Can using emergent technology incur liability?

by
Susan H. Adelman, MD, FACS, Ann Arbor, MI,
and Angus M. McBryde, Jr., MD, FACS, Charleston, SC

Practicing surgeons continually learn to incorporate new and emerging technologies into their surgical practice following residency. They do so by participating in formal and informal continuing medical education (CME). However, along with the use of emergent technology there are a number of liability issues involved for the faculty, for the practicing surgeon, and for their organizations. There is also exposure for the product manufacturers /vendors in certain cases. Some current areas of interest are: laparoscopic techniques, laser applications, image-guided biopsy, telemedicine, specialty instrumentation and implants, and new techniques of all types.

Any entity (person or organization) who has responsibility at any time from inception to clinical application for a device and/or a technique can incur liability. These entities include:

• The surgeon who instructs and provides CME for a new device or technique.
• The entity that sponsors/endorses the formal or informal instruction about a new device or technique.
• The surgeon who introduces that technology into his or her clinical practice.
• The proctor and/or credentialing body that monitors the surgeon's early/initial efforts to implement that technique or use that device.
• The employing hospital, surgi-center, physician, or corporation.
• The patient's insurance carrier or health care plans.

Equipment and liability standards

National or state specialty societies, hospitals, or health plans all may set standards for equipment. Local standards (especially urban) are becoming less important due to the free flow of information and geographic provider overlap. New equipment and devices often need Food and Drug Administration (FDA) approval.

Liability increases when the equipment, device, or technique is used other than intended, as the FDA alleged in the case of the orthopaedic pedicle screw. Expensive litigation affecting the manufacturer, numerous societies, and individual surgeons resulted from the pedicle screw liability issues. More than 7,000 lawsuits related to the pedicle screw spinal instrumentation have been filed. Product liability can involve surgeons and surgical groups. Since 1993, a class action suit involving 3,000 claims led one manufacturer to settle for more than $100 million. Numerous vendors, societies, hospitals, and surgeons were released from the lawsuit by the terms of that settlement. Other manufacturers continue litigation. Even though always defensible, the orthopaedic spine industry along with numerous orthopaedic societies and surgeons have suffered a long, painful, and financially devastating battle. Insurance policies that theoretically can protect the surgeon, the vendor, or the society are important but may in themselves motivate litigation.

As Jim Heckman, MD, FACS, president of the American Academy of Orthopaedic Surgeons (AAOS) has noted, ``Those involved in teaching and sponsoring educational programs must clearly disclose their relationships with manufacturers and their role in developing any devices involved.''* FDA decisions in classifying device status are important to prevent similar liability issues in the future. So is the need to better define the relationship between educational course content and an objective assessment that the surgeon has mastered and can implement that content.

Among those who set standards are the Federal Communications Commission (FCC), the Federal Trade Commission (FTC) and, of course, the FDA. The FCC sets national standards for medical equipment and devices. The FDA develops nomenclature standards. The American College of Radiology and the National Electrical Manufacturers Association (NEMA) created the digital imaging and communications in medicine (DICOM) standard for interconnected diagnostic imaging systems.

In general, standards for medical devices and products have evolved more rapidly than have educational and performance standards for surgeons who perform new techniques or who use those devices that qualify as emergent technology.

Documentation of training

The medical profession now faces the need to standardize the teaching of new procedures, to reliably document that training, and to quantitate the proficiency of the surgeon to apply that training. Traditionally, multiformat courses from one to several days in duration are available at local, regional, and national venues. The hospital then has—through its administrative and medical staff—the obligation to require a period of proctoring before a surgeon obtains unrestricted hospital privileges to perform the new procedure. The American Medical Association (AMA) proposes documentation of one of the following levels of training: Level 1—verification of attendance; Level 2—verification of satisfactory completion of course objectives ("took a test''); Level 3—verification of "proctor readiness''; and Level 4—verification of physician competence to perform the procedure.

The American College of Surgeons (ACS) through its Committee on Emerging Surgical Technology and Education (CESTE) has been active in crystallizing guidelines for surgeons who introduce new technology into their practice. The ACS defines three levels of training: Level 1—verification of attendance; Level 2—verification of satisfactory completion of course objectives; and Level 3—instructor level.

In February 1998, the ACS Board of Regents approved recommendations for the College to provide voluntary verification to individual Fellows for the use of emerging new technological procedures and equipment, according to a set of general guidelines. The new technologies chosen for the verification process will be evaluated for the Board of Regents by CESTE. The criteria appropriate for verification, to be determined by a panel of experts, will include: (1) eligibility of applicants, based on previous training and experience; (2) education required; (3) the environment recommended for appropriate use of the subject technology; and (4) recommended techniques for ongoing assessment and for documenting that the surgeon has maintained current knowledge and skills in this technology.

