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August 31, 2021 - Robotically assisted surgical devices (RASD) are one type of computer-assisted surgical systems. RASD have become popularized in recent years and are now commonly used by health practitioners to perform a variety of different surgical procedures. The precision and minimal invasiveness offered by these devices make them attractive to health practitioners and patients, but like all products, RASDs are not flawless and generally not regulated by any singular government agency.
The U.S. Food and Drug Administration (FDA) cleared RASDs for use in laparoscopic surgical procedures in general surgery, cardiac, colorectal, gynecologic, head and neck, thoracic and urologic. The FDA does not supervise or credential physician training, however. That role is assumed by manufacturers, physicians, and health care facilities. Some professional societies and specialty board certification organizations have developed and support training for RASD specialty physicians. Specialty boards also maintain RASD specialty physician certification status.
RASDs have been the subject of increased litigation due to alleged defects in the manufacturing or design, as well as the failure by health care facilities and practitioners to properly maintain and operate the devices. A variety of causes of action are available to plaintiffs in these matters, including strict products liability, negligence, corporate negligence, medical malpractice, and breach of warranty.
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A common element of each cause of action applicable to RASD litigation is causation, and a trend in RASD litigation is the difficulty plaintiffs experience in establishing causation. Understanding the various causes of action applicable to RASD litigation and the nature of the causation problem is critical to parties prosecuting and defending these matters.
The element of causation, linking the wrongdoing of a defendant to the harm incurred by the plaintiff, is an essential element to every RASD cause of action. In fact, the causation element is the most frequently contested issue at the summary judgment stage in RASD case law. Causation, in broad terms, refers to two critical and related components: actual cause and proximate cause. Actual cause is the simpler concept that merely connects the injury to the cause-in-fact; e.g., a scalpel nicked tissue, causing injury. Proximate causation is the more difficult aspect to establish, as it is the primary cause of injury: e.g., what caused the scalpel to nick the tissue?
To establish causation, a plaintiff generally must prove that the defect, design, warning, maintenance or use of the robotic device proximately caused the injury. The failure of a plaintiff to establish causation is fatal to their cause of action. Although causation is generally held to be a question of fact appropriate for a jury to determine, defendants have effectively established the lack of causation as grounds for summary judgment. Certain key issues have been addressed by courts in the struggle of litigants to establish or eliminate the causation element.
Causation involving complex medical devices has been most typically established through the use of expert witnesses. Where a jury is expected to consider complex medical or scientific issues beyond the scope of the common person's knowledge, expert testimony is favored and the lack of expert testimony can be fatal to a plaintiff's causation requirement. In addition to it being proffered at the trial stage, plaintiffs often present expert testimony at the summary judgment stage to overcome defensive arguments regarding the lack of causation.
In Mraceck v. Bryn Mawr Hosp., a 2010 case in the 3rd U.S. Circuit Court of Appeals, the plaintiff filed a strict products liability lawsuit arising from an RASD prostatectomy surgery. Plaintiff alleged the RASD malfunctioned and displayed an "error" screen, which the surgery team was unable to resolve. The surgeon opted to finish surgery without the RASD. Shortly after surgery, plaintiff began experiencing symptoms, which he attributed to the malfunction of the RASD.
The device manufacturer defendant sought summary judgment, arguing the plaintiff failed to submit expert testimony and could not establish the RASD caused his injuries. Summary judgment was granted and affirmed at the appellate level because the plaintiff had not created an issue of fact for a jury to resolve regarding the causal link between his injuries and the RASD.
While expert testimony may not be required in all RASD cases, plaintiffs opting to proceed without expert testimony are ideal summary judgment targets for defendants on the causation issue.
Because it is difficult to prove a defect and causation in RASD cases, plaintiffs try to employ the res ipsa loquitur theory. Under res ipsa loquitur, an inference that the defendant was negligent is created if the plaintiff can establish:
(1) the product was under the exclusive control of the defendant;
(2) the plaintiff did not contribute to the incident; and
(3) the incident resulting in the injury does not normally occur without negligence on the part of the party in control of the product.
Res ipsa loquitur has been disfavored in RASD cases. In Brown v. Griffin, a 2016 Kentucky Court of Appeals case, the appellate court affirmed summary judgment in favor of a surgeon in a medical malpractice action arising from an RASD hysterectomy. The plaintiff argued res ipsa loquitur should apply because the surgeon testified about his relative inexperience with the RASD, from which she argued a jury could infer the surgeon's "newness" in the use of RASD contributed to her injury. The trial and appellate courts rejected this argument, holding jurors do not have general knowledge sufficient to understand the complex nature of RASD surgeries, complications, and mechanisms by which injury or complications occur.
A causation issue arises in these cases where certain aspects of a procedure were performed using an RASD and while certain aspects were performed without using an RASD. The plaintiff bears the burden of establishing that the RASD component of surgery caused injury as opposed to the non-RASD aspect.
In Mohler v. St. Luke's Medical Center, LP, a 2008 Arizona Court of Appeals case, the plaintiff underwent a laparoscopic surgery at the defendant's medical center. The attending surgeon performed part of the surgery using a RASD and the other part without. Plaintiff's small intestine was perforated during surgery.
In his lawsuit, the plaintiff alleged the medical center negligently failed to ensure the surgeon was properly credentialed to operate the RASD, causing his injuries. The trial court granted summary judgment, finding the plaintiff was unable to establish the failure to ensure credentialing or even the uses of RASD caused his injuries. The Court of Appeals disagreed and found that issues of fact existed for a jury to decide; namely, whether the perforation occurred during the use of the RASD.
While RASDs are becoming more common in the practice of health care, it cannot be said that layperson knowledge of these devices has increased proportionally. Because the use of these devices remains heavily specialized, courts will continue to defer to expert testimony and strict causation requirements without allowing causation inferences or more relaxed proof requirements available in more commonplace cases. Counsel on both sides of litigation should expect causation to continue to be the primary point of contention in RASD cases.