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The New York City Health and Hospitals Corporation participated in a feasibility study to measure the participants' satisfaction with mediation of medical malpractice lawsuits. Twenty-nine cases were referred to the study, twenty-four agreed to mediation, and nineteen were mediated. Satisfaction data indicate that the plaintiffs and their attorneys and the defendant's attorney were satisfied with the process whether or not settlement was reached. The mean length of a mediation was 2.34 hours. Of the cases mediated, thirteen settled, with a median payment of 111,000 dollars. The defendant's and plaintiffs' attorneys estimated spending approximately one-tenth the amount of time preparing their case for mediation that they would have spent preparing for trial. [ABSTRACT FROM AUTHOR]

Allogeneic hematopoietic stem cell transplantation (allo-HSCT) efficacy is complicated by graft-versus-host disease (GVHD), a leading cause of morbidity and mortality. Regulatory T cells (Tregs) have shown efficacy in preventing GVHD. However, high Treg doses are often required, necessitating substantial ex vivo or in vivo expansion that may diminish suppressor function. To enhance in vivo suppressor function, murine Tregs were transduced to express an anti-human CD19 chimeric antigen receptor (hCAR19) and infused into lethally irradiated, hCD19-transgenic recipients for allo-HSCT. Compared with recipients receiving control transduced Tregs, those receiving hCAR19 Tregs had a marked decrease in acute GVHD lethality. Recipient hCD19 B cells and murine hCD19 TBL12-luciferase (TBL12luc) lymphoma cells were both cleared by allogeneic hCAR19 Tregs, which was indicative of graft-versus-tumor (GVT) maintenance and potentiation. Mechanistically, hCAR19 Tregs killed syngeneic hCD19+ but not hCD19- murine TBL12luc cells in vitro in a perforin-dependent, granzyme B-independent manner. Importantly, cyclophosphamide-treated, hCD19-transgenic mice given hCAR19 cytotoxic T lymphocytes without allo-HSCT experienced rapid lethality due to systemic toxicity that has been associated with proinflammatory cytokine release; in contrast, hCAR19 Treg suppressor function enabled avoidance of this severe complication. In conclusion, hCAR19 Tregs are a potentially novel and effective strategy to suppress GVHD without loss of GVT responses.

The clinical success of chimeric antigen receptor (CAR) T cell therapy for CD19 + B cell malignancies can be limited by acute toxicities and immunoglobulin replacement needs due to B cell aplasia from persistent CAR T cells. Life-threatening complications include cytokine release syndrome and neurologic adverse events, the exact etiologies of which are unclear. To elucidate the underlying toxicity mechanisms and test potentially safer CAR T cells, we developed a mouse model in which human CD19 (hCD19)-specific mouse CAR T cells were adoptively transferred into mice whose normal B cells express a hCD19 transgene at hemizygous levels. Compared to homozygous hCD19 transgenic mice that have ∼75% fewer circulating B cells, hemizygous mice had hCD19 frequencies and antigen density more closely simulating human B cells. Hemizygous mice given a lethal dose of hCD19 transgene-expressing lymphoma cells and treated with CAR T cells had undetectable tumor levels. Recipients experienced B cell aplasia and antigen- and dose-dependent acute toxicities mirroring patient complications. Interleukin-6 (IL-6), interferon γ (IFN-γ), and inflammatory pathway transcripts were enriched in affected tissues. As in patients, antibody-mediated neutralization of IL-6 (and IFN-γ) blunted toxicity. Apparent behavioral abnormalities associated with decreased microglial cells point to CAR-T-cell-induced neurotoxicity. This model will prove useful in testing strategies designed to improve hCD19-specific CAR T cell safety., (Copyright © 2018 The American Society of Gene and Cell Therapy. Published by Elsevier Inc. All rights reserved.)

Mediation of medical malpractice lawsuits provides savings for the parties by shortening the litigation process. In theory, information that aids emotional healing and improves patient care can also surface through mediation. The study discussed in this article used structured interviews of participants and mediators in thirty-one mediated malpractice lawsuits involving eleven nonprofit hospitals. The study measured perceptions of the process and mediation's effects on settlement, expenses, apology, satisfaction, and information exchange. Defense lawyers were less likely than plaintiff attorneys to mediate. Both plaintiff and defense attorneys were satisfied with the process, as were plaintiffs, hospital representatives, and insurers. Changes in hospitals' practices or policies to improve patient safety were identified. This study demonstrates that major challenges stand in the way of achieving mediation's full benefits. Absence of physician participation minimizes the chances that mediated discussion of adverse events and medical errors can lead to improved quality of care. Change will require medical leaders, hospital administrators, and malpractice insurers to temper their suspicion of the tort system sufficiently to approach medical errors and adverse events as learning opportunities, and to retain lawyers who embrace mediation as an opportunity to solve problems, show compassion, and improve care.

The New York City Health and Hospitals Corporation participated in a feasibility study to measure the participants' satisfaction with mediation of medical malpractice lawsuits. Twenty-nine cases were referred to the study, twenty-four agreed to mediation, and nineteen were mediated. Satisfaction data indicate that the plaintiffs and their attorneys and the defendant's attorney were satisfied with the process whether or not settlement was reached. The mean length of a mediation was 2.34 hours. Of the cases mediated, thirteen settled, with a median payment of 111,000 dollars. The defendant's and plaintiffs' attorneys estimated spending approximately one-tenth the amount of time preparing their case for mediation that they would have spent preparing for trial.

In 2002 Pennsylvania became the first state to impose on hospitals a statutory duty to notify patients in writing of a serious event. If the disclosure conversations are carefully planned, properly executed, and responsive to patients' needs, this new requirement creates possible benefits for both patient safety and litigation risk management. This paper describes a model for accomplishing these goals that encourages health care providers to communicate more effectively with patients following an adverse event or medical error, learn from mistakes, respond to the concerns of patients and families after an adverse event, and arrive at a fair and cost-effective resolution of valid claims.