McConologue v. Smith & Nephew Inc

Filing 32

ORDER granting in part and denying in part the Defendant's 16 Motion to Dismiss, as set forth in the attached Memorandum of Decision. The Plaintiff shall file an amended complaint within twenty-one (21) days of the date of this Order, or by April 15, 2014. Signed by Judge Vanessa L. Bryant on 3/24/14. (Ives, D)

UNITED STATES DISTRICT COURT
DISTRICT OF CONNECTICUT

JOHN MCCONOLOGUE,
Plaintiff,
v.
SMITH & NEPHEW, INC.,
Defendant.

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CIVIL ACTION NO.
3:13-CV-00880 (VLB)

March 24, 2014

MEMORANDUM OF DECISION GRANTING IN PART AND DENYING IN PART
DEFENDANT’S MOTION TO DISMISS [Dkt. 16]

I.

Introduction
The Plaintiff, John McConologue (“McConologue”), brings this action

against Defendant Smith & Nephew, Inc. (“Smith & Nephew”) for injuries allegedly
sustained as a result of the placement in Plaintiff’s hip of the Defendant’s
allegedly defective medical device. The Plaintiff alleges one count sounding in
products liability pursuant to Connecticut General Statute § 52-572m,
encompassing the legal theories of strict liability in tort (itself encompassing
design defect, manufacturing defect, failure to warn), negligence (also
encompassing failure to warn), breach of express and implied warranty, and
misrepresentation. The Defendant has moved to dismiss pursuant to Fed. R. Civ.
P. 12(b)(6) for failure to state a claim upon which relief may be granted. For the
reasons that follow, the Defendant’s Motion to Dismiss is GRANTED in part and
DENIED in part.
II.

Factual Background

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The following facts and allegations are taken from Plaintiff’s complaint.
On or about March 22, 2010 John McConologue underwent a right total hip
arthroplasty surgery, during which Dr. John M. Keggi implanted in
McConologue’s body an R3 Ceramic Ace Liner Biolox Forte, Ref. # 71338954, Lot
# 09FT32751 (the “Liner” or “Ceramic Liner”), manufactured and marketed by
Defendant Smith & Nephew. [Dkt. 1-1, Compl. ¶¶3, 4]. McConologue alleges that
the Liner was expected to and did reach the Plaintiff without substantial change
in condition from which it was manufactured and sold, and was not altered or
modified in any way by McConologue or any third party from the condition in
which it was manufactured, retailed, distributed, packaged and/or sold by Smith &
Nephew. [Id. at ¶ 6].
Dr. Keggi notified McConologue by letter dated March 21, 2011 that Smith &
Nephew was conducting a recall of the Liner that had been implanted in the
Plaintiff. [Id. at ¶ 7]. A stated reason for the recall was that the Defendant failed
to manufacture the Liner according to the U.S. Food and Drug Administration’s
(“FDA”’s) approved manufacturing process. [Id. at ¶ 8]. During the
manufacturing process for several batches of R3 Ceramic Liners, including the
Liner implanted in Mr. McConologue, titanium rings were pressed onto the
ceramic component with a higher force than allowed by manufacturing
specifications approved by the FDA, which had the potential to result in lower
than expected strength for the liners. [Id. at ¶ 9]. Although the Liner implanted in
the Plaintiff was subject to recall because it was manufactured outside of
specifications, Dr. Keggi’s letter indicated that “[t]he Smith & Nephew liners are
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expected to continue to function well and no change is recommended in your
level of activity. No surgery is required to change the liner and Smith & Nephew
has informed [Dr. Keggi] that the liner is expected to have the same durability as
those not affected by the recall.” [Id. at ¶ 10].
About twenty-seven months after his hip surgery (and fifteen months after
Dr. Keggi’s letter), in June 2012, Mr. McConologue began to notice squeaking and
pain in his right hip. [Id. at ¶ 11]. Dr. Keggi saw the Plaintiff approximately one
month later in connection with this squeaking and pain. [Id. at ¶ 12]. A follow-up
CT scan on the Plaintiff’s right hip, which was ordered by Dr. Keggi and
performed on August 17, 2012, indicated in an addendum to the report that the
Ceramic Liner had fractured. [Id. at ¶ 13]. As a result of clinical findings from
physical examinations of the Plaintiff, including findings that substantiated the
pain, discomfort, and squeaking that McConologue reported, and the reported
fracture to the Ceramic Liner reported in the addendum to the CT scan,
McConologue underwent a total right hip arthroplasty revision surgery on
September 11, 2012, performed by Dr. Keggi. [Id. at ¶ 14]. This revision surgery
confirmed that the Liner was fractured. [Id. at ¶ 15].
The Plaintiff alleges that Smith & Nephew’s conduct in manufacturing the
Liner in violation of the FDA approved process makes the Defendant liable in
products liability pursuant to Conn. Gen. Stat. § 52-572m in the following ways:
a. The Liner was in a defective and unreasonably dangerous
condition, was inherently unsafe, was inherently unreliable,
and could not be used without subjecting the plaintiff to an
unreasonable risk of injury;
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b. The defendant failed to properly or adequately warn,
disclose or instruct the plaintiff that the product was defective
prior to implantation;
c. The defendant misrepresented to the plaintiff and third
parties that the Liner was safe for use;
d. The defendant failed to disclose to the plaintiff and third
parties that the Liner was defective and unreasonably
dangerous;
e. The defendant was negligent:
(i) in failing to properly and adequately test the Liner prior
to marketing it;
(ii) in designing, building and packaging the Liner in a
defective manner;
(iii) in that the defendant knew or should have known that
the liners, including the Liner implanted in the plaintiff,
were being manufactured in violation of FDA approved
manufacturing specifications, yet continued their
manufacture and distribution;
(iv) in failing to perform a proper study to evaluate whether
the press settings that were being used to press the
titanium rings onto the Liner were appropriate;
f. The defendant breached an implied warranty of
merchantability in that the Liner was not of merchantable
quality and fit for its intended purpose;
g. The defendant breached its express warranty that the Liner
was safe and effective for its intended use;
h. The defendant failed to employ adequate techniques in
manufacturing, assembling, labeling, testing, inspecting and
marketing the Liner.
[Dkt. 1-1, Compl. ¶ 16].
III.

Standard of Review

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“‘To survive a motion to dismiss, a complaint must contain sufficient
factual matter, accepted as true, to state a claim to relief that is plausible on its
face.’” Sarmiento v. U.S., 678 F.3d 147 (2d Cir. 2012) (quoting Ashcroft v. Iqbal,
556 U.S. 662, 678 (2009)). While Rule 8 does not require detailed factual
allegations, “[a] pleading that offers ‘labels and conclusions’ or ‘formulaic
recitation of the elements of a cause of action will not do.’ Nor does a complaint
suffice if it tenders ‘naked assertion[s]’ devoid of ‘further factual enhancement.’”
Iqbal, 556 U.S. at 678 (citations and internal quotations omitted). “Where a
complaint pleads facts that are ‘merely consistent with’ a defendant's liability, it
‘stops short of the line between possibility and plausibility of ‘entitlement to
relief.’ ” Id. (quoting Bell Atl. Corp. v. Twombly, 550 U.S. 544, 557 (2007)). “A
claim has 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.” Id. (internal citations omitted).
In considering a motion to dismiss for failure to state a claim, the Court
should follow a “two-pronged approach” to evaluate the sufficiency of the
complaint. Hayden v. Paterson, 594 F.3d 150, 161 (2d Cir. 2010). “A court ‘can
choose to begin by identifying pleadings that, because they are no more than
conclusions, are not entitled to the assumption of truth.’” Id. (quoting Iqbal, 556
U.S. at 679). “At the second step, a court should determine whether the ‘wellpleaded factual allegations,’ assumed to be true, ‘plausibly give rise to an
entitlement to relief.’” Id. (quoting Iqbal, 556 U.S. at 679). “The plausibility
standard is not akin to a probability requirement, but it asks for more than a sheer

