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.
First Trial
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.
First Patient
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).
To contact the reporter
on this story: Joel Rosenblatt in Port Orchard, Washington, atjrosenblatt@bloomberg.net
To contact the editor
responsible for this story: Michael Hytha at mhytha@bloomberg.net
No comments:
Post a Comment