Paesano v. Ethicon, Inc.

CourtDistrict Court, S.D. New York
DecidedMarch 22, 2022
Docket7:19-cv-10979
StatusUnknown

This text of Paesano v. Ethicon, Inc. (Paesano v. Ethicon, Inc.) is published on Counsel Stack Legal Research, covering District Court, S.D. New York primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Paesano v. Ethicon, Inc., (S.D.N.Y. 2022).

Opinion

UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF NEW YORK -------------------------------------------------------------x DEBORAH PAESANO and ANTHONY PAESANO,

Plaintiffs, OPINION & ORDER

- against - No. 19-CV-10979 (CS)

ETHICON, INC., JOHNSON & JOHNSON, and

JOHN DOES 1-20,

Defendants. -------------------------------------------------------------x

Appearances:

Thomas G. Cascione Cascione Purcigliotti & Galluzzi, P.C. Eastchester, New York Counsel for Plaintiffs

Maha M. Kabbash Riker, Danzig, Scherer, Hyland & Perretti, LLP Morristown, New Jersey Counsel for Defendants Ethicon, Inc. and Johnson & Johnson

Seibel, J. Before the Court is the motion for summary judgment of Defendants Ethicon, Inc. and Johnson & Johnson (collectively, “Ethicon”). (ECF No. 38.) For the following reasons, the motion is GRANTED. I. BACKGROUND This case arises out of injuries experienced by Plaintiff Deborah Paesano that she attributes to Defendants’ wrongful conduct in connection with the development, design, manufacture, marketing, distribution, and sale of Ethicon’s pelvic mesh products – specifically, the Gynemesh PS mesh device and TVT mesh mid-urethral sling – that were implanted in Ms. Paesano’s body to treat medical conditions. Facts The following facts are based on Defendants’ Local Civil Rule 56.1 statement, (ECF No. 38-3 (“Ds’ 56.1 Stmt.”)), Plaintiffs’ response thereto, (ECF No. 39-2 (“Ps’ 56.1 Resp.”)), and

supporting materials, and are undisputed except as noted. 1. Initial Visit and Implantation In July 2008, urogynecologist Dr. Robert Lobel diagnosed Ms. Paesano with “pelvic organ prolapse involving a third-degree cystocele and rectocele, fourth-degree enterocele, and vaginal vault prolapse, as well as levator (pelvic floor) weakness and urethral hypermobility.” (Ds’ 56.1 Stmt. ¶ 1.) In layman’s terms, her bladder, rectum, and small intestine had fallen into her vaginal vault, and her small intestine was protruding through the vaginal opening, while her bladder and rectum “were coming to the opening.” (ECF No. 38-2 Ex. B (“Lobel Depo.”) at 54:14-56:13.)1 These conditions resulted in her experiencing urinary incontinence, constipation,

vaginal pain, and sexual dysfunction. (Ds’ 56.1 Stmt. ¶ 2.) On January 19, 2009, Dr. Lobel implanted Ethicon’s Gynemesh PS mesh device and an AlloDerm acellular dermis graft to treat Ms. Paesano’s pelvic organ prolapse, and Ethicon’s TVT mesh mid-urethral sling to address her urinary incontinence. (Id. ¶ 3.) He understood that short-term or long-term vaginal or pelvic

1 Dr. Lobel’s deposition appears at pages 29-72 of ECF No. 38-2. Citations to page numbers are to the page numbers of the deposition transcript, not the numbers assigned by the Court’s Electronic Case Filing (“ECF”) system. pain, and pain with intercourse, were risks of surgery using those products. (Id. ¶¶ 18-20, 23-24, 27-29.) He also was aware that a fistula2 was an infrequent but possible risk. (Id. ¶¶ 36-37.) 2. September 4, 2009 Visit to Dr. Lobel’s Office On September 4, 2009, Ms. Paesano returned to Dr. Lobel’s office and reported that she had been experiencing pain and bleeding during intercourse. (Id. ¶ 4.) The clinical notes from

that visit, prepared by members of Dr. Lobel’s staff, (Lobel Depo. at 123:12-124:7), state that Ms. Paesano’s gynecologist –Dr. Sitara Choudhury, (ECF No. 38-2 Ex. G at 206)3 – “told [Ms. Paesano] the mesh had eroded [through her] vag[ina],” (ECF No. 38-2 Ex. C at 74),4 and that Dr. Choudhury “was worried about an abscess and sent her for CT (which came back neg[ative]) and put her on [antibiotics] and told her to come [to Dr. Lobel’s office],” (id.). Ms. Paesano denies being told by Dr. Choudhury that the mesh had eroded through her vagina. (Ps’ 56.1 Resp. ¶ 6; see P Depo. at 113:6-17.) During this visit, the nurse practitioner who examined Ms. Paesano observed a “red friable area” at the top of her vagina and noted, “Palpation causes [patient] discomfort. Some

bleeding noted.” (ECF No. 38-2 Ex. C at 74; Ds’ 56.1 Stmt. ¶ 7.) Dr. Lobel testified that the “Gynemesh would certainly [have been] a prime culprit here.” (Lobel Depo. at 128:3-23; Ds’ 56.1 Stmt. ¶ 8.) The notes include the assessment, “possible erosion of vaginal mesh.” (ECF

