August 4, 2009
JESSICA COTTER, PLAINTIFF-APPELLANT/ CROSS-RESPONDENT,
GUS SLOTMAN, M.D., COOPER UNIVERSITY HOSPITAL - THE COOPER HEALTH SYSTEM, DEFENDANTS-RESPONDENTS, AND ETHICON ENDO-SURGERY, INC., A JOHNSON & JOHNSON COMPANY, DEFENDANT-RESPONDENT/CROSS-APPELLANT.
On appeal from the Superior Court of New Jersey, Law Division, Camden County, Docket No. L-4125-04.
NOT FOR PUBLICATION WITHOUT THE APPROVAL OF THE APPELLATE DIVISION
Argued March 16, 2009
Before Judges Carchman, Sabatino and Simonelli.
This is an appeal from a jury verdict in a medical malpractice and products liability case related to laparoscopic gastric bypass (LGB) surgery and alleged manufacturing defects and failure to warn. The jury determined that: (1) defendant Gus Slotman, M.D. was negligent in his treatment of plaintiff Jessica Cotter; but (2) the negligence was not the proximate cause of plaintiff's injuries. The jury further concluded that:
(1) defendant Ethicon Endo-Surgery, Inc. (Ethicon) did not manufacture a defective surgical stapling device or staples used in the surgery; and (2) did not distribute the stapler and staples without adequate warning. Plaintiff appeals as to both defendants and seeks a new trial. We affirm.*fn1
These are the relevant facts adduced from the record. Dr. Slotman is a board certified surgeon, who specializes in head and neck cancer and bariatric surgery. In January 1999, he began performing open bariatric surgery.*fn2 After Dr. Slotman had performed approximately 300 open gastric bypasses, he trained to perform LGB surgery. This methodology involves the surgeon making multiple small incisions in the patient's abdomen and then inserting surgical instruments, as well as a camera.
Dr. Slotman performed his first LGB surgery in early 2002, and continued to perform LGB surgery instead of open gastric bypass surgery at Cooper Hospital. On July 29, 2002, Dr. Slotman performed LGB surgery on plaintiff at Cooper Hospital. As described to the jury, he used the Roux-en-Y procedure utilizing a linear surgical stapler*fn3 (linear stapler) to divide the stomach into two pieces: a small "pouch," which is connected to the esophagus and serves as the functioning stomach, and the larger dormant portion, known as the "remnant" stomach. The surgeon then used the linear stapler to divide the intestine at the jejunum, or beginning of the small intestine, and took that end of the intestine and attached it to the pouch. He used a circular stapler to make a small hole in the pouch, and then connect the pouch and intestine,*fn4 allowing food to pass through. The surgeon then used the circular stapler to reattach the portion of the lower intestine that had been disconnected. This was done to allow bile and pancreatic-digestive juices to be mixed with the food and allow the food to be broken down.
Prior to plaintiff's surgery, Dr. Slotman and plaintiff discussed the various risks associated with LGB surgery, and plaintiff signed a written consent form detailing these risks. Included in the consent form were references to various risks including "staple disruption" and "stoma leakage." Dr. Slotman used Ethicon staplers and staples during plaintiff's surgery.
During surgery, when Dr. Slotman attempted to use a linear stapler it did not work. He discarded it and obtained a new one. After the second linear stapler properly made one or two cuts, Dr. Slotman noticed that the staples had not held both walls of the pouch together and had left a hole. At this point, he inspected the remnant stomach to see if a similar hole, or "mirror image," had been created on that side. The doctor determined that no such hole occurred, and because he had to create a hole later in the procedure to insert the anvil of the circular stapler, he left the hole as it was. Dr. Slotman then used a third linear stapler to finish creating the pouch. He also used the stapler to connect the pouch to the intestine and complete the procedure.
At this point, Dr. Slotman tested the connection between the pouch and the intestine to determine if there were any leaks. The first test revealed possible leaks, so he reinforced the area with sutures and tested again. This test revealed no leaks. He also performed an upper gastrointestinal (GI) series on plaintiff before her discharge. A GI study involves a series of X-rays administered after the patient has consumed a liquid that would reveal obstructions or leaks. The test proved negative as to both obstructions and leaks.
