A class of heart surgery patients have accused Intuitive Surgical Inc., which builds the “da Vinci” surgical robot, of building a defective medical device that caused metallic debris to end up on their brains. In the complaint, filed in a Georgia federal court in mid June, the Plaintiffs claim that Intuitive and its affiliate, Intuitive Surgical Operations Inc., designed, manufactured, marketed and sold defective medical instruments that were used during surgeries at hospitals across the country. It’s alleged that Intuitive knew, or should have known, about the defects in the instrument, including the fact that it can leave metallic debris inside the body, and thus should be held liable for breaching implied and express warranties, negligence and other claims for not warning anyone about possible harm.
Both Plaintiffs claim to have discovered the metallic debris after undergoing a mitral valve repair surgery by a cardiac surgeon at Saint Joseph’s Hospital in Atlanta. The doctor is one of the surgeons listed on Intuitive’s website as being qualified to use the da Vinci device for mitral valve repair.
One Plaintiff underwent heart surgery on June 16, 2015, and had no evidence of metallic debris on his brain before that date, but imaging done after the procedure showed findings that suggested he had metal in his head. The other Plaintiff underwent the same surgery three days later and experienced the same issue, the complaint says.
Both Plaintiffs allege they have suffered, and will continue to suffer, physical and mental effects, including the emotional distress of having metallic fragments in their brains, as well as the cost of medical expenses to address those effects. Both expect to lose future wages.
Plaintiffs seek to represent three subclasses of patients who underwent a surgery within the last two years that used the device and who didn’t previously have any evidence of metallic debris on their brains. Those subclasses are:
• those who still don’t know if they have debris on their brains;
• those who have found that they may have debris on their brains, and
• those who have suffered an injury from having debris on their brains.
In April, Intuitive reached a last-minute settlement in the $30-million trial over a woman’s serious internal injuries stemming from a da Vinci-assisted hysterectomy. If you need more information on this subject, contact Clay Barnett, a lawyer in our firm’s Consumer Fraud and Commercial Litigation Section, at 800-898-2034 or by email at Clay.Barnett@beasleyallen.com.
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