Jury verdicts and outcomes of malpractice cases involving arteriovenous hemodialysis access.

OBJECTIVE: To analyze malpractice cases involving hemodialysis access to prevent future litigation and improve physician education. METHODS: Jury verdict reviews from the WESTLAW database from 1 January 2005 to 1 January 2015 were reviewed. The search terms "hemodialysis," "dialysis," "graft," "fistula," "AVG," "AVF," "arteriovenous," "catheter," "permacatheter," and "shiley" were used to compile data on the demographics of the defendant, plaintiff, allegation, complication, and verdict. RESULTS: Sixty-six cases involving the litigation pertaining to hemodialysis catheter, arteriovenous fistula (AVF) or arteriovenous grafts (AVGs) were obtained. Of these, 55% involved catheter-based hemodialysis access, 18% involved AVF, and 27% involved AVG. The most frequent physician defendants were vascular surgeons (36%), internists (14%), nephrologists (14%), general surgeons (9%), and interventional radiologists (6%). Of the patients, 38% involved were male and the average patient age was 56.3 (standard deviation (SD) = 20.1) years. Region of injury was 50% in the neck or chest, 42% in the arm, and 8% in the groin. Injury was listed as death in 79% of cases. Of the deaths, 95% involved bleeding at some point in the chain of events. The most common claims related to the cases were failure to perform the surgery or procedure safely (44%), failure to diagnose and treat in a timely manner (30%), and negligent hemodialysis treatment (11%). The most common complications cited were hemorrhage (62%), loss of function of limb (15%), and ischemia due to steal syndrome (11%). A total of 26 cases (39%) were found for the plaintiff or settled. The median award was US$463,000 with a mean of US$985,299 (SD = US$1,314,557). CONCLUSION: While popular opinion may indicate that steal syndrome is a commonly litigated complication, our data reveal that the most common injury litigated is death which may frequently be the result of a hemorrhagic episode. In addition to hemorrhage, the remaining most common complications included steal syndrome and loss of limb function. Therefore, steps to better prevent, diagnose and treat bleeding, nerve injury, and steal syndrome in a timely manner are critical to preventing hemodialysis-access-associated litigation.

A surgeon's perspective regarding the regulatory, compliance, and legal issues involved with physician-modified devices.

Physician-modified endovascular devices are becoming commonplace in a modern climate where innovation outpaces regulated technological advancement. Off-label use of medical devices occurs on a daily basis throughout many institutions across the United States and when performed by physicians, is both legal and unregulated. The purpose of this invited commentary is to review the regulatory, compliance, and legal issues regarding the practice of medical device modification.

Drug-eluting stent task force: final report and recommendations of the working committees on cost-effectiveness/economics, access to care, and medicolegal issues.

Coronary artery disease remains a major health problem worldwide. Since introduction of percutaneous transluminal coronary angioplasty and stents, much progress has been made. Percutaneous coronary intervention, however, has been limited by restenosis (repeat obstruction of arteries that have been previously treated. Introduction of drug-eluting stents (DESs) in April 2003 was a major breakthrough in preventing restenosis. In March 2003, The Society for Cardiovascular Angiography and Interventions (SCAI) published a position statement on the clinical implications of DESs, recommending an evidence-based adoption strategy. Subsequently, in May 2003, SCAI formed a multidisciplinary Drug Eluting Stent (DES) Task Force to address the significant nonclinical ramifications posed by DESs: medicolegal, financial, and access to care. The Task Force included representatives from physician societies, industry, academia, the reimbursement community, and health policy organizations. The resultant report presents analyses, options, and recommendations regarding those nonclinical issues based on the collective experience and knowledge of the Task Force members. The Task Force trusts that this report will be of value to the diverse constituencies involved with introduction of this important new technology.