This study examined the medical information contained in a sample of television ads soliciting consumers for lawsuits against drug and medical device manufactures. Almost all such ads involved drugs or devices that have not been recalled and remain on the market. These ads raise important public health questions because they may influence the prospective medical decisions of viewers.

The ads contained extensive descriptions of serious adverse events associated with the drugs or devices but almost uniformly failed to disclose information relating to the likelihood of such events. They also failed to effectively advise viewers to consult a doctor.

Results also identified a subset of ads that mimicked public service announcements, claiming to be a “medical alert” “consumer alert” or “FDA warning” at the start of the ad. Most such ads did not disclose the attorney source of the advertising until the final few seconds.

Perhaps no single policy topic better illustrates the tensions within American politics at the beginning of a new millennium than does Medicare, the nation's thirty-five year commitment to ensuring senior citizens' financial protection against the costs of acute medical care. Our politics seems nearly overwhelmed by conflicting promises to balance the budget and pay down the national debt, enact tax cuts and protect broadly popular “entitlements.” Medicare, one of the largest of such entitlement programs, has become a lightning rod for conflicts over how to resolve these competing goals. As a result, the nation finds itself in the midst of a bewildering mix of crisis talk, fact throwing and ideological name calling, with all the confusion and distortion one would expect from such a mix.

Approximately 128,000 Americans are hospitalized and 3000 die each year from foodborne illness. A ten-year study of 4589 foodborne outbreaks attributed 46% of these hospitalizations and 43% of the deaths to meat. The Food and Drug Administration (FDA), the primary federal agency tasked with regulating food, is aware of these statistics, and characterizes them as “largely preventable.” It is becoming clear that modern meat production methods allow pathogens to spread with ease, creating great food safety risks. Startling numbers of people continue to get sick each year from food, even though regulators believe the harms are preventable, and know the source of many of the risks. This Note explores why the United States under-regulates its food as compared to other nations, and suggests improvements to the domestic regulatory structure that would facilitate better regulation.

In the case of In re Grady, the New Jersey Superior Court addressed important issues concerning the propriety of a court's exercise of parens patriae jurisdiction to ratify parents’ substituted consent to the sterilization of their mentally retarded child. This Note discusses the genesis of the fundamental right to choose sterilization, its application to mentally retarded individuals, and the adequacy of the procedural framework enunciated in Grady to assure that substituted consent by the parents is exercised solely in the mentally retarded individual's “best interests.” This Note concludes that, while the Grady court properly exercised its parens patriae jurisdiction, the procedural framework enunciated is inadequate. The Note proposes a model that would implement the procedural elements the Note determines are essential to a “best interests” inquiry. The proposal requires: (1) that the individual be adjudicated incompetent; (2) that a guardian ad litem be appointed and required to argue that sterilization is not in the incompetent's “best interests”; and (3) that the court determine, as a question of fact, whether the parents’ exercise of substituted consent is in the incompetent's “best interests.” The Note also suggests criteria which can be used in making the “best interests” determination, and recommends that “clear and convincing” evidence be required to support the “best interests” standard.

As of January 2014, 26 states had chosen to expand Medicaid under the Affordable Care Act (ACA) to cover individuals with incomes up to 138% of the federal poverty level. In these states, Medicaid agencies are facing one of the largest implementation challenges in the program’s history. We undertook a survey of high-ranking Medicaid officials in these states to assess their priorities, expectations, and programmatic decisions related to the coming expansion.

The Medicaid expansion poses major challenges in the domains of enrollment, management of health care costs, and providing adequate access to services for beneficiaries. Previous research has documented that millions of individuals eligible for Medicaid are currently not enrolled and remain uninsured, suggesting that state outreach strategies may underpin the success or failure of the ACA’s coverage expansion.

As implementation of the World Health Organization (WHO) Framework Convention on Tobacco Control (FCTC) accelerates and states seek to address risk factors for non-communicable disease more broadly, tension has increased between the law of the World Trade Organization (WTO) and public health. For example, Indonesia recently brought a successful claim against a U.S. law that prohibits cigarettes with a characterizing flavor other than menthol or tobacco. Indonesia succeeded in arguing that the regulation discriminates against clove-flavored cigarettes of Indonesian origin in favor of menthol-flavored cigarettes of U.S. origin.

Also in the WTO context, the Dominican Republic, Honduras, and Ukraine have challenged an Australian law prohibiting the presence of branding on tobacco packaging other than product and variant names in a standardized location, font size, and style. This regulation, commonly referred to as “plain packaging,” is the first of its kind and may represent a turning point in the regulation of tobacco packaging.

