‘Robo Surgery’ Manufacturer Sued for Inadequate Device Training

The medical device injury attorneys at Farah & Farah in Jacksonville have been following the allegations of Intuitive Surgical Inc. – a manufacturer of surgical robots that were used in 367,000 U.S. operations last year. The manufacturer allegedly failed to adequately train doctors in the use of its Da Vinci robotic system in a rush to get it out on the market.

Bloomberg News
reports that 10 lawsuits have been filed against Intuitive Surgical Inc. stemming from injuries sustained during robotic-assisted surgery. Majority of those suits claim that the company’s lack of an adequate training regimen on the device led to those injuries.

A lawsuit filed at Washington state court suggests that the plaintiff’s attorney introduced emails, in which Intuitive salesmen were aggressively seeking to cut back the number of doctors’ training procedures required by hospitals. According to Bloomberg, one email detailed how a manager told a sales team not to “let proctoring and credentialing get in the way” of meeting sales goals. Another email described how a clinical sales manager congratulated a salesman who had talked a hospital into reducing the number of training procedures they required.

Intuitive told the U.S Food and Drug Administration (FDA) before the robotic-device was cleared in 2000 that they would implement a three-day training course where all operating-room personnel would be mandated to attend. The manufacturer also promised to create a 70-question quiz that surgeons would need to pass in order to claim they were proficient with the Da Vinci robotic system.

Bloomberg reports that just months after approval of the Da Vinci robotic system, a marketing official was put in charge of training. He reduced the off-site training to once a day and the quiz to 10 questions -which allegedly made it nearly impossible to fail.

Intuitive states that it is not their responsibility, but the responsibility of a hospital to “credential and privilege” surgeons to use the robotic device. Intuitive’s recent attempt to throw out the lawsuit at Washington state court failed.

Sometimes, meeting commission sale goals take precedence over patient safety for medical device manufacturers. If you believe you have suffered a personal injury during a Da Vinci robotic surgery procedure, call Farah & Farah. We can be reached at (800) 533-3555 or contact us online for a free review of your case.