Goodling v. Johnson & Johnson

CourtDistrict Court, M.D. Pennsylvania
DecidedFebruary 10, 2022
Docket4:21-cv-00082
StatusUnknown

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

Bluebook
Goodling v. Johnson & Johnson, (M.D. Pa. 2022).

Opinion

IN THE UNITED STATES DISTRICT COURT FOR THE MIDDLE DISTRICT OF PENNSYLVANIA

KIM GOODLING and No. 4:21-CV-00082 NORMAN GOODLING, SR., (Chief Judge Brann) Plaintiffs,

v.

JOHNSON & JOHNSON and ETHICON, INC.,

Defendants.

MEMORANDUM OPINION

FEBRUARY 10, 2022 Plaintiffs Kim and Norman Goodling bring this fourteen-count suit against Johnson & Johnson and its wholly-owned subsidiary Ethicon, Inc., seeking damages for injuries they allegedly suffered after Ms. Goodling was implanted with the Defendants’ pelvic mesh product. This is one of many suits filed across the country by women implanted with this medical device. The Defendants move to dismiss the Goodlings’ Amended Complaint, raising particular issue with the lack of case-specific allegations—indeed, many (if not most) of the 358 paragraphs in the Amended Complaint appear to be copied verbatim from other complaints filed by other plaintiffs. Although the Court finds the allegations insufficient to sustain certain claims, others will be allowed to proceed. For the reasons provided below, the Defendants’ motion to dismiss is granted in part, denied in part. I. BACKGROUND On December 5, 2011, Kim Goodling went to the Milton S. Hershey

Medical Center in Hershey, Pennsylvania for a surgical procedure to treat stress urinary incontinence.1 Specifically, her physician, Dr. Matthew Davies, implanted in her a Gynecare TVT-Exact pelvic mesh product (“TVT device” or “pelvic mesh

product”) designed and manufactured by Defendant Ethicon, Inc., a wholly-owned subsidiary of Defendant Johnson & Johnson.2 Prior to the implantation procedure, Ms. Goodling met with her medical providers, including Dr. Davies, to discuss possible treatments for the mild stress

urinary incontinence she was experiencing.3 At that time, the Defendants “made assurances” to Dr. Davies and other health care professionals that their TVT device “was safe and reasonably fit” to address health concerns like Ms. Goodling’s.4 The

Defendants represented that the TVT device is a “permanent implant” that would “permanently cure or alleviate” stress urinary continence—the pelvic mesh product would not “contract,” “shrink,” or “degrade,” and as such, “would not need to be partially removed.”5 Relying on these commitments—which the Defendants made

in their “instructions for use” for the TVT device as well as in pamphlets, commercial documents, and other oral and written statements—Dr. Davies

1 Doc. 13 ¶¶ 2, 217. 2 Id. ¶¶ 2, 12, 30. 3 Id. ¶¶ 5, 81. 4 Id. ¶ 198. recommended the pelvic mesh product as a treatment option.6 Ms. Goodling consented to the implantation procedure.7

Unbeknownst to either Ms. Goodling or Dr. Davies, the TVT device “has high rates of failure, injury, and complications, fails to perform as intended, requires frequent and often debilitating re-operations, and has caused severe and irreversible injuries, conditions, and damages to a significant number of women.”8

Specifically, after implantation, the TVT device often “contracts, shrinks, frays, cords, curls, migrates, stiffens, loses pore size with tension, and/or otherwise degrades.”9 These complications are attributable to defects in the pelvic mesh

product’s design—in particular, the use of “polypropylene,” a type of plastic that is “biologically incompatible with human tissue”: [P]olypropylene and other surgical polymers promote a severe foreign body reaction and chronic inflammatory response in a large subset of the population implanted with Defendant’s TVT [device]. This “host defense response” by a woman’s pelvic tissues promotes degradation of the polypropylene mesh and the pelvic tissue, and causes chronic inflammation of the pelvic tissue, shrinkage or contraction of the mesh leading to nerve entrapment, further inflammation, chronic infectious response, and chronic pain. It also can cause new-onset painful sexual relations, significant dysfunction, vaginal shortening and anatomic