The AMA and the ACS have not reached consensus. Both, however, would require that levels of training are identifiable and that these should be documented.

The ACS has previously published generic and specific statements that include: Statements on Emerging Surgical Technologies and Evaluation of Credentials (June 1994),1 Statement on Issues to be Considered Before New Surgical Technology Is Applied to the Care of Patients (September 1995),2 Approval of Courses in New Skills (March 1998),3 Verification by the American College of Surgeons for the Use of Emerging Technologies (May 1998),4 and Physician Qualifications for Stereotatic Breast Biopsy (May 1998).5

In ``Guidelines for evaluation of credentials of individuals for the purpose of awarding surgical privileges in new technologies,'' (which is contained in the ACS's June 1994 emerging surgical technologies statement) the ACS stipulates that the surgeon must complete and document a defined didactic and practical educational program in a new technology. Additionally:

• The surgeon must be a member in good standing of the department.
• The surgeon must be qualified, experienced, and knowledgeable in the management of the diseases for which the technology is applied.
• The qualifications of the surgeon to apply the new technology must be assessed by a surgeon who is qualified and experienced, and should result in a written recommendation to the department.

Maintenance of skills should be documented through periodic outcomes assessment and evaluation.

The ACS image-guided breast biopsy course faculty, for instance, is honing educational objectives and assessment tools to meet standards proposed for courses in new skills.

A joint statement with the American College of Radiology (ACR) has already been adopted related to image-guided breast biopsy (Physician Qualifications for Stereotactic Breast Biopsy [May, 1998]). The long-standing, successful Advanced Trauma Life Support|Pr (ATLS) course is the prototype CME course that has tested both cognitive and hands-on skills acquisition. This same validation of skills acquisition by observer is being increasingly applied to other ACS courses involving emergent technology.

Liability and CME

Legal liability is present whenever physicians are trained or their competence is verified. Medical societies and other accredited CME sponsors verify that a physician has obtained training through a CME program. This is analogous to a medical school or residency training program certifying that an individual has successfully completed a prescribed course of education. CME sponsors have liability exposure if representations are made in a negligent manner, such as verifying completion of the course without taking reasonable steps to ensure that this is true.

Proctoring/supervision

The AMA defines clinical proctoring as an objective evaluation of a physician's actual clinical competence by a monitor or proctor who represents the medical staff and is responsible to the medical staff. In contrast, clinical supervision is the imposition, usually subsequent to peer review, of significant consultation, oversight, and/or close monitoring of a physician holding clinical privileges when his or her competence, cognitive skills, and actual performance of procedural skills or outcomes are questionable.

This is an important distinction because the hospital must report any professional review action based on competence to the National Practitioner Data Bank (NPDB). If a proctor is assigned to a surgeon and is required to grant approval before certain medical care is administered, the hospital must report this action to the NPDB. If the proctor is not required to grant prior approval, this need not be reported, because the surgeon's privileges have not been restricted.

In Clark v Hoek (174 Cal App 3d, 219 Cal Rptr 845 [1st Dist 1985]) the patient sued a proctor who observed an attending orthopaedic surgeon, claiming that the proctor, having seen the attending surgeon's negligent conduct, owed the plaintiff the duty of taking over the surgery to prevent the malpractice. The court held as a matter of law that the proctor had no liability for the plaintiff's alleged injuries based on a variety of facts:

1. There was not a patient-physician relationship between the plaintiff and proctor.
2. The proctor had no contractual relationship with the patient or the physician he proctored.
3. He was not authorized to take control over the surgeons providing the care.
4. He did not create the situation in which the patient was injured.
5. His presence did not increase the peril.

The court further stated that the agreement to proctor was only an agreement to observe and report and that the proctor did not undertake to intervene in, supervise, or control the operation. The court rejected the theory that the proctor had responsibility for the quality of care provided by the individual he proctored. Finally, the court found that establishing liability for proctors would not be good public policy, and it recognized proctoring as a valuable aspect of peer review that should be protected. The court further held that the spirit of state laws extending confidentiality and immunity protection to good faith peer review would be violated if proctors were held to have a duty to patients whose care was being proctored. Due to its importance, this case has been cited in 25 subsequent suits.

