In financial disputes involving research, the parties are traditionally individual researchers and their institutions, biotech and pharmaceutical companies, and other entities engaged in the commercial development of biomedical research. Occasionally, research subjects claim that researchers have misled them or misappropriated their biological materials to derive financial gain. The best known example is the case of Moore v. Regents of the University of California, decided in 1990.

With new developments in genomics, large-scale repositories of tissue and other biological specimens are increasingly important. Biobanks have been established by various researchers, commercial entities, health-care institutions, and even entire countries. Individuals who contribute specimens almost always retain no commercial interest in any resulting research and language to that effect is now customarily included in informed consent documents signed at the time the specimen is given. Suppose, however, that the research subjects actually collect the specimens themselves, recruit the researcher, and provide financial support for the research.

This article examines the Emergency Medical Treatment and Labor Act (EMTALA) in a public health emergency context. Congress enacted EMTALA in 1986 to prohibit the practice of “patient clumping,” which involved hospitals’ refusal to undertake emergency screening and stabilization services for individual patients who sought emergency room care, typically because of insurance status, inability to pay, or other grounds unrelated to the patient’s need for the services or the hospital’s ability to provide them. But in fact EMTALA, whose conceptual roots can be found in the Hospital Survey and Construction Act of 1946 (Hill Burton) as well as an evolution in both the common law and state statutes related to hospital licensure, can be viewed as having a far broader purpose than protection of individuals, and indeed, one that is related to the protection of communities and the public health.

Employers of all types, including group practices, health maintenance organizations (HMOs), and university and other hospital practices, commonly include noncompetition clauses in physician employment contracts. The clauses only apply in the event physicians leave their employers, and typically only limit activities in relatively narrow geographic areas. Consequently, physicians often agree to the clauses without much thought or analysis. This is a mistake, as the clauses may have broad adverse ramifications for both physicians and patients.

This article identifies the standard components of noncompetition clauses, addresses the ethical and practical concerns they raise, and reviews recent court decisions on point. The article concludes that despite public policy concerns, courts can and often do enforce the clauses. The purpose of the article, therefore, is to increase physicians’ awareness of the potential impact of these clauses, and to encourage physicians to carefully consider whether to accept contracts that contain them, or at the very least to negotiate for the least restrictive terms possible.

The, Police Executive Research Forum is completing a major initiative that encourages police chiefs to formalize working relationships with emergency medical personnel. The effort is sponsored by the U.S. Department of Justice, Bureau of Justice Assistance as a demonstration with the goal of preventing recurring violence that eventually leads to homicide. The initiative originally involved a consortium of emergency room clinicians, emergency medical service (EMS) personnel, as well as police executives. The collaboration initially focused on arguably preventable dimensions of domestic violence and homicide. However, after “9/11” and the ensuing anthrax crisis, the project developed into a three-step draft interactive protocol for earlier police intervention in situations involving possible deaths and mass casualties. With this shift in the project, Police Executive Research Forum’s (PERF) principal collaborators shifted from emergency clinicians to public health practitioners.

The Mayday Scholars Program for 2001-2002 provided an opportunity to boards of nursing to present their experiences in monitoring the prescribing practices of advanced practice nurses and to research ways for improving their own investigation processes as professional disciplinary agencies for prescribing practices related to pain management. The Alabama Board of Nursing was interested in participating in the program based on its commitment to accountability for public protection. A gradual increase in disciplinary cases involving violations of prescribing practices by certified registered nurse practitioners (CRNPs) prompted our inquiry as to whether a proactive monitoring system was needed to determine compliance with regulations for advanced practice nurses in collaborative practice.

In this article, we discuss selected elements related to pain management and regulatory factors, including nursing, that affect the treatment of pain. We present a brief overview of the evolution of advanced practice nursing, with an emphasis on the nurse practitioners movement, and prescription practices and pain management by nurse practitioners.

Despite advances in medical knowledge regarding pain management, pain continues to be significantly undertreated in the United States. There are many drug and nondrug treatments, but the use of controlled substances, particularly the opioid analgesics, is universally accepted for the treatment of pain from cancer. Although opioid analgesics are safe and effective in treating chronic pain, there is continued research and discussion about patient selection and long-term effects. A number of barriers in the health care and drug regulatory systems account for the gap between what is known about pain management and what is practiced. Among the barriers are physicians’ fears of being disciplined by state regulatory boards for inappropriate prescribing.

State medical boards are in a unique position not only to address physicians’ concerns about being investigated, but also to encourage pain management. Prior to 1989, a few state medical boards had policies relating to controlled substances or pain. Subsequently, state medical boards began adopting policies regarding the prescribing of opioids for the treatment of pain; many of these specifically addressed physicians’ fear of regulatory scrutiny.

