FDA EXPRESSES CONCERN ABOUT DA VINCI ROBOT
Written By: Rheingold, Valet, Rheingold, Ruffo & Giuffra LLP
In April of this year the FDA expressed its concern about the number of adverse reports associated with the use of the da Vinci robot machine. It has undertaken to gather more information about bad outcomes while the robot was being used during surgery of various types.
The FDA sent a letter to users of the robot who were on a contact list
it maintains, asking them about their experiences. They offered to do
a phone interview to get more information. The letter was reported on
in the Wall Street Journal and Bloomberg News, among other media.
The new interest on the part of the FDA in gathering safety data was precipitated by increased reports of adverse outcomes with the use. And it is possible, as well, that the recent spate of lawsuits against the da Vinci manufacturer, Intuitive Surgical, Inc., brought the issue to the FDA's attention.
Our firm has taken two routes in representing persons injured during robotic surgery, where we can assign a role to the machine in causing injury or to the manufacturer in not doing proper training and credentialing. Either we put the case into suit or we work on a tolling agreement with the company. The later method stops the running of the time within which suit must be brought and allows both sides to gather information about the case with a possibility of resolving the issues.