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Physicians' liability in ophthalmology practice.

PURPOSE: The aims of this paper are to point out the importance of coherence in established guidelines in daily practice, highlight the value of signed patient informed consent forms and stress the value of a good understanding of the law, while focusing on issues related to malpractice in ophthalmology. METHODS: Search of the current relevant literature. RESULTS: The most common causes of medical litigation in ophthalmology are related to LASIK surgery, cataract surgery, glaucoma care, radial keratotomy for myopia reduction and failure to diagnose binocular vision anomalies in children and adults in a timely fashion. The litigation raised in most cases is driven by unfavourable outcomes and not by malpractice. CONCLUSION: Maintenance of high standards in daily practice, with continuous training and clear communication along with the appropriate documentation of any procedure carried out, may improve the professional safety of practising eye specialists in the event of medical litigation. Although the use of patient informed consent varies substantially among European countries, it may serve as useful evidence in the physician's defence.

Consent Forms↗

Noncredible cognitive performance in the context of severe brain injury.

In two litigating patients with histories of severe brain injury (i.e., coma > or =2 days and residual brain imaging abnormalities), noncredible cognitive symptomatology was demonstrated by: (1) "failed" performance on multiple cognitive "effort" tests, (2) noncredible performance on standard neuropsychological instruments, (3) questionable validity of personality inventory profiles, and (4) marked inconsistency in test performance across testing evaluations or marked inconsistency between test scores and activities of daily living documented through surveillance videotapes. Some patients with severe traumatic brain injury show substantial, if not full recovery, and in a litigating context, may feign cognitive symptoms. These cases indicate that tests to verify cognitive effort should be routinely administered to all patients in litigation or who have other motive to feign symptoms, not just patients with mild or questionable brain injury.

Adult↗

The Fake Bad Scale and MMPI-2 F-family in detection of implausible psychological trauma claims.

We tested the validity of the Lees-Haley Fake Bad Scale (FBS) and the family of MMPI-2 F scales (F-family; F, F(p), and F-K scales) in predicting improbable psychological trauma claims in an applied setting. Litigants reporting implausible symptoms long after minor scares and nonlitigants clinically referred following severe stressors completed the MMPI-2. Both groups were naturally matched on social class. The FBS demonstrated sensitivity, specificity, and positive predictive power in the detection of atypical problems but the F-family showed poor utility. FBS cutting scores derived from logistic regression were applied to a third group made up of litigants with histories of undeniably severe traumas. A substantial number of this third group scored above cutoffs for exaggeration, but this finding is ambiguous. Reasons for the F-family's insensitivity to real-world exaggeration may include using student simulators for validation and content reflective of psychotic simulation. The superiority of the FBS in applied forensic settings could derive from its development in actual litigants and content reflective of nonpsychotic exaggerations. The FBS appears acceptable for use in applied forensic settings where persons seek compensation for nonpsychotic syndromes.

Adult↗

Hatch-Waxman in the Federal Courts: from 1994--2004.

Decisions of the federal courts play a crucial role in drug development. Litigation related to drug development and approval under the abbreviated new drug application ("ANDA") process over the past 10 years was evaluated, examining over 300 written decisions from 22 U.S. District Courts and the U.S. Court of Appeals for the Federal Circuit. These written decisions represent the majority of patent litigation between brand and generic drug manufacturers. The reported data set provides critical information for the drug development and litigation strategies of both brand and generic manufacturers. The examination also provides a realistic portrayal of the anticipated outcome if a legal action is initiated.

Drug Approval↗

Managed care and the judicial system: another avenue for reform?

Over the past several years the judiciary has become a major venue for challenging managed care. This article examines the present and potential effect of such litigation, focusing on the recent Supreme Court decision in Pegram v. Herdrich and class action litigation-filed under the Racketeer Influenced and Corrupt Organizations Act. The author concludes that although court-based reforms are a necessary and pragmatic response to managed care, they can result in only incremental changes. Litigation also cannot resolve the larger conflicts that result when a social welfare service such as health care is provided through a corporate model. Social workers need to look beyond the "next best" reform of managed care and advocate for more fundamental solutions to the inequities and inefficiencies in the provision of health care.

Consumer Advocacy↗

A longitudinal study of compensation-seeking and return to work in a treated mild traumatic brain injury sample.

