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Chasing New Technology—Is the Da Vinci Surgical Robot a Good Idea or the Next Big Mass Tort MDL?

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America is in love with technology. We can't wait for the latest, greatest gadget, and in our hurry to be one of the first to get the new and improved products, we often put ourselves at risk. Take the so-called "updated" hip devices that came out over the last few years. In our rush to try them out, many ended up with serious and even life-changing injuries because these products just weren't ready for mass-market use. The companies had hurried them through FDA review and out into the world in search of renewed profits, and we were only too eager to accommodate them.

Now it seems we're facing a potentially similar situation with the da Vinci Surgical Robot. According to the manufacturer, California-based Intuitive Surgical, the machine actually makes it easier for surgeons to perform many operations, allowing smaller incisions while improving recovery time for patients.

Maybe, but now we're hearing reports about serious injuries related to the use of this robot. Part of the problem? Surgeons are being rushed through training and are being put in the operating rooms before they're ready. And, most recently, patients injured by the robots are filing lawsuits and recently asked a coordinating panel of federal district court judges to consolidate the litigation involving the da Vinci Surgical Robot before a single federal court.

Dangling the Technological Carrot

Like many corporations, Intuitive Surgical aggressively marketed their new product, leading doctors and hospitals to believe that if they didn't have this new technology, they were going to have a hard time remaining competitive. Dangling the carrot of increased revenues and patients, the company allegedly exaggerated reports of better surgical outcomes with their robot and managed to convince several medical facilities to dole out the $1-2.5 million for initial purchase and about $140,000/year maintenance costs.

On May 4, 2010, however, the Wall Street Journal issued an in-depth article on the product, noting severe injuries related to its use. One patient was so badly injured, they reported, that she required four more surgeries to repair the damage. In earlier robotic surgeries, two patients suffered lacerated bladders.

Reports of Injuries with the Robot

Marketing materials accompanying the da Vinci Robot state that it can be used in surgeries to help treat or repair obesity, endometriosis, throat cancer, prostate removal, kidney cancer, coronary artery disease, and gallbladder removal. The robot has four arms—three for surgical instruments and a fourth with an endoscopic camera. It is purported to give the surgeon increased range of motion, and to provide a less invasive option to many traditional surgeries.

According to evidence so far, the robot itself is not the problem. Technically, it seems to perform as designed. But doctors warn that it takes a long time to become proficient in using it, and that the company is not making that clear.

Plaintiffs who have filed lawsuits against the manufacturer claim that complications from the procedures may include tears and burns to the uterus, intestines, and blood vessels, as well as vaginal cuff dehiscence—a separation of the vaginal incision, after which abdominal or pelvic contents may be expelled through the opening. A 2009 study noted that vaginal cuff dehiscence with small bowel evisceration after hysterectomy may be occurring more frequently with the advent of robotic laparoscopic hysterectomies.

Not Enough Surgeon Training

One woman whose ureters were accidently cut during surgery with the robot in 2010 filed a lawsuit against Wentworth-Douglass Hospital in Dover, New Hampshire, and the two surgeons that operated on her. The suit echoes the concerns of many across the country that hospitals aren't requiring enough practice before certifying surgeons on the machine.

Intuitive Surgical seems to encourage the idea that using the robot doesn't take much training, as they pay for only a two-day training course for only two surgeons at each hospital. For additional training, the hospital needs to pay more. Yet the Reviews in Urology journal noted a surgeon must perform up to 200 cases to be proficient with robotic surgery, and Jim Hu, a surgeon at Brigham and Women's Hospital in Boston, who has done more than 1,000 surgeries with the robot, says it takes a urologist anywhere from 250 to 700 cases to master it.

Intuitive Surgical maintains that it's up to the hospitals to create guidelines for when their surgeons can do surgeries unsupervised. As the company defends itself in an increased number of lawsuits, however—including a wrongful death suit filed by a New York father after his daughter died as a result of burns caused by the robot—we can only hope they will change that stance, for the sake of patient safety.

Organization of Litigation

Recently, plaintiffs petitioned the U.S. Judicial Panel on Multidistrict Litigation (JPML) to consolidate all Da Vinci surgical robot lawsuits currently in federal courts before a single court. Recently, Patricia and Drennan Mayfield filed a Da Vinci lawsuit in the U.S. District Court for the Southern District of Mississippi on May 7, and subsequently requested a consolidation of all federal Da Vinci lawsuits as part of an MDL, or multidistrict litigation.

In the Mayfield’s suit, the plaintiffs allege that Patricia Mayfield suffered bowel and vaginal damage in a hysterectomy surgery in January 2010. They also claim that Intuitive Surgical was negligent in their failure to provide proper training for the device and that they promoted robotic surgery without providing adequate safety warnings. Claims similar to the Mayfields’ have already been filed in New York, Louisiana, and Alabama.

There are at least four such lawsuits currently pending in U.S. federal courts. These claims are based on allegations that design defects, poor training, and a failure to warn of risks associated with the surgical robots led to internal injuries or the death of a patient. Law firms such as my firm, Chaffin Luhana, are handling similar cases.

If MDL status is granted, current and future federal Da Vinci lawsuits would be overseen by a single federal judge for pretrial proceedings and potential disposition. The Mayfields requested that the JPML consolidate the cases U.S. District Court for the Southern District of Mississippi, before Judge Carlton Wayne Reeves.