August 13, 2013
Hospitals throughout Connecticut keep their competitive technological edge by offering the surgical services of a million-dollar, multi-armed robot named da Vinci. The robots were used in nearly 400,000 surgeries nationwide last year — triple the number of just four years earlier.
But in the past year or so, there's been a spate of lawsuits filed in federal courthouses across the country against the leading maker of surgical robots. Plaintiffs say they have been burned or suffered other severe injuries during surgery.
The use of robotic technology for surgical procedures is not new. But the growing wave of lawsuits against the da Vinci Surgical System robot, manufactured by Intuitive Surgical of California, has prompted increased scrutiny. The federal Food and Drug Administration has reported problems, including several deaths, that may be linked to the technology. According to a regulatory filing, there have been more than 40 lawsuits filed nationally against da Vinci's manufacturer.
The majority of the da Vinci robot lawsuits have been filed in U.S. District Court for the Northern District of California, where Intuitive is based. But in May, 17 Louisiana residents also filed suits, claiming a total of $1.2 billion in damages. They claimed that they suffered unexpected injuries from the deficient design and negligent use of the robots. The claim, like others, alleges inadequate training of surgeons on the part of Intuitive, noting "there is no standardized curriculum in existence for training in basic robotic surgical skills."
The lawsuits have been fueled by warning letters the FDA sent to Intuitive this summer for failing to notify regulators of problems. If true, the claims document a series of disturbing incidents, including a robotic hand that wouldn't let go of tissue grasped during surgery and a robotic arm hitting a patient in the face as she lay on the operating table.
One allegation that has been made repeatedly is that a defect, in the form of tiny cracks in the surgical arms of the robots, allow an electric current to pass outside of the surgical area, causing burns and cutting organs and blood vessels.
As a result of these lawsuits, a number of Connecticut law firms that represent plaintiffs in malpractice and personal injury lawsuits say they are researching the legal issues, in preparation to represent clients with similar claims.
The da Vinci robot has been on the market since the year 2000 and is used for operations that include removing prostates and gall bladders, performing hysterectomies and bypass surgeries, repairing heart valves, and transplanting organs.
Intuitive Surgical, the maker of the da Vinci robotic arm, received a warning letter July 17, 2013 from the FDA. FDA inspections in April and May found a number of deficiencies, including that the Sunnyvale, California-based company in some cases hadn't adequately reported device corrections and patient adverse events, according to a report dated May 30.
Safety and cost effectiveness of the company's da Vinci robot devices have been under scrutiny. Bloomberg News reported in February that U.S. regulators were surveying surgeons about the robots following a rise in adverse event reports that include as many as 70 deaths since 2009.
Tremont Sheldon Robinson Mahoney is actively investigating cases involving the da Vinci robotic arm in several Connecticut hospitals.
Excerpts from The Connecticut Law Tribune by Jay Stapleton; MSN