UPDATED Feb. 11, 2017, with comment from Intuitive Surgical.
Intuitive Surgical (NSDQ:ISRG) must face another trial over whether it gave adequate warnings about using its da Vinci robot-assisted surgery platform in prostatectomies after a botched surgery in which a doctor failed to heed its warnings, the Washington Supreme Court ruled yesterday.
Plaintiff Fred Taylor went in for a prostatectomy in September 2008. During the procedure, Dr. Scott Bildsten noticed that Taylor’s rectal wall was lacerated and converted from robot-assisted to open surgery, according to court documents.
“Taylor’s quality of life was poor after the surgery. He suffered respiratory failure requiring ventilation, renal failure (that ultimately resolved itself), and infection. He was incontinent and had to wear a colostomy bag. He also suffered neuromuscular damage and could no longer walk without assistance. Roughly 4 years after the surgery, Taylor passed away. A doctor testified that the prostatectomy’s complications hastened his death,” according to the documents.
Taylor sued a year after the procedure (the case was taken up by his wife, Josette Taylor, after his death), naming Bildsten and his partner Dr. John Hedges, their medical practice and Harrison Medical Center and eventually Intuitive Surgical. Taylor settled with all of the defendants except Intuitive, which was cleared after a jury found that it was not negligent in its warnings or instructions to Bildsten on using the da Vinci device in prostatectomies. The jury heard that Bildsten ignored 3 key instructions from Intuitive: 1) Never perform a da Vinci prostatectomy on obese patients with a body mass index of more than 30 (Taylor, who weighed 280 pounds, had a BMI of 39); 2) Never perform a da Vinci prostatectomy on patients who have had prior abdominal surgeries (Taylor had 3 prior lower abdominal surgeries); and 3) Always position patients for a da Vinci prostatectomy in a steep Trendelenburg position with their head lower than their feet (Bildsten worried that Taylor was too heavy to safely use the Trendelenburg position).
Taylor was denied on appeal after arguing that the trial court should have instructed the jury that Intuitive had a duty to warn Harrison Medical Center in addition to Bildsten. On appeal to the Washington Supreme Court, however, Taylor prevailed.
“The manufacturer’s duty to warn purchasing hospitals is not excused when a manufacturer warns doctors who use the devices because hospitals need to know the dangers of their own products, which cannot be accomplished simply by the manufacturer’s warnings to the doctor who uses the product. Thus, we conclude that the trial court erred by failing to instruct the jury there was a duty to warn Harrison Medical Center of the da Vinci system’s risks,” the court ruled yesterday.
The Evergreen State’s high court remanded the case for a new trial on whether Intuitive’s warnings were adequate, according to the documents.
Intuitive argued in a supplemental brief that the high court ignored the fact that the company provided its user manual – which includes the 3 warnings Bildsten ignored – both to the surgeon and to the Harrison Medical Center.
“The user manual for the da Vinci System, which was submitted to the United States Food and Drug Administration (“FDA”), contained a number of instructions, warnings, contraindications, and precautions, including a specific direction that robotically-assisted surgery should not occur on persons who are morbidly obese. Intuitive provided that manual to purchasers like Harrison,” according to the brief.
“The Washington Supreme Court fails to note in its ruling that Intuitive Surgical presented evidence at trial showing that, consistent with our usual practice, we delivered the hospital’s da Vinci System with the user manual, which includes warnings and precautions about the device,” Intuitive Surgical spokesman Joe McGrath told MassDevice.com via email.