OBJECTIVE: In patients with mild traumatic brain injury (MTBI), to assess: (1) changes in financial compensation-seeking status over time and (2) the relationship between compensation-seeking and return to work. DESIGN: Longitudinal evaluation of financial compensation-seeking status (i.e., at intake, 3 months postinjury, and 12 months postinjury) and relationship of such status to return to work. SETTING: Outpatient rehabilitation clinic. SUBJECTS: Ninety-seven patients with MTBI. MAIN OUTCOME MEASURES: Compensation-seeking status at 3 and 12 months and days taken to return to preinjury vocational activity. RESULTS: Those in litigation at intake generally continued to be in litigation at 3 and 12 months postinjury. Those seeking or receiving compensation via administrative means (e.g., sick pay or workers' compensation) at intake were generally not seeking or receiving compensation by 3 months or later, as was the case for most of those not seeking any financial compensation at intake. Patients seeking or receiving financial compensation via litigation and/or administrative means at intake took longer to return to work than did people who were not seeking or receiving compensation at intake. CONCLUSION: The present study design does not allow for determination of the reasons for the strong relationship between financial compensation-seeking soon post-MTBI and a slow return to work. However, the strength of the present findings indicates that the presence or absence of financial compensation-seeking soon post-MTBI should be routinely evaluated when return to work is an issue.

Adolescent↗

An analysis of orthopaedic liability in the acute care setting.

The risk of litigation in the emergency room is not directly proportional to the severity of injury. In fact, the risk of initiation of legal action is greater in cases of relatively modest permanent and partial disability. In these cases, failure to obtain and document informed consent, failure to effectively communicate with the patient and family, and failure to assure followup and prompt assessment of complications are the factors that have most frequently led to litigation. Orthopaedic surgery ranks fifth among medical specialties in the total number of claims filed and also fifth in the cumulative amount of financial payments. Approximately 30% of filed cases ultimately result in some form of financial payment. The driving force behind litigation is financial gain for plaintiff's attorneys and compensation for plaintiffs. The motive is not the improvement of medical delivery systems or individual behavior. Access to useful data of a legal nature is extremely difficult. Only a small number of cases go on to a jury-based decision of public record. It is difficult to get accurate and complete information on the total number of cases filed, cases withdrawn, terms of settlements, and arbitrations because of the confidential nature of the settlement process.

Emergency Medical Services↗

The legal landscape at the threshold of viability for extremely premature infants: a nursing perspective, part II.

This is the second of a 2-part article exploring the legal landscape overlying the difficult decisions that can confront a family with an extremely premature infant at the threshold of viability. In Part I, recent legal regulations and litigation were analyzed to show that the baby doe regulations are largely inert and that recent litigation arises out of state laws and regulations. Part II takes up the analysis to show that the common thread through all these conflicts, and the subsequent litigation, is a failure to obtain parental consent for the course of treatment at issue. The author argues that the central focus of all parties seeking to minimize legal risks in these situations must be on creating a transparent decision-making process that includes the parents from the onset. Nurses play a pivotal role in that process and are supported broadly by the professional guidelines of the American Nurses Association, the Association of Women's Health Obstetric and Neonatal Nurses, the National Association of Neonatal Nurses, the American Academy of Pediatrics, and the Principles of Family-Centered Neonatal Care.

Fetal Viability↗

Cancer of the oral cavity and medical malpractice.

OBJECTIVE: To analyze malpractice litigation initiated by patients with cancer of the oral cavity as a result of allegations concerning their diagnosis and treatment. STUDY DESIGN: Retrospective review. METHODS: Jury verdict reviews from 1984 to 2000 were obtained from a computerized legal database and analyzed. Reviews compile pertinent data on defendants, plaintiffs, verdict outcomes, indemnity payments, and allegations of wrongdoing and provide case summaries. Fifty cases from 21 of all 50 states were obtained. Data were entered into a spreadsheet for analysis. RESULTS: Overall, a young age (mean age, 45 y) and poor oncological outcome (47% dead) were seen. The younger age group (<47 y) had a better outcome (65% without disease), were more often misdiagnosed (19%), won awards (60%), and had higher awards (average award, $755,824) as compared with those older than 47 years of age, who had 39% without disease, 0% misdiagnosed, and 52% who won awards that were less, on average, at $495,417. Failure to diagnose the cancer was alleged, overall, in 43 of 50 cases (86%), and in general practice, dentists, and otolaryngologist in 100%, 85%, and 89%, respectively. Suits alleging a delay in diagnosis of less than 3 months were defendant verdicts in 86%, and of more than 3 months, in 40%. Failures to perform biopsy and to refer were common allegations. CONCLUSIONS: Young age of patients bringing litigation is seen in patients with oral cancer. These patients frequently have poor oncological outcomes. Risk management goals to prevent delays in diagnosis may help prevent subsequent litigation.

