Green v. Covidien LP

KAREN GREEN, Plaintiff, v. COVIDIEN LP, Defendant.

18 Civ. 2939 (PGG)

UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF NEW YORK

August 30, 2019

ORDER

PAUL G. GARDEPHE, U.S.D.J.:

Plaintiff Karen Green brings this action against Defendant Covidien LP, asserting claims for strict products liability, negligence, breach of warranty, fraudulent misrepresentation, negligent misrepresentation, unjust enrichment, and consumer fraud. Plaintiff alleges that she suffered injuries after her physician used Defendant's Symbotex Composite Mesh (hereinafter, "Symbotex Mesh") to repair a hernia. Defendant has moved to dismiss the Amended Complaint pursuant to Fed. R. Civ. P. 12(b)(6). For the reasons stated below, Defendant's motion will be granted.

BACKGROUND

"A hernia is a medical condition caused by the penetration of fatty tissue, intestine, or organs through a weakened or compromised location in muscle [or] connective tissue." (Am. Cmplt. (Dkt. No. 14) ¶ 16) Hernias can be treated surgically, with or without the use of surgical mesh. (Id. ¶¶ 19, 29) When mesh is used, it is "introduced to the hernia site to strengthen the repair, in hopes of reducing the likelihood of recurrence." (Id. ¶ 22)

On March 4, 2016, Plaintiff underwent a laparoscopic hernia repair procedure. (Id. ¶ 49) During the procedure, Plaintiff's surgeon used the Symbotex Mesh - "designed, patented, manufactured, labeled, packaged, marketed, sold, and distributed" by Defendant - to repair the hernia. (Id. ¶¶ 30, 49-50) On March 13, 2016, Plaintiff underwent a second surgery to investigate "complaints of abdominal pain, possible adhesions, partial small bowel obstruction[,] and infected abdominal wall[s]." (Id. ¶ 51) During this procedure, Plaintiff's "mesh was revised and adhesions¹ were taken down." (Id. ¶ 52)

Since that time, Plaintiff "has experienced and continues to experience recurring hernias . . . [a]s a direct and proximate result of the implanted mesh products [in] her body." (Id. ¶¶ 53-54)

DISCUSSION

I. MOTION TO DISMISS STANDARD

"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.'" Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (quoting Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570 (2007)). "In considering a motion to dismiss . . . the court is to accept as true all facts alleged in the complaint," Kassner v. 2nd Ave. Delicatessen Inc., 496 F.3d 229, 237 (2d Cir. 2007) (citing Dougherty v. Town of N. Hempstead Bd. of Zoning Appeals, 282 F.3d 83, 87 (2d Cir. 2002)), and must "draw all reasonable inferences in favor of the plaintiff." Id. (citing Fernandez v. Chertoff, 471 F.3d 45, 51 (2d Cir. 2006)).

A complaint is inadequately pled "if it tenders 'naked assertion[s]' devoid of 'further factual enhancement,'" Iqbal, 556 U.S. at 678 (quoting Twombly, 550 U.S. at 557), and does not provide factual allegations sufficient "to give the defendant fair notice of what the claim is and the grounds upon which it rests." Port Dock & Stone Corp. v. Oldcastle Northeast, Inc.,507 F.3d 117, 121 (2d Cir. 2007) (citing Twombly, 550 U.S. at 555 (quoting Conley v. Gibson, 355 U.S. 41, 47 (1957))).

Fed. R. Civ. P. 9(b) sets standards for pleading fraud claims and requires that "[i]n alleging fraud or mistake, a party must state with particularity the circumstances constituting fraud or mistake." Fed. R. Civ. P. 9(b); see also In re Pfizer Inc. Sec. Litig., 584 F. Supp. 2d 621, 632-33 (S.D.N.Y. 2008) (quoting Kalnit v. Eichler, 264 F.3d 131, 138 (2d Cir. 2001)). Rule 9(b) requires a plaintiff to "(1) specify the statements that the plaintiff contends were fraudulent, (2) identify the speaker, (3) state where and when the statements were made, and (4) explain why the statements were fraudulent." Kottler v. Deutsche Bank AG, 607 F. Supp. 2d 447, 462 (S.D.N.Y. 2009) (quoting Stevelman v. Alias Research, Inc., 174 F.3d 79, 84 (2d Cir. 1999) (internal quotation marks and citation omitted)).

II. STRICT PRODUCTS LIABILITY

The Amended Complaint asserts strict products liability claims for defective design, defective manufacturing, and failure to warn. For the reasons stated below, these claims will be dismissed.

A. Defective Design

To state a claim for defective design, Plaintiff must allege that "(1) the product as designed posed a substantial likelihood of harm; (2) it was feasible to design the product in a safer manner; and (3) the defective design was a substantial factor in causing the plaintiff's injury." Cowan v. Costco Wholesale Corp., No. 15 Civ. 5552 (PKC), 2017 WL 59080, at *2 (E.D.N.Y. Jan. 5, 2017) (citing Simon v. Smith & Nephew, Inc., 990 F. Supp. 2d 395, 403 (S.D.N.Y. 2013)).

