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Smith v. Covidien LP

United States District Court, D. New Jersey

December 31, 2019

SHARON SMITH, Plaintiff,
COVIDIEN LP, Defendant.

          ALEXANDRA COLELLA MARC J. BERN & PARTNERS, LLP On behalf of Plaintiff

          STEPHEN C. MATTHEWS DLA PIPER LLP (US) On behalf of Defendant


          NOEL L. HILLMAN, U.S.D.J.

         This matter concerns claims by Plaintiff arising from injuries she allegedly sustained from Defendant's surgical mesh used to repair Plaintiff's hernia. For the reasons stated below, Defendant's motion will be granted in part and denied in part.

         I. BACKGROUND

         On November 11, 2016, Plaintiff, Sharon Smith, underwent a laparoscopic incarcerated incisional and umbilical hernia repair procedure using Symbotex Mesh in Plaintiff's abdomen to reinforce tissue affected by a hernia. Symbotex Mesh is manufactured and sold by Defendant Covidien LP.

         Plaintiff claims that within a few weeks of surgery, she suffered from abdominal pain, swelling, drainage from the wound site, and other complications, which required three subsequent surgeries on December 1, 3, and 5, 2016. The surgeries included removal of infected mesh, drainage of abscess, abdominal washout, and necrotic tissue debridement. She was also found to have ischemic (restricted blood flow) tissue as well as purulent drainage from the right lateral edge of the wound. Plaintiff claims that she has experienced, and continues to experience, debilitating abdominal pain since the implant of the Symbotex Mesh and the multiple surgeries since the implantation of the Symbotex Mesh.

         Plaintiff has advanced claims under the New Jersey Product Liability Act (“PLA”) for defective design, defective manufacture, and failure-to-warn. Plaintiff has also brought claims under New Jersey common law for negligence, breach of the implied warranty of fitness for a particular purpose, breach of express warranty, as well as a claim for punitive damages.

         Defendant has moved to dismiss Plaintiff's complaint in its entirety. Defendant argues that Plaintiff's common law claims for negligence and breach of the implied warranty are subsumed within the PLA and must be dismissed. Defendant also argues that Plaintiff has failed to properly plead her claims brought under the PLA and for breach of the express warranty. Finally, Defendant argues that Plaintiff's count for punitive damages is derivative and cannot survive where the substantive claims fail as a matter of law. Plaintiff has opposed Defendant's motion.


         This Court exercises jurisdiction pursuant to 28 U.S.C. § 1332(a), diversity of citizenship. Plaintiff is a citizen of New Jersey. Defendant is a limited partnership with limited liability companies and corporations as its members, none of which are citizens of New Jersey. (See Docket No. 6 at 2-3.) The amount in controversy exceeds $75, 000 exclusive of interest and costs.


         A. Standard for Motion to Dismiss

         When considering a motion to dismiss a complaint for failure to state a claim upon which relief can be granted pursuant to Federal Rule of Civil Procedure 12(b)(6), a court must accept all well-pleaded allegations in the complaint as true and view them in the light most favorable to the plaintiff. Evancho v. Fisher, 423 F.3d 347, 351 (3d Cir. 2005). It is well settled that a pleading is sufficient if it contains “a short and plain statement of the claim showing that the pleader is entitled to relief.” Fed.R.Civ.P. 8(a)(2).

         “While a complaint attacked by a Rule 12(b)(6) motion to dismiss does not need detailed factual allegations, a plaintiff's obligation to provide the ‘grounds' of his ‘entitle[ment] to relief' requires more than labels and conclusions, and a formulaic recitation of the elements of a cause of action will not do . . . .” Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555 (2007) (alteration in original) (citations omitted) (first citing Conley v. Gibson, 355 U.S. 41, 47 (1957); Sanjuan v. Am. Bd. of Psychiatry & Neurology, Inc., 40 F.3d 247, 251 (7th Cir. 1994); and then citing Papasan v. Allain, 478 U.S. 265, 286 (1986)).

