Cordova (“Cordova”) claims
that Smith & Nephew’s R3 Ceramic
Acetabular System artificial hip joint (the
“R3 Ceramic System”) caused her great
discomfort and deteriorated prematurely due
to design and manufacturing defects. This
lawsuit followed, in which Cordova and her
husband Glen Cordova (collectively,
“plaintiffs”) allege the following causes of
action under New York state tort law: (1)
strict liability based on design defect,
manufacturing defect, and failure to warn;
(2) negligent failure to warn; (3) breach of
express warranty; (4) breach of implied
warranty; (5) negligence; and (6) loss of
consortium.
1
to the extent they rely on an alleged design
defect or failure to warn, but not insofar as
they are premised upon an alleged
manufacturing defect.
review of one application for premarket
approval takes “an average of 1,200 hours,”
during which the FDA weighs “‘any
probable benefit to health from the use of
the device against any probable risk of
injury or illness from such use,’” and also
considers the device’s proposed labeling.
Riegel, 552 U.S. at 318 (quoting 21 U.S.C.
§ 360c(a)(2)(C)); see also Lohr, 518 U.S. at
477. After its review is complete, the FDA
may either grant premarket approval, deny
premarket approval, or condition premarket
approval “on adherence to performance
standards, restrictions upon sale or
distribution, or compliance with other
requirements.” Riegel, 552 U.S. at 319
(internal citations omitted).
I. BACKGROUND
A. Federal Regulation of Medical Devices
The FDCA “has long required FDA
approval for the introduction of new drugs
into the market.” Riegel v. Medtronic, Inc.,
552 U.S. 312, 315 (2008). In 1976, in light
of the perceived “inability of the commonlaw tort system to manage risks associated
with
dangerous
devices,”
Congress
empowered the FDA to regulate medical
devices by enacting the MDA. See id. at
315–16. As part of the new regulatory
regime, the MDA created three categories of
medical devices—Class I, Class II, and
Class III—according to the risks a device
presents. 21 U.S.C. § 360c(a); see Riegel,
552 U.S. at 316; Medtronic, Inc. v. Lohr,
518 U.S. 470, 476–77 (1996). A device falls
into Class III if it either “(I) is purported or
represented to be for a use in supporting or
sustaining human life or for a use which is
of substantial importance in preventing
impairment of human health, or (II) presents
a potential unreasonable risk of illness or
injury.” 21 U.S.C. § 360c(a)(1)(C)(ii).
Once the FDA grants premarket
approval to a device, the device is subject to
various reporting requirements. Id. (citing
21 U.S.C. § 360i). Additionally, the
manufacturer cannot make any changes “in
design
specifications,
manufacturing
processes, labeling, or any other attribute,
that would affect safety or effectiveness,”
unless the FDA approves the manufacturer’s
application for supplemental approval to do
so. Id. (citing 21 U.S.C. § 360e(d)(6)(A)(i)).
Before a Class III device can be brought
to market, it is subject to a “rigorous regime
of premarket approval,” Riegel, 552 U.S. at
317, in order “to provide reasonable
assurance of its safety and effectiveness,” 21
U.S.C. § 360c(a)(1)(C)(ii). 1 The FDA’s
premarket approval. § 360c(f)(1)(A). The
agency’s review of devices for substantial
equivalence is known as the § 510(k)
process, named after the statutory provision
describing the review. Most new Class III
devices enter the market through § 510(k).
In 2005, for example, the FDA authorized
the marketing of 3,148 devices under
§ 510(k) and granted premarket approval to
just 32 devices. P. Hutt, R. Merrill, & L.
Grossman, Food and Drug Law 992 (3d ed.
2007).
A device may also enter the market through “the
§ 510(k) process.” Riegel, 552 U.S. at 317. As the
Supreme Court has explained,
1
A new device need not undergo premarket
approval if the FDA finds it is “substantially
equivalent” to another device exempt from
Id.
2
B. Allegations in the Amended Complaint
sized titanium rings into the liners of the R3
Ceramic Systems. (Id.)
The following facts are taken from the
amended complaint and the exhibits
attached thereto, and are not findings of fact
by the Court. Instead, the Court will assume
these facts to be true and, for purposes of the
pending motion to dismiss, will construe
them in the light most favorable to plaintiffs,
the non-moving parties.
