The first of at least a dozen lawsuits involving catastrophic complications from the da Vinci surgical system recently went to trial. The suit was filed against its manufacturer, Intuitive Solutions, alleging the company aggressively marketed the robot to surgeons without providing proper training.
In 2008, Fred Taylor went into surgery to remove his prostate gland. The procedure was the first the surgeon performed unassisted using the da Vinci system. In the seventh hour of surgery, one of the robot hands accidentally lacerated Taylor’s colon, and physicians rushed in to perform traditional surgery. Taylor died in August 2011 from heart failure, a condition his family claims was the result of the da Vinci complications.
His family filed a lawsuit against Intuitive Solutions, alleging that the company did not provide his surgeon with adequate training or warning about the system’s risks, and that the mistakes made during his prostate surgery were the direct result of this. There are about a dozen lawsuits filed since 2011 alleging similar complications from the robotic surgical system.
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The surgeon in this case had previously performed more than 100 successful traditional prostatectomies. During Taylor’s procedure (the first he was conducting unsupervised), he failed to create a watertight seal between the urethra and bladder when the prostate gland was removed. This inflated the patient’s abdomen with carbon dioxide pressure, ultimately leading to a stroke.
During a robotic surgery, tiny incisions are made only big enough for surgical tools to fit, as surgeons sitting a few feet away guide the four-armed robot through the procedure using a 3-D camera, joysticks, and foot pedals.
The surgeon stated that Intuitive’s training did not inform him that he even needed to create a watertight seal, nor did it warn him of the risks of abdomen-carbon dioxide inflation. According to court filings, after the surgeon was given the FDA’s documents about the significant learning curve associated with the da Vinci system, the surgeon stated that he likely would not have agreed to ever even start training on the robot if that information had been known to him. He went on to state that Intuitive told him he would have basic competency with the system after only two assisted procedures. Realistically, such basic competency could not be reached until 20 or more completed surgeries.
Intuitive is arguing that, under Washington law (where the suit was filed), the company did not have any duty to train the surgeon nor to warn him of the risks. It is stating that the surgeon himself was solely responsible for making sure he could successfully and safely perform the surgery.
Intuitive is also arguing that it did inform the surgeon that, during his first four to six unassisted surgeries, he should choose simple cases in patients with low body mass indexes. Taylor had a BMI of 39, which made him obese.
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A simple search on the FDA’s website under ‘da Vinci’ brings up 4,080 adverse event reports. The federal agency is currently investigating the safety of these surgical robots, which were used in almost 500,000 surgeries last year. The FDA is now asking surgeons at top hospitals to list all the complications they have seen with the da Vinci, which cost about $1.5 million apiece. Physicians were also asked which procedures the robots were best and least suited for, and asked to describe the training they received by the company. The agency is trying to determine whether the increase in adverse event reports is a realistic reflection of the system’s inadequacies.
Gynecological surgeries make up about half of da Vinci’s regular procedures, and complications can be catastrophic, including damage to bowels or ureters and instances of instruments breaking off and burning various organs and vessels. Most malfunctions were the result of user error.
There is an intense debate about the safety of these da Vinci robots, among surgeons and medical associations alike: one study published in the Journal of the American Medical Association found that hysterectomies performed with Intuitive robots cost patients thousands of dollars more but did not reduce complications. If you or a loved one was seriously injured in a procedure using Intuitive’s products, contact one of the da Vinci surgical robot lawyers at Pintas & Mullins Law Firm for a free legal consultation.