Medical malpractice in aortic valve and mitral valve replacement surgery in North America.

BACKGROUND: Aortic and mitral valve replacement are commonly performed by cardiovascular surgeons, but little data quantitatively analyzes the etiology and prevalence of medical malpractice litigations involving these operations. This study aims to analyze incidence, cause, and resolution of medical malpractice lawsuits involving aortic and mitral valve replacements, alone and in combination with coronary artery bypass and/or aortic procedures. METHODS: The Westlaw legal database was utilized to compile relevant litigations across the United States from 1994-2019. Clinical data, verdict data, demographic data, and litigation attributes were compiled. Fisher's Exact Tests and Mann-Whitney tests were performed for statistical analyses. One hundred four malpractice litigations involving aortic valve replacement and 55 litigations involving mitral valve replacement were included in this analysis. The mean age of patients was 55.2 years and proportion of female patients was 32.7% in aortic valve replacements litigations, compared to a mean age of 54.1 years and female patients in 61.8% of mitral valve replacements litigations. RESULTS: Significant relationships exist between an alleged failure to monitor the patient and defendant verdicts (P=0.01), delayed treatment and defendant verdicts (P=0.04), and incidence of infective endocarditis and plaintiff verdicts (P=0.04) in aortic valve replacement litigations. Similarly, significant relationships exist between an alleged failure to diagnose and settlement verdicts (P=0.047), and stroke incidence and defendant verdicts (P=0.03) in mitral valve replacement litigations. CONCLUSIONS: In addition to excellent surgeon patient/family communication, administering surgical treatment in a timely manner, diagnosing acting on concomitant medical conditions, and close patient monitoring may diminish medical malpractice litigation involving aortic and mitral valve replacement operations.

Jury verdicts, outcomes, and tort reform features of malpractice cases involving thoracic outlet syndrome.

OBJECTIVE/BACKGROUND: Thoracic outlet syndrome (TOS) is most often referred to vascular surgeons. However, there is a lack of understanding of the malpractice cases involving TOS. The goal of this study is to better understand the medicolegal landscape related to the care of TOS. METHODS: The Westlaw Edge AI-powered proprietary system was retrospectively reviewed for malpractice cases involving TOS. A Boolean search strategy was used to identify target cases under the case category of "Jury Verdicts & Settlements" for all state and federal jurisdictions from 1970 to September 2020. The settled case was described but not included in the statistical analysis. Descriptive statistics were used to report our findings, and when appropriate. The P ≤ .05 decision rule was established a priori as the null hypothesis rejection criterion to determine associations between jury verdicts outcomes and state's tort reform status. RESULTS: In this study, 39 cases were identified and met the study's inclusion criteria from the entire Westlaw Edge database. Among plaintiffs who disclosed age and/or gender, median age was 35.0 years with a female majority (67.6%). Cases involving TOS were noted to be steadily decreasing since the mid-1990s. The cases were unevenly spread across 18 states, with the highest number of cases (14, 35.9%) from California and the second highest (4, 10.3%) from Pennsylvania. A similar uneven distribution was seen among U.S. census regions, in which the West had the highest cases (39.5%). The study revealed that more cases were brought to trials in tort reform states (26, 68.4%) than in non-tort reform states (12, 31.6%). A total of 24 of 39 (61.5%) plaintiffs had one specific claim, which resulted in their economic and noneconomic damages. Negligent operation and treatment complication represented an overwhelming majority of claims brought by 38 of 39 plaintiffs (97.4%). Misdiagnosis and lack of informed consent were both brought nine times (23.1%) by the group. Intraoperative nerve injury (20 patients, 51.3%) was the most commonly reported complication. Excluding one case with a settlement of $965,000, 30 of 38 (78.9%) cases went to trials and received defense verdicts. Eight cases (20.5%) were found in favor of plaintiffs with a median payout of $725,581. CONCLUSIONS: This study highlighted higher than average payouts to plaintiffs and risk factors that may result in malpractice lawsuits for surgeons undertaking TOS treatment. Future studies are needed to further clarify the relationships between tort reform and outcomes of malpractice cases involving TOS.

