Law.com Subscribers SAVE 30%

Call 855-808-4530 or email [email protected] to receive your discount on a new subscription.

Managing Liability Risks from Robotic Surgery

By Kevin Quinley
September 26, 2012

The movie “Star Wars” and its progeny featured futuristic robots, like R2D2 and C3PO, whose almost human characteristics captured the imaginations of moviegoers worldwide. Fast-forward to 2012, where robotic technologies have evolved ' not so much in the image of Star Wars characters, but in ways equally as fantastic. A good deal of manufacturing is accomplished by robots. Generals now increasingly fight wars through robotic drones that fly overhead or crawl on the ground to neutralize IEDs. And robotic technology has entered the surgical suite.

Some herald the use of robots in the healthcare field as a logical next chapter in the unfolding story of medical innovation. Others decry the trend, fearing that it positions one more barrier between the physician/healer and suffering patients. Despite concerns, though, the robotic surgery genie is out of the proverbial bottle. In the summer of 2012, Intuitive Surgical, a manufacturer of medical robotics, reported that use of robotic surgery systems had surged by 26% in the second quarter of the year.

These developments have caught the attention of the personal injury bar, which is likely to focus robotic surgery litigation on many potential defendants and “deep pockets,” including: 1) Doctors and medical staffs conducting procedures on patients; 2) Hospitals where the medical procedures are undertaken; and 3) Manufacturers of robotic surgery equipment.

Touted advantages of robotic surgery include smaller incisions in the patient's body, smaller scars and, in many cases, accelerated patient recoveries. In addition, some surgeons believe that robotic arms provide practitioners with larger ranges of motion than are provided by the human hand. Other advantages of robotic surgery include the availability of three-dimensional views of the surgical field; up to 12-fold magnification; and smoother, more precise, control of surgical instruments. In addition, from an ergonomic standpoint, viewing surgical fields through eyeglasses is more comfortable and less fatiguing than standing hunched over a patient on an operating room table.

Potential Hazards

Robotic technology may spawn both medical malpractice and product liability exposures, claims and lawsuits. Suits and claims may arise from one area or both. Savvy plaintiffs may name the device manufacturer, the physician and professional medical staff.

Critics have warned that robotic surgery poses the following problems: 1) Doctors lose tactile sense and do not feel the tissues they are suturing, cutting or cauterizing; 2) Robotic surgeries often take more time, causing patients to be under anesthesia longer, with attendant risks and complications; and 3) Bedazzled by new gadgetry and striving to compete with other doctors and facilities, physicians and hospitals over-use the technology by venturing outside their comfort zones or using the equipment for procedures that they could as easily do laparoscopically.

Like any new technology, robotic surgery systems require practice before a doctor becomes proficient. No patient wants to feel like a test case for a doctor learning the ropes on robotic surgery. On the other hand, doctors cannot develop experience and proficiency on robotic surgery systems if they do not at some point operate on live patients.

None of the statistics or anecdotes necessarily show that robotic surgery is more hazardous than traditional surgery. All surgical procedures carry risks. Rather, tales of robotic surgery mishaps illustrate that liability perils from robotic surgery are not purely fanciful; they represent real risks, which practitioners, proactive legal counsel and medical facilities can manage.

Litigation Is Now in Progress

Plaintiffs have already filed individual and class action lawsuits over injuries allegedly caused by robotic surgery systems. This summer, plaintiffs unsuccessfully sought to consolidate individual lawsuits into Multi-District Litigation (MDL). Other lawsuits are “one-off” complaints, focusing on manufacturers. For example, in July 2012, Michigan patient Lawanda Salisbury sued the maker of a robotic surgery system. She had entered the hospital for a hysterectomy, opting for robotic surgery due to the touted benefits of a less invasive procedure and shorter recovery time. During surgery, however, the device's mono-polar scissors blade allegedly fragmented and was lost. The medical team then converted the procedure into an open abdominal hysterectomy. The doctor explored her body cavity to retrieve the half-centimeter blade fragment. www.aboutlawsuits.com/lawsuit-blades-off-robotic-surgery-da-vinci-30324/.

Among patients who file lawsuits involving robotic surgery devices, injury allegations commonly include internal burns, tears and complications therefrom. One risk, for example, is that electric current from the robotic arms can travel beyond the operative field. This could injure arteries, blood vessels, the bowel, bladder, ureter, vaginal cuff or other organs and tissues.

