Nagel et al v. Smith & Nephew Inc

Filing 42

ORDER. For the reasons in the attached ruling, the Court concludes that the complaint does not allege claims that are not either preempted or that give rise to plausible grounds for relief. Accordingly, defendant's motion to dismiss (Doc. #21) is GRANTED with prejudice. The Clerk is ordered to close this case. It is so ordered. Signed by Judge Jeffrey A. Meyer on 7/28/16. (Gorsuch, A)

UNITED STATES DISTRICT COURT
DISTRICT OF CONNECTICUT

RANDALL NAGEL and KAREN NAGEL,
Plaintiffs,
v.

No. 3:15-cv-00927 (JAM)

SMITH & NEPHEW, INC.,
Defendant.

RULING GRANTING MOTION TO DISMISS
This is a products liability case involving an artificial hip-replacement device that was
implanted in plaintiff Randall Nagel and manufactured by defendant Smith & Nephew, Inc. The
device included a metal liner that allegedly harmed plaintiff. Because of severe medical
complications stemming from the failure of the metal liner, plaintiff had to undergo surgery to
have the metal liner removed.
The legal issue before me is whether plaintiff and his spouse may seek state law tort relief
against the defendant device manufacturer. I conclude that federal law largely preempts
plaintiff’s state law claims and that to the extent his claims are not preempted by federal law,
plaintiff has failed to plausibly allege sufficient facts that would give rise to grounds for relief.
Accordingly, I will grant defendant’s motion to dismiss.
BACKGROUND
The following facts are taken from those alleged in the complaint. In 2010, plaintiff
Randall Nagel underwent surgery to have an artificial hip implanted in his body. The hip device
and its components were manufactured by defendant Smith & Nephew, Inc. Plaintiff’s hip socket
and ball joint were replaced by a titanium alloy ball-and-socket prosthetic known as the
REFLECTION 3 Acetabular System (“R3 System”). Part of the system required the use of a

liner component. With plaintiff’s consent, plaintiff’s surgeon chose to use a metal liner (the “R3
metal liner”) rather than a polymer plastic liner that was part of the original R3 system.
Plaintiff developed severe medical complications from the hip replacement device,
including the growth of a pseudotumor and significant pain. Blood testing indicated abnormal
amount of metal content in his blood, consistent with failure of the metal liner. In early 2015,
plaintiff underwent surgery to have the metal liner removed.
Medical devices like those implanted in plaintiff are subject to federal regulatory
requirements as overseen by the Food and Drug Administration (FDA). A company that seeks
regulatory approval for a medical device may ordinarily seek approval in one of two ways. First,
the company may pursue a rigorous premarket approval (PMA) process that entails scrupulous
evaluation of the device’s safety and effectiveness. Alternatively (and far more commonly), if
the device in question is substantially similar to another PMA-approved product that is already in
use, then the company may instead pursue a more streamlined approval process known as
§ 510(k) clearance that involves premarket notification to the FDA. See Medtronic v. Lohr, 518
U.S. 470, 477–79 (1996); Phillip G. Palmer, Jr., Medical Device Immunity: Should Promotion of
Off-Label Uses Leave Medical Device Manufacturers Vulnerable to Unlimited Liability?, 35 J.
Legal Med. 553, 558–60 (2014).
The R3 system that plaintiff received was approved by the FDA in 2006 using the
streamlined § 510(k) clearance process. But it was approved with the use of a plastic polymer
liner, not the metal liner that was eventually implanted in plaintiff. The R3 metal liner was
originally approved by the FDA in 2008 as part of a different hip replacement system known as
the Birmingham Hip Resurfacing (BHR) system, which contained all-metal components. In
contrast to the streamlined § 510(k) clearance process by which the R3 system (with its use of a

