Robotic Surgical Procedures with da Vinci Robot Up 26%, Despite Concerns

Despite safety concerns and mounting product liability lawsuits filed against Intuitive Surgical by individuals who allege that they suffered complications following robotic surgery with the company’s da Vinci System, use of the surgical robot continues to increase at hospitals throughout the United States.

In a quarterly earnings report released earlier this month, Intuitive Surgical indicated that robotic surgical procedures with the da Vinci robot increased 26% during the second quarter, and the company sold 15% more systems than they did during the same quarter last year. As a result, second quarter profits topped most analysts’ estimates.

The da Vinci Surgical System is a remote-controlled robot that features four arms and a camera, which allow the surgeon to operate through a small incision while viewing an image on a screen.

Hospitals pay up to $2 million for the system, and then pay thousands in annual maintenance costs and replacement parts for each procedure. As the devices are sold, more and more hospitals are promoting the da Vinci System on their websites, in brochures and directly to their patients, increasing demand for robotic procedures.

Questions are now emerging about the adequacy of this information, as a recent study published in the American Journal of Obstetrics & Gynecology found that many hospitals fail to provide information about the risk of complications, costs of robotic surgical procedures and alternative options for patients on their websites when promoting robotic surgery.

Safety Concerns with the da Vinci Robotic Surgical System

As the number of da Vinci robotic procedures performed at hospitals throughout the United States continues to increase, so have concerns over the safety of the system.

So far this year, at least four da Vinci robot lawsuits have been filed against Intuitive Surgical, alleging that individuals suffered burns, tears and other internal injuries during surgery as a result of problems with the robot.

The complaints all involve similar allegations, that Intuitive Surgical aggressively promotes the da Vinci System without providing adequate warnings, instructions or training. In addition, claims suggest that the device features design defects, which may cause individuals to suffer damage to surrounding organs, vessels or tissue.

Lawsuits allege that the da Vinci robot’s use of monopolar energy to cut, burn and cauterize tissue poses an unreasonably dangerous design, and that safer methods are available, which could substantially reduce the risk of complications. The device also features insulation on the shafts, which complaints allege may become worn or torn in places, allowing the electrical current to pass outside of the operative field, causing damage.

In many cases, reports suggest that surgeons are unaware of the problems caused by the da Vinci robot after surgery. Complaints describe situations where the patient was discharged home, only to require re-admission to the hospital for emergency surgery to repair internal injuries suffered during the robotic surgery.

Lawsuits Attack Intuitive Surgical’s Marketing of da Vinci Robot

According to one lawsuit filed in April by Gilmore McCalla, whose daughter died two weeks following a da Vinci hysterectomy, Intuitive Surgical has been accused of over-promoting the robotic system while failing to conduct adequate post-marketing surveillance of complications and injuries that have occurred in actual practice.

“Defendant sold [the da Vinci robot] through a calculated program of intimidation and market management, forcing hospitals and physicians to purchase it in order to appear to be competitive, and creating a fear in their minds that if they did not have this technology they would lose business to competitors,” alleged McCalla in the complaint filed in the U.S. District Court for the Southern District of New York.

Similar allegations have been raised in other lawsuits filed in courts throughout the United States, and a panel of federal judges met last week to consider whether the increasing litigation over da Vinci surgery should be consolidated and centralized for pretrial proceedings as part of an MDL, or multi-district litigation.

Lawyers reviewing potential claims have suggested that the number of lawsuits filed will continue to increase as public attention and awareness of the claims increases.