Robots holding the scalpel

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Medical Negligence

May 2012, Volume 48, No. 5

Robots holding the scalpel 

J. Douglas Peters

As surgeons and hospitals turn to robotic surgery, these systems will become a factor in more medical malpractice cases. Although cases involving robotic surgery resemble other malpractice suits, there are several unique considerations you must keep in mind.

Although there have been many breakthroughs in surgical technology throughout history, one thing has remained constant: The surgeon’s hands were the most important tools. Now, however, we may be witnessing the dawn of a new age of medicine, as more surgeons are relying on robotic hands during procedures.

With robotic surgical systems (RSS), the lead surgeon sits at a site remote from the patient and directs the robotic hands using hand and foot controls. Currently, the systems are typically used only in minimally invasive surgeries, as opposed to large-incision open surgeries. Between 2000, when the first robotic surgery was performed, and November 2011, almost 1 million people were operated on using robotic systems, including about 350,000 in 2011 alone.1 This growing number is still a small part of the total number of surgeries performed, but the significant increase makes RSS a must-watch technology.

RSS are so new that patients, doctors, hospitals, insurers, manufacturers, and the FDA are still trying to determine their efficacy and risks. Much will be answered by ongoing controlled clinical studies trying to determine when robotic surgery works better than open procedures or laparoscopy, as well as the relative costs of each. Until more is known, trial lawyers bringing medical malpractice suits involving robotic surgery must be aware of special considerations and liability issues.

You must be able to knowledgeably query witnesses as to the strengths and limitations of the RSS used in the client’s procedure. Different RSS have varying numbers of arms, attachments, and capabilities, and you must understand what components make up the specific system used in your client’s case. Generally, the surgeon sits at a console—typically in the operating room, although the technology would allow for off-site locations—looking into a hooded screen that presents images obtained with an endoscopic camera placed inside the patient’s body through a small incision. The console is equipped with master manipulators, or “hands,” that the surgeon uses to control the movements of the corresponding manipulators that perform the procedure.

There are many benefits of robotic surgery. Proponents contend that patients are safer because a surgeon seated at a console is more ergonomically comfortable than standing at the patient’s side, and the computer is not subject to tremors, unlike the surgeon’s hands in open or laparoscopic surgery. The systems have 3-D views and higher magnification than traditional surgical loupes. The improved visualization allows a more precise dissection and, as a result, less blood loss and lower transfusion rates. Manufacturers and surgeons also claim, without strong empirical support, that robotic surgery is associated with shorter hospital stays and decreased use of pain medication.

Unlike traditional laparoscopic systems, where the picture on the video monitor is inverted and the surgeon moves the instrument in the opposite direction from the desired target on the monitor, the image is not inverted. Advocates of RSS claim the inverted image, ridged tools, and other drawbacks of laparoscopic surgery create a longer and steeper learning curve than robotic surgery for the same procedure.2 Advocates also say that the robotic arms, wrists, and hands articulate like human hands, as opposed to the fixed non-articulating tools used for the past 90 years in traditional laparoscopy.

There is a financial component as well: Expensive robotic procedures are profitable for hospitals. Proponents of RSS predict that in the future, a single surgeon will be able to perform the entire surgery without assistance, reducing the hospital’s labor costs.3 If this happens, there will no longer be a second set of eyes looking down on the patient at the operative table.

Proving liability

As with any emerging field, robotic surgery brings new challenges that patients, and even surgeons, might not know about. Although pretrial investigation in cases involving robotic surgery is the same as in many other areas of medical malpractice, you must be aware of unique details.

Standard of care. The appropriate standard of care in this new field has not been fully established. Until it is, analogies to open or laparoscopic techniques on the same procedure offer the best analytical support for expert witnesses. Some injuries associated with RSS may be unacceptable, no matter the type of surgery. Such injuries define a breach of any standard of care, regardless of the techniques or tools used. As with any other type of medical malpractice, a highly qualified and experienced surgery expert witness will provide opinions that may or may not make sense to jurors.

There is little in the published medical literature about robotic surgery patient-selection standards. Some medical authors suggest that robotic surgery might be too risky for patients with a history of significant cardiovascular morbidity, cerebrovascular disease, poor pulmonary function, pulmonary hypertension, or glaucoma.4 Many of the risks—including compartment syndrome, cardiac arrest, increased risk of blood loss, and stroke—are caused by the longer anesthesia and operative times involved in robotic surgeries, which may be more dangerous for patients with those conditions. Other than these considerations, because both laparoscopy and robotic surgery involve minimally invasive surgery, any patient who is an appropriate candidate for laparoscopy could be an appropriate candidate for robotics.

Carefully read through the medical research to determine whether your client’s preexisting condition was contraindicated for robotic surgery. Make sure to highlight this issue during depositions and trial testimony.

