Simon v. LarreateguiSimon v. Larreategui
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.
OPINION
Rendered on the 3rd day of June, 2022.
EPLEY, J.
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-
{¶ 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
{¶ 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
{¶ 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.
{¶ 14} Finally, on March 16, 2021, more than five years after Mrs. Simon‘s initial surgery, the case went to trial. The eight-day trial saw the presentation of testimony from, among others, Mr. and Mrs. Simon, Dr. Larreategui, the engineer who invented the Ethicon stapler, and other experts (both surgeons and engineers). The jury also
{¶ 15} Ultimately, the jury made two separate findings that are pertinent to this appeal. First, it found that Dr. Larreategui had not been negligent. Then the jury unanimously concluded that it was Ethicon‘s stapler that had caused Mrs. Simon‘s injuries; it awarded damages for Mrs. Simon in the amount of $9,314,174.50 and for Mr. Simon in the amount of $1,000,000. Collectively, Ethicon was liable for $10,314,174.50 in damages. The trial court denied Ethicon‘s motion for judgment notwithstanding the verdict (JNOV), and, after briefing and a separate hearing, it awarded the Simons $311,975.11 in prejudgment interest.
{¶ 16} Ethicon appeals, raising three assignments of error which challenge the trial court‘s decision not to grant its JNOV motion, the trial court‘s decision to allow certain testimony, and the prejudgment interest award.
II. Judgment Notwithstanding The Verdict
{¶ 17} In its first assignment of error, Ethicon contends that the trial court erred by failing to grant its JNOV motion. Its principal argument is that the Simons failed to establish a manufacturing defect claim. We disagree.
{¶ 18} The Ohio Supreme Court has confirmed that the standard for a judgment notwithstanding the verdict is the same as that of a directed verdict. Gallagher v. Cleveland Browns Football Co., 74 Ohio St.3d 427, 435, 659 N.E.2d 1232 (1996). “A directed verdict is proper if, construing the evidence most strongly in favor of the non-moving party, the trial court ‘finds that upon any determinative issue reasonable minds
{¶ 19} The test “requires the court to discern only whether there exists any evidence of substantive probative value that favors the position of the nonmoving party.” Goodyear Tire Co. v. Aetna Cas. & Sur. Co., 95 Ohio St.3d 512, 2002-Ohio-2842, 769 N.E.2d 835, ¶ 3. Put a different way, a reviewing court must affirm the trial court‘s denial of a motion for directed verdict if there is any evidence that supports the non-moving party‘s claim.
{¶ 20} Because motions for directed verdicts (and likewise, JNOV motions) test the legal sufficiency of the evidence, not its weight or witness credibility, our review of the trial court‘s judgment is de novo. Schafer v. RMS Realty, 138 Ohio App.3d 244, 257, 741 N.E.2d 155 (2d Dist.2000).
Manufacturing Defect
{¶ 21} Ethicon‘s assignment of error asserts that the Simons failed to establish that there was a manufacturing defect in the stapler used in Mrs. Simon‘s surgery. According to
{¶ 23} Ethicon first argues that the Simons have no direct evidence of a specific defect in the stapler, a point that is at odds with the views of both the Simons and the trial court. The Simons argue that there was direct evidence of the defect in the form of testimony from Dr. Larreategui, Erica Penrod (physician‘s assistant), and Jamie Myers (surgical tech) that despite following all the IFUs, the Ethicon Contour Stapler malfunctioned: it cut, but it did not staple. The jury heard testimony from Anthony Nguyen, an Ethicon witness (and creator of the device), that if the IFUs were followed, the stapler would always cut and staple. Trial Tr. Day 7, p. 226-227. Similar testimony was given by Bernadsky. Trial Tr. Day 3, p. 43. The medical professionals’ testimony was direct evidence that the device had deviated in a material way from the performance standards articulated by Nguyen and Bernadsky, an element that a plaintiff must prove. However, we do not believe that this evidence resolved the entire equation; it did not prove that the product was defective when it left the control of the manufacturer. To demonstrate that element, in the absence of direct evidence, the Simons turned to circumstantial evidence, something that Ethicon argues was foreclosed in the present situation. With the differing opinions from the parties, we turn to the statute for guidance.