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possibility that a defendant has acted unlawfully.” Iqbal, 556 U.S. at 678 (internal
quotations omitted).
In general, the Court’s review on a motion to dismiss pursuant to Rule
12(b)(6) “is limited to the facts as asserted within the four corners of the
complaint, the documents attached to the complaint as exhibits, and any
documents incorporated in the complaint by reference.” McCarthy v. Dun &
Bradstreet Corp., 482 F.3d 184, 191 (2d Cir. 2007). The Court may also consider
“matters of which judicial notice may be taken” and “documents either in
plaintiffs' possession or of which plaintiffs had knowledge and relied on in
bringing suit.” Brass v. Am. Film Techs., Inc., 987 F.2d 142, 150 (2d Cir.1993);
Patrowicz v. Transamerica HomeFirst, Inc., 359 F. Supp. 2d 140, 144 (D. Conn.
2005)(MRK). Here, the Plaintiff has attached to his complaint the letter from Dr.
Keggi notifying him of the recall of certain batches of ceramic liners and the letter
from Smith & Nephew to Dr. Keggi.
IV.

Analysis
The Defendant argues that McConologue’s complaint must be dismissed

for failure to state a claim because the Ceramic Liner is a Class III medical device
approved by the Food and Drug Administration pursuant to a stringent premarket
approval process, and thus claims involving this device are preempted by the
Medical Device Amendments to the Food, Drug and Cosmetic Act. The Defendant
also argues that the Plaintiff’s complaint is inadequately pled under Federal Rule
of Civil Procedure 8(a) and the standards set forth in Iqbal and Twombly. The

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Plaintiff counters that the Medical Device Amendments are inapplicable to the
device surgically implanted in his hip and thus cannot preempt his claims, that
his claims are based on a violation of federal law and are thus not preempted, and
that he has sufficiently pled claims for the strict liability claims of manufacturing
defect, failure to warn, and design defect; negligence; misrepresentation; and
breach of both express and implied warranties.
a. Products Liability
Connecticut statutory law provides that a “product liability claim … may be
asserted and shall be in lieu of all other claims against product sellers, including
actions of negligence, strict liability and warranty, for harm caused by a product.”
Conn. Gen. Stat. § 52-572n(a). Product liability claims include those actions
based on the theories of strict liability in tort; negligence; breach of express or
implied warranty; failure to warn; and misrepresentation or nondisclosure. Conn.
Gen. Stat. § 52-572m(b).
“Manufacturers in Connecticut are strictly liable for defective products
under § 402A of the Restatement (Second) of Torts. A product may be defective
due to a flaw in the manufacturing process, a design defect or because of
inadequate warnings or instructions.” Breen v. Synthes-Stratec, Inc., 108 Conn.
App. 105, 110 (2008) (internal quotation marks and citation omitted). Strict tort
liability “relieves the plaintiff from proving that the manufacturer was negligent
and allows the plaintiff to establish instead the defective condition of the product
as the principal basis of liability.” Potter v. Chicago Pneumatic Tool Co., 241

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Conn. 199, 211 (1997). To recover under the doctrine of strict liability in tort, a
“plaintiff must prove that: (1) the defendant was engaged in the business of
selling the product; (2) the product was in a defective condition unreasonably
dangerous to the consumer or user; (3) the defect caused the injury for which
compensation was sought; (4) the defect existed at the time of the sale; and (5)
the product was expected to and did reach the consumer without substantial
change in condition.”  Metro. Prop. & Cas. Ins. Co. v. Deere & Co., 302 Conn. 123,
131 (2011) (citations omitted). For a product to be unreasonably dangerous, it
“must be dangerous to an extent beyond that which would be contemplated by
the ordinary consumer who purchases it, with the ordinary knowledge common
to the community as to its characteristics.” Id. (citation omitted). “Proper
warnings, however, may prevent a product from being unreasonably dangerous.”
Vitanza v. Upjohn Co., 257 Conn. 365, 374 (2001). In a products liability action
“the plaintiff must plead and prove that the product was defective and that the
defect was the proximate cause of the plaintiff's injuries.” Haesche v. Kissner,
229 Conn. 213, 218 (1994).
Conn. Gen. Stat. § 52-572q governs products liability actions based on a
failure to warn theory. The statute provides that a “product seller may be subject
to liability for harm caused to a claimant who proves by a fair preponderance of
the evidence that the product was defective in that adequate warnings or
instructions were not provided.” Conn. Gen. Stat. § 52-572q(a). In determining
what factors or warnings were required and whether they were adequate, a trier of
fact may consider the likelihood that the product would cause the harm suffered,
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the ability of the product seller to anticipate at the time of manufacture that the
expected product user would be aware of the product risk, and the nature of the
potential harm, and the technological feasibility and cost of warnings and
instructions. Conn. Gen. Stat. § 52-572q(b). To prevail, a claim must prove by a
preponderance of the evidence that if adequate warnings or instructions had
been provided, the claimant would not have suffered the harm. Conn. Gen. Stat. §
52-572q(c).
b. MDA Preemption
The Medical Device Amendments of 1976 (the “MDA”) to the Food, Drug
and Cosmetic Act (“FDCA”), 21 U.S.C. § 301 et seq. require certain medical
devices to undergo a lengthy and rigorous premarket approval process before
such devices may be marketed to the public. 21 U.S.C. § 360e; Riegel v.
Medtronic, Inc., 552 U.S. 312, 317 (2008). This premarket approval (“PMA”)
process involves the submission to the Food and Drug Administration (“FDA”) of
voluminous, comprehensive information including, among other things, full
reports of all studies and investigations of a device’s safety and effectiveness, a
full description of the methods used in, and the facilities and controls used for,
the manufacture, processing and, when relevant, the packing and installation of
the device, samples or device components, and a specimen of the proposed
labeling. Riegel, 552 U.S. at 318–19. The FDA spends an average of 1,200 hours
reviewing each application. Id. at 318. Class III devices, which are those used “in
supporting or sustaining human life or for a use which is of substantial
importance in preventing impairment of human health” or those that “present[ ] a
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potential unreasonable risk of illness or injury,” are subject to the highest level of
government oversight. Id. at 316; 21 U.S.C. § 360c(a)(1)(c).
In analyzing whether a device should be granted approval, the FDA must
weigh “any probable benefit to health from the use of the device against any
probable risk of injury or illness from such use.” 21 U.S.C. § 360c(a)(2)(C). The
FDA will grant premarket approval only if it finds that there is “reasonable
assurance” of the device’s “safety and effectiveness.” 21 U.S.C. § 360e(d);
Riegel, 552 U.S. at 319. Once approved, “all PMA-approved devices are subject to
the same federal device-specific regulation: complying with the standards set
forth in their individual approved PMA applications.” Riegel v. Medtronic, Inc.,
451 F.3d 104, 119 (2d Cir. 2006) aff'd, 552 U.S. 312 (2008).
After approval, the MDA imposes a rigorous oversight regime and forbids
the manufacturer from making, absent FDA permission, changes in design
specifications, manufacturing processes, labeling, or any other attribute that
would affect the device’s safety or effectiveness. 21 U.S.C. § 360e(d)(6)(A)(i);
Riegel, 552 U.S. at 319. Approved medical devices are also subject to continuing
recording and reporting requirements, including the obligation to inform the FDA
of new clinical investigations or scientific studies concerning the device of which
the manufacturer knows or reasonably should know, and the obligation to report
incidents in which the device may have caused or contributed to death or serious
injury, or malfunctioned in a manner that would likely cause or contribute to
death or serious injury were it to recur. 21 U.S.C. § 360i; 21 C.F.R. §§ 814.84(b)(2),
803.50(a); Riegel, 552 U.S. at 319. The FDA must withdraw premarket approval of
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a medical device if, inter alia, it learns that the device is unsafe or ineffective
under the conditions or use prescribed, recommended, or suggested in the
device’s labeling; if new information demonstrates that there is a lack of
reasonable assurance that the device is safe or effective, that the manufacture,
processing, packaging, or installation of such device do not conform with FDA
requirements, that the device’s labeling is false or misleading; or if the applicant
fails to establish a system for maintaining records or repeatedly or deliberately
fails to maintain records or make reports. 21 U.S.C. § 360e(e)(1).
The Defendant has warranted and the Plaintiff does not deny that Smith &
Nephew’s Reflection Ceramic Acetabular System, encompassing the R3 Ceramic
Liner, underwent and was approved as a Class III device pursuant to the FDA’s
premarket approval process in 2008.
Plaintiffs attempting to assert claims regarding devices approved by the
FDA face two initial hurdles: potential implied and express preemption of their
claims. The FDCA, of which the Medical Device Amendments are a part, provides
no private right of action for violations of the Act. Section 337 dictates, in
relevant part, that “all such proceedings for the enforcement, or to restrain
violations, of this chapter shall be by and in the name of the United States.” 21
U.S.C. § 337(a). The Supreme Court has posited that, pursuant to § 337, “[t]he
FDCA leaves no doubt that it is the Federal Government rather than private
litigants who are authorized to file suit for noncompliance with the medical device
provisions.” Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 349 n. 4
(2001). See also PDK Labs, Inc. v. Friedlander, 103 F.3d 1105, 1113 (2d Cir. 1997)
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(“no such private right of action exists [under the FDCA]. See 21 U.S.C. § 337(a)
(restricting enforcement to suits by the United States)”); Stokes v. I-Flow Corp.,
6:12-CV-991-ORL-36, 2013 WL 1715427, at *4-5 (M.D. Fla. Apr. 8, 2013) (noting that
“only the Federal Government is authorized to enforce FDA regulations”). Thus,
a private litigant may not base a claim explicitly on an alleged violation of the
FDCA as the Act does not confer a private right of action, and a litigant’s common
law claim may be impliedly preempted “when the state-law claim is in substance
(even if not in form) a claim for violating the FDCA—that is, when the state claim
would not exist if the FDCA did not exist.” Riley v. Cordis Corp., 625 F. Supp. 2d
769, 777 (D. Minn. 2009).
Further, section 360k of the MDA contains an express pre-emption
provision that applies to medical devices that have received the FDA’s premarket
approval and that states:
no 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.
21 U.S.C. § 360k. The case at hand involves this express pre-emption provision.
Notwithstanding that the FDCA does not provide a private right of action
for violations of that Act, and notwithstanding that § 360k provides for express
preemption in certain instances, a private litigant may bring a common law claim
regarding a device regulated by the FDCA in narrow circumstances where it is not
impliedly preempted pursuant to § 337 or expressly preempted under § 360k. The
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Supreme Court has recently attempted to refine the parameters of the MDA’s
express preemption provision in Riegel v. Medtronic, Inc., 552 U.S. 312 (2008). In
Riegel, the Court held that where a plaintiff seeks to assert state law causes of
action stemming from injuries caused by a medical device that has received the
FDA’s premarket approval, claims based on state tort-law duties imposing
different or additional requirements than those imposed by the FDA’s premarket
approval process are preempted pursuant to § 360k. In so holding, the Riegel
Court affirmed the Second Circuit’s conclusion that the plaintiff’s New York
common law claims of negligence, strict liability, and breach of implied warranty
against the manufacturer of a balloon catheter were preempted pursuant to §
360k of the MDA. The Court recognized that the FDA’s premarket approval
process, which is “specific to individual devices,” is “in no sense an exemption
from federal safety review – it is federal safety review” that imposes federal
requirements triggering the preemption clause of § 360k. Riegel, 552 U.S. at 32223. This premarket approval process requires that a device approved through it
“be made with almost no deviations from the specifications in its approval
application, for the reason that the FDA has determined that the approved form
provides a reasonable assurance of safety and effectiveness.” Id. at 322-23.
Thus, state law claims challenging the safety and efficacy of an FDA approved
Class III device which has complied with its premarket approval requirements are
preempted pursuant to § 360k of the MDA as they would be different from or in
addition to federal requirements provided by the premarket approval process.

