Background

Sarcoma care is highly litigated in medical malpractice claims. Understanding the reasons for litigation and legal outcomes in sarcoma care may help physicians deliver more effective and satisfying care to patients while limiting their legal exposure. However, few studies have described malpractice litigation in sarcoma care.

Questions/purposes

(1) What percentage of sarcoma malpractice cases result in a defendant verdict? (2) What is the median indemnity payment for cases that result in a plaintiff verdict or settlement? (3) What are the most common reasons for litigation, injuries sustained, and medical specialties of the defendant physicians? (4) What are the factors associated with plaintiff verdicts or settlements and higher indemnity payments?

Methods

The national medicolegal database Westlaw was queried for medical malpractice cases pertaining to sarcomas that reached verdicts or settlements. Cases from 1982 to 2018 in the United States were included in the study to evaluate for trends in sarcoma litigation. Demographic and clinical data, tumor characteristics, reasons for litigation, injuries, and legal outcomes were recorded for each case. A univariate analysis was performed to identify factors associated with plaintiff verdicts or settlements and higher indemnity payments, such as tumor characteristics, defendant's medical or surgical specialty, reason for litigation, and injuries sustained. A total of 92 cases related to sarcomas were included in the study, of which 40 were related to bone sarcomas and 52 were related to soft-tissue sarcomas. Eighty-five percent (78 of 92) of cases involved adult patients (mean age ± SD: 40 ± 15 years) while 15% (14 of 92) of cases involved pediatric patients (mean age ± SD: 12.5 ± 5 years).

Results

Thirty-eight percent (35 of 92) of the included cases resulted in a defendant verdict, 30% (28 of 92) resulted in a plaintiff verdict, and 32% (29 of 92) resulted in a settlement. The median (interquartile range [IQR]) indemnity payment for plaintiff verdicts and settlements was USD 1.9 million (USD 0.5 to USD 3.5 million). Median (IQR) indemnity payments were higher for cases resulting in a plaintiff verdict than for cases that resulted in a settlement (USD 3.3 million [1.1 to 5.7 million] versus USD 1.2 million [0.4 to 2.4 million]; difference of medians = USD 2.2 million; p = 0.008). The most common reason for litigation was delayed diagnosis of sarcoma (91%; 84 of 92) while the most common injuries cited were progression to metastatic disease (51%; 47 of 92) and wrongful death (41%; 38 of 92). Malpractice claims were most commonly filed against primary care physicians (26%; 28 of 109 defendants), nononcology-trained orthopaedic surgeons (23%; 25 of 109), and radiologists (15%; 16 of 109). Cases were more likely to result in a ruling in favor of the plaintiff or settlement if a delay in diagnosis occurred despite suspicious findings on imaging or pathologic findings (80% versus 51%; odds ratio 3.84 [95% CI 1.34 to 11.03]; p = 0.02). There were no differences in indemnity payments with the numbers available in terms of tumor type, tumor location, defendant specialty, reason for litigation, and resulting injuries.

Conclusions

Many lawsuits were made against primary care physicians, nononcology-trained orthopaedic surgeons, or radiologists for a delayed diagnosis of sarcoma despite the presence of imaging or histologic findings suspicious for malignancy. Although previous studies of bone and soft-tissue sarcomas have not shown a consistent association between time to diagnosis and decreased survival, our study suggests that physicians are still likely to lose these lawsuits because of the perceived benefits of an early diagnosis.

Clinical relevance

Physicians can mitigate their malpractice risk while reducing delays in diagnosis of sarcomas by carefully reviewing all existing diagnostic studies, establishing closed-loop communication protocols to communicate critical findings from diagnostic studies, and developing policies to facilitate second-opinion consultation, particularly for imaging studies, with an experienced sarcoma specialist. Musculoskeletal oncologists may be able to help further reduce the rates of malpractice litigation in sarcoma care by helping patients understand that delays in diagnosis do not necessarily constitute medical malpractice.

