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Legal issues related to medical decision support systems.

The use of computer-based decision support programs in medicine will result in litigation when adverse health care outcomes affect patients. This paper reviews how the United States legal system is likely to handle such cases. To date, there is minimal direct experience with such cases in the American legal system. Medical decision support systems are more likely to be viewed as tools used by physicians in providing a service to patients than as products owned by patients. Therefore, it is fairly certain that the negligence principles applied in medical malpractice cases will also be applied in cases involving computer-based medical decision support systems. Only under special circumstances will principles of strict product liability apply. As there are no existing standards, and medical decision support programs are hybrids having characteristics of both services and products, future litigation will be handled on a case by case basis.

Decision Making, Computer-Assisted↗

Failure to diagnose hereditary colorectal cancer and its medicolegal implications: a hereditary nonpolyposis colorectal cancer case.

PURPOSE: We describe a patient who had precancerous colonic symptoms and a positive family history of multiple occurrences of early-onset colorectal cancer in her first-degree and second-degree relatives consistent with hereditary nonpolyposis colorectal cancer. Hereditary nonpolyposis colorectal cancer diagnosis had not been made before her diagnosis of carcinoma of the cecum with liver metastasis. She died at age 20, leading to litigation. Controversies about standards of care, their malpractice implications, and pertinent legal issues are discussed. METHODS: Review of the medical and family history was made by the expert witness (HTL) with appropriate documentation of the chronology of symptoms, as derived from depositions. These documents revealed that the patient's mother had repeatedly discussed with the caregivers her concern about the family history of colon cancer and the need for appropriate surveillance. RESULTS: The patient's colonic symptoms progressed for a period of three years. Flexible sigmoidoscopy was performed by a nonphysician. The physician who ordered the procedure considered this appropriate because isolated polyps were reported in the patient's father and paternal uncle, which apparently led him to believe that the diagnosis was familial adenomatous polyposis. During litigation procedures, a pedigree was constructed and found to be consistent with hereditary nonpolyposis colorectal cancer. The case was settled in favor of the plaintiff before trial. CONCLUSION: It is essential to understand the natural history of hereditary nonpolyposis colorectal cancer, inclusive of the need for surveillance colonoscopy in patients at increased risk by virtue of their position in their family pedigree.

Adenomatous Polyposis Coli↗

Cervical dystonia following peripheral trauma--a case-control study.

Post-traumatic cervical dystonia as a diagnostic entity remains a subject of debate. Patients with cervical dystonia (CD) were asked to identify any significant illness prior to the onset of their CD. Sixteen patients of 95 respondents reported a history of injury in the four-week period prior to onset of their dystonia. A retrospective study of the clinical characteristics of the 16 patients with early post-traumatic CD (CD-PT) in comparison with the 52 patients reporting no antecedent trauma (CD-NT) was performed. In this comparison the CD-PT group had a significantly increased frequency of laterocollis, significantly more reported pain and more reported depression. Non-significant trends were noted for less responsiveness to botulinum toxin and less use of gestes antagonistes in the CD-PT group. There were no group differences in the presence of a family history of dystonia. Eleven of the CD-PT group had been or were currently involved in litigation. A sub-group of seven CD-PT patients had laterocollis, six of whom conformed to a clinical pattern of persistent non-spasmodic laterocollis with marked pain; all seven had been involved in litigation. This form of CD-PT is a distinct clinical entity and has an onset within hours or a few days of the trauma. In contrast, no significant differences were noted between patients with CD-NT and the eight patients with later onset of CD between 4 weeks and one year after peripheral trauma.

Adolescent↗

A. Lincoln, esquire defends the murderer of a physician.

After only about a year of law practice, Abraham Lincoln participated in his first murder trial. Dr. Jacob M. Early was shot and killed in a bitter political imbroglio. Lincoln joined a defense team of highly accomplished litigators. Despite his having the least legal experience, he was selected to give the defense summation. In his argument, he spoke to the jury in a conversational tone making his point that Dr. Early had a deadly weapon in his hands, namely an upraised wooden chair, when he was shot. His self-defense plea indicated that Henry B. Truett, the defendant, truly believed that he was in danger of being crushed by the upraised chair. Interestingly, Lincoln knew both the defendant and the murdered physician. He handled litigation for the former and served in the Black Hawk War under the command of the latter. Furthermore Lincoln knew at least five of the jurors.

Adult↗

Mock jurors' reactions to selective presentation of evidence from multiple-opportunity searches.