Adult↗

Medicolegal analysis of injury during endoscopic sinus surgery.

OBJECTIVES: To survey the causes, characteristics, and outcomes of malpractice litigation resulting from injuries sustained during endoscopic sinus surgery (ESS). STUDY DESIGN: A retrospective analysis of United States state and federal civil litigation involving injuries resulting from ESS. METHODS: Sources were state and federal court decisions and jury verdict reports accessed through a computerized legal database. The 41 cases were decided or settled between 1990 and 2003. The cases and reports were analyzed for pertinent data regarding plaintiffs, defendants, allegations of wrongdoing, resulting injury, expert witnesses, and resulting verdict or settlement. Correlation between severity of injury and case outcome was analyzed. RESULTS: All suits reviewed involved ESS. Many cases included multiple causes of action, or types of malpractice, including negligent technique, 31 (76%); lack of informed consent, 15 (37%); and wrongful death, 2 (5%). The defendant-physician specialty was overwhelmingly otolaryngology, 40 (98%). The most common presenting complaint, or indication for surgery, was chronic sinusitis, 30 (73%). The injuries caused by surgery were frequently multiple, including cerebrospinal fluid (CSF) leak, 10 (24%); brain damage, 6 (15%); diplopia, 7 (17%); and death, 2 (5%). The majority of cases reviewed (83%) resulted in a verdict rather than settlement. The result of the verdict or settlement was 17 (41%) in favor of the plaintiff, 23 (56%) in favor of the defendant, and 1 (2%) unknown. The average award was 751,275 dollars, with a median of 410,239 dollars and a range of 61,000 dollars to 2,870,000 dollars. CONCLUSIONS: This is the first study to review malpractice litigation resulting from injuries sustained during ESS and shows a hitherto unexpected pattern between severity of injury and case outcome.

Endoscopy↗

Predictors of outcome in patients with chronic back pain and low-grade spondylolisthesis.

STUDY DESIGN: Retrospective case series. OBJECTIVES: To determine the factors influencing symptom relief after uninstrumented posterolateral spinal fusion with or without decompression in adult patients with chronic back pain and previously asymptomatic low-grade isthmic spondylolisthesis. SUMMARY OF BACKGROUND DATA: The role of previously asymptomatic low-grade isthmic spondylolisthesis in chronic adult low back pain is unclear. Operative intervention in this setting is controversial. METHODS: Twenty-four consecutive adult patients with chronic low back pain and low-grade isthmic spondylolisthesis first detected during routine work-up of new onset low back pain underwent spinal fusion with or without decompression. The influence of active worker's compensation or litigation claims, radicular pain, concomitant laminectomy, age, gender, fusion to L4, intervertebral disc bulge, and pseudarthrosis were investigated. RESULTS: All 13 patients involved in worker's compensation claims or pending litigation had fair or poor results. Nine of 11 patients without such issues had good or excellent results. Although the strong association of worker's compensation with poor results made it difficult to assess the importance of other risk factors, the data suggest that good results may be more likely in patients with radiculopathy who undergo laminectomy. CONCLUSIONS: This investigation, although limited by a number of factors including small sample size and retrospective, unblinded review, suggests that active worker's compensation and litigation issues are associated strongly with poor results of operative management for chronic low back pain in adult patients with low-grade spondylolisthesis.

Adult↗

Medical malpractice and head and neck cancer.