BACKGROUND: Sarcoma care is highly litigated in medical malpractice claims. Understanding the reasons for litigation and legal outcomes in sarcoma care may help physicians deliver more effective and satisfying care to patients while limiting their legal exposure. However, few studies have described malpractice litigation in sarcoma care. QUESTIONS/PURPOSES: (1) What percentage of sarcoma malpractice cases result in a defendant verdict? (2) What is the median indemnity payment for cases that result in a plaintiff verdict or settlement? (3) What are the most common reasons for litigation, injuries sustained, and medical specialties of the defendant physicians? (4) What are the factors associated with plaintiff verdicts or settlements and higher indemnity payments? METHODS: The national medicolegal database Westlaw was queried for medical malpractice cases pertaining to sarcomas that reached verdicts or settlements. Cases from 1982 to 2018 in the United States were included in the study to evaluate for trends in sarcoma litigation. Demographic and clinical data, tumor characteristics, reasons for litigation, injuries, and legal outcomes were recorded for each case. A univariate analysis was performed to identify factors associated with plaintiff verdicts or settlements and higher indemnity payments, such as tumor characteristics, defendants medical or surgical specialty, reason for litigation, and injuries sustained. A total of 92 cases related to sarcomas were included in the study, of which 40 were related to bone sarcomas and 52 were related to soft-tissue sarcomas. Eighty-five percent (78 of 92) of cases involved adult patients (mean age ± SD: 40 ± 15 years) while 15% (14 of 92) of cases involved pediatric patients (mean age ± SD: 12.5 ± 5 years). RESULTS: Thirty-eight percent (35 of 92) of the included cases resulted in a defendant verdict, 30% (28 of 92) resulted in a plaintiff verdict, and 32% (29 of 92) resulted in a settlement. The median (interquartile range [IQR]) indemnity payment for plaintiff verdicts and settlements was USD 1.9 million (USD 0.5 to USD 3.5 million). Median (IQR) indemnity payments were higher for cases resulting in a plaintiff verdict than for cases that resulted in a settlement (USD 3.3 million [1.1 to 5.7 million] versus USD 1.2 million [0.4 to 2.4 million]; difference of medians = USD 2.2 million; p = 0.008). The most common reason for litigation was delayed diagnosis of sarcoma (91%; 84 of 92) while the most common injuries cited were progression to metastatic disease (51%; 47 of 92) and wrongful death (41%; 38 of 92). Malpractice claims were most commonly filed against primary care physicians (26%; 28 of 109 defendants), nononcology-trained orthopaedic surgeons (23%; 25 of 109), and radiologists (15%; 16 of 109). Cases were more likely to result in a ruling in favor of the plaintiff or settlement if a delay in diagnosis occurred despite suspicious findings on imaging or pathologic findings (80% versus 51%; odds ratio 3.84 [95% CI 1.34 to 11.03]; p = 0.02). There were no differences in indemnity payments with the numbers available in terms of tumor type, tumor location, defendant specialty, reason for litigation, and resulting injuries. CONCLUSIONS: Many lawsuits were made against primary care physicians, nononcology-trained orthopaedic surgeons, or radiologists for a delayed diagnosis of sarcoma despite the presence of imaging or histologic findings suspicious for malignancy. Although previous studies of bone and soft-tissue sarcomas have not shown a consistent association between time to diagnosis and decreased survival, our study suggests that physicians are still likely to lose these lawsuits because of the perceived benefits of an early diagnosis. CLINICAL RELEVANCE: Physicians can mitigate their malpractice risk while reducing delays in diagnosis of sarcomas by carefully reviewing all existing diagnostic studies, establishing closed-loop communication protocols to communicate critical findings from diagnostic studies, and developing policies to facilitate second-opinion consultation, particularly for imaging studies, with an experienced sarcoma specialist. Musculoskeletal oncologists may be able to help further reduce the rates of malpractice litigation in sarcoma care by helping patients understand that delays in diagnosis do not necessarily constitute medical malpractice.

