Teague v. Johnson & Johnson, Inc.

• Decision Date: 05 January 2022
• Docket Number: 5:21-CV-68-FL
• Citation: 578 F.Supp.3d 743
• Parties: Katina TEAGUE, Plaintiff, v. JOHNSON & JOHNSON, INC. and Ethicon, Inc., Defendants.
• Court: U.S. District Court — Eastern District of North Carolina

578 F.Supp.3d 743

Katina TEAGUE, Plaintiff,

v.JOHNSON & JOHNSON, INC. and Ethicon, Inc., Defendants.

NO. 5:21-CV-68-FL

United States District Court, E.D. North Carolina, Western Division.

Signed January 5, 2022

Rebecca L. Fredona, Moll Law Group, Chicago, IL, Christopher James Anglin, Anglin Law Firm, PLLC, Raleigh, NC, for Plaintiff.

Shelley Walters Coleman, Butler Snow LLP, Wilmington, NC, for Defendants.

ORDER

LOUISE W. FLANAGAN, United States District Judge

This matter is before the court on defendants’ motion for judgment on the pleadings pursuant to Federal Rule of Civil Procedure 12(c) (DE 14). The motion has been briefed fully, and in this posture the issues raised are ripe for ruling. For the following reasons, the motion is granted in part and denied in part.

STATEMENT OF THE CASE

Plaintiff commenced this products liability action on February 8, 2021, against defendants, alleging that defendants’ medical device, the GYNECARE TVT ABBREVO Continence System ("TVTA product"), is defectively designed, that defendants failed to warn of the dangers associated with the TVTA product, and that they breached implied warranties regarding the TVTA product, all as arising under North Carolina law.¹ Plaintiff seeks compensatory damages, interest, and costs and fees.

On April 9, 2021, defendants filed their respective answers to the complaint. Shortly after, they jointly filed the instant motion for judgment on the pleadings. Plaintiff responded in opposition, and defendants filed a reply in support.

STATEMENT OF THE FACTS

The facts alleged in the complaint may be summarized as follows.

Defendants are alleged to be in the business of developing, manufacturing, marketing, and selling medical devices, including the TVTA product, with defendant Ethicon, Inc. serving as the wholly owned subsidiary of defendant Johnson & Johnson. Defendants promote the use of the TVTA product to "women who suffer from ...stress urinary incontinence

" as a "minimally invasive procedure" that "permanently correct[s] ...stress urinary incontinence." (Compl. ¶ 11). The TVTA product "contain[s] polypropylene mesh," which can result in "severe adverse reactions" in "a large subset of the population," including plaintiff. (Id. ¶¶ 12, 31-32). The TVTA product also has a "biomechanical issue[ ] with [its] design" in that it has a "propensity ... to contract or shrink inside the body ..., resulting in injury." (Id. ¶ 39).

Plaintiff, who suffers from stress urinary incontinence

, had defendants’ TVTA product implanted on or about October 15, 2015, to treat her condition. Thereafter, she began suffering from "infections; dyspareunia ; open wounds; constant excruciating pain; and mesh erosion," (id. ¶ 61), which, based on alleged "medical and scientific literature studying the effects" of the TVTA product," are "causally related" to the TVTA product. (Id. ¶¶ 49-50). Accordingly, on August 25, 2020, she underwent a procedure to remove the TVTA product. Plaintiff alleges that, because of the TVTA product implantation, she suffered "significant mental and physical pain," "permanent injury," and "economic loss" and will likely require additional medical treatment in addition to that she has already received due to the product. (Id. ¶ 63).

Additional alleged facts pertinent to the motion will be discussed in the analysis below.

COURT'S DISCUSSION

A. Standard of Review

"After the pleadings are closed[,] ... a party may move for judgment on the pleadings." Fed. R. Civ. P. 12(c). In reviewing a motion for judgment on the pleadings, the court "appl[ies] the same standard as a 12(b)(6) motion to dismiss." Mayfield v. Nat'l Ass'n for Stock Car Auto Racing, Inc., 674 F.3d 369, 375 (4th Cir. 2012) ; see, e.g., Occupy Columbia v. Haley, 738 F.3d 107, 115 (4th Cir. 2013) ; Butler v. United States, 702 F.3d 749, 752 (4th Cir. 2012).

"To survive a motion to dismiss" under Rule 12(b)(6), "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, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009) (quoting Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007) ). "Factual allegations must be enough to raise a right to relief above the speculative level." Twombly, 550 U.S. at 555, 127 S.Ct. 1955. In evaluating whether a claim is stated, "[the] court accepts all well-pled facts as true and construes these facts in the light most favorable to the plaintiff," but does not consider "legal conclusions, elements of a cause of action, ... bare assertions devoid of further factual enhancement[,] ... unwarranted inferences, unreasonable conclusions, or arguments." Nemet Chevrolet, Ltd. v. Consumeraffairs.com, Inc., 591 F.3d 250, 255 (4th Cir. 2009).