Informed consent. Because robotic surgery is so young and has little supporting data, the standard of disclosure of the risks and benefits that hospitals must provide each patient is fluid and evolving. Some have argued that in situations where a procedure is novel or a practitioner is unfamiliar with it, the duty to disclose all relevant information exists.5

During discovery, it is imperative to request production of all informed consents. Ask whether the surgeon advised the patient that robotic surgeries are relatively new procedures and discussed the surgery’s risks and limitations and the operating surgeon’s experience. Use interrogatories to find out how many RSS procedures the surgeon had performed as lead surgeon before your client’s surgery, especially those involving the same RSS used in your case. Ask how often the surgeon’s practice has had to switch to an open or laparoscopic procedure during surgeries similar to your client’s—which usually happens only when something goes wrong and adds time and risk to the operation—and what the morbidity and mortality rates are for both the surgeon and hospital for similar robotic surgeries. Did the surgeon pre¬sent this information to your client when obtaining consent?

Learning curve. Every new technology carries a learning curve. The surgeon’s performance on the first procedure is more likely to produce adverse events than on the 100th procedure. Medical professionals have said it could take at least 200 and up to 700 robotic-assisted surgeries for a surgeon to become highly proficient.6

Find out the number of operations the surgeon has performed as lead surgeon and gather opinions on how many procedures similar to your client’s should be performed before competence can be presumed. It is also important to distinguish the role the surgeon played—lead or assistant—in the number of procedures performed. More broadly, ask the number of robotic surgeries performed at the hospital each year and how many different surgeons performed them, and identify those surgeons.

The RSS manufacturer typically provides offsite training to each surgeon, assistant surgeon, and operation team member. Because hospitals credential the providers, they will be the malpractice defendants if patient-plaintiffs prove inadequate training of surgeons and operating room staff in the use of RSS.7 Interrogatories to the defendant hospital should seek copies of all credentialing guidelines applicable to the granting of RSS privileges to surgeons and support staff.

At deposition, you should thoroughly explore how much training each member of the surgical team received, and where and when it occurred. Ask them what written training materials they were given and who provided them. Have they reviewed any of these materials in preparation for their deposition? Has the manufacturer provided bulletins for service or changes to setup instructions? What types of mechanical failures were they taught to anticipate? Try to secure copies of the hospital’s RSS training manuals, films, videos, DVDs, other training materials, and protocols.

It is always important to compare the training levels of the surgeon and staff with the information provided to the patient in the informed consent period. For example, was the patient advised before surgery that members of the surgical team had performed a limited number of these surgical procedures?

Sometimes the type of injury—such as damage to collateral organs and structures, excessive bleeding, an unexpectedly long surgical time, or conversion to a laparoscopic or open procedure—indicate errors due to learning curve and lack of experience.

Longer surgical time. Because it is difficult to reposition the patient once the robotic arms and instrumentation are placed in the incision, or “port,” robotic surgery often results in longer surgical times. This may cause complications, including patient-positioning injuries, such as compartment syndrome; the need for blood transfusions; neuromuscular injuries; breakdown of muscle fiber into the bloodstream; and increased anesthesia risks, such as cardiac complications.8

Knowing the potential injuries associated with longer surgeries helps attorneys recognize viable claims. You should consult your experts and the medical literature to learn the expected time range for a given procedure and ask the defendants about it in depositions.

As robotic surgeries grow in popularity, average surgical times should shorten and time ranges will become more established for each procedure. Understanding these ranges is key to recognizing outliers. Until the surgical times are comparable to those of laparoscopy or open procedures, injuries caused by prolonged surgical times will be hard for juries to accept unless robotic surgery is superior in efficacy.

Open conversions. Open conversions indicate that something unplanned happened because conversion from robotic to open procedure is so difficult. Open conversions also extend the procedure’s time, increase the need for more blood, and increase anesthesia and prolonged-positioning risks. One study found that open conversions were prompted by technical fault with the RSS, uncontrolled intraoperative bleeding, suspected nerve injury, and in one case, poor patient selection.9

In any case where there has been a conversion to an open procedure, ask all witnesses why the open conversion was needed and which member of the surgical team timed the conversion effort.

Machine setup. As a surgeon confronts a learning curve, so do the support staff in setting up the RSS for new or infrequent applications.10 An improper setup may cause the instruments to clash or be unable to reach the complete operative field.11 You should identify the members of the setup team. Ask how long they had been working with this specific piece of equipment and with each other as a team.

Although there is some information in the medical literature to suggest how many incision ports are required in different procedures and where they should be positioned, there is no set standard, and there is variation based on physician preference.12 Four or five ports are common for each surgery.13

If the ports are positioned in the wrong place or the robotic arms are not placed properly in the ports, the arms and the instruments they hold may not be able to perform optimally. This could require a time-consuming new setup or conversion to a laparoscopic or open procedure.

