Procedures performed by Vinci robot surgery have resulted in thousands of cases of injury, severe complications and even death. More than 3,000 cases of injury caused by use of da Vinci robot technology were settled in 2013 and two cases have gone to trial. One trial resulted in a decision for Intuitive Surgical, but the family of the victim has been awarded a new trial. The second trial was settled during jury deliberations when the company offered a $30 million payout, but many lawsuits are still pending.
As of September 2017, more than 100 victims or family members of those who died as a result of da Vinci robot-assisted surgery have lawsuits against Intuitive Surgical waiting in the court systems.
Da Vinci Robot Surgery Complications
Between 2000 and 2013, 10,624 reports for injuries or adverse events associated with da Vinci robotic surgery system were listed in the FDA’s MAUDE database. These reports included 8,061 device malfunctions, 1,391 injuries, and 144 deaths associated with the da Vinci system.
Though it represents only a fraction of the 1.5 million surgeries that were performed in the same period, some experts believe that the number of serious adverse events may be severely underreported. In addition, many of these events may have been preventable.
The most common da Vinci robot injuries include:
- Bowel or bladder injuries
- Punctured or cut ureters
- Perforations or tears in organs
- Burns to organs
Many of these issues may be attributable to either a lack of proper training or Da Vinci robot malfunctions.
Surgeon inexperience has been cited as a major cause for da Vinci robot injuries. The use of robot-assisted technology may not come naturally to all physicians. It requires the surgeon to become comfortable operating on a patient using an electronic control panel and hand/wrist controls that may be similar to a joystick. The company requires only a few sessions for training but many have said this is inefficient.
Surgeons must complete the following steps to use the device:
- Complete one hour of online instructional training
- Watch two complete da Vinci robotic procedures (four hours)
- Spend at least seven hours in practice operation (on a pig)
- Perform at least two surgeries under the supervision by an experienced robotic surgeon
Some hospitals or healthcare groups may require more training but few require more than five supervised surgeries and some company sales representatives may have tried to get hospitals to lower their requirements.
Da Vinci Device Malfunction
Device malfunction has also been cited as a major cause for negative outcome. One series of events was caused by a device accessory which was ultimately recalled. The da Vinci EndoWrist Monopolar Curved Scissors attachment developed invisible cracks in several cases. This allowed electricity to arc, resulting in internal burns to the patient. In another cases, a robotic arm broke free of control and hit a patient in the face.
In cases where device malfunction or other complications result in long surgery or a requirement to convert the procedure to an open surgery, the patient may be placed at added risk and may have resulted in at least one death. Many patients have decided to seek restitution for their injuries, and families of patients that have died as a result of Da Vinci related injuries are also seeking compensation for their loss.
Underreporting of da Vinci Adverse Events
A study authored by a Johns Hopkins Hospital physician showed that many cases of da Vinci robot injury are incorrectly reported or simply, not reported at all. Many injuries and deaths that may be linked to da Vinci robot-assisted surgery may not occur during the patient’s hospital stay but may be delayed for weeks, months or even years before requiring treatment.
When symptoms occur after the patient has returned home, both the patient and their primary care physician may be unaware that an illness or event is related to the surgery. The operating surgeon may not be informed of the event if the illness is treated only by the primary physician and no report is ever filed with the FDA. FDA adverse event reporting is voluntary and though the agency recommends that they be notified, there are no regulations which require reporting.
Da Vinci Robot Surgery Lawsuit Settlements
In 2013, Intuitive announced they were setting $67 million aside to be used for 3,000 complaints which had been filed against the company. Rather than going to court, the company decided to offer settlements. This allowed them to avoid costly litigation and deny responsibility while still compensating the complainants.
2013 – Trial One
Separately, in May of 2013, the first jury trial involving da Vinci robot surgery was conducted. The plaintiff was the family of a prostatectomy patient who had died four years after the surgery from complications associated with the procedure.
The jury ruled in favor of Intuitive Surgical, finding that the company was not negligent in training the surgeon involved in the case. Intuitive Surgical placed the blame for negative outcome on the surgeon that who had allegedly ignored guidelines despite numerous health concerns with the patient.
The trial was also lost on appeal, but the Washington Supreme Court ruled that the lower court should have determined that Intuitive had a duty to warn the hospital and granted the family a new trial. That trial date is still pending. The plaintiff’s family has been awarded a new trial
2016 – Trial Two
In April of 2016, the second of the da Vinci robot injury trials went to court. The plaintiff was a woman who claimed that she had been injured during a hysterectomy procedure. The case was settled while the jury was in deliberations, for a total of $30 million offered to the plaintiff.
Over 100 da Vinci Robotic Surgery System lawsuits are pending in courts, but a number of lawsuits are waiting to be filed or settled, including at least one class-action lawsuit.
Filing a Da Vinci Robot Lawsuit
In past medical injury lawsuits, plaintiffs who have been injured have been awarded compensation for medical costs, lost wages, future medical costs, and pain and suffering. Family members of those who have died due to a defective medical device have been awarded compensation for wrongful death.
There are no guarantees when filing a da Vinci robot surgery lawsuit, but past medical injury cases have resulted in compensation amounts that range from $thousands to $millions. Each case is unique and must be evaluated separately but people who have suffered injury or loved ones of those who died due to a da Vinci robotic procedure should seek legal advice.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.