Simoneau v. Stryker Corp et al
RULING granting in part and denying in part 14 Motion to Dismiss; granting in part and denying in part 15 Motion to Dismiss. Motion is denied as to the strict liability, negligence, and breach of implied warranties theories of Simoneau's CP LA claim to the extent that these relate to defective manufacturing of the Trident Hip Implant and are premised on a violation of the FDA's requirements. Motion is granted as to all other theories of products liability. With respect to all of the theories dismissed, Simoneaus request for leave to amend her Complaint is granted. An amended complaint, if any, shall be filed no later than April 21, 2014. Signed by Judge Janet C. Hall on 3/31/2014. (Lamb, K.)
UNITED STATES DISTRICT COURT
DISTRICT OF CONNECTICUT
STRYKER CORP. et al.,
CIVIL ACTION NO.
MARCH 31, 2014
RULING RE: STRYKER CORPORATION AND HOWMEDICA OSTEONICS
CORPORATION’S MOTION TO DISMISS (Doc. Nos. 14 & 15)1
Plaintiff Denise Simoneau brings this action in connection with components of the
“Trident Acetabular System” (“Trident Hip Implant”) used in a total left hip replacement
surgery that she underwent in December 2003. The Complaint (Doc. No. 1) alleges two
counts against Stryker Corporation and Howmedica Osteonics Corporation (collectively,
the “Stryker defendants”).2 Count One alleges violations of the Connecticut Product
Liability Act (“CPLA”), Conn. Gen. Stat. § 52-572m et seq. Count Two alleges
negligence in the design, production, manufacture, marketing, sale, and/or distribution
of the Trident Hip Implant and its components.3 The Stryker defendants move to
dismiss both counts for failure to state a claim, arguing, inter alia, that Simoneau‟s state
Albeit docketed as two separate motions, the instant Motion is a single motion filed jointly by two
defendants, and the court treats it as such, referring to the Motion in the singular throughout this Ruling.
Count Three alleges a claim against Windham Community Memorial Hospital (“Windham”), who
is not a party to this Motion to Dismiss. Windham filed a separate Motion to Dismiss (Doc. No. 16), which
the court has addressed in a separate Ruling.
Although Simoneau‟s Complaint alleges two counts against the Stryker defendants, “[t]he CPLA
creates a consolidated cause of action for all product liability claims.” Lamontagne v. E.I. Du Pont de
Nemours & Co., Inc., 834 F. Supp. 576, 587 (D. Conn. 1993), aff'd, 41 F.3d 846 (2d Cir. 1994). Because
“an action alleging harm from a product due to negligence . . . may not be pleaded as a separate common
law claim but may only be asserted as a part of the CPLA,” id., the court reads the Complaint as alleging
several theories of products liability within one CPLA claim against the Stryker defendants.
law claims are preempted by the Medical Device Amendments (“MDA”) to the Federal
Food, Drug and Cosmetic Act (“FDCA”), 21 U.S.C. §§ 360c et seq.
For the reasons stated below, the Stryker defendants‟ Motion to Dismiss (Doc.
Nos. 14 & 15) is GRANTED in part and DENIED in part.
Simoneau‟s Surgical Procedures
Simoneau underwent a left total hip arthroplasty in December 2003. Compl.
(Doc. No. 1), Count One ¶ 6. During that procedure, she received components of the
Trident Hip Implant designed, manufactured, and marketed by the Stryker defendants.
Id. In August 2011, Simoneau began experiencing pain in her left hip and was advised
that she had developed a hematoma. Id. ¶ 20. In September 2011 and October 2012,
respectively, she underwent two hip aspirations, see id., Count Three ¶ 6, which
revealed infection and metallosis from metal debris in and around her left hip, id., Count
One ¶ 20. As a result of continuing pain, in November 2012, Simoneau underwent a
“complete revision Left Total Hip Arthoplasty, which involved completely replacing the
liner of her original Left Hip Implant with a polyethylene liner and the head of her original
Left Hip Implant with a Cobalt chrome head.” Id. ¶ 21.
The FDCA has long required approval by the U.S. Food and Drug Administration
(“FDA”) of new drugs prior to their introduction into the market. Riegel v. Medtronic,
Inc., 552 U.S. 312, 315 (2008). Until Congress enacted the MDA, however, oversight of
the introduction of new medical devices was left largely to the states. Id. The
development of medical devices using new technology—such as “kidney dialysis units,
artificial heart valves, and heart pacemakers”—prompted concern among policymakers
and the public “about the increasingly severe injuries that resulted from the failure of
such devices.” Medtronic, Inc. v. Lohr, 518 U.S. 470, 475-76 (1996). In response,
Congress enacted the MDA, “which swept back some state obligations and imposed a
regime of detailed federal oversight.” Riegel, 552 U.S. at 316.
The MDA classifies medical devices into three categories based upon the “risks
they present.” Id. Medical devices in Class III receive the greatest federal oversight.
Id. at 317. “In general, a device is assigned to Class III if it cannot be established that a
less stringent classification would provide reasonable assurance of safety and
effectiveness, and the device is „purported or represented to be for a use in supporting
or sustaining human life or for a use which is of substantial importance in preventing
impairment of human health,‟ or „presents a potential unreasonable risk of illness or
injury.‟” Id. (quoting 21 U.S.C. § 360c(a)(1)(C)(ii)). The product at issue in this case is a
Class III medical device. See Compl., Count One, ¶ 3.
A new Class III device must undergo a rigorous premarket approval (“PMA”)
process, unless “the FDA finds it is „substantially equivalent‟ to another device exempt
from premarket approval.” Riegel, 552 U.S. at 317 (quoting 21 U.S.C. § 360c(f)(1)(A)).
The FDA also reviews the medical device‟s proposed label to establish that it is “neither
false nor misleading.” Id. at 318 (citing 21 U.S.C. § 360e(d)(1)(A)). Most new Class III
devices enter the market through the FDA‟s less stringent review of “substantial
equivalence” known as the section 510(k) process. Id. at 317. Only a small percentage
of new Class III devices (roughly 1% in 2005) are approved annually by the FDA
through the PMA process. Id.
