Williams v. Johnson & Johnson

• Decision Date: 18 January 2022
• Docket Number: C.A. No. 1:20-CV-00544-MSM-LDA
• Parties: Maria WILLIAMS, Plaintiff, v. JOHNSON & JOHNSON et al., Defendants.
• Court: U.S. District Court — District of Rhode Island

581 F.Supp.3d 363

Maria WILLIAMS, Plaintiff,

v.JOHNSON & JOHNSON et al., Defendants.

C.A. No. 1:20-CV-00544-MSM-LDA

United States District Court, D. Rhode Island.

Signed January 18, 2022

Andrew J. Feldman, Pro Hac Vice, Jacob A. Flint, Pro Hac Vice, Flint Law Firm, LLC, Edwardsville, IL, Stephen E. Breggia, The Breggia Law Firm, Providence, RI, for Plaintiff.

Kathleen M. Guilfoyle, Campbell Conroy & O'Neil, P.C., Boston, MA, for Defendants.

MEMORANDUM AND ORDER

Mary S. McElroy, United States District Judge.

This matter comes before the Court on the defendants’, Johnson & Johnson ("J&J") and Ethicon, Inc. ("Ethicon") (together "defendants"), Motion to Dismiss for failure to state a claim upon which relief may be granted pursuant to Federal Rule of Civil Procedure 12(b)(6). (ECF No. 12.) The plaintiff, Maria Williams, has alleged claims in her First Amended Complaint ("FAC") against the defendants in connection with Ms. Williams’ Ethicon¹ Gynecare TVT pelvic mesh ("TVT")² implant, which was implanted on March 7, 2011. (ECF No. 10 ¶ 2.) J&J and Ethicon have moved to dismiss all but the plaintiff's Count I negligence claim, "to the extent that it is predicated on a failure to warn theory" and her Count IV strict liability claim for failure to warn. (ECF No. 12 at 1.) Ms. Williams filed a Response in Opposition to Defendants’ Motion. (ECF No. 13.) For the following reasons, the Court GRANTS in part and DENIES in part the defendants’ Motion to Dismiss.³

I. BACKGROUND

These facts have been gleaned from Ms. Williams’ First Amended Complaint ("FAC"). On March 7, 2011⁴ , Ms. Williams’ physician, Dr. Gretchen Paranya, performed a TVT implant procedure to treat Ms. Williams’ stress urinary incontinence

("SUI"). (ECF No. 10 ¶ 68.) Ms. Williams’ FAC recites the unfortunate history of TVT⁵ , detailing the various problems with the product and the complications that its implantation can cause in recipients. Similar mesh products have been used in patients suffering from pelvic organ prolapse ("POP"). Id. ¶ 11. In 2008 and 2011, adverse effects caused by contraction or shrinkage of the mesh implanted in POP patients that had been reported to the Food and Drug Administration led the agency to issue a public health notice and later a warning related to pelvic mesh. Id. ¶¶ 26, 28. The material used for POP treatment "is the same mesh used in the TVT." Id. ¶ 36. Ms. Williams asserts that the risks associated with the POP repairs using polypropylene mesh are the same for SUI repairs using TVT.⁶ Ms. Williams further alleges that she "developed complications arising from the implant ... including complications necessitating removal, worsening mixed incontinence, pelvic pressure and pain, dyspareunia, difficulty voiding, dysuria, polyuria, frequency, nocturia, urinary tract infections, urgency, abnormal uterine bleeding, severe emotional distress, stress, anxiety, fear, anger, and sadness." Id. ¶ 3.

At some point after receiving the TVT implant, Ms. Williams underwent "corrective surgery" to remove it. Id. ¶ 103. Ms. Williams makes the following claims: Count I for negligence "in designing, researching, manufacturing, marketing, labeling, training, inspecting, testing, packaging, supplying, distributing, and selling" TV; Count II for strict liability for defective design; Count III for strict liability for manufacturing defect; Count IV for strict liability for failure to warn; Count V for breach of express warranty; Count VI for breach of implied warranty of merchantability; Count VII for fraudulent concealment; Count VIII for constructive fraud; Count IX for negligent misrepresentation; Count X for common law fraud; Count XI for gross negligence; Count XII for negligent infliction of emotional distress; and Count XIII for unjust enrichment. Ms. Williams’ prayer for relief requests damages, including punitive damages, restitution, attorneys’ fees and costs, and demands a jury trial. Id. at 68.

II. MOTION TO DISMISS STANDARD

On a motion to dismiss, the Court "must assume the truth of all well-plead[ed] facts and give plaintiff the benefit of all reasonable inferences therefrom." Ruiz v. Bally Total Fitness Holding Corp. , 496 F.3d 1, 5 (1st Cir. 2007). To survive a motion to dismiss, the complaint must state a claim 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 relevant question ... in assessing plausibility is not whether the complaint makes any particular factual allegations but, rather, whether ‘the complaint warrant[s] dismissal because it failed in toto to render plaintiffs’ entitlement to relief plausible." Rodriguez-Reyes v. Molina-Rodriguez , 711 F.3d 49, 55 (1st Cir. 2013) (quoting Bell Atlantic Corp. v. Twombly , 550 U.S. 544, 569 n.14, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007) ).