Four months later, on April 22, 2011,
Smith & Nephew conducted an FDA Class
II Recall of the R3 Ceramic Systems. (Am.
Compl. ¶ 35.) The recall provided the
following
information:
“Manufacturer
Reason
for
Recall:
During
the
manufacturing process for several batches of
R3 Ceramic Liners, the titanium rings were
pressed onto the ceramic component with a
higher force than allowed by manufacturing
specifications. This has the potential to
result in lower than expected strength for the
liners.” (Id.)
1. The R3 Ceramic System
The FDA classified the R3 Ceramic
System as a Class III medical device. (Am.
Compl. ¶ 19.) Accordingly, Smith &
Nephew had to apply for premarket approval
of the R3 Ceramic System before bringing it
to market, and the FDA granted conditional
premarket approval for the R3 Ceramic
System on December 17, 2004. (Id. ¶ 20; see
Am. Compl. Ex. A, Premarket Approval
Letter, Dec. 17, 2004.) After receiving
premarket approval to sell the R3 Ceramic
System, Smith & Nephew submitted several
applications for supplemental approval of
proposed changes, which the FDA granted.
(Am. Compl. ¶ 23.) On February 18, 2008,
the FDA granted supplemental approval No.
S008. (Id. ¶ 24.)
On June 20, 2013, the FDA sent a
“Close Out” Letter to Smith & Nephew,
which indicated that Smith & Nephew had
“addressed the violations contained in the
Warning Letter.” (Id. ¶ 37; Am. Compl. Ex.
E, Close Out Letter, at 1.)
2. Cordova’s Hip Implant
About six months before the FDA issued
the Warning Letter, Cordova underwent
right hip replacement surgery on June 11,
2010, during which defendant’s R3 Ceramic
System was used. (Am. Compl. ¶¶ 6–7, 25.)
Following hip surgery, plaintiff experienced
“continuous periods of grinding sensations,
squeaking sounds and limited ranges in
motion” in her hip. (Id. ¶ 41.) As a result,
she became unable to carry out “her normal
and ordinary household and vocational
duties.” (Id.) By July 18, 2013, plaintiff was
experiencing “great discomforts” from her
artificial hip, and on that date, she
underwent another surgery to replace the R3
Ceramic System with a different artificial
hip device. (Id. ¶¶ 31–32.) When the R3
Ceramic System was removed, inspection of
it revealed cracks and strength failures to its
ceramic liner and proximate component
structures, indicating that it had deteriorated
On December 21, 2010, the FDA issued
Warning Letter No. 147052 (the “Warning
Letter”) to Smith & Nephew. (Id. ¶ 26.) The
Warning Letter advised Smith & Nephew
that the R3 Ceramic Systems manufactured
at Smith & Nephew’s plant in Tuttlingen,
Germany were adulterated because they
were not being produced in conformity with
the Current Good Manufacturing Practice
(“CGMP”) requirements set forth in 21
C.F.R. Part 820. (See Am. Compl. Ex. C,
Warning Letter, at 1.) Specifically, the FDA
found that there was “no process validation
study to support the minimum and
maximum settings” used to press different
3
prematurely. (Id. ¶ 33.) The deficiencies in
plaintiff’s artificial hip were the same
deficiencies identified by the FDA in the
Warning Letter. (Id. ¶ 34.)
Fund v. Smith Barney Fund Mgmt. LLC, 595
F.3d 86, 91 (2d Cir. 2010) (quoting Bell Atl.
Corp. v. Twombly, 550 U.S. 544, 555
(2007)). This standard does not require
“heightened fact pleading of specifics, but
only enough facts to state a claim to relief
that is plausible on its face.” Twombly, 550
U.S. at 570.
C. Procedural History
Plaintiffs commenced this action in the
Supreme Court of the State of New York,
County of Suffolk, on December 4, 2013.
Defendant timely removed the case to this
Court on January 16, 2014.
The Supreme Court clarified the
appropriate pleading standard in Ashcroft v.
Iqbal, setting forth two principles for a
district court to follow in deciding a motion
to dismiss. 556 U.S. 662 (2009). The Court
instructed district courts first to “identify[ ]
pleadings that, because they are no more
than conclusions, are not entitled to the
assumption of truth.” Id. at 679. “While
legal conclusions can provide the framework
of a complaint, they must be supported by
factual allegations.” Id. Second, if a
complaint contains “well-pleaded factual
allegations, a court should assume their
veracity and then determine whether they
plausibly give rise to an entitlement to
relief.” Id.