Once the FDA has approved a medical device for sale under the PMA process,
the MDA prohibits the manufacturer from making “changes in design specifications,
manufacturing processes, labeling, or any other attribute, that would affect safety or
effectiveness” without filing a supplementary premarket approval application and
obtaining permission from the FDA to make such changes. Id. at 319 (citing 21 U.S.C.
§ 360e(d)(6)(A)(i)); 21 C.F.R. § 814.39(a). Furthermore, following approval, the
manufacturer must report to the FDA any adverse results it has become aware of in
patients using the medical device. Id. (citing 21 U.S.C. § 360i). “The FDA has the
power to withdraw premarket approval based on newly reported data or existing
information and must withdraw approval if it determines that a device is unsafe or
ineffective under the conditions in its labeling.” Id. at 319-20 (citing 21 U.S.C. §§
Medical device manufacturers in general must comply with the FDA‟s current
good manufacturing practice requirements (“CGMPs”), which set forth a “quality system
regulation” and “govern the methods used in, and the facilities and controls used for, the
design, manufacture, packaging, labeling, storage, installation, and servicing of all
finished devices intended for human use.” 21 C.F.R. § 820.1(a)(1). The CGMPs serve
“to ensure that finished devices will be safe and effective and otherwise in compliance
with the [FDCA].” Id. “They do not specifically address the design, production and
marketing requirements for each and every type of medical device. The CGMP
requirements, therefore, leave it up to the manufacturer to institute a quality control
system specific to the medical device it produces to ensure that such device is safe and
effective.” Horowitz v. Stryker Corp., 613 F. Supp. 2d 271, 278-79 (E.D.N.Y. 2009)
History of the Trident Hip Implant
The FDA approved the Trident Hip Implant for sale in the United States in
February 2003. Compl., Count One ¶ 3. The parties agree that the Trident Hip Implant
received FDA approval pursuant to the PMA process and is classified as a Class III
medical device. Id. ¶ 3. Simoneau alleges that the Stryker defendants modified the
Trident Hip Implant subsequent to the FDA‟s initial approval and obtained FDA approval
of these modifications pursuant to section 510(k) submissions. Id. ¶ 4.
FDA Warning Letters
In 2007, the FDA issued two warning letters to the Stryker defendants regarding
certain of their facilities. Id., Count One ¶ 12. After inspecting these facilities, the FDA
concluded that the Stryker defendants‟ Trident Hip Implant components were
“adulterated” as defined in 21 U.S.C. § 351(h). Id.
Stryker Defendants‟ Voluntary Recalls
The Stryker defendants initiated several recalls relating to the Trident Hip
Implant. Id. ¶¶ 13-16. In June 2008, they recalled the “Trident Hemispherical
Acetabular Cluster Shells.” Id. ¶ 13. Simoneau alleges that this recall stemmed from an
investigation revealing the existence of “manufacturing residuals” and included the
specific Acetabular Shell implanted into her in 2003. Id. In August 2009, the Stryker
defendants recalled the “Trident Acetabular System Surgical Protocol instructions for
use of hip prosthesis, Literature Number LSP55.” Id. ¶ 14. They then issued new
surgical protocol instructions creating “separate and distinct surgical protocols, one for
the Trident PSL Shell and one for the Trident Hemispherical Shell,” to clarify “the
differences in reaming technique required depending on the type of shell used.” Id. In
September 2009, the Stryker defendants recalled the “Stryker Cancellous Bone Screw”
due to non-compliance with certain metallurgical standards. Id. ¶ 15. Simoneau alleges
that such bone screws had been implanted into her in 2003. Id.
All three recalls were classified by the FDA under federal regulation—the June
2008 and August 2009 recalls as Class II recalls, the September 2009 as a Class III
recall. Id. ¶ 13-15. Simoneau was never advised of any of these recalls. Id.
STANDARD OF REVIEW
A case is properly dismissed under Rule 12(b)(6) if the complaint fails to allege
facts sufficient “to state a claim for relief that is plausible on its face.” Bell Atl. Corp. v.
Twombly, 550 U.S. 544, 547 (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.” Ashcroft v. Iqbal, 556 U.S. 662, 678,
(2009). As articulated by the Supreme Court in Iqbal and Twombly, the standard for
dismissal on a Rule 12(b)(6) motion reflects two working principles. See Pension Ben.
Guar. Corp. ex rel. St. Vincent Catholic Med. Centers Ret. Plan v. Morgan Stanley Inv.
Mgmt. Inc., 712 F.3d 705, 717 (2d Cir. 2013). First, the court's customary acceptance
of all allegations in a complaint does not apply to legal conclusions. Iqbal, 556 U.S. at
678. Hence, to survive a motion to dismiss, a complaint must provide more than
“[t]hreadbare recitals of the elements of a cause of action, supported by mere
conclusory statements.” Id. Second, assuming the truth of all well-pleaded factual
allegations, and drawing all reasonable inferences in the plaintiff's favor, the court must
determine whether these allegations and inferences plausibly entitle the plaintiff to
relief—that is, whether the complaint shows “more than a sheer possibility that a
defendant has acted unlawfully.” Id. This second task is context-specific and “requires
the reviewing court to draw on its judicial experience and common sense.” Id. at 679.
The plausibility standard does not impose an across-the-board, heightened fact
pleading standard. Boykin v. KeyCorp, 521 F .3d 202, 213 (2d Cir. 2008). Rather, the
standard is “flexible,” obliging the plaintiff “to amplify a claim with some factual
allegations in those contexts where such amplification is needed to render the claim
plausible.” Id. (citation omitted); accord Arista Records, LLC v. Doe 3, 604 F.3d 110,
119 (2d Cir. 2010).
The Stryker defendants argue that the MDA preempts all claims against them in
the Complaint and that, in addition or in the alternative, Simoneau has not plausibly pled
breach of express warranty. Having reviewed the Complaint, the parties‟ submissions,
and the expansive and conflicting case law in this area, the court holds that Simoneau‟s
CPLA claim is not preempted under theories of strict liability, negligence, and breach of
implied warranties to the extent that these theories are premised on a violation of
federal requirements. All other theories of Connecticut products liability are dismissed
as preempted—with the exception of express breach of warranty, which is dismissed for
failure to state a claim, independent of the preemption issue.