Prior to trial, litigants sometimes conduct broad investigations in which there are multiple opportunities to find supportive evidence by chance alone. During trial, litigants may selectively present only the most helpful evidence uncovered by their investigations. Two experiments examined whether mock jurors appreciate that the evidence they hear at trial may be a selective and unrepresentative sample of underlying facts. The data suggest that people do understand the significance of multiple-opportunity searches for legal inference. However, they may not consider the possibility that evidence was strategically selected from a larger sample space of facts unless that sample space is identified.

Attitude↗

A 12-year follow-up study of malpractice claims against radiologists in Italy.

PURPOSE: Malpractice claims filed against radiologists have become a relevant phenomenon in Italy and are a real risk in the radiologists' professional activity. MATERIALS AND METHODS: Insurance claims of Italian radiologists over the 1993-2004 period were anonymously assessed. A total of 990 insurance claims were classified according to cause: (1) missed diagnosis, (2) complications of the radiological procedure, (3) failure to order further radiological examinations, (4) radiation treatment, (5) slip-and-fall injuries, (6) miscellaneous causes. RESULTS: A total of 990 claims were filed during the period, with most claims being filed a considerable time after the event. As a consequence, the estimated incidence may be 44 per 1,000. In other words, 44% of Italian radiologists have received, or will receive, a summons regarding their professional activity of the past 10 years. Misdiagnosis made up the first and most important claim category. Missed abnormalities on breast radiographs accounted for the greatest percentage of cases. Missed bone abnormalities were the following most common diagnostic errors. Complications following interventional procedures accounted for 10% of all cases. A few cases resulted from the radiologist's failure to order further diagnostic examinations. Lastly, radiologists were frequently named as one of multiple defendants, together with medical (or surgical) doctors, in cases of patient death in roughly 6% of all cases. CONCLUSIONS: The risk of medical malpractice litigation for Italian radiologists is by now comparable to that for American radiologists. Strict adherence to radiological standards may be a means of reducing the risk of legal action and obviating litigation.

Follow-Up Studies↗

Health care reform: identifying some cost culprits.

In terms of both total cost and fraction of the gross national product, the cost of health care in the United States is considerably greater than anywhere else in the world. The reasons for the excessively high cost are complex and include issues of administration, issues of quality, and issues peculiar to American culture. Some contributing factors are the demographics of the population, the cost of defensive medicine and litigation, costly regulation, extensive application of technology in response to public demand and expectations, and finally, waste and abuse of the system. Control of costs cannot realistically be achieved by simply changing the way we finance health care, but will require changing the economic incentives for both providers and patients. Reforming the system will necessarily include compromising some of our expectations about health care, changing unhealthy lifestyles, and more realistically analyzing the costs of litigation and regulations.

Defensive Medicine↗

The Pain Disability Index: factor structure and normative data.

The factor structure and normative data for the Pain Disability Index (PDI) were examined in a large (N = 1,059) sample of chronic pain patients. The results support a one-factor solution for the PDI. Analyses of normative data indicated very small effects associated with gender, age, and pain duration. Relatively larger effects were associated with compensation status, litigation status, and circumstances of pain onset. Working patients reported less disability than their nonworking counterparts, litigating patients reported more disability than nonlitigants, and patients injured at work reported higher levels of disability than those with pain origins unrelated to work. The results reflect the disability level of patients referred to a hospital-based pain management program and may be useful as a reference point when comparing disability levels of other patient groups or research samples.

Adult↗

Measurement of conscious symptom exaggeration by questionnaire: a clinical study.

This study compared measures of conscious exaggeration of symptoms by 157 patients with chronic pain who were involved in personal injury litigation with 106 patients not seeking compensation who were also attending a multidisciplinary pain clinic. Pain severity was assessed using a visual analogue scale and the adjectival check-list of the McGill Pain Questionnaire. There was no difference between the two groups on scores obtained on the Conscious Exaggeration (CE) scale; it was found that there was a significant correlation between CE scores and trait anxiety, hostility, state anxiety, and pain descriptors in the 'Miscellaneous' category of the McGill Pain Questionnaire. It was concluded that there is no support for the claim that the Conscious Exaggeration scale can detect deception with the object of financial gain among chronic pain patients involved in litigation.

Adolescent↗

Psychological disturbances and an exaggerated response to pain in patients with whiplash injury.

Psychological state, response to pain and style of interpreting everyday experiences were measured in 32 patients who had suffered a whiplash injury 1-84 months before the study. For comparison, measures were also obtained in 15 general practice attenders. Ratings of depression and anxiety were greater in patients than in controls, and patients reported more cold-induced pain during a cold pressor test. Within the patient sample, anxious subjects gave the highest ratings of cold-induced pain. Those with the longest history of pain gave the highest ratings of whiplash injury pain, and were most depressed. Most of these patients were involved in litigation. The findings demonstrate that, like most patients with chronic pain, whiplash injury sufferers are anxious and depressed. Their psychological distress could be aggravated by litigation. Behavioural assessment and treatment of chronic pain syndromes such as whiplash injury could benefit from early evaluation of the patient's psychological state, and response to standard painful stimuli.