By letter dated February 21, 2014,
defendant
requested
a
pre-motion
conference in anticipation of moving to
dismiss the complaint. The Court held a premotion conference on March 13, 2014,
during which the parties agreed that
plaintiffs would submit an amended
complaint.
Plaintiffs filed the amended complaint
on April 8, 2014. Defendant filed the present
motion to dismiss on May 23, 2014.
Plaintiffs filed their opposition to the motion
on June 24, 2014, and defendant filed its
reply on July 8, 2014. The Court heard oral
argument on July 29, 2014. The Court has
fully considered the submissions of the
parties.
The Court notes that, in adjudicating a
motion to dismiss under Rule 12(b)(6), it is
entitled to consider: (1) facts alleged in the
complaint and documents attached to it or
incorporated in it by reference, (2)
documents integral to the complaint and
relied upon in it, even if not attached or
incorporated by reference, (3) documents or
information contained in defendant’s motion
papers if plaintiff has knowledge or
possession of the material and relied on it in
framing the complaint, (4) public disclosure
documents required by law to be, and that
have been, filed with the Securities and
Exchange Commission, and (5) facts of
which judicial notice may properly be taken
under Rule 201 of the Federal Rules of
Evidence. E.g. Jones v. Nickens, 961 F.
Supp. 2d 475, 483 (E.D.N.Y. 2013); David
II. STANDARD OF REVIEW
In reviewing a motion to dismiss
pursuant to Rule 12(b)(6), the Court must
accept the factual allegations set forth in the
complaint as true and draw all reasonable
inferences in favor of the plaintiff. See, e.g.,
Cleveland v. Caplaw Enters., 448 F.3d 518,
521 (2d Cir. 2006); Nechis v. Oxford Health
Plans, Inc., 421 F.3d 96, 100 (2d Cir. 2005).
“In order to survive a motion to dismiss
under Rule 12(b)(6), a complaint must
allege a plausible set of facts sufficient ‘to
raise a right to relief above the speculative
level.’” Operating Local 649 Annuity Trust
4
§ 360k(a); Riegel, 552 U.S. at 323. “If a
state common law, for instance, requires that
a medical device manufacturer design a
certain device in a manner that is safer than
a model that the FDA has already
approved,” a design defect claim under that
state law would be preempted because the
state law “could ‘disrupt the federal
scheme.’” Bertini v. Smith & Nephew, Inc., -- F. Supp. 2d ----, No. 13-CV-79 (BMC),
2014 WL 1028950, at *3 (E.D.N.Y. Mar.
17, 2014) (quoting Riegel, 552 U.S. at 325).
To avoid preemption, therefore, a plaintiff
must establish that the state’s duties merely
“parallel” the federal requirements. Riegel,
552 U.S. at 330 (noting that the MDA “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”); see also
Bertini, 2014 WL 1028950, at *3 (holding
that, to avoid dismissal of a state law claim
related to the safety or effectiveness of a
device that has received FDA premarket
approval, “a plaintiff must establish that the
state and federal requirements are
equivalent”).
Lerner Assocs., Inc. v. Phila. Indem. Ins.
Co., 934 F. Supp. 2d 533, 539 (E.D.N.Y.
2013), aff’d, 542 F. App’x 89 (2d Cir.
2013); SC Note Acquisitions, LLC v. Wells
Fargo Bank, N.A., 934 F. Supp. 2d 516, 524
(E.D.N.Y. 2013), aff’d, 548 F. App’x 741
(2d Cir. 2014).
III. DISCUSSION
A. Legal Standard
Defendant’s motion turns primarily on
the following preemption provision in the
MDA:
[N]o State or political subdivision of
a State may establish or continue in
effect with respect to a device
intended for human use any
requirement—
(1) which is different from, or in
addition to, any requirement
applicable under this chapter to the
device, and
(2) which relates to the safety or
effectiveness of the device or to any
other matter included in a
requirement applicable to the device
under this chapter.
“To complicate the preemption doctrine
further, however, a plaintiff’s claim cannot
be based solely on [a violation of federal
law].” Franzese v. St. Jude Med., Inc., No.