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The Riegel Court, however, took care to point out the exception to the
MDA’s preemption provision, noting that certain claims may be asserted:
[s]tate requirements are pre-empted under the MDA only to the
extent that they are ‘different from, or in addition to’ the
requirements imposed by federal law. Thus, § 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. Section 360k, then, protects manufacturers of medical devices from
liability to the extent that they have complied with federal law, including the
device’s premarket approval standards. Where a plaintiff claims that an approved
Class III device has violated its own premarket approval standards, state law
claims based on such a violation are not preempted under § 360k so long as they
are parallel claims. Id. at 330. See also Riegel v. Medtronic, Inc., 451 F.3d 104,
106 (2d Cir. 2006), aff’d 552 U.S. 312 (2008) (“tort claims that are based on a
manufacturer’s departure from the standards set forth in the device’s approved
[premarket approval] application … are not preempted”); Gale v. Smith & Nephew,
Inc., 12 CV 3614 VB, 2013 WL 563403, at *3 (S.D.N.Y. Feb. 13, 2013) (as to
preemption pursuant to the MDA, “a plaintiff's state tort claim would be preempted if it alleged the device, as approved by the FDA, was unreasonably
dangerous. But a plaintiff could bring a state tort claim alleging a manufacturer's
device, as produced, was adulterated and therefore did not conform to that
device's specific FDA premarket approval requirements.”); Horowitz v. Stryker
Corp., 613 F. Supp. 2d 271, 280 (E.D.N.Y. 2009) (“What is clear after Riegel is that
claims which impose liability as to a PMA-approved medical device,
notwithstanding that device's adherence to the standards upon which it obtained
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premarket approval from the FDA, are preempted. However, if plaintiff's state
common law claims are premised on the device's failing to comply with FDA
standards, then they are parallel”) (citation and internal quotation marks omitted);
Walker v. Medtronic, Inc., 670 F.3d 569, 577 (4th Cir. 2012) (common law claims not
preempted where state duties parallel, rather than add to, federal requirements,
which occurs when claims are premised on a violation of FDA regulations); Bass
v. Stryker Corp., 669 F.3d 501, 509 (5th Cir. 2012) (“state common law claims are
not preempted, provided that such claims are premised entirely on violation of
the applicable federal requirements”); Bausch v. Stryker Corp., 630 F.3d 546, 558
(7th Cir. 2010) (same; “federal law does not preempt parallel claims under state
law based on a medical device manufacturer’s violation of federal law”); Stengel
v. Medtronic Inc., 704 f.3d 1224, 1228 (9th Cir. 2013) (“the MDA does not preempt a
state-law claim for violating a state-law duty that parallels a federal-law duty
under the MDA”). Thus, where state tort-law duties impose no additional or
different requirements than a device’s premarket approval plan, and where a
plaintiff asserts that a device approved by the premarket approval process has
violated that very process, such state law claims are not automatically preempted
by § 360k.
Circuit courts have held that the pleading standard applicable to a Class III
medical device claim alleging a violation of federal law is the same as the
plausibility standard articulated in Iqbal and Twombly. See Bass v. Stryker Corp.,
669 F.3d 501, 509 (5th Cir. 2012) (“to plead a parallel claim successfully, a
plaintiff’s allegations that the manufacturer violated FDA regulations must meet
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the Twombly plausibility standard.”); Bausch v. Stryker Corp., 630 F.3d 546, 558
(7th Cir. 2010) (“[t]here are no special pleading requirements for product liability
claims in general, or for Class III medical device claims in particular. The federal
standard of notice pleading applies, so long as the plaintiff alleges facts sufficient
to meet the new ‘plausibility’ standard applied in Iqbal and Twombly”). The
Eleventh Circuit has held that parallel claims must be “specifically stated in the
initial pleadings,” whereby a plaintiff must set forth facts pointing to a specific
premarket approval requirement that has been violated. Wolicki-Gables v. Arrow
Intern., Inc., 634 F.3d 1296, 1301 (11th Cir. 2011); see also Gale v. Smith & Nephew,
Inc., 12 CV 3614 VB, 2013 WL 563403, at *4 (S.D.N.Y. Feb. 13, 2013) (same);
Desabio v. Howmedica Osteonics Corp., 817 F. Supp. 2d 197, 204 (W.D.N.Y. 2011)
(same). “Plaintiffs cannot simply incant the magic words [the manufacturer]
violated FDA regulations in order to avoid preemption.” Gelber v. Stryker Corp.,
752 F. Supp. 2d 328, 334 (S.D.N.Y. 2010) (quoting In re Medtronic, 592 F. Supp. 2d
1147, 1158 (D. Minn. 2009)).
In applying the Iqbal and Twombly standard to claims for defective
manufacture of a Class III in violation of federal law, the Seventh Circuit has
cautioned that “district courts must keep in mind that much of the productspecific information about manufacturing needed to investigate such a claim fully
is kept confidential by federal law,” and thus plaintiffs may not be able to allege
with specificity the exact federal requirement that was violated. Bausch v.
Stryker Corp., 630 F.3d 546, 558, 560 (7th Cir. 2010). Moreover, the Fifth Circuit
has held that a finding by the FDA that a device has violated the premarket
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approval standards is not required to successfully plead a parallel claim, nor is
an enforcement action by the FDA against the manufacturer. Bass, 669 F.3d at
509, 511.
Here, premarket approval was a federal requirement imposed on Smith &
Nephew’s Ceramic Liner, and McConologue’s claims relate to the safety and
effectiveness of the Liner. Therefore, Plaintiff’s state law claims will not be
preempted by § 360k of the MDA if they are not different from or in addition to
federal law, Riegel, 552 U.S. at 330, and will stand if they meet the pleading
requirements of Iqbal and Twombly.
i. Wholesale Preemption
The Defendant’s first argument that the Plaintiff’s complaint is wholly and
expressly preempted by the MDA because the ceramic liner at issue received
approval from the FDA and because Plaintiff’s claims challenge the safety and
effectiveness of the device – an argument that ignores the Plaintiff’s allegations
that Smith & Nephew’s Ceramic Liner was not manufactured according to the
FDA’s premarket approval process – is misinformed. The Defendant has
provided no support for its proposition that the MDA expressly preempts the
entirety of the Plaintiff’s complaint simply because the Class III Liner had
received premarket approval, but where the plaintiff’s general claims are based
on a failure to adhere to the FDA’s premarket approval standards. This argument
ignores the conclusions reached in Riegel and its progeny regarding exceptions
to MDA preemption. Thus, insofar as the Defendant argues that the MDA