B. Analysis

Defendants argue that plaintiff fails to allege sufficient facts to support her claims under North Carolina law. The court addresses each claim in turn.

1. Design Defect Claim

Per North Carolina statute, "[n]o manufacturer of a product shall be held liable in any product liability action for the inadequate design ... of the product unless the claimant proves that at the time of its manufacture the manufacturer acted unreasonably in designing ... the product, [and] that this conduct was a proximate cause of the harm for which damages are sought." N.C. Gen. Stat. § 99B-6(a). Additionally, such a plaintiff-claimant must prove either that "[a]t the time the product left the control of the manufacturer, the manufacturer unreasonably failed to adopt a safer, practical, feasible, and otherwise reasonable alternative design ... that would have prevented or substantially reduced the risk of harm without substantially impairing the usefulness, practicality, or desirability of the product" or that "[a]t the time the product left the control of the manufacturer, the design ... of the product was so unreasonable that a reasonable person, aware of the relevant facts, would not use or consume a product of this design." Id. § 99B-6(a)(1)-(2).

Accordingly, "[u]nder North Carolina law, ... a plaintiff bringing a products liability action based on negligence must prove (1) the product was defective at the time it left the control of the defendant, (2) the defect was the result of defendant's negligence, and (3) the defect proximately caused plaintiff damage." Farrar & Farrar Farms v. Miller-St.Nazianz, Inc., 477 F. Appx 981, 984 (4th Cir. 2012) (quoting Red Hill Hosiery Mill, Inc. v. MagneTek, Inc., 138 N.C. App. 70, 75, 530 S.E.2d 321 (2000) ); see Ruffin v. Shaw Indus., Inc., 149 F.3d 294, 301 (4th Cir. 1998). Further, North Carolina's courts recognize that "a product defect may be inferred from evidence of the product's malfunction, if there is evidence the product had been put to its ordinary use." Red Hill, 138 N.C. App. at 76-77, 530 S.E.2d 321 ; see DeWitt v. Eveready Battery Co., 355 N.C. 672, 684, 565 S.E.2d 140 (2002). This is true even where "a plaintiff does not produce evidence of a specific defect." Cf. DeWitt, 355 N.C. at 684, 565 S.E.2d 140 ; see also DeWitt v. Eveready Battery Co., 144 N.C. App. 143, 150, 550 S.E.2d 511 (2001), aff'd, 355 N.C. 672, 565 S.E.2d 140.

Here, plaintiff alleges that the TVTA product, by design, "contain[s] polypropylene mesh," which can result in "severe adverse reactions" in "a large subset of the population," including plaintiff. (Compl. ¶¶ 12, 31-32, 39, 78).² The inclusion of such material in defendants’ product plausibly could constitute a defect in its design. See Huskey v. Ethicon, Inc., 848 F.3d 151, 156-57 (4th Cir. 2017) (concluding at the summary judgment stage that plaintiff had "offered sufficient evidence for a reasonable jury to find that [defendant's] use of heavyweight polypropylene mesh in the TVT–O caused [plaintiff's] injuries," which constituted proof of "a specific defect of the TVT-O's design"); accord Eghnayem v. Bos. Sci. Corp., 873 F.3d 1304, 1320 (11th Cir. 2017). Plaintiff alleges that this inclusion was negligent and supports this with competent factual allegations rising above a speculative level. (See, e.g., Compl. ¶¶ 12, 31-32, 37-38, 53).

Plaintiff also alleges that the TVTA product has a "biomechanical issue[ ] with [its] design" in that it has a "propensity ... to contract or shrink inside the body ..., resulting in injury." (Id. ¶¶ 34, 39, 78). This is joined with allegations that the Food and Drug Administration has issued public health notifications regarding the risk of "contraction" and "shrinkage" in use of "mesh" for such procedures, which can result in "vaginal shortening, vaginal tightening, and vaginal pain," in congruence with the findings of other scientific and medical organizations. (Id. ¶¶ 18-27). Plaintiff alleges that the defects of the TVTA product described in her complaint,³ including its propensity to contract or shrink inside the body, caused her injuries such as vaginal pain. (See id. ¶ 21, 63, 80). Factual matter alleged in the complaint makes plausible that this defect's inclusion in the TVTA product was the product of defendants’ negligence. (See, e.g., id. ¶ 28).

In sum, plaintiff has pleaded sufficient factual material, taken as true and construed in the light most favorable to her, to raise her right to relief for a negligent design defect above a speculative level.

Defendants advance several arguments contesting this conclusion which are unavailing.

First, defendants contend that plaintiff's allegations regarding "biomechanical issues with the design of the Mesh Products" fail to "identify how the design of the products" leads to alleged biomechanical issues. (Defs.’ Mem. (DE 15) at 4 n.1). However, the complaint describes these biomechanical issues as issues with the design of the product that stem from the propensity of the TVTA product to contract, retract, and shrink inside the body, which happened even when the product was "implanted in [p]laintiff ... in the condition directed by and expected by [d]efendants." (Compl. ...