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PubMed1998

The war against junk science: the use of expert panels in complex medical-legal scientific litigation.

In the legal context, junk science is defined as evidence that is outside of mainstream scientific or medical views. Junk science does not have indicia of reliability and is not generally accepted. Despite the lack of scientific reliability, US courts, expert witnesses and juries are increasingly reliant on junk science in making causation decisions in complex medical liability cases. Courts have accepted junk science even where reliable scientific evidence is available. The United States silicone gel breast implant litigation is a prime example of this phenomenon. The issue of whether silicone breast implants are associated with disease has been a controversial subject for scientists and physicians, an emotional issue for women who have breast implants, and a lucrative business for the lawyers and expert witnesses who are the proponents of junk science. Junk science has provided to juries a quick and convenient explanation for claimed diseases or syndromes which have required years for reliable scientists to conclude are not related to breast implants. The breast implant litigation highlights the often dramatic difference between decisions based upon junk science and decisions grounded in scientific method, fact and reality. Recently, judges involved in the breast implant litigation have become concerned about the use of junk science in light of the growing body of legitimate scientific evidence that breast implants do not cause disease. Several judges have been motivated to take the unique and novel approach of convening scientific panels of independent experts to study the scientific issues and make findings to the court. Through the use of independent scientific experts, several judges have meaningfully assessed the evidence that the litigants present and have prevented or strictly limited the use of junk science in the courtroom. Using this procedure, other judges are weighing the evidence for future cases. This paper will briefly explore the background of mass tort medical products litigation and the development of junk science. The paper will then focus on the history of the breast implant litigation and the steps that the courts have already taken to combat junk science, including the use of scientific panels.

Biocompatible Materials↗
PubMed2005

Fast forwarding: the evolution of neurosurgery. The 2005 presidential address.

Despite the major social and economic reorganization of medical practice that has taken place during the past 40 years, neurosurgery-the most fascinating specialty in all of clinical medicine-has grown and prospered. Today, this specialty is poised for an era of spectacular advancement and improvement in care; however, significant problems with the potential to retard this growth face neurosurgery. Among these problems is the medical liability situation, which has the potential to destabilize neurosurgical practices and the current health care delivery system. Other issues facing neurosurgery include the potential for loss of the unique nature of the specialty through a conversion to shift-worker surgeons and increasing reliance on profit-seeking institutions for financial stability and liability protection. Lifestyle choices are of growing importance and currently discourage women from entering the field. With a growing knowledge base, there is the recognition that it may not be possible for most individuals to master all aspects of the specialty. There is continued confusion about manpower needs. In addition, some neurosurgeons are choosing to practice in ways that fail to meet the neurosurgeon's obligations to society. There is a growing number of neurosurgeons who dislike providing trauma coverage and there is the potential for some neurosurgeons to give up intracranial neurosurgery. The author believes that it is not competition that will improve the delivery of neurosurgical care and allow for continued growth, but cooperation, and that it will be possible to alleviate many of our problems through increased regionalization of neurosurgical care delivery. This proposal has the potential to promote the formation of neurosurgical teams, ameliorate the problem of physician fatigue, allow greater development of subspecialty skills, and ease the burden of trauma call. It should allow satisfactory solutions to lifestyle considerations and encourage more women to enter the field of neurosurgery. Such a transformation would encourage advances in care to be brought rapidly into the clinical setting and allow neurosurgery to be practiced at the very highest level.

Curriculum↗
PubMed1975

[Panel discussion: problems of the specialist's duty to inform the patient (author's transl)].

The obligation of the physician to inform the patient -- which he has to prove in a case of a suit -- is based on the patient's right of self-determination. This self-decision information was subject of the panel discussion. Not discussed in detail were the information concerning diagnosis and prognosis, and the instruction of the patient regarding his conduct postoperatively and during medical treatment. Not considered was the so-called malpractice and negligence respectively. Medical liability suits are increasing for various reasons and are frequently directed at a failure to inform the patient because the patient is often unable to prove a negligence of the physician ("surrogate liability"). The dimension of the duty of disclosure (complete information -- no information at all) is discussed in general and with special regard to the Ear-Nose- and Throat field. Special questions are answered regarding otoplasty, middle ear surgery, transplantations, extension of laryngeal surgery without prior informed consent, paranasal sinus and rhinobasis operations as well as surgery in minors and foreigners. In cases of non-vital indication and particularly in plastic-cosmetic procedures and outsider methods the requirements for informed consent are particularly important. The so-called rate of complications has perhaps a relative, but never an absolute meaning, and even this only in connection with the other circumstances of an individual case. The evidence of an adequate informed consent which must be included in a physician -- patient-dialogue is most convincing by means of a written consent and the additional signature of a witness, perhaps also of the patient. The value, the problems and even the risks of an information based only on forms or brochures is discussed in detail. The panel discussion from the four points of view of the organizers should by no means confuse the otorhinolaryngologist. It should inform him about the medicolegal aspects of his activity and protect him from avoidable burdens.

