Heart surgery patients failed to prove that they were injured after Intuitive Surgical Inc.’s da Vinci surgical robot left metal fragments in their brains, said the Eleventh Circuit in upholding a District Court decision dismissing their case. The plaintiffs alleged that MRIs showed that metal fragments discharged from the robot’s surgical instruments, entered their bloodstreams and ended up in their brains. The complaint in Gabriel Fernando Nassar Cure v. Intuitive Surgical Inc. asserted that Intuitive designed, manufactured, marketed, and sold defective medical instruments that were used during surgeries at hospitals across the country.

In dismissing the case, the district court cited to Boyd v. Orkin Exterminating Co. The district court found that the injuries allegedly caused when Intuitive’s da Vinci surgical robot inadvertently sent bits of metal debris into the brains of patients were speculative, similar to injuries claimed due to toxic chemical exposure. The patients, however, argued the injury is similar to foreign object claims where objects left in the body constitute an injury. The plaintiffs asserted that their injuries are not speculative and that Intuitive designed and manufactured a defective instrument or instruments which caused them injury by improperly shedding metal fragments into their bodies during surgery. The patients alleged they have suffered physical, neurological, and mental impairments as a result of the metal shavings left in their brains following surgery.

On appeal, the plaintiffs argued that Boyd is about heptachlor epoxide, a chemical found in the general population and by contrast, metal is not normally found in the brain. The Eleventh Circuit panel held that the district court correctly compared the brain shavings case to toxic chemical exposure cases, thus the plaintiffs were required to prove more injury than the presence of the metal shavings in their brains. Finding the Boyd holding applied, the circuit court found that under Georgia law, the presence of metal shavings in the plaintiffs’ brains does not by itself constitute a legally recognizable injury. The patients also failed to outline what could go wrong from having the metal in their brains, and failed to indicate symptoms that could lead to future medical costs or lost work, according to the circuit court. The court found that the plaintiffs’ claims that they suffer from physical, neurological, and mental effects related to the metal in their brains constituted “vague, conclusory statements” and that plaintiffs failed to provide examples of symptoms. The court noted the lack of factual specificity about the medical effects of the alleged negligence claimed by the plaintiffs.

The plaintiffs discovered the metallic debris after undergoing mitral valve repair surgery by a cardiac surgeon. The metal fragments allegedly discharged from the robot’s surgical instruments entered into the patients’ bloodstreams and became lodged in their brains, as later shown in MRIs.

Intuitive Surgical issued a Field Safety Notice in April 2016 stating that the use of some of its instruments during cardiac surgery has been shown to increase the amount of microscopic metallic particulate. The notice indicated that as of the notice date, Intuitive had received reports of five post-da Vinci valve repair patients whose MRIs “may show artifacts consistent with the presence of metallic microemboli.” The notice indicated that metallic particulate not removed by flushing could potentially travel to the brain and possibly contribute to microemboli, pose a possible toxicological risk, or pose a risk to a patient during future MRIs.