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PubMed1991

Liability considerations presented by human gene therapy.

Through the use of a hypothetical scenario, this article examines the legal liability associated with gene therapy. Basic negligence principles are applied to the factual context of a human gene therapy experiment gone awry, including its prior governmental review and its potential effect on future generations. The federal requirements, while not preempting state law damages claims, do provide a mechanism for achieving some protection from liability. The effect on future generations raises questions about the limits of liability.

Clinical Trials as Topic↗
PubMedDate not supplied

Advocacy for foster families in the United States facing child abuse allegations: how social agencies and foster parents are responding to the problem.

Response to a 1989 national survey in the United States revealed pioneer efforts of a few state foster care agencies and foster parent associations to assist foster parents facing child maltreatment allegations. Most agency policies and procedures, however, reflect little awareness or understanding of the issue for foster parents; prescribe abrupt and potentially deleterious action; omit important foci; and appear to be strongly influenced by considerations of agency legal liability. Specific changes are recommended in recognition of the issue; revision of policy and procedures governing agency response to maltreatment reports against foster homes; and development, evaluation, and dissemination of more constructive response models.

Child↗
PubMedDate not supplied

The fiduciary responsibilities of the hospital board of directors.

With the dynamic movement toward healthcare reform, increased attention is being focused on the duties and legal liabilities of hospital governing board members. Given the dual duties of loyalty and care and the legal and regulatory pressures to contain costs and assure quality, the role of the governing board is increasing in complexity and importance.

Conflict of Interest↗
PubMed2005

[Telemedicine--legal aspects].

Due to the complexity of its scope of use, telemedicine involves new risks of legal liability against which often neither physicians nor clinics are insured; for example, division of responsibility which is not legally defined between the consultant and the attending physician, or demands for compensation from abroad. Special information sheets and forms of consent for telemedicine must be introduced, and particularly the risks of this type of diagnostics and therapy must also be pointed out. On these forms patients must give their consent to their physician consulting a specialist via data line. Furthermore, the court of jurisdiction and the law under which a court must judge in a liability case must be defined on these forms. Insurers must be informed about the type and scope of telemetric activities without delay.

Germany↗
PubMed1991

Effects of alcoholic beverage server liability on traffic crash injuries.

We examined effects on the frequency of injuries due to motor vehicle crashes of a sudden change in exposure to legal liability of servers of alcoholic beverages in Texas. A multiple time-series quasi-experimental research design was used, including the Auto-Regressive Integrated Moving Average and intervention-analysis statistical models on injury data from 1978 through 1988. We controlled for the effects of several other policy changes expected to influence injury rates in Texas, and for broader nationwide changes in injury rates in the 1980s. Results revealed 6.5% and 5.3% declines in injurious traffic crashes following the filing of two major liability suits in 1983 and 1984, respectively. Sever liability is one of several important public policy tools in efforts to achieve health objectives regarding reduced injury morbidity, and mortality.

Accidents, Traffic↗
PubMed2006

Effects of the medical liability system in Australia, the UK, and the USA.

Although the direct costs of the medical liability system account for a small fraction of total health spending, the system's indirect effects on cost and quality of care can be much more important. Here, we summarise findings of existing research on the effects of the medical liability systems of Australia, the UK, and the USA. We find systematic evidence of defensive medicine--medical practice based on fear of legal liability rather than on patients' best interests. We conclude with discussion of four avenues for reform of traditional tort compensation for medical injury and several suggestions for future research.

Australia↗
PubMed2000

Malpractice risk assessment among different approaches for informed consent.

INTRODUCTION: The standards for obtaining informed consent, set forth by the Hawaii Revised Statutes, establish that it is the physician's duty to disclose what a reasonable person objectively needs to hear in order to make an informed decision. It is the purpose of this study to report the opinions of medical malpractice attorneys to survey their opinion whether full or limited disclosure of alternative treatments in informed consent is viewed as having a lower malpractice risk. METHODS: Hawaii medical malpractice attorneys viewed a compilation of arguments for and against both full and limited disclosure, and completed an opinion survey after reading samples of disclosure statements in two different case scenarios: 1) a pediatric emergency department case involving a febrile child at risk for occult bacteremia, and 2) an obstetrics case involving a woman with a postdate pregnancy. RESULTS: A vast majority of respondents believe that, in general and in the obstetrics case, full disclosure results in less liability. In the pediatrics ED case, 46% chose full disclosure as having less liability, 38% believe that the same liability exists with both full and limited disclosure, and 15% believe that limited disclosure is associated with less liability in this case. CONCLUSIONS: Hawaii attorneys with medical malpractice experience overwhelmingly agree that, in general, full disclosure is associated will less medical legal liability. Full disclosure was also the option selected as associated with less liability by a majority of attorneys in a sample obstetrical case. Opinions were more diverse in the pediatrics ED case. Many attorneys stressed that judging the risk of liability in general is difficult, and should be done on a case by case basis.

Adult↗
PubMed1996

Legal issues in the information age--part 1.