Plaintiffs accuse product manufacturers of over-promoting robotic surgery and of not conducting adequate post-market surveillance of injuries and complications. And while these allegations are lodged against manufacturers, litigation can ensnare physicians in claims that they were gullible in buying into, and being over-zealous early adopters of, new technology.

Theories of Liability and Discovery Concerns

There are particular challenges in gauging complication rates from robotic surgery and making hospital-to-hospital and doctor-to-doctor comparisons. Hospital peer-review regulations preserve physician confidentiality. This, combined with hospital nondisclosure, makes it hard to identify facilities with higher than normal complication rates from robotic surgery. These realities pose challenges not only for patients who want to comparison-shop based on outcomes, but also for attorneys bringing or defending liability actions rooted in robotic surgery as they try to gauge the standard of care and levels of complications.

Another argument defense attorneys can expect is that medical manufacturers seduce physicians and hospitals through overhyped marketing. Manufacturers may promote the technology as a way for hospitals to boost revenues and expand market share. For many surgeons ' including urologists ' proficiency and use of robotic surgery creates new marketing opportunities to tout state-of-the-art technologies that address various surgical needs. While understandable in a business sense, this plays into the hands of plaintiff attorneys who develop a trial theme of “profits over patients.”

Plaintiff liability theories frequently feature allegations of the following:

  • A manufacturer's, physician's and/or hospital's over-promotion of robotic surgery technology as a presumed panacea for the many dangers of surgery;
  • A manufacturer's and/or healthcare facility's failure to properly train physicians (no training, inadequate training, insufficient training, etc.);
  • A doctor's personal failure to adequately obtain training on this complex technology; and
  • A failure to warn doctors and patients of robotic surgery risks, leading to lack of informed consent from patients.

After asserting such theories, plaintiffs will proceed with a discovery strategy intended to buttress their allegations of negligence. Here are areas where physicians can anticipate examination and probing:

Patient selection. Some patients are not suited for robotic surgery; was this patient a suitable candidate? What is an appropriate patient profile, and did the doctor stray from that profile in opting for robotic surgery?

Informed consent. Did the doctor give the patient a “stock” informed consent, or was it customized to reflect the potential of the hazards and risks of robotic surgery? Was the informed consent merely handed to the patient to read and sign, with the comment, “Here's the form the lawyers say you have to sign”? Or did a medical professional sit down with the patient to review the form, explain risks and answer questions? As with other types of surgery, the more thorough the informed consent process is, the stronger the defense will be.

Training. Expect plaintiff attorneys to explore the amount and type of training that the doctor received. They will want dates, locations and the duration of the sessions. They will want to know who provided and sponsored the training. Production requests will include copies of training materials, handouts, slides, course syllabi, videos, DVDs, etc.

Doctor seasoning. As everyone is aware, proficiency takes time. Often, in acquiring new technical skills, one tends to be “bad” before becoming “good.” While the practice of medicine is no exception, there is little room in surgery for “beta testing” on live patients. One area of inquiry will be the number of times a doctor has used the robotic surgery system. Was the doctor still traveling up the learning curve, or was he or she deeply experienced?

These areas of expected focus provide a roadmap for where to concentrate risk management efforts.

Risk-Management Strategies

Knowing the likely areas of discovery in robotic surgery cases provides a weathervane for the direction of risk-management efforts. Risk-management strategies for robotic surgery will likely take several forms, the first and most obvious of which is insurance. Doctors and allied healthcare professionals may all want to procure medical malpractice insurance coverage to address claims and lawsuits arising from complications of robotic surgery.

Non-insurance contractual transfer is another option. Doctors may contractually shift financial responsibility to the makers of robotic surgery equipment. (Note: This would only shift the financial consequences, not the legal liability.) While manufacturers of the robotic surgery equipment might theoretically try to shift financial responsibility to doctors, marketing pressures to build brand loyalty and promote usage will likely stifle any such notions.

Finally, loss control offers the most fertile area for risk management. This includes efforts to improve patient safety and prevent errors and complications that could cause patient injuries. Since loss control is a cornerstone of risk management here, let us turn to some specific approaches in that realm.

