FDA Confirms Da Vinci Robotic Surgery Injuries and Deaths Growing
Written By: Rheingold, Giuffra, Ruffo & Plotkin LLP
As the first trial litigation firm in New York State to file a case against Intuitive Surgical, we feel the need to report injuries and deaths with the use of the da Vinci robotic surgery machine have been on the increase in recent months. A study using FDA and other data was performed by Dr. Jai Raman, a surgeon a t Rush University Medical Center, in association with other institutions. It was reported on in the Wall Street Journal, 11/9/13, p. B4.
Dr. Raman stated the rate of injury and death in cases with the use of the robot, as compared to similar surgeries using other methods, was an actual phenomenon and could not be attributed alone to increased awareness or reporting of adverse problems. So far the study revealed 84 deaths, 414 injuries, as well as 3402 "device malfunctions." The medical group will be presenting a more up to date report at a medical meeting in early 2014.
It is likely that the lawsuits filed by firms which have been recently been brought, by persons who have sustained organ burns, tears, nerve damage and other serious injuries, have been a spur to the FDA in investigating the safety of the da Vinci device. The FDA has also been critical of the maker of the robot, Intuitive Surgical, in not fully reporting all of the information they have on injuries during robotic surgery. While the company has acknowledged lawsuits, it has not reported the claims which are made that are not turned into lawsuits.
After commencing the first suit for robotic injuries, the McCalla case, described in our website in detail, our firm has followed the practice of presenting claims to Intuitive. These involve hysterectomies, prostatectomies and other types of surgeries. Burns and tears are the common injuries which result in the need for reoperation.