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Comment: litigation involving manufacturers' liability for defective medical products: judicial perspectives.

In this Comment, Judge Rosenn discusses, from a judicial perspective, the development of manufacturer's liability for defective medical products, with particular attention to the evolution of the strict liability doctrine, the courts' willingness to apply that doctrine to medical manufacturers, and recent suggestions for seriated trials as a means of more effective resolution of the complex litigation that arises in cases of alleged faculty design of medical products.

Equipment and Supplies↗

Medical malpractice in perspective. I--The American experience.

Concern over the possibility of an American style medical malpractice "crisis" in the United Kingdom has recently been voiced by members of both medical and legal professions. The validity of such fears is examined by reviewing the conditions that have given rise to the current American difficulties. It is argued that the rise in malpractice insurance premiums and associated restrictions in availability should be seen against the background of underwriting problems specific to medical liability in conjunction with a general decline in reinsurance cover. The evidence in relation to the clinical and resource implications of malpractice is analysed. In particular, arguments that increased litigation has influenced the practice of "defensive" medicine and the choice of specialty are critically examined. Medical malpractice claims and insurance are only part of a professional environment which is undergoing dramatic social and economic changes, many of which seem more plausible candidates to be treated as important influences on the nature and organisation of health care in the United States.

Costs and Cost Analysis↗

Factors influencing cessation of pregnancy care in Oregon.

BACKGROUND AND OBJECTIVES: Anecdotal evidence suggests that many providers who previously delivered babies are no longer doing so, both in Oregon and nationally. This study determined the proportion of pregnancy care providers who have stopped or are planning to stop providing this care in Oregon and identified the important factors influencing such practice changes. METHODS: We mailed a survey in October and November 2002 to all obstetrician-gynecologists, family physicians, general practitioners, and certified nurse midwives practicing in Oregon. The survey inquired about whether they currently perform deliveries. If they did not do so, or if they did so but planned to stop, further questions were asked about reasons for not providing this care. RESULTS: A total of 2,158 surveys were mailed; 1,232 were returned (58% adjusted response rate), and 1,069 had sufficient information to be included in our analysis. Of respondents, 511 (47.8%) currently perform deliveries. Of these, 157 (30.7%) indicated that they planned to stop doing so in 1 to 5 years, with cost of professional liability insurance (59%) and fear of lawsuits (43%) most frequently cited as major reasons. A total of 367 (34%) respondents had previously stopped performing deliveries. Providers who stopped providing this care since 1999 were significantly more likely to cite cost of medical liability insurance and low reimbursement as major reasons, compared to providers who stopped earlier. CONCLUSIONS: Our study suggests that as many as half of clinicians who previously performed or currently perform deliveries in Oregon are planning to stop or have already stopped providing this service, raising concern about access to pregnancy care services for women in the state.

Cross-Sectional Studies↗

Professional liability: epidemiology and demography.

Because of increasing numbers of claims, professional liability for obstetrician-gynecologists carries an ever-increasing cost in dollars, emotions and time. The tort system in medicine is slow and inefficient in time and dollars going to injured patients compared to dollars supporting courts and lawyers. As a result of medical liability costs and a rising number of claims, patients are losing basic access to care, especially for pregnancy and are treated defensively when the receive care.

Defensive Medicine↗

The yin and yang of neurological surgery. The 1993 AANS presidential address.

The President of the American Association of Neurological Surgeons (AANS) discusses the present socioeconomic milieu, which has created anxiety in the neurosurgical community. The underlying factors are technological advances, hospital-physician relationships, medical liability, quality assurance reviews, and physician reimbursement. It is proposed that neurosurgeons be proactive in the development of health-care reform.

Forecasting↗

Alternative medicine use in presurgical patients.

