Sunnyvale, CAAs a da Vinci lawsuit continues, concerns have been raised about a lack of training resulting in Da Vinci robot injury to patients. The US Food and Drug Administration (FDA) has said it is surveying doctors about the da Vinci robot, following reports of death linked to the surgical device.
The wrongful death lawsuit currently in courts was filed by the widow of a man - Fred Taylor - who died four years after his prostate gland was removed using the da Vinci robot. The lawsuit alleges that errors made during the surgery resulted in injury to the victim - including a stroke, kidney failure and infection - later resulting in his death. During the lawsuit, a witness described training sessions she gave for doctors who used the system.
According to Bloomberg (5/8/13), Karen Lederer, who was a training specialist with Intuitive Surgical Inc - maker of the da Vinci robot - said her training program was not watered down to allow quicker certification of doctors. She did testify that the three-day training sessions could be shortened to one or two days because the robots were found in large medical centers so training did not have to be conducted at the company’s labs.
But the doctor involved in the lawsuit alleged in court papers that he was told he could perform the surgery after only taking the company course and conducting two supervised surgeries, Seattle Times (5/3/13) notes. Taylor’s surgery was his first unsupervised surgery and he claims he would not have agreed to be trained on the robot if he knew how much was involved in mastering it, possibly conducting up to 100 robotic surgeries just to get the same patient results he got when performing alternative procedures.
Meanwhile, the American Congress of Obstetricians and Gynecologists (ACOG) has issued a statement on the robot. In a statement posted on the organization’s website (acog.org; 3/14/13), ACOG President James T. Breeden notes that a surgeon’s skill is directly associated with surgical outcomes and that expertise is attained through years of training and direct experience.
“Studies show there is a learning curve with new surgical technologies, during which there is an increased complication rate,” Breeden writes. “Expertise with robotic hysterectomy is limited and varies widely among both hospitals and surgeons.” He goes on to write that there is no good data that shows a robotic hysterectomy is as good as or better than less costly alternatives.
The FDA is also looking into the surgical robots. Bloomberg (2/28/13) notes that the agency sent surveys to various hospitals to send a list of complications they experienced that were linked to the devices. Among adverse event reports submitted to the FDA were burns to the patient and damage to the patient’s uterus.
The case is Estate of Fred E. Taylor v. Intuitive Surgical Inc. (ISRG), 09-2-03136-5, Superior Court, State of Washington, Kitsap County (Port Orchard). It is the first da Vinci lawsuit to go to court.
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