Intuitive Surgical faces dozens of product liability lawsuits brought on behalf of individuals throughout the United States who have suffered complications following da Vinci robotic surgery, but the makers of the surgical robot have actually entered into “tolling agreements” in many more cases, allowing individuals to hold off on filing complaints while the cases are evaluated and possible da Vinci lawsuit settlements are considered.
The da Vinci Surgical System is a complex robot that has been heavily marketed and increasingly used in recent years for a number of surgical procedures to provide a less invasive surgery, which reduces recovery time. The device is controlled by a surgeon looking at a virtual reality representation of the patient’s internal organs and manipulating its four metal arms with hand and foot controls.
Since it was introduced in 2000, use of the da Vinci robot-assisted surgical system has increased dramatically throughout the United States amid aggressive marketing and promotions by the manufacturer, Intuitive Surgical. However, concerns have also emerged about the risk internal injuries and death, leading the FDA to launch a probe earlier this year into the safety of the da Vinci surgical robot.
In a recent SEC filing, Intuitive Surgical indicated that the company has been named in at least 26 individual da Vinci robotic surgery lawsuits filed on behalf of individuals who have suffered personal injuries or death due to alleged problems with the design of the device and training provided to surgeons.
However, the manufacturer reports that it has entered into agreements with certain law firms, allowing the parties to hold off on filing cases in the court system.
Tolling Agreement with da Vinci Robotic Surgery Lawyers
While Intuitive Surgical has maintained that it intends to vigorously defend lawsuits that are brought, information released in the SEC filing suggests that the manufacturer is considering potential settlement agreements and establishing an “orderly process for evaluating claims before they result in costly litigation.”
The company points out that in recent months a number of product liability lawyers are advertising for da Vinci surgery claims, soliciting clients who have undergone robotic surgery with the da Vinci Surgical System and died or suffered an injury.
“The Company has seen a substantial increase in these claims, however, it has only received detailed information regarding a small number of them. In an effort to provide an orderly process for evaluating claims before they result in costly litigation, we have entered into tolling agreements with certain plaintiff’s counsel acting on behalf of such claimants,” stated Intuitive Surgical in the disclosure. “The tolling agreements provide the parties and their legal counsel with additional time to evaluate the claims, to explore whether the claims have merit and whether they can be resolved without litigation.”
The tolling agreements allow additional time for individuals to file suit, delaying the statute of limitations for a period of three to six months, in exchange for an agreement that if any lawsuit is filed it will be brought in agreed upon courts.
First da Vinci Wrongful Death Trial Underway in Washington
The report comes as the first da Vinci lawsuit trial began last week in Washington state court, involving a wrongful death lawsuit brought by the family of a man who died due to complications following da Vinci robot surgery.
The family of Fred Taylor allege he died due to complications following a robotic prostatectomy in 2008, which resulted in multiple complications, including kidney damage, lung damage, incontinence, sepsis, and a stroke. The lawsuit specifically attacks the marketing and training provided by Intuitive, arguing that Intuitive Surgical provided poor instructions and information about the risk of complications.
Last week, Intuitive’s director of marketing, Ryan Rhodes, admitted during testimony that Intuitive Surgical marketed the da Vinci to physicians who were less skilled in traditional laparoscopic surgery, such as prostate removals. A document to sales representatives for the company called on them to spend 80 percent of their clinical time targeting these less-skilled surgeons.
In recent years, the da Vinci Surgical System has gained widespread use at hospitals throughout the United States, amid agressive marketing and direct-to-consumer promotion designed to encourage patients to seek out robotic surgery, even though lawsuits and medical literature suggest that there are no long-term benefits.
Many doctors and hospitals have reported feeling pressured to have the device to stay competitive with other facilities that offer it. However, given the high costs associated with the surgical robot, the facilities are then in a position where they were pressured to start using it as often as possible to make up for the costs.
Concerns have been raised by state health officials in Massachusetts about the adequacy of robotic surgery training and patient selection.
Amid the mounting concerns, Intuitive Surgical’s first quarter earnings released this month were higher than expected. However, the company indicated that it is seeing a slowdown in sales, and lowered its expectations slightly for 2013, saying it expects the number of procedures to come in at the lower end of its earlier projections.