2395 COPYRIGHT © 2005 BY THE JOURNAL OF BONE AND JOINT SURGERY, INCORPORATED The Medical-Legal Aspects of Informed Consent in Orthopaedic Surgery BY TIMOTHY BHATTACHARYYA, MD, HOWARD YEON, MD, JD, AND MITCHEL B. HARRIS, MD Investigation performed at Medical Professional Mutual Insurance Company (ProMutual), and Risk Management Foundation, Boston, Massachusetts Background: Orthopaedic surgeons routinely obtain informed consent prior to surgery. Legally adequate informed consent requires a thorough discussion of treatment options and risks and proper documentation; however, there is little data to guide orthopaedic surgeons regarding effective methods of obtaining informed consent. Methods: We performed a closed claims analysis on malpractice claims involving an allegation of inadequate informed consent brought during a twenty-four-year period with two malpractice insurers. Relevant malpractice claims were reviewed, and data were abstracted. We then performed statistical analyses to identify factors that positively correlated with a successful defense. Results: We identified twenty-eight lawsuits that included a claim of inadequate informed consent. All of the cases involved elective orthopaedic surgical procedures; there were no emergent cases. Three cases involved a disputed surgical site; all three cases involved foot and ankle surgery and resulted in an indemnity payment. Documentation of appropriate informed consent in the office notes of the surgeon was associated with a decreased indemnity risk (p < 0.005). Obtaining the informed consent on the hospital ward or in the preoperative holding area was associated with an increased indemnity risk (p < 0.004). When informed consent was obtained in the office by the operating surgeon, the risk of malpractice payment was significantly decreased (p < 0.004). Conclusions: Surgeons may be able to decrease the risk of a malpractice claim by obtaining informed consent in their offices, rather than in the preoperative holding area, and by documenting the informed consent discussion within their dictated office or operative notes. T he ongoing malpractice crisis continues to endanger physicians’ ability to practice medicine1. In order to practice medicine in an increasingly litigious environment, orthopaedic surgeons must gain expertise in the relevant legal aspects of their profession. Prior to every surgical procedure, surgeons are required to obtain informed consent. Informed consent embodies the communication between surgeon and patient in which the patient learns of the risks and benefits of a proposed procedure and decides whether to proceed. While orthopaedic surgeons obtain informed consent on a regular basis, there is very little data to guide them regarding effective methods of obtaining and documenting this essential communication2. Closed claims analysis is one analytical method that can be applied to complex legal issues3,4. In closed claims analysis, clinicians review the malpractice claims of an insurance company to identify factors that are associated with higher indemnity payments or with a successful defense. We conducted a closed claims analysis of malpractice claims involving in- formed consent with the hypothesis that written documentation of informed consent would be associated with decreased indemnity risk. Methods ata on closed claims involving orthopaedic surgeons from two large malpractice insurers from a single state over a twenty-four-year period (January 1, 1980, to May 31, 2004) were reviewed electronically for cases containing allegations involving informed consent. The database encompasses all of the malpractice claims filed with the insurers that reach either a settlement or a verdict; pending cases were not included. The cases are prospectively coded into the database, and there is a distinct code for “inadequate informed consent.” Twenty-eight claims involving twenty-eight surgeons and twenty-eight patients were found. The insurance company files containing medical records, depositions, and other work product were reviewed. In order to protect confidentiality, a prospective data D 2396 THE JOUR NAL OF BONE & JOINT SURGER Y · JBJS.ORG VO L U M E 87-A · N U M B E R 11 · N O VE M B E R 2005 T H E M E D I C A L -L E G A L A S P E C T S IN OR THOPAEDIC SURGER Y OF INFORMED CONSENT ➤ TABLE I Data on the Cases Case Sex, Age Diagnosis Procedure Subspecialty 1 M, 22 Lumbar burst fracture L4 corpectomy and arthrodesis Spine 2 M, 21 Knee instability Anterior cruciate ligament reconstruction Sports 3 F, 57 Carpal tunnel syndrome; ulnar sided wrist pain Carpal tunnel release and ulna resection Hand 4 F, 53 Neuromuscular foot; hammertoes Distal interphalangeal resection arthroplasty of second toe Foot and ankle 5 F, 42 Posterior cruciate ligament tear Posterior cruciate ligament reconstruction Sports 6 F, 76 Bilateral bunion deformity Exostectomy of bilateral bunions Foot and ankle 7 M, 26 Medial meniscal tear