YELINEK V ETHICON, INC.

CourtDistrict Court, W.D. Pennsylvania
DecidedOctober 19, 2021
Docket2:20-cv-00799
StatusUnknown

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Bluebook
YELINEK V ETHICON, INC., (W.D. Pa. 2021).

Opinion

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

NANCY YELINEK, ) ) Plaintiff, ) ) Civil Action No. 20-799 v. ) Judge Nora Barry Fischer ) ) JOHNSON & JOHNSON; ETHICON INC., ) ) Defendants. )

MEMORANDUM OPINION I. INTRODUCTION Plaintiff Nancy Yelinek sued Defendants Johnson & Johnson and Ethicon Inc. for injuries allegedly sustained from a mesh product implanted in Yelinek to treat a parastomal hernia. (Docket No. 55 ¶ 1). Presently before the Court are Defendants’ Motion for Summary Judgment, (Docket No. 52), Yelinek’s Brief in Opposition, (Docket No. 57), and Defendants’ Reply, (Docket No. 60). After careful consideration of the parties’ positions and for the following reasons, Defendants’ Motion [52] is granted. II. FACTUAL BACKGROUND The factual background derives from the undisputed evidence in the record, and any disputed evidence is viewed in the light most favorable to Yelinek as the non-moving party. The record consists of Yelinek’s medical records, her deposition testimony, and the deposition testimony of two physicians who provided her medical care: Dr. Brent Angott and Dr. David Medich. A. Yelinek’s Interstitial Cystitis Diagnosis and Pre-2008 Treatment Yelinek suffered from interstitial cystitis. Interstitial cystitis is a chronic condition that causes pain and dysfunction in the bladder. (Docket 55 ¶ 4 n.2). Yelinek described interstitial cystitis as a “disease of the bladder that eats the bladder away.” (Docket No. 54-4 at 19). She testified that her interstitial cystitis symptoms included “burning,” “numbness,” and frequent visits

to the restroom. (Docket No. 54-4 at 19). She estimated that she first began suffering from interstitial cystitis in the “mid to late ‘90s.” (Docket No. 54-4 at 19). At first, she was visiting the restroom twenty to thirty times per day. (Docket No. 54-4 at 19). As time went on, her bladder was “shrinking and hardening,” to the point where her bladder could only hold “six to eight ounces.” (Docket No. 54-4 at 19). At the height of her symptoms, she visited the restroom sixty to seventy times per day. (Docket No. 54-4 at 19). She could not recall if anyone discovered a cause for her interstitial cystitis diagnosis. (Docket No. 54-4 at 19). After several unsuccessful treatments for interstitial cystitis, Yelinek testified that she underwent an “ileal conduit urinary diversion” procedure. (Docket No. 54-4 at 22). Ileal conduit urinary diversion is a technique in which a medical professional “creates a new passage for urine

to leave the body by taking a small piece of the patient’s intestine and forming it into a conduit” that “connect[s] the ureters to a stoma, or opening, in the lower abdomen, [thus] bypassing the bladder.” (Docket No. 55 ¶ 4 n.2). According to Yelinek’s medical records, Dr. Shirish Desai performed the ileal conduit urinary diversion on October 4, 2007 to address Yelinek’s “severe intractable interstitial cystitis.” (Docket No. 54-2 at 2). The procedure involved creating a stoma in Yelinek’s abdomen. (Docket No. 54-2 at 2). Yelinek explained that the stoma was placed on the right side of her abdomen. (Docket No. 54-4 at 22; Docket No. 55 ¶ 4). Yelinek’s medical records and her testimony reveal that at some point after the 2007 procedure, Yelinek developed a “large parastomal hernia” next to her stoma on the right side of her abdomen. (Docket No. 54-4 at 22-23; Docket No. 54-5 at 2; Docket No. 54-6 at 2). A parastomal hernia is an expansion of a surgically- made defect in the muscle that can occur when a stoma is created in a person’s abdomen. (Docket No. 54-7 at 7). B. The July 10, 2008 Surgery

