A da Vinci robot surgery lawsuit has been filed on behalf a Louisiana man who alleges that he was injured during a surgical procedure he was undergoing while the da Vinci Surgical System was being used. The da Vinci robot lawsuit was filed by Sandra Marshall, as agent for, and Barry Webster, who experienced these risks firsthand. Webster was suffering from a prostate adenocarcinoma, and underwent a laparoscopic prostatectomy at Ochsner Medical Center. His surgeon reportedly used the da Vinci system as directed in the procedure until half way through the surgery when the surgery was converted to an open radical retopubic prostatectomy. Webster’s surgery allegedly did not go as planned. He suffered “injuries and damages to his ureters, urinary tract and bladder causing incontinency and impotence,” according to the da Vinci robot lawsuit. This has caused pain, suffering, and the need for additional doctor visits that continue to this day. Webster is also dealing with significant medical expenses. According to the da Vinci lawsuit, neither Marshall nor Webster was aware of the link between the use of the da Vinci robotic system and Webster’s da Vinci robotic surgery complications until Marshall saw a commercial discussing the “defective nature of the machine” in June 2013.

Power Issues with the da Vinci Surgical Robot

According to the da Vinci robot lawsuit, Intuitive promoted its device as safer than other comparative methods of laparoscopic surgery. Webster’s surgeon reportedly followed the methods instructed him, including using the monopolar current. However, Webster alleges that Intuitive “was aware, or should have been aware, of the known dangers of monopolar current in regard to capacitive coupling, which like insulation failure can cause a thermal injury to occur in adjacent structures like bowel, bladder, ureters, urinary tract or blood vessel.” The plaintiffs also claim that Intutive knew there were safer energy sources available, and safety systems that could be used, but continued with the use of monopolar current “based on not wanting to pay for the cost of having to license these safer energy technologies,” the da Vinci robot lawsuit states. Webster and Marshall are not alone in these accusations. Enough victims have come forward with equipment safety issues and false advertising claims as to the safety of the product that a da Vinci class action lawsuit has been launched.

History of da Vinci Robot Surgery Complications

The U.S. Food and Drug Administration (FDA) database of Manufacturer and User Facility Device Experience (MAUDE) tracks patient injuries and deaths. Since January 2013, a number of adverse event reports have been filed regarding the da Vinci system. This spike in events got the FDA’s attention, so they started an investigation asking surgeons around the country to take a survey regarding the number of robot-assisted surgeries performed. However, the assessment occurred at a time when the value of robot-assisted surgery in general was coming under fire. In February 2013, JAMA published a study that reported that robotic assisted hysterectomies showed similar rates of complication as a traditional laparoscopic hysterectomy, but cost about $2200 more per procedure. A few weeks later, a statement was issued by the American College of Obstetricians and Gynecologists recommending a traditional vaginal hysterectomy as their procedure of choice. This was based on studies showing that adding “expensive technology for routine surgical care does not improve patient outcomes. Consequently, there is no good data proving that robotic surgery is even as good as, let alone better, than existing, and far less costly, minimally invasive alternatives.” Marshall and Webster’s da Vinci robotic surgery lawsuit addresses defective design and promotion of the device, and accuses Intuitive of product liability; negligence, negligent training and proctoring and negligent certification; fraud; breach of express and implied warranties; and unjust enrichment. The Da Vinci Robot Surgery Lawsuit is Sandra Marshall, et al., v. Intuitive Surgical Inc., Case No. 2:14-cv-00915-HGB-MBN, in the U.S. District Court for the Eastern District of Louisiana.

The Da Vinci Surgical System

With a $2 million price tag, the da Vinci Surgical System is not an inexpensive medical device. A set of robotic arms meant to assist doctors with laparoscopic surgery, the system translates a surgeons’ movement into microscopic motions. This is important, as laparoscopic procedures use tiny tools inserted into the body through a small incision. However, critics say that such an investment, plus the need to justify upkeep fees, drives hospitals to employ the device as much as possible, even with inadequate training or consideration of possible risks. One of those risks was announced, but never addressed. Intuitive Surgical, Inc., manufacturer of the da Vinci system, issued an “urgent medical device notification” warning in 2013 that “certain components of the robotic device could be susceptible to micro-cracks … [and] admitted that these micro-cracks could leak monopolar current, resulting in inadvertent burns and damages.” It’s alleged, however, that they should have known of these issues since 2000, and has been cited in an ever growing number of da Vinci robot surgery lawsuits.