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holding “[p]laintiff's breach of implied warranty claims . . . are subsumed by the NJPLA”
Summary of this case from In re Smitty's/Cam2 303 Tractor Hydraulic Fluid Mktg. Sales Practices & Prods. Liab. Litig.Opinion
Civil Action No. 19-06585 (FLW)
2019-10-30
Darlene HINDERMYER, Plaintiff, v. B. BRAUN MEDICAL INC., et al., Defendants.
Alexandra Colella, Gordon Drew Kessler, Marc J. Bern & Partners, LLP, New York, NY, for Plaintiff. Aaron Van Nostrand, Greenberg Traurig LLP, Florham Park, NJ, for Defendant.
Alexandra Colella, Gordon Drew Kessler, Marc J. Bern & Partners, LLP, New York, NY, for Plaintiff.
Aaron Van Nostrand, Greenberg Traurig LLP, Florham Park, NJ, for Defendant.
WOLFSON, United States District Judge:
This matter comes before the Court on Defendants B. Braun Medical Inc. and B. Braun Interventional System's (collectively, "Defendants") Motion to dismiss Plaintiff Darlene Hindermyer's ("Plaintiff") Complaint, pursuant to Federal Rule of Civil Procedure 12(b)(6). This suit arises from the alleged personal injuries that Plaintiff sustained as a result of a defective medical device that Defendants manufactured, designed, and sold. In the Complaint, Plaintiff asserts the following ten causes of action against Defendants: (1) negligence; (2-4) design, manufacturing, and warning defect claims pursuant to the New Jersey Products Liability Act, N.J.S.A. 2A:58C-1 et seq. ("NJPLA"); (5) breach of the express warranty; (6-7) breaches of the implied warranty of fitness and implied warranty of merchantability; (8) fraudulent misrepresentation; (9) fraudulent concealment; and (10) negligent misrepresentation.
For the reasons set forth below, Defendants' Motion is GRANTED , and Plaintiff's Complaint is dismissed in its entirety. Plaintiff's claims for negligence (Count I), fraudulent misrepresentation (Count VIII), fraudulent concealment (Count IX), negligent misrepresentation (Count X), breach of the implied warranty of merchantability (Count VI), and breach of the implied warranty of fitness (Count VII) are dismissed with prejudice, as those claims are subsumed by the NJPLA. Plaintiff's NJPLA claims, including defective design (Count II), manufacturing defect (Count III), and failure to warn (Count IV), as well as her breach of the express warranty claim (Count V), are dismissed without prejudice. Plaintiff is given leave to amend those claims in accordance with the dictates of this Opinion, within fourteen (14) days of the date of the accompanying Order.
I. FACTUAL BACKGROUND AND PROCEDURAL HISTORY
The following factual allegations are taken from Plaintiff's Complaint and are accepted as true for the purposes of this Motion. A pulmonary embolism ("PE") occurs when a blood clot "travels from the blood vessels in the legs and pelvis, through the inferior vena cava ("IVC"), which is "the vein that returns blood to the heart from the lower extremities," and into the lungs. Complaint ("Compl."), ¶ 18. Blood clots can also form in the deep leg veins, causing a dangerous condition known as deep vein thrombosis ("DVT") that, like PE, "can often result in death." Id.
An IVC filter is a medical device that traps and filters blood clots that develop in the lower extremities to prevent them from reaching the lungs. These device are used to treat patients who are prone to high risks of PE and DVT, in order to reduce the likelihood of a thrombotic event. Id. at ¶¶ 20-21. Developed in 1967, IVC filters were originally designed for permanent implantation in a patient, but eventual concerns over long-term health complications prompted the creation of a retrievable filter. Id. at ¶¶ 23-24. Unlike their permanent counterparts, which remain in a patient indefinitely, retrievable filters are intended for removal after the risk of a thrombotic event subsides. Id.
In 2001, Defendants obtained U.S. Food and Drug Administration ("FDA") clearance to market the B. Braun VenaTech™ vena cava filter (the "VenaTech Filter") under Section 501(k) of the Medical Device Amendment, which obviated the requirement of having the FDA conduct an independent evaluation of the device. Id. at ¶¶ 29-31. As manufactured, the VenaTech Filter possesses a cone-like shape comprising cobalt-chromium-nickel alloy, and it is designed to prevent "recurrent pulmonary embolism via placement in the vena cava." Id. at ¶¶ 8, 25-27, 39-40. In addition, the VenaTech Filter is "self-centering, with patented stabilizing legs which [are] intended to prevent filter tilting during the implantation to eliminate the possibility of perforation or migration." Id.
As alleged in the Complaint, § 501(k) of the Medical Device Amendment "allows for the marketing of medical devices, so long as the medical device is deemed substantially equivalent to other legally marketed predicate devices ...." Compl., ¶ 30.
In 2007, faulty packaging, sterility, and safety concerns promoted a Class II Device Recall of the VenaTech Filter, which the FDA lifted on March 2, 2008. Id. at ¶ 41. The FDA also published "MAUDE Adverse Event Reports," detailing instances where the VenaTech Filter caused adverse health complications in certain patients, who, for medical reasons, had to surgically remove the device. Id. at ¶¶ 42-47. In 2010 and, once again, in 2014, the FDA issued "alerts" about "the problematic nature of permanent and retrievable filters," urging "doctors to remove IVC filters," particularly those which were retrievable, within one to two months after the risk of a pulmonary embolism subsides. Id. at ¶¶ 48-50. Notwithstanding these alerts, however, Plaintiff alleges that Defendants continued to manufacture and promote the VenaTech Filter for "long-term use." Id. at ¶ 51. As to the specific factual allegations concerning Plaintiff, on June 20, 2007, Plaintiff underwent a surgical implant of the VenaTech Filter at the Robert Wood Johnson University Hospital as treatment for recurrent PEs. Id. at ¶¶ 58-61. Dr. Reza Shah, M.D. performed the procedure by inserting the filter in Plaintiff's right groin at the L3-L4 level, in accordance with Defendants' "specific instructions, guidelines, and directives." Id. at ¶¶ 62, 64. Approximately eight years after her surgical procedure, on December 7, 2015, Plaintiff alleges that she was hospitalized for "chronic right side pain" in the area where the IVC filter was inserted. Id. at ¶ 66. A medical scan confirmed that "an IVC filter was present at the L3-L4" level, at which the VenaTech Filter was originally implanted; importantly, Plaintiff has not "considered for revision or removal of the device," nor has she been provided with such a recommendation from her physicians. Id. at ¶¶ 65-66.
Although she has not experienced any of the following medical issues, Plaintiff alleges that her chronic pain "can be an indicator of further complications, including "migration, tilt, fracture or breakage of the filter, perforation of the vena cava or other soft tissue," and other unspecified "serious problems," because the medical device is unable to withstand "the normal anatomical and physiological cycles exerted in vivo." Id. at ¶¶ 67, 70-71, 77. Plaintiff alleges that Defendants promoted the VenaTech Filter as a "safe and effective" medical device, concealing "the known risks and fail[ing] to warn of known or scientifically knowable dangers and risks associated with" its product. Id. at ¶¶ 72-73, 78-80. Because of Defendants' "wrongful acts and omissions," Plaintiff alleges a higher "risk of suffering from serious health complications ... and future injuries." Id. at ¶¶ 81-82.