13-CV-3203 (JS)(WDW), 2014 WL
2863087, at *3 (E.D.N.Y. June 23, 2014)
(emphasis added). This is because the
Supreme Court has held that there is no
private cause of action for noncompliance
with the medical device provisions of the
FDCA. See Buckman Co. v. Plaintiffs’ Legal
Comm., 531 U.S. 341, 349 n.4 (2001); see
also Gale v. Smith & Nephew, Inc., --- F.
Supp. 2d ----, No. 12-CV-3614 (VB), 2013
WL 563403, at *3 (S.D.N.Y. Feb. 13, 2013)
(noting that “a plaintiff would not have a
private right of action under federal law to
bring claim alleging the device did not
21 U.S.C. § 360k(a). In Riegel, the Supreme
Court held that FDA premarket approval
constitutes a federal “requirement” that
activates this preemption provision. 522
U.S. at 322. Moreover, a state’s common
law may constitute a “requirement” for
purposes of this statute. Id. at 323–24.
Accordingly, where a medical device has
received premarket approval, a plaintiff’s
state common law claim is preempted if it
relates to “the safety or effectiveness of the
device” and is “different from, or in addition
to,” the federal requirements. See 21 U.S.C.
5
comply with the MDA”); Gelber v. Stryker
Corp., 788 F. Supp. 2d 145, 153 (S.D.N.Y.
2011) (“Noncompliance with a MDA
provision does not in and of itself provide a
cause of action for a private litigant.”).
are three distinct claims for strict products
liability: (1) a manufacturing defect, which
results when a mistake in manufacturing
renders a product that is ordinarily safe
dangerous so that it causes harm; (2) a
warning defect, which occurs when the
inadequacy or failure to warn of a
reasonably foreseeable risk accompanying a
product causes harm; and (3) a design
defect, which results when the product as
designed is unreasonably dangerous for its
intended use.” (internal citations omitted)).
Riegel and Buckman taken together thus
“‘create a narrow gap through which a
plaintiff’s state-law claim must fit if it is to
escape express or implied preemption.’”
Gale, 2013 WL 563403, at *3 (quoting In re
Medtronic, Inc., Sprint Fidelis Leads Prods.
Liab. Litig., 623 F.3d 1200, 1204 (8th Cir.
2010)). On the one hand, the plaintiff’s
claim must be based on conduct that violates
federal law (i.e., a parallel claim), or else it
is preempted, but “‘the plaintiff must not be
suing because the conduct’ violates federal
law, because he has no private right to bring
such a claim.” Id. (quoting Medtronic, Inc.,
Sprint Fidelis Leads Prods. Liab. Litig., 623
F.3d at 1204). In other words, to state a
plausible products liability claim that avoids
federal preemption, a plaintiff must “set
forth facts pointing to specific premarket
approval requirements that have been
violated, and link those violations to his
injuries.” Id. (emphasis added); see also
Franzese, 2014 WL 2863087, at *3; Burkett
v. Smith & Nephew Gmbh, No. 12-CV-4895
(LDW) (ARL), 2014 WL 1315315, at *4
(E.D.N.Y. Mar. 31, 2014); Bertini, 2014 WL
1028950, at *3; Simon v. Smith & Nephew,
Inc., --- F. Supp. 2d ----, No. 13-CV-1909
(PAE), 2013 WL 6244525, at *4 (S.D.N.Y.
Dec. 3, 2013).
At the outset, the Court notes that
defendant does not move to dismiss the
manufacturing defect claim. (See Def.’s
Mem. at 5 n.3; Def.’s Reply at 2.)
Accordingly, the Court does not address that
component of the first cause of action, and
the manufacturing defect claim remains.
a. Design Defect
To state a claim for defective design, 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 ex rel.
Molina v. BIC USA, Inc., 199 F. Supp. 2d
53, 83 (S.D.N.Y. 2001) (citing Voss v. Black
& Decker Mfg. Co., 59 N.Y.2d 102, 108
(1983)); see also Emslie v. Borg-Warner
Auto., Inc., 655 F.3d 123, 125 (2d Cir.
2011).
Here, Cordova only vaguely alleges that
Smith & Nephew’s product design was
“unreasonably dangerous” and “contrary to
safer reasonable alternatives.” (Am. Compl.
