Da Vinci Robot Lawsuit Filed Against Intuitive Surgical

An Oregon couple has filed a product liability lawsuit against the makers of the da Vinci Surgical System, saying that the robot sliced through the wife’s vaginal cuff and helped spread cancer to her abdominal wall during a robotic hysterectomy. 

Kathleen and Harry Tremblay filed the complaint (PDF) in U.S. District Court for the Northern District of California on January 17, naming Intuitive Surgical, Inc. as the only defendant in the action.

The da Vinci robot is a complex, remote-controlled machine that has been heavily marketed by Intuitive Surgical, resulting in increasing usage in recent years during a wide variety of surgical procedures.

While it has been promoted as a safe and effective alternative to traditional surgical procedures, providing less investive surgery and reduced recovery times, Tremblay indicates that the problems with the da Vinci robot can cause damage to the bowel, blood vessels, arteries, ureters, bladder, vaginal cuff and other surrounding tissue.

According to the lawsuit, Kathleen was diagnosed with uterine cancer in February 2010 and it was recommended that she undergo a hysterectomy. Her doctor recommended the use of the da Vinci robot for the surgery, informing her that the use of the system would reduce her healing time, cause her less pain and would result in a better outcome. However, Tremblay indicates that instead the da Vinci machine tore her vaginal cuff and caused the cancer to advance to her abdominal wall, leaving her with severe and on-going injuries.

The Tremblays allege that the complications experienced following the da Vinci robotic hysterectomy were caused by design defects with the system and Intuitive Surgical’s failure to provide adequate training, instructions or warnings about the risk of problems, including “de-vascularization of the vaginal cuff impeding healing, partial thermal injury burns to (the) bowel, post-surgical abscesses, tears, dehiscences, bleeding, hematomas, sepsis and fistulas.”

Lawsuits Against Intuitive Surgery Over da Vinci Robot

The da Vinci robot is remotely controlled by a surgeon looking at a virtual reality representation of the patient’s internal organs and manipulating its four metal arms with hand and foot controls. However, Trembly’s complaint and a growing number of similar lawsuits over the da Vinci system do not include allegations of medical malpractice or surgical error, instead pursuing claims solely against the manufacturer of the device.

More than a dozen da Vinci robot lawsuits have been filed in recent months, and the number of claims is continuing to steadily increase. The complaints commonly allege that surgical complications following da Vinci surgery were caused by an unsafe electrical cauterizing design and defective insulation, which may allow the electric current to pass outside of the surgical field. Lawsuits also also allege that Intuitive surgical has overpromoted the da Vinci robot to hospitals and failed to ensure proper training on the use.

A recent report by Citron Research, an investment analysis firm, warned that the da Vinci may be linked to more than 80 deaths, and criticized the company for trying to downplay adverse event reports, abuse event reporting systems put in place by the FDA to protect consumers, and said that it appears that there is little to no benefit in using the da Vinci for most of its prescribed uses.