Adolescent↗

Recognizing and managing the litigious patient.

There is no accurate pre-treatment profile of the litigious patient. It is usually the lawsuit-causing physician who drives the patient to initiate litigation. The establishment and control of the physician-patient relationship are the keys to preventing litigation; this is achieved by improving physicians' ability to communicate, demonstrate empathy and support, and conduct appropriate discussion of informed consent. After treatment, physicians must pay special attention to patients who exhibit certain behavior typical of dissatisfaction. They should be accorded extra time and attention and, in some instances, should be referred to another practitioner for a second opinion and follow-up care.

Humans↗

Methodology of forensic neurotoxicity evaluation: PCB case.

Many scientists and doctors are not aware that the level of certainty for litigation purposes differs from that usually associated with scientific studies. Although the 0.05 probability level is commonly used in scientific studies ("beyond a reasonable doubt"), in U.S. civil litigation the diagnostic criteria is "more probable than not" (greater than 0.50 or chance probability level). The following case of PCB neurotoxicity will be discussed within the context of a forensic evaluation. A number of workers were employed by a metal salvage company to strip copper coils from used electrical transformers. Symptoms of neurotoxicity developed in the men, which were evaluated by questionnaire, interview and psychological examination. Neuropsychological and nerve conduction tests were administered. Results showed deficits in nervous system function related to PCB exposure. An individual case is described in detail.

Environmental Exposure↗

The role of compensation in chronic pain: analysis using a new method of scoring the McGill Pain Questionnaire.

Patients who receive worker's compensation or are awaiting litigation after an accident have long been regarded as neurotics or malingerers who are exaggerating their pain for financial gain. However, there is a growing body of evidence that patients who receive worker's compensation are no different from patients who do not. In particular, a recent study found no differences between compensation and non-compensation patients based on pain scores obtained with the McGill Pain Questionnaire (MPQ). Since the MPQ is usually scored by using rank values rather than more complex scale values, the negative finding might be attributable to the loss of information by using rank values. Consequently, a simple technique was developed to convert rank values to weighted-rank values which are equivalent to scale values. A study of 145 patients suffering low-back and musculoskeletal pain revealed that compensation and non-compensation patients had virtually identical pain scores and pain descriptor patterns. They were also similar on the MMPI pain triad (depression, hysteria, hypochondriasis) and on several other personal that were examined. The only differences were significantly lower affective or evaluative MPQ scores and fewer visits to health professionals by compensation patients compared to non-compensation patients. These results suggest that the financial security provided by compensation decreases anxiety, which is reflected in the lower affective or evaluative ratings but not the sensory or total MPQ scores. Compensation patients, contrary to traditional opinion, appear not to differ from people who do not receive compensation. Accidents which produce injury and pain should be considered as potentially psychologically traumatic as well as conducive to the development of subtle physiological changes such as trigger points. Patients on compensation or awaiting litigation deserve the same concern and compassion as all other patients who suffer chronic pain.

Adult↗

Workers' Compensation and return-to-work in low back pain.

The relationship of Workers' Compensation and litigation to low back pain (LBP) outcome is not established in the literature. Our study investigated the characteristics of disabled persons applying for Worker's Compensation or employing a lawyer, the factors predicting receipt of compensation, and the effects of compensation and litigation on employment outcome. One hundred sixty-nine unemployed persons with LBP were assessed by medical history, physical exam, biomechanical testing, psychiatric interview, and MMPI. Subjects were asked whether they had applied for compensation, received it, or had employed a lawyer. Six months later, subjects were asked about their employment and compensation status. Neither compensation status nor involvement of a lawyer significantly improved prediction of employment status 6 months later. Receipt of compensation predicted better outcome in those at risk for poor outcome due to external locus of control. Factors predicting failure to obtain compensation over 6 months, having applied, include education, spinal flexion, ability to do daily activities and affective inhibition. Neurological dysfunction did not predict receipt of compensation in univariate or multivariate analyses; emotional distress reduced the probability of receiving compensation, after controlling for severity of spinal dysfunction. Receipt of compensation and use of a lawyer did not reduce the probability of RTW in disabled persons in the present sample, but increased the likelihood of return to work for groups of individuals at higher risk such as those with external locus of control. Although compensation is awarded on the basis of physical evaluation under the present system, the present findings suggest that the likelihood of receiving compensation is also significantly determined by level of emotional distress.

