When the Silicon Valley startup Intuitive Surgical went public 13 years ago, the company was posting $10 million in annual sales, and its little-known surgical robot had been used on just 600 patients worldwide.
Intuitive has since experienced the kind of meteoric growth cherished in the nation's high-tech hotbed, blossoming into a corporation with $610 million in sales of a product, the da Vinci Surgical System, which is considered one of the most coveted status symbols of 21st-century medicine. But along the way, scores of critics say, the company exhibited a baffling disregard for patient safety as it aggressively marketed machines that can cost up to $2.3 million each.
Intuitive is now facing at least 25 product liability lawsuits, and one attorney in the field confirmed that he personally has more than 1,000 potential clients who are claiming injuries from the device. While a Washington state jury cleared the company of liability last week in an initial case involving allegations that the company failed to properly train surgeons, scores of other cases are waiting in state and federal courts that contain wider allegations about defects in the surgical robots themselves.
“This company grew at a tremendous rate, and they were able to successfully create this aura of the robot that everyone fell in line with,” said malpractice attorney and obstetrician Dr. Francois Blaudeau. “We can't let a company from Sunnyvale, Calif., just walk in and change medicine that easily. There will be a lot of litigation, and some of it is going to carry over to the hospitals and the doctors. … They are not going to escape the blowback as more and more information comes out.”
Regulators have already taken note of the complaints. The Food and Drug Administration opened an inquiry this year into the safety of the da Vinci system following numerous adverse event reports. Massachusetts and New Hampshire are also investigating safety concerns stemming from an increasing number of patient complications.
This month the company published an urgent medical device warning of a potential flaw in one of the components of the system that can cause tissue burns inside patients. Hospital officials across the country are now reconsidering their rules for which patients are right for robotic surgery.