The conflict between courts and medicine is best shown in the mental health cases requiring judgment of whether a person should be confined, and whether they should be medicated or left free to decide for themselves. In such cases, deprivation of liberty for noncriminal offenders is at question, but if they are released, they may be exposed to injury or injure others. “Clear and convincing” evidence is hard to prove in such cases.

The TOPOFF 2 terrorism preparedness exercise was two years in planning, but the courts were involved only seven days before the exercise (because quarantine issues were added to that exercise only two weeks beforehand). Judge Murphy was put in charge of the Circuit Court building and was asked to stop all court proceedings to stop people from going into a building that might have been contaminated.

In Ferguson v. City of Charleston, the Medical University of South Carolina (MUSC) developed a policy in conjunction with police and prosecutors that requires pregnant and post-pregnancy women to be tested for cocaine in their urine if they presented with certain factors. If the patient is still pregnant, her first positive test results in referral to a substance abuse program. After a second positive test, or upon failure to comply with the substance abuse program, the woman would be arrested. If a patient tested positive upon delivery of her baby, she would be arrested “as soon as medically possible.” A Solicitor’s Letter given to and signed by each woman after her first positive test explains these comequences. Concomitantly, a letter given to all patients receiving prenatal care informs them of the effects of drug use and warns of possible referral to the prosecutor’s office.

Senate Bill 1435, the “Prison Rape Elimination Act of 2003,” was introduced into the Senate on July 21, 2003, and in less than a week passed both the Senate and House by unanimous consent. The Bill was presented to President Bush on September 2, 2003, and he signed it two days later on September 4, 2003. The stated purposes of the Act are far-reaching and ambitious:

1. (1) establish a zero-tolerance standard for the incidence of prison rape in prisons in the United States;

2. (2) make the prevention of prison rape a top priority in each prison system;

3. (3) develop and implement national standards For the detection, prevention, reduction, and punishment of prison rape;

4. (4) increase the available data and information on the incidence of prison rape, consequently improving the management and administration of correctional facilities;

5. (5) standardize the definitions used for collecting data on the incidence of prison rape;

The continuing spread and development of electronic data interchange in health care settings is fuelling a significant global debate about the practicality, ethics, and legality of such a practice. The uncertainties implicit in this debate are particularly acute in the context of disease or population groups for whom multidisciplinary, multipleagency teamworking has become acknowledged as the “best practice” for providing effective and timely care or support. The greying of the population is a demographic phenomenon that will have a profound impact on the health care system, social care agencies, and caregivers, and will require a greater degree of service coordination in order to meet the complex care needs of both care-receiver and caregiver.

Traditionally, hospital emergency readiness plans primarily addressed natural disasters, but because of preparations for year 2000, the arrival of terrorism in the United States, and the potential for mass casualties, hospitals were prompted to bring together new partners and create new emergency readiness plans. These new plans, however, give rise to a number of important issues hospitals must consider. First, hospitals must consider legal liability that might arise during an emergency. For example, what liability might arise when decision are made regarding the provision of individual treatment versus mass triage? Second, hospitals must be cognizant of relevant privacy rules, such as the Health Insurance Portability and Accountability Act (HIPAA), as they apply to public health emergencies activities. Third, hospitals must be aware of the Emergency Medical Treatment and Active Labor Act (EMTALA) which requires Medicarefunded hospitals to screen patients for emergency medical conditions and prohibits their transfer until they are stabilized.

Changes in the scope of health policy in the United States are creating opportunities and obligations for lawmakers and the lawyers who advise them. These changes are the result of a new politics of policy for the health of populations. The new politics is connecting areas of policy that, because they have had separate histories, are governed by distinct, usually uncoordinated laws and regulations.

The subject of the new politics of health policy is what the Iowa Senate President, speaking in a plenary at the 2003 conference on Public Health Law in the 21st Century, called the “quality of life, what the people think is important.” An increasing number of leaders in general govemment–people who run for office and their staff–have practical reasons to make policy that acknowledges the expanding scope of what their constituents define as health policy.

Since the Supreme Court of New Jersey decided the Quinlan case a quarter of a century ago, three American Supreme Court decisions and a host of state appellate decisions have addressed end-of-life issues. These decisions, as well as legislation addressing the same issues, have prompted a torrent of law journal articles analyzing every aspect of end-of-life law. In recent years, moreover, a number of law review articles, many published in this journal, have also specifically addressed legal issues raised by palliative care. Much less is known in the United States, however, as to how other countries address these issues. Reflection on the experience and analysis of other nations may give Americans a better understanding of their own experience, as well as suggest improvements to their present way of dealing with the difficult problems in this area.