Based on these allegations, Plaintiff filed the instant Complaint in the New Jersey Superior Court, Law Division, Mercer County, seeking punitive damages and asserting various common law claims and violations under the NJPLA. On February 22, 2019, Defendants removed this action on the basis of diversity jurisdiction to this Court. Now, Defendants move for dismissal of Plaintiff's Complaint pursuant to Fed. R. Civ. P. 12(b)(6), arguing that the NJPLA subsumes her common law causes of action for negligence, breach of the implied warranties, and her fraud-based claims. As to Plaintiff's remaining claims, Defendants contend that Plaintiff has neither pled a cognizable theory of design, manufacturing, or warning defect under the NJPLA, nor has she alleged a breach of the express warranty. Plaintiff opposes the motion.
II. DISCUSSION
A. Standard of Review
In reviewing a motion to dismiss pursuant to Fed. R. Civ. P. 12(b)(6), the court must, as an initial matter, separate the factual and legal elements of the claims, accepting the well-pleaded facts as true and drawing all reasonable inferences in the plaintiff's favor. See In re Ins. Brokerage Antitrust Litig. , 618 F.3d 300, 314 (3d Cir. 2010) ; see also Fowler v. UPMC Shadyside , 578 F.3d 203, 210-11 (3d Cir. 2009). To survive a motion to dismiss, the plaintiff must provide "enough facts to state a claim to relief that is plausible on its face." Bell Atl. Corp. v. Twombly , 550 U.S. 544, 570, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007). "The plausibility standard is not akin to a ‘probability requirement,’ but it asks for more than a sheer possibility that a defendant has acted unlawfully." Ashcroft v. Iqbal , 556 U.S. 662, 678, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009). The Third Circuit requires a three-step analysis to meet the plausibility standard mandated by Twombly and Iqbal . First, the court should "outline the elements a plaintiff must plead to a state a claim for relief." Bistrian v. Levi , 696 F.3d 352, 365 (3d Cir. 2012). Next, the court should "peel away those allegations that are no more than conclusions and thus not entitled to the assumption of truth." Id. ; see also Iqbal , 556 U.S. at 678-79, 129 S.Ct. 1937 ("While legal conclusions can provide the framework of a complaint, they must be supported by factual allegations."). Indeed, it is well-established that a proper complaint "requires more than labels and conclusions, and a formulaic recitation of the elements of a cause of action will not do." Twombly , 550 U.S. at 555, 127 S.Ct. 1955 (internal quotations and citations omitted). Third, the court should assume the veracity of all well-pled factual allegations, and then "determine whether they plausibly give rise to an entitlement to relief." Bistrian , 696 F.3d at 365 (quoting Iqbal , 556 U.S. at 679, 129 S.Ct. 1937 ). A claim is facially plausible when there is sufficient factual content to support a "reasonable inference that the defendant is liable for the misconduct alleged." Iqbal , 556 U.S. at 678, 129 S.Ct. 1937. This final step is "a context-specific task that requires the reviewing court to draw on its judicial experience and common sense." Id. at 679, 129 S.Ct. 1937.
B. Analysis
i. Subsumption Under The NJPLA
As a threshold issue, Defendants contend that Plaintiff's negligence (Count I), breach of the implied warranty (Counts VI, and VII), and fraud-based claims (Counts VIII, IX, and X) are subsumed under the NJPLA, because that statute provides the sole basis for relief in products liability cases. Therefore, before addressing the sufficiency of Plaintiff's pleadings, I consider whether the NJPLA subsumes her common law claims. I answer that question in the affirmative.
In implementing the NJPLA, the Legislature intended "to limit the expansion of products-liability law" and "to limit the liability of manufacturers so as to balance[ ] the interests of the public and the individual with a view towards economic reality." Zaza v. Marquess & Nell, Inc. , 144 N.J. 34, 48, 675 A.2d 620 (1996) (internal quotations and citations omitted). To strike the appropriate balance of interests, the NJPLA "established the sole method to prosecute a product liability action," and following its enactment, "only a single product liability action remains." Tirrell v. Navistar Int'l, Inc. , 248 N.J. Super. 390, 398-99, 591 A.2d 643 (App. Div. 1991). The Third Circuit has explained that the NJPLA "effectively creates an exclusive statutory cause of action for claims falling within its purview." Repola v. Morbark Indus., Inc. , 934 F.2d 483, 492 (3d Cir. 1991). As such, "the NJPLA generally subsumes common law product liability claims, thus establishing itself as the sole basis of relief under New Jersey law available to consumers injured by a defective product." Id. ; see In re Lead Paint Litig. , 191 N.J. 405, 436, 924 A.2d 484 (2007) (finding that the NJPLA accomplishes its liability-limiting function by creating "one unified, statutorily defined theory of recovery for harm caused by a product.").
The New Jersey Supreme Court has explained that "[t]he language chosen by the Legislature in enacting the PLA is both expansive and inclusive, encompassing virtually all possible causes of action relating to harms caused by consumer and other products." In re Lead Paint Litig. , 191 N.J. at 436-37, 924 A.2d 484. The rule that the NJPLA subsumes almost all other causes of action stems from the language of the statute itself. More specifically, § 2A:58C-2 of the NJPLA provides:
A manufacturer or seller of a product shall be liable in a product liability action only if the claimant proves by a preponderance of the evidence that the product causing the harm was not reasonably fit, suitable or safe for its intended purpose because it: a. deviated from the design specifications, formulae, or performance standards of the manufacturer or from otherwise identical units manufactured to the same manufacturing specifications or formulae, or b. failed to contain adequate warnings or instructions, or c. was designed in a defective manner.
N.J.S.A. § 2A:58C-2. Under the definitional section of the NJPLA, "harm" is defined as: "(a) physical damage to property, other than to the product itself; (b) personal physical illness, injury or death; (c) pain and suffering, mental anguish or emotional harm; and (d) any loss of consortium or services or other loss deriving from any type of harm described in subparagraphs (a) through (c) of this paragraph." N.J.S.A. § 2A:58C-1(b)(2). Furthermore, a "product liability action" is defined as "any claim or action brought by a claimant for harm caused by a product, irrespective of the theory underlying the claim, except actions for harm caused by breach of an express warranty." N.J.S.A. § 2A:58C-1(b)(3).
To determine whether the NJPLA subsumes a particular claim, the court must ascertain the type of harm that a plaintiff is alleging; namely, whether the harm involves property damage or bodily injury caused by the alleged defective product, or whether the harm was solely to the product, itself. That is, "courts do not simply determine whether or not the victim's injury was literally ‘caused by a product,’ " but rather, "courts tend to look at the essence of the claims and decide whether or not the plaintiff is disguising what would traditionally be considered a products liability claim as an alternative cause of action." See New Hope Pipe Liners, LLC v. Composites One, LCC , No. 09-3222, 2009 WL 4282644, at *2, 2009 U.S. Dist. LEXIS 111217, at *2 (D.N.J. Nov. 30, 2009) ; see also In re Lead Paint Litig. , 191 N.J. at 437, 924 A.2d 484 ("Were there any doubt about the essential nature of the claims asserted by plaintiffs, a careful reading would demonstrate that they sound in products liability causes of action."). Indeed, even "quasi-products liability claim[s] ... would properly be brought only under the [NJ]PLA." Volin v. Gen. Elec. Co. , 189 F. Supp. 3d 411, 418 (D.N.J. 2016). However, "when the ‘essential nature’ of the claim is not that of a [NJ]PLA claim, ‘the plaintiff may maintain a separate cause of action.’ " Id. (citation omitted).