Informed consent matters — so does protecting people from infectious diseases. This paper examines what the appropriate informed consent process for vaccines should look like and how the process is conceptualized by law and health authorities. Drawing on the extensive theoretical and empirical literature on informed consent and vaccination, this article sets out what an ideal informed consent process for vaccination would consist of, highlighting the need for autonomous decisions. To be autonomous, decisions need to be based on full, accessible information and reached without coercion. We suggest that the information provided must address the nature of the procedure — including benefits to the child, benefits to society, and risks. Parents should have their concerns and misconceptions addressed. The information needs to be accessible and include an opportunity to ask questions. Based on this ideal model we examined in detail the legal framework surrounding informed consent to vaccination and the process as conceptualized by health authorities in two countries, Israel and the United States, to assess whether they meet the requirements. These two countries are similar in some of their values, for example, the importance of individual autonomy, and face similar problems related to vaccine hesitancy. At the same time, there are meaningful differences in their vaccine policies and the current structures of their informed consent processes, allowing for a meaningful comparison. We found neither country met our ideal informed consent process, and suggested improvements both to the materials and to the processes used to obtain informed consent.

This Note examines how both the law and the health care profession neglect women's needs for abortion counseling before, during and after an abortion. Part I analyzes the health care profession's view of counseling, the psychological effects of abortion and how counseling both positively and negatively influences those effects. Part II reviews Supreme Court cases and state law regarding abortion counseling, critizing both the Court's narrow view of counseling and the states’ failure to use the legislative process to create laws which benefit maternal health. Part III recommends an expanded role for abortion counseling, in which the counselor can provide emotional support from before the day of an abortion until a woman emotionally recovers from an abortion. This expanded role would be state-mandated, but would remain within constitutional boundaries by providing flexibility for counselors to give individual treatment while respecting a woman's privacy.

Within the physicians' services industry, doctors of osteopathy are the only "full line" competitors of medical doctors. Given the current interest in merger of the two schools of practice, this Article examines the benefits of having an independent osteopathic school. These benefits include: (1) reduction of the monopoly power of medical doctors in malpractice litigation, fee negotiations with third party payors and the formulation of health policy; (2) greater satisfaction of consumer desires; and (3) diversity and innovation in physicians' training and methods of practice. The Article concludes that society has an interest in discouraging merger of the two groups; osteopathy should be maintained as an independent school of practice. To this end, society should carefully consider the impact of legislation and regulatory policies that may have the unintended effect of eliminating osteopathy as an independent competitor.

Everyone condemns medical quackery. Government regulators seek to protect us from it. Alternative providers strive to distance themselves from it. Orthodox medicine wants to stamp it out.

The question is: What constitutes “quackery”? How do we distinguish quacks from mainstream practitioners? Even more problematic, how do we distinguish between quackery, which everyone agrees is beyond the pale and therefore should be fair game for sanction, and practices that, while unorthodox, should be tolerated in the interests of promoting medical progress and patient choice? These are particularly challenging questions now, when a number of factors are combining to undermine the hegemony of mainstream medicine, when some of the same forces that spurred the growth of quackery in the 19th century are remerging, and when neo-conservatives are clamoring for greater freedom of choice for health care consumers.

This article begins with a brief history of quackery in America and the factors that encourage its growth. The article then attempts to distinguish between quackery and acceptable medical practice.

Imagine the following scenario:

Medical research is heavily funded: the National Institutes of Health had a budget of over $20 billion in 2001, and even more money was spent by the pharmaceutical industry on research. Children's health issues, however, receive only a small fraction of these funds. In 2001, for example, less than $1 billion of NIH funding was allocated to the National Institute of Child Health and Human Development (NICHD). In part, the problem stems from a modern predisposition to protect children from participating in research.

Several federal policies in the 1990s changed the face of the “typical research subject.” Historically, researchers sought “white men,” but the NIH announced in 1994 that all research would need to include women and minorities, and in 1998, the NIH added the requirement of including children. The shift in policies reflects a shift in focus. When the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research addressed fairness in subject selection in the Belmont Report of 1979, the main concern was ensuring fairness in the distribution of risks.

Discovering the genetic basis of a particular disease is not only of great interest to the medical community; private health insurers are also anxiously awaiting the results of genetic linkage studies. Apart from the scientific value of DNA studies, the results of genetic linkage research are relevant to health care delivery in two principal ways. First, identifying the genetic origin of a disease may allow doctors to detect the disease earlier. If doctors know that an individual is genetically predisposed to a particular disease, then health care providers can increase screening efforts and watch for early symptoms. Second, if an individual has a genetic predisposition to a particular disease, health care providers may employ preventive or “prophylactic" measures to reduce or eliminate the risk of developing the disease or condition to which the individual is genetically predisposed. Genetic linkage studies will soon allow more individuals to learn of their own genetic predispositions to certain diseases. Currently genetic predisposition tests (both pedigrees of family history and DNA analysis) can indicate that an individual is at high risk for developing a disease.

