Tuesday, April 16, 2013

$2.2 billion in revenue, but training is not our job

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.


Ralf Lippold said...

From Google+:

Even though robotics can bring potential value to operations, there are certain shortcomings, especially when experience, assumptions and mental models are so much based on current situation (not robotics involved, and the surgeon being the "captain on the bridge").

Technology only plays out positively when people are wisely engaged, trained, and taught.

Saying, no or little training would be necessary to fulfill operations with robots (in this rather early stage) is like saying "autopilot will do the landing alone - no pilots on board".

Nick Dawson said...

From Twitter:

Intuitive news is disconcerting--had feared their rapid growth would expose problems and tarnish the surgeons who honed their skills.

R said...

Since I'm from the area I hope I can add some context to this discussion. The surgery occurred at the community hospital in Bremerton, Wa. (a one hour ferry ride across Puget Sound from Seattle or two hours by road). Unfortunately this facility has a longstanding reputation for not fostering an environment resulting in safe high quality care for the community. There are many facilities in adjacent communities that are reasonable options for patients seeking elective surgery. Sadly I suspect that rather than applying resources to process improvement and staff development I suspect resources were diverted to a shiny new toy.

John Gallagher said...

"If you are a surgeon using this equipment, I bet the interplay gives you a warm and fuzzy feeling." - Yeah. Imagine how the patient feels, too... Fascniating.

David Joyce MD said...

Another example of choosing the instrument instead of the surgeon to provide your health care. When non data driven decision making occurs in any industry it results in lower quality and higher cost. Who is to blame here, the patient for making an uniformed decision, the surgeon, and the payer for supporting a marginally better highly expensive procedure, and not really the company. You think DaVinci is expensive wait until protons really hit for prostate cancer. It will blow the roof off Mediciare with little increased benefit over standard therapy.