Williams v. Johnson & Johnson

CourtDistrict Court, D. Rhode Island
DecidedJanuary 18, 2022
Docket1:20-cv-00544
StatusUnknown

This text of Williams v. Johnson & Johnson (Williams v. Johnson & Johnson) is published on Counsel Stack Legal Research, covering District Court, D. Rhode Island primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Williams v. Johnson & Johnson, (D.R.I. 2022).

Opinion

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF RHODE ISLAND

) MARIA WILLIAMS, ) Plaintiff, ) ) v. ) C.A. No. 1:20-CV-00544-MSM-LDA ) JOHNSON & JOHNSON et al., ) 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

1 Ethicon “is a wholly owned subsidiary of J&J.” (ECF No. 10 ¶ 6.) 2 TVT “is a medical device that is generally used to repair weakened or damaged tissue” by being “permanently implanted [in patients] to support the urethra to treat urinary incontinence.” (ECF No. 10 ¶ 13.) 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”). . ¶ 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. . ¶¶ 26, 28. The material used for POP treatment “is the

3 Although the defendants have argued that some of Ms. Williams’ claims are mutually exclusive, Fed. R. Civ. P. 8(2) permits alternative pleading. 4 The Court assumes the accuracy of this date but notes that elsewhere in the FAC, Ms. William’s implant procedure is described as occurring on October 12, 2011. (ECF No. 10 ¶ 71.) 5 According to the FAC, TVT “contains polypropylene mesh, a type of plastic” and “[d]espite claims that this material is inert . . . this mesh material is biologically incompatible with human tissue and promotes an immune response . . . [that] promotes degradation of the polypropylene mesh, as well as the pelvic tissue, and can contribute to the formation of adverse reactions to the mesh.” . ¶ 15. same mesh used in the TVT.” . ¶ 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.” . ¶ 3. At some point after receiving the TVT implant, Ms. Williams underwent

“corrective surgery” to remove it. . ¶ 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

6 In 2019, “the [Food and Drug Administration] ordered all transvaginal POP device manufacturers, including Defendants, to stop selling and distributing POP products immediately” but “has not banned Defendants’ TVT as of the date of [the plaintiff’s FAC] filing.” . ¶ 40. damages, including punitive damages, restitution, attorneys’ fees and costs, and demands a jury trial. . 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.” , 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. , 550 U.S. 544, 570 (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 to render plaintiffs’ entitlement to relief plausible.” , 711 F.3d 49, 55 (1st Cir. 2013) (quoting , 550 U.S. 544, 569 n.14 (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. , 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.” . 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.

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Williams v. Johnson & Johnson, Counsel Stack Legal Research, https://law.counselstack.com/opinion/williams-v-johnson-johnson-rid-2022.