The Amended Complaint alleges two defects in the design of the Symbotex Mesh: First, "[m]icroporous meshes such as those made with ePFTE, including the Symbotex Mesh[],are at a higher risk of infection and seroma formation because bacteria can survive within the smaller pores." (Am. Cmplt. (Dkt. No. 14) ¶ 60) Second, "lightweight meshes, such as the Symbotex Mesh[,] are not able to adhere as strongly to the abdominal wall and cause a higher rate of recurrence." (Id.)

As an initial matter, Plaintiff concedes in her opposition brief that the Symbotex Mesh is a macroporous rather than a microporous product. (Pltf. Br. (Dkt. No. 17) at 11)² Accordingly, the factual predicate for Plaintiff's defective design claim is admittedly false, and this sloppy error alone requires that Plaintiff's defective design claim be dismissed. Although Plaintiff asserts in her opposition brief that Defendant's macroporous product is also defective, Plaintiff cannot use her opposition brief to amend the Amended Complaint. Lazaro v. Good Samaritan Hosp., 54 F. Supp. 2d 180, 184 (S.D.N.Y.1999) ("[I]t is axiomatic that the Complaint cannot be amended by the briefs in opposition to a motion to dismiss."). To the extent that Plaintiff also asserts that the Symbotex Mesh is a "[l]ightweight mesh," this allegation - which is not supported by any facts - is not sufficient, particularly given that Plaintiff concedes that theAmended Complaint addresses the wrong product. (Pltf. Br. (Dkt. No. 17) at 11 (citing Am. Cmplt. (Dkt. No. 14) ¶ 60))

Even if Plaintiff had properly characterized the nature of Defendant's product, the Amended Complaint does not adequately allege that there is a feasible alternative design for the Symbotex Mesh. Although Plaintiff states that "[a]lternative designs for hernia mesh products and/or procedures existed that were and/or are less dangerous and equally, i[f] not more, effective" (Am. Cmplt. (Dkt. No. 14) ¶ 62), this conclusory assertion is nothing more than a "[t]hreadbare recital[] of the elements of [the] cause of action." Iqbal, 556 U.S. at 678 (citing Twombly, 550 U.S. at 555). Simply asserting that a feasible alternative design exists - without pleading any supporting facts - is not sufficient to plead a defective design claim or to put Defendant on notice as to what that design might be. See id. at 698-99; see also Kennedy v. Covidien, LP, No. 118 Civ. 1907 (LTS) (KNF), 2019 WL 1429979, at *4 (S.D.N.Y. Mar. 29, 2019) (in a hernia mesh case asserting a design defect claim, "Plaintiff's conclusory allegation alluding to a safer alternative is not pleaded in sufficient detail to support a reasonable inference that there are indeed feasible alternative products").

The Amended Complaint also alleges that "[s]afer and more effective alternatives to hernia mesh exist and have existed since the introduction of hernia mesh products into the market. These include the Shouldice Repair, McVay Repair, Bassini Repair, and Desarda Repair." (Am. Cmplt. (Dkt. No. 14) ¶ 29) "However, alleging that the product should not be used at all is insufficient to satisfy the feasible alternative design element." Kennedy, 2019 WL 1429979, at *4 (citing S.F. v. Archer Daniels Midland Co., 594 Fed. App'x 11, 12-13 (2d Cir. 2014); Hilare v. DeWalt Indus. Tool Co., 54 F. Supp. 3d 223, 248 (E.D.N.Y. 2014)) (finding thathernia repair procedures that do not use surgical mesh do not constitute a feasible alternative design in a hernia mesh defective design claim).

Although Plaintiff contends that she is not required to plead an alternative feasible design (Pltf. Br. (Dkt. No. 17) at 12), she is incorrect. "Although a plaintiff need not possess specialized scientific or technical knowledge at the pleading stage, courts have routinely dismissed strict products liability claims premised on a design defect where the plaintiff has failed to plead that it was feasible to design the product in a safer manner." Kennedy, 2019 WL 1429979, at *3 (citing DiBartolo v. Abbott Labs., 914 F. Supp. 2d 601, 622-23 (S.D.N.Y. 2012) (rejecting plaintiff's argument that a design defect claim does not require a pleading of a feasible alternative design)). Accordingly, Plaintiff's defective design claim will be dismissed.

B. Defective Manufacturing

"A manufacturing defect occurs when 'a mistake in manufacturing renders a product that is ordinarily safe dangerous so that it causes harm.'" Church Ins. Co. v. Trippe Mfg. Co., No. 04 Civ. 6111 (HB), 2005 WL 2649332, at *1 (S.D.N.Y. Oct. 17, 2005) (quoting McCarthy v. Olin Corp., 119 F.3d 148, 154 (2d Cir. 1997)). To state a claim for defective manufacturing, "the plaintiff must show [(1)] that a specific product unit was defective as a result of 'some mishap in the manufacturing process itself, improper workmanship, or because defective materials were used in construction,' and [(2)] that the defect was the cause of plaintiff's injury." Colon ex rel. Molina v. BIC USA, Inc., 199 F. Supp. 2d 53, 85 (S.D.N.Y. 2001) (quoting Caprara v. Chrysler Corp., 52 N.Y.2d 114, 129 (1981)). "Moreover, it is well-settled that a plaintiff may rely upon the circumstances of an accident to prove the existence of a manufacturing defect if the product did not perform as intended and the possibility of other causes...