Scope of Federal Preemption Under the MDA
The MDA includes an express preemption provision:
[N]o State or political subdivision of a State may establish or continue in
effect with respect to a device intended for human use any requirement—
(1) which is different from, or in addition to, any requirement applicable
under this chapter to the device, and
(2) which relates to the safety or effectiveness of the device or to any
other matter included in a requirement applicable to the device under this
21 U.S.C. § 360k(a).4
In Riegel, the Supreme Court held that the “requirement[s]” covered by section
360k(a) include common law products liability claims. 552 U.S. at 323-25 (“State tort
law . . . disrupts the federal scheme no less than state regulatory law to the same
effect.”). The Riegel Court noted, however, that section 360k does not prohibit states
“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 (quoting Lohr, 518 U.S. at 495). While the MDA does not
create a private right of action for a violation of the federal requirements applicable to a
medical device, Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341, 349 (2001),5
neither does it preempt state tort claims that do not differ from or add to such
requirements, Riegel, 552 U.S. at 330.
Application to Simoneau‟s State Claims
Riegel dictates a two-step inquiry in determining whether a state claim is
preempted by the MDA pursuant to section 360k(a). Id. at 321-322. First, the court
While section 360k excepts certain state requirements from being preempted by the MDA, see
21 U.S.C. § 360k(b), Simoneau does not assert any such exception here.
In Buckman, the Supreme Court held that state “fraud on the FDA” claims are impliedly
preempted because such claims conflict with the FDCA scheme. 531 U.S. at 348. Central to the Court‟s
reasoning in that case was the fact that policing fraud against federal agencies is not a field traditionally
occupied by the states, such that the presumption against preemption rooted in federalism concerns does
not apply. Id. at 347-48. Although the Stryker defendants have pressed implied preemption, in the
court‟s view, Buckman is wholly inapposite to this case. Simoneau is not seeking merely or even
primarily to enforce FDA requirements but, rather, to secure relief for her injury by recourse to traditional
state tort law. Indeed, her claims are the very type distinguished by Buckman and with respect to which
the presumption against implied preemption is strongest due to “the historic primacy of state regulation of
matters of health and safety.” Id. at 348, 352-53 (citation and internal quotation marks omitted).
must find that the federal government has imposed requirements on the medical device
at issue. Id. at 321. If so, then the court must determine whether the plaintiff‟s claims
are based on state requirements that are “„different from, or in addition to‟ the federal
ones, and that relate to safety and effectiveness.” Id. at 321-22 (quoting 21 U.S.C. §
360k(a)). Because there is no question either that the Trident Hip Implant is a Class III
medical device approved by the FDA through the PMA process, or that Simoneau‟s
state claims relate to safety and effectiveness, preemption in this case turns on whether
the state claims are “parallel”—that is, whether they are premised on violations of
federal requirements applicable to this device, and neither differ from nor add to such
All of Simoneau‟s state claims are governed by the CPLA, 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 Winslow v. Lewis-Shepard, Inc., 212 Conn.
462, 471 (1989) (“The legislature clearly intended to make our products liability act an
exclusive remedy for claims falling within its scope.”). While all products liability claims
have thus been consolidated into “a single form of action,” LaMontagne v. E.I. Du Pont
De Nemours & Co., Inc., 41 F.3d 846, 855 (2d Cir. 1994), the CPLA permits a plaintiff to
assert various common law theories of liability, Rosenthal v. Ford Motor Co., Inc., 462
F. Supp. 2d 296, 307 n.11 (D. Conn. 2006). 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 innocent.”).
As the court has already observed, see supra note 3, despite Simoneau‟s having
separately pled two counts against the Stryker defendants, her Complaint presents a
single CPLA cause of action premised on multiple theories within each count. Liberally
construed, the Complaint asserts the following four theories altogether: (1) strict
liability; (2) negligence; (3) breach of the implied warranties of merchantability and
fitness for a particular purpose; and (4) breach of express warranty. See Compl., Count
One ¶¶ 26-29; id., Count Two ¶¶ 26-29.
Taking all factual allegations in the Complaint as true, and drawing all reasonable
inferences in Simoneau‟s favor, the court finds that the Complaint pleads a plausible
parallel CPLA claim under some, but not all, of these theories. Specifically, a CPLA
claim under strict liability, negligence, and breach of implied warranties is not preempted
to the extent that these pertain to manufacturing defects and are premised on a violation
of federal requirements. All other theories are preempted—except breach of express
warranty, under which Simoneau has failed to state a claim, parallel or otherwise.
To recover on a theory of strict liability under the CPLA, Simoneau must prove,
inter alia, that the Trident Hip Implant was in a defective condition unreasonably
dangerous to her and that this defect caused the injury for which she seeks damages.
D'Ascanio v. Toyota Indus. Corp., 309 Conn. 663, 674 (2013); Izzarelli v. R.J. Reynolds
Tobacco Co., 731 F.3d 164, 167 (2d Cir. 2013) (applying strict liability doctrine in CPLA
action). “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). Simoneau has alleged all three types of defect, but
only her CPLA claim based on strict liability for defective manufacturing is not preempted
by the MDA.
Simoneau alleges, in pertinent part, that the Stryker defendants‟ manufacture of
the Trident Hip Implant did not meet FDA regulations and PMA specifications, Compl.,
Count One ¶¶ 25(b), 26(e); that this device was in an unreasonably dangerous and
defective condition as a result, id. ¶ 25; and that its defective condition was the actual
and proximate cause of her injury, id. ¶ 24.
In particular, Simoneau alleges that, in 2007, the FDA issued two warning letters
relating to the Stryker defendants‟ facilities and that the resulting FDA investigation
revealed components of the Trident Hip Implant to be “adulterated” as defined by
federal law. Id. ¶ 12. A device is deemed “adulterated” if, inter alia, “the methods used
in, or the facilities or controls used for, its manufacture, packing, storage, or installation
are not in conformity with applicable [CGMPs].” 21 U.S.C. § 351(h).
Simoneau further alleges that two recalls by the Stryker defendants—one in June
2008, the other in September 2009—directly relate to the manufacture of the Trident Hip
Implant she received in 2003. Compl., Count One ¶¶ 13, 15. The June 2008 and
September 2009 recalls were allegedly intended to address, respectively, foreign
material that exceeded internal acceptance criteria for manufacturing residuals in the
Acetabular Shell, id. ¶ 13, and non-compliance with metallurgical standards applicable
to cancellous bone screws, id. ¶ 15.