Ethics, Medical↗
PubMed2002

How liability law affects medical productivity.

Previous research suggests that "direct" reforms to the liability system-reforms designed to reduce the level of compensation to potential claimants-reduce medical expenditures without important consequences for patient health outcomes. We extend this research by identifying the mechanisms through which reforms affect the behavior of health care providers. Although we find that direct reforms improve medical productivity primarily by reducing malpractice claims rates and compensation conditional on a claim, our results suggest that other policies that reduce the time spent and the amount of conflict involved in defending against a claim can also reduce defensive practices substantially. In addition, we find that "malpractice pressure" has a more significant impact on diagnostic rather than therapeutic treatment decisions. Our results provide an empirical foundation for simulating the effects of untried malpractice reforms on health care expenditures and outcomes, based on their predicted effects on the malpractice pressure facing medical providers.

Aged↗
PubMed1993

Ophthalmology and the Resource-Based Relative Value Fee Scale.

The Medicare Resource-Based Relative Value Scale for ophthalmology has significantly reduced the level of reimbursement for surgical fees and only minimally increased evaluation and management fees. Some observers have felt that the methods for determining fees were flawed, and, generally, practitioners have been concerned about a potential loss of income. While reimbursement for individual services is being cut, projections through 1996 indicate that ophthalmology, as a specialty, will receive 55% more funding due to historical trends and increasing ranks of providers. This will translate into a more moderate global reduction in revenue of approximately 11%. The possible implications of the Resource-Based Relative Value Scale include a concentration of ophthalmic surgery into fewer practices, which may be able to distribute medical liability costs over a larger number of procedures. To counter the constraints of fee limits, individual physicians will probably seek to enhance their net income by greater use of paraprofessional personnel, the acquisition of new technologies, and the application of improved management skills.

Centers for Medicare and Medicaid Services, U.S.↗
PubMed1984

[Iatrogenic lesions of peripheral nerves in surgery].

The frequency of various iatrogenic nerve injuries is reported based on an evaluation of representative material from medical liability proceedings. During operations, nerve injuries occurred most frequently in the neck (lymph node biopsy, thyroidectomy) and the extremities (operations on the hand, total hip arthroplasty). Paralysis of the sciatic nerve following intragluteal injection is still the main injury caused by injection.

Cranial Nerve Injuries↗
PubMed2005

Consent or submission? The practice of consent within UK chiropractic.

BACKGROUND: A patient's right to accept or reject proposed treatment is both an ethical and legal tenet. Valid consent is a multifaceted, controversial and often complicated process, yet practitioners are obligated to try to obtain consent from their patients. Its omission is a common basis for malpractice suits and increasing utilization of complementary and alternative services in conventional medical settings is intensifying the focus on medical liability issues. This has important implications for individual professions and their members. OBJECTIVE: To investigate approaches to consent among a small (n = 150) sample of practicing UK chiropractors. RESULTS: Of 150 randomly selected chiropractic practitioners in the United Kingdom, 55% responded. Of these, 25% report not informing patients of physical examination procedures prior to commencement. By contrast, only 6% do not fully explain proposed treatment, although over one-third do not advise patients of alternative available treatments. Nearly two-thirds of the practitioners report that there are no specific procedures for which they always obtain written consent and 18% that there are no instances in which they document when verbal consent has been obtained. Ninety-three percent said they always discuss minor risk with their patients but only 23% report always discussing serious risk. When treatment carries a possible risk of a major side-effect only 14% of the sample obtain formal written consent. Documentation of patient understanding is omitted by 75% of practitioners in this sample. CONCLUSION: Results suggest that valid consent procedures are either poorly understood or selectively implemented by UK chiropractors.

Chiropractic↗
PubMed1997

Liability issues in the treatment of patients with rheumatic diseases.

In clinical practice, risk management focuses primarily on concerns regarding adverse occurrences and the possibility of resulting civil litigation. Tort law, one of the major branches of civil law, is most relevant to clinical risk management. Duty, breach, causation, and damages are the four elements of the tort of professional liability, i.e., medical malpractice. Liability concerns in clinical practice commonly involve adverse drug reactions. Other potential liability concerns include informed consent, adverse outcomes, and economic considerations.

Antirheumatic Agents↗
PubMed1993

A case study in progress: practice guidelines and the affirmative defense in Maine.

To encourage physicians to practice less defensively, the Maine Medical Liability Demonstration project adopted the controversial "affirmative defense" to combat runaway malpractice liability by granting immunity to physicians who follow practice guidelines. Despite challenges from trial lawyers, physicians are beginning to accept the program.

