Ruling: Intuitive Must Face Claims it Marketed Surgical Robot without Adequate Training


A Washington State court has denied Intuitive Surgical’s bid to dismiss a lawsuit involving its da Vinci surgical robot system.

Intuitive Surgical now must face claims that it marketed the da Vinci to physicians without providing appropriate training, according to a judge’s ruling, said Bloomberg News. The case was brought over a patient’s death following surgery in which the da Vinci surgical system was used, according to court filings.

The judge found that Washington State product liability laws mandate that medical device makers properly train physicians who purchase their products, Bloomberg News explained. The plaintiff’s family is now able to move forward with its claims that seek damages for “harm allegedly caused by the improper marketing of the da Vinci surgical system,” Kitsap County Superior Court Judge Jay Roof concluded in his ruling, Bloomberg News wrote.

The plaintiff’s family alleges that their family member suffered injuries during a procedure to remove his prostate in 2008 and claim his physician had never used the da Vinci system on a patient without supervision, according to Bloomberg News. The plaintiff suffered an array of injuries, including kidney failure, brain damage, permanent incontinence, and a one-inch rectal tear. He ultimately died of heart failure his family claims was caused by the robotic surgery.

The family accuses Intuitive of failing to adequately train doctors on the da Vinci system and of pushing unsupervised surgeries too quickly. The family also alleges that the doctor made a number of errors during the unsupervised surgery, including a decision to rely on the da Vinci, according to court filings, which also indicate this physician had conducted two prior surgeries with the da Vinci and under supervision by more experienced robot surgery practitioners, said Bloomberg News. “These lawsuits are highlighting training issues in the field and they are raising issues with outcomes that aren’t optimal” after robotic surgery, Suraj Kalia, a New York- based analyst at Northland Securities, told Bloomberg News. “There would be headline risk for this stock” if the case reaches trial and Intuitive Surgical’s marketing efforts are made public, he added. Kalia has a sell rating on Intuitive stock, noted Bloomberg News.

We’ve long written about robotic surgery devices, specifically, the da Vinci. The state-of-the-art system has been the focus of an increasing number of lawsuits and death and injury reports and is at the center of a growing dispute over the technology and how it is marketed and used. In robotic-assisted surgery, a surgeon sits at a console operating four robotic arms. Those arms manipulate small tools that are inserted into the patient’s body via tiny incisions. The system also utilizes a small, lighted camera that displays the surgical area in 3-D video. Some 70 deaths have been linked to robotic surgical systems since 2009, as well as at least 10 lawsuits in the last 14 months.

Some argue that robotic surgery creates less scarring, pain, and blood loss; decreased complications; shorter hospital stays; and quicker recovery, when compared to traditional open surgery in which a larger incision is made and the healing time is longer. Critics say it is the minimal invasiveness of the procedures and not the robotics that offer the advantage.

Hospitals set credentialing, or training, requirements for doctors who will operate the system; however, Intuitive documents reveal that its sales reps were very close to the process, presenting themselves as da Vinci experts, and working toward reduced standards so that training could be eased for busy surgeons, all to increase use of the da Vinci and its sales, said The New York Times recently.

Meanwhile, in Massachusetts, health officials announced that mounting robotic injury reports prompted the state to seek improved training oversight and patient disclosure concerning the technology’s possible risks. The U.S. Food and Drug Administration (FDA) is seeking information from surgeons at key hospitals regarding complications seen with the da Vinci and the surgeries robotic surgery devices are best and least suited for.  A 2011 study revealed that hospital web sites often overstate the benefits of robotic surgery; none described risks and sites often utilized stock images or text provided by Intuitive. Most recently, The American College of Obstetricians and Gynecologists (ACOG) issued a statement advising women that robotic surgery is not the ideal option when undergoing routine hysterectomy.

Personal injury lawsuits allege the da Vinci has caused severe internal injuries, including burns, tears, and other complications, some of which had resulted in death or chronic pain and disability. da Vinci Surgical Robot lawsuits fault the aggressive marketing tactics used by Intuitive to convince hospitals to purchase the expensive surgical robot, and allege that a combination of design flaws inherent in the robot, coupled with poor physician training on the device, have resulted in serious injuries.

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