On the court‟s liberal reading of the Complaint, such factual allegations, together
with all reasonable inferences drawn from them, suffice to state a parallel CPLA claim.
Indeed, the Stryker defendants do not explain how a strict liability theory of defective
manufacturing imposes duties different from or additional to the federal ones. Rather,
they argue that Simoneau‟s allegations lack the requisite specificity to be parallel,
because they do not rest on any PMA specification referring to the Trident Hip Implant
itself and rely instead on broad swaths of the Code of Federal Regulations and
generalized CGMPs applicable to all devices and device manufacturers. See Stryker
Defs.‟ Mem. in Supp. of Mot. to Dismiss (“Stryker Defs.‟ Mem.”) (Doc. No. 15-1) at 1519; Stryker Defs.‟ Reply (Doc. No. 57) at 4-6.
While Simoneau‟s Complaint doubtless would benefit from the type of specificity
suggested by the Stryker defendants, the court rejects the need for medical devicerelated CPLA claims to be pled with that level of detail in order to defeat a Rule 12(b)(6)
motion. In so doing, the court is mindful that “much of the critical information,” including
PMA specifications for a particular device, “is kept confidential as a matter of federal
law” and will, therefore, be unavailable to a plaintiff without discovery. Bausch v.
Stryker Corp., 630 F.3d 546, 560 (7th Cir. 2010) (citing 21 C.F.R. § 814.9).6
To evade preemption, Simoneau‟s CPLA claim need only be plausibly premised
on a violation of “any requirement” applicable to the Trident Hip Implant under the
FDCA. 21 U.S.C. § 360k(a)(1); see Riegel, 552 U.S. at 330. The predicate violation of
With respect to the appropriate pleading standard, the court finds the Seventh Circuit‟s
reasoning in Bausch persuasive and faithful to the Supreme Court‟s direction to lower courts to make
“context-specific” determinations rooted in “judicial experience and common sense.” Iqbal, 556 U.S. at
679. The court notes, however, that the issue is scarcely settled and that, in the absence of direction
from the Second Circuit, district courts have not uniformly agreed on the level of specificity required to
meet the plausibility standard articulated in Iqbal and Twombly. See, e.g., Ilarraza v. Medtronic, Inc., 677
F. Supp. 2d 582, 589 (E.D.N.Y. 2009) (requiring “a particular federal specification referring to the device”);
Horowitz v. Stryker Corp., 613 F. Supp. 2d 271, 283 (E.D.N.Y. 2009) (requiring plaintiff to show link
between specific federal violation and plaintiff's injury); Gelber v. Stryker Corp., 788 F. Supp. 2d 145, 157
(S.D.N.Y. 2011) (rejecting heightened pleading requirement).
In this court‟s opinion, to adopt the Stryker defendants‟ view of what must be pled to survive a
Rule 12(b)(6) motion would, in effect, be to heighten the pleading standard for medical device torts—a
path that the court declines to follow for the reasons set forth in Bausch. 630 F.3d at 558-61.
a federal requirement has been sufficiently pled in the instant case in two ways: by
reference to violations of the CGMPs and by the Stryker defendants‟ two recalls in June
2008 and September 2009.7
CGMPs. In the court‟s view, Simoneau‟s reliance on generally applicable
CGMPs is permissible at this stage and suffices to state a parallel CPLA claim based on
strict liability for a manufacturing defect alleged to have personally injured her. The
Second Circuit, however, has not yet spoken to the issue of plaintiffs‟ reliance on
CGMPs, which impose general requirements applicable to all medical devices and
device manufacturers rather than device-specific requirements like those found in PMA
documents. Courts are split on this issue, see Bausch,630 F.3d at 554, including in this
Circuit, compare Horowitz v. Stryker Corp., 613 F. Supp. 2d 271, 284 (E.D.N.Y. 2009)
(disallowing reliance on CGMPs), and Ilarraza v. Medtronic, Inc., 677 F. Supp. 2d 582,
588 (E.D.N.Y. 2009) (same), with Gelber v. Stryker Corp., 788 F. Supp. 2d 145, 159
(S.D.N.Y. 2011) (permitting reliance on CGMPs).
The court agrees with the reasoning in Gelber and Bausch that there is no
“sound legal basis” for limiting the phrase “any requirement” in section 360k to devicespecific requirements contained in PMA documents. Bausch, 630 F.3d at 555. Such a
limitation “would leave injured patients without any remedy for a wide range of harmful
violations of federal law.” Id. Even assuming a plaintiff may recover only for claims
premised on a violation of device-specific requirements (a conclusion with which the
The predicate violation might also have been pled in a third way: by the two FDA warning letters
and related investigation in 2007. Simoneau fails, however, to connect these to the specific Trident Hip
Implant she received in 2003—for example, by alleging that the investigation was of the particular
facilities where her device was manufactured. Absent some such connection, the alleged FDA warning
letters and investigation do not plausibly state a parallel CPLA claim. Horowitz, 613 F. Supp. 2d at 282
(rejecting reliance on warning letters that lack “such a tie”).
court disagrees), policing that limitation at the pleadings stage would work especial
hardship for plaintiffs in this context, who, prior to discovery, have access to generally
applicable CGMPs, but not to confidential PMA specifications. Id. at 560.
As emphasized in Gelber, the CGMPs govern manufacturing controls and
methods for “all finished devices intended for human use,” including devices approved
through the PMA process. 788 F. Supp. 2d at 158 (quoting 21 C.F.R. § 820.1(a)(1)).
The concern that CGMPs are too generic to be enforced by juries is also mitigated, if
not obviated, by the fact that “the meaning of the FDA's requirements will present
questions of law for the court to decide, not questions of fact for a jury.” Bausch, 630
F.3d at 556. Such “questions of federal law [are] subject to the usual process for
reconciling conflicting views.” Id.