Background

Reduced creatinine clearance is an indication for surgery in asymptomatic primary hyperparathyroidism, and a significant proportion of patients undergoing parathyroidectomy have chronic kidney disease. The purpose of this study was to evaluate the kinetics of intraoperative parathyroid hormone decline during parathyroidectomy in patients who have chronic kidney disease compared with those with who have normal renal function.

Methods

This is a single-center, retrospective study of patients with primary hyperparathyroidism undergoing parathyroidectomy (n = 646). Patients were grouped based on estimated glomerular filtration rate greater than (normal renal function) or less than (chronic kidney disease) 60 mL/min/1.73m². All patients had intraoperative parathyroid hormone monitoring and ≥6-month postoperative serum studies to confirm surgical cure. Intraoperative parathyroid hormone kinetic curves were analyzed using a linear mixed model.

Results

Despite similar pre-excision values, patients with chronic kidney disease had significantly higher intraoperative parathyroid hormone values at 5 minutes (76 vs 58 pg/mL, P = .02) and 10 minutes (54 vs 37 pg/mL, P = .004) postexcision. No significant difference was observed in whether patients met Miami criterion by 5 minutes (chronic kidney disease 71%, normal renal function 78%, P = .255) or by 10 minutes (chronic kidney disease 95%, normal renal function 96%, P = .751) postexcision. Using a linear mixed model, glomerular filtration rate did not have a significant effect on the change in intraoperative parathyroid hormone over time.

Conclusion

Patients with chronic kidney disease had significantly higher postexcision intraoperative parathyroid hormone levels. However, renal function did not affect the change in intraoperative parathyroid hormone over time, nor did renal function ultimately affect the likelihood of meeting the Miami criterion. Intraoperative parathyroid hormone monitoring remains useful in this population, although additional time points may be needed to observe normalization of values.

Flow cytometry is a ubiquitous, multiparametric method for characterizing cellular populations. However, this method can grow increasingly complex with the number of proteins that need to be screened simultaneously: spectral emission overlap of fluorophores and the subsequent need for compensation, lengthy sample preparation, and multiple control tests that need to be performed separately must all be considered. These factors lead to increased costs, and consequently, flow cytometry is performed in core facilities with a dedicated technician operating the instrument. Here, we describe a low-cost, label-free microfluidic method that can determine the phenotypic profiles of single cells. Our method employs Node-Pore Sensing to measure the transit times of cells as they interact with a series of different antibodies, each corresponding to a specific cell-surface antigen, that have been functionalized in a single microfluidic channel. We demonstrate the capabilities of our method not only by screening two acute promyelocytic leukemia human cells lines (NB4 and AP-1060) for myeloid antigens, CD13, CD14, CD15, and CD33, simultaneously, but also by distinguishing a mixture of cells of similar size—AP-1060 and NALM-1—based on surface markers CD13 and HLA-DR. Furthermore, we show that our method can screen complex subpopulations in clinical samples: we successfully identified the blast population in primary human bone marrow samples from patients with acute myeloid leukemia and screened these cells for CD13, CD34, and HLA-DR. We show that our label-free method is an affordable, highly sensitive, and user-friendly technology that has the potential to transform cellular screening at the benchside.

Background

Cervical radiculopathy is a relatively common problem that often affects individuals in their 5^th decade. Most cases resolve with conservative treatment, but when unsuccessful, many opt for surgical intervention. Anterior cervical discectomy and fusion is currently considered the gold standard for the surgical management of cervical radiculopathy. One promising alternative, the DTRAX facet system is minimally invasive and may significantly reduce or eliminate cervical radicular symptoms. This case series and literature review looks to investigate the safety and efficacy of the DTRAX facet system in treating cervical radiculopathy.

Methods

This retrospective analysis was performed by chart review of patients who underwent posterior cervical fusion and received the DTRAX spinal implant at University of California, Los Angeles within the last 8 years. Patient charts were located using the surgical cases report function of Epic electronic medical record, and patients were included in the study if they received a DTRAX implant during the stated time period. Data were compiled and analyzed using Microsoft Excel.

