Simon v. Larreategui

2022 Ohio 1881
Ohio Court of Appeals·Decided June 3, 2022·No. 2021-CA-41·Published·Cited by 8 cases

Opinion

IN THE COURT OF APPEALS OF OHIO SECOND APPELLATE DISTRICT MIAMI COUNTY

NICOLETTE SIMON, et al. :

:

Plaintiffs-Appellees : Appellate Case No. 2021-CA-41 :

v. : Trial Court Case No. 2018-CV-443 :

PATRICK A. LARREATEGUI, et al. : (Civil Appeal from : Common Pleas Court)

Defendant-Appellant :

:

...........

OPINION

Rendered on the 3rd day of June, 2022.

...........

TODD B. NAYLOR, Atty. Reg. No. 0068388, 4445 Lake Forest Drive, Suite 490, Cincinnati, Ohio 45242 & MARC G. PERA, Atty. Reg. No. 0069231, 1095 Nimitzview Drive, Suite 403, Cincinnati, Ohio 45230 & JOHN D. HOLSCHUH, Atty. Reg. No. 0019327, 600 Vine Street, Suite 2700, Cincinnati, Ohio 45202 Attorneys for Plaintiffs-Appellees

BENJAMIN C. SASSE, Atty. Reg. No. 0072856, SUSAN M. AUDEY, Atty. Reg. No. 0062818, & ELISABETH A. ARKO, Atty. Reg. No. 0095895, 950 Main Avenue, Suite 1100, Cleveland, Ohio 44113

MICHAEL P. FOLEY, Atty. Reg. No. 0061227, JEFFREY M. HINES, Atty. Reg. No. 0070485, JAMES J. ENGLERT, Atty. Reg. No. 0051217, 600 Vine Street, Suite 2650, Cincinnati, Ohio 45202 Attorneys for Defendant-Appellant Ethicon Endo-Surgery, Inc.

.............

EPLEY, J.

{¶ 1} Defendant-Appellant Ethicon Endo-Surgery, Inc. (“Ethicon”) appeals from a judgment of the Miami County Court of Common Pleas which, after an eight-day jury trial on the tort claims of Plaintiffs-Appellees Nicolette and Steven Simon, imposed the jury’s verdict against Ethicon, denied Ethicon’s motion for judgment notwithstanding the verdict, and then awarded prejudgment interest to the Simons. For the reasons that follow, the judgment of the trial court will be affirmed.

I. Facts and Procedural History

{¶ 2} In 2016, Nicolette Simon (“Mrs. Simon”) started noticing blood in her stool during bowel movements and, after consulting with her doctor, decided to undergo a colonoscopy. During the procedure, the physician noticed a few polyps on her colon; while he was able to remove some of them, there was one that could not be removed in that setting. Before finishing the procedure, the doctor marked, or “tattooed,” the area close to the remaining polyp so it could be located at a later date.

{¶ 3} To address the remaining polyp, Mrs. Simon was referred to Dr. Patrick Larreategui, a board-certified general surgeon who frequently performs colorectal and abdominal surgeries. Based on the way the polyp was attached to the colon wall (its base was described as “carpet-like”), Mrs. Simon, in consultation with her doctors and husband, decided a colon resection surgery was the best option. The plan for the procedure was that Dr. Larreategui would make an incision above and below the polyp to remove that section of colon and then rejoin the remaining sections. The Simons were told that the procedure would last a couple of hours and then would require a three-to-

five-day post-operative hospital stay to recover.

{¶ 4} The surgery commenced on the morning of December 16, 2016. Dr.