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preempts the Plaintiff’s complaint in its entirety solely because Smith & Nephew’s
Ceramic Liner was approved by the FDA’s premarket approval process, the
motion to dismiss is DENIED.
ii. “Device Intended for Human Use”
In response to each of the Defendant’s preemption arguments (discussed
in the prior section and in the sections to follow), the Plaintiff counters that
preemption under § 360k is inapplicable to this case because the defective
ceramic liner implanted in Mr. McConologue was not “a device intended for
human use” within the meaning of § 360k(a). In other words, the Plaintiff argues,
Smith & Nephew has failed to present any facts tending to show that the specific
device with the specific alleged defect implanted in the Plaintiff’s hip, which was
not manufactured in accordance with FDA approved processes, was a device
intended for human use such that it could come under the purview of the MDA.
Rather, the specific Liner the Plaintiff received was not FDA-approved pursuant to
the rigorous premarket approval process, as the device did not comport with that
prescribed process. As 21 U.S.C. § 360k only preempts state law claims relating
to devices intended for human use, the Plaintiff asserts that his claims cannot be
preempted as to the specific Liner he received.
The Plaintiff’s theory does not find footing in the case law and this Court
finds no reason to depart from precedent. The Riegel Court explicitly noted that
Ҥ 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

18

‘parallel,’ rather than add to, federal requirements.” Riegel, 552 U.S. at 330. Thus,
pursuant to Riegel, a plaintiff may assert state law claims relating to Class III
devices where those devices fail to comply with their premarket approval
specifications, as state law claims may merely parallel the federal requirements.
Consequently, a plaintiff bringing state law claims regarding a Class III device
must allege a violation of federal law or regulations in order to capitalize on a
state law cause of action. In other words, because the FDA’s device-specific
premarket approval process “is federal safety review,” a plaintiff bears the
burden of alleging deviations from those safety standards in order to avoid
preemption and assert state tort-law causes of action. Id. at 322-23. A claim
which fails to allege a violation of federal regulations which a state law claim
would parallel will fail. The assumption in Riegel, then, is not that the MDA is
inapplicable to any suit involving an allegedly noncompliant medical device as, in
order to avoid preemption, a plaintiff must still plead noncompliance with federal
requirements. Plaintiff’s argument fails.
c. Products Liability: Manufacturing Defect
The Defendant argues that McConologue’s manufacturing defect theory of
products liability must fail because it is preempted by the MDA, as it “relates to
the safety and effectiveness of the R3 ceramic liner.” [Dkt. 16-1, MSJ p. 12].
Smith & Nephew further contends that the complaint “fails to link [plaintiff’s]
alleged injury to any purported manufacturing defect noted in the letter sent by
Smith & Nephew to his physician, or to any purported defect addressed by the
voluntary recall” of the Ceramic Liner, and thus pleads only conclusory
19

allegations insufficient to comport with Iqbal and Twombly. [Id. at p. 13]. The
Court disagrees.
The Plaintiff has sufficiently alleged that the Ceramic Liner implanted in his
body was not manufactured in accordance with federal standards and that the
failure to meet these standards resulted in the defect observed on the device
implanted in his body; thus his manufacturing defect claim survives preemption
under § 360k and meets the pleading standards set forth in Iqbal and Twombly.
McConologue has pleaded that (1) he received a Ceramic Liner manufactured by
Smith & Nephew; (2) after the Liner was implanted, he was notified by his doctor
that the batch from which the Liner hailed was manufactured outside Smith &
Nephew’s specifications, and that products in these batches not yet implanted in
patients were being recalled for their failure to comply with the FDA’s
specifications; (3) specifically, titanium rings were pressed onto the ceramic
component of these Liners with a higher force than allowed by manufacturing
specifications, which had the potential to result in lower than expected strength
for the liners; (4) twenty-seven months after his surgery, McConologue noticed
squeaking and pain in his hip; (5) a CT scan on the Plaintiff’s right hip indicated
that the Ceramic Liner had fractured; (6) the Plaintiff underwent total right hip
arthroplasty revision surgery as a result of the pain, squeaking, and reported
Liner fracture; and (7) the surgery confirmed that the Liner was fractured.
McConologue has specified the defect in the Liner he received and how that
defect differed from the federal standards applicable to the device, including
Smith & Nephew’s apparent admission that the Liner departed from its acceptable
20

