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Reuse and reprocessing of disposable medical devices. Legal liability issues.

Reuse and reprocessing of disposable medical devices raises issues of legal liability, especially among physicians, hospitals, and device manufacturers. The practice of reuse has been, at least informally, reported to be fairly widespread. However, the medical risks associated with reuse are unresolved in most cases, which may lead to circumstances conducive to litigation. In this paper, the characteristics of reuse pertaining to legal liability, the parties potentially subject to civil liability suits as a result of reuse, the legal theories underlying claims of injury, and the legal implications of possible policy actions will be examined.

Disposable Equipment↗

[Medical responsibility in the public hospital environment].

Patients can take action against physicians in front of different courts: Penal or Administrative Courts. Most of the time, the counsel chooses the legal proceedings. In the past, it was always necessary to prove the existence of malpractice; today, since 1990, the Administrative Court admits that it is no more necessary to find a malpractice, a damage and a link between the both. The medical expert valuation takes an important place in this matter. Nevertheless, the magistrate is not bound by the expert's report. In the last ten years several decisions have changed the usual rules in the matter of medical liability. Actually, in some special cases the Administrative Court admit a medical responsibility without malpractice, and so judges speak of medical risk.

Ethics, Medical↗

[Medical expert assessment in civil and criminal law--stand for evaluating medical expert assessment].

The standard for the assessment of the medical expert opinion is defined by the high demands expected from the judgement of a high court: Objectiveness, solid knowledge, self-criticism, in contestability in diction and firmness in the argumentation. From the legal point of view, the knowledge of the medical expert witness has to clearly go beyond the knowledge of his profession. The obligation for objectiveness is the basis of expert witness' activity. From the medical point of view, the physician has to take into account during the preparation of his expert assessment that structural deficiency of the personnel and surgical equipment of a department for surgery frequently plays a role due to the development of surgery to high tech medicine and the hospital physician cannot affect this. It is necessary for a physician as an expert witness to have basic knowledge about the evidence law and the medical liability process. On the other hand, judges and lawyers should basically know the medical way of thinking.

Criminal Law↗

Medical malpractice.

Medical liability insurance is in a state of emergency brough on by escalating premiums or withdrawal of insurance companies from the market. Solutions, supported by legislation, must be sought for the sake of both patient and physician. As a temporary method of correction joint underwriting associations appear to be the most practical suggestion. Long-range changes should include the establishment of powerful malpractice arbitration boards whose conclusions and evidence would be submitted in case of further appeal, the delegation of more power to the medical profession to enforce standards, shortening of the period specified in the statutes of limitation, limitations on contingency fees, and elimination of the applicability of such legal doctrines as ad damnum clauses and res ipsa loquitur.

Economics, Medical↗

Medical malpractice claims and quality improvement program as viewed by a forensic pathologist.

This is a review article dealing with the half-century evolution of the quality assurance program to improve patient care in the United States. The author attempted to point out some differences in approach to solving the medical error and medical malpractice problems between Japan and the U.S. In the 1970s, an increase in the medical malpractice claims resulted in such high premiums for medical liability insurance that it threatened the healthcare system in the U.S. Urgent legislative remedy, the Medical Injury Compensation Reform Act (MICRA) was put into place in the State of California. This act was the beginning of the definitive quality improvement in our health care system. It was followed by other improvement programs, such as the National Practitioner Data Bank (NPDB) for tracking physicians with malpractice judgments or settlements against them, or who have problems with the medical licensing Board or other impairments. By comparison, in recent years, in Japan, there has been a rash of medical malpractice claims, similar to the situation in the U.S. in the 1970's. The two pronged approach to maintaining and assuring quality health care are: (1) Set standards by inspection and accreditation of hospitals and healthcare facilities and (2) by credentialing and peer review program to assure the competency of the physicians and other healthcare personnel. Clinical medicine has made a major effort in setting up a quality assurance program and so has forensic medicine. Similar approaches have been used in both programs. The current emphasis in forensic medicine is on inspection and accreditation of the medical examiner and coroner's offices by the National Association of Medical Examiners (NAME) and re-certification for the medical license and specialty board and credentialing and peer review activities.

California↗

[Evaluation of 157 arbitration procedures against maxillofacial surgeons handled by the arbitration office of the North German Medical Associations from 2000 to 2005].