On August 1, 2002, the hospital discharged plaintiff. Dr. Slotman felt that plaintiff was healthy and expected that the staples put in place would remain intact. In the days following the surgery, plaintiff started to feel sick and felt worse within a few days of her discharge. On the fourth day, plaintiff experienced a fever, was sweating profusely and had difficulty breathing. Plaintiff's step-mother, Amy Cotter (Amy), attempted to contact Dr. Slotman's office but was unable to reach the doctor as he was on vacation. On August 6, Amy brought plaintiff to the emergency room at Cooper Hospital. At the time of plaintiff's admission, she had both a high fever and high white blood count.
Since Dr. Slotman was unavailable, Dr. Frank Koniges treated plaintiff and performed surgery on her the night of her admission. Dr. Koniges observed that the connection between plaintiff's stomach and intestine, as well the staple line that divided the stomach, had broken down. Additionally, there was free fluid and air in plaintiff's abdomen, a sign of intestinal leakage. Dr. Koniges found that approximately two liters of fluid had leaked into plaintiff's abdomen. As a result of the this leakage, plaintiff developed a severe infection, which led to severe sepsis, septic shock and pending multiple organ failure.
Dr. Koniges also discovered that the posterior wall of plaintiff's stomach was still intact, indicating that Dr. Slotman had not completely separated the pouch and the remnant stomach, and the two parts remained connected. Additionally, Dr. Koniges could not re-attach the pouch and small intestine due to the infection. However, he used this connection to create a different pathway for food than intended in the initial surgery. This pathway allowed food to travel from the pouch into the remnant stomach and into the intestine. Tests performed following this corrective surgery revealed that there was still a leak. Both Dr. Koniges and Dr. Slotman performed a third surgery on plaintiff to repair these leaks.
When discharged from the hospital, plaintiff required physical therapy. She was discharged from Cooper Hospital on September 11, 2002, and transferred to Mediplex Rehabilitation Hospital.
At trial, plaintiff utilized Dr. Slotman as a witness to prove her case against Ethicon. Although not admitted as an expert, Dr. Slotman provided an overview of LGB surgery, as well as a description of plaintiff's surgery and subsequent treatment. He also indicated that the staples that sealed the remnant stomach "let loose," and that this is not an expected complication of LGB surgery. He was unable to determine if these staples "let loose" because of infection, but he stated that he "inspected those staples at the time of surgery and they clearly had closed in the way that they're supposed to, but they did not hold the way they were supposed to." The doctor opined that the pouch and small intestine became detached because the staples put in place to keep them connected did not hold.
Dr. Slotman testified that following plaintiff's surgery, he never performed LGB surgery again. The doctor stated that leakage following LGB surgery occurs in anywhere from one to four percent of all patients. Dr. Slotman felt that this percentage was too high, and only performs open bariatric surgery.
In support of her failure to warn claim, plaintiff introduced a memorandum addressed to the Quality Review Board of Ethicon and prepared by the Vice President of Clinical Affairs, Dr. Robert Honigberg. This memorandum stated that Ethicon had been receiving "increased reports of . . . leakage and staple line dehiscence,"*fn5 which could result in sepsis and prolonged hospitalization, from users of the ETS45 Endoscopic Linear Cutter. Dr. Slotman observed that this was the linear stapler used in plaintiff's procedure and that these problems occurred in plaintiff. Finally, the doctor stated that he had not been informed of these increased complaints, and if he had, he would not have used that stapler in plaintiff's procedure.
Dr. Julie Kim was proffered on behalf of Ethicon as an expert in the field of LGB surgery. She provided general background regarding bariatric surgery, LGB surgery in particular, and the Ethicon staplers used in plaintiff's procedure. Dr. Kim opined that the Ethicon staplers and staples used for LGB surgery in 2002 were "safe and effective." She stated that leaks were a known complication of LGB surgery in 2002, even without complications during surgery and staples that work properly, and that "a competent and qualified bariatric surgeon" should have known that. On cross-examination, Dr. Kim stated that although she discussed the potential for leaks with patients before surgery, the leak that occurred in plaintiff was "extensive," and not the type that happens when surgery "went fine." She commented that a surgeon should inspect all the staple lines made during the procedure but did not know if one can be one hundred percent certain that the staples are intact simply by a visual inspection.