2

polymer liner) was approved, the BHR system (with its use of the R3 metal liner) was subject to
the demanding PMA approval process.
Several months after the approval of the R3 metal liner with the BHR system, defendant
issued a press release in 2009 indicating that the R3 metal liner could be used by hip replacement
surgeons in conjunction with the R3 system. But beginning in 2008, studies showed that “metalon-metal” hip replacement systems with metal liners similar to the R3 metal liner had higher
revision rates (meaning that the patient had to have the implant removed) than with plastic liners.
In 2010, two unrelated metal-on-metal hip replacement systems underwent voluntary recalls by
the manufacturers. In May 2011, the FDA instructed manufacturers of metal-on-metal systems to
conduct postmarket surveillance. From January 2008 through May 2014, the FDA received 317
adverse event reports regarding the R3 system and the R3 metal liner. 1 In June 2012, defendant
voluntarily recalled all R3 metal liners from the market after finding a higher than expected
number of revision surgeries on patients with those liners. After 2012, studies across the world
continued to show higher revision rates for metal-on-metal systems.
In 2014, plaintiff began having discomfort in his implanted hip. Examination showed that
the implant was failing, that plaintiff had developed a pseudotumor, and that plaintiff had
elevated metal levels in his blood. In February 2015, plaintiff had surgery to remove the R3
metal liner and the pseudotumor.
Plaintiff now brings a number of claims based on the harm caused to him by the R3 metal
liner used with his R3 system. According to plaintiff, “[t]he Liner was in an unsafe and
unreasonably dangerous condition, was inherently unsafe, and could not be used without
subjecting [him] to an unreasonable risk of injury” because the “R3 metal acetabular liner has

1

The complaint is not clear if these 317 complaints were about each component individually, or both in
combination with each other.

3

been linked to the accelerated release of metal debris and ions into the body and/or blood stream
from articular abrasion with the femoral head, excessive liner wear, liner breakage, corrosion, or
a combination of these elements,” which he himself experienced. Doc. #17 at 6.
Through the PMA process, plaintiff claims, the FDA approved the R3 metal liner “for use
only with Smith & Nephew’s [BHR] System” and “did not receive FDA approval to be used
with the R3 System or with any other total hip replacement system.” Doc. #17 at 5. Any
commercial marketing or sale of the R3 metal liner that did not conform to the conditions
described by the FDA in its PMA approval was a violation of the Food, Drug, and Cosmetics Act
(FDCA), plaintiff contends. At the time plaintiff received his hip replacement, defendant was
marketing the R3 metal liner for use with the R3 system.
Plaintiff alleges that defendant failed to warn him of the R3 metal liner’s defects, because
it did not test the R3 metal liners, report adverse events, or warn the FDA often or well enough to
comply with FDA requirements for devices that have received premarket approval, and it also
failed to comply with the FDA’s postmarket surveillance obligations. Plaintiff further alleges
that defendant was negligent in not testing the R3 metal liners with enough sufficiency and care
as required by the FDA, and that defendant misrepresented information to the FDA that resulted
in inadequate warnings being approved by the FDA for the R3 metal liner.
Plaintiff now brings this lawsuit alleging one count with multiple theories of liability. 2 He
alleges strict liability for the product’s manufacture, design, and inadequate warning; negligence
in manufacture, design, and warning; and breach of implied warranty. Plaintiff also complains
that defendant negligently misrepresented the safe use of the R3 metal liner with the R3 system
in violation of state and federal law. Defendant has moved to dismiss the complaint in its

2

The complaint includes a second count by co-plaintiff Karen Nagel for loss of consortium that is wholly
derivative of the first count.

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entirety, contending that plaintiff’s claims are either preempted by federal law or that plaintiff
has failed to allege sufficient facts to establish plausible grounds for relief. Doc. #21.
DISCUSSION
The principles governing this Court’s consideration of a Rule 12(b)(6) motion are well
established. First, the Court must accept as true all factual matter alleged in a complaint and draw
all reasonable inferences in the plaintiff’s favor. See Johnson v. Priceline.com, Inc., 711 F.3d
271, 275 (2d Cir. 2013). But, “‘[t]o 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.’”
TechnoMarine SA v. Giftports, Inc., 758 F.3d 493, 505 (2d Cir. 2014) (quoting Ashcroft v. Iqbal,
556 U.S. 662, 678 (2009)).
Preemption
It is well established that Congress may preempt state law, whether expressly or
impliedly, if state law is in conflict or otherwise inconsistent with federal law in a manner that
defeats the federal purpose. See Arizona v. United States, 132 S. Ct. 2492, 2500–01 (2012). But a
federal statute will not be found to preempt claims arising under state law unless the express or
implied intent of Congress to do so is “clear and manifest.” Wyeth v. Levine, 555 U.S. 555, 565
(2009).
Federal law regulates medical devices of the type at issue in this case pursuant to the
Medical Device Amendments (MDA) to the FDCA. See 21 U.S.C. § 360c et seq.; Riegel v.
Medtronic, Inc., 552 U.S. 312, 316–17 (2008) (describing MDA’s “regime of detailed federal
oversight”). Under the MDA, medical devices are grouped into three classes based on the risks
that the type of device presents; a Class III device of the type at issue in this case is subject to the

