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.

[Handling of retrieved implants in orthopedic surgery : Results of a survey within the framework of the EndoCert initiative]. / Bestandsaufnahme zum Umgang mit ausgebauten Implantaten in der orthopädischen Chirurgie : Ergebnisse einer Umfrage im Rahmen der EndoCert-Initiative.

BACKGROUND: Although investigations of retrieved medical implants can provide valuable information about the cause of the revision, there is a lack of information, which could be avoided by consequent failure analyses. In the framework of the EndoCert certification system it is obligatory to record and report incidents. OBJECTIVES: The present work examines how the willingness to report has developed in certified arthroplasty centers and which method of handling retrievals is preferred and actually used. MATERIALS AND METHODS: On the basis of a questionnaire for handling retrievals, all 508 arthroplasty centers that were certified till June 1, 2016, were included (return rate = 97.2%). RESULTS: A total of 93.3% of the centers have established an algorithm for handling of retrievals and 83.0% of the centers prefer to hand out the retrieval to the patient, while only 25.7% wish to store it in the center for research purposes. In the case of a potential incident as the cause of revision, centers prefer to forward the retrieval to damage analysis, whereby the centers act in different ways, depending on the case. An implant fracture is, e.g., considered a reportable event in most cases without temporal limitation. On the other hand, breakage or failure of surgical instruments is considered not to be reported in the case of more than half of the centers. In 2014 and 2015, approximately 71% of EPZs reported no incidents. CONCLUSIONS: According to our survey, many certified arthroplasty centers are sensitized to careful handling of retrievals. The treatment of the explanted components is conducted in different ways. The assessment of whether an incident is to be reported shows large differences. In view of the relatively high number of revision surgeries, the number of reports to the authorities appears to be low.

[Consequences of uncritical indication assessment for hardware removal]. / Folgen einer unkritischen Indikationsstellung der Metallentfernung.

A 43-year-old woman sustained a severe ankle dislocation with distal fibular fracture in a domestic accident. This was initially treated with external fixation for 3 weeks. In addition to distal fibular fracture treatment using a fixed-angle locking plate system, a vacuum-assisted wound closure of the medial und lateral malleolus had to be performed due to a persisting difficult soft tissue situation with swelling and necrosis of the medial malleolus. Subsequently, after prolonged wound healing the soft tissue defect over the distal fibula could be covered with a split skin graft and the external fixation was removed. Implant removal was performed 2 years after primary treatment - following radiologically confirmed consolidation of the fracture. Intraoperatively, an iatrogenic oblique fracture of the fibula occurred due to a cold welded screw in the plate, which had to be treated with lag screws. In the further course, there was renewed extensive wound healing with methicillin-resistant Staphylococcus aureus (MRSA) infection. The patient filed a complaint for the iatrogenic fibular fracture during hardware removal and also criticized the insufficient wound closure which led to an impairment of wound healing. The expert opinion of the arbitration board ascertained a medical malpractice in terms of indications. Due to the already prolonged course after the primary osteosynthesis hardware removal was not recommended. In addition, the surgical technique that led to the iatrogenic fracture was criticized. The arbitration board furthermore concluded that with a pre-existing osteoarthritis of the ankle, hardware removal was not indicated. In a critical wound situation implant removal would only be indicated with simultaneous treatment of the osteoarthritis of the ankle. By means of a critical indication assessment the patient should have been advised to leave the plate in place and the complicated course with iatrogenic fracture and severely delayed wound healing could have been avoided.

Harms and responsibilities associated with battery-operated implants (BOI): who controls postmortem explantation?

The postmortem issues raised by battery-operated implants (BOI) are complex and issues of consent, setting (clinical vs research), and environmental risks have received little attention in bioethics literature. Analyzing the issues, the following are argued: (1) Patients receiving BOIs should sign a consent form that includes a requirement for postmortem explant of the device; (2) BOI consent forms should require the explanted devices be returned to their manufacturers for Returned Product Analysis; (3) Failure to explant and analyze devices from the research setting fails the research goal of generation of knowledge for the benefit of future patients; (4) Failure to explant and analyze devices from the clinical setting allows product defects to be potentially hidden from patients, families, clinicians, manufacturers, and regulatory agencies; (5) Bodies buried with BOIs potentially harm the environment; (6) Religious or philosophical objections to autopsy should not supersede the duty to explant and analyze BOIs; (7) The concepts herein for BOIs could potentially extend to non-BOI if the device has failure modes that can lead to a potentially life-threatening event or can cause permanent debilitating health issues, and the burial or cremation of the device poses environmental harm. In these situations, neither the patient (premortem) nor family (postmortem) should have the right to refuse explant.

[Registration procedure for incidents with implants]. / Meldeverfahren bei Vorkommnissen mit Implantaten.