III. DISCUSSION

The defendants have moved to dismiss all counts except those predicated on the failure to warn theories of Count I (negligence) and Count IV (strict liability). To assess the sufficiency of the FAC, the Court addresses each count in turn.

A. Count I – Negligence

Ms. Williams has asserted a negligence claim based on "designing, researching, manufacturing, marketing, labeling, training, inspecting, testing, packaging, supplying, distributing, and selling." (ECF No. 10 ¶ 80.) The negligence count appears to parallel Ms. Williams’ strict liability claims based on design, manufacturing, and marketing (or failure to warn).

As mentioned above, the defendants do not seek dismissal of Ms. Williams’ negligence claim based on the defendants’ failure to warn of the risks associated with TVT. The defendants do, however, ask the Court to dismiss Ms. Williams’ negligence claim based on manufacturing. Ms. Williams puts forth both a negligence claim and strict liability claim premised on a manufacturing defect. While strict liability, unlike negligence "will lie due to a manufacturing defect without ... the additional requirement that defendant knew or should have known of the defect," Ms. Williams has nevertheless asserted both claims. Guilbeault v. R.J. Reynolds Tobacco Co. , 84 F. Supp. 2d 263, 280-81 (D.R.I. 2000). Under either theory, however, the plaintiff's manufacturing defect claims fail because she has not sufficiently pleaded "a mistake or accident in the manufacturing process." Id. at 281. The Court finds that without facts to support the requisite irregularity in the manufacturing process, the FAC fails to state a claim for relief for negligence in manufacturing. See id. at 280-81 (dismissing negligent manufacturing claim because the plaintiff did not assert that an error in the manufacturing process caused the alleged defect).

With the defendants not challenging the sufficiency of the negligent failure to warn claim, and the Court finding insufficient allegations of negligent manufacturing, what remain for the Court's consideration are the other negligence theories associated with the TVT design. "To make a prima facie case of negligence under Rhode Island law, Plaintiffs must show that 1) defendants owed them a legal duty to refrain from negligent activities; 2) Defendants breached that duty; 3) the breach proximately caused Plaintiffs’ injuries; and 4) actual loss or damages resulted." Gray v. Derderian , 365 F. Supp. 2d 218, 226 (D.R.I. 2005) (citing Splendorio v. Bilray Demolition Co. , 682 A.2d 461, 466 (R.I. 1996) ). "In a negligent design claim, ‘one can only be liable in negligence if the plaintiff[s] ha[ve] met [their] burden of introducing credible evidence that the defendant[s] knew, or had reason to know, of a defective design or that [they] w[ere] negligent in failing to test or inspect the product prior to sale." Raimbeault v. Takeuchi Mfg. (U.S.), Ltd. , 772 A.2d 1056, 1063 (R.I. 2001) (quoting Thomas v. Amway Corp. , 488 A.2d 716, 721 (R.I. 1985) ) (alterations in original).

In support of her negligence claims, Ms. Williams alleges (1) that the defendants owed a duty of "care in designing, researching, manufacturing, marketing, labeling, training, inspecting, testing, packaging, supplying, distributing and selling the Ethicon Gynecare TVT pelvic mesh product implanted in Plaintiff," (2) which they breached when they "failed to avoid an unreasonable risk of harm to women in whom the product was implanted, including the Plaintiff," which in turn (3) caused the injuries Ms. Williams sustained after receiving the TVT implant, and (4) resulted in damages to the plaintiff. (ECF No. 10 at ¶¶ 80-81.) The defendants do not challenge the assertion that they owed a duty to the plaintiff. Their argument in favor of dismissing Ms. Williams’ negligence claims simply contends that because her strict liability claims fail, her claims based on negligence fail as well. (ECF No. 12-1 at 9.) This broad challenge seems to center on the defendants’ argument that Ms. Williams has failed to link her injuries to her TVT implant and, therefore, failed to establish proximate cause.

"In most cases, proximate cause is established by showing that but for the negligence of the tortfeasor, injury to the plaintiff would not have occurred." Skaling v. Aetna Ins. Co. , 742 A.2d 282, 288 (R.I. 1999) (citing Fondedile, S.A. v. C.E. Maguire, Inc. , 610 A.2d 87, 95 (R.I. 1992) ). The FAC identifies ten ways in which the TVT product is known to fail or cause injury. Ms. Williams alleges, albeit with brevity, that after receiving her TVT implant she "subsequently developed complications arising from ... the TVT ... including mesh implant complications

necessitating removal, worsening mixed incontinence, pelvic pressure and pain, dyspareunia, difficulty voiding, dysuria, polyuria, frequency, nocturia, urinary tract infections, urgency, [and] abnormal uterine bleeding ...." (ECF No. 10 at ¶ 2-3.) Although the defendants contend that Ms. Williams has not identified the precise way her implant failed and caused her injuries, the Court is satisfied at this stage of litigation that Ms. Williams has...