¶ 47.) Cordova does not claim that the
design of the R3 Ceramic System deviated
in any way from the design approved by the
FDA; the Warning Letter and recalls cited in
the amended complaint relate only to a
manufacturing defect, not a design defect.
B. Application
1. Strict Liability
Cordova’s first cause of action alleges
strict products liability based on theories of
manufacturing defect, design defect, and the
failure to warn. (See Am. Compl. ¶¶ 45–52);
cf. McCarthy v. Olin Corp., 119 F.3d 148,
155–56 (2d Cir. 1997) (“In New York, there
6
Because Cordova does not claim that the
design of the R3 Ceramic System differed
from the design approved by the FDA,
Cordova’s design defect claim boils down to
a direct attack on the very design approved
by the FDA. Accordingly, based on the
allegations in this case, the imposition of
liability on defendant for a design defect
would constitute a state law requirement “in
addition to” federal requirements, which the
MDA expressly forbids. See 21 U.S.C.
§ 360k; see also Franzese, 2014 WL
2863087, at *6 (“Plaintiffs point to an FDA
warning letter relating primarily to
manufacturing issues, and have not alleged
that Defendants strayed from the design
approved by the FDA. Accordingly, this
claim is preempted.”); Burkett, 2014 WL
1315315, at *4 (holding design defect claim
preempted where medical device at issue
had received premarket approval, and
plaintiffs did not claim any change from
approved design); Bertini, 2014 WL
1028950, at *6 (same); Simon, 2013 WL
6244525, at *7 (“[D]esign defect claims
regarding a PMA-approved device are
squarely preempted by the MDA.”). The
Court thus grants defendant’s motion to
dismiss the design defect claim.
With respect to this claim, Cordova
alleges that Smith & Nephew failed to warn
the public that the R3 Ceramic System was
defective (Am. Compl. ¶¶ 18, 49), and that
“the instructions and warnings provided
were inaccurate and/or inadequate” (id.
¶ 55). Cordova does not claim that Smith &
Nephew modified or failed to include the
labels and warnings that the FDA approved
as part of the premarket approval process.
Nor does Cordova allege that Smith &
Nephew’s alleged failure to warn violated
any other federal requirement.
Based on the allegations in the amended
complaint, Cordova’s failure to warn claim
is preempted. In particular, it is significant
that Cordova does not base her claim upon
the violation of any federal requirement.
Absent the violation of a federal
requirement, a failure to warn claim must be
dismissed as preempted by the MDA. See,
e.g., Medtronic, Inc., Sprint Fidelis Leads
Prods. Liab. Litig., 623 F.3d at 1205 (“The
FDA’s PMA approval includes specific
language for Class III device labels and
warnings. Plaintiffs did not allege that
Medtronic modified or failed to include
FDA-approved warnings. Rather, they
alleged that, by reason of state law,
Medtronic was required to give additional
warnings, precisely the type of state
requirement that is ‘different from or in
addition to’ the federal requirement and
therefore preempted.”); Bertini, 2014 WL
1028950, at *8 (“Because plaintiffs fail to
identify a federal requirement that defendant
warn the public and health care
professionals directly that its devices were
defective, plaintiffs’ ‘failure to warn’ theory
b. Failure to Warn
“Under New York law, a plaintiff may
recover in strict products liability ‘when a
manufacturer fails to provide adequate
warnings regarding the use of its product.’”
In re Methyl Tertiary Butyl Ether (MTBE)
Prods. Liab. Litig., 725 F.3d 65, 123 (2d
Cir. 2013) (quoting Rastelli v. Goodyear
Tire & Rubber Co., 79 N.Y.2d 289, 297
(1992)).2
negligence and strict liability claims as equivalent.’”
Anderson v. Hedstrom Corp., 76 F. Supp. 2d 422,
439 (S.D.N.Y. 1999) (quoting Martin v. Hacker, 83
N.Y.2d 1, 8 n.1 (1993)). Accordingly, the Court
considers plaintiff’s failure to warn claims together.
2
The amended complaint appears to assert both strict
liability and negligence claims based upon the
alleged failure to warn. “‘Where liability is
predicated on a failure to warn, New York views
7
of strict liability does not ‘parallel’ federal
requirements.”);
Burkett,
2014
WL
1315315, at *6 (holding that plaintiff failed
to plead parallel failure to warn claim where
she did not “sufficiently reference federal
requirements or regulations related to
adequate warnings”); Horowitz v. Stryker
Corp., 613 F. Supp. 2d 271, 286–87
(E.D.N.Y. 2009) (holding that MDA
preempted a failure to warn claim where
plaintiff failed to allege that defendant’s
warnings violated federal requirements); cf.