Medical work is, just like any other profession, not always without error and even when no mistake has been made the patient may suffer health damages, because such are the unavoidable risks. Arbitration procedures of medical liability disputes can in particular cases resolve the individual conflict between physician and patient. The results of these arbitration procedures can point towards the main focus of diagnosis, patient accusations (patient dissatisfaction) and treatment errors. In the space of 6 years from 2000 until 2005 the North-German arbitration office handled 157 arbitration procedures against Maxillofacial surgeons. The decisions were statistically and casuistically analysed with regard to patient accusations, type of treatment error, frequency of treatment error, health damages that were caused and not caused by errors. Liability claims against a physician result only from those errors that have caused health damages to a patient. Not all errors cause damage automatically. Patient claims were found to be justified in 28% of all procedures and a recommendation for regulation was made to the physician's insurance. Maxillofacial surgery, with reference to the 20.4% of cases analysed, clearly represents less than the total average. The main focus of accusations raised by patients and also the main focus of the observed treatment errors are operative errors as a cause of sensitivity defects of the lower lip and the tongue, also of tongue damages and their associated taste defects. Parallel to the 20.4% of cases, which showed iatrogenic health damages caused by errors, 60.9% of cases showed patients had also suffered iatrogenic damages even though no medical errors had caused them.

Cross-Sectional Studies↗

The wheel of misfortune. Genesis of malpractice claims.

Unlike other surgical specialists, plastic surgeons attending patients who seek aesthetic improvement are not trying to make sick patients well, but rather well patients better. This not only places a much heavier burden of responsibility on the operating surgeons, but also subjects them to a much broader range of a patient's reasons for unhappiness. This article examines various fields of plastic surgery in terms of liability and offers advice on how best to reduce the frequency of such medical liability claims.

Humans↗

Improving the medical malpractice litigation process.

Critics charge that judges and juries are incompetent to address medical liability issues. Some advocate shifting authority away from ordinary judges and juries, either by appointing "expert" decisionmakers, such as "medical screening panels" or specialized "medical courts," or by instituting caps on damages. Problems with the tort liability system may weigh in favor of a shift to a no-fault administrative compensation system. If the current fault-based system is retained, however, policymakers should not adopt half-measures by creating "expert" panels or "expert" courts. Rather, they should better equip the existing decisionmakers to deal with liability and damages questions.

Expert Testimony↗

Professional liability claims and Central Association of Obstetricians and Gynecologists members: myth versus reality.

OBJECTIVE: The purpose of this study was to survey members of the Central Association of Obstetricians and Gynecologists about professional liability claims. STUDY DESIGN: A survey was mailed to Central Association of Obstetricians and Gynecologists members regarding medical liability experience. RESULTS: Of the 897 surveys mailed, 73% were completed. The responding 658 clinicians had been in practice for 17,136 years and had 1507 closed claims. The respondents had a claim every 11 years of practice and a trial every 69 years. Matched for years of practice, a case control comparison indicated that the litigation is significantly lower for female physicians (1.5 +/- 1.8) than for male physicians (2.2 +/- 2.0; P = .019) although the mean cases that were dropped or dismissed were higher for men (1.3 +/- 1.7 vs 0.8 +/- 1.4; P = .022). However, the mean number of trials, defense trial verdicts, and the settlement amounts were similar for both genders. CONCLUSION: We found that professional liability claims are uncommon and that the gender of the obstetrician-gynecologist influences the litigation profile.

Adult↗

A large community hospital's experience with an obstetrics-gynecology risk management committee: quality assurance.

In an era when medical-legal suits and awards are escalating, a major metropolitan hospital in Seattle, Washington, has developed a plan to identify and effectively deal with problem physicians, improve patient care, and reduce medical liability for the institution. The Department of Obstetrics and Gynecology of The Swedish Hospital Medical Center formed a risk management committee that met regularly to monitor and evaluate clinical complications and questions of professional incompetence or physician impairment. A system for detecting such cases was established through liaison with other hospital peer review committees or any physician or nurse who was privy to specific information and willing to submit it in writing. Cases were carefully and objectively analyzed and evaluated as to their significance and severity. Single serious errors in case management were brought to the attention of the offending physician. Chronic offenders had privileges restricted or revoked with the approval of the hospital executive committee. This has resulted in improved medical care for patients and a reduction in medical-legal action against the hospital.

Defensive Medicine↗

The impact of medical legal risk on obstetrician-gynecologist supply.

OBJECTIVE: To evaluate the effects of medical legal risk on practice location of obstetrician-gynecologists. METHODS: We used the American College of Obstetricians and Gynecologists (ACOG) Membership Record to determine the number of Fellows and Junior Fellows by state. We obtained state malpractice premiums from the Medical Liability Monitor and state birth rates from the National Center for Health Statistics. The American Medical Association (AMA) "Crisis" and ACOG "Red Alert" designations, as well as state malpractice premium levels, were used to approximate malpractice risk. We examined the changes in state births to obstetrician-gynecologist rates from 1995 to 2003 by using the Student t test and Mann-Whitney tests. Comparisons were made between states of different risk levels. RESULTS: We found no significant difference in the percentage changes in births per Fellow or births per Junior Fellow between AMA "Crisis" and remaining states, nor between ACOG "Red Alert" and Safe states. The percentage changes in births per Fellow were similar in the 10 highest-premium states and the 10 lowest-premium states. The percentage increase in births per Junior Fellow in the 10 highest-premium states was significantly greater than the 10 lowest-premium states (median 28.5% versus 5.0%, P = .03). CONCLUSION: Malpractice premiums appear to influence practice location of new obstetrician-gynecologists. Neither the AMA designation of "Crisis" nor the ACOG designation of "Red Alert" had supply implications in the analysis. More research on the interaction of malpractice rates and obstetrician-gynecologist supply is needed for informed decisions regarding malpractice premium management.