5

most stringent review and oversight protections. See id. at 317; Simoneau v. Stryker Corp., 2014
WL 1289426, at *1 (D. Conn. 2014).
Apart from its detailed regulatory oversight requirements, the MDA largely insulates
manufacturers of approved medical devices from state law tort claims if the manufacturer has
complied with federal regulatory requirements. The MDA has an express preemption clause that
bars the application of any state law that would impose any requirement which is “different from,
or in addition to” any federal MDA requirement. See 21 U.S.C. § 360k(a); see also Riegel, 552
U.S. at 316. Moreover, in addition to the MDA’s express preemption clause, the Supreme Court
has otherwise held that a state law claim is impliedly preempted under the FDCA if the
conclusion that the state law has been violated is based solely on a violation of the FDCA rather
than on some independent state law duty. See Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S.
341, 349 (2001) (state law claim alleging fraud-on-the-FDA preempted because dependent
entirely on federal law obligations of disclosure to the FDA).
Importantly, the scope of federal preemption may vary depending on whether a medical
device has been subject to approval by means of the rigorous PMA process or if it has been
subject to approval by means of the streamlined § 510(k) clearance process. A plaintiff who
wishes to pursue state law claims involving a PMA-approved medical device must carefully
frame his claim to avoid either express preemption or implied preemption under the MDA. On
the one hand, the plaintiff must allege a state law claim that runs parallel to a federal law claim
(or else the state law claim is expressly preempted under § 360k(a), because it would rely on a
requirement that is “different from” or “in addition to” the FDCA requirements). Yet on the other
hand, the plaintiff’s claim must not rely solely on a requirement that is already imposed under
the FDCA (or else the claim is impliedly preempted under Buckman).

6

Thus, a plaintiff must navigate a “narrow gap” to advance a parallel state law claim
involving conduct that amounts to a violation of federal regulatory requirements but which claim
is not wholly derivative of federal law. See In re Medtronic, Inc., Sprint Fidelis Leads Products
Liab. Litig., 623 F.3d 1200, 1204 (8th Cir. 2010). “It’s no wonder,” as Judge Gorsuch has
suggested, “that the difficulty of crafting a complaint sufficient to satisfy all these demands has
been compared to the task of navigating between Scylla and Charybdis.” Caplinger v. Medtronic,
Inc., 784 F.3d 1334, 1340 (10th Cir. 2015).
Such is the daunting preemption hurdle for any state law claims involving medical
devices that have been subject to rigorous PMA approval. By contrast, preemption looms less
likely for state law claims involving devices that have gained federal approval by means of the
streamlined § 510(k) clearance process. Because the § 510(k) clearance process does not involve
the same type of federal safety-and-effectiveness review as the PMA approval process, the
Supreme Court has made clear that claims involving such § 510(k)-cleared devices are not
subject to the MDA’s express preemption provision under § 360k(a). See Medtronic, Inc. v.
Lohr, 518 U.S. 470, 493 (1996). Accordingly, a far less demanding standard of only implied
preemption applies for state law claims involving devices that have been approved by means of
the § 510(k) clearance process.
All that said, a further question remains about what level of preemption should apply in
the context of a device subject to mixed levels of approval. For example, what level of
preemption should apply where a plaintiff’s claim involves a component of a device (here, the
R3 metal liner) that was initially approved within a device (here, the BHR system) that gained
the FDA’s approval by way of the rigorous PMA process, but which component (here, the R3