Defensive Medicine↗
PubMed1999

[Special characteristics of expert assessment of olfactory and taste disorders].

BACKGROUND: The number of medical expert opinions dealing with smell and taste disorders has continuously increased in recent years. However, an overview of the specific problems and results of those expert opinions has not been published until now. INDIVIDUALS AND METHODS: Olfaction was assessed by multiple subjective tests in 145 individuals with chemosensory dysfunction caused by trauma or occupational and environmental exposures. Additionally, a gustatory test, nasal endoscopy, anterior rhinomanometry, and radiography of the paranasal sinuses were performed. Malignering was diagnosed on a trial of multiple symptoms. Retronasal olfaction was tested using the Güttich gustatory olfaction test. RESULTS: Most of the medical expert opinions have been ordered by professional associations (42%) and insurance companies (28%). Compensation for olfactory dysfunction was claimed after trauma (64%), occupational exposure (23%) rhinosurgical procedures (8%), and laryngectomy (5%). Anosmia or hyposmia was claimed by 66% and 24% of all individuals, respectively. According to the results of the chemosensory tests, 41% of patients suffered from anosmia and 40% had hyposmia. Malignering was registered in 14%. CONCLUSIONS: The study shows that the "characteristic case" is a male in the late fourties, complaining of anosmia initially noticed after an occipital or frontobasal head trauma. The assessment of olfactory deficits related to toxic or chemical occupational exposure is difficult when a latency between the occupational exposure and the onset of chemosensory dysfunction is present. Moreover, interactions between the occupational exposure and nicotine or alcohol abuse must be taken into consideration. Claims for medical liability arose in 3% of the study group after septoplasty and sinus surgery.

Adolescent↗
PubMed1986

Legal aspects of freezing and filiation in in-vitro fertilization.

The legal rights of embryos are discussed by an academic lawyer. Medical liability in relation to in-vitro fertilization, oocyte donation and surrogacy and embryo stage are considered. The status of the human embryo is considered, including French law on embryonic rights. Embryo research and its donation are debated, and potential conflicts in relation to the laws of torts and contracts are discussed.

Fertilization in Vitro↗
PubMed1990

Children and pregnant women.

A review of the literature of the 1980s reveals that women living in rural American are at risk for receiving inadequate prenatal and maternal care. Documented risk factors include poverty and concomitant lack of medical insurance, residence in the most restrictive Medicaid states, and loss of local services including the closure of obstetric units of rural hospitals and the decision by local physicians to discontinue obstetrics. A prominent factor in a physician's decision to stop providing maternity care is the escalating cost of medical liability insurance; however, other forces are also at work, including interference with personal and family activities, disruption of other aspects of professional life (e.g., office schedule), inadequate reimbursement, and an inability to keep up with advancing technology. A research agenda for the 1990s should be consistent with previous recommendations and must stimulate the development of new programs that will induce the maximum number of providers to again offer high quality perinatal care to rural women. Other items on the 1990s research agenda include: (1) the clarification of the impact of lost perinatal services in rural areas, (2) the effects of travel time and distance on perinatal outcomes and cost of care, (3) the effect of loss of obstetric services on other health care services for women and children, and (4) comparisons of regionalized versus centralized systems for the provision of perinatal services.

Child↗
PubMed2005

The Bush Administration's record on nursing issues.

The article addresses a number of initiatives taken in 2005 by the Bush Administration to address nursing issues. Summaries are provided of the investments in the Nurse Reinvestment Act, Financial Aid, access issues (including expanded community health centers), costs (including medical liability reform), information technology and the revised fair labor standards. Finally, the author concludes with rationale for complete workforce and workplace system redesign and the need for advanced practice nurses to engage in full scope practice without artificially imposed boundaries.

Education, Nursing↗
PubMed2006

A knowledge, attitudes, and practice survey among obstetrician-gynaecologists on intimate partner violence in Flanders, Belgium.