Medical and Legal Aspects of the Practice of Teledermatology in Spain. / Aspectos medicolegales de la práctica de la teledermatología en España.

Teledermatology is now fully incorporated into our clinical practice. However, after reviewing current legislation on the ethical aspects of teledermatology (data confidentiality, quality of care, patient autonomy, and privacy) as well as insurance and professional responsibility, we observed that a specific regulatory framework is still lacking and related legal aspects are still at a preliminary stage of development. Safeguarding confidentiality and patient autonomy and ensuring secure storage and transfer of data are essential aspects of telemedicine. One of the main topics of debate has been the responsibilities of the physicians involved in the process, with the concept of designating a single responsible clinician emerging as a determining factor in the allocation of responsibility in this setting. A specific legal and regulatory framework must be put in place to ensure the safe practice of teledermatology for medical professionals and their patients.

Pandemic Poses Legal Pitfalls: TMA Seeks Better Liability Shields.

Under Texas law, physicians treating COVID-19 patients in a volunteer capacity have potential defenses against lawsuits that might arise from that care. But for non-volunteer physicians on the COVID battlefield - often working in harrowing, overloaded settings, high on patient count and low on equipment - the same liability shields don't exist. And with a resurgence in COVID-19 cases and hospitalizations taking hold in June, the Texas Medical Association continued its pandemic-long push to extend liability protections to all frontline physicians, volunteer or not.

Denuncias por responsabilidad profesional médica en Barcelona (2004-2009). Análisis médico-forense / Medical professional liability claims in Barcelona (2004-2009). Medico-legal analysis

En los últimos años ha habido un incremento de reclamaciones contra médicos por presunta mala praxis. Nuestro objetivo ha sido analizar retrospectivamente las denuncias por responsabilidad médica en los juzgados de Barcelona durante los años 2004-2009, evaluadas en el Instituto de Medicina Legal y Ciencias Forenses de Cataluña. MATERIAL Y MÉTODO: Se realizó a partir de 3 bases de datos: la primera, las 283 periciales elaboradas por los médicos forenses durante estos años; la segunda, el programa informático judicial TEMIS-2; y la tercera, revisión de sentencias judiciales. RESULTADOS: En 257 casos (90,81%) la reclamación fue penal, 18 (6,36%) procedimientos contencioso-administrativos, 5 civiles (1,77%) y 3 de Fiscalía (1,06%). La edad media fue de 48,38 años (DE±19,39), en el 62,77% la perjudicada fue una mujer, siendo estas las que sufrieron más secuelas. En el 88,34% la reclamación era contra un médico, siendo la más habitual el mal resultado terapéutico (32,86%). Las especialidades más denunciadas fueron la traumatología, obstetricia y ginecología y cirugía general. Hubo más reclamaciones en la sanidad privada. En el 72,41% de los casos que llegaron a juicio la sentencia fue absolutoria y de los 8 que fueron condenados, solo en uno hubo prisión. La mediana del tiempo hasta la sentencia fue de 1.602 días. CONCLUSIONES: La vía penal es la más frecuente. Las mujeres reclaman más y sufren más secuelas. Las especialidades quirúrgicas son las más denunciadas. En el 27,59% de los casos que llegaron a juicio hubo sentencias condenatorias y solo en uno privación de libertad

In recent years there has been an increase in claims against doctors for alleged malpractice. Our objective was to retrospectively analyze complaints of medical liability in the courts of Barcelona between 2004-2009, evaluated at the Institute of Legal Medicine and Forensic Sciences of Catalonia. MATERIAL AND METHOD: We used 3 databases: the first, the 283 forensic reports prepared by forensic doctors during those years; the second, the judicial computer programme TEMIS-2; and the third, a review of judicial sentences. RESULTS: In 257 cases (90.81%) the claim was criminal, 18 (6.36%) contentious-administrative proceedings, 5 civil (1.77%) and 3 Prosecutor's Office claims (1.06%). The average age was 48.38 years (SD±19.39), in 62.77% the injured party was a woman, and they suffered more sequelae. In 88.34% the claim was against a doctor, a poor therapeutic outcome being the most common (32.86%). The most reported specialties were traumatology, obstetrics and gynaecology, and general surgery. There were more complaints in private healthcare. In 72.41% of the cases that came to trial the sentence was acquittal, and of the 8 convictions, only one was imprisoned. The median time to sentencing was 1,602 days. CONCLUSIONS: The criminal route is the most frequent. Women claim more and suffer more consequences. Surgical specialties are the most reported. In 27.59% of the cases that came to trial there were convictions, and only one resulted in deprivation of liberty

Malpractice Litigation for Compartment Syndrome.