In general, the Physicians Insurance Association of America (PIAA) has found that proctors are usually dropped before a suit comes to conclusion.

Laparoscopic surgery

The PIAA reports an average lag time of 21 months before a suit is filed, and an average of two to five years until a suit reaches a result; thus, many laparoscopic cases still have not reached a conclusion. Stereoscopic breast cases have not even appeared yet. Nevertheless, there have been a number of instructive cases following laparoscopic procedures.

The article, ``Litigious consequences of open and laparoscopic biliary surgical mishaps,'' reported 306 injuries or complications in 296 laparoscopic cholecystectomies.6 In comparison with 261 open cholecystectomy injuries, laparoscopic injuries were significantly more severe, more likely to result in indemnity, and had higher awards. Surprisingly, injury recognition at the time of the procedure had no mitigating effect. The authors' recommendations for risk avoidance included: attention to placement of first port; more liberal use of the Hasson technique; placement of other ports under direct vision; elimination of intraoperative anatomic uncertainty; programmed inspection of abdomen before withdrawing the scope; and safe use of electrocautery.

The PIAA Laparoscopic Procedure Study, published in May 1994, reported a high average morbidity for laparoscopic cholecystectomy, presumably reflecting the underlying number of bile duct injuries. Tubal ligation was the next commonest cause of claims. Gynecologic injuries often were related to an injured ureter. Lysis of adhesions caused a number of bowel burns or perforations, usually recognized by the end of the procedure, and usually in gynecologic procedures.

Diagnostic laparoscopy was the commonest cause of claims in general surgery. Those claims were usually for bowel perforations, more than half of which were not recognized prior to the conclusion of surgery. In 1994, half of the closed claims resulted in payments under $85,000, with a median of $34,000. Laparoscopic appendectomy was responsible for three claims from 1985 to 1992: two procedures injured the iliac artery and vein, both recognized, and one procedure resulted in infection and abscess.

Laparoscopic hernia was responsible for three claims by 1992; the injuries include a clipped femoral nerve, an unrecognized bladder perforation, and a punctured aorta resulting in death.

The PIAA study recommended the following for risk management:

• Document the indications in support of performance of the laparoscopic procedure.
• Obtain and document informed consent, including any potential complication.
• Document reasons for performing or not performing cholangiography.
• Evaluate for injuries or complications prior to the conclusion of the procedure.
• Closely monitor the patient in the recovery room.
• Promptly treat and document any complications.

Litigation

A Lexis search for cases subsequent to the PIAA study revealed no matches either for stereoscopic surgery or telemedicine. There were 162 matches for laparoscopic surgery/laparoscopy in all reported state and federal courts, 43 of which were since January 1, 1995. Of these, 12 did not appear to be related to the laparoscopy itself. Of the remaining 31 cases, 13 were in gynecologic procedures, 12 in laparoscopic cholecystectomy, one in a laparoscopic appendectomy, and five in diagnostic laparoscopy, mostly gynecologic.

The appendectomy resulted in a lacerated common iliac, which was repaired but later required a graft. The issue raised during the trial was whether or not a gynecologist should be admitted as an expert in general surgical laparoscopy, and whether or not the standard of care differs in general surgery.

The 12 cases of laparoscopic cholecystectomy included a number of known complications, such as one case of postoperative bleeding and subsequent death from sepsis, an unrecognized right hepatic duct injury, a missed duodenal laceration causing death, a readmission for a missed bowel perforation, and a laceration of a right iliac artery, which was repaired, after which a second perforation was found and repaired by a second surgeon. Other, more unusual, cases include the following:

• Sudden death occurred several days postoperatively, with an allegation that the surgeon concealed the patient's known coronary disease prior to the operation.
• While doing a laparoscopic cholecystectomy, the surgeon decided to repair a left inguinal hernia, injured the femoral nerve, and was sued for lack of consent.
• After a laparoscopic cholecystectomy accompanied by spillage of bile and stones, a schizophrenic patient was discharged the next day with instructions. When the patient was found dead at home two days later, the issue was whether the postoperative instructions were appropriate.
• In a laparoscopic cholecystectomy, a small bowel laceration was sustained, requiring reoperation. The issues included the hospital's vicarious liability and whether the surgeon's laparoscopy manuals should be considered learned treatises, thus admissible as evidence.
• In a laparoscopic cholecystectomy, the surgeon clipped the common bile duct, requiring reoperation. The surgeon had only performed one previous laparoscopic cholecystectomy, and that patient had died from a punctured common bile duct. The issue raised was of negligent credentialing, with the hospital at risk under respondeat superior.
• After discharge following a laparoscopic cholecystectomy, CO2 distended the patient's scrotum, causing massive swelling and deep vein thrombosis. The issues included lack of informed consent and inadequate discharge instructions.
• A surgeon injured the common bile duct while performing his first laparoscopic cholecystectomy on a patient, after taking a two-day class in which he practiced on three pigs. The issues were: the duty to disclose that he had never done one before, lack of informed consent, inadequate discharge instructions, and the duty to disclose that he had never performed this operation on a patient.

