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.

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.

Características de individuos sometidos a infiltración de materiales extraños con fines estéticos sobre los que se realizó investigación judicial en Colombia / Characteristics of individuals subjected to infiltration of foreign materials for aesthetic purposes and subject to a judicial investigation in Colombia

Introducción y Objetivo. La infiltración de materiales como silicona en los tejidos blandos es una práctica clandestina documentada en varios lugares del mundo; estos materiales buscan mejorar la apariencia estética y se han vuelto populares entre la población en general. El objetivo del presente estudio es describir las características de individuos sometidos a infiltración de materiales extraños en tejidos blandos con fines estéticos entre los que se desarrolló una investigación judicial en Bogotá, Colombia. Material y Método. Presentamos una serie de 26 pacientes sometidos a investigación judicial por la Fiscalía General de la Nación en Bogotá, Colombia, por muerte o complicaciones asociadas a estos procedimientos entre 2005 y 2015. Resultados. La mayoría de los pacientes del grupo de estudio fueron mujeres (62%). El procedimiento realizado con mayor frecuencia fue el aumento de glúteos por un esteticista en clínicas de estética o centros de belleza. Del total de pacientes, el 58% falleció por embolismo pulmonar de silicona; entre los supervivientes, la complicación más frecuente fue la aparición de cicatrices inestéticas. Conclusiones. La infiltración de materiales extraños en tejidos blandos es un procedimiento que reporta complicaciones y alta frecuencia de mortalidad; la mayoría de estos procedimientos se realizan en lugares y con materiales no autorizados, y por personal no capacitado. De ahí la importancia de generar acciones que prevengan este tipo de prácticas (AU)

Background and Objective. Infiltration of materials such as silicone in soft tissues is a documented clandestine practice in several places around the world.These substances seek to improve the aesthetic appearance of the patient, and have become popular in the general population. The aim of this study is to describe the characteristics of individuals that were under infiltration of foreign materials in soft tissues for aesthetic purposes in which a judicial inquiry was conducted in Bogotá, Colombia. Methods. We present a case series of 26 patients who were part of a legal investigation by the Colombian General Prosecution in Bogotá, Colombia, due to death or complications associated to these procedures between 2005 and 2015. Results. Most of the patients in our clinical serie were women (62%). The most frequently performed procedure was buttock augmentation, mainly done by a beautician in aesthetic clinics or beauty centers. Of the total of patients 58% died due to pulmonary embolism of silicone; among the survivors, the most frequent complication was anesthetic scar. Conclusions. Infiltration of foreign materials into soft tissue is a procedure that reports complications and a high frequency of mortality; most of these procedures are performed in illegal places and with unauthorized materials, and done by unqualified personnel. Thus remarks the importance of generating actions that prevent this type of practices (AU)

Comentario al artículo ‘Características de individuos sometidos a infiltración de materiales extraños con fines estéticos sobre los que se realizó investigación judicial en Colombia’ / No disponible

No disponible

Respuesta al comentario del Dr Felipe Coiffman: Comentario al artículo «Características de individuos sometidos a infiltración de materiales extraños con fines estéticos sobre los que se realizó investigación judicial en Colombia» / No disponible

No disponible

Scientific evaluation and pricing of medical devices and associated procedures in France.

Medical devices are many and various, ranging from tongue spatulas to implantable or invasive devices and imaging machines; their lifetimes are short, between 18 months and 5 years, due to incessant incremental innovation; and they are operator-dependent: in general, the clinical user performs a fitting procedure (hip implant or pacemaker), a therapeutic procedure using a non-implantable invasive device (arrhythmic site ablation probe, angioplasty balloon, extension spondyloplasty system, etc.) or follow-up of an active implanted device (long-term follow-up of an implanted cardiac defibrillator or of a deep brain stimulator in Parkinson's patients). A round-table held during the XXVIII(th) Giens Workshops meeting focused on the methodology of scientific evaluation of medical devices and the associated procedures with a view to their pricing and financing by the French National Health Insurance system. The working hypothesis was that the available data-set was sufficient for and compatible with scientific evaluation with clinical benefit. Post-registration studies, although contributing to the continuity of assessment, were not dealt with. Moreover, the focus was restricted to devices used in health establishments, where the association between devices and technical medical procedures is optimally representative. An update of the multiple regulatory protocols governing medical devices and procedures is provided. Issues more specifically related to procedures as such, to non-implantable devices and to innovative devices are then dealt with, and the proposals and discussion points raised at the round-table for each of these three areas are presented.