Loss-Control Strategies

Investing in loss control will yield multiple dividends for physicians. Not only will it reduce the chances of adverse patient outcomes, it will enable practitioners to demonstrate to insurance underwriters that they have sound risk management programs. Being able to demonstrate this will allow physicians to position themselves as superior risks, so that they can command more favorable premiums and rates for medical malpractice coverage.

Components of a sound loss control program in the realm of robotic surgery should include:

Savvy patient selection. Patients who may not be suited for robotic surgery procedures include those who cannot withstand extended periods of being in extreme positions. Other possible non-candidates include patients with cardiovascular comorbidity, cerebrovascular disease, compromised pulmonary function, hypertension and glaucoma. Prem Kakar et al., “Robotic Invasion of Operation Theatre and Associated Anaesthetic Issues: A Review,” Indian J Anaesthesia, 2011, Jan-Feb; 55(1): 18-25.

A thorough, informed consent process with patients. This is key in any medical risk management program, but it takes on heightened importance with new therapies or technologies.

File documentation. This is a best practice in any medical risk management program. Since robotic surgery is relatively new, careful chart
documentation is of paramount importance. File documentation should include recordings of what was done or not done, what was said or not said. In robotic surgery as in other clinical realms, practitioners should heed the precept, “If it wasn't documented, it wasn't done.”

Physician seasoning in the use of the technology. This involves making sure that the practitioner has had sufficient training and experience in using robotic surgery equipment to attain a reliable level of proficiency.

These are pre-loss risk management techniques. Savvy practitioners will go further, though, to include steps at the post-loss phase, to mitigate potential claims. These include close post-surgical follow-up with patients, to gauge their conditions and their recoveries. They might also include swift action on cases of reported adverse patient outcomes.

Some observers estimate that it takes about 200 procedures to become proficient at robotic surgery and to reduce the odds of surgical complications. Much training falls to product manufacturers, which are understandably eager to get the technologies into hospitals. This may create implicit or explicit pressures for hurried training. For example, at one New Jersey hospital, physicians were deemed trained on the robot after two days of operating on pig and on human cadavers. Hospitals may need guidelines for when physicians can “fly solo” and perform robotic surgeries without supervision. Those guidelines may then be subject to attack by personal injury attorneys; having guidelines creates a blueprint for plaintiff attorneys to use in comparing what was done versus what the guidelines required. On the other hand, having no guidelines regarding robotic surgery competence exposes hospitals to other types of claims. As a result, while some may be reluctant to develop guidelines, having no guidelines may be more damning still.

Conclusion

Few studies have demonstrated statistically that robotic surgical outcomes consistently beat conventional or open surgery. Definitive conclusions must await further analysis. In late 2011, a San Antonio, TX-area physician began a national study to compare cystectomy success rates between the da Vinci surgical robot and conventional open surgery. Results may not be known for some time. If the findings show no appreciable benefit from robotic surgery or show higher complication rates, one can expect personal injury attorneys to seize upon this as fodder for pursuing medical malpractice claims.

The certainties of life do not fall exclusively into the realms of death and taxes. A third certainty is that any medical development touted as a breakthrough is likely to become a magnet for litigation and claims of safety risks for patients. The development of robotic surgical technologies and techniques creates new opportunities for patient treatment, but may also spawn concomitant risks. The good news is that these risks are manageable, using the techniques discussed herein.


Kevin M. Quinley, CPCU, ARM, a member of this newsletter's Board of Editors, is Principal of Quinley Risk Associates LLC, a risk management consulting firm. He can be reached at [email protected].

The movie “Star Wars” and its progeny featured futuristic robots, like R2D2 and C3PO, whose almost human characteristics captured the imaginations of moviegoers worldwide. Fast-forward to 2012, where robotic technologies have evolved ' not so much in the image of Star Wars characters, but in ways equally as fantastic. A good deal of manufacturing is accomplished by robots. Generals now increasingly fight wars through robotic drones that fly overhead or crawl on the ground to neutralize IEDs. And robotic technology has entered the surgical suite.

Some herald the use of robots in the healthcare field as a logical next chapter in the unfolding story of medical innovation. Others decry the trend, fearing that it positions one more barrier between the physician/healer and suffering patients. Despite concerns, though, the robotic surgery genie is out of the proverbial bottle. In the summer of 2012, Intuitive Surgical, a manufacturer of medical robotics, reported that use of robotic surgery systems had surged by 26% in the second quarter of the year.