PURPOSE OF REVIEW: The purpose of this review is to evaluate medical malpractice involving patients with head and neck cancer. In the United States, problems associated with the medical malpractice environment are reaching proportions that threaten the delivery of health care. RECENT FINDINGS: Several methods to learn more about the trends and ramifications of litigation have been developed. Although patients with cancer of the head and neck bring suits rarely, when they do several themes seem prevalent. Delays in diagnosis are common allegations. Plaintiffs are frequently much younger than expected, and the oncologic outcome is frequently poor. Defendant physicians occasionally unwittingly add to the delay by not expecting the younger patient. The poor oncologic outcome may be related to the delay or to a biologically more aggressive disease. Relationships between these factors are explored. Consent issues are also relatively common. SUMMARY: Physicians must strive to know as much as possible about tort reform, and to contribute to the process. Litigation analysis and other tools to expand our understanding can be used to educate ourselves and the legal community. Scientific standards must be developed along with clinical pathways to guide ourselves to prevent litigation. They may also guide the legal community to establish more rational standards of care based on a consensus of expert opinions.

Critical Pathways↗

Injectable collagen and autoimmune disease.

BACKGROUND: The media and litigation in the United States have alleged a link between the use of injectable bovine collagen and the development of autoimmune disease, specifically dermatomyositis/polymyositis. OBJECTIVE: To present the scientific and epidemiologic data with regard to this issue. METHODS: Literature was reviewed as well as reports to Collagen Corporation and the litigation. RESULTS: After review of the literature and review of data currently available to Collagen Corporation, no link can be established at this time between collagen injectable material and autoimmune disease, specifically dermatomyositis/polymyositis. CONCLUSION: There are no epidemiologic or scientific data to support the alleged link in the media and litigation between injectable bovine collagen material and dermatomyositis/polymyositis.

Animals↗

The physician survey on the post-concussion and whiplash syndromes.

BACKGROUND: The post-concussion syndrome (PCS) and whiplash syndrome (WS) have been controversial topics among physicians for many decades. There is little information available on the opinions and practices of physicians. METHODS: In June of 1992, we performed a national survey by mail of the four physician groups most commonly treating these problems. The number of respondents and response rates were as follows: family physicians, 118, 16%; neurologists, 100, 21%; neurosurgeons, 97, 23%; orthopedists, 82, 13%. The survey instrument contained items on demographics, definitions, causation, prognosis, medico-legal aspects, testing, and treatment. RESULTS: Only a minority of respondents believe that PCS and WS are clearly defined syndromes. A substantial minority report that psychogenic and litigation factors are most responsible for the conditions. Most of the physicians believe that PCS and WS have a 3-6 month recovery time. A significant minority concur that symptoms of the two syndromes resolve when litigation is settled. Most of the physicians order tests to rule out pathology although a minority order tests to reassure patients or because of litigation concerns. Only a minority of respondents believe that effective treatments are available. Not surprisingly, a multitude of conventional and unconventional treatments are sometimes recommended. CONCLUSIONS: Many aspects of PCS and WS are controversial among treating physicians. This controversy can have a profound impact on the quality and cost of patient care. Ongoing research is required to discover more effective treatments for mild brain injury and chronic pain.

Brain Concussion↗

Hospital and health plan liability in granting privileges for endoscopy.

In December 1992, the American College of Gastroenterology (ACG) published a legal opinion which had been developed by the nationally renowned litigation law firm, Williams & Connolly, which has long served as ACG's litigation counsel. The opinion set forth potential litigation liabilities/risks that hospitals incur if they are negligent in their credentialing practices and enable undertrained physicians to perform endoscopy in their inpatient and outpatient facilities. The opinion was published as part of a broader joint effort by ACG and the American Society for Gastrointestinal Endoscopy (ASGE) that resulted in ASGE's Guidelines on Appropriate Training for GI Endoscopy together with the legal opinion on undertrained endoscopists being circulated to all of America's hospitals. Much has changed in both the practice of medicine and the law, since 1992. The two societies decided to join forces again to update these materials. The ACG legal opinion was expanded to also provide guidance about liability of insurance plans when they indicate preferences as to where and by whom procedures should be performed. Some of the key findings from the liability update section of this joint effort follow.

Certification↗

Cognitive complaints in patients after whiplash injury: the impact of malingering.