         To determine the sufficiency of a complaint, a court must take three steps: (1) the court must take note of the elements a plaintiff must plead to state a claim; (2) the court should identify allegations that, because they are no more than conclusions, are not entitled to the assumption of truth; and (3) when there are well-pleaded factual allegations, a court should assume their veracity and then determine whether they plausibly give rise to an entitlement for relief. Malleus v. George, 641 F.3d 560, 563 (3d Cir. 2011) (quoting Ashcroft v. Iqbal, 556 U.S. 662, 664, 675, 679 (2009) (alterations, quotations, and other citations omitted).

         A district court, in weighing a motion to dismiss, asks “not whether a plaintiff will ultimately prevail but whether the claimant is entitled to offer evidence to support the claim.” Twombly, 550 U.S. at 563 n.8 (quoting Scheuer v. Rhoades, 416 U.S. 232, 236 (1974)); see also Iqbal, 556 U.S. at 684 (“Our decision in Twombly expounded the pleading standard for ‘all civil actions' . . . .”); Fowler v. UPMC Shadyside, 578 F.3d 203, 210 (3d Cir. 2009) (“Iqbal . . . provides the final nail in the coffin for the ‘no set of facts' standard that applied to federal complaints before Twombly.”). “A motion to dismiss should be granted if the plaintiff is unable to plead ‘enough facts to state a claim to relief that is plausible on its face.'” Malleus, 641 F.3d at 563 (quoting Twombly, 550 U.S. at 570).

         A court in reviewing a Rule 12(b)(6) motion must only consider the facts alleged in the pleadings, the documents attached thereto as exhibits, and matters of judicial notice. S. Cross Overseas Agencies, Inc. v. Kwong Shipping Grp. Ltd., 181 F.3d 410, 426 (3d Cir. 1999). A court may consider, however, “an undisputedly authentic document that a defendant attaches as an exhibit to a motion to dismiss if the plaintiff's claims are based on the document.” Pension Benefit Guar. Corp. v. White Consol. Indus., Inc., 998 F.2d 1192, 1196 (3d Cir. 1993). If any other matters outside the pleadings are presented to the court, and the court does not exclude those matters, a Rule 12(b)(6) motion will be treated as a summary judgment motion pursuant to Rule 56. Fed.R.Civ.P. 12(b).

         B. Plaintiff's claims under the PLA

Under the New Jersey Product Liability Act (PLA), 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.

         The cited statutory text establishes three causes of action under the PLA: (1) design defect, (2) manufacturing defect, or (3) warnings defect. Mendez v. Shah, 28 F.Supp.3d 282, 296 (D.N.J. 2014) (citing Roberts v. Rich Foods, Inc., 139 N.J. 365, 375, 654 A.2d 1365 (N.J. 1995); Dziewiecki v. Bakula, 361 N.J.Super. 90, 97-98, 824 A.2d 241 (App. Div. 2003)). The standard of liability is that the product “was not reasonably fit, suitable or safe for its intended purpose.” Id. (citing Cornett v. Johnson & Johnson, 414 N.J.Super. 365, 998 A.2d 543 (App. Div. 2010)). 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. (citation omitted).

         Defendant takes the position that hernia mesh products are generally reliable and have been used successfully for many years in hundreds of thousands of surgeries. Moreover, it contends that the Symbotex mesh product at issue has not been subject to any recalls, withdrawals, or adverse regulatory action, and that the alleged complications from Plaintiff's surgery are common side-effects disclosed in the product's Instructions for Use. Under these circumstances, Defendant contends, Plaintiff cannot maintain her claims that the Symbotex mesh was defectively designed, improperly manufactured, or Defendant should have warned her of the product's dangers. In short, Defendant argues that Plaintiff has not, and cannot, plead any facts to support her claims that the Symbotex mesh used to repair Plaintiff's hernia was not “reasonably fit, suitable or safe.”

         Contrary to Defendant's view of Plaintiff's claims, while Plaintiff's complaint is admittedly thin it does not assert in conclusory fashion that simply because Plaintiff suffered complications from the surgical use of Symbotex mesh it must be because the product was defective in some fashion. The Court concludes that, at this pleading stage, Plaintiff has alleged enough facts to establish the plausibility of her three claims under the PLA.