Arthroscopy with anterior cruciate ligament repair Sports 8 F, 26 DeQuervain tenosynovitis Tendon release Hand 9 F, 27 Hammertoe deformities Resectional arthroplasty of the proximal interphalangeal joint in toes 2-5 Foot and ankle 10 M, 40 C5-C6 myelopathy Cervical corpectomy and fusion Spine 11 M, 33 Tibial plateau fracture Open reduction and internal fixation of tibial plateau Trauma 12 F, 60 Kienbock disease Lunate excision and space placement Hand 13 F, 46 Congenital kyphoscoliosis Anterior thoracic release followed by posterior arthrodesis Spine 14 M, 44 L5 spondylolisthesis L4-S1 spinal arthrodesis with pedicle screws Spine 15 F, 56 Hand cyst Cyst removal Hand 16 M, 39 Locked knee Arthroscopy with arthrotomy medial meniscectomy Sports 17 F, 39 Radiculopathy Anterior cervical discectomy and fusion Spine 18 F, 52 Rotator cuff syndrome Open acromioplasty Sports 19 M, 69 Acetabular fracture Total hip arthroplasty Arthroplasty 20 F, 63 Osteonecrosis of the hip Total hip arthroplasty Arthroplasty 21 F, 60 22 M, 31 Failed total knee arthroplasty Revision total knee arthroplasty Arthroplasty Back pain Lumbar arthrodesis Spine 23 24 F, 28 Anterior knee pain Fulkerson osteotomy Sports F, 30 Pelvic instability Symphysis arthrodesis Trauma 25 F, 71 Back pain Lumbar arthrodesis Spine 26 M, 70 Back pain Laminectomy Spine 27 M, 76 Low back pain Epidural steroid injection Spine 28 F, 49 Hallux rigidus Arthrodesis of first metatarsophalangeal joint Foot and ankle *NA = not available. sheet was constructed. Information collected included demographic data on the patients and surgeons, clinical details regarding the patients’ diagnosis and procedure, clinical outcome information, data on the legal strategy of the plaintiffs and defendants, and data on the legal outcome. Data were also collected on where and when the informed consent was obtained, how it was documented, and who obtained the con- sent. Experienced legal analysts extracted the data from the files. A synopsis of the testimony of each expert witness was also produced. When available, the actual written consents were stripped of identifying information and reviewed. The datasheets were reviewed by one orthopaedic surgeon (T.B.), and the data were entered into an SPSS database (version 10.0; SPSS, Chicago, Illinois) for statistical analysis. 2397 THE JOUR NAL OF BONE & JOINT SURGER Y · JBJS.ORG VO L U M E 87-A · N U M B E R 11 · N O VE M B E R 2005 T H E M E D I C A L -L E G A L A S P E C T S IN OR THOPAEDIC SURGER Y OF INFORMED CONSENT TABLE I (continued) Written Consent Who Obtained Consent? Consent by Surgeon in Office* Documentation of Consent in Notes Outcome Total Expense Total Case Indemnity Yes Resident No No Settlement with payment $157,638.00 $3,100,000.00 Yes Operating surgeon Yes Yes Settlement with payment $107,503.00 $406,000.00 Yes Operating surgeon No No Settlement with payment $8,646.00 $200,000.00 Yes Operating surgeon No No Settlement with payment $15,822.00 $165,000.00 Yes Resident No Yes Settlement with payment $12,900.00 $1,220.00 Yes Resident No No Verdict for plaintiff $26,891.29 $94,527.00 Yes Operating surgeon No No Settlement with payment $8,524.00 $60,000.00 Yes Operating surgeon No No Settlement with payment $15,330.00 $54,000.00 Yes Another surgeon No No Settlement with payment $24,909.00 $45,000.00 Yes Nurse practitioner No No Settlement with payment $875,000.00 $26,068.00 Yes Operating surgeon No Yes Verdict for defendant $59,881.00 $0.00 Yes Operating surgeon Yes No Verdict for defendant $109,175.00 $0.00 Yes Operating surgeon, resident No Yes Verdict for defendant $28,877.00 $0.00 No No written consent NA Yes Dismissed $14,337.00 $0.00 No No written consent NA Yes Dismissed $4,829.00 $0.00 Yes Operating surgeon Yes Yes Dismissed $6,846.00 $0.00 Yes Operating surgeon Yes Yes Dismissed $18,451.00 $0.00 Yes Operating surgeon Yes Yes Dismissed $3,651.00 $0.00 Yes Operating surgeon Yes Yes Dismissed $116.00 $0.00 Yes Operating surgeon Yes Yes Dismissed $2,775.92 $0.00 Yes Operating surgeon Yes Yes Dismissed $11,960.00 $0.00 Yes Operating surgeon Yes Yes Dismissed $75,000.00 $0.00 Yes Operating surgeon Yes Yes Dismissed $50,000.00 $0.00 Yes Operating surgeon Yes Yes Dismissed $3,003.00 $0.00 Yes Operating surgeon Yes Yes Dismissed $3,927.00 $0.00 Yes Operating surgeon Yes Yes Dismissed $4,762.00 $0.00 Yes Operating surgeon No No Dismissed $10,464.00 $0.00 Yes Resident No Yes Dismissed $4,740.00 $0.00 Categorical variables were analyzed with the Pearson chisquare test or the Fisher exact test. Results Epidemiology f the 30,504 closed claims in the combined databases, 1810 (5.9%) involved orthopaedic surgeons. Twenty-eight claims O involving twenty-eight cases with an allegation of inadequate informed consent were identified. The insurers provided coverage for an average of 494 orthopaedic surgeons per year. The majority were community-based orthopaedic surgeons. Thus, the rate of malpractice claims