Larreategui led the surgical team which included, among others, Erica Penrod, a physician’s assistant, and Jamie Myers, a surgical technician. Cameron Bernadsky, an Ethicon representative, was an observer in the operating room as well, although he took no part in the surgery. According to the testimony, Dr. Larreategui’s plan was to perform a hand-assisted laparoscopic surgery. He made a small incision just below Mrs. Simon’s belly button to give access to the abdominal cavity and then inserted a small camera to look for the “tattooed” section of colon. Unfortunately, Dr. Larreategui and his team could not find the “tattoo” with just the camera, so Penrod deployed a proctoscope which ultimately located the tattoo. When the polyp was found, it was in an area of the abdomen much lower than expected, and Dr. Larreategui could not access it in a minimally-invasive way. This necessitated the conversion of the surgery from minimally invasive to open, and the small incision was extended to allow for better access to the anatomy.

{¶ 5} Testimony indicated that due to the nature of Mrs. Simon’s anatomy, the targeted area was extremely difficult to get to, and once Dr. Larreategui was able to access the section of colon with the polyp, things got even more difficult.

{¶ 6} To effectuate the transection and then resection of the colon, Dr. Larreategui used the Ethicon Contour Curved Cutter Stapler. According to Ethicon, the device both cuts and staples. When actuated, a knife comes down the middle of the device and transects the colon or rectum, then the stapler forms two lines of staples on either side of the cut. Appellant’s Brief at 4-5; Trial Tr. Day 7 (Vol. I), p. 60, 132, 143, 146. There was

testimony that if the instructions for use (IFU) were followed, there was no chance of the stapler failing to make a cut and the staple lines. Trial Tr. Day 7, p. 226-227. In this case, however, the stapler malfunctioned (although it is vigorously debated how and why), and while it cut the tissue, it did not form the lines of staples as intended.

{¶ 7} After the stapler malfunction, Dr. Larreategui attempted to reconnect the rectal stump to the sigmoid colon (the section of the colon where the polyp was located), but leakage was discovered. The occurrence of leakage was significant because feces seeping into the abdominal cavity could be fatal. Unable to reconnect the colon to the rectal stump, the decision was made to create a stoma (a hole) in Mrs. Simon’s abdomen, pull the sigmoid colon through the stoma, and attach a colostomy bag.

{¶ 8} Following the cut and staple misfire, Bernadsky, Ethicon’s representative in the operating room, reported the situation to the company. He then took possession of the stapler used in Mrs. Simon’s surgery and immediately shipped it to Ethicon’s manufacturing facility in Juarez, Mexico, to be examined by product engineers there.

{¶ 9} The surgery, which was expected to take only a few hours, lasted much longer, and created a difficult, painful recovery for Mrs. Simon. In fact, after further complications from the initial operation, another surgery was performed by Dr. Larreategui to remove the entire sigmoid colon. As a result, a new stoma was created, higher up in her abdomen.

{¶ 10} Mrs. Simon spent 30 days in the hospital recovering from the two surgeries performed by Dr. Larreategui. After a brief stint at home, she was readmitted into the hospital with further complications. Due to the complexity of Mrs. Simon’s continued

issues, she was referred to a specialist at the Cleveland Clinic, where she underwent two additional surgeries. During the first procedure, it was discovered that her transverse colon was compromised. That portion of her bowel was removed, leaving her without multiple sections of her colon. In addition, testing prior to her second scheduled Cleveland Clinic surgery revealed a rectovaginal fistula - a leak from the colon that deposits waste into the vaginal cavity.

{¶ 11} Because most of her colon was removed, Mrs. Simon now has an ileostomy bag (the ileum is part of the small intestine) to collect her body’s solid waste products. The bag must be emptied approximately every three hours, including during the night, and her condition has put an incredible strain on almost every aspect of Mrs. Simon’s life.

{¶ 12} On November 16, 2018, the Simons filed their initial complaint – as a medical malpractice action – against Dr. Larreategui, Upper Valley Medical Center, and UVPC Specialists, Inc. A few weeks later, the complaint was amended to include product liability claims against Ethicon. Eventually, however, claims against ancillary parties were dismissed, and only Dr. Larreategui and Ethicon remained as defendants.

{¶ 13} On March 17, 2020, after over a year of depositions and motion practice, Ethicon moved for summary judgment. While the trial court denied Ethicon’s motion, the Simons abandoned all theories against it except manufacturing defects.

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