         1. Defective Design

         In determining whether a product was defectively designed, courts apply a risk-utility analysis. Lopez v. Borough of Sayreville, 2008 WL 2663423, at *25 ( N.J.Super.Ct.App.Div. 2008), cert. denied, 960 A.2d 395 (N.J. 2008) (citing Cavanaugh v. Skil Corp., 164 N.J. 1, 8, 751 A.2d 518 (2000); Lewis v. American Cyanamid Co., 715 A.2d 967, 980 (N.J. 1998)). “A plaintiff must prove either that the product's risks outweighed its utility or that the product could have been designed in an alternative manner so as to minimize or eliminate the risk of harm.” Id. (citing Lewis, 715 A.2d at 980).

         There are seven listed factors in the classical statement of the risk-utility analysis, [1] but the prevalent view is that unless one or more of the other factors might be relevant in a particular case, the issue upon which most claims will turn is the proof by plaintiff of a reasonable alternative design, the omission of which renders the product not reasonably safe. Cavanaugh v. Skil Corp., 751 A.2d 518, 522 (N.J. 2000) (citation omitted). The burden is on the plaintiff to prove “the existence of an alternative design that is both practical and feasible” and “safer” than that used by the manufacturer. Lopez, 2008 WL 2663423 at *25 (citing Lewis, 715 A.2d at 980) (“Plaintiffs 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.”).

         Generally, the factfinder is required to perform a risk-utility analysis in order to determine whether a product is defective in its design, and in performing a risk-utility analysis, an expert opinion is ordinarily relied upon to establish a reasonable alternative design. Rocco v. New Jersey Transit Rail Operations, Inc., 749 A.2d 868, 879 ( N.J.Super.Ct.App.Div. 2000). “Except in the rare case when the risk-utility analysis points to the appropriate result as a matter of law, the jury, not the court, ultimately resolves factual issues arising from a risk-utility analysis.” Lewis, 715 A.2d at 979 (citing Dreier et al., Current N.J. Products Liability and Toxic Torts Law, § 5.2 at 29 (1998)); see also Toms v. J.C. Penney Co., Inc., 304 Fed.Appx. 121');">304 Fed.Appx. 121, 124 (3d Cir. 2008) (citations omitted) (“[T]he existence of a design defect is frequently proven through the testimony of an expert who has examined the product and offers an opinion on its design.”).

         Here, Plaintiff alleges in her complaint:

• Symbotex mesh is a “three-dimensional textile non-absorbable monofilament polyester mesh with absorbable collagen film and marking.”
• Issues with polyester concern “the terminal product in a chain of very reactive and toxic precursors. Most are carcinogens; all are poisonous, ” and polyester is increasingly toxic because it is often treated with a flame retardant.
• These components are alleged to cause issues where: “the collagen film fails to mitigate the body's adverse reaction to the non-absorbable polyester mesh”; “polyester is prone to tearing, ripping, and/or fraying” and “once the polyester fibers unravel, they become detached from the mesh and migrate to other regions of the body, ” which cause imbedding and an inflammatory response; and “polyester mesh contracts over time, causing tension to increase.”
• The collagen barrier dissolves, and when it does, internal organs are left unprotected from the dangers associated with the synthetic polyester textile.
• Both polycarbonate and polystyrene are reasonable alternative designs which are less dangerous and equally, if not more, effective than polyester.
• The defective design was a proximate cause of Plaintiff's injuries.

(Docket No. at 20-22.)

         Defendant argues that these allegations are not sufficient to state a design defect claim because Plaintiff fails to plead any facts to answer the questions of “What is it about collagen that causes it to ‘fail[] to mitigate the body's adverse reaction'?” or “[W]hat is it about polyester that causes an ‘adverse reaction,' and what type of ‘adverse reaction' does it cause?” or “What are the characteristics of polyester that make it ‘prone to tearing and ripping and/or fraying'?” (Docket No. 16 at 9-10.) Additionally, Defendants argue that Plaintiff has not alleged that these defects caused her injuries, particularly because her alleged injuries can be suffered with any mesh product. Defendant further argues that Plaintiff has ...

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