Plaintiffs Gabriel Fernando Nassar Cure & Alan M. Kozarsky both underwent heart surgery. Apparently, the equipment used in the procedures for both patients left behind metal shavings which wound up in their brains. The patients brought a medical malpractice claim, which was dismissed by a District Court and then brought to the U.S. Court of Appeals Eleventh District. Both courts found that the plaintiffs failed to prove their case that Intuitive Surgical Inc.'s da Vinci surgical robot, which was used in both the operations, led to their injuries.
An MRI suggested that metal shavings (fragments) reached the patient's bloodstreams and traveled to their brains. Intuitive Surgical is the designer, manufacturer, and seller of these products used in many U.S. hospitals. In dismissing the claims, the case of Boyd v. Orkin Exterminating was referenced, which was a similar type of case where the victims claimed to have been exposed to toxic chemicals.
In Boyd, the parents of two children claimed the exterminating company improperly used a termite product when working at their home. The plaintiff stated that the children incurred injuries from the error based on toxic exposure. Tests indicated that the children had elevated levels of heptachlor epoxide in their blood, yet had no specific injuries that could be determined. The Supreme Court found that simply asserting that an injury exists without further factual support does not suffice in proving that an injury actually occurred.
When reviewing Boyd, the court found that (in this case) simply the mere presence of metal particles in the brain does not constitute an injury. The plaintiffs claimed to have physical, psychological and neurological problems. They also explained that they will have to cope with long-term medical costs to treat these problems and future losses in wages. The patients disagreed with the court's findings that the injuries are speculative.
The court found that the plaintiff's injury claims were “vague” and were not accompanied by specific symptoms. The court felt the plaintiffs did not truly explain the potential negative results for having the fragments in the brain.
Intuitive Surgical released a Field Safety Notice in 2016 explaining that their product has the potential to increase the volume of microscopic metallic particles when used in cardiac procedures. Intuitive claims that five cases were reported showing MRI evidence that metallic microemboli were present in patients who underwent similar surgery. The notice further explained that if this metallic particulate is not removed it is capable of traveling to the brain and could potentially pose a toxicological risk.
Georgia law requires that negligence claims prove four specific factors:
- That a legal duty to provide reasonable care existed
- That the duty of care was breached
- An injury resulted from the breach
- The cause of injury is attributed to the breach