7

metal liner) is later used with a different device (here, the R3 system) that the FDA has approved
only by means of the streamlined § 510(k) clearance process?
Courts that have previously considered claims like plaintiff’s claim have reached
differing conclusions. Several courts have concluded that a state law claim that challenges the
safety and effectiveness of the R3 metal liner—which was subject to rigorous PMA approval as
part of the BHR system—will be preempted by the MDA’s express preemption clause typically
associated with PMA-approved devices, notwithstanding that the R3 metal liner has been
incorporated into the § 510(k)-approved R3 system. See Shuker v. Smith & Nephew, Inc., 2015
WL 1475368, at *8–10 (E.D. Pa. 2015); Bertini v. Smith & Nephew, Inc., 8 F. Supp. 3d 246, 254,
255 (E.D.N.Y. 2014); Simon v. Smith & Nephew, Inc., 990 F. Supp. 2d 395, 404–06 (S.D.N.Y.
2013).
But other courts have disagreed and concluded that a claim involving a § 510(k)-cleared
device should not be subject to the MDA’s express preemption clause merely because a
component material of a PMA-approved device has been incorporated into the § 510(k)-cleared
device. See Huskey v. Ethicon, Inc., 29 F. Supp. 3d 736, 751–52 (S.D.W. Va. 2014). One of my
colleagues on this Court has also recently declined to recognize express preemption of a very
similar claim alleging failure of a § 510(k)-approved hip replacement system in combination
with a PMA-approved liner “because the combination of component parts . . . had not undergone
the premarket approval process.” Lafountain v. Smith & Nephew, Inc., 2016 WL 3919796, at *6
(D. Conn. 2016).
I am persuaded by the initial line of cases that applies the MDA’s express preemption
clause to claims involving device components subject to mixed levels of approval, particularly in
the context of the allegations that are present in this case, which focus on harm allegedly caused

8

either independently by the PMA-approved R3 metal liner, or by the R3 metal liner’s interaction
with the R3 system (and as distinct from any harm stemming from the § 510(k)-approved R3
system not related to the PMA-approved R3 metal liner). 3 Because the FDCA does not prohibit
off-label use of a component within a PMA-approved device in another medical device, I
conclude that a manufacturer should not lose the protections of express preemption under §
360k(a) because of a surgeon’s permissible choice to use the PMA-approved component in a
§ 510(k)-approved device, even if the interaction of the two components causes problems. See 21
U.S.C. § 396 (off-label use or promotion not prohibited).
Indeed, the term “device” under the FDCA includes “any component, part, or accessory,”
21 U.S.C. § 321(h), and once a device—including its components—is approved, then the
manufacturer is required to produce and market the device—including its components—in
accordance with the specifications approved by the FDA. See Shuker, 2015 WL 1475368, at *9.
A physician may then take approved devices, or parts of devices, and use them “off label”—
or in a manner inconsistent with the manufacturer’s label or FDA approval—and such use by a
physician does not mean that the manufacturer somehow violated federal law. See ibid (noting
that “[a] physician’s decision to use a PMA-approved device off-label does not change the
manufacturer’s obligation to produce and market the device with almost no deviations from the
3

See Doc. #17 at 6 (“R3 metal acetabular liner has been linked to the accelerated release of metal debris
and ions into the body and/or blood stream” and “recalled all batches of R3 metal liners from the market”); id. at 7
(“the failure and revision rates for total hip replacements with the defective R3 metal liner have been significantly
higher than the standard revision rates”); id. at 11 (describing that the plaintiff had the “recalled R3 Acetebular
Metal Liner” removed surgically) and (“At all times mentioned herein, the R3 metal acetabular liner, both by itself
and in articulation with the R3 Acetabular System, generated an adverse reaction in the Plaintiff Randall Nagel
including the accelerated release of metal debris and ions into his body.”); id. at 13 (“Had Plaintiff Randall Nagel
known that the R3 System had an increased rate of failure due to the defects set forth herein, Plaintiff would not
have elected to use the R3 metal liner for his total hip replacement.”); id. at 13–14 (“The Plaintiff’s injuries and
damages were caused as a result of Defendant Smith & Nephew’s violations of the Connecticut Product Liability
Act . . . related to the design, testing, fabrication, assembly, manufacturing, construction, repair, packaging,
composition of instructions, compositions of warnings, labeling, marketing, and sale of the R3 acetabular metal liner
in one or more of the following respects”). The complaint’s main count includes dozens of paragraphs and
subparagraphs describing the various harms.

