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NOT FOR PUBLICATION WITHOUT THE APPROVAL OF THE APPELLATE DIVISION
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 ...