BACKGROUND: A dramatic increase in the use of complementary and alternative medicines has been observed. The use of such remedies in the presurgical population has implications for the anesthesiologist because of the potential for drug interactions, side effects, and medical liability. This study was undertaken to quantify the use of herbal remedies and vitamins in the presurgical population of a large tertiary care center. METHODS: A one-page questionnaire was distributed to all patients presenting for evaluation in the preoperative clinic over an 11-week period. Patients answered questions regarding use of prescription and nonprescription medications, herbal remedies, and vitamins. RESULTS: Twenty-two percent of presurgical patients reported the use of herbal remedies, and 51% used vitamins. Women and patients aged 40-60 yr were more likely to use herbal medicines. Over-the-counter medication use was strongly associated with herbal preparation use. The most commonly used compounds, from highest to lowest, included echinacea, gingko biloba, St. John's wort, garlic, and ginseng. CONCLUSIONS: Alternative medicine use is common in the preoperative period.

Adult↗

Malpractice crisis and reform.

Medical liability coverage has become increasingly expensive and scarce since 2001, especially for obstetrics and other high-risk specialties. Physicians, whose own fees are constrained, see this as a crisis needing tort reform to cap payouts. Plaintiffs' lawyers fight caps; they blame insurance trends and call for stronger regulation of insurers and physicians. Doctors' arguments are somewhat better than lawyers' about insurance developments, but the huge tort reform battle wholly ignores the biggest problems--the medical system has too many preventable medical injuries, and the legal system fails to prevent them. It is time to try out better approaches, three of which are discussed in this paper.

Compensation and Redress↗

The hospital doctor in legislation and medical deontology: tension between profession and institution.

1. Every health policy should make clear the organization of its offer of care; also, more particularly, the role of the individual professionals and their groups, as well as the role of the services and institutions, all within the chosen private, public or mixed framework. 2. Both in public law and in private law as well as in deontology, clear rules will have to be formulated concerning the relationship of doctor-patient and institution-patient; therefore also concerning the relationship of hospital-doctor. 3. It is evident that the lack of clarity frequently encountered in the Belgian and many other national legal systems with respect to these matters is unfortunately also reflected in international health law. 4. The issue of the legal relationships in the patient-doctor-hospital triangle should no longer be delayed until the catastrophic moment when medical liability should be considered. 5. Can we indeed speak of integral quality of a hospital, when it is anything but clear whether it concerns a single integrated enterprise or a roof under which two or more enterprises or entrepreneurs organize their own separate services to the clients? 6. Although the decision is a societal matter, the organisations of institutions and professionals should (continue to) play an important role in the preparation of this debate, which must bring the necessary clarity to the present relations and preferably also about the future options with respect to these relations. 7. A fundamental question, which remains to be solved for the future health policy, appears to be whether hospitals can be integrated institutions and, in the affirmative, whether they should be so. 8. The law, with priority to deontology, should formulate basic rules to clarify all possibilities in the patient-hospital-doctor triangle relationship--which is evolving into a polygon through fusion and group practices--and especially to trace out the consequences of health policy options with regard to the integrated hospital formula, also for patients, and to enhance its chances of success. 9. Will the professionals succeed in convincing the hospital responsibles that the integrated hospital itself is already a far too traditional construction to offer a valuable answer to the future needs of the patients?

Belgium↗

[Administrative procedures in cases of medical errors: the jurisdiction of the hospitalist].

The administrative jurisdiction is, with the exception of free practice within hospitals, that which judges whether actions of hospital doctors are at fault, and evaluates the harm done to the plaintiff. After a reminder of the fundamentals of medical liability as regards the administration, a short update on private practice in hospital, and the notion of fault being separate from the hospital function, the author analyses the important elements such as the concept of the preliminary decision and the status of the expert, and then a number of characteristic elements of this type of procedure, stressing in particular the absolute necessity of a perfectly kept hospital medical record.

France↗

Changing physician behavior to improve disease prevention.

Physicians often fail to provide nationally recommended preventive services for their patients. Addressing this, we have reviewed selected literature on changing physician behavior using the organizational construct of the "readiness for change" transtheoretical model. This model suggests that behavior evolves through stages from precontemplation, to contemplation, to preparation, to initiation, and to maintenance of change. Traditional continuing medical education may affect knowledge and beliefs, but rarely results in behavior change. However, motivational strategies such as practice feedback reports and influential peers can foster stage change. Successful interventions aimed at physicians preparing for change frequently use an office-system approach that targets not only physicians, but office staff and patients as well. Illustrating how the readiness to change model can guide the design and implementation of interventions, we describe strategies being used in a statewide randomized controlled trial to improve cancer prevention counseling and early detection by primary care physicians. The multistage interventions of Partners for Prevention include support from a medical liability carrier, a motivational videotape, a task-delineated office manual, chart flowsheets, patient activation forms, practice feedback reports, a designated prevention coordinator within each practice and regular telephone calls and office visits by project staff.

