26 lawsuits against Intuitive Surgical alleging injuries linked to its da Vinci robotic system. The first of an estimated 26 lawsuits against Intuitive Surgical alleging injuries linked to its da Vinci robotic system has gone to the jury. Deliberations were scheduled to begin today.
Yesterday during closing arguments, the jurors were told that Intuitive had behaved like a “car dealership” in the way it trained physicians to use the da Vinci system, and that the company should pay in excess of $8 million in damages to the estate of Fred Taylor, according to a Bloomberg News report. The device maker sought to retain hospitals as customers and to increase the frequency of da Vinci robotic surgeries, the plaintiff’s attorney also told the jury.
Intuitive behaved “just like a car dealership” in the way it attempted to tie auto sales and service for its customers, the plaintiff’s attorney said, adding that Intuitive “wanted to do all the training to keep control of surgeons, to keep control of hospitals, and keep control of surgeries,” according to Bloomberg News.
Intuitive simplified its training program requirements after 2006; those requirements were part of the data submitted to the U.S. Food and Drug Administration (FDA) in 2000 when Intuitive sought approval of the system, he noted in his closing remarks. This was a sign that Intuitive knew it was providing inadequate instruction to physicians, he added.
Fred Taylor suffered multiple medical conditions
Fred Taylor, the deceased plaintiff in this case, suffered a multiple medical conditions after undergoing da Vinci-assisted surgery in September 2008 for removal of his cancerous prostate gland, Bloomberg News said. Taylor died in 2012.
Personal injury lawsuits have alleged that the da Vinci robotic system has caused patients to suffer from a variety of adverse events including, serious internal injuries, many the result of burns, tears, and other complications. In some cases, patients have died or suffer from chronic pain, even disability.
Da Vinci lawsuits fault aggressive Intuitive marketing positioned to induce hospitals to buy the costly system. Lawsuits also allege that a combination of design flaws and poor physician training on the da Vinci caused serious injuries. At last count, about 70 deaths have been tied to the system since 2009.
Taylor’s lawsuit alleges that his death was accelerated because of prostate surgery conducted with the da Vinci system. Recent physician testimony indicated that the stress of the long surgery and the complications the patient suffered from that surgery brought about the man’s death, Bloomberg News previously reported.
John S. MacGregor, a cardiologist and professor of medicine at University of California, San Francisco, told the jury that the man might have lived five more years, and with a better quality of life, had he not been harmed in the botched robotic-assisted surgery in 2008.
Intuitive spokeswoman Kate Lederer recently testified that the company’s training is sufficient
Intuitive spokeswoman Kate Lederer recently testified that the company’s training is sufficient and complies with data submitted to the FDA in 2000 when federal approval was sought for the da Vinci robotic system, wrote Bloomberg News.
Taylor’s widow alleges that da Vinci training was simplified to better enable Intuitive to sell more of the systems, which she claims led to errors during her husband’s prostate surgery. Intuitive disagrees with the allegations, according to Bloomberg News, arguing that the surgeon in this case, urologist Scott Bildsten, performed 100 successful prostatectomies via traditional surgery; this was his first unassisted da Vinci surgery.
For his part, Bildsten testified that Intuitive deemed him sufficiently ready to operate with the da Vinci after he received just one day of Intuitive training and had undergone two supervised surgeries. Bildsten had never operated unassisted on a patient using the da Vinci prior to this surgery, according to a Bloomberg News report. He says he now realizes he should have received additional training before performing the unassisted robotic surgery.
After seven hours of problems in the operating room, Bildsten and other doctors ceased using the da Vinci and continued using traditional surgery, following with emergency care to repair a rectal laceration.