Results

A total of 14 patient charts were reviewed. Of the 14, there were no immediate postoperative complications. One international patient was subsequently lost to follow-up, and of the remaining 13, mean follow-up duration was 273 days, with a range of 15-660 days. All but one reported improvement of symptoms postoperatively, there were no device failures, and no reoperations were required. There were similar outcomes in patients who received single versus multilevel operations.

Conclusion

The findings of this retrospective study of 14 patients who received the DTRAX facet system over the last 8 years support the conclusions of previous studies that DTRAX is safe and effective. In addition, this is the first study to look for differences in outcomes between single and multi-level DTRAX operations, of which there were none. Further investigation with larger cohorts should be conducted as DTRAX becomes more widely adopted in order to verify its safety and efficacy in various clinical scenarios.

Background

There is a paucity of data on long-term survivorship and outcomes for total humerus replacements (THR) with only two series reporting 10-year survival.

Patients and methods

A review of 769 consecutive, prospectively collected endoprosthetic reconstructions for oncological diagnoses at a single-center between 1980 and 2019 was performed. Patients with THRs were isolated and analyzed for outcomes, complications, and modes of failure.

Results

Eighteen patients with 20 THR implants were identified. The median follow-up for surviving patients was 148 months (interquartile range [IQR] = 74-194) and 60 months (IQR = 17-155 months) for all patients. Two prostheses required revision for failure, both for symptomatic shoulder dislocation. There were three local recurrences. Revision-free survival at 5, 10, and 15 years was 100%, 86% and 86%, respectively. There were no cases of ulnar component failure, radial nerve palsy, or periprosthetic infection.

Conclusions

THR prosthesis survivorship is comparable to the previous series, with a longer follow-up than has previously been reported. Symptomatic shoulder instability was common (25%), and was the only cause of revision. Reverse total shoulder could be an important way to address this in the future. Local recurrence rates were high, as has been reported elsewhere for THR.

AIMS:We aimed to examine the long-term mechanical survivorship, describe the modes of all-cause failure, and identify risk factors for mechanical failure of all-polyethylene tibial components in endoprosthetic reconstruction. METHODS:This is a retrospective database review of consecutive endoprosthetic reconstructions performed for oncological indications between 1980 and 2019. Patients with all-polyethylene tibial components were isolated and analyzed for revision for mechanical failure. Outcomes included survival of the all-polyethylene tibial component, revision surgery categorized according to the Henderson Failure Mode Classification, and complications and functional outcome, as assessed by the Musculoskeletal Tumor Society (MSTS) score at the final follow-up. RESULTS:A total of 278 patients were identified with 289 all-polyethylene tibial components. Mechanical survival was 98.4%, 91.1%, and 85.2% at five, ten and 15 years, respectively. A total of 15 mechanical failures were identified at the final follow-up. Of the 13 all-polyethylene tibial components used for revision of a previous tibial component, five (38.5%) failed mechanically. Younger patients (< 18 years vs > 18 years; p = 0.005) and those used as revision components (p < 0.001) had significantly increased rates of failure. Multivariate logistic regression modelling showed revision status to be a positive risk factor for failure (odds ratio (OR) 19.498, 95% confidence interval (CI) 4.598 to 82.676) and increasing age was a negative risk factor for failure (OR 0.927, 95% CI 0.872 to 0.987). Age-stratified risk analysis showed that age > 24 years was no longer a statistically significant risk factor for failure. The final mean MSTS score for all patients was 89% (8.5% to 100.0%). CONCLUSION:The long-term mechanical survivorship of all-polyethylene tibial components when used for tumour endoprostheses was excellent. Tumour surgeons should consider using these components for their durability and the secondary benefits of reduced cost and ease of removal and revision. However, caution should be taken when using all-polyethylene tibial components in the revision setting as a significantly higher rate of mechanical failure was seen in this group of patients. Cite this article: Bone Joint J. 2020;102-B(2):170-176.