Birth Rate↗

Florida Legislature passes medical malpractice law.

The Florida Legislature recently adopted a medical liability tort reform package, a step toward what physicians hope is an eventual solution to the medical malpractice problem. In the August issue, Dr. Coleman chronicled the Florida Medical Association's efforts to pass a statewide constitutional amendment to accomplish similar reforms. Here, FMA's immediate past president tells how the previously unsuccessful efforts led to a promising legislative victory.

Florida↗

[Surgical risk. A developmental concept].

The word risk has several senses. Whether in civil, penal or administrative law, it supposes the notion of liability. Liability too often leads to decide in advance that there has been a fault. The corollary of fault is repair. One condition for this is that there is damage, a cause-effect relationship and evidence. Then what about liability without fault, with the notion of burden of the proof, of compensation for damage, in the ill-defined context of presumed fault? There is a praetorian law about medical liability. It is an adaptation, with the passing years, of common law to the specific issues of medicine. Surgery is a profession with risks and duties. The reasonable liability of the surgeon represents his claims for fame. The surgeon must neither be released of any liability nor assumed to be guilty a priori. There is enough matter for a wide ethical and legal debate about a concept-risk-that has undergone many vagaries.

Ethics, Medical↗

It is easier to confuse a jury than convince a judge: the crisis in medical malpractice.

STUDY DESIGN: A study of cervical spine malpractice cases was conducted. Identifying tort reform models may help to resolve a crisis in medical malpractice. OBJECTIVE: To identify tort reform models that may help to resolve a crisis in medical malpractice. SUMMARY OF BACKGROUND DATA: Medical malpractice faces a crisis. Insurance rates are exorbitant, yet many injured patients go uncompensated. Physicians practice defensive medicine for fear of suits, and society pays the price. METHODS: Using, 36 malpractice cases involving cervical spine surgery were identified: 20 from California ($250,000 cap on pain and suffering) and 16 from New York ("the sky's the limit"). Queries included who sued, who was sued, who won, who lost, and why? Six different tort reform models also were identified and explored. RESULTS: Common bases for suits included failure to diagnose and treatment (56%), lack of informed consent (64%), new neurologic deficits (64%), and pain and suffering (72%). All of the six plaintiff verdicts (average, $4.42 million) and four of the nine settlements (average, $1.6 million) involving surgery that resulted in new postoperative quadriplegia appeared to be appropriate. However, the author could discern "no fault" in cases five defendants had settled, and the surgeons did not deserve to lose. On the other hand, the author found "fault" in five defense verdicts rendered to three newly quadriplegic patients and two with new postoperative root injuries. These patients deserved monetary awards, but received no compensation whatsoever. There currently are two models that would work better than the system in place in most states. These include the American Medical Association National Specialty Societies Medical Liability Project with the Alternative Dispute Resolution Model (SSMLP), and the Selective No Fault Models. Among the advantages shared by one or more of these models is their ability to reimburse injured patients while eliminating physician liability, to use malpractice panels rather than trials, and to put a cap on damages. CONCLUSIONS: To solve the medical malpractice crisis, Congress, the individual states, or both should adopt tort reform. Two tort reform models compensating injured patients and eliminating physician liability appear to be not only effective but also fair to all concerned parties.

California↗

Practice guidelines & medical malpractice litigation.

In 1973, the United States Congress enacted legislation requiring physicians to initiate Peer Review Organizations to monitor utilization and quality of hospital and physician services in the federally funded Medicare program. A hardly noticed provision of the statute intimated the desirability of formulating guidelines for medical treatment. What was originally intended to simplify and universalize general standards by which quality of care could be objectively measured has more recently escalated into formalized projects, subsidized by government, to create "practice parameters". The impetus to define clinical conditions and methods of treatment for specific medical conditions (practice parameters) and standards of practice to avoid or defend malpractice claims (risk management protocols) are part of the movement in the United States for tort reform. If the vague "reasonable man" standard of care in negligence law can be supplanted by a scientifically developed, particularized medical practice standard, it is anticipated that spurious claims and defensive medical practice will be discouraged, quality improved, iatrogenic injury and malpractice litigation diminished. Many U.S. states undertook tort reform in the last decade. A few have embarked on medical-legal reform. One state is conducting a five-year medical liability project that calls for the development of practice parameters and risk management protocols in four medical specialties. The parameters will have the effect of law and may be introduced as evidence in medical malpractice trials. How the parameters are established, their effect on the strategies of litigation, the resultant trial problems in the introduction of evidence and in the burden of proof and their potential for acceptance by a significant number of jurisdictions-are the issues to be explored in this paper.

Humans↗