Intuitive Surgical is the global market leader in robotic surgery. The company gained its market dominance by developing a robotic surgical system called the “da Vinci” which has been approved for use by the FDA since the year 2000. The da Vinci Surgical System is a computer-assisted device designed to facilitate surgery using a minimally invasive approach. The da Vinci robot is used in several medical specialties and for multiple indications. Most commonly it is used by obstetricians and urologists in performing laparoscopic hysterectomies and prostatectomies, respectively.
As of September 2013, there were 2042 da Vinci robots being utilized hospitals across the United States. The robot has gained significant traction in these hospitals by promoting the manufacturer’s promise of a shorter hospital stay, fewer complications, and a faster recovery. However, as the da Vinci robot gains in popularity, the FDA warned that an increasing number of adverse events have been associated with the device, including perforations, lacerations, tears, and electrical burns of surrounding organs leading to thousands of patient injuries and well over 100 deaths. In the first 8 months of 2013 the FDA saw a massive increase in adverse events connected with the da Vinci Surgical System (2332 compared to 4603 reports posted in the entire 12 year period since the first adverse event tracking for the da Vinci). In many cases the da Vinci surgery is considered successful and the patient is discharged, only to return to the hospital days or weeks later with internal bleeding, infection, robotic parts still inside of them, and other serious injuries.
Adding fuel to the fire, many recent medical studies have come to light that scrutinize the claims of the da Vinci manufacturers. High profile surgeons have begun to take note of these studies and have begun to voice their own criticism:
The critics are right — if they’re talking about innovations like the da Vinci robot, which costs more than a million dollars and yet has never been shown by a randomized trial to improve the outcomes of prostate surgery.
The major concern is that the robotic procedure really didn’t show a lower complication rate yet it was substantially more expensive. Why the robot took off so fast is the million dollar question.
If the 600,000 hysterectomies performed in the United States were all done robotically, the reported cost increases would result in an extra $960 million to $1.9 billion burden on the health care system.
As a result of painful complications associated with the da Vinci Surgical Systems, hundreds of lawsuits have been filed across the country naming the manufacturer and some of the doctors who have utilized the robot as defendants. The lawsuits allege that Intuitive Surgical has influenced doctors and patients to use the robot by making materially false statements regarding the costs, safety, and efficacy of the da Vinci robot, failing to adequately train doctors how to use the product, and failing to report observed problems to the FDA and to its customers.
If you or someone you know has suffered severe complications as a result of a da Vinci robot assisted surgery, please contact our law firm for a free and confidential consultation.