{¶ 24}
If a claimant is unable because the manufacturer‘s product in question was destroyed to establish by direct evidence that the manufacturer‘s product in question was defective or if a claimant otherwise is unable to establish by direct evidence that the manufacturer‘s product in question was defective, then, consistent with the Rules of Evidence, it shall be sufficient for the claimant to present circumstantial or other competent evidence that establishes, by a preponderance of the evidence, that the manufacturer‘s product in question was defective[.]
Ohio courts have weighed in on the issue as well. In State Farm Fire & Cas. Co. v. Chrysler Corp., 37 Ohio St.3d 1, 6, 523 N.E.2d 489 (1988), the Ohio Supreme Court stated that “[p]roduct defects may be proven by direct or circumstantial evidence.” The Eighth District Court of Appeals has held that “a product liability case can be proven by demonstrating the existence of a defect by circumstantial evidence.” Colboch v. Uniroyal Tire Co., Inc., 108 Ohio App.3d 448, 458, 670 N.E.2d 1366 (8th Dist.1996).
{¶ 25} Here, we find that the stapler in question was effectively destroyed, allowing proof by circumstantial evidence. Nguyen, Ethicon‘s expert, testified that before he had a chance to examine the stapler, it was broken into pieces in Mexico, so there was no attempt made to test the actual device. Trial Tr. Day 7, p. 209, 211. Pictures presented at trial showed the stapler used in Mrs. Simon‘s surgery in pieces, making it impossible for anyone to recreate the event. Therefore, it was appropriate for the jury to consider circumstantial evidence that the stapler had been defective when it left the Ethicon‘s control.
{¶ 27} Ethicon, however, argues that no reasonable juror could have concluded that there was a manufacturing defect in the stapler because there was evidence presented that the problem with the stapler could have been caused by user error on the part of Dr. Larreategui, specifically that the “retaining pin” was not in the “anvil” when the device was fired. Ethicon first points to the testimony of Dr. William Schirmer (the Simons’ expert) who posited that he was “more concerned about the possibility the stapler wasn‘t properly utilized than [he] was about the stapler malfunction.” Trial Tr. Day 3, p. 42. He went on to testify: “[I]f I had to go fifty-one percent/forty-nine percent, I would have to lean towards that scenario, as maybe it was not properly utilized, rather than a malfunction.” Trial Tr. Day 3, p. 42.
{¶ 28} Ethicon also relies heavily on the hypotheses of its expert, Nguyen, who concluded that (1) Dr. Larreategui had trouble closing the device; (2) Dr. Larreategui did not manually advance the pin into the anvil; and (3) the pin was not in the anvil (hole) when the stapler was fired. Trial Tr. Day 7, p. 216, 219-220. See also Brian Davis testimony, Trial Tr. Day 6, p. 59-60, 67. While the factfinder was entitled to believe this theory, it was directly contradicted by the testimony of Dr. Larreategui, Penrod, and Myers, which the jury apparently believed. Additionally, when other expert witnesses attempted to recreate Nguyen‘s theory of the malfunction, they were unable to do so
{¶ 29} Penrod testified that Dr. Larreategui manually inserted the pin into the hole, as he always does, and did not have to use any unusual force to close or fire the stapler. Trial Tr. Day 5, p. 89. Myers similarly testified that she did not recall the doctor having any trouble or using excessive force to get the stapler to fire. Trial Tr. Day 5, p. 71. Dr. Larreategui testified that he manually advanced the pin after placing the “jaws” of the device across Mrs. Simon‘s colon and then observed that the pin was in the anvil. Trial Tr. Day 2, p. 91-92, 93, 100, 108, 143. In addition to visualizing the pin in the hole, Dr. Larreategui testified that he heard an audible “click,” indicating its proper position. Trial Tr. Day 2, p. 102, 143. He also told the jury that he had experienced no trouble closing the device and had not forced the trigger closed. Trial Tr. Day 5, p. 108-109, 136; Trial Tr. Day 2, p. 153.
{¶ 30} In addition to the testimony from the medical professionals in the operating room, who all stated that Dr. Larreategui followed the IFUs, every expert witness testified that if Dr. Larreategui was to be believed, and the directions were followed, then the Ethicon stapler did not meet its performance standards. The following exchanges at trial illustrate this point.
