Although medical care delivery by one's personal physician is the paradigmatic American healthcare arrangement, in the workplace setting, many Americans undergo medical evaluations to assess their fitness for duty or degree of impairment. This Article explores the complex and evolving legal status of occupational medical evaluations. Beginning with the legal and ethical frameworks of occupational medical practice, the Article then examines the effects of increasingly detailed legal regulation under the Americans with Disabilities Act and the Genetic Information Nondiscrimination Act on employees, employers, and physicians.

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.

Food system regulation must negotiate intensely individual and hyper-local preferences with the national and collective implications of food production and consumption. The regulatory scheme permits the coincidence of multiple sets of regulators, and there is an active interchange between federal and state authorities. This kind of “dynamic” or “polyphonic” federalism entails “the interaction of multiple independent voices” and “the dynamic interaction among states and the national government.”

The market for direct-to-consumer (DTC) health services continues to grow rapidly with former patients converting to customers for the opportunity to purchase varied diagnostic tests without the involvement of their clinician. For the first time a DTC genetic testing company is advertising health-related reports “that meet [Food and Drug Administration] standards for being clinically and scientifically valid.” Ethicists and regulatory agencies alike have recognized the need for a more informed transaction in the DTC context, but how should we classify a commercial transaction for something normally protected by a duty of care? How can we assure informed agreements in an industry with terms and conditions as varied as the services performed? The doctrine of “informed consent” began as an ethical construct building on the promise of beneficence in the clinical relationship and elevating the principle of autonomy—but in the DTC context should we hold providers to legal standards of informed consent and associated medical malpractice liability, or contractual obligations where consumers would seek remedy for breach?

This Article analyzes the fine balance that must be struck in an industry where companies are selling services for entertainment or non-medical purposes that possess the capacity to produce serious and disquieting medical information. It begins by reviewing current standards of consent in the clinical setting from both a legal and ethical perspective and then lays forth current standards for DTC consent using two currently controversial case studies: that of keepsake fetal ultrasound and genetic testing.

DTC keepsake ultrasound and genetic testing providers attempt to de-medicalize the devices used for these procedures from their intended medical uses to non-medical uses. But while keepsake ultrasound is marketed as “intended for entertainment purposes only,” it can provide medical information as an incidental finding. 23andMe currently purports to be the only DTC genetics service that “includes” reports that meet FDA qualifications, despite disclaimers of intent to “provide medical advice.” The attempted de-medicalization of these devices, therefore, has not been fully transformative, and DTC providers should have more robust ethical and legal duties than the average goods and services seller.

This Article delineates these responsibilities, beginning with ethical duties surrounding marketing, entering into, and providing DTC services. It then turns to the legal paradigms necessary to enable, or at least allow for, DTC providers to meet these ethical obligations. While it argues that contractual, as opposed to fiduciary, requirements are most appropriate and that waivers of liability will likely be upheld, it also advocates for a heightened expectation of disclosure during contracting.

Alongside the constitutional controversy ultimately addressed by the Supreme Court, the colossal Patient Protection and Affordable Care Act (ACA) ushered in a new paradigm for regulation of biologics by the Food and Drug Administration (FDA). Nestled within the expansive ACA, the Biologics Price Competition and Innovation Act (BPCIA) set forth an abbreviated pathway to market for “biosimilar” and “interchangeable” biological products. While the current BPCIA implementation debate focuses chiefly on the scope of scientific and technical assessments by the FDA and the effect on the emergent biosimilar industry, two issues will prove essential for determinations of access to and costs of the resulting products: how the biosimilar and interchangeable biosimilar biologics are to be named, and whether pharmacist substitution is appropriate for products the FDA deems interchangeable. This article examines the current debate surrounding the use of nonproprietary names for biosimilar biologics, as well as state efforts to reconcile automatic substitution laws for the eventual products. In particular, the article addresses the implications for patients and the United States health care system, highlighting the potential negative effect on anticipated cost-savings, hindrances for effective tracking and reporting of adverse events, and a general lack of consistency in state laws.

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.

For another thing, the division of medical opinion about the matter at most means uncertainty, a factor that signals the presence of risk, not its absence. That division here involves highly qualified knowledgeable experts on both sides of the issue.—Stenberg v. Carhart, 20001

While we find no reliable data to measure the phenomenon, it seems unexceptionable to conclude some women come to regret their choice to abort the infant life they once created and sustained.—Gonzales v. Carhart, 20072

In the wake of growing public concerns over salmonella outbreaks and other highly publicized food safety issues, Congress passed the FDA Food Safety Modernization Act in 2011, which placed more stringent standards on food growing and packaging operations. In negotiations preceding the Act's passage, farmers of local, sustainable food argued that these rules would unduly burden local agricultural operations or, at the extreme, drive them out of business by creating overly burdensome rules. These objections culminated in the addition of the Tester-Hagan Amendment to the Food Safety Modernization Act, which created certain exemptions for small farms. Proposed Food and Drug Administration (FDA) rules to implement the Act threatened to weaken this victory for small farm groups, however, prompting a loud response from small farmers and local food proponents.