The ethics of non-invasive scientific research on human skeletal remains are poorly articulated and lack a single, definitive analogue in western law. Laws governing invasive research on human fleshed remains, as well as bio-ethical principles established for research on living subjects, provide effective models for the establishment of ethical guidelines for non-invasive research on human skeletal remains. Specifically, non-invasive analysis of human remains is permissible provided that the analysis and collection of resulting data (1) are accomplished with respect for the dignity of the individual, (2) do not violate the last-known desire of the deceased, (3) do not adversely impact the right of the next of kin to perform a ceremonious and decent disposal of the remains, and (4) do not unduly or maliciously violate the privacy interests of the next of kin.

Henry Fan, owner of T.I. Drugstores, one of the city's largest pharmacies, just walked into your office for legal advice. He sits down across from your desk and holds his head in his hands. With a worried look on his face, he tells you that his pharmacy has just been sued by one of its customers, Elaine Jones. A year ago, T.I. Drugstores received a prescription for Jones from Dr. Kenneth Brown for Bendectin, a prescription drug used for the treatment of nausea and vomiting during the early stages of pregnancy. After reviewing the prescription for errors, the pharmacist filled the prescription according to its directions and sold it to Jones.

Approximately eight months later, Jones gave birth to a baby girl with severe deformities as a result of the ingested Bendectin. Sadly, her child will never be able to sit or walk properly. Jones is suing T.I. Drugstores for negligently failing to advise her of the potential hazards associated with ingesting Bendectin. Additionally, Jones claims that T.I. Drugstores is strictly liable for failing to warn her of the fact that ingesting Bendectin causes birth defects in children.

Fan informs you that the pharmacist assumed that Brown had forewarned Jones of the risks associated with Bendectin. Outraged, Fan insists that neither his drugstore nor his pharmacist acted incorrectly. They simply did what they were supposed to do: fill the prescription according to its specifications.

The Food Safety Modernization Act (FSMA) reforms law governing the safety of human and animal foods produced for consumption in the United States. Recognizing the challenges that the proposed regulations would impose on small farms, Congress included an amendment to exempt small farms from the full scope of FSMA requirements. This special treatment and other issues left unaddressed by FSMA, however, present challenges for buyers of small farm products and is inducing a private sector response to these regulatory gaps. This Article reviews the current treatment of small farms under FSMA and explores some key impacts and implications of FSMA on these organizations. Particular consideration is given to the unintended consequences of the Tester-Hagan Amendment and the unaddressed issue of liability for foodborne illness.

The emergence of genetic screening techniques will permit employers to exclude hypersusceptible individuals from potentially hazardous workplace environments. The denial of employment opportunities to these individuals, however, may constitute discrimination. This Note analyzes genetic screening cases with respect to currently available remedies contained in Title VII of the Civil Rights Act of 1964 and the Rehabilitation Act of 1973. The Note concludes that Title VII claims may succeed but only in limited circumstances and that Rehabilitation Act claims will encounter numerous obstacles to relief. Additionally, the Note discusses some of the implications of the use of genetic screening in the workplace.

The medical liability crisis is affecting our healthcare system. Medical liability and limited physician and hospital access to malpractice insurance have pushed many providers to leave their states, reduce their services, or simply retire. For many, a labor of love has become an agonizing search for insurance to ensure continued practice in an industry for which they trained eight, fifteen, or even twenty years. Limited insurance and potential liability has also led to defensive medicine, in which providers try to avoid lawsuits by ordering tests, procedures, and anything else that might help protect against liability. Moreover, providers may also attempt to avoid high-risk patients or practices altogether to limit opportunities for lawsuits. Although it is questionable whether these efforts actually help, the provider perception of self-preservation through defensive medicine is undeniable—and providers, like everyone, act on their perceptions.

Health care rationing has gained greater visibility in the United States and the United Kingdom, for quite different reasons. As patients in both countries become more aware that potentially beneficial medical services can be denied them on economic — as opposed to purely medical — grounds, they are beginning to seek help from the judiciary. This Article contends that as rationing becomes more explicit, the doctrine of informed consent will come under increased pressure. The Article suggests that courts and legislatures consider imposing a legal obligation on physicians to inform their patients when potentially effective treatment is to be withheld for economic or other non-clinical reasons.