Poor Technology & Training Leads to Surgical Robot Litigation

 

Intuitive Surgical is facing multi-district litigation with their da Vinci robotic surgical products.  Dr. Francois Blaudeau, a practicing attorney and gynecological surgeon with The Center for Advanced Gynecological Surgery in Birmingham, Alabama, spoke with The Legal Broadcast Network about the lawsuit facing Intuitive Surgical, as he was one of the first to file a lawsuit with the manufacturer.

Dr. Blaudeau says the robotic surgery was initially developed for the military, to allow them to do things in the field and then the technology grew to the private sector.  Intuitive Surgical came out about 10 years ago and has emerged as a leader in robot technology in civilian operating rooms and really made their mark with radical prostectomy.  After looking at how to apply the technology to other surgeries, they decided to go into hysterectomies.  This was a calculated growth strategy by Intuitive Surgical, as there are about 600,000 hysterectomies performed each year in the U.S.

The marketing material for Intuitive Surgical's robot technology compared it to open laperotomy, with a faster recovery time.  What they didn't compare it to was laparoscopic hysterectomy, which didn't require a robot and this is the basis for the litigation, Dr. Blaudeau says.  In using the robot, certain issues occurred, causing certain complications to occur in numbers not seen before in hysterectomies, Dr. Blaudeau adds.

A lot of Intuitive Surgical's marketing claims have not been backed up by facts.  Dr. Blaudeau says that not only did they over-market their product but they also bullied the hospitals into incorporating robotic technology by creating a sense of fear and loss that if they didn't open a robotic surgery program, they'd be perceived as not as sophisticated in technology.  He adds that they almost created an "arms race" in the operating rooms, that if they didn't go purchase a robot and train their surgeons, that they were going to lose market share.  Dr. Blaudeau points out that just this past month, The Journal of Obstetrics and Gynecology came out with an article about how a lot of the claims Intuitive Surgical made were not backed up by facts.  "We are going to see a real blow-back to the surgical company for over-branding and over-marketing their product line," Dr. Blaudeau said.

Dr. Blaudeau says that the goal of Intuitive Surgical is to get as many cases done as possible because they make money on the cases that are done.  Since this is a whole new way to operate, they had to train the surgeons, so a program was set up to send surgeons to one day, hands-on courses, then come back and be proctored by another surgeon that Intuitive Surgical paid for.  The surgeon being trained would do 2-3 cases and then turned loose, leaving them inadequately trained.  Source: http://www.intuitivesurgical.com/products/davinci_surgical_system/

The technical issues that arose were with the monopolar current, which is an antiquated type of energy.  This type of technology was commercially available to Intuitive Surgical without having to license a newer type of technology, such as ultrasonic or bipolar energy.  Intuitive Surgical would have had to license these technologies from other companies, such as Johnson and Johnson, and in order to get their foot in the robotic surgical market, they made a business decision to just go ahead with the older technology.  With this older technology, however, there was more risk of thermal damage to tissue, causing a long list of complications to occur due to the use of this monopolar energy, Dr. Blaudeau says.

On top of the energy problems, they also had issues with the insulation in the arms of robots. Dr. Blaudeau says that the robots were used 10-15 times before they got swabbed, due to the cost of swabbing.  While tips were changed for each patient, in the course of these 10-15 cases, there was a degredation in the insulation of these arms and injuries would occur that the physician couldn't see as the energy went down the arm into the tip.

One of the big issues with robotic surgery, from a medical standpoint, is you don't get the feedback of tactile sensation, Dr. Blaudeau notes.  A surgeon can tear tissue with a robot, not having a tactile sense and there has to be sufficient training in this regard.  Intuitive Surgical actually develops techniques using their platform and teaching this technique which was endangering patients and causing injuries, he adds.

Frederick Kuykendall, attorney and partner with The Murphy Firm in Baltimore, Maryland, says all of these cases "boil down to who knew what and when."  Kuykendall says that because there were multiple filings against Intuitive Surgical, there may be multi-district litigation, most likely in San Francisco, the home of Intuitive Surgical.  

Kuykendall refers to the first case in the country filed against Intuitive Surgical by Dr. Blaudeau, which was a 43-year-old woman with bleeding and cramping.  The patient had robot surgery and during the surgery, as a direct consequence of the technology, she received a bladder injury which required further surgery.  The patient now suffers from many complications, such as urinal leaking, painful intercourse and intermittent pelvic pain.

Dr. Blaudeau says that other allegations against Intuitive Surgical include that they decided to license other technology but not deploy it and that they knew the technology was unsafe and the training was inadequate.  He also adds that the false advertising and marketing they did, along with direct to consumer marketing, built the momentum of their product, which created a false premise for the patient.

"There should have been a better path to certify the surgeons on these machines but hospitals were so committed to push the envelope once they invested millions of dollars into the program," Dr. Blaudeau says.

For more information on the article in The American Journal of Obstetrics and Gynecology, click here

Dr. Francois Blaudeau practices gynecological surgery at The Center for Advanced Gynecological Surgery in Birmingham, Alabama and is also a practicing attorney.  Frederick Kuykendall is an attorney in Baltimore, Maryland with The Murphy Firm and is also a featured commentator with The Legal Broadcast Network, providing legal commentary through on-demand videos.