The FDA's second set of proposed rules, issued in September 2014 in response to these and other complaints, were, perhaps surprisingly, responsive to small farmers' concerns. Using comments submitted to the FDA, this article explores the responses of the agriculture industry and public health organizations, as well as small farm groups, consumers of local food, and sustainable agriculture interests (which, for simplicity, I alternately describe as comprising the “sustainable agriculture” or “small farm” movement), to three aspects of the FDA's proposed rules—involving manure application, on-farm packing activities, and exemptions for very small farms—to assess the strength of the sustainable agriculture movement. The rules involving manure application and on-farm packing, it turns out, reveal little about the independent political strength of the local food movement, as large industry groups also objected to these provisions. But for the third issue discussed here—exemptions for very small farms—the interests of sustainable agriculture groups were directly opposed to both industry and public health organizations, and yet prevailed. This suggests that the high salience of locavore and “slow food” issues might have allowed relatively small, dispersed interests to overcome traditional obstacles to political organization, and that the sustainable agriculture movement has indeed become an effective political force.

The Affordable Care Act (ACA) may be the most important health law statute in American history, yet much of the most prominent legal scholarship examining it has focused on the merits of the court challenges it has faced rather than delving into the details of its priority-setting provisions. In addition to providing an overview of the ACA's provisions concerning priority setting and their developing interpretations, this Article attempts to defend three substantive propositions.

First, I argue that the ACA is neither uniformly hostile nor uniformly friendly to efforts to set priorities in ways that promote cost and quality.

Second, I argue that the ACA does not take a single, unified approach to priority setting; rather, its guidance varies depending on the aspect of the healthcare system at issue (Patient Centered Outcomes Research Institute, Medicare, essential health benefits) and the factors being excluded from priority setting (age, disability, life expectancy).

Third, I argue that cost-effectiveness can be achieved within the ACA's constraints, but that doing so will require adopting new approaches to cost-effectiveness and priority setting. By limiting the use of standard cost-effectiveness analysis, the ACA makes the need for workable rivals to cost-effectiveness analysis a pressing practical concern rather than a mere theoretical worry.

Behavioral scientists have understood for decades that when it comes to food, we are anything but fully autonomous. One's choice of what and how much to eat is strongly influenced by environment and context. Give someone a larger bowl and serving spoon, and he will unwittingly eat more ice cream than if he used a smaller bowl and spoon. A person will eat more if out with friends, and may eat less if eating at a leisurely pace. The food industry has been fully aware of this science for decades; indeed, its scientists have been among the leading researchers in the area. Using this science to its advantage, the industry has manipulated the appearance, smell, taste, texture, and packaging of food to get Americans to eat more of the foods the industry sells, with often devastating consequences for the public health.

Environmental, public health, alternative food, and food justice advocates are working together to achieve incremental agricultural subsidy and nutrition assistance reforms that increase access to fresh fruits and vegetables. When it comes to targeting food and beverage products for increased regulation and decreased consumption, however, the priorities of various food reform movements diverge. This article argues that foundational legal issues, including preemption of state and local authority to protect the public's health and welfare, increasing First Amendment protection for commercial speech, and eroding judicial deference to legislative policy judgments, present a more promising avenue for collaboration across movements than discrete food reform priorities around issues like sugary drinks, genetic modification, or organics. Using the Vermont Genetically Modified Organism (GMO) Labeling Act litigation, the Kauai GMO Cultivation Ordinance litigation, the New York City Sugary Drinks Portion Rule litigation, and the Cleveland Trans Fat Ban litigation as case studies, I discuss the foundational legal challenges faced by diverse food reformers, even when their discrete reform priorities diverge. I also explore the broader implications of cooperation among groups that respond differently to the “irrationalities” (from the public health perspective) or “values” (from the environmental and alternative food perspective) that permeate public risk perception for democratic governance in the face of scientific uncertainty.

By the end of 2013, almost 122,000 organ transplant candidates in the United States remained active on the national waiting list. The current number of candidates exceeds 123,000. To address this overwhelming need, researchers have been exploring methods to supplement traditional organ donations. At the forefront of this research is regenerative medicine, the field of regenerating or replacing tissue and organ function by studying the body’s own healing mechanisms. Regenerative medicine is quickly fulfilling its promise of producing vascularized, functioning organs in vitro by combining two other areas of research: the replication of cell lines in vitro and the recent adaptation of three-dimensional printing for the health care industry. Today, physicians armed with the latest generation of bioprinters and imaging equipment are creating high-resolution airway splints and personalized bone replacements for human use. These techniques have even achieved success with more complicated structures, including human kidneys and livers.

Transparency for consumers through nutrition labeling should be the last, not the first, step in a transformative food policy that would reduce dramatic health disparities and raise the United States to the health standards of other nations with similar resources. Nonetheless, transparency in the food system is a key focal point of efforts to improve health by providing consumers with necessary information to make good nutritional choices, as well as to achieve sustainable food chains and ensure food safety and quality. In fact, nutrition labeling on packaging and in restaurants is the centerpiece of policy designed to decrease obesity, a condition many health advocates consider to be the most urgent public health crisis of the twenty-first century. The resulting increased transparency about food ingredients has led to some changes in industry practices and allowed many middle- and upper-income consumers to make informed choices about the products they purchase and consume. Unfortunately, however, research reveals that increased nutritional information does not improve health.

As of April 2015, twenty-three states and the District of Columbia permit the therapeutic use of marijuana1 to treat various illnesses or conditions, with legalization statutes currently pending in eight other states. Despite the growing number of states that allow for the prescription and use of medicinal marijuana, the federal government still classifies the drug as a Schedule I controlled substance, the strictest classification of controlled substances and the only type healthcare providers may not legally prescribe. As states continue to deliberate the merits of allowing access to marijuana for therapeutic use, it is useful to examine the structural and political forces that have prevented a similar movement at the federal level. This Note does so, and argues that proactive changes—either legislative or administrative—are necessary to remove the handicap that the current regulatory system places on attempts to change federal marijuana policy.