involving informed consent can be estimated as 0.0024 claims per year of practice per surgeon. On the basis of this rate, a group of twenty orthopaedic sur- 2398 THE JOUR NAL OF BONE & JOINT SURGER Y · JBJS.ORG VO L U M E 87-A · N U M B E R 11 · N O VE M B E R 2005 geons practicing for thirty years each could anticipate approximately one malpractice claim involving informed consent for the entire group. Descriptive Data Summary information on the twenty-eight cases is shown in Table I. All of the cases involved elective orthopaedic surgery. There were no emergent cases. The cases were from a variety of orthopaedic subspecialties. The average age of the patients was forty-six years. Twenty-four of the twenty-eight patients were white with at least a high-school education, which is consistent with previous studies noting that patients of higher socioeconomic status are more likely to file a malpractice claim5. The average time from the surgical procedure to the filing of a malpractice claim was 3.1 years. The average time from the filing of a claim to the settlement or verdict was 3.1 years. All of the orthopaedic surgeons had been in practice for a minimum of three years. The average age of the surgeons was forty years. The majority (64%) were board-certified in orthopaedic surgery. The legal outcome of the claims is summarized in Table II. Fifteen claims were dismissed by the courts. Three claims went to trial and had judgment in favor of the defense. One claim resulted in a jury verdict for the plaintiff. The remaining nine cases were settled with an indemnity payment. Thus, eighteen of the twenty-eight claims were resolved in favor of the defendant, and ten of the twenty-eight were resolved in favor of the plaintiff. The 36% rate of indemnity payment is slightly higher than the 30% rate of indemnity payment seen in all orthopaedic malpractice suits6. Patient Allegations In twenty-eight cases, the plaintiffs alleged a lack of informed consent. Fifteen plaintiffs alleged that the underlying orthopaedic condition was not adequately described. Five plaintiffs alleged that the natural history of the condition without intervention was not discussed. Thirteen plaintiffs alleged that they experienced a complication that had not been described preoperatively, and twenty plaintiffs alleged that all of the risks of the procedure had not been described. Only one patient alleged that they were incapable of giving informed consent (an alleged language barrier; the surgeon’s TABLE II Summary of Legal Outcomes for the Twenty-eight Cases Legal Result Dismissed No. (%) of Cases 15 (54) Settled without an indemnity payment 0 Settled with an indemnity payment 9 (32) Verdict for plaintiff 1 (4) Verdict for defense 3 (11) T H E M E D I C A L -L E G A L A S P E C T S IN OR THOPAEDIC SURGER Y OF INFORMED CONSENT notes documented that an interpreter was present). Twenty-six plaintiffs alleged negligence and a failure to adhere to the standard of care. In general, the allegation of a lack of informed consent was part of a number of allegations constituting negligence. Only one patient alleged battery; the case was dismissed very early on in the process. With the numbers available, no particular plaintiff strategy was associated with an indemnity payment. Surgical Site Three cases could best be described as a dispute involving the surgical site. All three involved foot and ankle surgery. In one case, the hospital chart described a unilateral bunion procedure, the surgeon’s notes described a unilateral procedure, and the written consent documented a bilateral procedure. A bilateral procedure was performed. The patient sustained a complication on the foot that had been operated on second, and the case resulted in an indemnity payment of $94,527. In another case, there was a discrepancy between the notes and the consent regarding which hammertoe (e.g., the third or the fifth toe) was to have the operation; the case resulted in an indemnity payment. In the third case, the consent was for the correction of two hammertoes. Intraoperatively, the surgeon thought that two additional toes should be corrected as well, for cosmetic reasons. The patient sustained a poor result with chronic pain. The malpractice claim was settled with an indemnity payment. In total, all three cases involving a dispute about the surgical site resulted in an indemnity payment to the plaintiff that averaged $101,000. Informed Consent Documentation In twenty-six of the twenty-eight cases, a written consent for the procedure, including the patient’s signature, was obtained. In two cases in which no written consent for the procedure was obtained, the surgeons’ notes documented that a discussion of the risks and benefits had taken place. It is of note that neither case resulted in an indemnity payment. Of the twenty-six cases with written consent, twenty had documentation that the operating surgeon had obtained the consent. In five