I don't really want to write so much about the problems of robotic surgery, but when I hear a quote like this from the main manufacturer of the equipment, I can't let it go without commentary:
Intuitive has no duty to train doctors on the da Vinci system under Washington law, the company has said in its court filings.
Here's the context, in this latest story from Bloomberg:
Intuitive Surgical Inc. (ISRG), a maker of surgical robots used in more than 300,000 U.S. operations last year, faces its first trial over claims it marketed the devices to doctors without providing adequate training.
A state court jury in Port Orchard, Washington, is scheduled to hear opening arguments tomorrow afternoon about whether Intuitive properly trained a physician who, in his first unassisted surgery using the company’s da Vinci surgical system, removed the prostate gland of a patient who later died.
The lawsuit is one of at least a dozen filed against Intuitive since 2011 alleging injuries tied to the robot-surgery systems. Intuitive’s robots, which cost about $1.5 million each, are used in 1,371 U.S. hospitals, the company has said. The robots and related products generated most of the company’s $2.2 billion revenue in 2012.
Kitsap County Superior Court Judge Jay Roof last month rejected Intuitive’s bid to throw out the suit and scheduled the trial to conclude in May. The judge found the state’s product- liability laws require medical-device makers to properly train physicians who buy their products.
Now look how the company and the doctor end up on opposite sides of the case.
According to court filings, [Doctor] Bildsten said Intuitive’s training didn’t inform him of the need to create the watertight seal or warn of the risk of abdomen inflation. After reading Food and Drug Administration documents about the “learning curve to obtain basic competency” with the da Vinci system, Bildsten said, “I believe I likely would not have agreed to begin training on the robot had I been given this information,” according to the filing.
Bildsten said Intuitive told him he could achieve “basic competency” after two assisted surgeries, and that the company did not tell him that consultants paid by Intuitive reported that such proficiency couldn’t be reached “until twenty or more operations were complete,” according to the filing.
Intuitive has argued in court documents that lawyers for Taylor’s family are attempting to create a “totally new cause of action” against medical device manufacturers -- the “duty to train” -- under the Washington Product Liability Law.
Under the state law, Intuitive had no duty to train Bildsten or warn him of the risk of the surgery, according to the filing.
“Dr. Bildsten, a board-certified, licensed surgeon was responsible for making sure he could perform the surgery he chose to perform and to do so safely,” Intuitive argues in the filing.
If you are a surgeon using this equipment, I bet the interplay gives you a warm and fuzzy feeling.
I wonder which medical malpractice insurance company is watching this, wondering why they didn't engage in risk mitigation procedures as part of their underwriting process.
Meanwhile, back on Wall Street:
Investors are so far unconcerned with what the trial result might mean for Intuitive, said Andrew S. Zamfotis, an analyst at evaDimensions in New York. The company is “practically printing money with these robots,” and for shareholders the trial “hasn’t moved the needle yet,” he said in a phone interview.
Intuitive has no duty to train doctors on the da Vinci system under Washington law, the company has said in its court filings.
Here's the context, in this latest story from Bloomberg:
Intuitive Surgical Inc. (ISRG), a maker of surgical robots used in more than 300,000 U.S. operations last year, faces its first trial over claims it marketed the devices to doctors without providing adequate training.
A state court jury in Port Orchard, Washington, is scheduled to hear opening arguments tomorrow afternoon about whether Intuitive properly trained a physician who, in his first unassisted surgery using the company’s da Vinci surgical system, removed the prostate gland of a patient who later died.
The lawsuit is one of at least a dozen filed against Intuitive since 2011 alleging injuries tied to the robot-surgery systems. Intuitive’s robots, which cost about $1.5 million each, are used in 1,371 U.S. hospitals, the company has said. The robots and related products generated most of the company’s $2.2 billion revenue in 2012.
Kitsap County Superior Court Judge Jay Roof last month rejected Intuitive’s bid to throw out the suit and scheduled the trial to conclude in May. The judge found the state’s product- liability laws require medical-device makers to properly train physicians who buy their products.
Now look how the company and the doctor end up on opposite sides of the case.
According to court filings, [Doctor] Bildsten said Intuitive’s training didn’t inform him of the need to create the watertight seal or warn of the risk of abdomen inflation. After reading Food and Drug Administration documents about the “learning curve to obtain basic competency” with the da Vinci system, Bildsten said, “I believe I likely would not have agreed to begin training on the robot had I been given this information,” according to the filing.
Bildsten said Intuitive told him he could achieve “basic competency” after two assisted surgeries, and that the company did not tell him that consultants paid by Intuitive reported that such proficiency couldn’t be reached “until twenty or more operations were complete,” according to the filing.
Intuitive has argued in court documents that lawyers for Taylor’s family are attempting to create a “totally new cause of action” against medical device manufacturers -- the “duty to train” -- under the Washington Product Liability Law.
Under the state law, Intuitive had no duty to train Bildsten or warn him of the risk of the surgery, according to the filing.
“Dr. Bildsten, a board-certified, licensed surgeon was responsible for making sure he could perform the surgery he chose to perform and to do so safely,” Intuitive argues in the filing.
If you are a surgeon using this equipment, I bet the interplay gives you a warm and fuzzy feeling.
I wonder which medical malpractice insurance company is watching this, wondering why they didn't engage in risk mitigation procedures as part of their underwriting process.
Meanwhile, back on Wall Street:
Investors are so far unconcerned with what the trial result might mean for Intuitive, said Andrew S. Zamfotis, an analyst at evaDimensions in New York. The company is “practically printing money with these robots,” and for shareholders the trial “hasn’t moved the needle yet,” he said in a phone interview.