BACKGROUND: The aim of this study was to analyze litigation involving compartment syndrome to identify the causes and outcomes of such malpractice suits. A better understanding of such litigation may provide insight into areas where clinicians may make improvements in the delivery of care. METHODS: Jury verdict reviews from the Westlaw database from January 1, 2010 to January 1, 2018 were reviewed. The search term "compartment syndrome" was used to identify cases and extract data on the specialty of the physician defendant, the demographics of the plaintiff, the allegation, and the verdict. RESULTS: A total of 124 individual cases involving the diagnosis of compartment syndrome were identified. Medical centers or the hospital was included as a defendant in 51.6% of cases. The most frequent physician defendants were orthopedic surgeons (45.96%) and emergency medicine physicians (20.16%), followed by cardiothoracic/vascular surgeons (16.93%). Failure to diagnose was the most frequently cited claim (71.8% of cases). Most plaintiffs were men, with a mean age of 36.7 years, suffering injuries for an average of 5 years before their verdict. Traumatic compartment syndrome of the lower extremity causing nerve damage was the most common complication attributed to failure to diagnose, leading to litigation. Forty cases (32.25%) were found for the plaintiff or settled, with an average award of $1,553,993.66. CONCLUSIONS: Our study offers a brief overview of the most common defendants, plaintiffs, and injuries involved in legal disputes involving compartment syndrome. Orthopedic surgeons were most commonly named; however, vascular surgeons may also be involved in these cases because of the large number of cases with associated arterial involvement. A significant percentage of cases were plaintiff verdicts or settled cases. Failure to diagnosis or delay in treatment was the most common causes of malpractice litigation. Compartment syndrome is a clinical diagnosis and requires a high level of suspicion for a timely diagnosis. Lack of objective criteria for diagnosis increases the chances of medical errors and makes it an area vulnerable to litigation.

[Legal pitfalls in urology]. / Juristische "pitfalls" in der Urologie.

The juridification of medicine affects all disciplines, including urology. Therefore, in this discipline it can well happen that patients not only feel wrongly treated or complain that a treatment was not performed lege artis but also demand compensation or even bring criminal charges. From the patient point of view, the doctor is often more likely to blame for a complication that has arisen or for a hoped for but failed treatment success, than that it is accepted that a complication is typical for the intervention, which, despite the greatest medical care, unfortunately can become reality and is a fateful course. Insurance against claims for damages can be taken out. Not to be underestimated, however, is the personal burden of the accusations with which doctors are confronted by patients, relatives, expert witnesses and courts and against which one must defend oneself. This can mean additional work in addition to the normal medical workload. Therefore, the legal pitfalls in urology should be known.

Financial liability for environmental damage: insurance market in Italy, focus on Veneto region experience.

Making good environmental damage caused by industrial accidents and restoring impaired ecosystems may be associated with high costs. The European Environmental Liability Directive requires that environmental damage is prevented or remediated and confers financial liability on operators responsible for the activities that caused the damage. The directive encourages adoption of financial risk instruments for environmental liability, ensuring that operators stand up for their responsibilities. We analyse the risk financing instruments for environmental liability in Italy, with emphasis on waste treatment and disposal plant management in Venice Metropolitan City, where financial guarantees and environmental insurance are mandatory. The regional legislation obliges operators of waste treatment plants to seek financial protection through financial guarantees and environmental insurance. We have conducted online survey and in-depth interviews with both suppliers and users of financial protection instruments. On national level, the relatively high environmental consciousness is countered by a low perception of risk and subsequently very low penetration of financial security instruments. Among the identified barriers, we have singled out a limited knowledge of cumulative and long-lasting impacts of industrial activities on environment and ecosystems. Financial and insurance are well developed, but a deep support for specific risk identification and coverage lacks. A closer cooperation between public and private sector can be an opportunity to foster the adoption of these instruments and to improve the coverage of public costs for environmental restoration, due to unattended liability.