cases, the informed consent was obtained by a resident or nurse practitioner, and, in one case, the informed consent was obtained by another surgeon. In eighteen cases, the surgeon had documented some form of a discussion of informed consent in his or her notes. The documentation was generally in the office notes or at the beginning of the operative notes. The most common method of documentation was a dictated statement that the risks and benefits had been discussed. Two cases included a more exhaustive list of possible risks and benefits. No case included a progress note in the chart. Sixteen of the eighteen cases resulted in no indemnity payment. Documentation of the informed-consent process in the notes was associated with a significantly decreased indemnity risk (p < 0.005). Because the cases were elective, the consent could have been obtained in the office, the preoperative holding area, or on the hospital floor. Thirteen cases had documentation indi- 2399 THE JOUR NAL OF BONE & JOINT SURGER Y · JBJS.ORG VO L U M E 87-A · N U M B E R 11 · N O VE M B E R 2005 cating that consent was not obtained in the surgeon’s office, and nine of those cases resulted in an indemnity payment. In thirteen other cases, consent was obtained in the surgeon’s office and only one case resulted in an indemnity payment. For the remaining two cases, no written consent was available. Thus, obtaining the informed consent on the hospital ward or in the preoperative holding area was associated with an increased indemnity risk (p < 0.004). Interestingly, cases in which the informed consent was obtained in the surgeon’s office by the operating surgeon were associated with a significantly reduced indemnity risk (p < 0.004). Documentation of Risks Most courts require surgeons to disclose the risks inherent to a procedure that would be deemed material by a reasonable person. Although this so-called objective legal standard ostensibly protects physicians against having to guess the subjective preferences of individual patients, in practice, orthopaedic surgeons have little guidance regarding which risks must be disclosed. For example, it is unclear whether a minimal risk of a catastrophic complication such as amputation or death would be deemed a material risk. Unfortunately, there were insufficient data in our analysis to clarify this question. In seven of the twenty-eight patients, a complication developed that had been documented as a risk in the consent; five of the seven cases resulted in no indemnity payment. Of the twenty-eight patients, thirteen had development of a complication that had not been documented in the consent; seven of the thirteen cases resulted in no indemnity payment. With the data available, the occurrence of a complication that had not been described in the informed consent was not significantly associated with an indemnity payment. Discussion he doctrine of informed consent for surgery arose in the early twentieth century as courts moved to protect patient autonomy. A prominent jurist, Justice Cardozo, articulated the principle in 1914, stating that “Every human being of adult years and sound mind has a right to determine what shall be done with his own body; and a surgeon who performs an operation without his patient’s consent commits an assault . . .”7 Subsequent case law has further defined informed consent in various jurisdictions generally to require the disclosure of a reasonable spectrum of risks that would be relevant to the decision of a reasonably prudent patient. After informed consent is obtained, documentation including a signed surgical consent form is essential evidence of the communication. Currently, there is a wide variation among orthopaedic surgeons regarding the procedures used to obtain and document informed consent. In the present study, using closed claims analysis, we have elucidated some factors that strengthen an orthopaedic surgeon’s claim that appropriate informed consent was, in fact, obtained. Our main finding was that the location where the informed consent was obtained is important. When informed consent was obtained by the operating surgeon in the office, there was a decreased risk of indemnity payment (p < 0.004). T T H E M E D I C A L -L E G A L A S P E C T S IN OR THOPAEDIC SURGER Y OF INFORMED CONSENT This finding is likely due to the effect of communication on malpractice claims. Poor communication has been established as the critical factor linked to malpractice claims8-10. It seems logical that the physician-patient communication that occurs in the office is more interactive and substantive than discussions that occur on the hospital floor or in the preoperative holding area. A closed claims analysis conducted in Florida, which included 127 mothers of infants who had experienced permanent perinatal injuries and who subsequently sued their physicians, showed that nearly all complained that their physicians would not talk, answer