In recognition of the broad scope of the NJPLA, New Jersey federal and state courts have consistently dismissed product liability-related claims based on common law theories when at the heart of those theories is the potential "harm caused by a product." See, e.g. , Port Auth. of N.Y. & N.J. v. Arcadian Corp. , 189 F.3d 305, 313 (3d Cir. 1999) (dismissing negligence claim, because "under New Jersey law negligence is no longer viable as a separate claim for harm caused by a product"); Thomas v. Ford Motor Co. , 70 F. Supp. 2d 521, 528-29 (D.N.J. 1999) (dismissing common-law claim for negligent manufacture); Reiff v. Convergent Techs. , 957 F. Supp. 573, 583 (D.N.J. 1997) (dismissing negligence and implied breach of warranty claims); McWilliams v. Yamaha Motor Corp. USA , 780 F. Supp. 251, 262 (D.N.J. 1991) (dismissing negligence and breach of implied warranty claims), aff'd in part, rev'd in part on other grounds , 987 F.2d 200 (3d Cir. 1993) ; Green v. GMC , 310 N.J. Super. 507, 517, 709 A.2d 205 (App. Div. 1998) (stating that "causes of action for negligence, strict liability and implied warranty have been consolidated into a single product liability cause of action" under the NJPLA).
In addition, courts have found that the NJPLA subsumes common law and statutory fraud claims so long as the harm alleged was caused by a product. See Brown v. Philip Morris, Inc. , 228 F. Supp. 2d 506, 517 (D.N.J. 2002) (fraud claim preempted by the NJPLA when the defendant's alleged misrepresentations resulted in "harm caused by a product."); Sinclair v. Merck & Co. , 195 N.J. 51, 66, 948 A.2d 587 (2008) (statutory consumer fraud claim subsumed by the NJPLA when the "[t]he heart of plaintiff's case [was] the potential harm caused by Merk's drug."); McDarby v. Merck & Co. , 401 N.J. Super. 10, 95-96, 949 A.2d 223 (App. Div. 2008) (statutory consumer fraud claim subsumed by the NJPLA because "the gravamen of [the] claim was that Merk marketed Vioxx fully aware of its cardiovascular risk [and] made misrepresentations[ ] and ... omis[ssions]" in connection with its marketing). Indeed, in Lopienski v. Centocor, Inc. , No. 07-4519, 2008 WL 2565065, at *1 n.2, 2008 U.S. Dist. LEXIS 49099, at *3 n.2 (D.N.J. Jun. 25, 2008), this Court found that the plaintiff's causes of action for negligence, breach of implied warranty, negligent and fraudulent misrepresentation, statutory consumer fraud, and fraudulent concealment were subsumed, because they were premised on physical injuries caused by a product.
Here, the factual allegations, as pled in the Complaint, demonstrate that the instant action arises from the alleged personal injuries that Plaintiff sustained, as a result of an allegedly defectively designed and manufactured product—the VenaTech Filter. More specifically, in the factual background section of her pleadings, Plaintiff alleges that she "was injured as a result of the use of [the VenaTech Filter]," which suffers from a defect and/or improper design, and that she has commenced this action "for damages" that were "caused as a direct result of" the implantation of the medical device, including "chronic right side pain," and the increased risk of experiencing future adverse health complications. Compl., ¶¶ 56-57, 66, 70, 77. Therefore, based on the allegations, as pled, Plaintiff has clearly asserted a "harm" which falls within the broad reach of the NJPLA, and her negligence, implied warranty, and fraud-based claims are subsumed by that statute.
Nonetheless, without addressing her negligence claim, Plaintiff contends that her breach of warranty and fraud-based causes of action should coexist with her statutory claims under the NJPLA. Plaintiff's Opposition to Defendants' Dismissal Motion ("Pl.'s Opp."), at 2, 10. Citing to this Court's prior decision in Montich v. Miele , Plaintiff argues that the NJPLA does not subsume her implied warranty claims, because she has alleged that "Defendants' device is no longer viable for long term use." Id. at 2. Plaintiff, in addition, references Nafar v. Hollywood Tanning Systems to support her position that she can pursue fraud-based claims which arise from Defendant's alleged "misleading advertisements and/or representations," as opposed to solely the failure to warn about, or disclose, the risks associated with the VenaTech Filter. Id. Plaintiff's arguments are addressed in turn.
a. Implied Warranty Claims
Plaintiff's reliance on this Court's prior decision in Montich is misplaced. 849 F. Supp. 2d 439 (D.N.J. 2012). In that case, the plaintiff purchased a front loading-washing machine which emitted odors of mold and mildew after regular household use. Id. at 442. Displeased, the plaintiff brought suit against the defendant manufacturer, asserting consumer protection, breach of the implied warranty, and unjust enrichment claims. Id. Concluding that the NJPLA's subsumption doctrine was inapplicable to the parties' dispute, this Court reasoned that the claimed harm fell outside of the purview of that statute, because the plaintiff, there, did not allege a harm which was caused by the washing machine, including adverse health effects, personal injuries, or damage to her other property. Id. at 457. Rather, the claimed harm pertained to the malfunctioning of the washing machine, itself, as the plaintiff sought to recover a significant sum for an unusable product which required repair. Id. Therefore, because the plaintiff's factual allegations did not sound in products liability, she was permitted to pursue state and common law claims.
Unlike Montich , the gravamen of the Complaint, here, does not relate to the deficiencies of the VenaTech Filter, itself. In support of her claims, Plaintiff alleges that Defendants "impliedly warranted [their] product to be of merchantable quality and safe and fit for its intended use." Compl., ¶¶ 200-01, 214-15. Plaintiff also alleges that Defendants breached the implied warranty, because the VenaTech Filter was, in fact, "defective, "not of merchantable quality," and unfit for its "particular purpose." Id. at ¶¶ 202, 219. Significantly, however, and unlike the plaintiff in Montich , her alleged damages arise solely from her "serious physical injuries" and the "medical costs and expenses" which are required "to treat and care for [those] injuries." Id. at 210, 202, 219, 221. Thus, because the claimed damages fall squarely within the NJPLA's statutory definition of harm, i.e. , personal injury, the reasoning in Montich is inapplicable to the instant action, and Plaintiff's breach of the implied warranty claims, as alleged in Counts VI and VII of the Complaint, are subsumed by the NJPLA. See, e.g. , Mendez v. Shah , 28 F. Supp. 3d 282, 294 (D.N.J. 2014) (finding that the "plaintiff's claim for implied warranty is subsumed under the [NJ]PLA and not cognizable as a state law claim under New Jersey law."); Fid. & Guar. Ins. Underwriters, Inc. v. Omega Flex, Inc. , 936 F. Supp. 2d 441, 447 (D.N.J. 2013) (holding that, "[t]o the extent [that the plaintiff] asserts a claim for breach of implied warranty, ... th[at] claim is subsumed by the [NJ]PLA and must be dismissed.").
b. Fraud-Based Claims
Plaintiff's reliance on Nafar , an unpublished and non-binding decision, is, too, misplaced. 2010 WL 2674482, 2010 U.S. Dist. LEXIS 65183 (D.N.J. June 30, 2010). In Nafar , the plaintiff purchased a monthly tanning membership from the defendant franchisor, which also manufactured the tanning beds in its facilities. Id. at *1, 2010 U.S. Dist. LEXIS 65183, at *2. In asserting a New Jersey Consumer Fraud Act violation, the plaintiff claimed that the defendant franchisor exaggerated the benefits of artificial tanning, and failed to warn about the health risks of ultraviolet ray exposure. Id. at *1, 2010 U.S. Dist. LEXIS 65183, at *2-3. The court, in considering the issue, held that, while the NJPLA subsumed the plaintiff's consumer fraud allegations which were based on the defendant's failure to warn, the allegations which related to the defendant's misleading representations were permitted to "potentially proceed under the CFA." Id. at *11, 2010 U.S. Dist. LEXIS 65183, at *32.
