Intuitive Surgical off the hook in erectile dysfunction lawsuit

February 2, 2010 by MassDevice staff

A federal appeals court clears Intuitive Surgical Inc. in a case involving a malfunction of one of its da Vinci surgical robots during a prostatectomy.

A federal appeals court cleared Intuitive Surgical Inc. (NSDQ:ISRG) of any liability in a lawsuit alleging that one of its malfunctioning da Vinci surgical robots caused a Pennsylvania man's erectile dysfunction.

Roland Mracek sued Intuitive after undergoing a prostatectomy at Bryn Mawr hospital in June 2005. During the surgery, the da Vinci robot went on the fritz and displayed error messages; after his surgical team and an Intuitive rep couldn't make the robot work, surgeons performed a traditional laparoscopic prostatectomy, according to court documents. A week later Mracek suffered an episode of gross hematuria (visible blood in the urine) and later developed severe groin pain and erectile dysfunction.

The U.S Court of Appeals for the Third Circuit's three-judge panel upheld the U.S. District Court for Eastern Pennsylvania's March 2009 decision that Mracek failed to prove that the robot's malfunction caused his injury.

"Most importantly, there is no record evidence that would permit a jury to infer Mracek's erectile dysfunction and groin pain were caused by the robot's alleged malfunction," the judges wrote. "The District Court held that Mracek did not offer any evidence to eliminate reasonable, secondary causes for the malfunction of the robot or to demonstrate that the malfunction caused his injury. Mracek contends that the Court erred in so holding because he would offer his own testimony and testimony from two treating physicians, including the surgeon who performed the procedure and his urologist who would testify about his pre- and post-operative condition. Although he did not submit any expert reports, Mracek argues that it was unnecessary to do so because his treating physicians were not retained in anticipation of litigation, and because the alleged defect is obvious and easily understood by a jury given that the robot displayed 'error' messages and was unable to complete the surgery."

Even Mracek's urologist didn't make the link between the robot's malfunction and his injury, according to court documents, calling his prostatectomy "very successful."