Clinical Competence↗

Evidence-based guidelines and critical pathways for quality improvement.

Clinical practice guidelines have a long and distinguished tradition in pediatrics. Currently, the American Academy of Pediatrics has developed more than 15 practice guidelines and more than 250 clinical policy statements. In the past, practice guidelines have been used to improve care through the dissemination of evidence-based, clinically effective practices to pediatric practitioners. In the current environment this purpose has been broadened to include cost reduction, standardization of practice, and reduction of medical liability. This has led to both confusion and distrust on the part of the pediatrician. Practice guidelines are best understood as a tool to insure that children receive evidence-based care. They are best used in association with a set of outcome and performance measures that provide feedback to clinicians and allow for modification of the guidelines to meet the needs of the local patient population. The quality of practice guidelines is directly dependent on the quality of the medical evidence supporting the recommendation. Unfortunately only a small percentage of the evidence supporting practice guidelines comes from randomized clinical trials with the majority of the evidence coming from expert clinical panels. The success of practice guidelines in improving care for children has yet to be convincingly demonstrated. Currently, there is a dearth of well designed studies that document the effectiveness of practice guidelines. Their ultimate effectiveness will depend on both an improved evidence base and effective strategies for rapid dissemination of the recommendations. The development of evidence-based practice guidelines does not insure that it will have a major impact on physician practice. In the past, effective dissemination of new knowledge has been a long process, often taking years. This cycle time can be dramatically shortened through the development of networks of practice sites that share knowledge and experience in the implementation of practice guidelines and the use of strategies that take advantage of key groups in the dissemination process. When used appropriately, practice guidelines can provide an important adjunct to clinical research by facilitating the dissemination of new clinical findings and can provide an important platform for encouraging innovations in patient care.

Critical Pathways↗

Automation of the medical chart.

A properly implemented automated charting system should improve patient care by providing patient information in more meaningful formats to assist the nurse and physician in making better, more timely decisions. It should save the nurse's time in collecting and recording data. Most importantly, it should economically benefit the hospital by making the nursing staff more efficient and decrease missed DRG reimbursements. Better charting will also decrease the hospital's exposure to medical liability. Patient charting should be an integral part of a nurse's daily activities, not something added to the end of the shift. The automation of the patient chart should allow the nurse to enter the data into the computer throughout the day without interfering with normal nursing activities. It is evident that a need exists and software is now becoming available to fill that need. The next five years should see automated patient charting as one of the fastest growing areas in medical computing.

Database Management Systems↗

Medical malpractice in urology, 1985 to 2004: 469 consecutive cases closed with indemnity payment.

PURPOSE: Malpractice premiums have increased by up to 57% for urologists in the last 3 years, for which the reasons are not clearly reported. We sought to better understand factors contributing to the current medical malpractice crisis in urology. MATERIALS AND METHODS: Working with the Medical Liability Mutual Insurance Company of New York State we evaluated malpractice claims in urology that were closed with indemnity payment between 1985 and 2004. Individual claims were assessed for the purported negligent act, the procedure when applicable and the expense incurred. We also evaluated the impact of new technologies, eg laparoscopic nephrectomy, on reported claims. RESULTS: A total of 469 urology malpractice claims were closed with indemnity payment during the period evaluated for a total loss indemnity of Dollars 99,335,431. The number of files closed with indemnity payment yearly remained relatively constant at an average of 22 claims. The average indemnity payment increased each year and after correcting for inflation a 191% increase was observed for the period evaluated. The greatest number of claims was related to postoperative events (total of 101), followed by intraoperative events (96), failure to diagnose a given condition (60), medication administration error (21) and a foreign body left following surgery (20). In the area of new technologies laparoscopic surgery accounted for 4 claims and transurethral needle ablation accounted for 1. Vasectomy accounted for 8 claims. CONCLUSIONS: In the current study surgical procedures were the greatest generator of claims with the most common being oncological. Emerging and new technologies, eg laparoscopy and robotics, did not account for the increase in indemnity payments observed to date. Only further investigation will determine whether this is secondary to a lag time in the closure of suits related to these emerging technologies or to a lack of such suits. The actual number of claims closed with indemnity payment yearly remained relatively constant. However, the indemnity payment per claim far outpaced that expected for inflation. The observed increase in indemnity payment per claim would appear to be a significant contributing factor to the current malpractice crisis in urology.