Plaintiff's interpretation of Nafar is overly broad. In contrast to her position, that case does not hold that a fraud-based claim will evade the doctrine of subsumption, so long as that claim is "not solely based on a failure to warn" theory of liability. Pl.'s Opp., at 2. Indeed, the plaintiff's consumer fraud claim in Nafar was subsumed, to the extent that it arose from the defendant franchisor's failure to disclose the risks of artificial tanning. And, while the additional claims which related to the alleged misrepresentations and false advertisements proceeded in that case, that ruling was limited to a specific scenario, involving the "purchase of services, rather than the purchase of a defective product." See Crouch v. Johnson & Johnson Consumer Cos. , No. 09-2905, 2010 WL 1530152, at *7 n.1, 2010 U.S. Dist. LEXIS 37517, at *17 n.1 (D.N.J. April 15, 2010). Thus, because the instant action arises from the alleged manufacture and design of a defective product, Nafar is readily distinguishable. Flint Group N. Am. Corp. v. Fox Indus. , No. 16-3009, 2017 WL 1838763, at *, 2017 U.S. Dist. LEXIS 69934, at *21 (D.N.J. May 5, 2017) (distinguishing Nafar v. Hollywood Tanning Systems, Inc. , 2007 WL 1101440 (D.N.J. April 10, 2007), and finding NJPLA subsumption, because the plaintiff's "action does not concern the purchase of services").
Nevertheless, even if an exception for "misleading advertisements and/or representations" exists under the NJPLA, the statute would still subsume Plaintiff's fraud-based claims, as alleged in the Complaint. As stated, Plaintiff asserts fraudulent misrepresentation, fraudulent concealment, and negligent misrepresentation causes of action, based, in large part, on the same set of factual allegations that describe Defendants' purported "concealment and omissions of material fact" in her failure to warn claim. The remaining factual allegations in support of these common law claims concern Defendants' false representations, which, by way of example, include:
(a) Defendants ... had actual knowledge of facts, which demonstrated that representations of the [VenaTech Filter] made in literature distributed to the medical community, consumers and the public via website and brochures regarding this IVC filter were false and misleading; (b) Defendants disseminated false information regarding the IVF Filters ....; (c) Defendants misrepresented material fact [sic] in the safety of the [VenaTech Filter] for its intended use; (d) Defendants expressly represented and warranted ... that the [VenaTech Filter] was safe and effective for its intended and reasonably foreseeable use; (e) Based on the representation of these materials, the Plaintiff's medical providers and the medical community believed the Defendants' device was safe for long term use ....; (f) The representations made by Defendants were, in fact, false ....; (g) Defendants negligently misrepresented the implanted device's high risk of unreasonable, dangerous side effects; (h) Defendants negligently provided Plaintiff ... with false or incorrect information ... including, but not limited to, misrepresentations relating to the safety, efficacy, failure rate and approved uses of the IVC filter.
Id. at ¶¶ 224, 236, 238, 253, 263 272, 281, 282. Although Plaintiff relies on these "misrepresentations," which are either unspecified or relate, in a general sense, to the safety and efficacy of the VenaTech Filter, I find that "the essence of" her claims, nonetheless, sound in products liability.
In determining whether a tort claim is subsumed under the NJPLA, the New Jersey Supreme Court has observed that "[t]he essential question is whether plaintiffs' effort to recover ... damages is limited by the definition of ‘harm’ in the PLA," Sinclair , 195 N.J. at 62, 948 A.2d 587, which the statute, in relevant part, defines to include: "personal physical illness, injury or death." N.J.S.A. 2A:58C-1(b)(2). Here, Plaintiff's fraudulent misrepresentation claim, as asserted in Count VIII of the Complaint, alleges: "[a]s a direct and proximate consequence of Defendants' fraudulent misrepresentations, the Plaintiff sustained serious personal injuries and related losses including mental anguish, physical pain and suffering, diminished capacity for the enjoyment of life, a diminished quality of life, diminished ability to work, medical and related expenses, and other losses and damages." Compl., ¶ 251. Counts IX and X, wherein Plaintiff asserts a fraudulent concealment and negligent misrepresentation claim, respectively, likewise allege personal injury damages, on the basis of Defendants' representations about the VenaTech Filter. As such, because Plaintiff's harm, as alleged, falls within the scope of the NJPLA, the statute subsumes her fraud-based claims.
Indeed, federal and state courts in New Jersey routinely dismiss fraud claims on the basis of NJPLA subsumption, when a plaintiff purchases a defective product and sustains a personal injury, as a result of a manufacture's "false representations" concerning that product's "safety and efficacy." See, e.g. , Mendez , 28 F. Supp. 3d at 302 ("Although [the] plaintiff stresses the representations made by" the defendant, including those which relate to the "safe and effective use," as well as the "side effects," of the manufactured drug, "ultimately, the essence of her claim is that the misrepresentations resulted in physical harm from the product," and, therefore, the NJPLA subsumption applies to her fraud and misrepresentation claims); Indian Brand Farms v. Novartis Crop Prot., Inc. , 890 F. Supp. 2d 534, 547 (D.N.J. 2012) (finding that the NJPLA subsumed the plaintiffs' CFA and misrepresentation claims, even though the plaintiffs alleged that the defendant published "misrepresentations" which related to the safety and efficacy of the substance in question, because the "alleged harm" was "caused by a product"); Arlandson v. Hartz Mt. Corp. , 792 F. Supp. 2d 691, 704 (D.N.J. 2011) (finding NJPLA subsumption, where the plaintiff's fraud-based allegations were "that [the defendants] marketed and continued to market their products to consumers as safe when used as intended, when they knew that the products posed substantial risk regardless of application and use," because the "core issue ... is harm caused by a product."); Sun Chem. Corp. v. Fike Corp. , No. 13-4069, 2015 WL 881961, at *4, 2015 U.S. Dist. LEXIS 24634, at *9 (D.N.J. March 2, 2015) ("A claim will not survive merely because it is labeled as representation-based if the core of the issue is, in fact, the danger inherent in a product.") (citations omitted); Schraeder v. Demilec (USA), LLC , No. 12-6074, 2013 WL 3654093, at *4, 2013 U.S. Dist. LEXIS 97515, at *13 (D.N.J. July 12, 2013) ("However, while the [p]laintiffs here allege that [the defendant fraudulently] promoted [its product] as ‘green’ and non-toxic" and safe, because "the essence of" the plaintiffs' "real claim ... sounds in products liability," it is subsumed by the NJPLA); Bailey v. Wyeth, Inc. , 424 N.J. Super. 278, 285, 37 A.3d 549 (Law Div. 2008) (finding NJPLA subsumption, even though the plaintiffs alleged that the defendants "mislead physicians and the public about the safety of" their product). Accordingly, Counts VIII, IX, and X of the Complaint are dismissed as subsumed by the NJPLA.
c. Negligence
Plaintiff also pleads a negligence claim in Count I of the Complaint, which is titled "Negligence Under NewJersey [sic] Product Liability Act." See Compl., Count 1, ¶¶ 95-112. As a threshold issue, however, I note the NJPLA establishes a basis for liability under three circumstances, none of which include negligence. N.J.S.A. § 2A:58C-2 ; Roberts v. Rich Foods , 139 N.J. 365, 375, 654 A.2d 1365 (1995) ("The Act left intact the three theories under which a manufacturer or seller may be held strictly liable for harm caused by a product—defective manufacture, defective design, and defective warnings.") (internal quotations and citations omitted); Nelson v. Biogen IDEC Inc. , No. 12-7317, 2017 WL 1382910, *2, 2017 U.S. Dist. LEXIS 57941, *4-5 (D.N.J. April 17, 2017) ("[U]nder the NJPLA there are only three available causes of action: manufacturing defect, failure to warn, and design defect."). Therefore, the Court construes Plaintiff's negligence claim as a common law claim.
