Plaintiffs who have filed da Vinci robot lawsuits against manufacturer Intuitive Surgical claim the company failed to provide adequate warnings about the health risks associated with the advanced technology. Now, it seems these claims are having an effect, as the company recently reported a drop in sales for the second quarter of 2013.
According to a report in Bloomberg, Intuitive’s stock fell by 16 percent at the close of trading on July 9, 2013”the largest single-day drop since 2008. Sales have also slowed from about $229 million in the second quarter of 2012 to about $215 million in the second quarter of 2013. The company blames the drop on shrinking healthcare budgets, with hospitals taking a more cautious approach to spending. A new da Vinci surgical system costs between $1 million and $2.3 million.
Critics, however, say the controversy surrounding da Vinci robot injuries hasn’t helped sales.
Injuries Associated with da Vinci
The FDA approved the da Vinci robot in 2000 for use in certain types of surgeries, including prostatectomies, hysterectomies, gall bladder removals, and bladder surgery, among others. The device consists of four robotic arms and a high-tech console where the surgeon controls the movements of the components. Company advertising materials state surgery with the da Vinci produces less blood loss, less pain, less scarring, and a lower rate of complications.
Post-marketing complaints, however, describe injuries like lacerated or perforated organs, surgical burns, torn blood vessels, severe bowel injuries, vaginal cuff dehiscence, and more. In March 2013, Bloomberg reported that robosurgery was connected to at least 70 deaths since 2009.
Growing Number of Complications
On April 30, 2013, Medscape Medical News reported that a spike in the number of adverse event reports associate with the da Vinci prompted the FDA to survey surgeons about their experience with robot-assisted surgery. In some of the reports, surgeons had accidentally punctured bladders, severed nerves and blood vessels, and caused other harm when using the robotic arms and various tools attached to them. In other cases, the robot seemed to cause damage on its own, requiring a total system shutdown.
The number of adverse event reports related to the da Vinci increased 34 percent from 2011 to 2012. In March 2013, the American College of Obstetricians and Gynecologists stated that robotic surgery is not the only or the best minimally invasive approach for hysterectomy. Nor is it the most cost-efficient. The Massachusetts Board of Registration in Medicine also issued an advisory on robotic-assisted surgery in response to a growing number of reported complications.
On May 30, the FDA issued an inspection report faulting Intuitive Surgical for failing to report measures it took to guard patients from accidental electrical burns. They also stated in the report that the company failed to report some illnesses or injuries that had occurred with use of the device. The company responded that it has fixed these problems.
Nearly 30 da Vinci Lawsuits
According to their sales report, Intuitive Surgical expects to bring in a net income of $160 million in 2013, with a total revenue of $575 million. That compares to predictions of about $178 million in net income and a total revenue of $630 million. Intuitive faces at least 26 lawsuits filed by plaintiffs alleging injuries from the da Vinci surgical system.