Lawsuits After Primary and Revision Total Knee Arthroplasty

A Malpractice Claims Analysis

Diana C. Patterson, MD; Ronald Grelsamer, MD; Michael J. Bronson, MD; Calin S. Moucha, MD

Disclosures

J Am Acad Orthop Surg. 2017;25(10):e235-e242. 

In This Article

Discussion

We examined a large series of TKAs to determine the most common causes of malpractice claims. In a quest for sources of patient dissatisfaction that could be preventable, we also analyzed the relationship between the indemnity that patients received and the nature of their allegations.

In 2010, approximately 4.7 million individuals in the United States—4.6% of the population aged >50 years—were estimated to be living with a TKA; the prevalence increased with age, to 10.4% at age 80 years. In addition, trends in the numbers of procedures performed indicated a shift to younger patients.[13] With such projected increases, the opportunity for complications, poor outcomes, and dissatisfied patients also will likely increase.[14] Despite high success rates,[3,4,13] the proportion of dissatisfied patients has been quoted as being as high as 28%.[14–16]

Survey studies showed that only obstetricians and general surgeons had greater numbers of claims (12%) than did orthopaedic surgeons (8%), and that after 30 years of practice, the incidence of being sued is over 90 %.[17–19] In a study from Italy, the country with the greatest number of physicians subject to criminal proceedings related to medical malpractice, the highest number of complaints across all specialties related to orthopaedics.[20] In a malpractice claims analysis of all types of orthopaedic procedures, Matsen et al[21] showed that the second most frequently alleged cause, but also the group of allegations with the highest impact on orthopaedic liability, was failure to protect structures in the surgical field.

In Finland, where 17,535 TKAs were entered into a database between 1998 and 2003, male patients and patients aged >65 years were less likely to file claims.[22] This finding also was seen across other subspecialties,[23,24] as well as in our data, with 60% of the claims filed by women and 60% of claims filed by patients aged ≤65 years.

Our study uses data from a single malpractice carrier, but other studies show our results to be consistent across TKAs performed by a wide cross section of orthopaedic surgeons. Upadhyay et al[25] presented a series of surgeon self-reported claims; similar to our findings, theirs showed nerve injury, chronic pain, and infection to be common sources of malpractice claims: 13% of respondents cited nerve injury, 8% cited leg-length discrepancy, 7% cited infection, and 4% cited chronic pain as sources of litigation. In a study of only orthopaedic surgeries, Matsen et al[21] showed that the most common allegations of 58 cases after TKA were implant malposition (19%), followed by failure to diagnose or treat infection (16%) and injury to surrounding structures (14%). This frequency of infection is similar to that in our study, except for a higher rate of malpositioning of implants than in our study.

Similar studies using international databases also have outcomes similar to ours. McWilliams et al,[26] using the NHSLA, also showed that infection and surgical error were common complaints after TKA and that vascular injuries resulted in the highest payments per case. TKA totaled 6% of all orthopaedic claims and 5% of the total costs. Infection was alleged in 16.7% of cases; nonspecific alleged negligence, in 11.2% of cases; surgical technical error, in 11.1% of cases; and neurologic deficit, in 6.3% of cases. In a similar population, 24% of cases were caused by ongoing pain and 18% were caused by infection; 30% of the cases caused by infection resulted in amputation.[16] These results are consistent with our US data over a similar period.

In France, Gibon et al[27] found that the most frequent causes of litigation were infection, neurologic deficit, and nonspecific patient dissatisfaction. That said, the most common reasons for the surgeon to be found liable were delays in the diagnosis or treatment of a complication, infection, and technical error. There were 44 cases of infection and 14 postoperative fatalities, 3 of which followed infection and its treatment. These incidences are far greater than those we found, which may be related to differences between countries in the preoperative antibiotic protocol, diagnostic criteria of infection, or surgical techniques.

Chen et al,[28] using NHSLA data, indicated that there is both a significant increase in the number and, more importantly, an increase in the value of claims after TKA. In a 5-year span, 11% of orthopaedic cases were related to knee surgery (515 of 4,609 total orthopaedic surgeries), and 58% of these (298 of 515 surgeries) involved TKA complications. Litigation success rates were highest after surgical technique errors, such as malalignment (71%), retained drains (100%), and incorrect prosthesis sizing (78%) compared to those after events less under the surgeon's control, such as infection (42%) or deep vein thrombosis or pulmonary embolism (38%).[28]

In the group of patients in our study, 34 claims were opened for cases performed between 1982 and 1998 and 43 for cases between 1999 and 2012. In contrast, in England, in two periods from 1995 to 2002 and 2003 to 2010, the number of claims increased 46% (232 versus 337 claims, respectively).[26] Claims for alleged negligence increased from 5% to 16%, and claims for technical errors increased by 5%. Although this finding could be caused by methodologic changes in data collection, it also could be secondary to an increase in the general dissatisfaction of patients undergoing TKA or a concerning transition to patients being more litigious.

Universally across all series, the highest amounts of indemnity payments are made after vascular injuries, particularly vascular injuries that lead to amputation,[26,27] followed closely by those that lead to infection[16,26,28] and nerve injury,[26] and followed more distantly by those involving technical error[26,27] and chronic pain.[16,26] A unique aspect of our study is that we were able to compare the indemnity payment to patients with the carrier's cost to defend the cases. In our study, the life-altering complications (ie, amputation, paralysis) resulted in the highest indemnity payments by far, but in several cases of infection or general dissatisfaction, the cost to the carrier came more from the defense than from the payout. However, we were not given access to the breakdown of those costs.

Although an indirect goal of this study was to limit our exposure to lawsuits, the larger issue is improving patient satisfaction. The source of negligence allegations is frequently a lack of adequate communication in the preoperative consent and postoperative recovery period or suboptimal education of patients and families about the risks and limitations of TKA. Communication skills are critical in the setting of realistic expectations, as is the honest, timely, and appropriately mannered relaying of medical errors.[20,29] Bhutta et al[16] showed that failure to obtain informed consent for the risk of ongoing pain following surgery resulted in an indemnity payment in 29% of claims. However, communication requires time, a precious commodity in a healthcare landscape requiring increased "productivity" (ie, an increased volume of patients seen and treated). In addition, communicating effectively also involves striking a balance between informing patients and scaring them away, a diplomatic skill that traditionally has not been part of orthopaedic training. Nevertheless, an improved commitment to establishing patients' knowledge of and expectations about the procedure, and of all risks and benefits, including the potential for dissatisfaction or loss of function, may reduce the number of malpractice claims.

To our knowledge, there are no published communication guidelines for orthopaedic surgeons, and there is no established formulation of informed consent that is superior to another. One recent study on the informed consent process for TKA found that 62% of patients felt they had received sufficient information about the TKA procedure, but only 28% reported feeling they had received enough information about complications.[30] In a blinded and randomized group of patients undergoing TKA, Johnson et al[31] found that there was no statistical difference in the level of satisfaction with the consent process for the three study groups: (1) those who received an informed consent and a paper handout explaining the risks and benefits of TKA, (2) those who received the informed consent and the handout, and watched a video on the risks and benefits, or (3) those who received the informed consent, a handout, watched the video, and received formal education by a nurse.

Our study has several limitations. Most importantly, because of the anonymity of the data, we were unable to correlate the likelihood of filing a claim with surgeon practice factors, such as years in practice, fellowship training, or type of practice (ie, academic, group, individual). In addition, the patients in this study were drawn from only one malpractice insurer, in contrast to patients in the database studies of other international groups, in which health data were collected more universally and in a centralized manner, thereby providing a large number of patients available for study.

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