Intuitive Surgical Inc. (ISRG), a maker of surgical robots used in more than 300,000 U.S. operations last year, must face claims it marketed the devices to doctors without providing adequate training, a judge ruled.
A Washington state court yesterday denied Intuitive’s bid to throw out a lawsuit over the death of a patient operated on using the company’s da Vinci surgical system, according to court filings. The judge found the state’s product-liability laws require medical-device makers to properly train physicians who buy their products.
Fred Taylor’s family can proceed with claims seeking damages for “harm allegedly caused by the improper marketing of the da Vinci surgical system,” Kitsap County Superior Court Judge Jay Roof concluded in a five-page ruling.
The lawsuit in Kitsap County is among almost 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. The company faces allegations it provides insufficient training for the surgical devices in its push to speed revenue growth.
The judge’s ruling “was not a decision based on the merits of the case,” Angela Wonson, a spokeswoman for the Sunnyvale, California-based company, said in an e-mailed statement. The decision “indicates there are disputed facts that require this issue to be resolved at trial.”
Intuitive rose 1.8 percent to $497.25 in trading in New York today.
Massachusetts officials said this month they have been receiving a rising number of reports about injuries linked to the surgical robots, spurring calls for better training oversight and more disclosure about health risks posed by the devices.
In robot surgery, a doctor sits at a video-game style console several feet from the patient and peers into a high- definition display. Foot pedals and hand controls maneuver mechanical arms equipped with surgical tools, guided by a 3-D camera that shows the work as it is done inside a patient.
Taylor’s family contends he was injured during a 2008 procedure to remove his prostate. They contend his doctor, who relied on the da Vinci system to perform the surgery, had never before used it on a patient without being supervised, according to court filings.
Taylor suffered kidney failure, brain damage, permanent incontinence, and a 1-inch tear in his rectum as a result of the surgery, lawyers for his family said in the filings. He later died of heart failure that his family contends was caused by the robotic procedure.
Taylor’s family accused Intuitive officials of failing to properly train doctors about the da Vinci system and then recommending they perform unsupervised surgeries too quickly.
They said Taylor’s doctor made several mistakes during the unmonitored operation, including deciding to rely on the robotic system at all, according to court filings. The two previous surgeries he’d done with the device were supervised by more experienced robot-surgery practitioners, the filings show.
Intuitive’s lawyers argued in their court filings the company has no duty to train doctors on the da Vinci system under Washington state’s law and federal regulations governing approval of medical devices.
The company contends Taylor’s family can only bring medical-malpractice claims against his doctor rather than product-liability claims against the device’s maker.
The family’s suit against Intuitive amount to “an educational malpractice claim, which has been barred” by most states, the company’s lawyers said in court filings.
Roof, the judge in Taylor’s case, said a review of Washington’s product-liability laws shows medical-device makers have a duty to adequately train doctors in the state to safely use their systems.
Whether the company failed “to provide adequate warnings regarding the use of the da Vinci surgical system” and neglected “to properly train and instruct” Taylor’s doctors on the device must be considered by a jury, the judge said.
Taylor’s lawyers said today that the family’s claims are set for trial starting April 15 in Port Orchard, Washington.
“These lawsuits are highlighting training issues in the field and they are raising issues with outcomes that aren’t optimal” after robotic surgery, said Suraj Kalia, a New York- based analyst at Northland Securities.
“There would be headline risk for this stock” if the case went to trial and details of the company’s marketing efforts were made public, he added. Kalia has a sell rating on Intuitive stock.
The case is Estate of Fred E. Taylor v. Intuitive Surgical, 09-2-03136-5, Superior Court, State of Washington, Kitsap County (Port Orchard).