manufacturing specifications. At the motion to dismiss stage, McConologue has
pleaded sufficient facts to find that his injury plausibly resulted from a violation
of FDA manufacturing standards, resulting in a fractured Liner, in connection
with his manufacturing defect claims. He has thus successfully pleaded a
parallel manufacturing defect claim that is not preempted by § 360k. See, e.g.,
Riegel v. Medtronic, Inc., 451 F.3d 104, 123 (2d Cir. 2006), aff’d 552 U.S. 312 (2008)
(“Riegel’s negligent manufacturing claim was not preempted, to the extent that it
rested on the allegation that the particular Evergreen Balloon Catheter that was
deployed during Mr. Riegel’s angioplasty had not been manufactured in
accordance with the PMA-approved standards. A jury verdict in the Riegels’
favor on this claim would not have imposed state requirements that differed from,
or added to, the PMA-approved standards for this device, but would instead have
simply sought recovery for [the manufacturer’s] deviation from those
standards.”); Gelber, 788 F. Supp. 2d at 156 (manufacturing defect claim not
preempted where plaintiffs alleged that device was not manufactured in
accordance with the FDA's current good manufacturing practice requirements,
even though plaintiffs did not expressly state which specific provision the
defendants violated, but where plaintiffs pointed to FDA warning letter to
manufacturer, and to manufacturer’s voluntary recall of device); Bass, 669 F.3d at
510 (manufacturing defect claim was plausibly pled and survived preemption
where plaintiff pleaded he received implant of hip replacement shell, the FDA had
warned manufacturer of noncompliance with regulations regarding an excess of
bioburden and residuals on shell, shell was voluntarily recalled after implantation

21

in plaintiff, shell was loose due to lack of bony ingrowth, and lack of bony
ingrowth was known effect of bioburden and manufacturing residuals on device);
Bausch, 630 F.3d at 553 (manufacturing defect claim was not preempted where
plaintiff alleged that hip replacement device was manufactured in violation of FDA
regulations).
Smith & Nephew’s motion to dismiss McConologue’s products liability
claim on a manufacturing defect theory is DENIED.
d. Products Liability: Failure to Warn
Smith & Nephew argues that the Plaintiff’s failure to warn claim is
preempted by the MDA because it relates to the safety and effectiveness of the
ceramic liner, and because it seeks to hold the Defendant liable for failing to
provide warnings above and beyond those specifically approved and required by
the FDA as part of the premarket approval process. Smith & Nephew further
argues that the Plaintiff’s failure to warn claim must be dismissed because he has
not identified any warnings regarding the ceramic liner that were mandated by the
FDA and which Smith & Nephew did not provide to consumers.
The Defendant has cited in support of its argument for dismissal only the
district court’s holding in Horowitz v. Stryker Corp., 613 F. Supp. 2d 271 (E.D.N.Y.
2009), in which the court dismissed the plaintiff’s claim that the defendant failed
to properly warn her about the risk of an audible noise emanating from the
allegedly defective artificial hip implanted in the plaintiff’s body. Id. at 286. The
court concluded that plaintiff’s claim “would clearly impose requirements
22

different from, or in addition to, the federal regulations,” as her claim constituted
an attack on the device’s federally approved label, which contained information
about audible squeaking emanating from the device. Id. Allowing the claim to
proceed, the court concluded, would permit a jury to find that the defendants
were required to provide warnings above and beyond those on the device’s
product label, which was specifically approved by the FDA as part of the PMA
process. Id. at 286-87. The Defendant here does not explain how Horowitz is
applicable to this case, given that the failure to warn claim in Horowitz was
premised on the insufficiency of the label on a device which was manufactured as
mandated by the FDA and bore the FDA approved label. The Court thus finds
Horowitz to be inapposite.
The Plaintiff, on the other hand, contends that courts “uniformly reject the
notion that defendants can dismiss failure to warn cases in the MDA preemption
context where it is alleged that the specific device at issue that was placed into
the stream of commerce was not an FDA approved device.” [Dkt. 19, P’s Opp. at
p. 21]. This argument is not supported by the cases to which the Plaintiff cites.
On the contrary, the weight of authority establishes that only parallel claims and
not independent state law claims are not preempted by the MDA. For instance, in
Stengel v. Medtronic Inc., the Ninth Circuit held that a failure to warn claim which
“rests on a state-law duty that parallels a federal-law duty under the MDA” was
not preempted where the plaintiffs alleged (1) that the manufacturer violated a
specific continuing duty to monitor the medical device after it had received
premarket approval, (2) that the manufacturer violated a duty to discover and
23

report to the FDA any complaints about the product’s performance and any
adverse health consequences, and (3) that the manufacturer failed to warn the
FDA. 704 F.3d 1224, 1232-33 (9th Cir. 2013). The Ninth Circuit did not presage a
broad rejection of preemption wherever a plaintiff alleges a manufacturing defect
but fails to allege a violation of federal law that speaks precisely to a duty to
warn, nor did the Court allow the failure to warn claim to survive because, as
McConologue urges, the medical device at issue was not an FDA approved
device.1
Indeed, courts have dismissed as preempted pursuant to § 360k failure to
warn claims that were not based on a violation of FDA requirements to warn
consumers, even where plaintiffs successfully alleged other violations of FDA
regulations. See Bass, 669 F.3d at 515 (claims for negligence as based on
manufacturer’s failure to warn plaintiff that Class III device was adulterated were
preempted by § 360k, as plaintiff did not plead that the manufacturer “failed to
include FDA-approved warnings,” even where manufacturing defect and
negligent manufacturing claims survived “as they are parallel claims that do not
impose different or additional requirements than the FDA regulations because
[plaintiff] pleaded that [the manufacturer] failed to abide by the FDA regulations in
the manufacture of the [device]”); In re Medtronic, Inc., Sprint Fidelis Leads
Products Liab. Litig., 623 F.3d 1200, 1205 (8th Cir. 2010) (“The FDA’s PMA
approval includes specific language for Class III device labels and warnings.

1

The Plaintiff also cites to the Seventh Circuit’s decision in Bausch v. Stryker
Corp., 630 F.3d 546 (7th Cir. 2010). Bausch, however, dealt only with claims
alleging a manufacturing defect, not failure to warn.
24

Plaintiffs did not allege that Medtronic modified or failed to include FDA-approved
warnings”); Gale, 2013 WL 563403, at *5 (dismissing one of two failure to warn
claims where complaint “neither specifie[d] the legal basis for any such duty [to
warn], nor to whom the duty [was] allegedly owed,” and concluding that duty to
warn claim was “pre-empted because the FDA's premarket approval established
the information [the manufacturer] was obligated to disclose”); Purcel v.
Advanced Bionics Corp., 3:07-CV-1777-M, 2010 WL 2679988, at *6 (N.D. Tex. June
30, 2010) (“Plaintiffs' fraud by nondisclosure claim asserts that Bionics owed a
duty to the Plaintiffs to disclose that the devices were adulterated. Plaintiffs cite
no federal requirement obligating Bionics to warn them that the devices were
adulterated. These claims of fraud by nondisclosure and negligence by failure to
warn impose a requirement in addition to those approved by the FDA—the duty to
warn consumers if devices are adulterated—and are therefore preempted by §
360k(a).”).
Courts have also held that a failure to warn claim may be based on a
violation of the FDA’s continuing reporting requirements for manufacturers of
Class III devices. See Stengel, 704 F.3d at 1232-33 (holding that proposed failure
to warn claim was not preempted and was a claim paralleling federal law where
plaintiffs alleged that manufacturer violated continuing duty to monitor the
product after pre-market approval, to discover and report to the FDA any
complaints about the product’s performance and any adverse health
consequences, and to warn the FDA; the claim “rests on a state-law duty that
parallels a federal-law duty under the MDA”); Hughes v. Boston Scientific Corp.,
25