OBJECTIVES: The validity of memory and concentration complaints that are often reported after a whiplash trauma is controversial. The prevalence of malingering or underperformance in post-whiplash patients, and its impact on their cognitive test results were studied. METHODS: The Amsterdam short term memory (ASTM) test, a recently developed malingering test, was used as well as a series of conventional memory and concentration tests. The study sample was a highly selected group of patients, who were examined either as part of a litigation procedure (n=36) or in the normal routine of an outpatient clinic (n=72). RESULTS: The prevalence of underperformance, as defined by a positive score on the malingering test, was 61% (95% CI: 45-77) in the context of litigation, and 29% (95% CI: 18-40) in the outpatient clinic (p=0.003). Furthermore, the scores on the memory and concentration test of malingering post-whiplash patients (n=43) and non-malingering post-whiplash patients (n=65) were compared with the scores of patients with closed head injury (n=20) and normal controls (n=46). The malingering post-whiplash patients scored as low as the patients with closed head injury on most tests. CONCLUSIONS: The prevalence of malingering or cognitive underperformance in late post-whiplash patients is substantial, particularly in litigation contexts. It is not warranted to explain the mild cognitive disorders of whiplash patients in terms of brain damage, as some authors have done. The cognitive complaints of non-malingering post-whiplash patients are more likely a result of chronic pain, chronic fatigue, or depression.

Adult↗

Tobacco industry strategy to undermine tobacco control in Finland.

OBJECTIVE: To identify and explain tobacco industry strategy in undermining tobacco control measures in Finland and results of these interferences in tobacco policy development during the 1980s and early 1990s. METHODS: Tobacco industry documents, which have been publicly available on the internet as a result of litigation in the USA, were analysed. Documents were sought by Finland and by names of organisations and tobacco control activists. Documents were accessed and assessed between September 2000 and November 2002. Tactics of the tobacco industry activities were categorised as presented by Saloojee and Dagli. RESULTS: The international tobacco companies utilised similar strategies in Finland as in other industrial markets to fight tobacco control and legislation, the health advocacy movement, and litigation. These activities slowed down the development and implementation of the Tobacco Act in Finland. However, despite the extensive pressure, the industry was not able to prevent the most progressive tobacco legislation in Europe from being passed and coming into force in Finland in 1977 and in 1995. CONCLUSION: Denying the health hazards caused by tobacco-despite indisputable scientific evidence-decreased the credibility of the tobacco industry. Strategy of denial was falsely chosen, as health advocacy groups were active both in society and the parliamentary system. The strong influence of the tobacco industry may have in fact increased the visibility of tobacco control in Finland as the litigation process was also drawing attention to negative health effects of tobacco. Therefore the tobacco industry did not manage to convince public opinion. However, the tobacco industry did obtain experience in Finland in how to object to tobacco control measures.

Finland↗

"Stay away from them until you're old enough to make a decision": tobacco company testimony about youth smoking initiation.

OBJECTIVE: To determine common themes used by US tobacco industry witnesses pertaining to youth smoking initiation during litigation in the United States. METHODS: Qualitative thematic analysis of transcripts from 29 tobacco litigation cases dating from 1992 to 2002. RESULTS: Youth smoking is portrayed by the tobacco industry as a source of great concern to them. Youth smoking prevention programmes developed by US tobacco companies are supposedly intended to delay decision-making about smoking until age 18, when individuals are then seen to be of an age where they are able to "choose to smoke". Tobacco industry media campaigns, youth access, community and school-based programmes are predicated on peer influence, parental factors, and commercial access being the primary influences on youth smoking uptake, rather than tobacco marketing, inaccurate risk appraisal, price and other factors known to influence youth smoking. Despite substantial financial investment in tobacco industry programmes, their witnesses were able to describe only weak evaluation methods, being preoccupied with measures of message comprehension, programme reach and uptake, and the associated costs of their efforts, rather than any evaluation designed to assess effects on youth smoking behaviour. CONCLUSION: Stated concerns about youth smoking and youth smoking prevention programmes are put forward in litigation as evidence that the tobacco industry is "serious" about tackling youth smoking, and serve as a primary strategy to improve the tobacco industry's public image. The tobacco industry's evaluation of the effectiveness of their youth smoking prevention programmes is demonstrably insufficient under current public health evaluation standards. Public health and welfare agencies should avoid engagement with tobacco industry-sponsored programmes.

Adolescent↗