By Jeffrey H. Brochin, J.D.
No reasonable construction of the patient’s expert’s testimony supported her claim that an insulation defect in the thermal scissors device caused her bowel burns during surgery.
The U.S. Court of Appeals for the Eleventh Circuit has affirmed a district court’s grant of summary judgment in favor of the manufacturer in a medical device products liability lawsuit brought by a patient who was injured during hysterectomy surgery. Although the patient cited recalls of the thermal scissors device used, and posited that an insulation defect caused the electrical arcing that injured her, her own expert witness offered testimony that her injuries likely were caused by a metal suction tube conducting energy from one of the electrosurgical instruments, thus leading to speculation as to causation (Pierre v. Intuitive Surgical, Inc., April 2, 2021, per curiam).
Multiple devices used. On January 24, 2014, the patient underwent hysterectomy surgery during which her surgeon used the da Vinci Surgical System, a robotic surgical device manufactured and sold by Intuitive Surgical, Inc. (Intuitive or manufacturer) that allows a surgeon to conduct minimally invasive surgery using a variety of instruments, including electrosurgical instruments. Intuitive manufactures electrosurgical laparoscopic instruments, including the Scissors, which use monopolar electric energy to cut and coagulate tissue, and the Fenestrated Bipolar Forceps, which use bipolar electric energy. The surgeon also used a metal suction tube not manufactured by Intuitive that was not docked to the da Vinci system.
Near the end of the surgery, the surgeon noticed that the patient had suffered damage to her bowel, and he brought in a general surgeon who was on call. The general surgeon looked at tissue for approximately five minutes, determined there was not much damage, and recommended keeping her in the hospital for observation. As a result, no repairs were made to her bowel during the surgery. Six days later, however, she began experiencing devasting physical side effects due to the damage to her bowel.
Trial court ruling. The patient filed suit against Intuitive, claiming that the thermal injury (burn) she suffered to her bowel during the robotically assisted hysterectomy was caused by an insulation defect in the Scissors, and that Intuitive had previously recalled earlier models of the device due to the alleged defect. She also presented the testimony of her surgeon as an expert witness as to his opinion regarding causation, and he further testified as to the remarks of an Intuitive instructor with whom he had shared a video of the surgical procedure. (The instructor died prior to the instant litigation.) The instructor had theorized that the injuries were caused by electrical "arcing," but did not specify whether it was from the Scissors or Forceps. The district court entered summary judgment in favor of the manufacturer, and the instant appeal ensued.
More than one possibility. The expert witness/surgeon stated that he did not witness any arcing from any of the devices used during the surgery, and that arcing alone does not necessarily indicate an insulation failure because arcing may come from either the tip of the instrument or the shaft of the instrument. Moreover, because arcing occurs quickly, it can be difficult to determine from which end arcing comes. He further testified that he believed the patient’s injury was caused by the metal suction tube conducting energy from one of the electrosurgical instruments to the bowel. In other words, he believed that it was "more likely" that energy from the Forceps-not the Scissors-transferred to the metal suction tube, which was near the patient’s bowel, and inadvertently conducted energy to the bowel.
Speculation or conjecture. The appellate court restated precedent that if a matter is one of pure speculation or conjecture, or the probabilities are at best evenly balanced, it becomes the duty of the court to direct a verdict for the defendant. Although the patient argued that a layperson would be able to interpret what was seen in the video of the surgery, the court ruled that in cases where a jury is asked to assess complex medical or scientific issues outside the scope of a layperson’s knowledge, an expert’s testimony is required to establish causation.
The court found that at best, the patient’s evidence presented a "mere possibility" that an insulation defect in the Scissors caused her thermal injury; but a mere possibility of causation is not enough. Because a verdict in the patient’s favor would require the jury to engage in impermissible "speculation or conjecture," it was the duty of the district court to enter judgment for the manufacturer. For the foregoing reasons, the appeals court affirmed the district court’s entry of summary judgment in favor of Intuitive.
The case is No. 20-11311.
Attorneys: Jeffrey Louis Haberman (Schlesinger Law Offices, PA) for Elmitha Pierre and Maxo Jean Jacques. Jessica Davidson Miller (Skadden Arps Slate Meagher & Flom, LLP) for Intuitive Surgical, Inc.
Companies: Intuitive Surgical, Inc.
MainStory: TopStory DesignManufacturingNews MedicalDevicesNews ExpertEvidenceNews CausationNews AlabamaNews FloridaNews GeorgiaNews
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