Q: If Dr. Larreategui is telling the truth, * * * then would you agree that the stapler deviated from expected performance and standard, based on what
Dr. Larreategui said? A: Yes.
Q: All right. And if what Dr. Larreategui said is true, what would our expectations be for how the device would perform?
A: I would expect it to apply two rows of staples to either side of the knife cut between the two pieces of bowel.
Testimony of Dr. Eric Haas, Trial Tr. Day 3, p. 119-120.
Q: If we take Dr. Larreategui‘s testimony at face value, we assume that it‘s true and that it‘s accurate, * * * would you agree that the contour stapler deviated from what Dr. Larreategui and other surgeons would expect that stapler to do from a performance standard?
A: Yes.
Testimony of Dr. Jonathan Snyder, Trial Tr. Day 3, p. 95.
{¶ 31} To be sure, Ethicon presented experts who discounted Dr. Larreategui‘s version of events, stating generally that the physical evidence pointed to misuse by the surgeon, but it is not our province to put our finger on the scale one way or the other. Based on the testimony and evidence presented at trial and discussed above, we conclude that there was at least some evidence of substantive probative value that favored the position of the Simons and which allowed a reasonable juror to find for them on the question of whether the Ethicon stapler had been defective in manufacture.
Causation
{¶ 32} The second prong of the test found in
{¶ 33} The jury heard testimony from Dr. Larreategui that if the Ethicon stapler had cut and stapled, Mrs. Simon would not have had the complications she has faced; specifically, the surgery would have been completed as planned and she would still have her sigmoid colon, transverse colon, and rectum. Trial Tr. Day 2, p. 186-187. Dr. Snyder similarly testified that if Dr. Larreategui‘s testimony were true, then the contour stapler malfunction was the proximate cause of Mrs. Simon‘s injuries. Trial Tr. Day 3, p. 102-103.
{¶ 34} “Judgment is warranted as a matter of law only where there is a complete absence of evidence which might give rise to a reasonable inference that the defective condition was the proximate cause of plaintiff‘s injuries.” Fogle v. Cessna Aircraft Co., 10th Dist. Franklin No. 90AP-977, 1992 WL 10272, *7 (Jan. 16, 1992). Based on the presented evidence, a reasonable juror could have concluded that the purportedly defective Ethicon stapler was the proximate cause of harm to Mrs. Simon.
The manufacturer produced the actual product that caused the harm
{¶ 35} The third and final prong of the test requires a claimant prove that the
Summary
{¶ 36} The Simons presented evidence sufficient for a reasonable juror to conclude that the Ethicon stapler was defective in manufacture, that a defective aspect of the product was a proximate cause of Mrs. Simon‘s injuries, and that Ethicon produced the stapler that was the cause of harm. The first assignment of error is overruled.
III. Witness Testimony
{¶ 37} In its second assignment of error, Ethicon argues that the trial court erred by allowing surgeon-witnesses to testify “whether the stapler had an unspecified manufacturing defect.” Appellant‘s Brief at 21. It believes that only an engineer should have been able to testify about the proper performance of the stapler and that the remedy for the alleged error is a new trial. The Simons counter that the surgeons should not have to be engineers to explain to the jury how a stapler, a device they had used hundreds of times in the past, should perform if used properly. They also claim that Ethicon failed to object to much of the testimony.
{¶ 38} Initially, it is important to note that this issue started as a motion in limine, filed by Ethicon, to exclude the testimony of the doctors as to this topic. “As a general rule, the grant or denial of a motion in limine is not a definitive ruling on the evidence,” State v. Grubb, 28 Ohio St.3d 199, 200-201, 503 N.E.2d 142 (1986), and objections to the introduction of testimony must be made at trial to preserve evidentiary rulings for
{¶ 39} Normally, evidentiary issues, such as witness testimony and even whether a witness can testify as an expert, are “committed to the sound discretion of the trial court.