9

specifications in its approval application,” and “[h]ence, the mere fact a device is used off-label
does not render [express preemption under] § 360k(a) inapplicable”); see also Caplinger, 784
F.3d at 1344–47 (rejecting argument that express preemption does not apply to off-label use of a
device); Otis-Wisher v. Medtronic, Inc., 616 Fed Appx. 433, 435 & n.2 (2d Cir. 2015) (noting
that the “weight of authority both in this Circuit and elsewhere casts doubt on the viability of
such claims” based on allegedly fraudulent off-label promotion).
Accordingly, based on my conclusion that the MDA’s high standard of both express and
implied preemption should apply in this case, I will evaluate each of plaintiff’s state law claims
to consider whether it alleges a sufficiently “parallel” state law claim that navigates the “narrow
gap” to escape preemption. Then, to the extent that any aspect of the complaint may allege such
a claim, I will consider in turn whether the facts alleged in support of such a claim otherwise
afford plausible grounds for relief.
Plaintiff’s Claims
All of plaintiff’s state claims are governed by the Connecticut Product Liability Act,
which provides the exclusive vehicle in this state for actions premised on “harm caused by a
product.” Conn. Gen. Stat. § 52-572n(a); see also Gerrity v. R.J. Reynolds Tobacco Co., 263
Conn. 120, 126 (2003) (“[T]he legislature clearly intended to make our products liability act an
exclusive remedy for claims falling within its scope.”). A plaintiff may nonetheless assert
various common law theories of liability under the statute. See Simoneau, 2014 WL 1289426, at
*5); see also Conn. Gen. Stat. § 52-572m(b) (“ ‘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

10

innocent.”). Plaintiff here has asserted claims for strict product liability, failure to warn,
misrepresentation, negligence, and breach of implied warranty of merchantability.
Strict Products Liability
In order to prevail on a strict products liability claim under Connecticut law, plaintiff
must prove, inter alia, that the product was in a defective condition that was unreasonably
dangerous to the plaintiff, and further that the defect caused the injury for which compensation is
sought. See D’Ascanio v. Toyota Indus. Corp., 309 Conn. 663, 673–74 (2013). “A product may
be defective due to a flaw in the manufacturing process, a design defect or because of inadequate
warnings or instructions.” Vitanza v. Upjohn Co., 257 Conn. 365, 373 (2001); see also
Simoneau, 2014 WL 1289426, at *5 (same).
The gravamen of plaintiff’s complaint is that he was harmed by the release of metal in
his body from the R3 metal liner when used off-label. The complaint does not allege facts that
are based on defendant’s violation of any FDA manufacturing requirements, or deviation from
the FDA-approved design, in the manufacture or design of the R3 metal liner implanted in
plaintiff. Plaintiff’s claim, then, seems to be simply that the FDA-approved design—despite the
FDA’s approval—still caused him harm. 4 Such state-law claims, if allowed, would “cast doubt
on the FDA’s findings concerning the safety of that device’s design and, thus, are categorically
preempted by the MDA.” Simoneau, 2014 WL 1289426, at *9 (citing Riegel, 552 U.S. at 330).
Recalls and FDA sanctions may constitute evidence of a defect if the facts underlying those
actions support a claim that the manufacturer or designer deviated from the FDA-approved
standards, see id. at *7–8, but here plaintiff has alleged only facts that indicate a higher-thanwished revision rate, not that defendant violated FDA standards. There are no allegations that the
4

As noted above, the FDCA does not regulate off-label use, and so no state-law claim may lie for harm
resulting from off-label use of an FDA-approved device. See 21 U.S.C. § 396 (off-label use or promotion not
prohibited).