631 F.3d 762, 776 (5th Cir. 2011) (the “failure to warn claim is neither expressly nor
impliedly preempted by the MDA to the extent that this claim is premised on [the
defendant manufacturer]'s violation of FDA regulations with respect to reporting
[adverse outcomes] caused by the [device].”); Gale, 2013 WL 563403 (second of
plaintiff’s failure to warn claims was not preempted because he successfully
alleged that he was injured based on manufacturer’s failure to comply with the
premarket approval's monitoring and reporting requirements; allegation was “a
state-law tort claim based on an alleged violation of a specific premarket approval
requirement, and it link[ed] the federal violation to plaintiff's injuries”); Simmons
v. Boston Scientific Corp., CV 12-7962 PA FFMX, 2013 WL 1207421 (C.D. Cal. Mar.
25, 2013) (“where a state law failure to warn claim is premised on a defendant's
failure to report to the FDA relevant adverse health consequences of its Class III
device of which it became aware after obtaining PMA, such a claim would not be
preempted, because FDA regulations require (rather than allow) recipients of
PMA to file an adverse event report with the FDA”).
McConologue contends that the Defendant did not warn him that the
allegedly mis-manufactured Liner implanted in his hip was defective at the time it
was implanted. However, McConologue has failed to allege the existence of any
FDA requirements applicable to consumer warnings such that the Court may
determine whether a state failure to warn claim is “different from, or in addition
to” FDA requirements and thus pre-empted, or contrastly whether the state duties
“parallel, rather than add to, federal requirements” such that they are organic to
or derivative of the device’s premarket approval and thus not preempted. Riegel,
26

552 U.S. at 330. He has also failed to allege both that Smith & Nephew violated
any duty of continuing reporting pursuant to the FDA’s premarket approval
process, and how the Defendant violated such a requirement. In sum, the
Plaintiff has not identified a federal law or regulation that his state duty to warn
claim would parallel. Absent factual support in the record as to the federal law
allegedly violated in connection with the failure to warn claim, Plaintiff has failed
to sufficiently plead a parallel claim.
Defendant’s motion to dismiss Plaintiff’s failure to warn claim is GRANTED,
without prejudice to the Plaintiff re-pleading this claim.
e. Products Liability: Design Defect
Paragraph 16(e)(ii) of the Plaintiff’s complaint alleges that the Defendant
was negligent in “designing, building and packaging the Liner in a defective
manner.” The Defendant contends that this claim must be dismissed as
preempted pursuant to the MDA because it relates to the safety and effectiveness
of the Ceramic Liner. Defendant further correctly contends that the Plaintiff’s
allegations relate only to the manufacture, not to the FDA-approved design, of its
Ceramic Liner and thus Plaintiff’s design defect claim is inadequately pled.
According to the Defendant, this amounts to the Plaintiff conflating two separate
claims for a manufacturing defect and a design defect. The Plaintiff, on the other
hand, argues that manufacturing a Class III device in a manner that violates the
FDA approved process, as in this case, constitutes the sale of a product that is
dangerous to an extent beyond that which would be contemplated by the ordinary

27

consumer with the ordinary knowledge common to the community as to the
product’s characteristics, and thus his design defect claim is not preempted.
Here, the Plaintiff does not contend that the original design of the Ceramic
Liner – which was FDA-approved pursuant to the premarket approval process –
was defective. Rather, McConologue alleges a products liability claim predicated
on a manufacturing defect, asserting only that the Liner was manufactured
contrary to its federally approved design specifications, thereby making it
unreasonably dangerous. As noted previously, the Plaintiff has effectively pled a
manufacturing defect claim pursuant to Connecticut law. Under Connecticut law,
“ ‘[p]roduct liability claim’ includes all claims or actions brought for personal
injury, death or property damage caused by the manufacture, construction,
design, formula, preparation, assembly, installation, testing, warnings,
instructions, marketing, packaging or labeling of any product.” Conn. Gen.Stat. §
52-572m(b). A product liability claim “shall include, but is not limited to, all
actions based on the following theories: Strict liability in tort; negligence; breach
of warranty, express or implied; breach of or failure to discharge a duty to warn
or instruct, whether negligent or innocent; misrepresentation or nondisclosure,
whether negligent or innocent.” Id. Connecticut merges the common law
products liability theories and recognizes three basic theories of products
liability: (1) manufacturing defects; (2) design defects; and (3) warnings defects.
Moss v. Wyeth Inc., 872 F. Supp. 2d 162, 165-66 (D. Conn. 2012) (SRU). A
manufacturing defect is a flaw in the manufacturing process which causes the
product to deviate from the design standards and intended specifications. Miller
28

v. United Technologies Corp., 233 Conn. 732, 779 (1995). Contrastly, a design
defect claim exists where the product is “unreasonably dangerous.” Potter v.
Chicago Pneumatic Tool Co., 241 Conn. 199, 214-15 (1997). Connecticut derives
its definition of “ ‘unreasonably dangerous’” from comment (i) to § 402A [of the
Restatement], which provides that ‘the article sold must be dangerous to an
extent beyond that which would be contemplated by the ordinary consumer who
purchases it, with the ordinary knowledge common to the community as to its
characteristics.’ ” Id. (citing 2 Restatement (Second), § 402A, comment (i)). See
also Vaccarelli v. Ford Motor Co., CV990153308, 2001 WL 862643 (Conn. Super.
Ct. July 6, 2001) (same). This “consumer expectation” standard, the Court noted,
is well-established in Connecticut strict liability law. Potter, 241 Conn. at 215.
McConologue has alleged that Smith & Nephew’s Ceramic Liner differed
from the federally approved premarket manufacturing design specifications
under which the Liner was deemed to be safe and effective for consumer use. A
design defect claim exists where a product is defectively designed, allowing
recovery where the product is “unreasonably dangerous.” Potter, 241 Conn. at
215. A products liability claim based on a design defect is a general intent tort
claim for injury resulting from the intentional manufacture of a device in
conformity with flawed design specifications. McConologue has not alleged that
the design of the Liner was defective; instead he alleges that Smith & Nephew
failed to manufacture the Liner in accordance with its FDA approved design
specifications. Thus, the facts alleged in the complaint do not support a
defective design claim.
29

The motion to dismiss the products liability claim premised on a design
defect is GRANTED without prejudice to re-pleading.
f. Products Liability: Negligence
The Defendant alleges that the Plaintiff’s product liability claim sounding in
negligence – including that Smith & Nephew (1) failed to properly and adequately
test the Liner prior to marketing it, (2) designed, built, and packed the Liner in a
defective manner, and (3) failed to perform a proper study to evaluate whether the
press settings that were being used to press the titanium rings onto the Liner
were appropriate – is preempted pursuant to the MDA because the allegations
relate solely to the safety and effectiveness of the Ceramic Liner. The Defendant
contends that these allegations are “merely an attack on the PMA process itself,
as PMA and supplemental PMA applicants are required to produce ample safety
information to FDA before FDA approves the device, and manufacturers are still
subject to strict FDA oversight even after their device has received PMA or
supplemental PMA approval.” [Dkt. 16-1, MTD, p. 14]. Smith & Nephew further
contends that these allegations, along with Plaintiff’s allegation that the
Defendant knew or should have known that the liners were being manufactured in
violation of FDA approved manufacturing specifications yet continued their
manufacture and distribution, amount to nothing more than conclusory
assertions devoid of further factual enhancement, and thus are not well-pled.
As explained previously, the Plaintiff has successfully pled a
manufacturing defect claim that is not preempted. For the same reasons, the