Dr. Kim offered an opinion as to Dr. Slotman. She stated that Dr. Slotman "depart[ed] from the accepted standard of care" with respect to certain aspects of plaintiff's procedure. She identified four reasons for her conclusion. First, when Dr. Slotman accidentally created the small hole in the pouch, instead of using that hole to insert the anvil for the circular stapler, he should have removed the portion of the stomach tissue. By his actions, Dr. Slotman crossed the circular and linear staple lines. Second, Dr. Kim concluded when Dr. Slotman accidentally created a hole on the pouch side, he created a hole on the remnant stomach side too. She stated that Dr. Slotman should have cut this portion of the stomach tissue out and created a new staple line, or sewn over the whole line with sutures. Third, Dr. Kim stated that Dr. Slotman should have noticed the portion of the pouch that was still connected to the remnant stomach when he conducted his visual inspection of the staple lines. Finally, Dr. Kim opined that, given the complications that arose during plaintiff's surgery, it would have been appropriate for Dr. Slotman to change from LGB surgery to open bariatric surgery.
Ethicon also proffered Neil Kulkarni, the manager for the business unit that produced all of Ethicon's linear staplers in 2002, as an expert in the field of the operation and function of Ethicon surgical staplers. Kulkarni opined that the staple dehiscence did not occur as a result of staple malformation because a malformation would have been visible to Dr. Slotman. Kulkarni stated that Cooper Hospital returned the Ethicon instruments used in plaintiff's surgery, and his inspection of these instruments demonstrated that none suffered from a manufacturing defect.
Finally, Dr. Slotman and Cooper Hospital proffered Dr. Robert Brolin,*fn6 who qualified as an expert in the field of bariatric surgery. Dr. Brolin stated that once the linear stapler misfired and created the hole, Dr. Slotman had to make a "judgment call" as to what action should be taken. Dr. Brolin opined that Dr. Slotman's use of this hole for the circular stapler's anvil was acceptable because in any event, Dr. Slotman had to create a hole for the circular stapler's anvil, and he closed the hole when he finished. Dr. Brolin continued that Dr. Slotman's method for testing for leaks and repairing the leak was an acceptable practice. Dr. Brolin disagreed with Dr. Kim that a mirror hole must have occurred in the remnant stomach, stating that "Dr. Slotman examined all of the staple lines and didn't see a mirror hole and so I assume there is no mirror hole."
Dr. Brolin opined that leaks are a known risk of gastric bypass surgery and can occur even in cases where the surgeon performs the operation correctly. The doctor stated that there are several known causes for leaks along staple lines, such as ischemia,*fn7 tension on the anastomosis*fn8 and poor nutritional status of the patient. He had also seen leaks in other cases where the amount of fluid was similar to the amount here, and finally, he concluded that the standard of care did not require Dr. Slotman to change plaintiff's procedure from LGB to open.
As we have noted, the jury found Dr. Slotman negligent but found no proximate cause. The jury absolved Ethicon of any liability. Following the jury verdict, plaintiff moved for a new trial, which Judge Freeman denied.
On appeal, plaintiff argues that the jury verdict constitutes a clear miscarriage of justice warranting a new trial and further that the judge erred in permitting the consent form executed by plaintiff to be introduced into evidence.
We first observe that our review of jury determinations is limited. Rule 4:49-1(a) provides that a motion for a new trial should be granted when, after carefully considering the record and credibility of trial witnesses, the judge concludes that "it clearly and convincingly appears that there was a miscarriage of justice under the law." As noted in Dolson v. Anastasia, 55 N.J. 2, 6 (1969), the judge must carefully scrutinize all of the evidence, and consider the "intangible 'feel of the case.'" See also Barber v. ShopRite of Englewood & Assocs, Inc., 406 N.J. Super. 32, 52 (App. Div. 2009). Jury verdicts should be set aside in favor of a new trial sparingly and "only in cases of clear injustice." Boryszewski v. Burke, 380 N.J. Super. 361, 391 (App. Div. 2005), certif. denied, 186 N.J. 242 (2006) (citation omitted).