As legal liability issues regarding managed care continue to emerge, almost simultaneously issues related to the age of technology are appearing. In some instances, the confluence of these two new rapidly developing health care trends has led to additional new legal issues for the health care provider.

Confidentiality↗
PubMed2001

Abortion, information & the law: what every doctor needs to know.

1. Before commencing any treatment, doctors must inform patients of all material risks of the treatment (Rogers v. Whitaker, 1992). 2. It is not up to the professional judgment of doctors to decide how much information to give to patients (Rogers v. Whitaker, 1992). 3. The same duty to inform applies to abortion ("Ellen's Case," 1998). 4. GPs and counsellors who refer for abortion also have a legal duty to inform women of risks, because everyone who gives specialized or professional advice may be sued for negligence if that advice is given without due care (Evatt's Care, 1969). 5. Doctors have been inadequately informed on the medical risks of abortion, by writers seeking to present abortion as a risk-free procedure. 6. Abortion may increase the risk of cancer. 7. Abortion carries risks of injury and illness. 8. Abortion caries risks of future reproduction. 9. Abortion may have adverse psychological and psychiatric sequelae. In some women, these sequelae are severe and intractable, and may occur irrespective of a woman's personal attitudes towards abortion (Melinda Tankard Reist, Giving Sorrow Words: Women's Stories of Grief After Abortion, Sydney, Duffy & Snellgrove, 2000). 10. Women still die in Australia from abortion. 11. It has not been proved that pregnancy and delivery are more dangerous than abortion. 12. The risks of mortality and morbidity in carrying a pregnancy to term are often exaggerated, in an effort to make abortion appear safer. 13. Doctors are not required to refer for abortion. On the other hand, doctors do have a duty to inform themselves of the professional competence of any practitioner to whom they refer any patient for any procedure. Doctors who are referring for abortion can avoid legal jeopardy by informing women fully of the risks, and by keeping very comprehensive records of the information they have given. Alternatively, doctors can avoid legal liability by declining to refer for abortion. There are compelling medical reasons for treating abortion as a social, non-therapeutic, potentially harmful procedure with which conscientious doctors would choose not to involve themselves.

Abortion, Legal↗
PubMed2004

E-mail consultation: clinical, financial, legal, and ethical implications.

BACKGROUND: Communication via e-mail has become widespread. Nearly every practicing neurosurgeon is confronted with numerous unsolicited e-mail requests for medical advice, guidance, or information. Neurosurgeons need to be aware of the clinical, financial, legal, and ethical implications of providing medical consultation via e-mail. METHODS: A literature review of the penetration of e-mail consultation in medical practice was performed. The data on the potential for reimbursement for provision of these services is presented. Precedents for legal liability are discussed, and issues of compliance with HIPAA regulations are reviewed. RESULTS: Communication between patients and physicians via e-mail is increasing in prevalence, and a substantial number of physicians are providing medical information via e-mail consultation. Billing for online consultation has been approved by the American Medical Association, and several medical insurance carriers are evaluating the economic consequences of reimbursement for e-mail consultation. E-mail consultation raises potential medico-legal concerns, including establishment of the physician-patient relationship, malpractice liability, and HIPAA compliance. CONCLUSIONS: The increasing prevalence of e-mail consultation raises new concerns for neurosurgeons. Some of these concerns have yet to be addressed by regulatory commissions or in the courts. If used appropriately, e-mail communication can facilitate physician-patient interactions, improve access to care, save time for each interaction, and possibly reduce costs of care.

Electronic Mail↗
PubMed1997

[Guidelines for clinical practice].

Clinical practice guidelines are systematically developed statements that are intended to support medical decision making in well-defined clinical situations. Essentially, their object is to reduce the variability in medical practice, to improve quality, and to make appropriated control of the financial resources possible. Internationally, ever more organisations, associations, and institutions are concerned with the development of guidelines in many different areas of care. Making implicit knowledge explicit is one of the associated advantages of guidelines: they have a potential utility in training, in process evaluation, and in the reevaluation of outcome studies. In liability issues, their existence has a double effect: they can be used to justify medical behaviour, and they constitute a generally accepted reference point. A derivative problem is the legal liability of the compilers of the guidelines. The principle of the guideline approach can be challenged academically: science cannot give a definition of optimal care with absolute certainty. What is called objectivity often rests on methodologically disputable analyses; also the opinion of opinion leaders is not always a guarantee for scientific soundness. Moreover, patients are not all identical: biological variability, situational factors, patient expectations, and other elements play a role in this differentiation. Clinicians are often hesitant with respect to clinical guidelines: they are afraid of cookbook medicine and curtailment of their professional autonomy. Patients fear reduction of individualization of care and the use of guidelines as a rationing instrument. The effects of the introduction of clinical practice guidelines on medical practice, on the results and on the cost of care vary but are generally considered to be favourable. The choice of appropriate strategies in development, dissemination, and implementation turns out to be of critical importance. The article ends with concrete suggestions for the various steps in the development of guidelines and their actual compilation.