Humans↗

Maternity care financing: universal access or universal care?

In an era of fiscal constraint, growing poverty, increased uninsuredness, medical liability problems, and increasing costs of maternity care, public and private financing mechanisms are changing rapidly and the service delivery system is increasingly fragmented. Despite the almost mercurial changes in the system, data from national studies show that access to care is a major problem affecting all childbearing women. This paper describes the three groups of women who require comprehensive maternity care, their insurance coverage, and the gaps for each group. It describes proposals which are currently under development to reduce uninsuredness and produce universal access and, in addition, presents an alternative plan for universal maternity care.

Costs and Cost Analysis↗

Physician professionalism for a new century.

During the past 50 years, physicians have become increasingly dissatisfied with certain aspects of their profession. Dissatisfaction has intensified with the advent of managed care in the late 20th century, the medical liability crisis, and the growing divergence between the professional and personal expectations placed upon physicians and their practical ability to meet these expectations. These and other factors have encroached on physician autonomy, the formerly ascendant professional value within medicine. As the underlying values and practical realities of the broader American health care system have changed, the professional values and practices of physicians have failed to adapt correspondingly, resulting in a "professionalism gap" that contributes to physician dissatisfaction. To improve the outlook and efficacy of modern American physicians, the profession must adopt a new values framework that conforms to today's health care system. This means foregoing the 20th century's preferred "independent physician" model in favor of a new professional structure based on teamwork and collaboration. Convincing established physicians to embrace such a model will be difficult, but opportunities exist for significant progress among a new generation of physicians accustomed to the realities of managed care, flexible practice models, and health information technology. The teaching of clinical anatomy, given its incorporation of student collaboration at the earliest stages of medical education, offers a prime opportunity to introduce this generation to a reinvigorated code of professionalism that should reduce physician dissatisfaction and benefit society.

Anatomy↗

71st legislature produces bills that improve health care in Texas.

The 71st Texas Legislature adjourned May 29, ending what was an extremely successful session for the Texas Medical Association. During the 140-day session, TMA tracked more than 600 individual bills and secured passage of major legislation addressing rural health care, Medicaid enhancement, medical liability reform, and other measures to improve the quality of health care and the practice of medicine. TMA also was successful in blocking passage of legislation that might have lowered the quality of care. As this issue of Texas Medicine was going to press, Gov Bill Clements was threatening to veto the rural health care bill, House Bill 18. That issue was a possible agenda item for the special session Clements called for June 20. The special session was called specifically to deal with workers compensation reform, an issue the lawmakers failed to resolve during the regular session. This article, prepared by Ken Ortolon, public relations assistant, and the TMA Public Affairs staff, lists some of the issues TMA was involved in during the 71st session and their outcomes.

Legislation, Medical↗

State healthcare reform: an arena for the osteopathic medical profession's influence.

While healthcare reform proposals are debated at the national level, states continue to propose and implement reform measures to address Medicaid, health insurance, universal coverage and access, medical liability, and cost-containment. The authors examine the shared responsibility of the federal and state governments for healthcare regulation and the surprising number of powers that reside with the states. They review the major barriers to state reform represented by restrictions within Medicaid and the Employee Retirement Income Security Act of 1974 (ERISA) legislation. Established state programs in Maryland, Hawaii, and Arizona are revisited, and innovative reforms in Oregon, Tennessee, and Washington are examined. Finally, the authors concentrate on the reform measures under way in the five most heavily DO-populated states, pointing out the potential for one of the big three (Michigan, Pennsylvania, and Ohio) to emerge as a model for the larger states. They urge osteopathic physicians to exert influence, based on their record of serving the Medicaid and other underserved populations, in state settings where they can be most effective.

Health Care Reform↗