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R3 metal liner was not designed and manufactured in accordance with the FDA-approved design
and manufacturing specifications. See, e.g., McConologue v. Smith & Nephew, Inc., 8 F. Supp.
3d 93, 106 (D. Conn. 2014) (state law claim not preempted where 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”). Because plaintiff fails to state facts alleging that the R3 metal
liner was defective in its FDA-regulated manufacture or design, the complaint does not
sufficiently allege a parallel state law claim and, therefore, is preempted.
Failure-to-warn
Under Connecticut law, a manufacturer is liable for failure to warn if the plaintiff “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. Ann. § 52-572q. The duty to warn of such
defects exists both before and after the sale of a product. See Densberger v. United Techs. Corp.,
297 F.3d 66, 71 (2d Cir. 2002). To determine whether warnings were required or adequate,
courts must consider
(1) [t]he likelihood that the product would cause the harm suffered by the
claimant; (2) 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 (3) the technological feasibility and cost
of warnings and instructions.
Conn. Gen. Stat. Ann. § 52-572q(b).
Plaintiff alleges facts insufficient to indicate that defendant failed to comply with FDA
requirements regarding reporting adverse events that would provide the basis for a parallel state
law claim. See Simoneau, 2014 WL 1289426, at *10 (“To be parallel, Simoneau’s theory of strict
liability for inadequate warnings or instructions must be premised on a violation of FDA

12

requirements.”) While plaintiff alleges that defendant failed “to comply with the FDA’s
premarket approval monitoring and reporting requirements,” to “discover and report to the FDA”
any adverse events, and to “warn the FDA . . . that the R3 acetabular metal liners had been
released by the Defendant into the stream of commerce with significant safety concerns,” these
claims are wholly conclusory. Plaintiff does not allege facts indicating that defendant knew of
adverse events and did not report them to the FDA, nor that defendant avoided doing testing
required by the FDA and that it was this non-reporting that caused the injury to plaintiff in this
case. Accordingly, plaintiff’s failure-to-warn claim is preempted as it fails to plead facts that
would state a claim for a parallel federal violation.
Misrepresentation
Under Connecticut law, a claim for negligent misrepresentation lies when a defendant
“made a misrepresentation of fact . . . that the defendant knew or should have known was false,
[and] that the plaintiff reasonably relied upon the misrepresentation, and . . . suffered pecuniary
harm as a result thereof.” Glazer v. Dress Barn, Inc., 274 Conn. 33, 73 (2005); see also
McConologue, 8 F. Supp. 3d at 112 (upholding a misrepresentation claim when the product had a
manufacturing defect). Plaintiff alleges that defendants violated federal law by “marketing the
R3 metal acetabular liner for use in applications other than the [BHR] System” and in so doing,
also violated state law.
Federal law does not explicitly ban off-label promotion unless it is false or misleading.
See United States v. Caronia, 703 F.3d 149, 162 (2d Cir. 2012) (finding that “the FDCA itself
does not expressly prohibit or criminalize off-label promotion”); see also Shuker, 2015 WL
1475368, at *14. Because the FDCA does not prohibit off-label use or promotion, off-label statelaw misrepresentation claims are preempted under § 360k. See Bertini, 8 F. Supp. 3d at 255;
Caplinger, 784 F.3d at 1345 (noting that Riegel preempted “any state safety requirement
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differing from or adding to the body of federal regulations . . . even if that requirement comes in
the guise of a general tort suit addressing only safety issues relating to off-label uses”). But see
Ramirez v. Medtronic Inc., 961 F. Supp. 2d 977, 990 (D. Ariz. 2013) (allowing a federal and
parallel state-law misbranding medical device claim). Courts have thus found that there is no
parallel claim under federal law that may be pled alongside a state law misrepresentation claim
based on off-label use alone that would allow such a claim to survive. See Caplinger, 784 F.3d at
1341–42; cf. McConologue, 8 F. Supp. 3d at 112.
There is no parallel claim pled here. Plaintiff’s claim of misrepresentation is based on
defendant’s press release that states that the R3 metal liner may be used with the R3 system,
which plaintiff claims constitutes “marketing” the R3 metal liner for off-label use. There is no
federal claim for off-label marketing, so no state-law claim can survive. And insofar as there is a
viable federal claim for false or misleading off-label marketing, plaintiff has alleged no facts in
support of such a claim. Plaintiff has not sufficiently alleged that the marketing was false or
misleading to constitute a parallel federal claim, and therefore the claim of misrepresentation is
preempted.
Negligence
Plaintiff alleges that defendant “knew or should have known in the exercise of reasonable
care that it should inspect, test, and monitor the R3 acetabular liners, and the process of
manufacturing the metal liners, as required under the FDA’s premarket approval monitoring and
reporting requirements.” Doc. #17 at 14. But again, plaintiff has pled no facts that would show
that defendant did not do the necessary testing or did not follow the FDA specifications for
manufacture and therefore was in violation of FDA requirements. Allowing a plaintiff to claim
that a particular testing or manufacturing regime was negligently inadequate, despite being