Absenteeism↗

Physicians should be expert witnesses.

Physicians have a responsibility to society, their peers, and patients to participate in malpractice litigation in a manner that ensures that medical malpractice cases are properly evaluated. Physicians are reluctant to involve themselves as expert witnesses in medical malpractice litigation because of not wanting to further any malpractice suits, mistrust of attorneys and misconceptions about expert witnesses and the legal system in general. The expert witness should be an impartial practicing physician who can select those suits that should or should not be filed and identify which parties were negligent in each case. If impartial physicians do not evaluate cases for attorneys, other more partisan and less objective physicians will.

Expert Testimony↗

Some considerations for the expert witness in cases involving birth defects.

Individuals serving as experts in litigation involving birth defects typically find that their scientific training has not prepared them well. A greater understanding of the choices and pitfalls involved can assist such individuals in promoting the legal process. Experts should carefully evaluate the evidence and should not become involved unless they have the needed expertise. Experts must understand what they will be asked to testify about and be completely comfortable with any positions that they may be asked to support. Experts must obtain the necessary facts, never merely relying on information from the retaining attorney. Experts should not make statements they cannot support, and they must be willing to say, "I don't know." Experts should not merely ignore facts that weaken their positions, but must be willing to take them into account. Although the court may require only that an accused agent be "more likely than not" the cause of a birth defect, experts must use recognized scientific principles, and the judge will decide what evidence is admissible. Experts must be willing to examine enormous amounts of information, and they should be organized, carefully filing information received. Experts must be both willing and able to spend large amounts of time in preparation, consultation, travel, deposition, court, and even "bookkeeping." It should be realized that the expert's role in birth defects litigation is essential, however, and knowledge of what experts should and should not do should aid in the promotion of justice.

Abnormalities, Drug-Induced↗

Bendectin: review of the medical literature of a comprehensively studied human nonteratogen and the most prevalent tortogen-litigen.

OBJECTIVE: to review the extensive literature pertaining to the reproductive and teratogenic effects of Bendectin and the opinions of the scientific experts for the defense and plaintiff. These data were evaluated with regard to the reproductive risks of Bendectin providing a scientific framework for evaluating the views of the experts in the Bendectin litigation. DESIGN: the Bendectin literature was primarily obtained from articles cited in Research Alert of the Institute for Science Information. Other articles were obtained from Medline, review articles, and colleagues. An attempt was made to be all-inclusive, citing and reviewing all articles related to each subject being discussed. The literature includes epidemiologic studies, animal studies, in vitro studies, and basic science articles related to the principles of teratology and reproductive toxicology. Review articles, meta analyses, editorials, commentaries, articles in the press, and case reports were also included. METHODOLOGY: the methodology utilized for the evaluation of Bendectin teratogenicity was presented. It consists of a five-part analysis of epidemiologic studies, secular trend analysis, animal studies, dose-response relationships, and biologic plausibility. CONCLUSION: the five-part analysis of Bendectin reproductive effects indicates that therapeutic use of Bendectin has no measurable teratogenic effects. Presentations by many of the plantiff's experts failed to meet the scientific standards that should be expected of knowledgeable scientists and contributed to the persistence of Bendectin litigation.

Animals↗

Is poor performance on recognition memory effort measures indicative of generalized poor performance on neuropsychological tests?

The detection of suboptimal effort has become crucial in clinical neuropsychological practice in order to make accurate diagnoses, prognoses, and referrals. Symptom Validity Testing (SVT) has been the most commonly utilized model for assessing effort, and frequently includes recognition memory tasks. Some conflicting views on this model purport, however, that measures of effort gathered from a recognition memory paradigm do not necessarily extend to effort in other cognitive domains and other areas of performance. The present study sought to investigate whether performance on an SVT measure, which utilizes recognition memory, the TOMM, could predict performance on other measures that do not evaluate recognition memory or just memory per se in a group of mildly traumatic brain-injured litigants. Results indicated that poor performance on the TOMM was significantly correlated with poorer performance on the WAIS-R and the HRNB-A. Further, experimental exploration of these results indicated that the overall neuropsychological performance of litigants with suboptimal effort was poorer than what is generally expected from mild TBI individuals, and was also lower than the other mild TBI examinees in the study, who were not classified by the TOMM as exhibiting suboptimal effort. These findings support the proposition that poor effort as measured by recognition memory effort measures is not restricted to recognition and memory measures. In fact, in the present study it appears that a poor performance on the TOMM is predictive of a generalized poorer performance on standardized measures such as the WAIS-R and the HNRB-A.

Adolescent↗