{¶ 40} In this case, the Simons correctly point out that there were many occasions where a surgeon was asked about the expected performance of the Ethicon stapler and no objection was asserted. That fact is important as this assignment of error is couched in the realm of motions in limine, and thus, the potential error must have been objected to at trial to be considered on appeal. See Witzmann v. Adam, 2d Dist. Montgomery No. 23352, 2011-Ohio-379, ¶ 25 (a ruling on a motion in limine does not preserve the record for appeal); 89 Ohio Jurisprudence 3d, Trial, Section 143 (2022) (“Failure to object to evidence at the trial constitutes a waiver of any challenge.“).
{¶ 41} Therefore, “when a party files a motion in limine regarding the exclusion of evidence but fails to timely object at trial, this court will review the admission of such evidence under a plain error analysis.” State v. Laghaoui, 2018-Ohio-2261, 114 N.E.3d 249, ¶ 42 (12th Dist.). However, a party must raise and address the issue of plain error on appeal. Ethicon has not done so, and as such, we will only consider the three instances
{¶ 42} In the first instance, Dr. Larreategui was asked if he thought the device, which cut, but did not staple, “performed in an unsafe and unexpected manner.” Trial Tr. Day 2, p. 140. Ethicon‘s trial attorney objected before the doctor could answer but was overruled by the court. The question posed to Dr. Larreategui had only a very limited nexus to engineering or biomechanics. He could answer that question simply based on his experience as a surgeon and experience with the device. An engineering degree was not required to answer the question. The trial court did not err in overruling Ethicon‘s objection.
{¶ 43} In the next scenario, Dr. Schirmer was asked, assuming Dr. Larreategui was accurate in his testimony that the stapler cut but did not staple, “would that be a result that has been different from the result you have gotten, the performance standards you have gotten with that identical stapler on hundreds of occasions?” Trial Tr. Day 4, p. 29-30. There was an objection, but like the previous example, this question posed to Dr. Schirmer did not call for any engineering or biomechanical expertise. He was able to answer it simply by relating his experience as a surgeon using the device. The trial court did not err in overruling the objection.
{¶ 45} Based on the record before us, we cannot say that the trial court abused its discretion. Ethicon‘s second assignment of error is overruled.
IV. Prejudgment Interest
{¶ 46} In its third and final assignment of error, Ethicon asserts that the trial court erred by awarding the Simons prejudgment interest.
{¶ 47} To award prejudgment interest in a tort action,
{¶ 48} “The purpose of
{¶ 49} In this case, the parties dispute whether Ethicon made a good faith effort to settle. The Ohio Supreme Court has explained what it means to act in good faith in accordance with
{¶ 50} The Simons argue that Ethicon failed to meet two of the elements. First, they assert that Ethicon did not make a good faith monetary settlement offer or respond to one of theirs. This position is supported by a series of “settlement reports” filed in the trial court prior to trial and testimony at the hearing. The January 25, 2021 report shows that the Simons made a settlement offer of $1,500,000, but it does not appear from the record that Ethicon responded. In fact, in its memorandum in opposition to prejudgment interest filed in the trial court, Ethicon admitted that the Simons had made a “global settlement demand” to all the defendants (Dr. Larreategui and Ethicon), but it claimed that they “never once made an individual settlement demand of Ethicon.” Memo in Opposition at 7. That argument is unavailing - a settlement demand had been made.
{¶ 51} The Simons also contend that Ethicon failed to rationally evaluate its risk
{¶ 52} Ethicon, however, argues that it “maintained a very viable defense to the one and only claim asserted against it,” and furthermore that a defendant has no duty to make a settlement offer if there is a good faith belief that it has no liability. See Baker v. Cleveland, 8th Dist. Cuyahoga No. 93952, 2020-Ohio-5588, ¶ 59; Evans v. Dayton Power & Light Co., 4th Dist. Adams No. 05CA800, 2006-Ohio-319, ¶ 12.
{¶ 53} While Ethicon‘s position here is plausible, the trial court did not believe it was a winning argument and expressed that sentiment in its well-reasoned, eight-page decision granting prejudgment interest to the Simons. The trial court did not abuse its discretion as the decision was not arbitrary, unreasonable, or unconscionable. Ethicon‘s third assignment of error is overruled.
V. Conclusion
{¶ 54} Having found no errors on the part of the trial court, its judgment will be affirmed.
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