A Contemporary Medicolegal Analysis of Outpatient Interventional Pain Procedures: 2009-2016.

BACKGROUND: Closed malpractice claim studies allow a review of rare but often severe complications, yielding useful insight into improving patient safety and decreasing practitioner liability. METHODS: This retrospective observational study of pain medicine malpractice claims utilizes the Controlled Risk Insurance Company Comparative Benchmarking System database, which contains nearly 400,000 malpractice claims drawn from >400 academic and community medical centers. The Controlled Risk Insurance Company Comparative Benchmarking System database was queried for January 1, 2009 through December 31, 2016, for cases with pain medicine as the primary service. Cases involving outpatient interventional pain management were identified. Controlled Risk Insurance Company-coded data fields and the narrative summaries were reviewed by the study authors. RESULTS: A total of 126 closed claims were identified. Forty-one claims resulted in payments to the plaintiffs, with a median payment of $175,000 (range, $2600-$2,950,000). Lumbar interlaminar epidural steroid injections were the most common procedures associated with claims (n = 34), followed by cervical interlaminar epidural steroid injections (n = 31) and trigger point injections (n = 13). The most common alleged injuring events were an improper performance of a procedure (n = 38); alleged nonsterile technique (n = 17); unintentional dural puncture (n = 13); needle misdirected to the spinal cord (n = 11); and needle misdirected to the lung (n = 10). The most common alleged outcomes were worsening pain (n = 26); spinal cord infarct (n = 16); epidural hematoma (n = 9); soft-tissue infection (n = 9); postdural puncture headache (n = 9); and pneumothorax (n = 9). According to the Controlled Risk Insurance Company proprietary contributing factor system, perceived deficits in technical skill were present in 83% of claims. CONCLUSIONS: Epidural steroid injections are among the most commonly performed interventional pain procedures and, while a familiar procedure to pain management practitioners, may result in significant neurological injury. Trigger point injections, while generally considered safe, may result in pneumothorax or injury to other deep structures. Ultimately, the efforts to minimize practitioner liability and patient harm, like the claims themselves, will be multifactorial. Best outcomes will likely come from continued robust training in procedural skills, attention paid to published best practice recommendations, documentation that includes an inclusive consent discussion, and thoughtful patient selection. Limitations for this study are that closed claim data do not cover all complications that occur and skew toward more severe complications. In addition, the data from Controlled Risk Insurance Company Comparative Benchmarking System cannot be independently verified.

Outcomes and associated factors in malpractice litigation involving inferior vena cava filters.

OBJECTIVE: Placement of inferior vena cava (IVC) filters is a controversial focus of medical malpractice. Clinicians currently have little information to guide them regarding key issues and outcomes in litigation. In this retrospective legal case review, we analyzed the factors associated with malpractice actions involving IVC filters. METHODS: The legal databases LexisNexis and Westlaw were searched from 1967 to 2016 for all published legal cases in the United States involving placement of IVC filters. Keywords included "IVC," "inferior vena cava," "filter," and "malpractice." Social Security Disability claims, product liability actions, and hospital employment contract disputes were excluded. RESULTS: There were 310 search results eligible for initial review. After application of exclusion criteria, 29 cases involving medical malpractice were included in final analysis. The majority of excluded cases were insurance disputes and tax revenue cases. Overall, private practitioners were most often sued (11/29 [37.9%]), whereas 24.1% of defendants were academic hospitals (7/29), 20.7% were prisons (6/29), and 17.2% were community hospitals (5/29). The most common specialty named was vascular surgery (8/29), whereas interventional radiologists were named only twice. The most common indications for IVC filter placement were hypercoagulable state (8/29 [29.6%]), recurrent pulmonary embolism (PE; 6/29 [22.2%]), and trauma (5/29 [18.5%]). The most common underlying allegations involved failure to insert IVC filter when indicated (14/29 [48.3%]), intraprocedural negligence (5/29 [17.2%]), and failure to timely remove device (5/29 [17.2%]). Common complications included failure to prevent occurrence of PE (14/29 [48.3%]), device migration (4/29 [13.8%]), and perforation of organs or vasculature (3/29 [10.3%]). Death of the patient occurred in 41.4% of total cases (12/29). In cases in which the patient died, the most common indications for filter placement were trauma (4/12 [33.3%]) and deep venous thrombosis (3/12 [25.0%]), and the most common complication in those patients who died was the failure to prevent a subsequent PE (9/12 [75.0%]). Available verdicts favored defendants (13/14 [92.9%]). In cases with defense verdicts, the most common indications for filter placement similarly were trauma (4/13 [30.8%]) and deep venous thrombosis (3/13 [23.1%)], and the most common complication was failure to prevent PE (9/14 [64.3%]). CONCLUSIONS: Analysis of malpractice cases involving IVC filters revealed key factors associated with litigation. Overall, verdicts favored defendants. Private practitioners were most commonly sued, and the most common reasons for bringing suit were failure to insert filter, intraprocedural complications, and failure to remove filter. Deeper awareness of issues related to malpractice litigation can inform clinical practice and improve patient care and safety.