2 “A fistula is an abnormal tunnel or connection between two organs.” (Lobel Depo. at 140:22-141:4.) 3 This page citation is to the page number generated by the ECF system. Dr. Choudhury has passed away, (ECF No. 38-2 Ex. D (“P Depo.”) at 103:5-10), and the parties were unable to obtain the medical records she maintained, (ECF No. 40 (“Ds’ Reply”) at 7 n.6). Ms. Paesano’s deposition, (P Depo.), appears at pages 76-136 of ECF No. 38-2. Citations to page numbers are to the page numbers of the deposition transcript, not the numbers assigned by the ECF system. 4 The notes from Ms. Paesano’s September 4, 2009 visit appear at ECF-generated page 74 of ECF No. 38-2. No. 38-2 Ex. C at 74.) Plaintiff testified that she has no memory of being informed of that assessment. (P Depo. at 114:5-21.)5 The notes further state that the nurse practitioner discussed various treatment options with Ms. Paesano, including “vaginoscopy to further investigate the cause of her symptoms, doing nothing, or possible surgery.” (Ds’ 56.1 Stmt. ¶ 9). Ms. Paesano was hesitant to get additional surgery, so she opted for pelvic rest and estrogen cream. (Id.)

Ms. Paesano testified that she experienced vaginal pain, which “was never good after the surgery,” although “the bowel wasn’t hanging out of me anymore.” (P Depo. at 105:5-14.) She experienced painful intercourse, bleeding, and difficulty starting her urine stream in the months following the implant procedure, (Ds’ 56.1 Stmt. ¶ 10), and sex had been painful since she resumed having sex in May 2009 after the surgery, (id. ¶¶ 5, 11-12.) 3. Post-2009 Treatment In 2011, Ms. Paesano met with Dr. Ronald Dinsmore, the gynecologist who took over Dr. Choudhury’s practice, and reported experiencing ongoing vaginal pain and burning. (Ds’ 56.1 Stmt. ¶ 13; P Depo. at 103:23-104:15.) Dr. Dinsmore prescribed antibiotics after examining her

and finding that her vagina was inflamed due to an infection. (P Depo. at 103:23-104:20.) On October 12, 2015, Ms. Paesano saw Dr. Bernadette Tillmon, a primary care physician, for an annual checkup, (ECF No. 38-2 Ex. E at 138),6 and reported vaginal burning, (Ds’ 56.1 Stmt. ¶ 14). Ms. Paesano testified that at this time, she was still experiencing the same pain with intercourse she had reported in 2009 and 2011. (P Depo. at 121:24-122:10.) According to Dr.

5 Plaintiffs in their 56.1 response cite to Ms. Paesano’s deposition and the deposition of Mr. Paesano, her husband and co-Plaintiff, (Ps’ 56.1 Resp. ¶ 9), but neither party provided Mr. Paesano’s deposition with their motion papers. 6 Dr. Tillmon’s notes from Ms. Paesano’s October 12, 2015 visit appear at pages 138-41 of ECF No. 38-2, and page references are to the page numbers generated by the ECF system. Tillmon’s notes from this visit, Plaintiff was experiencing “[v]aginal discomfort/burning which she attributes to mesh.” (ECF No. 38-2 Ex. E at 138.) On October 8, 2018, Ms. Paesano saw Dr. Steven Helft, a gastroenterologist. (ECF No. 39-1 Ex. 1 at 4.)7 She reported “a single episode of passage of fecal material through the vagina”

in May 2018 and “[s]ince then . . . ha[d] been passing air through the vagina suggestive of rectovaginal fistula.” (Id.) On October 18, 2018, Ms. Paesano saw Dr. Cornelius Verhoest, a urogynecologist, who suspected Ms. Paesano had a fistula between her vagina and either the small intestine or the large intestine. (ECF No. 39-1 Ex. 5 (“Verhoest Depo.”) at 25:21-26:9, 26:14-27:13, 30:22-32:14.)8 He referred Ms. Paesano to Dr. Asna Amin, a rectal surgeon, to undergo a right colectomy and possibly a small bowel resection to fix her fistula. (Id.

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