30

Plaintiff’s negligence theory based on defective manufacturing of the Ceramic
Liner survives.
However, Plaintiff’s claims that Smith & Nephew (1) failed to properly and
adequately test the Liner prior to marketing it, (2) designed and packed the Liner
in a defective manner, and (3) failed to perform a proper study to evaluate
whether the press settings that were being used to press the titanium rings onto
the liner were appropriate fail the Trombly and Iqbal pleading standard as the
only facts alleged in support of his claims are that the Liner was defectively or
negligently manufactured as described above; the additional claims amount to
nothing more than conclusory allegations and “naked assertion[s] devoid of
further factual enhancement.” Iqbal, 556 U.S. at 678.
The Defendant’s motion to dismiss Plaintiff’s negligence claim on a
negligent or defective manufacturing theory is DENIED. The Defendant’s motion
to dismiss the Plaintiff’s failure to test, negligent design and packaging, and
failure to perform a proper study or test claims is GRANTED without prejudice to
re-pleading.
g. Products Liability: Innocent and Negligent Misrepresentation
McConologue has pled that “the defendant misrepresented to the plaintiff
and third parties that the Liner was defective and unreasonably dangerous.”
[Dkt. 1-1, Compl. ¶ 16(c)]. The Defendant urges the Court to dismiss this
misrepresentation claim as preempted under the MDA because it relates to the
safety and effectiveness of the Liner, and “takes issue with language contained in
31

the FDA-approved product labeling and advertising.” [Dkt. 16-1, MTD p. 14]. The
Defendant also urges that this claim must be dismissed as insufficiently pled
because, if the Plaintiff is alleging fraudulent misrepresentation he has not met
the heightened pleading standards of Rule 9(b), and if he is alleging negligent
misrepresentation, he has not alleged the elements of the claim. The Plaintiff
counters that “[s]ince the defective liner allegedly at issue in this case was never
FDA approved, the representations accompanying that liner were not FDA
approved for that liner. Therefore, any state tort law enforcement activities with
respect to the representations accompanying this defective device are
necessarily parallel to the federal requirements.” [Dkt. 19, Opp. to MTD, p. 18].
Thus, the crux of Plaintiff’s claim is that, because the Liner implanted in Mr.
McConologue contained an alleged manufacturing defect, the FDA-approved
warnings accompanying the Liner but intended for devices manufactured in
accordance with the premarket approval process misrepresented the safety and
efficacy of the specific mis-manufactured Liner. The Plaintiff also counters that
he has alleged sufficient facts to plausibly support claims for negligent and
innocent misrepresentation. As the Plaintiff has conceded that he has not
plausibly alleged a fraudulent misrepresentation claim (see Dkt. 19, P’s
Opposition, p. 24), this Court will consider only his innocent and negligent
misrepresentation claims.
First, the Court declines to credit the Defendant’s preemption argument as
Smith & Nephew has utterly failed to explain how the Plaintiff’s misrepresentation
claim imposes requirements that are different from or in addition to requirements
32

imposed by federal law. Although the Defendant cites to various cases for the
proposition that preemption is necessary because the claim challenges the
Liner’s FDA-approved label, the cases to which Defendant cites are inapposite as
they are not premised on violations of federal law to which parallel state claims
could attach. Here, in contrast, the Plaintiff has successfully pled a
manufacturing defect claim, which informs his misrepresentation claim. See
Smith v. Depuy Orthopaedics, Inc., CIV.A. 11-4139 JAP, 2013 WL 1108555, at *10
(D.N.J. Mar. 18, 2013) aff'd in part, 13-2148, 2014 WL 116288 (3d Cir. Jan. 14, 2014)
(finding that device was safe and effective as per FDA’s premarket approval and
concluding that defective manufacture and misrepresentation claims were thus
preempted); Desabio v. Howmedica Osteonics Corp., 817 F. Supp. 2d 197
(W.D.N.Y. 2011) (dismissing state tort law claims as preempted where plaintiff
failed to allege facts implicating a violation of federal law); Anthony v. Stryker
Corp., 1:09-CV-2343, 2010 WL 1387790 (N.D. Ohio Mar. 31, 2010) (state tort law
claims preempted where plaintiff did not specifically mention either the FDA or its
regulations and did not plead any facts such that that the court could plausibly
infer that defendant’s noncompliance with FDA regulations led to his injury).
Thus, this Court cannot at this juncture determine – based on the Defendant’s
argument – that the Plaintiff’s misrepresentation claim is preempted pursuant to §
360k.
Nor is the Plaintiff’s misrepresentation claim insufficiently pled. To
establish a claim for negligent misrepresentation, a plaintiff must establish (1)
that the defendant made a misrepresentation of fact (2) that the defendant knew
33

or should have known was false, (3) that the plaintiff reasonably relied upon the
misrepresentation, and (4) that the plaintiff suffered pecuniary harm as a result
thereof. Glazer v. Dress Barn, Inc., 274 Conn. 33, 73 (2005); Coppola Const. Co.,
Inc. v. Hoffman Enterprises Ltd. P'ship, 134 Conn. App. 203, 208 (2012) aff'd, 309
Conn. 342 (2013). The elements of a claim for innocent misrepresentation are “(1)
a representation of material fact (2) made for the purpose of inducing the
purchase [of the product], (3) the representation is untrue, and (4) there is
justifiable reliance by the plaintiff on the representation by the defendant and (5)
damages.” Matyas v. Minck, 37 Conn. App. 321, 333 (1995).
The Defendant contends that the Plaintiff has failed to allege the second
and third prongs of a negligent misrepresentation claim, and has failed to allege
justifiable reliance to make out an innocent misrepresentation claim. The Plaintiff
counters that, “[h]aving placed into the stream of commerce a defective product
that the defendant made, it is reasonable to presume that the defendant either
knew or should have known it was defective,” given the FDA representations
about the safety of the device for its intended use as a Class III FDA approved
device, and given that the device was defective. [Dkt. 19, Opp. to MTD, p. 24-25].
McConologue also contends that there was justifiable reliance by consumers and
the physicians that implant the Ceramic Liners on the representations that the
devices are safe, fit, and effective for their intended purposes, which
representations are made for the purpose of inducing physicians to implant the
devices into their patients. The Plaintiff admits, however, that the justifiable
reliance element is not explicitly stated in his complaint, but contends that it is
34

“plausibly inferred from the very nature of this transaction and the purposes
behind requiring that Class III devices be designed, built and sold in accordance
with the purportedly stringent requirements imposed by the PMA process.” [Dkt.
19, P’s Opp. to MTD, p. 26].
Here, McConologue has alleged that a Ceramic Liner manufactured by
Smith & Nephew was implanted in his hip, that the Defendant conducted a recall
of a batch of liners which included the Plaintiff’s because titanium rings were
pressed onto the ceramic component with a higher force than allowed by the
FDA’s manufacturing specifications, that the Plaintiff experienced squeaking and
pain, that a CT scan revealed that the Liner was fractured, and that the Plaintiff
underwent revision surgery that further confirmed the fracture in the Liner.
Moreover, the parties agree that an R3 Ceramic Liner manufactured to FDA
specifications would be FDA compliant and therefore reasonably safe and
effective for its intended purpose, and that the Ceramic Liner is subject to the
stringent requirements of the FDA’s premarket approval process, which preempts
liability when an approved device complies with the federal standards it imposes.
Given that the premarket approval process is lengthy and rigorous, and that it
imposes numerous continuing obligations on manufacturers, who are held to
particular manufacturing specifications, the Plaintiff has sufficiently alleged that
Smith & Nephew should have known that a representation of safety and efficacy
geared toward a device fully compliant with FDA requirements would be false as
to a device with a manufacturing defect. Moreover, the fact of conferring Class III
status on a medical device, by its nature, means that McConologue was entitled
35

to reasonably rely on the warnings and representations made to his physician
acting as a learned intermediary in deciding whether to implant the Ceramic Liner
into the Plaintiff’s hip. See, e.g., Vitanza v. Upjohn Co., 257 Conn. 365, 376 (2001)
(“The learned intermediary doctrine provides that adequate warnings to
prescribing physicians obviate the need for manufacturers of prescription
products to warn ultimate consumers directly. The doctrine is based on the
principle that prescribing physicians act as ‘learned intermediaries' between a
manufacturer and consumer and, therefore, stand in the best position to evaluate
a patient's needs and assess the risks and benefits of a particular course of
treatment.”). The Defendant’s motion to dismiss the Plaintiff’s misrepresentation
claim is DENIED.
h. Products Liability: Breach of Warranty
Smith & Nephew urges dismissal of the Plaintiff’s claims for breach of
express and implied warranty as preempted by the MDA because the claims
challenge the safety and effectiveness of the Ceramic Liner and, for Plaintiff to
prevail, the Defendant contends that the Court would have to find that the device
was not safe and effective. The Defendant argues that this finding would
contradict the FDA’s determination of safety and effectiveness when it granted
approval to the Liner pursuant to the premarket approval process.
The Defendant’s argument, however, again refuses to recognize the
Plaintiff’s sufficient allegation that the Ceramic Liner was manufactured in
violation of FDA standards, which allegedly undermined the device’s safety and

