Product News and Recalls

Court Rules “Da Vinci” Maker Has Responsibility to Warn Parties of Possible Dangers

da vinci maker must warn of dangers with robotThe Washington state Supreme Court has overturned a jury’s ruling on Intuitive Surgical’s controversial robotic “da Vinci” laparoscopic surgical system. In a 6-3 vote, the court found Intuitive does have a duty to provide proper warnings and instructions to hospitals that use its devices.

Da Vinci robotic systems are used in minimally invasive procedures and include a camera at the end of a small tube. They are capable of aiding surgeons with everything from hysterectomies to prostatectomies, as well as heart surgery, kidney transplants, and hip replacements. The diversity of the system’s capabilities is one reason it was used in more than 600,000 surgeries in 2015 alone. But for all its success, the da Vinci system could pose great risk to patients.

Studies conducted by three prominent medical research centers suggest that da Vinci bears responsibility for the deaths of at least 400 people, and injured more than 1,000 others in the United States between 2000 and 2013. It is also possible those numbers are even greater, as all deaths or injuries may not have been reported. The devices have had parts break off inside some patients and electrocuted others because live wires became exposed during surgery.

Additional information suggests Intuitive Surgical may have known about safety issues with their robotic surgery platform as early as 2007, and only made customers aware in 2011. An FDA investigation in 2013 found that units may not have been properly tested. That finding eventually led to a recall.

Intuitive delivers the da Vinci system with a user manual and feels it has “no duty to warn any other party” of the dangers of their product because their actions are “consistent with our usual practice.”

With the amount of controversy surrounding the device, “usual practice” may require some examination. Healthline states that “the da Vinci hasn’t improved patient outcomes as dramatically” as previous innovations in minimally invasive surgery, and that “evidence that it trumps other methods is lacking.”

Undisclosed settlements for plaintiffs in previous da Vinci cases has left their attorneys “grinning ear to ear.” Such settlements won over the use of surgical aides only emphasizes that patients should always ask their medical professionals about the possible perils that accompany what may otherwise be presented as a safe and standard procedure.