These developments have caught the attention of the personal injury bar, which is likely to focus robotic surgery litigation on many potential defendants and “deep pockets,” including: 1) Doctors and medical staffs conducting procedures on patients; 2) Hospitals where the medical procedures are undertaken; and 3) Manufacturers of robotic surgery equipment.

Touted advantages of robotic surgery include smaller incisions in the patient's body, smaller scars and, in many cases, accelerated patient recoveries. In addition, some surgeons believe that robotic arms provide practitioners with larger ranges of motion than are provided by the human hand. Other advantages of robotic surgery include the availability of three-dimensional views of the surgical field; up to 12-fold magnification; and smoother, more precise, control of surgical instruments. In addition, from an ergonomic standpoint, viewing surgical fields through eyeglasses is more comfortable and less fatiguing than standing hunched over a patient on an operating room table.

Potential Hazards

Robotic technology may spawn both medical malpractice and product liability exposures, claims and lawsuits. Suits and claims may arise from one area or both. Savvy plaintiffs may name the device manufacturer, the physician and professional medical staff.

Critics have warned that robotic surgery poses the following problems: 1) Doctors lose tactile sense and do not feel the tissues they are suturing, cutting or cauterizing; 2) Robotic surgeries often take more time, causing patients to be under anesthesia longer, with attendant risks and complications; and 3) Bedazzled by new gadgetry and striving to compete with other doctors and facilities, physicians and hospitals over-use the technology by venturing outside their comfort zones or using the equipment for procedures that they could as easily do laparoscopically.

Like any new technology, robotic surgery systems require practice before a doctor becomes proficient. No patient wants to feel like a test case for a doctor learning the ropes on robotic surgery. On the other hand, doctors cannot develop experience and proficiency on robotic surgery systems if they do not at some point operate on live patients.

None of the statistics or anecdotes necessarily show that robotic surgery is more hazardous than traditional surgery. All surgical procedures carry risks. Rather, tales of robotic surgery mishaps illustrate that liability perils from robotic surgery are not purely fanciful; they represent real risks, which practitioners, proactive legal counsel and medical facilities can manage.

Litigation Is Now in Progress

Plaintiffs have already filed individual and class action lawsuits over injuries allegedly caused by robotic surgery systems. This summer, plaintiffs unsuccessfully sought to consolidate individual lawsuits into Multi-District Litigation (MDL). Other lawsuits are “one-off” complaints, focusing on manufacturers. For example, in July 2012, Michigan patient Lawanda Salisbury sued the maker of a robotic surgery system. She had entered the hospital for a hysterectomy, opting for robotic surgery due to the touted benefits of a less invasive procedure and shorter recovery time. During surgery, however, the device's mono-polar scissors blade allegedly fragmented and was lost. The medical team then converted the procedure into an open abdominal hysterectomy. The doctor explored her body cavity to retrieve the half-centimeter blade fragment. www.aboutlawsuits.com/lawsuit-blades-off-robotic-surgery-da-vinci-30324/.

Among patients who file lawsuits involving robotic surgery devices, injury allegations commonly include internal burns, tears and complications therefrom. One risk, for example, is that electric current from the robotic arms can travel beyond the operative field. This could injure arteries, blood vessels, the bowel, bladder, ureter, vaginal cuff or other organs and tissues.

Plaintiffs accuse product manufacturers of over-promoting robotic surgery and of not conducting adequate post-market surveillance of injuries and complications. And while these allegations are lodged against manufacturers, litigation can ensnare physicians in claims that they were gullible in buying into, and being over-zealous early adopters of, new technology.

Theories of Liability and Discovery Concerns

There are particular challenges in gauging complication rates from robotic surgery and making hospital-to-hospital and doctor-to-doctor comparisons. Hospital peer-review regulations preserve physician confidentiality. This, combined with hospital nondisclosure, makes it hard to identify facilities with higher than normal complication rates from robotic surgery. These realities pose challenges not only for patients who want to comparison-shop based on outcomes, but also for attorneys bringing or defending liability actions rooted in robotic surgery as they try to gauge the standard of care and levels of complications.

