A Comprehensive Analysis of Litigation in Organ Transplantation for Allegations of Insufficient Policy Coverage, Discrimination and Malpractice.

Introduction: Transplantation is a field with unique medical and administrative challenges that involve an equally diverse array of stakeholders. Expectantly, the litigation stemming from this field should be similarly nuanced. There is a paucity of comprehensive reviews characterizing this medicolegal landscape. Design: The Caselaw Access Project Database was used to collect official court briefs of 2053 lawsuits related to kidney, liver, heart, lung, and pancreas transplantation. A thematic analysis was undertaken to characterize grounds for litigation, defendant type, and outcomes. Cases were grouped into policy, discrimination, poor or unsuccessful outcome, or other categories. Results: One hundred sixty-four court cases were included for analysis. Cases involving disputes over policy coverage were the most common across all organ types (N = 55, 33.5%). This was followed by poor outcomes (N = 51, 31.1%), allegations of discrimination against prison systems and employers (N = 37, 22.6%) and other (N = 21, 12.8%). Defendants involved in discrimination trials won with the greatest frequency (N = 29, 90.62%). Defendants implicated in policy suits won 65.3% (N = 32), poor outcomes 62.2% (N = 28), and other 70% (N = 14). Of the 51 cases involving poor outcomes, plaintiffs indicated lack of informed consent in 23 (45.1%). Conclusion: Reconsidering the informed consent process may be a viable means of mitigating future legal action. Most discrimination suits favoring defendants suggested previous concerns of structural injustices in transplantation may not be founded. The prevalence of policy-related cases could be an indication of financial burden on patients. Future work and advocacy will need to substantiate these concerns and address change where legal recourse falls short.

Increased CMV disease and "severe" BK viremia with belatacept vs. sirolimus three-drug maintenance immunosuppression.

OBJECTIVES: Belatacept may provide benefit in delayed graft function, but its association with infectious complications is understudied. We aim to assess the incidence of CMV and BK viremia in patients treated with sirolimus or belatacept as part of a three-drug immunosuppression regimen after kidney transplantation. MATERIALS AND METHODS: Kidney transplant recipients from 01/01/2015 to 10/01/2021 were retrospectively reviewed. Maintenance immunosuppression was either tacrolimus, mycophenolate and sirolimus (B0) or tacrolimus, mycophenolate, and belatacept (5.0 mg/kg monthly) (B1). Primary outcomes of interest were BK and CMV viremia which were followed until the end of the study period. Secondary outcomes included graft function (serum creatinine, eGFR) and acute rejection through 12 months. RESULTS: Belatacept was initiated in patients with a higher mean kidney donor profile index (B0:0.36 vs. B1:0.44, p = .02) with more delayed graft function (B0:6.1% vs. B1:26.1%, p < .001). Belatacept therapy was associated with more "severe" CMV viremia >25,000 copies/mL (B0:1.2% vs. B1:5.9%, p = .016) and CMV disease (B0:0.41% vs. B1:4.2%, p = .015). However, there was no difference in the overall incidence of CMV viremia >200 IU/mL (B0:9.4% vs. B1:13.5%, p = .28). There was no difference in the incidence of BK viremia >200 IU/mL (B0:29.7% vs. B1:31.1%, p = .78) or BK-associated nephropathy (B0:2.4% vs. B1:1.7%, p = .58), but belatacept was associated with "severe" BK viremia, defined as >10,000 IU/mL (B0:13.0% vs. B1:21.8%, p = .03). The mean serum Cr was significantly higher with belatacept therapy at 1-year follow up (B0:1.24 mg/dL vs. B1:1.43 mg/dL, p = .003). Biopsy-proven acute rejection (B0:1.2% vs. B1:2.6%, p = .35) and graft loss (B0:1.2% vs. B1:0.84%, p = .81) were comparable at 12 months. CONCLUSIONS: Belatacept therapy was associated with an increased risk of CMV disease and "severe" CMV and BK viremia. However, this regimen did not increase the overall incidence of infection and facilitated comparable acute rejection and graft loss at 12-month follow up.

Transplant surgery departmental leaders do not represent workforce demographics especially among women and underrepresented minorities - A retrospective analysis.

INTRODUCTION: The diversity among surgical directors for liver, kidney, and pancreas transplant departments has not been previously evaluated. We aim to quantify the sex and racial demographics of transplant department leaders and assess the impact on patient outcomes. METHODS: Demographics were collected for 116 liver, 192 kidney, and 113 pancreas transplant directors using Organ Procurement and Transplantation Network (OPTN) directory and program websites. Scientific Registry of Transplant Recipients (SRTR) 5-tier program outcomes rankings were obtained for each program and matched to leader demographics. A retrospective analysis of transplant recipients from 2010 to 2019 was performed using the United Network for Organ Sharing (UNOS) database. RESULTS: 91.5% of transplant surgical directors were male. 55% of departments had a Non-Hispanic White leader. Asian, Hispanic and Black transplant chiefs were at the helm of 23.3%, 9%, and 5% of divisions respectively. Multivariate cox regression analysis did not identify any differences in patient outcomes by transplant director demographics. CONCLUSION: There is a paucity of female and URM leaders in transplant surgery. Initiatives to promote research, mentorship, and career advancement opportunities for women and URM are necessary to address the current leadership disparity.

Analysis of Linguistically and Culturally Tailored Initiatives in Websites of Kidney Transplant Programs in the United States Between 2013-2018.

INTRODUCTION: Minority patients constitute the majority of the kidney transplant waiting list, yet they suffer greater difficulties in listing and longer wait times to transplantation. There is a lack of information regarding targeted efforts by transplant centers to improve transplant care for minority populations. RESEARCH QUESTION: Our aim was to analyze all kidney transplant websites in the United States to identify changes over a 5-year period in the number of multilingual websites, reported culturally targeted initiatives, and center and provider diversity. DESIGN: Surveys were developed to analyze center websites of all transplant programs in the United States. Those with incomplete information about their nephrology or surgical teams were excluded, resulting in 174 (73%) sites in 2013 and 185 (76%) in 2018. Results: Few websites were available in a language other than English, 6.3% in 2013 and 9.7% in 2018 (P = 0.24). Only 3 websites (1.3%) in 2013 and 7 (3.7%) in 2018 reported any evidence of a culturally targeted initiative (P = 0.23). In 2018, 35% of centers employed a Hispanic transplant physician, 77% had a transplant physician who spoke a language other than English, and 39% had a transplant physician who spoke Spanish. DISCUSSION: Although minority patients are expected to grow in the United States, decreased access to transplantation continues to vex the transplant community. Very little progress has been made in the development of multilingual websites and culturally targeted initiatives.