A product liability trial began this week against the makers of the da Vinci robotic surgery system, involving allegations that problems with the design of the robot caused a woman to suffer severe internal injuries during a hysterectomy procedure.
The complaint was brought by Michelle Zarick, who underwent a robotic hysterectomy in 2009. Following the procedure, Zarick indicates that her intestines began protruding through her vagina, and she had to undergo emergency surgery.
The trial began on Thursday in California state court, involving allegations that problems with the da Vinci robotic system were the cause of these complications.
The da Vinci Surgical System is a complex robot manufactured by Intuitive Surgical, which is used in a variety of different urologic, gynecologic and other laparoscopic surgical procedures.
The device designed to provide a minimally invasive surgery, where four arms are remotely controlled by a surgeon through the use of hand and foot controls while sitting at a console that provides a virtual reality representation of the patients internal organs.
In recent years, Intuitive Surgical has faced a number of similar da Vinci robotic surgery lawsuits brought on behalf of individuals who alleged they suffered injuries following procedures, including allegations of design defect, failure to adequately train surgeons and failure to provide adequate warnings for consumers.
Zarick, and her husband, Ryan, are seeking up to $300 million, including $250 million for emotional distress and $50 million in economic damages. She indicates that she suffered extreme pain, damaged rectal muscles and a diminished sex life, according to the lawsuit.
The complaint alleges that Zarick’s problems were caused by an electrified scissor attachment on the da Vinci robot, which is used to cut and cauterize tissue at the same time. The lawsuit claims the scissors were not adequately insulated and caused injuries to surrounding tissues. It also alleges that Intuitive Surgical failed to adequately test the robot and then tried to cover up reports of complications from the FDA.
At least one prior da Vinci lawsuit has gone to trial, resulting in a defense verdict in 2013 from a Washington state jury.
In January 2013, a report by the investment research firm Citron Research highlighted a number of potential issues with the da Vinci robot and Intuitive Surgical’s response to those problems. Citron identified more than 4,600 adverse event reports submitted to federal health regulators involving the da Vinci robot, highlighting what the analysts described as a disturbing trend with the manufacturer making “clearly unfathomable” assertions that the complications had nothing to do with the da Vinci robot.
Growth in da Vinci procedures may have also been impacted by continuing concerns over whether the costs associated with robotic surgery are justified.
In February 2013, a study published in the Journal of the American Medical Association (JAMA) found that da Vinci hysterectomies increase costs by more than $2,000, while providing virtually the same complication rate as laparoscopic surgery.