To avoid NJPLA subsumption, a claimant must assert a negligence claim that arises from the independent conduct of a defendant, which is unrelated to the inherent defect in the product, itself. Universal Underwriters Ins. Grp. v. Pub. Serv. Elec. & Gas Co. , 103 F. Supp. 2d 744, 748 (D.N.J. 2000) (finding that the plaintiff's negligence claim did not fall under the NJPLA, where "the claim asserted by the Plaintiff is not related to a defect in the product (i.e. the electricity), but rather to the maintenance and oversight of PSE & G's emergency response service."). Here, Plaintiff's negligence claim is based solely on Defendants' alleged manufacture, design, and sale of a defective product, and, therefore, the NJPLA's doctrine of subsumption is applicable to that cause of action. Indeed, Plaintiff does not specifically address Defendant's Motion on this issue. See, e.g. , Karlson v. Dematic Corp. , No. 16-321, 2016 WL 4487849, at *, 2016 U.S. Dist. LEXIS 112668, at *11 (D.N.J. Aug. 24, 2016) ; Guardavacarro v. Home Depot , No. 16-8796, 2017 WL 3393812, at *8, 2017 U.S. Dist. LEXIS 124737, at *21 (D.N.J. Aug. 8, 2017) ; Confessore v. Agco Corp. , No. 14-7262, 2015 WL 4430472, at *6 n.6, 2015 U.S. Dist. LEXIS 93851, at *18 n.6 (D.N.J. July 20, 2015) ; Simons v. Goodyear Dunlop Tires N. Am., Ltd. , No. 10-4979, 2010 WL 5392877, at *2, 2010 U.S. Dist. LEXIS 134754, at *5 (D.N.J. Dec. 20, 2010). Plaintiff's negligence claim, as alleged in Count I of the Complaint, is dismissed.
ii. NJPLA Claims for Product Liability
In her Complaint, Plaintiff alleges all three causes of actions pursuant to the NJPLA, including claims for design defect (Count II), manufacturing defect (Count III), and warning defect (Count IV). The standard of liability for each claim is that the product "was not reasonably fit, suitable or safe for its intended purpose." Cornett v. Johnson & Johnson , 414 N.J. Super. 365, 998 A.2d 543 (App. Div. 2010). Moreover, to prove a defect, a plaintiff must show four elements: (1) the product was defective; (2) the defect existed when the product left the hands of the defendant; (3) the defect proximately caused injuries to the plaintiff; and (4) the injured plaintiff was a reasonably foreseeable user. Myrlak v. Port Auth. of New York & New Jersey , 157 N.J. 84, 97, 723 A.2d 45 (N.J. 1999).
"To prove both the existence of a defect and that the defect existed while the product was in the control of the manufacturer, a plaintiff may resort to direct evidence, such as the testimony of an expert who has examined the product, or, in the absence of such evidence, to circumstantial proof." Id. at 98, 723 A.2d 45 (citing Scanlon v. General Motors Corp. , 65 N.J. 582, 591, 326 A.2d 673 (1974) ). In addition, a plaintiff may establish a defect by "negat[ing] other causes of the failure of the product for which the defendant would not be responsible, in order to make it reasonable to infer that a dangerous condition existed at the time the defendant had control [of the product]." Id. at 99, 723 A.2d 45 (citing Scanlon , 65 N.J. at 593-94, 326 A.2d 673 ).
In addition to the shared, general standards, above, each of the three theories of liability under the NJPLA imposes its own additional pleading requirements. To establish a prima facie case of design defect, the plaintiff must prove the availability of a technologically feasible and practical alternative design that would have reduced or prevented the plaintiff's harm without substantially impairing the reasonably anticipated or intended function of the product. Cavanaugh v. Skil Corp. , 164 N.J. 1, 5, 751 A.2d 518 (2000) (internal quotations omitted); see also Lewis v. Am. Cyanamid Co. , 155 N.J. 544, 571, 715 A.2d 967 (1998) (explaining that, "[p]laintiffs who assert that the product could have been designed more safely must prove under a risk-utility analysis the existence of an alternative design that is both practical and feasible."). At the pleading stage, courts in this District have imposed this burden by observing that, "[t]hough there is no ‘per se rule that Plaintiffs must, under all circumstances, provide a reasonable alternative design,’ a plaintiff must plead either that the product's risk [of harm] outweighs its [utility], or that an alternate design exists, in order to state a claim for a design defect under the" NJPLA. Mendez , 28 F. Supp. 3d at 297-98 (quoting Schraeder v. Demilec (USA) LLC , 2013 WL 5770670, at *1–2, 2013 U.S. Dist. LEXIS 151995, at *5 (D.N.J. October 22, 1013) ).
By contrast, a manufacturing defect exists if a product "deviated from the design specification, formulae, or performance standards of the manufacturer or from otherwise identical units manufactured to the same manufacturing specifications or formulae." N.J.S.A. § 2A:58C-2(a). "To determine whether a product contains a manufacturing defect, the ‘product may be measured against the same product as manufactured according to the manufacturer's standards.’ " Mendez , 28 F. Supp. 3d at 298 (quoting Mickens v. Ford Motor Co. , No. 10-05842, 2011 WL 3444055, at *3, 2011 U.S. Dist. LEXIS 87422, at *9 (D.N.J. 2011) (citing Navarro v. George Koch & Sons, Inc. , 211 N.J. Super. 558, 576, 512 A.2d 507 (1986) )). "If the particular product used by the plaintiff fails to conform to those standards or other units of the same kind, it is a manufacturing defect." Id. (internal quotation marks omitted).
Significantly, New Jersey products liability law does not require the injured plaintiff "to prove a specific manufacturer's defect." Mendez , 28 F. Supp. 3d at 297 (quoting Myrlak , 157 N.J. at 98, 723 A.2d 45 citing Moraca v. Ford Motor Co. , 66 N.J. 454, 458, 332 A.2d 599 (1975) )). Rather, because the evidence of a flaw in the manufacturing process is uniquely within the knowledge and control of the manufacturer, "[p]roof that a product is not fit for its intended purposes ‘requires only proof ... that ‘something was wrong’ with the product.’ " Myrlak , 157 N.J. at 98, 723 A.2d 45 (citing Scanlon , 65 N.J. at 591, 326 A.2d 673 ); Cole v. NIBCO, Inc. , 13-7871, 2016 WL 10536025, at *16, 2016 U.S. Dist. LEXIS 24839, at *53 (D.N.J. Feb. 26, 2016) ("[A] plaintiff may demonstrate that a manufacturing defect exists with evidence that in a general sense and as understood by a layman ... something was wrong with the product."). However, notwithstanding this relaxed burden, it is axiomatic that the "mere occurrence of an accident and the mere fact that someone was injured are not sufficient to demonstrate the existence of a defect." Id.