Adolescent↗
PubMed2005

Palliative care: good legal defense.

The perceived risk of legal liability looms large as a major barrier to optimal palliative care among surgeons. Aggressive pain management may cause respiratory depression and death, whereas withdrawal of support may lead to a charge of manslaughter. Citing legal principles and precedents, this article explains why there is legal support for terminal analgesia and sedation, balanced chronic pain management, and effective surgeon-patient communication in the setting of good surgical palliative care.

Analgesia↗
PubMed1996

Medical records: information gathering and confidentiality.

This article focuses on protecting the confidentiality and privacy of workplace medical records. All employers should be concerned about the potential legal liability for unauthorized and improper disclosure of confidential employee medical data. Employers should adapt and follow a corporate policy governing the use and maintenance of confidential employee hiring, benefits, personnel and medical information. If there is any question concerning the confidentiality of records, employers should consult with legal counsel or other outside advisers.

Confidentiality↗
PubMedDate not supplied

Office gossip: a surprising source of liability.

Rumors and gossip are inevitable ingredients of work life. Within limits, they may have some beneficial functions. Still, practitioners and managers must be aware of the dangers inherent in defamation of character and harassment. This article defines workplace comments and activities that should be avoided and the employer's legal liability when situations get out of hand. It also outlines the manager's responsibilities and lists privacy rights that are codified by state and federal laws.

Communication↗
PubMed1998

Liability in prescribing choice: the example of the antidepressants.

OBJECTIVE: The aim of this study is to review issues of legal liability in prescribing choice. Prescribing not only occurs in a medical setting, but also in a social and legal context in this era of evidence-based medicine and greater consumer awareness. Prescribers may be unaware of the legal consequences of medical decision-making and prescribing choice. This issue affects all areas of medicine and can be illustrated by antidepressant choice for major depression. METHOD: A review was undertaken of liability issues that may arise in the context of prescribing, with particular reference to prescribing antidepressants. RESULTS: There are legal precedents which illustrate prescribers' potential liability. These impose duties on the prescriber including those of care, to inform, and to respond to patients' wishes. In particular, the duty of care requires that if medicines are of equal efficacy, one should prescribe the best tolerated and least toxic medicine that is most likely to be taken at an effective dose for an adequate duration. While older and newer antidepressants are generally of equal efficacy, the newer agents have higher tolerability, lower toxicity and are less likely to be associated with treatment failure (due to sub-therapeutic dose regimens, or the patient discontinuing medication), disabling psychomotor impairment, dietary interaction or fatal overdose. CONCLUSIONS: There needs to be compelling reasons for prescribing medicines with a greater likelihood of adverse outcomes such as the older antidepressants (e.g. tricyclics) rather than the newer antidepressants such as RIMAs, SSRIs, SNRIs and 5HT2 receptor antagonists. The higher likelihood of an adverse outcome of treatment where an older antidepressant has been prescribed raises the potential for professional negligence claims to be brought against medical practitioners who prescribe such medicines for reasons other than established medical need.

Antidepressive Agents↗
PubMed1997

Legal issues of computer imaging in plastic surgery: a primer.

Although plastic surgeons are increasingly incorporating computer imaging techniques into their practices, many fear the possibility of legally binding themselves to achieve surgical results identical to those reflected in computer images. Computer imaging allows surgeons to manipulate digital photographs of patients to project possible surgical outcomes. Some of the many benefits imaging techniques pose include improving doctor-patient communication, facilitating the education and training of residents, and reducing administrative and storage costs. Despite the many advantages computer imaging systems offer, however, surgeons understandably worry that imaging systems expose them to immense legal liability. The possible exploitation of computer imaging by novice surgeons as a marketing tool, coupled with the lack of consensus regarding the treatment of computer images, adds to the concern of surgeons. A careful analysis of the law, however, reveals that surgeons who use computer imaging carefully and conservatively, and adopt a few simple precautions, substantially reduce their vulnerability to legal claims. In particular, surgeons face possible claims of implied contract, failure to instruct, and malpractice from their use or failure to use computer imaging. Nevertheless, legal and practical obstacles frustrate each of those causes of actions. Moreover, surgeons who incorporate a few simple safeguards into their practice may further reduce their legal susceptibility.

Communication↗
PubMed2006

[Non-commercial clinical trials--who will be the legal sponsor? Sponsorship of investigator-initiated clinical trials according to the German Drug Law].

Non-commercial clinical trials may be of great benefit to the patients concerned. The 12th amendment to the German Drug Law (AMG) changed legal liability of the initiators of investigator-initiated clinical trials with extensive consequences for traditional project leaders. The central point under discussion is the sponsor's responsibility according to the AMG. Presently leading management divisions of university hospitals and universities are developing proceedings to assume sponsor responsibility by institutions (institutional sponsorship), which should enable investigator-initiated clinical trials to be conducted according to legal requirements in the future. Detailed problems and special questions can only be resolved in a single-minded fashion, and if necessary political processes should be catalyzed.

Clinical Trials as Topic↗