In response to the parastomal hernia, Dr. Firooz Taghizadeh performed surgery to move the stoma on July 10, 2008. (Docket No. 54-4 at 23; Docket No. 54-1 at 2). In Yelinek’s medical records, Dr. Taghizadeh recorded that he moved the stoma from the right side of Yelinek’s abdomen to her left side. (Docket No. 54-1 at 2; Docket No. 55 ¶ 6). He recorded that the “[s]mall bowel and also cecum herniated through the peristomal hernia.” (Docket No. 54-1 at 2). Dr. Taghizadeh reduced the hernia and mobilized the small bowel. (Docket No. 54-1 at 2). He then repaired the herniated site by reinforcing the fascia “with application of Prolene soft mesh,” which he “sutured to [the] fascia.” (Docket No. 54-1 at 2). Yelinek could not recall Dr. Taghizadeh speaking to her about using mesh to repair the site of the hernia on the right side of her abdomen. (Docket No. 54-4 at 23). All she could recall him saying was that “he was going in to repair” the

herniated area. (Docket No. 54-4 at 23). Yelinek also made clear that the July 10, 2008 surgery was her “first ever hernia-related procedure.” (Docket No. 54-4 at 23). On July 19, 2008, nine days after surgery, Dr. Taghizadeh recorded that Yelinek was in “good condition,” was walking, and had a regular diet. (Docket No. 54-5 at 2). Yelinek did not recall conducting post-operation visits with Dr. Taghizadeh after the July 10, 2008 surgery. (Docket No. 54-4 at 24). After the July 10, 2008 procedure with Dr. Taghizadeh, Yelinek began to experience a burning sensation on the “insides of [her] stomach” and could feel “pinching at certain points” inside of her stomach. (Docket No. 54-4 at 24). While she could not remember exactly when the symptoms began after the July 10, 2008 surgery, she made clear that this burning sensation was not the “normal burning sensations from surgery.” (Docket No. 54-4 at 25). Rather, the symptoms occurred “after [she was] up and moving and everything,” not “immediately after” the surgery. (Docket No. 54-4 at 25). Later in her deposition, she estimated that the symptoms began “a month or so” after the July 10, 2008 surgery. (Docket No. 54-4 at 25). An investigation of her symptoms

revealed that she had developed another hernia at the original location of the stoma on the right side of her abdomen. (Docket No. 55 ¶ 7). She had also developed a new parastomal hernia at the new site of the stoma on the left side of her abdomen. (Docket No. 55 ¶ 7). C. The December 12, 2008 Surgery On December 12, 2008, Dr. Brent Angott performed surgery to repair the two new hernias. (Docket No. 55 ¶ 8). In Yelinek’s medical records, Dr. Angott recorded that he encountered a “ventral hernia” at the “previous stoma site.” (Docket No. 54-8 at 2; Docket No. 54-3 at 6). According to Dr. Angott, a ventral hernia is “any hernia on the anterior abdominal wall.” (Docket No. 54-3 at 15). Dr. Angott testified that his customary practice for surgeries, and the practice he undertook during Yelinek’s December 12, 2008 surgery, was to explain to the patient what he

intended to accomplish with the surgery. (Docket No. 54-3 at 13). Consistent with Dr. Angott’s testimony, Yelinek testified that Dr. Angott explained “what needed to be done and why.” (Docket No. 54-4 at 24). Regarding the diagnoses Dr. Angott gave her, Yelinek testified as follows: “He said that the mesh did - - it wasn’t - - the mesh didn’t hold up, it didn’t work, whatever, I don’t recall the exact words, but he said that it didn’t work, it didn’t hold up and he was to go in and repair.” (Docket No. 54-4 at 24). Later in her deposition, Yelinek again described her conversation with Dr. Angott leading up to the December 12, 2008 surgery. Yelinek testified that Dr. Angott told her that “the previous [mesh] did not hold. It was, like, in a ball inside of me, that it did not adhere.” (Docket No. 54-4 at 27). In Yelinek’s medical records, Dr. Angott recorded that after repairing the ventral hernia, he removed the “mesh that was located on the side that blew out from this previous hernia repair.” (Docket No. 54-8 at 2; Docket No. 54-3 at 7). In his deposition, Dr. Angott explained that the phrase “blew out” in the records meant that the ventral hernia repaired on July 10, 2008 by Dr.

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