Principle of robotic surgery litigation in the United States

Although robotic surgery has been available in the United States for almost a decade, ¹ only a single reported case of litigation after a robotic surgical misadventure exists in the literature. ² This, of course, does not mean that unhappy patients forego legal redress; because they do. Rather, the paucity of published robotic surgery litigation cases can be traced to three factors. First, because litigation after robotic surgery does not employ any novel legal theories, the litigation does not attract media attention. ³ Second, because such litigation often involves two legal actions proceeding in parallel (a medical malpractice action [against the surgeon and the hospital]) and a products liability action [against the robotic manufacturer]) the litigation frequently degenerates into a ‘finger-pointing’ case that is settled. ⁴ Third, settled litigation in the United States almost always contains a confidentiality clause that limits further publicity.

This article, which is intended for a foreign audience, reviews the basic anatomy of the litigation process that would likely follow an adverse robotic surgical outcome in the United States. The first part of this article reviews the key elements of medical malpractice and products liability actions. The second part of this article discusses metadata. ⁵ Until recently metadata was a subject known only to computer geeks. However, in an increasingly digital world, metadata is functionally an audit trail of how a computer was used. ⁶ It is therefore anticipated that metadata will become an important factor in robotic surgery litigation. Finally, the third part of this paper examines how and why a medical malpractice action can be used to fuel a larger medical malpractice action and/or a products liability action. This article concludes that because of the money at stake, litigation after an adverse robotic surgical outcome will continue to be a big business in America; but the liability of the robotic manufacturer is likely to be minimized by metadata.

Medical malpractice versus products liability

During a 2002 prostatic robotic surgical operation, a patient sustained a fatal iatrogenic injury to his abdominal aorta. During the ensuing investigation, questions were raised regarding the surgeon's training in robotic surgery and whether the robotic instrument was functioning properly. The robotic surgical instrument manufacturer conducted an on-site evaluation of its product and concluded that the robot was operating properly. After a lawsuit was filed, the surgeon settled the case for his policy limits (US$1 million); and the hospital entered into a confidential settlement with the family for an undisclosed amount. Although the robotic manufacturer was initially considered a Defendant, the Claimant let the manufacturer out of the case for tactical and technical reasons.

Robotic medical malpractice

This case with a surgeon, a hospital and a medical device manufacturer as Defendants is typical of healthcare litigation in America when a patient is injured by a medical device. While some of the Defendants, like the product manufacturer, may eventually be dismissed from the case, this does not make the litigation against those Defendants frivolous. Rather the reason that Claimants' attorneys name so many Defendants is to minimize the use of the ‘empty chair’ defence. The basic idea of an empty chair strategy is for all the named Defendants to blame the adverse outcome on the unnamed Defendant. If the jury believes this rationalization they are likely to return a verdict for the defence. This strategy even aides the unnamed Defendant to avoid liability because the statute of limitation for naming additional Defendants has usually run before the Claimant can have the unnamed Defendant served.

In the above reported case, the Claimant's legal action involved a medical malpractice action against the surgeon and hospital, and a products liability action against the robotics manufacturer. Like any tort case in America, to prevail in a medical malpractice action a Claimant must prove, by the preponderance of the evidence, that: (1) the providers (surgeon and hospital) had a duty to care; (2) the providers deviated from the standard of care; (3) the deviation from the standard of care caused the patient harm; and (4) the patient sustained objective damages. Because the Claimant's relationships with the surgeon and the hospital are different; the Claimant will usually use a different legal liability theory on each Defendant. Against the doctor, the Claimant will usually allege that the surgeon failed to provide the level of care that a reasonably prudent surgeon would have used under the same or similar circumstance. In the above case, the surgeon would have had a hard time explaining to a jury how a prudent surgeon injured the aorta during a prostate operation. So, it is not surprising that the surgeon settled the case at his policy limits.

Against the hospital the Claimant may advance a number of liability theories, but perhaps the most common theories against the hospital are: the negligent hiring and supervision of the robotic surgeon; and the failure to maintain the robotic surgical instrument in proper working order. When a surgeon is admitted to a hospital's medical staff, the hospital must credential the surgeon. The purpose of this credentialing process is to determine what procedures a surgeon is capable of performing safely based on the surgeon's training and prior experience. When a hospital credentials a surgeon it is, in essence, certifying that the surgeon can safely perform a procedure.

In the United States, few surgeons have received formal residency training in robotic surgery. Whether taking a weekend course in robotic surgery that provides operating experience on a pig (or other animal) is adequate training is a separate issue that a hospital must consider when it grants a surgeon privileges to use a robotic surgical instrument. However, after an adverse robotic surgery event, it is not hard to imagine that a jury might conclude that a hospital negligently granted a surgeon privileges to perform robotic surgery when the surgeon's only training in this field was limited to a single weekend course taken in Hawaii.

The second legal theory for imposing liability against a hospital after an adverse robotic surgical outcome concerns how well the hospital maintained the surgical instrument. A hospital must maintain a complex surgical instrument (like a robot) to the same extent that a reasonably prudent hospital would maintain a similar instrument under similar circumstances. At a minimum this standard means that hospital must maintain a robotic surgical instrument to the extent called for in the manufacturer's recommendations. Because compliance with a manufacturer's recommendations can be expensive, it is to be expected that some hospitals will be tempted to skimp on robotic maintenance. For example, routine use of a robotic surgical instrument consumes several high-priced disposable instruments. If it were discovered that these disposable instruments were not replaced as recommended by the manufacturer, a jury might conclude that the hospital had negligently maintained the surgical robot.