The Fifth Circuit, which has followed the Seventh in permitting reliance on
CGMPs, has indicated a further reason that this concern about jury enforcement may
well be misplaced in trials of Class III medical devices such as the Trident Hip Implant:
[B]y the time the case is tried, the jury will have before it the PMA
application that was approved by the FDA. To the extent a plaintiff can
show that the FDA-approved processes and procedures were not
followed, and that the injury was caused by this deviation, the plaintiff's
claim will be parallel. However, if the plaintiff challenges the suitability of
the precise processes or procedures chosen by the maker, and approved
by the FDA, to achieve the broader regulatory goals, such a claim could
Bass v. Stryker Corp., 669 F.3d 501, 512 (5th Cir. 2012). In the face of disagreement
among courts as to which complaints are sufficient to withstand a motion to dismiss, the
Bass decision advises that the dispositive factor “is not [a plaintiff‟s] reliance on CGMPs,
but rather the existence of a manufacturing defect caused by a violation of federal
regulations and allegations connecting a defect in the manufacture of the specific device
to that plaintiff's specific injury.” Id. 511-12.
While Simoneau did not allege a violation of any particular CGMP in the
Complaint, her citation to the CGMPs generally, taken together with her pleading as to
the specific conduct which violated these requirements and her description of evidence
such as FDA-classified recalls, gives the Stryker defendants “more than ample notice of
the alleged violation of federal law.” Gelber, 788 F. Supp. 2d at 156 (finding this
combination sufficient on similar facts). Indeed, one CGMP in particular—the
requirement “to ensure that [manufacturing material which could reasonably be
expected to have an adverse effect on product quality] is removed or limited,” 21 C.F.R.
§ 820.70(h)—is clearly as applicable to Simoneau‟s claim as it was to the plaintiff‟s
similar claim in Gelber.
The court concludes that where, as here, defective manufacturing is pled based
on a violation of the CGMPs, and the complaint contains factual allegations that are
plausible on their face and sufficient to put the defendant unquestionably on notice as to
the violation alleged to have resulted in the defect that caused the plaintiff‟s injury,
dismissal for lack of other device-specific allegations is improper and would unduly
focus the litigation on technicalities of pleading rather than the merits of the claims
brought. Cf. Foman v. Davis, 371 U.S. 178 (1962).
ii. Recalls. Simoneau‟s pleadings regarding the Stryker defendants‟ two recalls
in June 2008 and September 2009 plausibly suggest an additional link between a
violation of the federal requirements applicable to the Trident Hip Implant and the
manufacturing defect which allegedly caused her injuries. Indeed, unlike the plaintiff in
Horowitz, whose defective manufacturing claim was dismissed for failure to allege any
such link, 613 F. Supp. 2d at 283, Simoneau alleges that these recalls were of
components specifically implanted into her body in 2003, Compl., Count ¶¶ 13, 15.
According to the Complaint, the purpose of the two recalls was to address,
respectively, foreign material in the Acetabular Shell that exceeded internal acceptance
criteria for manufacturing residuals and non-compliance with specific metallurgical
standards in the manufacture of cancellous bone screws. Id. A reasonable inference is
that the Stryker defendants‟ manufacture of these components violated PMA
specifications as well. Gelber, 788 F. Supp. 2d at 157 (“It is certainly plausible that by
violating internal acceptance criteria, this conduct also violated manufacturing
specifications set forth in the premarket approval application.”).
In sum, the court concludes that a strict liability theory is not preempted to the
extent that the theory pertains to defective manufacturing and is premised on a violation
of FDA requirements. Given the unavailability of PMA documents prior to discovery,
Simoneau‟s reliance on CGMPs is permissible at this stage and, together with her
factual allegations regarding the Stryker defendants‟ particular conduct, is sufficient to
state a parallel CPLA claim. Moreover, the alleged recalls of specific components
implanted into her hip give rise to a reasonable inference of related violations of PMA
specifications and supply another ground for the court‟s conclusion.
Simoneau alleges that the Stryker Defendants failed to design the Trident Hip
Implant “in a manner which was safe for its intended users.” Compl., Count One ¶ 26(f).
However, with respect to a Class III medical device, which is subject to the rigorous
PMA process, state law claims for defective design cast doubt on the FDA's findings
concerning the safety of that device‟s design and, thus, are categorically preempted by
the MDA. See Riegel, 552 U.S. at 330; Bausch, 630 F.3d at 560 (“If the problem turns
out to be a design feature that the FDA approved, section 360k will protect the
manufacturer.”); Horowitz, 613 F. Supp. 2d at 284 (“Plaintiff's defective design claim,
which challenges the FDA's findings concerning the safety of the Trident System's
design, necessarily imposes requirements that are different from, or in addition to,
federal regulations.”); Simon v. Smith & Nephew, Inc., No. 13 CIV. 1909 PAE, 2013 WL
6244525, at *7 (S.D.N.Y. Dec. 3, 2013) (“[D]esign defect claims regarding a PMAapproved device are squarely preempted by the MDA.”).
Simoneau points the court to no contrary authority, nor does she suggest any
FDA requirement on which a strict liability theory for defective design of a Class III
medical device might conceivably be based. Accordingly, this theory is dismissed as
Labeling Defect / Failure to Warn
To prevail on a strict liability theory of defective labeling under the CPLA,
Simoneau must prove “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); see LaMontagne v. E.I. Du Pont De Nemours & Co., Inc., 41 F.3d
846, 859 (2d Cir. 1994).
Statutory factors to be considered by the trier of fact “[i]n determining whether
instructions or warnings were required and, if required, whether they were adequate,”
(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. § 52-572q(b). Simoneau‟s Complaint pleads strict liability for defective
labeling or warning based on overlapping allegations of misbranding, failure to warn,
and failure to report.
First, Simoneau alleges that the Trident Hip Implant was “misbranded” within the
meaning of 21 U.S.C. § 352. Compl., Count One ¶ 11. A device is “misbranded” if,
inter alia, “its labeling is false or misleading in any particular,” 21 U.S.C. § 352(a), or it is
“dangerous to health when used in the . . . manner . . . prescribed, recommended, or
suggested in the labeling,” id. § 352(j).