36

effectiveness. The Plaintiff has alleged a violation of federal law, and the
Defendant has failed to demonstrate how the requirements of state law causes of
action for breach of warranty add to or differ from these requirements. Moreover,
the cases to which the Defendant cites are inapposite, as each found state tort
law claims to be preempted where the plaintiff failed to sufficiently plead a
violation of the FDA requirements governing the devices. That is not the case
here, as McConologue has pleaded a violation of the device’s manufacturing
standards. See Horowitz, 613 F. Supp. 2d at 282 (dismissing as preempted state
law tort claims – including those for breach of express and implied warranty –
where plaintiff failed to allege sufficient facts substantiating her claim that hip
replacement device violated federal requirements and “failed to demonstrate that
the injuries she sustained resulted from the federal violations spelled out in the
warning letters” attached to her complaint); Bertini v. Smith & Nephew, Inc., 13
CIV. 0079 BMC, 2013 WL 6332684 (E.D.N.Y. July 15, 2013) (holding that “[b]ecause
they failed to plausibly show that the R3 liner is defective, plaintiffs have also
failed to plead a necessary element of their implied warranty claim;” and where
plaintiffs failed to allege sufficient facts to support breach of warranty claim).
Indeed, courts have held that, where a plaintiff has pled a defective
manufacturing claim, a state law claim for breach of implied warranty of
merchantability is not preempted. See Gelber, 788 F. Supp. 2d at 166 (“Plaintiffs
allege that defendants breached their implied warranty of merchantability by
selling plaintiffs an adulterated device because the Trident System was unfit for
its ordinary purpose. Plaintiffs’ implied warranty claims are not preempted to the
37

extent they allege a defective manufacturing claim.”). Several courts that have
addressed whether implied warranty claims are preempted after Riegel have
determined that, to the extent the plaintiff relies on the failure to comply with the
FDA's requirements in asserting his breach of implied warranty claim, such
claims may proceed. Bass, 669 F.3d at 517 (“Most post-Riegel cases that have
found implied warranty claims preempted either concluded that the claims failed
to rely on violations of the FDA's requirements, or the plaintiff pleaded that the
defendants complied with the FDA's requirements. We agree with the courts that
hold that an implied warranty claim is not preempted if the plaintiff alleges that
the defendant violated federal requirements and can ultimately show a causal link
between the violation and the breach of the implied warranty. If, however, the
plaintiff claims that the defendant breached the implied warranty despite its
compliance with FDA requirements, that claim is clearly preempted, as it would
be “ ‘different from, or in addition to,’ the requirements imposed by federal law.”)
(collecting cases).
The Defendant has failed to articulate how these claims are preempted.
Smith & Nephew’s motion to dismiss these claims based on preemption is
DENIED.
The Defendant also argues that both the express and implied warranty
claims must be dismissed because they are inadequately pled, unsupported by
sufficient facts, and conclusory. The elements for a claim for breach of warranty
in Connecticut are: (1) existence of the warranty; (2) breach of the warranty; and,
(3) damages proximately caused by the breach. Motley v. Jaguar Land Rover N.
38

Am., LLC, X03CV084057552S, 2012 WL 5860477 (Conn. Super. Ct. Nov. 1, 2012);
Gerrity v. R.J. Reynolds Tobacco Co., 399 F. Supp. 2d 87, 90 (D. Conn. 2005);
Omega Eng'g, Inc. v. Eastman Kodak Co., 30 F. Supp. 2d 226, 246 (D. Conn. 1998).
An express warranty is defined under Conn. Gen. Stat. § 42a–2–313(1) as:
(a) Any affirmation of fact or promise made by the seller to the
buyer which relates to the goods and becomes part of the
basis of the bargain, creates an express warranty that the
goods shall conform to the affirmation or promise. (b) Any
description of the goods which is made part of the basis of the
bargain creates an express warranty that the goods shall
conform to the description. (c) Any sample or model which is
made part of the basis of the bargain creates an express
warranty that the whole of the good shall conform to the
sample or model.
Conn. Gen. Stat. § 42a–2–313(1). The Defendant contends that McConologue’s
express warranty claim must fail because he has failed to set forth the terms of
the warranty upon which he relied, and instead merely states that the Defendant
“breached its express warranty that the Liner was safe and effective for its
intended use,” unsupported by any factual content. [Dkt. 1-1, Compl. ¶16(g)].
The Court first notes that each of the cases to which the Defendant cites is
based on New York tort law, whose relevance to a case premised on Connecticut
law the Defendant fails to explain. However, although the parties seem to agree
that the FDA approved Smith & Nephew’s Ceramic Liner pursuant to its
premarket approval process for Class III devices, which itself warrants with
“reasonable assurance” that the Liner was safe and effective for use, the
complaint fails to state this, and thus there are no allegations in the complaint

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that demonstrate the existence of an express warranty. The Plaintiff’s express
warranty claim is thus DISMISSED without prejudice to repleading.
As to the implied warranty of merchantability, courts have held that
“because the CPLA is silent as to the elements of a cause of action for breach of
warranty,” plaintiffs may rely on the Connecticut Uniform Commercial Code, Title
42a of the Connecticut General Statutes. Walters v. Howmedica Osteonics Corp.,
676 F. Supp. 2d 44, 55 (D. Conn. 2009); Johnson v. Sears Roebuck & Co., No.3:05–
cv–139(JCH), 2007 WL 2491897, at *4 (D. Conn. Aug. 29, 2007); Kuzmech v.
Werner Ladder Co., 3:10-CV-266 VLB, 2012 WL 6093898 (D. Conn. Dec. 7, 2012).
Conn. Gen. Stat. § 42a-2-314 states that “[u]nless excluded or modified … a
warranty that the goods shall be merchantable is implied in a contract for their
sale if the seller is a merchant with respect to goods of that kind.” Conn. Gen.
Stat. § 42a-2-314(a). Smith & Nephew does not allege that it was not a merchant,
nor does it allege that an implied warranty of merchantability did not apply to its
sale of the R3 Ceramic Liner. Instead, the Defendant alleges that Plaintiff’s claim
is inadequately pled because he has failed to factually support his claim that the
Liner used in his surgery was defective. Contrary to Defendant’s argument,
however, McConologue has successfully alleged that the Liner was defectively
manufactured. Thus, the Plaintiff has successfully pled that the Liner was not of
merchantable quality at the time it was implanted in his hip. Therefore, Smith &
Nephew’s motion to dismiss the Plaintiff’s implied warranty claim is DENIED.
V.

Conclusion

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For the foregoing reasons, the Defendant’s [Dkt. 16] Motion to Dismiss the
Complaint is GRANTED in part and DENIED in part. The Plaintiff shall file an
amended complaint within twenty-one (21) days of the date of this Order, or by
April 15, 2014.

IT IS SO ORDERED.

________/s/______________
Hon. Vanessa L. Bryant
United States District Judge
Dated at Hartford, Connecticut: March 24, 2014

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