In a nearly 2,400-word article titled “Intuitive Robosurgery Training Seen Lacking in Lawsuits,” Bloomberg News reports, “Intuitive Surgical Inc. (ISRG), the maker of surgical robots used in 367,000 US operations last year, is facing accusations in lawsuits that it put patients at risk by marketing the machinery to doctors without providing adequate training.” Currently, “no universally accepted guidelines exist on how to train people to use them, unlike the standards for many other sophisticated surgical procedures,” which has “left some hospitals dependent on guidance from Sunnyvale, California-based Intuitive, which has faced criticism it rushes training to speed revenue growth.” During the past 15 months, no less than 10 lawsuits have been filed over injuries allegedly resulting from surgeries using Intuitive robots, and nearly all of the lawsuits point to the company’s “training regimen.” The article discusses the details of one of these cases. The article also points out that before the device was approved by the FDA, some members of an advisory panel indicated that the company should put together a training program, and one Intuitive founder said that that would be done.
In a separate article, Bloomberg News reports, “A rising number of injuries linked to robotic surgery has been reported to Massachusetts health officials, spurring the state to call for better oversight on training and more disclosure to patients on potential risks.” Massachusetts’ “Board of Registration in Medicine said in a statement on its website yesterday that it has received ‘an increasing number’ of reports of patient complications related to the surgery in the last two years.” Although “the board doesn’t name any company, the only robot system cleared in the US for soft tissue surgery is made by Sunnyvale, California-based Intuitive Surgical Inc.”
From the American Association for Justice news release.