Incidents involving implants, whether there is a break in the osteosynthesis plate or a synthetic inlay of an endoprosthesis, are incidents with mostly severe repercussions for the patient with immediate and delayed effects for the clinic involved and the manufacturer.

[Treating ICD patients at the end of their lives: attitudes, knowledge, and behavior of doctors and patients. A critical literature analysis]. / Umgang mit ICD-Patienten an ihrem Lebensende: Einstellungen, Wissen und Verhalten von Ärzten und Patienten. Eine kritische Literaturanalyse.

BACKGROUND: The implantable cardioverter-defibrillator (ICD) is highly effective in the therapy of malign heart rhythm abnormalities. However, the ethical dilemma of harming a dying patient has received little attention. We studied the current state of knowledge and behavior of physicians and the subjective needs of ICD patients with respect to end-of-life issues. METHODS: A literature search of articles published between 8/2010 and 3/2011 in PubMed resulted in the identification of 32 reports, of which 25 met selection criteria. RESULTS: Practically no clinical institution (96% in Europe) offers routine counseling of ICD patients on end-of-life issues. In only about 25% of cases do doctors initiate a discussion on this issue with the ICD patient, of which the majority takes place during the final hours of the patient's life. Knowledge of legal aspects of ICD deactivation is insufficient in about 50% of physicians. Many physicians underestimate the impact of ICD shocks and often have unrealistic expectations about the patient's knowledge on technical aspects of the ICD device. The majority of patients are reluctant to address this topic and prefer to rely on the decision of their attending physician. CONCLUSION: Despite insufficient empirical data, findings point to a low willingness of ICD patients to confront the end-of-life issue and prefer decisions to be made by their physician. Substantial knowledge gaps of physicians may cause barriers in considering the option of deactivating the ICD.

Effective communication and ethical consent in decisions related to ICDs.

This Review examines recommendations and principles that promote good decision-making with regard to the insertion, deactivation, and potential malfunction of implantable cardioverter-defibrillators (ICDs). This guidance is important because ICDs are now used for primary and secondary prevention of arrhythmias in more than 20 diverse clinical populations, which accounts for the exponential increase in insertion rates over the past decade. Current guidelines require clinicians to provide personalized, culturally appropriate, and easy to understand information to patients on the benefits and harms of proposed treatment choices; however, obtaining valid informed consent for insertion and deactivation of ICDs is challenging. Initiating early conversations with patients and continuing this dialogue over time, implementation of localized care protocols, increased collaboration (particularly between cardiac and palliative care teams), and the provision of training for all health professionals involved in the care of these patients, can help to ensure that adequate informed consent is maintained throughout their care. In addition to providing information, health professionals should identify and address high levels of anxiety in patients and their next of kin and promote effective communication throughout decision making. In the future, use of standardized checklists or decision aids based on a clear understanding of the principles underlying key topics could support this process.

Management of cardiac electrical implantable devices in patients nearing the end of life or requesting withdrawal of therapy: review of the Heart Rhythm Society 2010 consensus statement.

Cardiac implantable electrical devices (CIEDs) are increasingly common interventions for a wide spectrum of cardiovascular diseases. Caring for patients with life-sustaining devices such as CIEDs at the end of life raises legal and ethical challenges. In 2010, the Heart Rhythm Society (HRS) published an expert consensus statement to review the principles and practice of CIED deactivation. This statement addressed a wide range of ethical and legal principles while providing guidance for communication, decision-making, and procedures in a variety of settings. In this article, we provide a summary of the HRS guidelines and highlight the most important features of CIED deactivation for the practicing clinician.

EHRA Expert Consensus Statement on the management of cardiovascular implantable electronic devices in patients nearing end of life or requesting withdrawal of therapy.

The purpose of this Consensus Statement is to focus on implantable cardioverter-defibrillator (ICD) deactivation in patients with irreversible or terminal illness. This statement summarizes the opinions of the Task Force members, convened by the European Heart Rhythm Association (EHRA) and the Heart Rhythm Society (HRS), based on ethical and legal principles, as well as their own clinical, scientific, and technical experience. It is directed to all healthcare professionals who treat patients with implanted ICDs, nearing end of life, in order to improve the patient dying process. This statement is not intended to recommend or promote device deactivation. Rather, the ultimate judgement regarding this procedure must be made by the patient (or in special conditions by his/her legal representative) after careful communication about the deactivation's consequences, respecting his/her autonomy and clarifying that he/she has a legal and ethical right to refuse it. Obviously, the physician asked to deactivate the ICD and the industry representative asked to assist can conscientiously object to and refuse to perform device deactivation.

A forgotten gauze swab--clinical and legal considerations.

In this report, we will present two cases of retained gauze swabs following open heart surgery. We will discuss diagnostic and treatment strategies as well as medicolegal implications with regard to individual liability and possible penalties according to the German law.