Why Do Vascular Surgeons Get Sued? Analysis of Claims and Outcomes in Malpractice Litigation.

BACKGROUND: The objective of the study was to analyze causes and outcomes of malpractice claims against vascular surgeons in the United States. METHODS: Cases entered into the Westlaw database from January 1, 1999 to December 31, 2014 were reviewed. Search terms "vascular" and "surgeon" were used. Data were compiled on the allegation, subject matter, and outcome of each case. Additional data including demographics of the defendant were obtained from the U.S. News Health reports on practicing physicians. RESULTS: Of a total of 785 cases identified from the Westlaw database using the search terms "vascular" and "surgeon", 485 (61.8%) were identified where a vascular surgeon was the defendant or expert witness. Of these, 135 (27.8%) had a vascular surgeon identified as a defendant. Among these 135 cases, 88 (65.2%) were found for the defendant with 31 (23%) and 15 (11.1%) being found for the plaintiff or settled, respectively. Of the 31 cases found for the plaintiff, the median award was $750,000 and mean award was $1,830,000. Mean time from incident to verdict was 4.8 years. The most common procedures which led to litigation were open or endovascular peripheral revascularization (PR) (14.8%), carotid interventions (CIs) (11.85%), aortic interventions (AI) (11.1%), vascular trauma (9.63%), dialysis access (8.15%), and venous surgery (5.93%). The most common allegation was "failure to diagnose and treat" (48.9%), followed by complication of open surgery (31.85%) and negligent procedure (25.19%). The most common injuries reported were death (31.85%), major amputation (23.7%), neurovascular injury (14.8%), and bleeding (5.9%). CONCLUSIONS: Analysis of vascular surgery malpractice litigation in the Westlaw database revealed details regarding the subject matter and outcomes of these cases. Through this closed claims analysis, the most common procedures leading to litigation were found to be PR, CI, and AI and not thoracic outlet syndrome procedures as commonly believed. Furthermore, the most common allegations were a "failure to diagnose and treat" and "open surgical complication". Analysis of the salient features and outcomes in these cases can provide a framework for heightened awareness of issues which lead to malpractice claims and can ultimately improve patient care and safety.

Inferior Vena Cava Filter Malpractice Litigation: Damned if You Do, Damned if You Don't.

