Paesano v. Ethicon Inc.

OPINION & ORDER 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. A. 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 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.