Second, Simoneau alleges that the Stryker defendants failed to warn her and
others, including hospitals and doctors performing hip replacement surgery, of the
hazards posed by the Trident Hip Implant, including the risk posed by the presence of
manufacturing residuals. Compl., Count One ¶¶ 25(c), 26(c)-(d); id., Count Two ¶¶
26(e)-(g). She also claims that they failed to advise her of three recalls relating to her
Trident Hip Implant in June 2008, August 2009, and September 2009, respectively. Id.,
Count One ¶¶ 13-15. Of particular relevance to her CPLA claim for inadequate
warnings or instructions, the August 2009 recall was of the “Trident Acetabular System
Surgical Protocol instructions for use of hip prosthesis, Literature Number LSP55.” Id. ¶
Lastly, Simoneau alleges that the Stryker defendants failed to comply with “FDA
requirements for records and reports,” id. ¶¶ 7-8, 17, including by failing “to timely report
any and all information concerning product failures and corrections,” id. at ¶ 19. As the
maker of a device intended for human use, the Stryker defendants have a continuing
obligation under the FDCA to report, inter alia, adverse events of which they become
aware that reasonably suggest the device “may have caused or contributed to a death
or serious injury, or has malfunctioned and . . . would be likely to cause or contribute to
a death or serious injury if the malfunction were to recur.” 21 U.S.C. § 360i(a)(1). In
the case of a Class III device like the Trident Hip Implant, the FDA must withdraw
premarket approval if it finds the applicant “has failed to establish a system for
maintaining records, or has repeatedly or deliberately failed to maintain records or to
make reports.” 21 U.S.C. § 360e(e)(1)(E)(i).
To be parallel, Simoneau‟s theory of strict liability for inadequate warnings or
instructions must be premised on a violation of FDA requirements. See Riegel, 552
U.S. at 330; Hughes v. Boston Scientific Corp., 631 F.3d 762, 769 (5th Cir. 2011) (“To
the extent that Hughes asserts a failure to warn claim based only on Boston Scientific's
failure to comply with FDA regulations, . . . such a claim is not expressly preempted.”);
Gelber, 788 F. Supp. 2d at 160 (dismissing plainitiff‟s failure to warn claim for lack of a
plausible connection to a violation of FDA requirements). Although Simoneau alleges
that the Stryker defendants violated FDA requirements, she does not link her injury to a
violation, nor can the court reasonably infer such a link from the pleadings regarding
misbranding, failure to warn, and failure to report in the Complaint.
With respect to misbranding, state claims based on labeling defects such as false
or missing information about health risks are similar to claims based on design defects
in general. Both are preempted in the case of Class III medical devices, because these
claims necessarily impose requirements different from or additional to the FDA‟s
requirements. See Riegel v. Medtronic, Inc., 451 F.3d 104, 120 (2d Cir. 2006)
(discussing the Riegels‟ labeling claims), aff'd, 552 U.S. 312. Indeed, like design
specifications, “proposed labeling” is subject to the PMA process, 21 U.S.C. §
360e(c)(1)(F), and the applicant cannot change it without FDA permission, id. §
360e(d)(6)(A)(i)); 21 C.F.R. § 814.39(a)(2); Riegel, 552 U.S. at 318-19. Simoneau cites
no authority permitting a misbranding claim against the manufacturer of a Class III
medical device, nor is such a claim plausibly parallel based on the scant pleadings
regarding misbranding in Simoneau‟s Complaint.8
With respect to Simoneau‟s other grounds—that the Styker defendants failed to
advise her of their recalls or to report adverse incidents to the FDA—preemption is not
so clearly categorical.9 However, in the instant case, these other grounds have not
been sufficiently pled to permit a careful preemption analysis. As to the first ground,
Simoneau identifies no federal requirement that the Stryker defendants warn an implant
recipient like her directly of their recalls. Cf. Bertini v. Smith & Nephew, Inc., No. 13
CIV. 79 BMC, 2014 WL 1028950, at *7-8 (E.D.N.Y. Mar. 17, 2014). As to the second
ground, she identifies no separate state law duty to warn the FDA.10
Simoneau did not brief failure to warn in connection with the Stryker defendants‟ August 2009
recall of the Trident Acetabular System Surgical Protocol instructions. Compl., Count One ¶ 14.
Although, at the motion to dismiss stage, the court may reasonably infer from the alleged recall that the
instructions were defective, a CPLA claim based on strict liability for such a defect is still preempted to the
extent that the instructions were submitted to the FDA pursuant to the PMA process.
The court notes that these two grounds presuppose a continuing duty to warn. While such a
duty does not fall within strict liability for inadequate warnings or instructions, as set forth in section 52572q of the Connecticut General Statutes, the Second Circuit has held that “the post-sale duty to warn
exists in negligence, and is cognizable under the CPLA.” Densberger v. United Technologies Corp., 297
F.3d 66, 71 (2d Cir. 2002). Rather than address failure to warn under strict liability and negligence
separately, the court has grouped all related allegations together here and incorporated this analysis into
the discussion of negligence in Part IV.B.2, infra.
At least two Circuits have held that failure to warn claims based on the manufacturer‟s failure to
report adverse events to the FDA may be permissible in some instances. Stengel v. Medtronic Inc., 704
F.3d 1224, 1233-34 (9th Cir. 2013) (en banc), petition for cert. filed, 2013 WL 1963892 (U.S. May 10,
2013) (No. 12-1351); Hughes v. Boston Scientific Corp., 631 F.3d 762, 769 (5th Cir. 2011). In both
While the court is mindful that Simoneau has not had the benefit of discovery, the
Complaint does not plausibly plead a parallel CPLA claim based on strict liability for
failure to advise her of recalls or to report adverse events to the FDA . This theory is,
therefore, dismissed as preempted, but without prejudice to replead.