BACKGROUND: The aim of this study was to analyze malpractice litigation trends and to better understand the causes and outcomes of suits involving inferior vena cava filters (IVCF) to prevent future litigation and improve physician education. METHODS: Jury verdict reviews from the Westlaw database from January 1, 2000, to December 31, 2015, were reviewed. The search term "inferior vena cava filter" was used to compile data on the demographics of the defendant, plaintiff, allegation, complication, and verdict. RESULTS: A total of 156 cases were identified. Duplicates and cases in which the IVCF was incidentally included were excluded from the analysis. Forty-nine cases involving either failure to place or a complication of IVCF placement were identified. Throughout the last 15 years, there has been increased number of jury verdicts toward IVCF. The most frequent defendants were internal medicine physicians (38%), vascular surgeons (19%), and cardiothoracic surgeons (12%). The most frequent claims were denied treatment or delay in treatment (in 35% of cases), negligent surgery (in 24% of cases), and failure to diagnose and treat complications (in 24% of cases). Of these, the most frequent specific claims were failure to place IVC filter (41%), implantation failure such as misplacement and/or misaligned implant (24%), erosion of IVC/retroperitoneal bleed (6%), and discontinuation of anticoagulation prematurely (6%). Seventeen cases (35%) were found for the plaintiff, with median awards worth of $1,092,500. In the 21 cases where pulmonary embolism (PE) was involved (43% of cases), 19 were fatal (90%). Of the fatal PE cases, 8 cases ended with verdicts in favor of the plaintiff (42%). Both nonfatal PE cases were won by the defense. CONCLUSIONS: IVCF placement with subsequent PE and death results in verdicts that favor the plaintiffs. This study emphasizes that adequate and transparent communication regarding preoperative planning, decision for IVCF placement, and informed consent may reduce the frequency of litigation. Public awareness of complications related to the placement of IVCF is increasing largely and spurned by aggressive advertising and marketing by plaintiff attorneys. Conditions for which IVCF placement is contemplated carry significant risk of malpractice litigation.

Variables That Impact Medical Malpractice Claims Involving Plastic Surgeons in the United States.

BACKGROUND: Medical malpractice lawsuits contribute directly and indirectly to the cost of healthcare in the United States. Reducing medical malpractice claims represents an often unrecognized opportunity for improving both the quality and affordability of healthcare. OBJECTIVES: The aim of this study was to better understand variables of the informed consent process that may contribute to reducing malpractice claims in plastic surgery. METHODS: A prospective multiple choice questionnaire was distributed via email to all of the 1694 members of the American Society for Aesthetic Plastic Surgery (ASAPS) to evaluate attitudes and practices of informed consent in relation to medical malpractice. RESULTS: A total of 129 questionnaires obtained from plastic surgeons were eligible for analysis (response rate 7.6%). Respondents who provided procedure-specific brochures to their patients were significantly less likely to be sued for medical malpractice (P = 0.004) than those who did not. Plastic surgeons that participated in malpractice carrier-required courses on avoiding medical malpractice litigation had a similarly significantly reduced likelihood of lawsuits. (P = 0.04). CONCLUSIONS: Variables that may reduce malpractice claims, and thereby both improve the quality and affordability of healthcare, include: (1) the use of procedure-specific patient education brochures; and (2) physician participation in malpractice insurance carrier-required courses. These findings should be of interest to physicians, hospitals, and insurance companies.

Maintaining the Punitive Element of Tort through Social Sanctions in Malpractice Reform.

In this piece, I focus on the limitations of moving medical malpractice from a tort to contracts basis, particularly in the loss of the punishment aspect of punitive damages. In doing so, I present the way in which medical malpractice is currently implemented in the United States under tort law. I then briefly review current malpractice reform efforts, focusing more so on the idea of "no-fault" administrative systems. Here, I also explore the fundamental legal differences between contracts and tort. I then discuss the ethics of blame-shielding and whether or not we are losing something by failing to blame bad actors. In doing so, I focus on the ethical implications of punishment. Operating under the assumption that the current tort-based medical malpractice system is driving up health care costs, I conclude by proposing a hybrid system that combines contract theory with noneconomic punitive sanctions: a "no-fault fault system."

[New Italian law on malpractice: the impact with risk, insurance and accountability management]. / La gestione del rischio clinico e l'impatto organizzativo richiesto dai cambiamenti apportati dalla cosiddetta legge Gelli (legge n. 24 del 8 marzo 2017).

The new Italian Law on malpractice redefined the risk profile of public and private healthcare Organization. This new law is a legislative response to the Italian medical malpractice insurance crisis. The law, in fact, requires an approach on risk thinking based and accountability. Finally, it also requires a review of the insurance management.