14

required or allowed by the FDA, would establish an additional requirement beyond federal law
and is subject to express preemption under § 360k. To the extent that plaintiff’s negligence
claims are not subject to express preemption, these claims—the “building/manufacturing [of] the
R3 acetabular metal liners in a defective manner” and “that the defendant should have
known . . . that the liners . . . failed to work as well” as other liners used in hip replacement
systems—lack any plausible factual allegations to give rise to any grounds for relief.
Implied warranty of merchantability
Under Connecticut law, an implied warranty of merchantability arises from the
Connecticut Uniform Commercial Code. See Conn. Gen. Stat. § 42a-2-314(a). To be
merchantable, the goods must be “fit for the ordinary purposes for which such goods are used”
and “conform to the promises or affirmations of fact made on the container or label.” Simoneau,
2014 WL 1289426, at *13. Plaintiff claims that defendant violated the implied warranty of
merchantability of the R3 metal liner based on factual allegations that the R3 metal liner did not
work as well as other liners, that it had a high likelihood of causing complications, and that
defendant knew the R3 metal liner was being used off-label.
Construing all of the plaintiff’s federal violation pleadings liberally, it is difficult to find
a parallel claim that does not add new requirements to the existing FDA testing, reporting, and
approval regime that the R3 metal liner was subject to as a PMA-approved device. As far as
plaintiff’s claims would demand a more safely-designed liner or more reporting to the FDA to
conform to the implied warranty, those state law claims add requirements that are preempted. See
Bertini, 8 F. Supp. 3d at 260. And as far as plaintiff’s claims rely on off-label use, such claims
are preempted for the reasons stated above.

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Leave to Amend
Finally, plaintiff has sought leave to file a second amended complaint in the event I grant
defendant’s motion to dismiss. Federal Rule of Civil Procedure 15(a)(2) provides that leave to
amend a complaint shall be “freely” given when “justice so requires.” “It is within the sound
discretion of the district court to grant or deny leave to amend.” WC Capital Mgmt., LLC v. UBS
Sec., LLC, 711 F.3d 322, 334 (2d Cir. 2013).
A court may deny leave to amend as futile if “a proposed claim could not withstand a
motion to dismiss pursuant to Rule 12(b)(6).” Dougherty v. Town of N. Hempstead Bd. of Zoning
Appeals, 282 F.3d 83, 88 (2d Cir. 2002). In requesting leave to amend in his opposition to the
pending motion to dismiss, plaintiff has not indicated what changes he would make to survive a
future challenge under Rule 12(b)(6), but rather steadfastly asserts that his first amended
complaint is sufficient. See Doc. #31 at 40.
While I understand that plaintiff filed his original complaint in state court, plaintiff has
already attempted one amended complaint in federal court. That amended complaint failed to
allege any facts that would plausibly support the contention that defendant violated requirements
established by the FDA for the R3 metal liner. Plaintiff’s underlying theory of the case—that the
PMA-approved R3 metal liner, in conjunction with the R3 system, caused harm—is otherwise
expressly preempted under §360k. See Shuker, 2015 WL 1475368, at *17; Simon v. Smith &
Nephew, Inc., 18 F. Supp. 3d 423, 429 (S.D.N.Y. 2014) (denying leave to amend for similar
claim involving R3 metal liner). Plaintiff has not suggested that he is missing discovery on vital
facts about how the defendant deviated from the FDA requirements in the design, manufacture,
or testing of the R3 metal liner, nor has he suggested what facts he would add to bolster the claim
that defendant’s representations regarding the R3 metal liner were misleading or false. Therefore,

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I will not allow leave to file a second amended complaint on the grounds that such pleading
would be futile.
CONCLUSION
I conclude that the complaint does not allege claims that are not either preempted or that
give rise to plausible grounds for relief. Accordingly, I GRANT defendant’s motion to dismiss
(Doc. #21) with prejudice. The Clerk is ordered to close this case.
It is so ordered.
Dated at New Haven this 28th day of July 2016.
/s/ Jeffrey Alker Meyer
Jeffrey Alker Meyer
United States District Judge

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