6 Id. ¶¶ 152, 158. 7 Id. ¶ 158. 8 Id. ¶ 65. deformation, and can contribute to the formation of severe adverse reactions to the mesh.10 Further, the TVT device contains “collagen,” which causes “adverse tissue reactions” that are “causally related to infection, as the collagen is a foreign organic material.”11 Other potential design defects include “[t]he use of laser-cut or

mechanical cut polypropylene mesh,” which “contributed to the sharp edges of the [TVT] device,” and the failure to use a “sheath” for insertion, which “can lead to mesh erosions.”12

The Defendants “were and are aware that their TVT [device]” causes these complications; however, they “failed to disclose and misrepresented” these risks to Ms. Goodling’s “implanting physician.”13 Specifically, the “Instructions for Use

(‘IFU’) and pamphlets or commercial documents for the TVT [device]” that the Defendants provided to implanting physicians, including Dr. Davies, “fail[ed] to detail the extent and frequency of known complications, including mesh erosion and extrusion.”14 If Dr. Davies knew of the risks associated with the Defendants’

pelvic mesh product, he “would have conveyed [this] information to [Ms. Goodling] during her consent process.”15 And had she been “informed of all known relevant risks,” Ms. Goodling “would not have consented to having the

10 Id. ¶¶ 3, 21–22. 11 Id. ¶ 23. 12 Id. ¶¶ 134–35. 13 Id. ¶¶ 63, 147. 14 Id. ¶¶ 152, 157. TVT device implanted in her” and her “implanting physician would not have implanted the TVT device.”16

After the implantation procedure, Ms. Goodling “developed complications arising from the implant.”17 Specifically, the mild stress urinary incontinence that she experienced prior to the procedure “significantly increased in frequency after

mesh implantation,” and she also suffered “onset pelvic pain, vaginal bleeding, urinary tract infections, dyspareunia, vaginal scarring, urinary urgency, [and] voiding dysfunction.”18 According to the Goodlings, these complications “were all caused by the defective propensities of the TVT [device].”19

The Goodlings initiated this lawsuit on January 14, 2021.20 Four months later, on May 19, 2021, the Goodlings filed an Amended Complaint, which included fourteen counts sounding in strict liability, negligence, fraud, breach of warranty, unjust enrichment, loss of consortium, and punitive damages.21 The

Defendants moved to dismiss the Amended Complaint on June 9, 2021.22 That motion has been fully briefed and is now ripe for disposition.23

16 Id. 17 Id. ¶ 4. 18 Id. ¶ 5. 19 Id. 20 Doc. 1. 21 Doc. 13. 22 Doc. 16. II. LAW Under Federal Rule of Civil Procedure 12(b)(6), the Court dismisses a

complaint, in whole or in part, if the plaintiff fails to “state a claim upon which relief can be granted.” Following the landmark decisions of Bell Atlantic Corp. v. Twombly24 and Ashcroft v. Iqbal,25 “[t]o 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.’”26 The United States Court of Appeals for the Third Circuit has instructed that “[u]nder the pleading regime established by Twombly and Iqbal, a court reviewing the sufficiency of a complaint must take three steps”:

(1) “take note of the elements the plaintiff must plead to state a claim”; (2) “identify allegations that, because they are no more than conclusions, are not entitled to the assumption of truth”; and (3) “assume the[] veracity” of all “well-

pleaded factual allegations” and then “determine whether they plausibly give rise to an entitlement to relief.”27 III. ANALYSIS A. Shotgun Pleading

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Goodling v. Johnson & Johnson, Counsel Stack Legal Research, https://law.counselstack.com/opinion/goodling-v-johnson-johnson-pamd-2022.