Stengel v. Medtronic Inc., 704 F.3d 1224,
1232 (9th Cir. 2013) (holding that MDA did
not preempt claim that defendant failed to
warn the FDA in violation of FDA reporting
requirements); Hughes v. Boston Scientific
Corp., 631 F.3d 762, 769–71 (5th Cir. 2011)
(holding that MDA did not preempt failure
to warn claim “to the extent that this claim
[was] predicated on Boston Scientific’s
failure to report ‘serious injuries’ and
‘malfunctions’ of the device as required by
the applicable FDA regulations” (emphasis
added)). Accordingly, the Court grants the
motion to dismiss the failure to warn claim.
Courts are split as to whether an express
warranty claim is subject to MDA
preemption at all. “The Third and Seventh
Circuits have held that such claims are not
preempted because any ‘requirements’
imposed by the warranty are voluntarily
assumed by the warrantor, not imposed by
the state.” Parker v. Stryker Corp., 584 F.
Supp. 2d 1298, 1302 (D. Colo. 2008) (citing
Mitchell v. Collagen Corp., 126 F.3d 902,
915 (7th Cir. 1997); Michael v. Shiley, Inc.,
46 F.3d 1316, 1327–28 (3rd Cir. 1995)).
This position finds support in Cipollone v.
Liggett Group, Inc., in which the Supreme
Court held that for purposes of the Federal
Cigarette Labeling and Advertising Act’s
preemption provision,3 “the ‘requirement[s]’
imposed by an express warranty claim are
not ‘imposed under State law,’ but rather
imposed by the warrantor.” 505 U.S. 504,
525 (1992). Other decisions have found this
reasoning to be persuasive. See, e.g.,
Medtronic, Inc., Sprint Fidelis Leads Prods.
Liab. Litig., 623 F.3d at 1207 (“Though
Cipollone construed a different, narrower
express preemption provision, the opinion
suggests that breach of express warranty
claims are not expressly preempted by §
360k.”); see also Gelber v. Stryker Corp.,
788 F. Supp. 2d 145, 165 (S.D.N.Y. 2011).
However, other courts have held that an
express warranty claim is preempted if it is
based upon representations approved by the
FDA. See, e.g., Parker, 585 F. Supp. 2d at
1303 (“Plaintiff’s express warranty claim
would contradict the FDA’s determination
that the representations made on the label
were adequate and appropriate and, thus,
impose requirements different from or in
2. Breach of Express Warranty
“To state a claim for breach of express
warranty under New York law, a plaintiff
must allege (1) the existence of a material
statement amounting to a warranty, (2) the
buyer’s reliance on this warranty as a basis
for the contract with the immediate seller,
(3) breach of the warranty, and (4) injury to
the buyer caused by the breach.”
Goldemberg v. Johnson & Johnson
Consumer Cos., Inc., --- F. Supp. 2d ----,
No. 13-CV-3073 (NSR), 2014 WL 1285137,
at *12 (S.D.N.Y. Mar. 27, 2014) (citing
Avola v. La.-Pac. Corp., --- F. Supp. 2d ----,
No. 11-CV-4053 (PKC), 2013 WL 4647535,
at *6 (E.D.N.Y. Aug. 28, 2013)); see CBS
Inc. v. Ziff-Davis Publ’g Co., 75 N.Y.2d
496, 502–504 (1990).
That statute states, in relevant part, that “[n]o
requirement or prohibition based on smoking and
health shall be imposed under State law with respect
to the advertising or promotion of any cigarettes the
packages of which are labeled in conformity with the
provisions of this chapter.” 15 U.S.C. § 1334(b).
3
8
In this Court’s view, a breach of
warranty claim is not preempted to the
extent it relies on a manufacturing defect.
