A flurry of bad publicity for Intuitive Surgical

by Frank Tobe

14 May 2013

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UPDATED 5-14-2013: Scroll to bottom of article to see updates.

One of robotics’ biggest stars, Intuitive Surgical (NASDAQ:ISRG), and their da Vinci robotic surgical systems, is receiving a lot of unfavorable media attention – including a 4-part “exposé” by MSNBC – because:

A month-long suit alleging injuries tied to the robot surgery used in a 2008 procedure to remove a patient’s prostrate claims that the surgeon was not adequately trained.
A recent JAMA article showed that although the number of robotically assisted hysterectomy procedures is up, their effectiveness is the same as laparoscopic methods but their costs are about $2,000 higher per procedure.
The FDA recently initiated a probe asking surgeons at numerous hospitals to identify complications with the da Vinci machines.
Intuitive sends note to customers about a scissor instrument known as Hot Shears saying the instrument could develop small, invisible cracks, which can potentially cause a leak of electricity that can burn patients.

The trial – Taylor v. Intuitive Surgical, Superior Court, State of Washington, Kitsap County, 09-2-03136-5 – began mid April and is expected to last a month. In the opening statements on the first day of the trial, lawyers for both sides stated their cases:

PLAINTIVE: That Intuitive Surgical designed a watered down training program to make it easier for them to sell systems to hospitals thereby compromising surgical quality which, in this case, led to complications which caused the man to die. They further claim that the lack of training and steep learning curve caused mistakes which led to kidney failure, brain damage, permanent incontinence, the need to wear a colostomy bag, and ultimately, heart failure and death.

DEFENDENT: That injuries suffered by the obese and medically-troubled patient occurred after the robotic systems was unplugged and not in use; the injuries happened after the robotic surgery was completed. That training, supervision and case selection warnings are and were adequate but in this case not heeded.

Since that time there have been stories from the courtroom suggesting that Intuitive targeted a category of urologists who have “basic or limited laparoscopic skills and who currently perform traditional prostate removals” as if that form of marketing was a bad thing.

Taking advantage of the notoriety of the court case are three class action suits alleging:

One firm is investigating potential claims against the board of Intuitive because the FDA MAUDE database of adverse events involving medical procedures is “significantly understated in terms of da Vinci-related complications.”
Another class action suit has been filed alleging that officers and directors of Intuitive violated SEC provisions and issued materially false and misleading statements highlighting the purported safety and effectiveness of the da Vinci system, concealed at least 10 lawsuits, and therefore are responsible for artificially inflating stock prices during the class action period.
A third class action suit has been filed almost identical to the one above.

MSNBC did a four-part story called “The Da Vinci Debate” with segments titled “Controversy over surgical robotics heats up,” “Patients scarred after robotic surgery,” Counting the problems of robot-assisted surgery,” and “Marketing is key to surgical robot’s success.”

In spite of all this, financial and stock results for Intuitive are doing quite well. Intuitive’s first quarter results showed surprisingly high profits and revenue. But Intuitive narrowed their 2013 revenue projections slightly to account for possibly lower procedure rates for hysterectomies and the stock took a severe drop mid-April.

Intuitive has yet to present their defense in the court case and to the public. For example, the JAMA article said that robotically-assisted procedures cost $2,000 more than similar laparoscopic methods but the researchers who wrote the paper didn’t reduce the $2,000 for the effects of reduced hospital stays and less post-recovery work which in many cases are said to save hospitals more than $2,000 per procedure.

UPDATE 5-6-2013:
As Intuitive begins to defend itself in the Taylor case, witnesses testified that heart disease, not a failed robotic procedure, killed the patient. Further, Taylor’s arteries were 50 to 90% blocked and he had bypass surgery. Another witness testified that Taylor’s health risks prior to the prostate surgery – diabetes, high blood pressure, high cholesterol, bypass surgery, and his obesity (280# on a 5’8″ frame) – ultimately caused his heart to stop.

UPDATE 5-14-2013:
Intuitive sends note out to customers about a scissor instrument known as Hot Shears saying the instrument could develop small, invisible cracks, which can potentially cause a leak of electricity that can burn patients. It describes precautions to take before using the instrument but also says an additional message will be sent once a replacement instrument is available.

Three additional law firms (Ryan & Maniskas, Rigrodsky and Long, and Hagens Berman Sobol Shapiro) filed class action suits alleging that ISRG issued a series of false or misleading statements to investors and thereby failed to fully disclose to investors the financial impact of safety problems with its da Vinci Surgical System.