Another argument defense attorneys can expect is that medical manufacturers seduce physicians and hospitals through overhyped marketing. Manufacturers may promote the technology as a way for hospitals to boost revenues and expand market share. For many surgeons ' including urologists ' proficiency and use of robotic surgery creates new marketing opportunities to tout state-of-the-art technologies that address various surgical needs. While understandable in a business sense, this plays into the hands of plaintiff attorneys who develop a trial theme of “profits over patients.”

Plaintiff liability theories frequently feature allegations of the following:

  • A manufacturer's, physician's and/or hospital's over-promotion of robotic surgery technology as a presumed panacea for the many dangers of surgery;
  • A manufacturer's and/or healthcare facility's failure to properly train physicians (no training, inadequate training, insufficient training, etc.);
  • A doctor's personal failure to adequately obtain training on this complex technology; and
  • A failure to warn doctors and patients of robotic surgery risks, leading to lack of informed consent from patients.

After asserting such theories, plaintiffs will proceed with a discovery strategy intended to buttress their allegations of negligence. Here are areas where physicians can anticipate examination and probing:

Patient selection. Some patients are not suited for robotic surgery; was this patient a suitable candidate? What is an appropriate patient profile, and did the doctor stray from that profile in opting for robotic surgery?

Informed consent. Did the doctor give the patient a “stock” informed consent, or was it customized to reflect the potential of the hazards and risks of robotic surgery? Was the informed consent merely handed to the patient to read and sign, with the comment, “Here's the form the lawyers say you have to sign”? Or did a medical professional sit down with the patient to review the form, explain risks and answer questions? As with other types of surgery, the more thorough the informed consent process is, the stronger the defense will be.

Training. Expect plaintiff attorneys to explore the amount and type of training that the doctor received. They will want dates, locations and the duration of the sessions. They will want to know who provided and sponsored the training. Production requests will include copies of training materials, handouts, slides, course syllabi, videos, DVDs, etc.

Doctor seasoning. As everyone is aware, proficiency takes time. Often, in acquiring new technical skills, one tends to be “bad” before becoming “good.” While the practice of medicine is no exception, there is little room in surgery for “beta testing” on live patients. One area of inquiry will be the number of times a doctor has used the robotic surgery system. Was the doctor still traveling up the learning curve, or was he or she deeply experienced?

These areas of expected focus provide a roadmap for where to concentrate risk management efforts.

Risk-Management Strategies

Knowing the likely areas of discovery in robotic surgery cases provides a weathervane for the direction of risk-management efforts. Risk-management strategies for robotic surgery will likely take several forms, the first and most obvious of which is insurance. Doctors and allied healthcare professionals may all want to procure medical malpractice insurance coverage to address claims and lawsuits arising from complications of robotic surgery.

Non-insurance contractual transfer is another option. Doctors may contractually shift financial responsibility to the makers of robotic surgery equipment. (Note: This would only shift the financial consequences, not the legal liability.) While manufacturers of the robotic surgery equipment might theoretically try to shift financial responsibility to doctors, marketing pressures to build brand loyalty and promote usage will likely stifle any such notions.

Finally, loss control offers the most fertile area for risk management. This includes efforts to improve patient safety and prevent errors and complications that could cause patient injuries. Since loss control is a cornerstone of risk management here, let us turn to some specific approaches in that realm.

Loss-Control Strategies

Investing in loss control will yield multiple dividends for physicians. Not only will it reduce the chances of adverse patient outcomes, it will enable practitioners to demonstrate to insurance underwriters that they have sound risk management programs. Being able to demonstrate this will allow physicians to position themselves as superior risks, so that they can command more favorable premiums and rates for medical malpractice coverage.

Components of a sound loss control program in the realm of robotic surgery should include:

Savvy patient selection. Patients who may not be suited for robotic surgery procedures include those who cannot withstand extended periods of being in extreme positions. Other possible non-candidates include patients with cardiovascular comorbidity, cerebrovascular disease, compromised pulmonary function, hypertension and glaucoma. Prem Kakar et al., “Robotic Invasion of Operation Theatre and Associated Anaesthetic Issues: A Review,” Indian J Anaesthesia, 2011, Jan-Feb; 55(1): 18-25.

A thorough, informed consent process with patients. This is key in any medical risk management program, but it takes on heightened importance with new therapies or technologies.