For instance, if a plaintiff alleges (1) a
defendant’s express warranty of safety and
compliance with certain manufacturing
standards, (2) reliance on this warranty, (3)
breach of the warranty due to a
manufacturing defect in violation of federal
requirements, and (4) resulting injury, the
MDA would not preempt this claim. See,
e.g., McConologue v. Smith & Nephew, Inc.,
--- F. Supp. 2d ----, Civil Action No. 3:13–
CV–00880 (VLB), 2014 WL 1246834, at
*16 (D. Conn. Mar. 24, 2014) (holding that
breach of express warranty claim was not
preempted where plaintiff had alleged that
device was defective in violation of federal
law); Hofts v. Howmedica Osteonics Corp.,
597 F. Supp. 2d 830, 839 (S.D. Ind. 2009)
(“Howmedica has confused Hofts’ express
warranty claim with a defective labeling
claim, which would be preempted under
Riegel. Hofts does not allege that the
Trident’s
FDA-approved
label
was
defective. Hofts is perfectly happy with the
label. He contends only that the device
implanted in his hip should fit the
description on that label. He claims that the
Trident did not live up to the FDA-approved
promises contained in its label and that he
was harmed as a result.”). By contrast, a
breach of express warranty claim premised
upon a defect in a design or label approved
by the FDA would be preempted because
such a claim would require a factfinder to
reach a determination completely at odds
with that of the FDA. See, e.g., Medtronic,
Inc., Sprint Fidelis Leads Prods. Liab.
Litig., 623 F.3d at 1208; Gomez, 442 F.3d at
932.
addition to the federal requirements.
Therefore, that claim is preempted by
section 360k.”); Burkett, 2014 WL 1315315,
at *8 (“To the extent that Burkett’s [breach
of express warranty] claim is based on FDAapproved representations, it is preempted.”);
Horowitz, 613 F. Supp. 2d at 285
(“Plaintiff’s breach of express warranty
claim is preempted to the extent that it is
premised on FDA approved representations
made by the manufacturer.”). The reasoning
behind these decisions seems to be that an
express warranty claim would require a
factfinder to decide whether representations
about a medical device were true,
notwithstanding the FDA’s initial approval
of those representations. See, e.g.,
Medtronic, Inc., Sprint Fidelis Leads Prods.
Liab. Litig., 623 F.3d at 1208 (“To succeed
on the express warranty claim asserted in
this case, Plaintiffs must persuade a jury that
Sprint Fidelis Leads were not safe and
effective, a finding that would be contrary to
the FDA’s approval of the PMA
Supplement. . . . The district court correctly
concluded that this express warranty claim
interferes with the FDA’s regulation of
Class III medical devices and is therefore
conflict preempted.”); Gomez v. St. Jude
Med. Daig Div. Inc., 442 F.3d 919, 932 (5th
Cir. 2006) (“A jury hearing Gomez’s statelaw breach of express warranty claim would
have to decide whether Kendall’s
representations about the Angio-Seal were
true. Because those representations—
including the label, warnings, and IFU—
were approved by the FDA through the
PMA process, the duties arising under the
Louisiana breach of warranty statute relate
to, and are potentially inconsistent with, the
federal regulatory scheme. The claim is
preempted.”); see also Leonard v.
Medtronic, Inc., No. 10-CV-03787-JEC,
2011 WL 3652311, at *10 (N.D. Ga. Aug.
19, 2011).
In the instant case, the Court concludes
that the allegations in the amended
complaint do not suffice to state a breach of
warranty parallel claim. Cordova alleges in a
wholly conclusory fashion that Smith &
9
Nephew breached express warranties
“regarding the performance of the [R3
Ceramic System]” (Am. Compl. ¶ 63),
including warranties “that it would be safe
to use” (id. ¶ 64), and that it was “inspected
and accepted in accordance with this
defendant’s own and other recognized safety
standards” (id. ¶ 66). The failure to set forth
with any detail “the terms of the particular
warranty” upon which the plaintiff allegedly
relied is grounds for dismissal under Rule
12(b)(6). Prue v. Fiber Composites, LLC,
No. 11-CV-3304 (ERK) (LB), 2012 WL
1314414, at *10 (E.D.N.Y. Apr. 17, 2012)
(dismissing breach of warranty claim where
plaintiff alleged “at a high order of
abstraction” that defendants had expressly
warranted their products to be free from
defects, reasonably safe, and fit for their
intended use); see, e.g., Bertini v. Smith &
Nephew, Inc., No. 13-CV-0079 (BMC),
2013 WL 6332684, at *5 (E.D.N.Y. July 15,
2013) (dismissing breach of warranty claim
as too conclusory, where plaintiff alleged
only that defendant had warranted its device
to be “safe and effective”); Reed v. Pfizer,
Inc., 839 F. Supp. 2d 571, 579 (E.D.N.Y.