This article offers a conceptual and comparative analysis of major legal issues relating to end-of-life treatment and to the treatment of pain in a number of countries. In particular, it focuses on the law of Australia, Canada, the United Kingdom, Poland, France, the Netherlands, Germany, and Japan.

In State v. McKnight, the Supreme Court of South Carolina decided 3-2 to affirm McKnight’s conviction for homicide by child abuse based on the finding that her cocaine use during pregnancy caused her daughter to be stillborn. Under South Carolina law, a person is guilty of homicide by child abuse if he or she “causes the death of a child under the age of eleven while committing child abuse or neglect, and the death occurs under circumstances manifesting extreme indifference to human life.” During the trial, the pathologist who conducted the autopsy testified that (1) the only way for the infant to have cocaine byproducts present in her system was ifthe mother had ingested cocaine, and (2) the cause of death was intrauterine fetal demise. Another pathologist testified that there was a reasonable degree of medical certainty that the cause of death was intrauterine cocaine exposure.

Preventable childhood injuries and deaths are a major public health problem in the United States. In 2000, the most recent year for which mortality data are available, over 10,000 children from birth to age 18 died from unintentional injuries in the United States and nearly 3,000 from the same age group died from homicide or suicide. According to the Childhood Injury Fact Sheet produced by the Centers for Disease Control and Prevention (CDC), “unintentional injuries are the leading cause of death for children one to 21 years of age.”

Preventing child fatalities requires further understanding of the causes and circumstances surrounding child deaths. One mechanism for doing this is multidisciplinary child fatality review teams. These teams exist at the state and local level and perform the functions of identifying, reviewing, and recommending preventive measures to reduce the number of preventable child deaths and life-threatening injuries.

The Tobacco Control Legal Consortium is a national “network” designed to tap expertise about tobacco control legislation and to leverage existing resources. Based at the William Mitchell College of Law in St. Paul, Minnesota, the Consortium supports local counsel with research, strategic advice, sample materials and pleadings, and amicus briefs. The Consortium’s priorities are to support capacity nationally, to offer education, and to perform outreach activities to a variety of audiences.

The Consortium seeks to advance policy change by making legal expertise more readily available to the tobacco control community. Legal issues are inevitably involved in policy change. The Consortium does not provide legal representation, but conducts analysis and research. They publish on important and emerging legal issues as well as on specific cases, assist in the development of legislation, and train public health practitioners and policy makers on recurring legal issues.

The word “epidemic” seems inadequate to describe the spread of the HIV virus in sub-Saharan Africa. The latest estimates suggest that 28.5 million people in this region are infected, including 5 million in South Africa alone. The HIV and AIDS pandemic, with infection rates of over 20 percent in seven African countries, rivals the worst of history's disease outbreaks, including the bubonic plague of medieval times. The devastating effects of the disease on the continent are compounded by extreme poverty in the region and the lack of medical infrastructure essential for delivering the full range of available treatments for HIV infection, AIDS, and the opportunistic infections associated with the disease. Of the 40 million people infected with HIV worldwide, only 730,000 receive combination antiretroviral therapies. In the entire African continent, only 30,000 infected people currently receive such forms of treatment.

On December 20, 2002, the Ohio Supreme Court issued an opinion in Dardinger v. Anthem Blue Cross & Blue Shield granting a landmark punitive damages award against the defendant-insurer for breach of contract and bad faith in its coverage of a cancer patient. The court directed that the punitive damages award of $30 million, should it be accepted by the plaintiff, be apportioned between the plaintiff and a cancer research fund to be established in the name of the plaintiff's deceased wife, Esther Dardinger. In so doing, the court broke new ground in the scope and social purpose of punitive damages in health care litigation, as well as the courts’ role in distributing those damages.

After being diagnosed with metastatic brain tumors in October 1996, Esther began intra-arterial chemotherapy (IAC) treatments at the recommendation of her physician, Dr. Newton. IAC is a targeted form of chemotherapy in which an arterial catheter is threaded through a cranial artery near the tumor and into the brain.

In February, the Food and Drug Administration announced a rule imposing new manufacturer labeling requirements for antibiotics. The aim of the new standards is to educate physicians and patients about the dangers of improper antibiotic use. Overprescription of antibiotics, as well as patient failure to comply with treatment regimens, has led to the development of drug-resistant bacteria. “Antibacterial resistance is a serious and growing public health problem in the United States and worldwide,” FDA Commissioner Mark McClellan said in a press release accompanying the rule. “Without effective antibiotic drugs, common infections, that were once easily treated, can create a serious health threat to children and adults alike.”

The FDA regulates foods, drugs, and cosmetics introduced into interstate commerce for safety and effectiveness. Currently, the agency requires drug labels to provide “adequate directions for use,” including indications, quantity of dose, frequency, duration, route, and preparation.