File documentation. This is a best practice in any medical risk management program. Since robotic surgery is relatively new, careful chart
documentation is of paramount importance. File documentation should include recordings of what was done or not done, what was said or not said. In robotic surgery as in other clinical realms, practitioners should heed the precept, “If it wasn't documented, it wasn't done.”

Physician seasoning in the use of the technology. This involves making sure that the practitioner has had sufficient training and experience in using robotic surgery equipment to attain a reliable level of proficiency.

These are pre-loss risk management techniques. Savvy practitioners will go further, though, to include steps at the post-loss phase, to mitigate potential claims. These include close post-surgical follow-up with patients, to gauge their conditions and their recoveries. They might also include swift action on cases of reported adverse patient outcomes.

Some observers estimate that it takes about 200 procedures to become proficient at robotic surgery and to reduce the odds of surgical complications. Much training falls to product manufacturers, which are understandably eager to get the technologies into hospitals. This may create implicit or explicit pressures for hurried training. For example, at one New Jersey hospital, physicians were deemed trained on the robot after two days of operating on pig and on human cadavers. Hospitals may need guidelines for when physicians can “fly solo” and perform robotic surgeries without supervision. Those guidelines may then be subject to attack by personal injury attorneys; having guidelines creates a blueprint for plaintiff attorneys to use in comparing what was done versus what the guidelines required. On the other hand, having no guidelines regarding robotic surgery competence exposes hospitals to other types of claims. As a result, while some may be reluctant to develop guidelines, having no guidelines may be more damning still.

Conclusion

Few studies have demonstrated statistically that robotic surgical outcomes consistently beat conventional or open surgery. Definitive conclusions must await further analysis. In late 2011, a San Antonio, TX-area physician began a national study to compare cystectomy success rates between the da Vinci surgical robot and conventional open surgery. Results may not be known for some time. If the findings show no appreciable benefit from robotic surgery or show higher complication rates, one can expect personal injury attorneys to seize upon this as fodder for pursuing medical malpractice claims.

The certainties of life do not fall exclusively into the realms of death and taxes. A third certainty is that any medical development touted as a breakthrough is likely to become a magnet for litigation and claims of safety risks for patients. The development of robotic surgical technologies and techniques creates new opportunities for patient treatment, but may also spawn concomitant risks. The good news is that these risks are manageable, using the techniques discussed herein.


Kevin M. Quinley, CPCU, ARM, a member of this newsletter's Board of Editors, is Principal of Quinley Risk Associates LLC, a risk management consulting firm. He can be reached at [email protected].

This premium content is locked for Entertainment Law & Finance subscribers only

  • Stay current on the latest information, rulings, regulations, and trends
  • Includes practical, must-have information on copyrights, royalties, AI, and more
  • Tap into expert guidance from top entertainment lawyers and experts

For enterprise-wide or corporate acess, please contact Customer Service at [email protected] or 877-256-2473

Read These Next
Strategy vs. Tactics: Two Sides of a Difficult Coin Image

With each successive large-scale cyber attack, it is slowly becoming clear that ransomware attacks are targeting the critical infrastructure of the most powerful country on the planet. Understanding the strategy, and tactics of our opponents, as well as the strategy and the tactics we implement as a response are vital to victory.

'Huguenot LLC v. Megalith Capital Group Fund I, L.P.': A Tutorial On Contract Liability for Real Estate Purchasers Image

In June 2024, the First Department decided Huguenot LLC v. Megalith Capital Group Fund I, L.P., which resolved a question of liability for a group of condominium apartment buyers and in so doing, touched on a wide range of issues about how contracts can obligate purchasers of real property.

The Article 8 Opt In Image

The Article 8 opt-in election adds an additional layer of complexity to the already labyrinthine rules governing perfection of security interests under the UCC. A lender that is unaware of the nuances created by the opt in (may find its security interest vulnerable to being primed by another party that has taken steps to perfect in a superior manner under the circumstances.

CoStar Wins Injunction for Breach-of-Contract Damages In CRE Database Access Lawsuit Image

Latham & Watkins helped the largest U.S. commercial real estate research company prevail in a breach-of-contract dispute in District of Columbia federal court.

Fresh Filings Image

Notable recent court filings in entertainment law.