BACKGROUND: Intimate partner violence (IPV) has consistently been found to afflict one in twenty pregnant women and is therefore considered a leading cause of physical injury, mental illness and adverse pregnancy outcome. A general antenatal screening policy has been advocated, though compliance with such guidelines tends to be low. We therefore attempted to identify potential barriers to IPV screening in a context where no guidelines have been instigated yet. METHODS: Questionnaire-based Knowledge, Attitude, and Practice survey among obstetrician-gynaecologists in Flanders, Belgium (n = 478). RESULTS: The response rate was 52.1% (249/478). Gynaecologists prove rather unfamiliar with IPV and therefore largely underestimate the extent of the problem. Merely 6.8% (17/249) of the respondents ever received or pursued any kind of education on IPV. Accordingly they do feel insufficiently skilled to deal with IPV, yet sufficiently capable of recognizing IPV among their patients. Survey participants largely refute the incentive of universal screening in favour of opportunistic screening and do not consider pregnancy as a window of opportunity for routine screening. They do consider screening for IPV as an issue of medical liability and therefore do not suffer from a lack of motivation to screen. In addition, obstetrician-gynaecologists do believe that screening for IPV may be an effective means to counteract abusive behaviours. Yet, their outcome expectancy is weighed down by their perceived lack of self-efficacy in dealing with IPV, by lack of familiarity with referral procedures and by their perceived lack of available referral services. Major external or patient-related barriers to IPV screening included a perceived lack of time and fear of offending or insulting patients. Overall, merely 8.4 % (21/245) of gynaecologists in this survey performed some kind of IPV questioning on a regular basis. Finally, physician education was found to be the strongest predictor of a positive attitude towards screening and of current screening practices. CONCLUSION: Endorsement of physician training on IPV is an important first step towards successful implementation of screening guidelines for IPV. Additional introduction of enabling and reinforcement strategies such as screening tools, patient leaflets, formal referral pathways, and physician feedback may further enhance compliance with screening recommendations and guidelines.

Adult↗
PubMed2001

Cost-effectiveness analysis in the courts: recent trends and future prospects.

This article provides an initial look at how managed care organizations (MCOs) might incorporate cost-effectiveness analysis (CEA) into their decision-making process and how the courts might respond. Because so few medical liability cases directly involve CEA, we must look at other areas of the law to assess potential MCO liability for applying CEA. In general negligence cases, courts rely on a risk-benefit test to determine customary practice. Likewise, in product liability cases, courts use a risk-utility calculus to determine liability for product design defects. And in challenges to government regulation, courts examine how agencies use CEA to set regulatory policy. The results have been mixed. In product liability cases, CEA has led to some punitive damage awards against automobile manufacturers. But courts have integrated it in negligence cases without generating juror antipathy, and generally defer to agency expertise in how to incorporate CEA. The article discusses the implications of these cases for MCO use of CEA and outlines various options for setting the standard of care in the managed care era.

Consumer Product Safety↗
PubMed2001

The delayed diagnosis of breast cancer: medicolegal implications and risk prevention for surgeons.

The delayed diagnosis of breast cancer is a leading source of error in clinical practice, and an important cause of medical malpractice claims for surgeons and other clinicians. If clinical situations frequently leading to the delayed diagnosis of breast cancer could be predicted, misdiagnosis could be avoided more easily. Therefore, a policy of risk prevention should focus on understanding which group of patients fall into a high-risk profile for diagnostic errors, and why physicians commonly commit errors when evaluating these specific patients. Drawing on multiple sources of medical malpractice information, a profile of high-risk for misdiagnosis was created and analyzed. We have identified a "Triad of Error" for misdiagnosed breast cancer, involving (1) young patients, with (2) self-discovered breast masses, and (3) negative mammograms. The "Triad of Error" accounts for the majority of cases of misdiagnosed breast cancer. An understanding by surgeons and other clinicians of the clinical, biological, and technical basis for the "Triad of Error", and how these factors interact to produce misdiagnoses, should lead to more rapid diagnosis of breast cancer, and fewer medical liability claims. The surgeon plays a central role in preventing the delayed diagnosis of breast cancer by interrupting this cycle of diagnostic error, through the use of tissue sampling techniques that rapidly establish a definitive diagnosis of breast abnormalities.

Journal Article↗
PubMed2005

Leg length inequality in total hip arthroplasty.

Postoperative leg length inequality after total hip arthroplasty frequently leads to medical liability issues because no standard exists regarding the acceptable disparity. Modular stems allow control of offset, independent sizing of the distal femoral anatomy, as well as proximal medullary sizing. The authors compared the restoration of leg length in two cohort protocols. In the 2001 cohort, tapered stems were exclusively used, giving priority to fit and fill of the medullary canal. In the 2004 cohort, porous-tapered stems, or an S-ROM modular stem (DePuy Orthopaedics Inc., Warsaw, Ind) when needed, were used based on preoperative templating to restore the center of femoral head rotation. Prior to and after surgery, length from center measurements were taken (center of rotation of the femoral head to the top of the lesser trochanter) and the vertical vector to compare the difference in actual leg length. In the 2001 cohort, the mean increase of length from center was 9 mm (7 mm leg length). In the 2004 cohort, 25% of the hips were inappropriate for tapered stems. S-ROMs were used because a tapered stem would lengthen the leg. In the standard offset tapered stem, the mean increase of length from center was 6 mm (4 mm leg length). In the high offset tapered stem, the mean increase of length from center was 7 mm (5 mm leg length). In the S-ROM stem with varying offsets, the mean increase of length from center was 6 mm (4 mm leg length). Only the S-ROM consistently avoids overlengthening in the majority of patients.

Arthroplasty, Replacement, Hip↗