Products liability

When a medical device is not properly maintained, the device is abused. Medical device abuse is important because it is an affirmative defence available to a manufacturer in a products liability action. In America, manufacturers can be held liable for the harm caused by their products under a number of legal theories that are collectively referred to as products liability. In general, all of these theories have three basic elements: (1) the product contained a defect; (2) the defect caused harm; and (3) the intended user sustained a foreseeable and objective harm. However, if the manufacturer can demonstrate that the product was abused or otherwise underwent substantial postproduction modifications, a Claimant's products liability claim will be substantially undermined. This fact explains why, in the reported robotic surgery litigation, the robot's manufacturer conducted an on-site evaluation of the robotic surgical instrument.

Metadata

In the reported robotic surgery litigation case, the focus of the manufacturer's on-site investigation was almost certainly the metadata within the robotic instrument. Metadata, commonly defined as ‘data about data’, is information that is necessary to run a computer or a robotic surgical instrument. For example, consider what happens when you are on the Internet and you hit the ‘back’ icon. Unlike a human, the computer cannot actually ‘remember’ the last website visited. On the other hand, by consulting the metadata generated during the course of its normal operation, a computer can identify the last website that was visited. That is to say, metadata is functionally an audit trail of how a computer has been used.

Metadata comes in two forms. ⁷ System metadata is a mark made on e-file by a computer to show who has used it, and when it was used. When a surgeon logs on to a robotic surgical instrument, the robot's metadata captures the surgeon's name and the time of the log-on. In essence, system metadata is a ‘digital fingerprint’ that every surgeon leaves behind on a robotic surgical instrument. In contrast, application metadata is a record of how a user manipulated an e-file. Perhaps the most well-known form of application metadata is Microsoft Word's ‘track changes’ feature. Normally, when this feature is switched on, the computer displays alterations made to the file.

Metadata will become increasingly important in robotic surgery litigation for three reasons. First, as many attorneys are ignorant about the scope of potential information that can be found in metadata, the stage is set for surprise at trial. Second, a robotic surgical instrument's metadata can potentially alter the course of litigation. ⁸ The reason is that the robot's metadata may potentially contain important information concerning how the instrument was maintained, whether it was working properly or whether the operator ignored a warning message.

Third, metadata is stored automatically and surgeons, like their attorneys, are unaware of the treasure trove of information in a robot's metadata. So, many surgeons who have steadfastly refused to record and preserve the intraoperative video of their cases are likely to be surprised at the metadata inferences that can be drawn about their surgical abilities. For example, if a surgeon overrides a warning message during an operation, that action may be recorded in the robot's metadata where, to the surgeon's chagrin, it may later be discovered.

With proper analysis, a robotic manufacturer can determine whether the instrument was abused. If a robotic instrument's metadata suggests that robot had been abused, the robot's manufacturer will likely set up a finger-pointing defence to shift blame for any surgical misadventure onto the surgeon and/or the hospital. If a robotic instrument's metadata suggests that the robot did malfunction, the robot's manufacturer will likely set up an alternative products liability defence (such as federal pre-emption of products liability laws ⁹ ).

Maximizing an injured patient's recovery

As a general rule, multiple Defendants are all losers in finger-pointing cases. The reason is that the finger-pointing defence usually leads to a settlement. Not knowing who to blame when a jury encounters a worthy plaintiff who has been injured by a medical device, the jury will often apportion blame to all of the Defendants. This observation of the behavior of American juries suggests that robotic surgery misadventures are likely to attack the attention of Claimants' attorneys. In the healthcare field a finger-pointing case is highly desirable because such cases tend to result in the maximal net recovery of money from the Defendants without having to deal with the vagaries of how a jury will decide a case.

In addition, money collected from the settlement with the weakest Defendant can be used as leverage against the more formidable Defendants. ¹⁰ In robotic surgery litigation the weakest Defendant is the surgeon. If there is any potential that a surgeon's liability will exceed his or her policy limits, the surgeon will almost always instruct his or her insurer to settle the case at the policy limits. By settling the case, the surgeon avoids exposing any personal assets to honor any judgment in excess of the policy limits; and is likely reason that the surgeon in the report case opted to settle.

The Claimant will then take this settlement money and use it to fund a lawsuit against the hospital and/or robotic surgical instrument manufacturer. In the United States, suing hospitals and medical device manufacturers is desirable because both of these business organizations are considered ‘deep pockets’. Unlike surgeons, hospitals and medical device manufacturers are not subject to any damage caps. Indeed, when you read about a multimillion dollar settlement after a surgical misadventure in the United States, there is almost always a deep-pocket Defendant like a hospital or robotic surgical manufacturer involved. ¹¹

Conclusion

Robotic surgical litigation does occur in the United States. Many of these cases are for garden variety negligence; such as when a patient sustains an injury because someone in the operating room bumps into the surgeon or robotic instrument. As these cases involve no novel legal theories and are frequently settled under confidentiality clauses, robotic surgical litigation has thus far attracted little media attention. Still, as the number of robotic surgical sites increase and more operation are robotic surgical operations are performed, lawsuits against the robotic surgical manufacturers and the hospitals are expected to increase.

In the past, complex medical device cases often settle because they degenerated into finger-pointing cases where the surgeon, the hospital and the medical device manufacturer all made contributions to the Claimant. However, the presence of metadata within the robotic instrument may contain sufficient details of the robot's use to demonstrate that the manufacturer was without fault; or else provide the manufacturer with an affirmative defence (like abuse). Thus, it is not reasonable to think that someday surgeons and hospitals will be exposed for the entire liability associated with robotic surgical instruments.