Intuitive Marketed Robot to Less-Skilled Surgeons, Witness Says
By Joel Rosenblatt - Apr 19, 2013 12:01 AM ET
Intuitive Surgical Inc. (ISRG) targeted surgeons with “basic or limited” skills in minimally invasive procedures to increase sales of its robotic surgical system, a company marketing executive told a jury.
Ryan Rhodes, Intuitive’s director of marketing, testified yesterday about a “surgical target list” contained in internal marketing documents at a state court trial in Port Orchard, Washington. The trial is over the company’s robotic da Vinci surgical system, and whether Intuitive’s training was compromised by aggressive marketing, which allegedly led to errors in removing a patient’s prostate gland, and eventually caused his death four years later.
A document pertaining to how sales people interact with physicians described a category of urologists who have “basic or limited laparoscopic skills who currently perform” traditional prostate removals. That group is “where 80 percent of your clinical time should be spent,” according to the document.
Rhodes was asked by a lawyer for the deceased patient’s widow if “a doctor who had mastered laparoscopic surgery would be less interested” in using the da Vinci system. A minimally invasive approach to surgery, laparoscopic procedures afford patients the benefit of smaller incisions, less pain, and shortened hospital stay.
“They might or might not, but yes, many times, yes, they might show less interest,” Rhodes said.
The case is the first to go to trial of at least a dozen lawsuits filed against Sunnyvale, California-based Intuitive since 2011 alleging injuries tied to its da Vinci surgical system. The robots were used in more than 300,000 U.S. operations last year.
The plaintiff’s attorney, Richard Friedman, was trying to show yesterday how the internal marketing conflicted with the company’s recommendations that the da Vinci system is for surgeons with “basic and advanced” skills in minimally invasive surgery– a criterion it used in materials submitted to the U.S. Food and Drug Administration to get approval for marketing the robotic devices.
Allen Ruby, a lawyer for Intuitive, told jurors yesterday that that the surgeon who operated on the patient, Fred Taylor, ignored Intuitive’s warnings that the procedure shouldn’t be performed on obese people when using the da Vinci.
Fred Taylor was five-feet, 11-inches tall (180 centimeters), and weighed 280 pounds (127 kilograms), giving him a body mass index of 39 — a measurement that should have precluded robotic surgery according to the training Intuitive provided to the doctor, Scott Bildsten, Ruby said.
Taylor was Bildsten’s first patient using the da Vinci unassisted. Bildsten, who is expected to testify as a witness at trial, was cautioned by Intuitive that for his early procedures with the da Vinci — at least the first four to six surgeries — he should choose simple cases and patients with a low body-mass index, Ruby said.
In robotic surgery, a doctor sits at 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 3D camera that shows the work as it is done inside a patient.
After seven hours of trouble with robotic surgery on Taylor in September 2008, Bildsten and other doctors turned to traditional surgery and then emergency care to repair a rectal laceration. Taylor died in August of heart failure resulting from injuries caused by Intuitive’s inadequate training of Bildsten, according to Friedman.
Bildsten settled claims against him by Taylor’s estate, according to court documents.
The case is Estate of Fred E. Taylor v. Intuitive Surgical Inc., 09-2-03136-5, Superior Court, State of Washington, Kitsap County (Port Orchard).
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