To prevail on her CPLA claim based on a negligence theory, Simoneau must
show, inter alia, that the Stryker defendants owed her a duty a care. See LaMontagne
v. E.I. Du Pont De Nemours & Co., Inc., 41 F.3d 846, 856 (2d Cir. 1994). The existence
of a cognizable duty is a legal question, although “the answer in a given case depends
in part on the factual circumstances.” Id. Under Connecticut law,
the test for the existence of a legal duty of care entails (1) a determination
of whether an ordinary person in the defendant's position, knowing what
the defendant knew or should have known, would anticipate that harm of
the general nature of that suffered was likely to result, and (2) a
determination, on the basis of a public policy analysis, of whether the
defendant's responsibility for its negligent conduct should extend to the
particular consequences or particular plaintiff in the case
Gazo v. City of Stamford, 255 Conn. 245, 250 (2001) (citation and internal quotation
Although negligence is pled separately as Count Two of the Complaint, Count
One likewise pleads negligent conduct by the Stryker defendants. Compl., Count One ¶
27 (“Said acts constituting the negligence and careless conduct as aforesaid . . . .”). In
fact, the underlying factual allegations for both counts are identical. Id., Count Two ¶¶
Stengel and Hughes, however, a continuing state law duty to warn of known risks was found to
encompass (or assumed to encompass) a duty to warn the FDA. Stengel, 704 F.3d at 1233 (“Arizona law
contemplates a warning to a third party such as the FDA.”); Hughes, 631 F.3d at 769 (“Assuming that a
failure to warn claim may be pursued under Mississippi law as Hughes argues . . . .”). Given that
Simoneau has not sufficiently pled such a theory or alleged any link to her injury, the court declines to
reach the issue—one of first impression in this jurisdiction—of whether Connecticut law recognizes a duty
to warn that encompasses warning a federal agency like the FDA.
1-25 (incorporating by reference paragraphs 1-25 of Count One). The Complaint can
reasonably be read to assert a negligence theory of Connecticut products liability based
on state common law duties to exercise due care in the manufacture and design of a
medical device intended for human use and to provide adequate warnings and
instructions for such use.
Simoneau alleges, in pertinent part, that:
(1) the Stryker defendants negligently manufactured the Trident Hip Implant
by failing to comply with federal regulations and PMA specifications, id.
Count One ¶¶ 17-19, 25(a)-(b), 26(e); id., Count Two ¶¶ 26(c)-(d), as
evidenced by FDA warning letters and recalls of specific components
implanted into Simoneau, id., Count One ¶¶ 12-13, 15, with the result that
the device she received contained excess debris and was adulterated
within the meaning of 21 U.S.C. § 351, id. ¶¶ 19-20;
(2) the Stryker defendants negligently designed the Trident Hip Implant, id.,
Count One ¶¶ 26(f), 27;
(3) the Stryker defendants negligently failed to warn Simoneau and others,
including doctors and hospitals performing hip replacement surgery, of the
risk of excess manufacturing residuals in the Trident Hip Implant, id.,
Count One ¶¶ 25(c), 26(c)-(d); id., Count Two ¶¶ 26(e)-(g)—including by
putting into the stream of commerce a device that was misbranded within
the meaning of 21 U.S.C. § 352(a), id., Count One ¶¶ 11, 19, not informing
recipients like her of device recalls, id. ¶¶ 13-15, and not complying with
FDA reporting requirements, id. ¶¶ 7-8, 17, 19.
With respect to these allegations, the court reaches the same conclusions
regarding preemption that it reached with respect to the related allegations under strict
liability, and for the same reasons outlined in Part IV.B.1, supra. First, negligent
manufacturing is not preempted, because to the extent such negligence is premised on
a violation of FDA requirements, the state common law duty parallels the federal
requirement. Bass, 669 F.3d at 515 (negligent manufacturing claim not preempted);
Bausch, 630 F.3d at 553 (same); Gelber, 788 F. Supp. 2d at 155-60 (same); see
discussion supra Part IV.B.1.a. Second, in contrast, negligent design is preempted, as
is negligent failure to warn where based on labels or instructions submitted to the FDA
pursuant to the PMA process. Riegel, 552 U.S. at 330; Bausch, 630 F.3d at 560;
Simon, 2013 WL 6244525, at *7; see discussion supra Part IV.B.1.b & c. Simoneau‟s
negligent design and negligent labeling theories are, therefore, dismissed.
Third, as to the remaining two grounds of negligent failure to warn—that the
Stryker defendants did not advise Simoneau of recalls and did not report adverse
events to the FDA—the court concludes that the Complaint does not plausibly plead a
parallel CPLA claim based on these allegations for the respective reasons given in Part
IV.B.1.c, supra: (1) Simoneau fails to identify a federal requirement that the Stryker
defendants directly notify implant recipients of recalls; and (2) she fails to identify a state
law duty requiring the Stryker defendants to warn the FDA.11 The dismissal of these
two grounds of negligent failure to warn is without prejudice to replead.
It bears reiterating that, while the court has grouped together all allegations of failure to warn,
not all allegations are cognizable under both strict liability and negligence. In particular, the failure to
advise Simoneau of recalls and to report adverse events to the FDA are predicated on a post-sale duty to
warn that the Second Circuit has held to exist only in negligence. See Densberger, 297 F.3d at 71.
Breach of the Implied Warranties of Merchantability and Fitness for
a Particular Purpose
The CPLA incorporates breach of warranty theories. Conn. Gen. Stat. § 52572m(b) (“„Product liability claim‟ shall include . . . breach of warranty, express or
implied.”). The elements of the theories, however, derive from a different statutory
source—namely, the Connecticut Uniform Commercial Code (“CUCC”), title 42 of the
Connecticut General Statutes. Walters v. Howmedica Osteonics Corp., 676 F. Supp. 2d
44, 55 (D. Conn. 2009). While the CPLA provides, then, the statutory vehicle for
Simoneau‟s action, the CUCC provides the substantive legal basis for her theories here
of breach of the implied warranties of merchantability and fitness for a particular
purpose, Conn. Gen. Stat. §§ 42a-2-314 & 42-2-315, as well as her theory of breach of
express warranty, id. § 42a-2-313, discussed in Part IV.B.4, infra.
Under the CUCC, “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(1). To be merchantable, the goods must be, inter alia, “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.” Id. §§ 42a-2-314(2). In addition,
“there is an implied warranty that the goods shall be fit for [any particular purpose for
which the goods are required]” if, at the time of contracting, the seller has reason to
know of such purpose and of the buyer‟s reliance “on the seller's skill or judgment to
select or furnish suitable goods.” Id. § 42a-2-315.