Finally, the accompanying table summarizes the recommendations for risk avoidance in laparoscopy.

Telemedicine/ultrasound

According to the PIAA the few telemedicine lawsuits to emerge so far have been related to failure to diagnose or to the electronic transfer of medical records. Many questions of liability, however, arise in the context of telemedicine and apply to the larger context of training in any new surgical skills and in proctoring, such as:

• What establishes the physician/patient relationship?
• When does a patient-physician relationship begin and end?
• What are the duties of referring and consulting physicians?
• Who is potentially liable for an incorrect diagnosis rendered through telemedicine?
• Are legal standards the same for telemedicine, telerobotic laparoscopic surgery, virtual reality, and telemedical education?
• What is the standard of care?
• Does enterprise liability apply?
• How is liability affected when there is a video record of the procedure?
• What should the patient be told (i.e. informed consent)?

The Michigan Physicians Medical Liability Company (MPMLC) reviewed claims from 1985 through 1997, finding 71 cases for which payments were made because of the improper use of ultrasound. Of these, 23 alleged an error in diagnosis, with an average indemnity of up to $250,000. Twenty-one cases alleged failure to recognize a complication. There were a total of 25 gynecologic cases.

No MPMLC claims were reported on telemedicine. A number of questions regarding liability, both generic and specific to telemedicine, may well arise eventually.

Summary

There are numerous areas of potential liability for the practicing surgeon attempting to upgrade skills and introduce emergent technology into his or her practice.

The College understands that graduate medical education in a teaching institution, continuing medical education at our College-sponsored venues, and all other sponsored or co-sponsored educational activities each carry risks and benefits. Current College activities are directed toward enhancing translation of emergent surgical technology into clinical practice as effectively, productively, safely, and as free of risk as possible.

Risk Avoidance Recommendations

Document the indications in support of performance of the laparoscopic procedure. Obtain and document informed consent, including any potential complication. Document the reasons for performing or not performing cholangiography. Pay attention to placement of first port. Use the Hasson technique more liberally. Place other ports under direct vision. Eliminate intraoperative anatomic uncertainty. Inspect abdomen for injuries or complications before withdrawing the scope. Use electrocautery safely. Monitor the patient closely in the recovery room. Promptly treat and document any complications.

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*Orthopaedics Today, 18(8), August 1998

This article on professional liability was generated through the efforts of the Committee on Professional Liability of the ACS Board of Regents. Members of the committee believe that this and other articles published in the Bulletin should stimulate thought and possible action on a wider spectrum of issues related to professional liability.

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References

1. American College of Surgeons: Statements on Emerging Surgical Technologies and the Evaluation of Credentials. Bull Am Coll Surg, 79(6):40-41, 1994.

2. American College of Surgeons: Statement on Issues to Be Considered Before New Surgical Technology Is Applied to the Care of Patients. Bull Am Coll Surg, 80(9):46-47, 1995.

3. American College of Surgeons: Approval of Courses in New Skills. Bull Am Coll Surg, 83(3):35-36, 1998.

4. American College of Surgeons: Verification by the American College of Surgeons for the Use of Emerging Technologies. Bull Am Coll Surg, 83(5):34-35, 1998.

5. American College of Surgeons: Physician Qualifications for Stereotactic Breast Biopsy: A Revised Statement. Bull Am Coll Surg, 83(5):30-33, 1998.

6. Chandler JG, Voyles CR, Floore TL, et al: Litigious consequences of open and laparoscopic biliary surgical mishaps. J Gastroint Surg, 1(2):138-145, 1997.

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Dr. Adelman, a member of the ACS Regental Committee on Professional Liability, is clinical associate professor of surgery, department of surgery, University of Michigan Medical Center, Ann Arbor, MI.

Dr. McBryde, a member of the ACS Committee on Emerging Surgical Technology and Education, is professor and chair, department of orthopaedics, Medical University of South Carolina, Charleston, SC.

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Bulletin of the American College of Surgeons
Vol.83, No.11, November 1998

Professional Liability

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