2012) (dismissing breach of warranty claim
where plaintiffs did not allege details of
warranty’s terms, such that they “alleged
nothing which makes plausible that [the]
various risks differ from what was
warranted.”). Moreover, Cordova has failed
to specify whether the breach of the alleged
warranty was a manufacturing defect or a
design defect. The failure to allege how a
breach of an express warranty violated
federal requirements—for instance, by
alleging that the breach was a manufacturing
defect in violation of FDA regulations—is
also grounds for dismissal under the MDA.
See, e.g., Burkett, 2014 WL 1315315, at *8.
In other words, Cordova has not pleaded
sufficient facts to allow this Court to
determine whether the MDA preempts her
breach of express warranty claim.
Nevertheless, because better pleading
could cure the defects identified in this
claim, the Court will give Cordova leave to
replead her breach of express warranty
claim. See, e.g., Oliver Sch., Inc. v. Foley,
930 F.2d 248, 253 (2d Cir. 1991) (“Where
the possibility exists that the defect can be
cured and there is no prejudice to the
defendant, leave to amend at least once
should normally be granted as a matter of
course.”). If Cordova wishes to do so,
plaintiffs’ counsel shall file a second
amended complaint amending Cordova’s
breach of express warranty claim no later
than thirty days from the date of this Order.
3. Breach of Implied Warranty, Negligence,
and Loss of Consortium
Finally, Smith & Nephew moves to
dismiss the breach of implied warranty,
negligence, and loss of consortium claims
only to the extent they rely on any theory of
liability other than a manufacturing defect.
(See Def.’s Mem. at 17–20; Def.’s Reply at
10.) For the reasons discussed supra, the
breach of implied warranty and negligence
claims are preempted to the extent they rely
on a design defect or failure to warn theory.
See, e.g., Bertini, 2014 WL 1028950, at
*10–12. Glen Cordova’s loss of consortium
claim must also be dismissed to the extent it
is derivative of those claims. See, e.g.,
Rodriguez v. Athenium House Corp., 557 F.
App’x 37, 38 n.1 (2d Cir. 2014) (summary
order) (noting that loss of consortium claim
is a derivative claim); Bertini, 2014 WL
1028950, at *12 (dismissing husband’s loss
of consortium claim because wife’s claims
were dismissed). However, the breach of
implied warranty, negligence, and loss of
consortium claims may proceed to the extent
they are premised on an alleged
manufacturing defect. See, e.g., Gelber, 788
F. Supp. 2d at 166–67 (holding that MDA
did not preempt plaintiffs’ implied warranty
10
and negligence claims to the extent they
alleged a manufacturing defect claim).
IV. CONCLUSION
For the reasons set forth herein, the
Court grants the motion to dismiss in its
entirety. Cordova’s design defect, failure to
warn, and breach of express warranty claims
are dismissed. Moreover, Cordova’s breach
of implied warranty and negligence claims
are dismissed to the extent they rely on a
theory of design defect or failure to warn;
however, they are not dismissed to the
extent they rely on a theory of
manufacturing defect. Glen Cordova’s loss
of consortium claim may proceed to the
extent it is derivative of Cordova’s
remaining claims. Finally, plaintiffs shall
file a second amended complaint no later
than thirty days from the date of this Order
if Cordova wishes to amend her breach of
express warranty claim.
SO ORDERED.
_______________________
JOSEPH F. BIANCO
United States District Judge
Dated: July 30, 2014
Central Islip, NY
*
*
*
Plaintiffs are represented by David J.
DeToffol of DeToffol & Associates,
Attorneys at Law, 30 Broad Street, 35th
Floor, New York, NY 10004. Defendant is
represented by Glenn S. Kerner, Nilda Maria
Isidro, and Carla Rose Karp of Goodwin
Procter LLP, The New York Times
Building, 620 Eighth Avenue, New York,
NY 10018.
11
Disclaimer: Justia Dockets & Filings provides public litigation records from the federal appellate and district courts. These filings and docket sheets should not be considered findings of fact or liability, nor do they necessarily reflect the view of Justia.
Why Is My Information Online?