Plaintiff's argument is narrow. She asserts that since the jury found that Dr. Slotman deviated from the standard of care or was negligent, then the only logical conclusion is that the deviation was the proximate cause of her injuries. Plaintiff argues that the verdicts are inconsistent, relying on Olah v. Slobodian, 119 N.J. 119 (1990).
Plaintiff did not call an independent witness as to Dr. Slotman's liability, but relied on the testimony of Ethicon's expert, Dr. Kim. Dr. Kim offered four theories of liability as against Dr. Slotman. It is impossible to know which theory the jury considered as establishing a deviation; moreover, at least one of the theories - creating a hole in the pouch - resulted in a repair that, in turn, resulted in a test and subsequent repair. The issues regarding the remnant stomach, likewise, may have been negligence, but as Dr. Brolin opined, the methodology utilized by Dr. Slotman was of no moment. A similar result follows from the failure to move from a LGB to an open procedure. The burden remains with plaintiff to affirmatively establish both the elements of negligence and proximate cause. Lanzet v. Greenberg, 126 N.J. 168, 195 (1991). The jury was free to accept the testimony of any witness as to one element and at the same time reject the testimony of the same witness as to the other. In sum, the jury had sufficient evidence from which it could conclude that Dr. Slotman was negligent but likewise conclude that the negligence did not cause the injury.
Plaintiff's reliance on Olah is misplaced. Olah involved a unique circumstance where the jury found negligence, no proximate cause and awarded damages for pain and suffering. The judge then sent the jury back to consider whether the negligence caused "'some' injury." Olah, supra, 119 N.J. at 127. The jury did so and ultimatly, the Court reversed commenting on the "obviously irregular procedure." Id. at 134. The Court's dicta regarding the inconsistency in the finding of negligence and no proximate cause came in the context of a jury award of damages for "pain and suffering" at the same time that the jury made a finding of no proximate cause for the death of the plaintiff. Ibid. Here, the jury's verdict was precise (and not unusual or irregular) that Dr. Slotman was negligent, but the undefined negligence was not the proximate cause of plaintiff's injury. We find no basis for our intervention and conclude that the trial judge properly denied the motion for a new trial.*fn9
We reach the same result regarding the admission of plaintiff's consent form. Plaintiff asserts that the admission of the form was confusing, misleading and unduly prejudicial.
Interestingly, plaintiff first raised the consent form during her questioning of Dr. Slotman. More important, however, the consent form was relevant as the various experts who testified indicated that leaks are a common complication of LGB surgery. The consent form supported this contention. Also, Judge Freeman's limiting instruction informed the jury that they were still obliged to determine the issues of negligence and causation.
N.J.R.E. 403 permits the exclusion of evidence if the probative value is outweighed by the prejudicial value including a risk of being misleading, confusing or causing undue prejudice. The exclusion of evidence under N.J.R.E. 403 is left to the discretion of the trial judge. Benevenga v. Digregorio, 325 N.J. Super. 27, 32 (App. Div. 1999), certif. denied, 163 N.J. 79 (2000). An abuse of discretion only arises on demonstration of "manifest error or injustice." Hisenaj v. Kuehner, 194 N.J. 6, 20 (2008) (quotations and citation omitted). An abuse of discretion occurs when the trial judge's "decision [was] made without a rational explanation, inexplicably departed from established policies, or rested on an impermissible basis." United States v. Scurry, 193 N.J. 492, 504 (2008) (quotations and citations omitted).
We are satisfied that the judge did not abuse his discretion in admitting the consent form. The form made specific reference to leaks and staple disruption. These were elements of plaintiff's theory in the case. There was no error here.
We conclude that the judge did not abuse his discretion in denying a new trial or admitting plaintiff's consent form. Our determination on these issues makes it unnecessary to consider Ethicon's cross-appeal.