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 Plaintiffs 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.
I. Factual Background
The following facts and allegations are taken from Plaintiffs complaint.
On or about March 22, 2010 John McCo-nologue underwent a right total hip arthro-plasty surgery, during which Dr. John M.
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 If 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 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. Keg-gi’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 Plaintiffs 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 ¶ 16].
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. GemStat. § 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;
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
“ ‘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.,
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,
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.
IV. Analysis
The Defendant argues that McCono-logue’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 Plaintiffs complaint is inadequately pled under Federal Rule of Civil Procedure 8(a) and the standards set forth in Iqbal and Twombly. The 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.,
Conn. GemStat. § 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. GemStat. § 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, 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(e).
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.,
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,
After approval, the MDA imposes a rigorous oversight regime and forbids the
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.,
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 effectwith 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 Supreme Court has recently attempted to refine the parameters of the MDA’s express preemption provision in Riegel v. Medtronic, Inc.,
The Riegel Court, however, took care to point out the exception to the MDA’s preemption provision, noting that certain claims may be asserted:
[sjtate 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,
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.,
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 product-specific 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.,
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, Plaintiffs 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,
i. Wholesale Preemption
The Defendant’s first argument that the Plaintiffs complaint is wholly and expressly preempted by the MDA because the ceramic liner at issue received approval from the FDA and because Plaintiffs claims challenge the safety and effectiveness of the device — an argument that ignores the Plaintiffs allegations that Smith & Nephew’s Ceramic Liner was not manufactured according to the FDA’s premark-et approval process — is misinformed. The Defendant has provided no support for its proposition that the MDA expressly preempts the entirety of the Plaintiffs complaint simply because the Class III Liner had received premarket approval, but where the plaintiffs 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 preempts the Plaintiffs 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 Plaintiffs 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.
c. Products Liability: Manufacturing Defect
The Defendant argues that McCono-logue’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 [plaintiffs] 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 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. McCono-logue 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 Plaintiffs right hip indicated that the Ceramic Liner had fractured; (6) the Plaintiff underwent total right hip ar-throplasty revision surgery as a result of the pain, squeaking, and reported Liner fracture; and (7) the surgery confirmed that the Liner was fractured. McCono-logue has specified the defect in the Liner he received and how that defect differed from the federal standards applicable to
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 Plaintiffs 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.,
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 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.
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,
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,
McConologue contends that the Defendant did not warn him that the allegedly mis-manufaetured 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 con-trastly 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,
Defendant’s motion to dismiss Plaintiffs 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 Plaintiffs 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 Plaintiffs allegations relate only to the manufacture, not to the FDA-approved design, of its Ceramic Liner and thus Plaintiffs 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 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, MeCono-logue 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, “ ‘[product 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. GemStat. § 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.,
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,
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 Plaintiffs product liability claim sounding in negligence&emdash;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&emdash;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 Plaintiffs 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 conelu-sory 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 Plaintiffs negligence theory based on defective manufacturing of the Ceramic Liner survives.
However, Plaintiffs 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 Twombly 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 assertions] devoid of further factual enhancement.” Iqbal,
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 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 Plaintiffs 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 pre-market 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 Plaintiffs misrepresentation claim imposes requirements that are different from or in addition to requirements 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,
Nor is the Plaintiffs 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 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.,
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 “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 Plaintiffs 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
h. Products Liability: Breach of Warranty
Smith & Nephew urges dismissal of the Plaintiffs 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 Plaintiffs sufficient allegation that the Ceramic Liner was manufactured in violation of FDA standards, which allegedly undermined the device’s safety and 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 MeConologue has pleaded a violation of the device’s manufacturing standards. See Horowitz,
Indeed, courts have held that, where a plaintiff has pled a defective manufacturing claim, a state law claim for breach of
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, (8) damages proximately caused by the breach. Motley v. Jaguar Land Rover N. Am., LLC, X03CV084057552S,
(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(l). 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
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.,
V. Conclusion
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.
Notes
. 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.