Plaintiffs Gabriel Fernando Nassar Cure and Dr. Alan Kozarsky sued Intuitive in June 2016 on behalf of all mitral valve surgery patients treated using the company’s da Vinci robot-assisted surgery platform over the past 2 years. Cure and Kozarsky alleged that the da Vinci devices used in their procedures at Atlanta’s St. Joseph’s Hospital left tiny metallic particles behind that eventually found their way to their brains.
Intuitive filed a series of motions to dismiss the case and block its certification as a class action. Yesterday Judge Orinda Evans of the U.S. District Court for Northern Georgia granted 1 of the motions to dismiss, ruling the others moot based on that decision.
Evans found that “plaintiff s cannot claim damages for emotional distress without evidence of a physical injury.”
“Plaintiffs allege negligence as to ‘1 or more instruments that would ultimately be used in mitral valve repair surgeries,’ but they apparently do not know which instrument caused their injury because they fail to specify 1. They allege that 1 of these instruments was ‘defective in design and unreasonably dangerous’ and had ‘an unreasonably dangerous manufacturing defect,’ but they offer no evidence of the specific defect at issue other than the metallic microemboli that have apparently caused no physical injury. Plaintiff s also impute knowledge – ‘defendants knew or had reason to know the instrument was defective and unsafe for use in patients’ – but offer no evidence to support the allegation. These statements simply constitute a recitation of the elements of negligence,” Evans wrote.
“In effect, plaintiffs have simply pled every possible applicable cause of action by listing the elements of strict liability and negligence and pairing them with conclusory statements with no evident factual basis. The plaintiffs ‘ claim appears to rest entirely upon the theory that they had no metallic microemboli before surgery and 1 of defendant’s many instruments was used, so defendants must have done something wrong,” she wrote.
In May 2016, Intuitive warned that small particulates could be introduced inside the heart during intra-cardiac procedures using its da Vinci Xi device.
Sunnyvale, Calif.-based Intuitive said it hadn’t received any reports of injuries related to the high-density polyethylene particles it turned up during quality inspections of its 5mm-8mm universal seal or the 12mm & stapler universal seal used with the da Vinci Xi. Intuitive said the particulate was found in the insufflation stopcocks used with the seals.