Finally, "[a] manufacturer is liable for harm caused by a failure to warn if the product does not contain an adequate warning or instruction." Sich v. Pfizer Pharm. , No. 17-2828, 2017 WL 4407930, at *3, 2017 U.S. Dist. LEXIS 164221, at *2 (D.N.J. Oct. 4, 2017) (citing N.J.S.A. § 2A:58C-4 ). A warning is adequate if it is "one that a reasonably prudent person in the same or similar circumstances would have provided with respect to the danger and that communicates adequate information on the dangers and safe use of the product." N.J.S.A. § 2A:58C-4 ; Banner v. Hoffmann-La Roche Inc. , 383 N.J. Super. 364, 375, 891 A.2d 1229 (App. Div. 2006) (cert. denied , 190 N.J. 393, 921 A.2d 447, (N.J. 2007) ).
a. Design Defect
In Count II of the Complaint, Plaintiff alleges that the VenaTech Filter suffers from a defective design. More specifically, Plaintiff asserts that Dr. Shaw performed the surgical implantation of her VenaTech Filter by inserting the medical device in her right groin, at the "L3-L4 level." Compl., ¶ 62. Plaintiff further alleges that, although Dr. Shaw performed the procedure in accordance with Defendants' "specific instructions, guidelines, and directives," she was subsequently hospitalized at Robert Wood Johnson University Hospital for chronic right side pain. Id. at ¶¶ 64, 66. After undergoing a scan, Plaintiff avers that her medical providers confirmed that a filter was present at the L3-L4 level, the area at which Defendants' VenaTech Filter was originally implanted. Id. at ¶ 66. The VenaTech Filter's inability to "withstand the normal anatomical and physiological loading cycles exerted in vivo," according to Plaintiff, is the cause of her chronic pain. Id. at ¶ 77. Contrary to Defendants' contentions, I find that Plaintiff has sufficiently pled that the VenaTech Filter was not "reasonably fit," or "suitable" for its intended purpose. Indeed, Plaintiff alleges that her personal injuries resulted from the VenaTech Filter's lack of sufficient structural integrity or strength to function as a permanent medical device. See, e.g. , McDowell v. Bos. Sci. Corp. , No. 18-3007, 2018 WL 6182625, at *4, 2018 U.S. Dist. LEXIS 199823, at *11 (C.D. Ill. Nov. 27, 2018) (applying Illinois products liability law, the elements of which are similar to the NJPLA, and finding that the plaintiff adequately pled that her permanent IVC filter was defective, on the basis of the medical device's alleged "inability to withstand normal placement within the human body.").
Citing to N.J.S.A. § 2A:58C-3(a)(2), Defendants contend that Plaintiff has failed to allege that the VenaTech Filter is not fit or suitable for its intended use, because "the design of the device as a permanent filter is an ‘inherent characteristic’ for which liability for defective design is exempted." Defendants' Reply Brief, at 6. Specifically, § 2A:58C-3(a)(2) of the NJPLA creates an exemption from liability when the characteristics of an alleged defective product "are known to the ordinary consumer or user, and the harm was caused by an unsafe aspect of the product that is an inherent characteristic of the product and that would be recognized by the ordinary person who uses or consumes the product with the ordinary knowledge common to the class of persons for whom the product is intended[.]" N.J.S.A. § 2A:58C-3(a)(2). Defendants' argument, however, is without merit. Indeed, § 2A:58C-3(a)(2) serves as an affirmative defense, and it cannot be raised as a basis to dismiss Plaintiff's claims at this juncture. Roberts v. Rich Foods , 139 N.J. 365, 369, 654 A.2d 1365 (1995) ; Stanziale v. Nachtomi , 416 F.3d 229, 242 (3d Cir. 2005) ("[A]ffirmative defenses generally will not form the basis for dismissal under Rule 12(b)(6).") (citing In re Adams Golf, Inc. Secs. Litig. , 381 F.3d 267, 277 (3d Cir. 2004) ).
Nonetheless, Plaintiff has not satisfied the additional pleading requirements of defective design—the existence of an alternative design that is both practical and feasible. In that regard, Plaintiff argues that she has met this pleading requirement, because she has identified an alternative design in the Complaint, pointing to the following allegation: "[t]he later use of retrievable and optional filter [sic] was a result of the noted long-term risks associated with IVC filters," including Defendants' "creation and marketing of the VenaTech Convertible™ Vena Cava filter." Compl., ¶¶ 130-31. In other words, the alternative design, Plaintiff argues, is the subsequent creation of a temporary filter made by Defendants. Although Plaintiff emphasizes the use of retrievable filters, she has not alleged that those products were capable of being made when Defendants manufactured the device in question. And, even more damning, the VenaTech Filter "is marketed and sold as a permanent filter," whereas retrievable filters are "designed to be removed." Therefore, based upon Plaintiff's own allegations, and the differences between the two devices, retrievable filters are inadequate comparators. See. e.g. , Oden v. Boston Sci. Corp. , 330 F. Supp. 3d 877, 889 (E.D.N.Y. 2018) (finding that permanent and retrievable IVC filters are "not comparable," because "the design and purpose of these two products is different."); Tears v. Boston Sci. Corp. , 344 F. Supp. 3d 500, 510 (S.D.N.Y. 2018) (holding that permanent and retrievable IVC filters are "entirely different" products). Count II of the Complaint is dismissed, as Plaintiff has failed to sufficiently plead an alternative design.
The Court notes that Plaintiff has not argued that, under a risk-utility analysis, the VenaTech Filter's harm outweighs its utility, nor does the Complaint sufficiently so allege. In conducting a risk-utility analysis, courts weigh the following seven factors: (1) the usefulness and desirability of the product-its utility to the user and to the public as a whole; (2) the safety aspects of the product-the likelihood that it will cause injury, and the probable seriousness of the injury; (3) the availability of a substitute product that would meet the need and not be as unsafe; (4) the manufacturer's ability to eliminate the unsafe character of the product without impairing its usefulness or making it too expensive to maintain its utility; (5) the user's ability to avoid danger by the exercise of care in the use of the product; (6) the user's anticipated awareness of the dangers inherent in the product and their avoidability, because of general public knowledge of the obvious condition of the product or of the existence of suitable warnings or instructions; and (7) the feasibility, on the part of the manufacturer, of spreading the loss by setting the price of the product or carrying liability insurance. O'Brien v. Muskin Corp. , 94 N.J. 169, 182, 463 A.2d 298 (1983). Plaintiff does not plead any of these factors, but rather alleges, in a conclusory fashion, that "the foreseeable risks caused by the [VenaTech Filter] exceeded the claimed benefits of the product." Compl., ¶ 123.
b. Manufacturing Defect
In Count III of the Complaint, Plaintiff alleges that she was implanted with a VenaTech Filter that contained a manufacturing defect. To allege a manufacturing defect, the "product may be measured against the same product as manufactured according to the manufacturer's standards." Mendez , 28 F. Supp. 3d at 298 ; Navarro , 211 N.J. Super. at 576, 512 A.2d 507. Should "the particular product used by the plaintiff fail[ ] to conform to those standards or other units of the same kind, it is a manufacturing defect." Mendez , 28 F. Supp. 3d at 294 (citations omitted).
As a preliminary matter, Plaintiff's manufacturing defect claim is inconsistent with her theory of the case. At its core, this action concerns Defendants' purported liability for the sale of the VenaTech Filter, a product that was allegedly harmful when used as a permanent filter. In other words, this suit arises from the use of a medical device that has failed to perform its intended purpose—permanent implantation. As such, Plaintiff is hard-pressed to allege, as is required to assert a manufacturing defect claim, that she was implanted with a VenaTech Filter that failed to conform to Defendants' manufacturing standards, or other units of the same kind. Indeed, common sense dictates that a product cannot deviate from another identical product when both suffer from the same inherent flaw. Ebenhoech v. Koppers Indus. , 239 F. Supp. 2d 455, 473 (D.N.J. 2002) (explaining that, to show a manufacturing defect, a plaintiff must prove that the disputed product deviated from the defendants "design specifications ... or from otherwise identical units manufactured ....") (internal quotations and citations omitted). Indeed, Plaintiff has not done so here.