questions, or listen11. Clearly, the office is the best setting for quality discussions on informed consent to occur. A second finding was that the method of documentation of informed consent proved pertinent. Written informed consent was obtained from the patients in twenty-six of the twentyeight cases. However, a signed surgical consent form alone proved to be of small value for a number of cases. Documentation in the surgeon’s notes that informed consent took place was associated with a decreased risk of an indemnity payment (p < 0.005). Dictating even a brief description of the informed consent process—whether as part of the operative notes or the office notes—provides strong evidence should a malpractice claim arise. The transcribed dictation is accessible, legible, and more legally substantive than the standard informed-consent form. In fact, the two cases in which no written informedconsent form was available were successfully defended with use of the surgeons’ dictated notes. Three cases involved a disputed surgical site. All three cases resulted in an indemnity payment, which averaged $101,000. Recent data have shown that marking of the surgical site can decrease the prevalence of wrong-site surgery12. We believe that marking the site complements the informed-consent discussion, but it does not substitute for it. The present data, unfortunately, do not clarify to what extent an orthopaedic surgeon is obligated to disclose or document the risks of a procedure; the best guidance for physicians regarding this issue remains the statutory and common law of each state. Also, our data do not elucidate whether it is better from a liability-limiting standpoint to document a comprehensive list of possible complications or simply to document that appropriate risks and benefits were discussed. The American Academy of Orthopaedic Surgeons recommends that physicians document at least one extreme complication, such as death or amputation5. This study has a number of limitations. First, the small number of claims results in limited power to examine the risk factors. Only strongly associated risk factors demonstrated a significant difference. Second, no negative cases were reviewed. There may be many cases in which poor informed consent is obtained but no malpractice claim is filed. Third, these data represent the experience of malpractice insurers in only one state and may not be applicable to the general population or other jurisdictions. Fourth, most of these cases included other allegations in addition to informed consent. Lack of informed consent was usually only a part of the plaintiffs’ strategy. However, presenting multiple allegations is the most 2400 THE JOUR NAL OF BONE & JOINT SURGER Y · JBJS.ORG VO L U M E 87-A · N U M B E R 11 · N O VE M B E R 2005 common strategy in pursuing legal claims. Considered together, this cohort provides insight into the role of informed consent in orthopaedic malpractice. Fifth, our findings may help surgeons to reduce the indemnity risk should a lawsuit be filed, but they may not reduce the number of lawsuits filed. Finally, the study uses indemnity payment as a surrogate marker of a poor informed-consent process. However, the fact that a malpractice claim results in an indemnity payment does not prove that any wrongdoing has occurred13. In summary, an analysis of closed malpractice claims involving informed consent in orthopaedic surgery identified significant potential liability. Surgeons may be able to reduce the risk of a malpractice claim by obtaining informed consent themselves in the office (rather than in the preoperative holding area) and by documenting the informed-consent process in their dictated office notes or operative report. NOTE: The authors thank Maureen Mondor and Elizabeth Halloran of ProMutual Group and Kathy Dwyer of the Risk Management Foundation for their generous assistance with this project. T H E M E D I C A L -L E G A L A S P E C T S IN OR THOPAEDIC SURGER Y OF INFORMED CONSENT Timothy Bhattacharyya, MD Howard Yeon, MD, JD Partners Orthopaedic Trauma Service, Massachusetts General Hospital, 35 Fruit Street, Yawkey 3600, Boston, MA 02114. E-mail address for T. Bhattacharyya: email@example.com Mitchel B. Harris, MD Department of Orthopaedic Surgery, Brigham and Women’s Hospital, 75 Francis Street, Boston, MA 02115 The authors did not receive grants or outside funding in support of their research or preparation of this manuscript. They did not receive payments or other benefits or a commitment or agreement to provide such benefits from a commercial entity. No commercial entity paid or directed, or agreed to pay or direct, any benefits to any research fund, foundation, educational institution, or other charitable or nonprofit organization with which the authors are affiliated or associated. doi:10.2106/JBJS.D.02877 References 1. Mello MM, Studdert DM, Brennan TA. 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