Simoneau pleads breach of these implied warranties based on factual allegations
regarding defective manufacture, which the court has already detailed in Part IV.B.1.a,
supra. The gravamen of this theory is that the Stryker defendants‟ failure to comply with
federal regulations and PMA specifications caused components of the Trident Hip
Implant received by Simoneau in 2003 to be unfit for their ordinary and intended
purposes. See Compl., Count One ¶ 26(g); id., Count Two ¶ 26(h). To the extent that
this theory relates to manufacturing defects and is premised on a violation of FDA
requirements, the state and federal requirements are parallel, and the theory is not
preempted. Bass, 669 F.3d at 517 (breach of implied warranty claim not preempted);
Gelber, 788 F. Supp. 2d at 166 (same); McConologue v. Smith & Nephew, Inc., No.
3:13-CV-00880 VLB, 2014 WL 1246834, at *16 (D. Conn. Mar. 24, 2014) (same).
Hence, for the reasons stated in Part IV.B.1.a, supra, the court concludes that the
Complaint plausibly pleads a theory of Connecticut products liability based on breach of
the implied warranties of merchantability and fitness for a particular purpose.
Breach of Express Warranty
To prevail on a breach of express warranty theory, Simoneau must prove, inter
alia, “the existence of an express warranty.” Web Press Servs. Corp. v. New London
Motors, Inc., 203 Conn. 342, 351 (1987). Under the CUCC,
Express warranties by the seller are created as follows: (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 goods shall
conform to the sample or model.
Conn. Gen. Stat. § 42a-2-313(1). Although the seller need not use specific words or
even intend to make such a warranty, “some statements of sellers are merely „puffing‟
and do not create express warranties.” Web Press Servs., 203 Conn. at 351; see
Conn. Gen. Stat. § 42a-2-313(2).
Simoneau alleges that the Stryker defendants breached their express warranty
that the Trident Hip Implant was “safe [and] effective for its intended use.” Compl.,
Count One ¶ 26(h). The underlying warranty of safety and effectiveness, however, is
not specifically pled, nor is the identity of the party to whom it was made “as part of the
basis of the bargain.” Conn. Gen. Stat. § 42a-2-313. Nor are there any factual
allegations from which the court could reasonably infer these prerequisites of a breach
of express warranty theory.
Such a theory is by no means categorically preempted in the case of Class III
medical devices.12 But the theory has not been sufficiently pled to state a CPLA claim,
parallel or otherwise. The court, therefore, dismisses it for that reason alone.
To analyze preemption, the court must have before it allegations in the Complaint
plausibly indicating a basis for breach of an express warranty. Such allegations are
entirely lacking at present. In her Opposition brief, Simoneau asserts that the basis is
not “labeling” submitted to the FDA but “commitments voluntarily undertaken, resulting
Although Riegel does not address whether courts should analyze breach of express warranty
claims like other state products liability claims, the Supreme Court has explained in a different preemption
A manufacturer's liability for breach of an express warranty derives from, and is measured by, the
terms of that warranty. Accordingly, the “requirement[s]” imposed by an express warranty claim
are not “imposed under State law,” but rather imposed by the warrantor. . . . While the general
duty not to breach warranties arises under state law, the particular [requirement] in an express
warranty claim arises from the manufacturer's statements in its advertisements. In short, a
common-law remedy for a contractual commitment voluntarily undertaken should not be regarded
as a “requirement . . . imposed under State law.”
Cipollone v. Liggett Grp., Inc., 505 U.S. 504, 525-26 (1992).
So long as the representation at issue is volunteered outside the PMA process, a breach of
warranty theory appears not to trigger express preemption. Mitchell v. Collagen Corp., 126 F.3d 902, 915
(7th Cir. 1997); Gelber, 788 F. Supp. 2d at 165; Horowitz, 613 F. Supp. 2d at 285. The MDA prohibits
states from imposing different or additional requirements. 21 U.S.C. § 360k(a). It does not, however,
prohibit the manufacturer from imposing such requirements on itself and being held to them by state law.
It would be strange indeed to read section 360k to preempt breach of an express warranty that neither
federal nor state law required the manufacturer to make in the first place.
from Stryker‟s marketing efforts.” Pl.‟s Mem. in Opp‟n to Stryker Defs. Mot. to Dismiss
(“Pl.‟s Opp‟n”) (Doc. No. 51) at 24 (citing Compl., Count One ¶ 6). Paragraph 6 of the
Complaint alleges that Simoneau received components that were marketed (as well as
designed and manufactured) by the Stryker defendants. The hospital record referenced
in Paragraph 6 and attached as Exhibit A to the Complaint lists, inter alia, such
components, with serial and lot numbers. None of this, however, suffices to indicate a
plausible factual basis for Connecticut products liability based on breach of an express
While Simoneau need not prove the existence of the warranty at this stage, the
Complaint must at least indicate the representation that the Stryker defendants are
alleged to have made and breached. Otherwise, Simoneau has not given them “fair
notice” of the nature and basis of her claim. Twombly, 550 U.S. at 556 n.3 (“Without
some factual allegation in the complaint, it is hard to see how a claimant could satisfy
the requirement of providing not only „fair notice‟ of, but also „grounds‟ on which the
claim rests.” (quoting Conley v. Gibson, 355 U.S. 41, 47 (1957))). Indeed, while the
Complaint need not plead every element of the prima facie case, Swierkiewicz v.
Sorema N. A., 534 U.S. 506, 511 (2002), a breach of express warranty claim without
any reference to the underlying representation lacks plausibility.
Accordingly, Simoneau‟s breach of express warranty theory is dismissed for
failure to state a claim, with the right to replead.
For the reasons set forth above, the Stryker Defendants‟ Motion to Dismiss (Doc.
Nos. 14 &15) is GRANTED in part and DENIED in part. The Motion is denied as to
the strict liability, negligence, and breach of implied warranties theories of Simoneau‟s
CPLA claim to the extent that these relate to defective manufacturing of the Trident Hip
Implant and are premised on a violation of the FDA‟s requirements. The Motion is
granted as to all other theories of products liability.
With respect to all of the theories dismissed, Simoneau‟s request for leave to
amend her Complaint is granted. An amended complaint, if any, shall be filed no later
than April 21, 2014.
Dated at New Haven, Connecticut this 31st day of March, 2014.
/s/ Janet C. Hall
Janet C. Hall
United States District Judge
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