In the Complaint, Plaintiff asserts that her VenaTech Filter contained an unspecified "condition or conditions, which Defendants did not intend, at the time it left Defendants' control and possession." Compl., ¶ 144. Plaintiff also references, without specifying, a "manufacturing defect of the filter" and a "malfunction" that eventually occurred while the VenaTech Filter was implanted, which "resulted in her subsequent injuries and health problems." Id. at ¶¶ 146, 149. These sparse allegations are pled in a conclusory fashion, and fail to meet the requisite level of specificity that is required in order to assert a manufacturing defect claim. Plaintiff has not identified, even in general terms, a particular error or mishap in the manufacturing process that caused her VenaTech Filter to deviate from Defendants' own standards, nor does she contend that her device failed to conform to other identical units. Thus, Count III of the Complaint is also dismissed on the basis of these pleading deficiencies. See, e.g. , Hughes v. Panasonic Consumer Elecs. Co. , No. 10-846, 2011 WL 2976839, at *19, 2011 U.S. Dist. LEXIS 79504, at *54 (D.N.J. July 21, 2011) (finding that the plaintiff's "vague conclusory allegation that the [d]efect was caused in part, due to ‘manufacturing errors’ is insufficient to satisfy the requisite pleading standards of Rule 8(a) and Iqbal . ").
c. Warning Defect
In Count IV of the Complaint, Plaintiff asserts a failure to warn claim. Citing to N.J.S.A. § 2A:58C-2, Defendants argue that, as medical device manufactures, their duty to warn is owed to the physician, not to the ultimate end-user of their products, i.e. , the patient. Defendants' Dismissal Brief, at 17. As such, Defendants contend that Plaintiff cannot allege a cause of action, on the basis of their alleged failure to inform her about the VenaTech Filter's potential adverse health risks and side effects. Id. Rather, according to Defendants, Plaintiff can only succeed on a warning defect claim if she establishes that the warnings to her prescribing physicians are inadequate. Id.
Section 2A:58C-2 of the NJPLA governs the adequacy of a medical product's warnings. That provisions states:
An adequate product warning or instruction is one that a reasonably prudent person in the same or similar circumstances would have provided with respect to the danger and that communicates adequate information on the dangers and safe use of the product, taking into account the characteristics of, and the ordinary knowledge common to, the persons by whom the product is intended to be used, or in the case of prescription drugs, taking into account the characteristics of, and the ordinary knowledge common to, the prescribing physician.
N.J.S.A. § 2A:58C-2. This section of the statute is commonly referred to as the "learned intermediary doctrine," which federal and state courts routinely apply within the context of products liability actions. Under this doctrine, "a pharmaceutical manufacturer generally discharges its duty to warn the ultimate user of prescription drugs by supplying physicians with information about the drug's dangerous propensities." See Niemiera v. Schneider , 114 N.J. 550, 559, 555 A.2d 1112 (1989) (citing Bacardi v. Holzman , 182 N.J. Super. 422, 442 A.2d 617 (App. Div.1981) ); see also Grobelny v. Baxter Healthcare Corp. , 341 Fed. Appx. 803, 806 (3d Cir. 2009) (explaining that, "[t]he crucial question [under the doctrine] is whether the warning was adequate to apprise a physician, not a consumer, of the risks."). In that regard, a defendant will not be held accountable on the basis of the failure to warn, if a sufficient warning would not have altered the physician's decision to prescribe the drug in dispute. Strumph v. Schering Corp. , 256 N.J. Super. 309, 323, 606 A.2d 1140 (App. Div. 1992).
As a threshold issue, the parties dispute whether the learned intermediary doctrine is applicable within the context of this case. Plaintiff contends that "New Jersey courts have not expanded this doctrine to cases involving medical devices," as its application, instead, is limited to the prescription of pharmaceutical drugs. Pl.'s Opp., at 8. Conversely, Defendants argue that "New Jersey courts regularly have applied the learned intermediary doctrine to prescription medical devices," citing to various federal and state court decisions. Defendants' Reply Brief, at 9. However, notwithstanding their disagreement, the Court need not resolve whether the learned intermediary doctrine applies here, as Plaintiff does not have standing to raise her failure to warn claim.
Determining whether a prescribing physician was given sufficient warning in connection with a defendant's medical product pursuant to the learned intermediary doctrine raises factual questions that generally cannot be resolved on an undeveloped record. See, e.g. , Adkins v. Bristol-Myers Squibb Co. , No. 07-0901, 2009 WL 5216986, at *8, 2009 U.S. Dist. LEXIS 121096, at *25 (D.N.J. Dec. 30, 2009) ("[T]he Court fails to see how a motion to dismiss could be granted based upon application of the learned intermediary doctrine, particularly when the issue of the adequacy of the warning is generally a question for the jury."). Nevertheless, Plaintiff's failure to warn claim cannot stand, regardless of Defendants' invocation of the learned intermediary doctrine, for the reasons described infra .
As a "bedrock requirement," Article IIII requires a claimant to "establish that they have standing to sue." Reilly v. Ceridian Corp. , 664 F.3d 38, 41 (3d Cir. 2011) (citing Raines v. Byrd , 521 U.S. 811, 818, 117 S.Ct. 2312, 138 L.Ed.2d 849 (1997) ). "Constitutional standing requires an injury-in-fact, which is an invasion of a legally protected interest that is (a) concrete and particularized, and (b) actual or imminent, not conjectural or hypothetical." Id. (internal quotations and citations omitted). Therefore, "allegations of a future injury, or the mere possibility of a future injury, will not establish standing." Estrada v. Johnson & Johnson , No. 16-7492, 2017 WL 2999026, at *4, 2017 U.S. Dist. LEXIS 109455, at *11 (D.N.J. July 14, 2017), aff'd 903 F.3d 278 (3d Cir. 2018) ; Reilly v. Ceridian Corp. , 664 F.3d 38, 42 (3d Cir. 2011) ("Allegations of ‘possible future injury’ are not sufficient to satisfy Article III.").
In her Complaint, Plaintiff asserts that Defendants advertised the VenaTech Filter "as a permanent filer, safe for long-term us [sic], and therefore had a duty to warn of the risks associated with the use of its product." Compl., ¶ 156. Plaintiff alleges that Defendants' marketing materials for the VenaTech Filter included the "product brochure and their Instructions for Use (‘IFU’)," but neither of those explained the full "extent of potential injuries caused by their IVC filters." Id. at ¶¶ 157-159. Rather, those materials listed "general complications," without warning of the health consequences that may potentially arise from the long-term use of the VenaTech Filter, including: "perforation, the migration of the filter to the other parts of the vena cava, heart, or other organs, DVT, blood clots, fracture or breakage of the filter and other" unspecified "complications." Id. at ¶¶ 159, 164. Here, Plaintiff does not allege that Defendants failed to provide a warning in connection with a particular health complication that she experienced from the implantation of her VenaTech Filter. That is, Plaintiff does not assert that Defendants had a duty to warn about chronic right side pain—her only alleged symptom. Rather, Plaintiff alleges that, "as a result of Defendants' failure to warn, she "is at risk of suffering from serious health complications," including "tilt, fracture, or breakage of the filter, perforation of the vena cava or other soft tissue, and other serious problems," without alleging that these adverse health effects have, in fact, occurred after the implantation of her device. Id. at ¶¶ 67, 81. What is more, the Complaint does not allege, nor can the Court reasonably infer, that Plaintiff's chances of experiencing those alleged harms are "imminent." Indeed, although Plaintiff asserts that she underwent a medical scan years following the device's implantation, she has not alleged that it revealed any adverse health complications such as those risks Plaintiff has alleged. In fact, Plaintiff asserts that the medical scan confirmed that her filter was still located at the "L3-L4 level," the region where it was originally implanted. As pled, no filter migration or tilting has occurred. And, more importantly, Plaintiff also alleges that no medical provider has recommended "revision or removal of [her] device," notwithstanding her alleged increased risk of experiencing adverse health complications. Id. at ¶¶ 65-65. Therefore, because Plaintiff's warning defect claim is asserted on the basis of "serious problems" that she has not experienced, Count IV of the Complaint is dismissed.