Because the operative chart usually does not have a diagram showing port positions, you should always photograph your client’s body, highlighting the scars with black marker so that a photograph can be used at deposition to ask about the positioning of the incisions and what instrumentation was placed through them if this is relevant to the case.

An experienced setup team is also imperative for proper placement of the mechanical arms. Minor misplacement of the trocars, or operating arms, away from ideal positions may hinder the operation. It’s important to ask the surgeon at deposition whether the arms were properly placed and, if not, whether their misplacement hindered his or her performance as a surgeon. Did the lead surgeon supervise or approve the cart installation, port positioning, and mechanical arm settings?

Keeping in mind that earlier RSS had fewer arms, you should also ask which particular system was used, as some have three arms and some have four. The evolutionary increase in the number of arms seems to suggest that the more arms, the better. In a case discussed in the medical literature, a shortage of robotic arms made it difficult to manage a bleeding episode with only two operating instruments. This forced a conversion to an open procedure.14

Finally, remember to investigate whether there is also a products liability aspect to your case, if only to rule out and prevent a surprise empty-chair defense at trial. If the machine broke or had computer-programming errors during the operation, the surgeon most likely recorded that in the operative report and would be forthcoming about it during deposition. Keep in mind that many manufacturers rely on the learned-intermediary doctrine to immunize themselves.

No one knows how many cases involving robotic surgeries will be brought when the technology becomes more common. It will depend on the outcome of studies on safety and efficacy and whether third-party payers will resist the dispersion of this emerging technology. During the next decade, informed trial lawyers will play an important role in monitoring the rush to disseminate RSS. Individual cases will encourage manufacturers and the government to standardize training and gather and critically analyze data. Although medical malpractice cases involving robotics are similar to typical malpractice suits, the success of your case might hinge on understanding how they are different.

J. Douglas Peters is a shareholder with Charfoos & Christensen in Detroit and an adjunct associate professor in the Department of Family Medicine at Wayne State University School of Medicine in Detroit. He can be reached at jdpeters@c2law.com.

Notes:

  1. Richard A. Marini, Robot’s Surgical Artistry vs. Art of Surgeon’s Skill, San Antonio Express-News (Nov. 22, 2011).
  2. Tamas J. Vidovszky et al., Robotic Cholecystectomy: Learning Curve, Advantages, and Limitations, 136 J. Surgical Research 172, 175–76 (2006).
  3. Id. at 172.
  4. Seee.g. Prem N. Kakar et al., Robotic Invasion of Operation Theatre and Associated Anaesthetic Issues: A Review, 55 Indian J. Anaesthesia 18, 21 (2011) (citing Jason E. Felger et al., Robotic Cardiac Valve Surgery: Transcending the Technologic Crevasse!, 16 Current Op. Cardiology 146 (2001)).
  5. See Bernard M. Dickens, Robotic Surgery in Canadian Law, 14 Clinical Risk 182 (Sept. 2008).
  6. See John Carreyrou, Surgical Robot Examined in Injuries, Wall St. J. (May 4, 2010); Gina Kolata, ResultsUnproven, Robotic Surgery Wins Converts, N.Y. Times (Feb. 13, 2010).
  7. Hospitals have been held liable for lack of training of technical staff. See e.g. Berg v. U.S., 806 F.2d 978, 982 (10th Cir. 1986); Strickland v. Community Health Sys., Inc., 2005 WL 210 WL 2105974 (W.D. La. 2005).
  8. See Rafael Ferreira Coelho et al., Prevention and Management of Complications During Robotic-Assisted Laparoscopic Radical Prostatectomy, in Robotic Urological Surgery 231, 232–37 (Vipul R. Patel ed., 2d ed., Springer 2012); see also Bernard M. Rocco et al., Evidence-Based Critical Analysis of Robotic Prostatectomy Outcomes, in Robotic Urological Surgery, supra at 61, 63–70.
  9. Khalid H. Sait, Early Experience With the daVinci® Surgical System Robot in Gynecological Surgery at King Abdulaziz University Hospital, 3 Intl. J. Women’s Health 219, 221 (2011).
  10. Pier Cristoforo Giulianotti et al., Robotics in General Surgery: Personal Experience in a Large Community Hospital, 138 Archives Surgery 777, 782–84 (2003); see also Vidovszky et al., supra n. 2.
  11. Id. at 783.
  12. Seeid. at 782–83.
  13. See Giulianotti et al., supra n. 10, at tbls. 1 & 2, 781.
  14. See Francesco Corcione et al., Advantages and Limits of Robot-Assisted Laparoscopic Surgery, 19 Surgical Endoscopy 117–19 (2004).


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