In the Complaint, Plaintiff also refers to the VenaTech Filters' "numerous serious side effects," its "risk of severe and permanent injuries," and its "serious and dangerous effects." Compl., ¶¶ 160, 165, 176. These vague, conclusory allegations, however, are insufficient to support her failure to warn claim.
Rather, in a speculative fashion, Plaintiff merely alleges that "[c]hronic pains in the area where" an IVC filter is inserted can be an indicator of further complications," without alleging that she has experienced those complications as a result of the implantation of the VenaTech Filter. Compl., ¶ 67.
iii. Breach of the Express Warranty
In Count V of the Complaint, Plaintiff asserts a breach of the express warranty claim. Although Plaintiff brings this claim under the NJPLA, breaches of the express warranty are explicitly excluded from the scope of the statute. See N.J.S.A. § 2A:58C-1(b)(3) (defining a "products liability action" to include "any claim or action brought by a claimant for harm caused by a product, irrespective of the theory underlying the claim, except actions for harm caused by breach of an express warranty .") (emphasis added). Therefore, the Court construes Plaintiff's allegations in accordance with the pertinent provisions of the Uniform Commercial Code of New Jersey (the "NJ UCC").
The Court notes that Plaintiff briefs her breach of the express warranty claim under the applicable provisions of the NJ UCC.
To state a claim for breach of express warranty under New Jersey law, a plaintiff must allege the following three elements: "(1) that Defendant made an affirmation, promise or description about the product; (2) that this affirmation, promise or description became part of the basis of the bargain for the product; and (3) that the product ultimately did not conform to the affirmation, promise or description." Snyder v. Farnam Companies, Inc. , 792 F. Supp. 2d 712, 721 (D.N.J. 2011). Moreover, the NJ UCC, N.J.S.A. § 12A:2-313, defines an "express warranty" as follows:
(1) 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.
N.J.S.A. § 12A:2-313. "A statement can amount to a warranty, even if unintended to be such by the seller, ‘if it could fairly be understood ... to constitute an affirmation or representation that the [product] possesse[s] a certain quality or capacity relating to future performance.’ " Volin , 189 F. Supp. 3d at 420 (citation omitted). However, "an affirmation merely of the value of the goods or a statement purporting to be merely the seller's opinion or commendation of the goods does not create a warranty." N.J.S.A. § 12A:2-313(2). Additionally, "statements that are nothing more than mere puffery are not considered specific enough to create an express warranty." Snyder , 792 F. Supp. 2d at 721.
Here, Plaintiff argues that Defendants' "brochures and IFUs provided warranties and specific claims of assurances for" the VenaTech Filter. Pl.'s Opp., at 9. In her Complaint, Plaintiff identifies four statements that were contained in a downloadable PDF on Defendants' "webpage," as a basis for alleging that Defendants created an express warranty through their marketing of the VenaTech Filter: (1) "proven conical design for effective clot trapping and preservation of caval patency"; (2) "unique, patented stabilizing legs and hooks to ensure optimal positioning;" (3) "extraordinary design for exceptional performance"; and (4) "[p]roven safety and efficacy in the prevention of pulmonary embolism." Compl., ¶¶ 183-187. However, to the extent that these representations establish the basis of the bargain, Plaintiff has not sufficiently alleged that her VenaTech Filter failed to conform to the affirmations on Defendants' webpage. Indeed, Plaintiff references statements as to the filter's design, which comprises "patented, stabilizing legs" that allow for "optimal positioning," but she fails to allege that her filter migrated or tilted. Plaintiff also identifies representations with respect to the VenaTech Filter's performance, i.e. , "clot trapping" and the "prevention of pulmonary embolism [s]," without alleging that she sustained a thrombotic event after the device was implanted. In fact, Plaintiff has not alleged that she suffered from a pulmonary embolism since the implantation of her filter. Rather, the only symptom that Plaintiff describes as a result of using Defendants' product is "chronic right side pain." But, she has not alleged that Plaintiff's statements of affirmation concern pain as unsafe or ineffective, nor has she alleged that her pain renders the VenaTech Filter unsafe. Instead, her pain is pled as a side effect. Thus, Plaintiff has not alleged a breach of the express warranty, and Count V of the Complaint is dismissed. iv. Punitive Damages
Although Plaintiff's Complaint references various "MAUDE Adverse Event Reports" which were published by the FDA, the examples described therein, including adverse health complications that required surgical removal of IVC filters in certain patients, cannot serve as the basis for Plaintiff's breach of the express warranty claim. Indeed, Plaintiff cannot rely on the adverse health complications that arose from the implantation of IVC filters in other patients to support her position that Defendants breached the express warranty with respect to her own VenaTech Filter. See supra .
Finally, Plaintiff seeks punitive damages as a result of Defendants' alleged conduct. However, because Plaintiff has failed to allege a cognizable claim under the NJPLA or common law, her request for punitive damages is dismissed. Indeed, Plaintiff is not entitled to such an award, without having asserted an "independent cause of action for compensatory damages." See O'Connor v. Harms , 111 N.J. Super. 22, 30, 266 A.2d 605 (App. Div. 1970) ; see also Gomez v. H&M Int'l Transp., Inc. , No. 17-231, 2017 WL 1483306, at *3–4, 2017 U.S. Dist. LEXIS 61816, at *11 (D.N.J. April 24, 2017) (dismissing punitive damages request, in the absence of an adequately pled underlying violation in a products liability action); Karlson v. Dematic Corp. , No. 16-321, 2016 WL 4487849, at *4, 2016 U.S. Dist. LEXIS 112668, at *11 (D.N.J. Aug. 24, 2016) (dismissing a request for punitive damages in a products liability suit, where the plaintiff "failed to state a claim for relief under the NJPLA or common law").
III. CONCLUSION
For the foregoing reasons, Defendants' Motion to dismiss is granted. Plaintiff's claims for negligence (Count I), fraudulent misrepresentation (Count VIII), fraudulent concealment (Count IX), negligent misrepresentation (Count X), breach of the implied warranty of merchantability (Count VI), and breach of the implied warranty of fitness (Count VII) are dismissed with prejudice as subsumed by the NJPLA. Plaintiff's NJPLA claims, including defective design (Count II), manufacturing defect (Count III), and failure to warn (Count IV), in addition to her breach of the express warranty claim (Count V) are dismissed without prejudice. Plaintiff is given leave to amend those claims in accordance with the dictates of this Opinion, within 14 days of the date of the accompanying Order.