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Table of Contents
Barbarians at the Gate: Consumer-Driven Health Data Commons and the Transformation of Citizen Science
Barbara J. Evans - [PDF]

Citizen science has a mixed reputation. It includes well-organized, crowd-sourced efforts like the 1830s British great tidal experiment that enlisted members of the public to monitor tides at 650 coastal locations, but it also includes less rigorous dabbling by amateurs. Successful citizen science projects often engage laypeople, supervised by professional scientists, to collect and analyze data or even to assist in creating the finished scholarly works - in other words, the citizens are a source of labor. This article explores an alternative model - citizen research sponsorship - in which citizens supply essential capital assets to support research. The assets could be monetary (research funding, for example), although this article focuses on a different kind of capital: data resources, which are a critical input for twenty-first century biomedical research.
AIDS Activists, FDA Regulation, and the Amendment of America's Drug Constitution
Lewis A. Grossman - [PDF]

The Parklawn Building, a massive, bland edifice erected in the late 1960s, looms over a neighborhood of nondescript office buildings and auto repair shops in Rockville, Maryland, about four miles outside the Washington, D.C. Beltway. Until recently, the building contained the headquarters of the U.S. Food and Drug Administration (FDA), as well as other Department of Health and Human Services (HHS) offices. It is an unlikely setting for a mass protest. For a thousand boisterous AIDS activists who stormed it on October 12, 1988, however, the Parklawn Building was the Bastille. And as this Article will explain, their demonstration sparked a profound transformation in the government's approach to regulating treatments for serious illnesses.
Are We Suffering from an Undiagnosed Health Right?
Christina S. Ho - [PDF]

Some of the United States' most significant health policies have been defeated, paradoxically because they did not go far enough to protect health. In FDA v. Brown & Williamson, the Food and Drug Administration's (FDA) tobacco rule was struck in part because it curbed tobacco marketing to minors rather than banning tobacco from the market for everyone. In Lorillard v. Reilly, Massachusetts shielded children from tobacco advertising in neighborhood retail stores, but only inside a five-foot-from-the ground buffer zone. This limited ban violated the First Amendment not because it failed to protect enough speech, but because it failed to protect the health of children taller than five feet. In the Eleventh Circuit case culminating in NFIB v. Sebelius, the Patient Protection and Affordable Care Act's (ACA) individual mandate fell outside Congress' Necessary and Proper power because it did not go far enough: it exempted certain immigrants and people facing economic hardship, thereby failing the constitutional fit test. Finally, the NFIB Medicaid ruling proclaimed the new eligibility expansion covering all residents under 133% of the federal poverty level unconstitutional because it carved non-expansion states out from the entitlement to "old Medicaid funding." It thus left key state health interests unprotected.
Missing the "Target": Preventing the Unjust Inclusion of Vulnerable Children for Medical Research Studies
Ruqaiijah Yearby - [PDF]

Nearly everyone has experienced a burn and the resulting pain. Now imagine that you suffer a third-degree radiation burn that injures all the layers of your skin as well as the tissue, causing you extreme pain. The burn turns your skin white, cherry red, or black and may produce blisters that are dry, hard, and leathery-looking. The burn can also be seen on the surface of your lungs and gastrointestinal tract. If the burn is big enough you will need skin grafts and surgery to replace the skin and tissue that will never grow back, as well as treatment to prevent infection. Assumedly, no human being would intentionally cause another human being to experience this type of pain and suffering. However, U.S. researchers did. Researchers at the Medical College of Virginia conducted radiation tests on healthy African American children, as young as 6 months old, deliberately causing third-degree burns to their skin. The tests not only damaged the skin of these children, causing them extreme pain, but it also required surgery and skin grafts.
Notes and Comments
Combatting Massachusetts's Opioid Epidemic: Reducing the Social Stigma of Addiction Through Increased Access to Voluntary Treatment Services and Expansion of Mandatory Clinician Education Programs
Julie Pearlman - [PDF]

The opioid epidemic is a significant global health problem affecting the health and economy of our nation. Massachusetts currently faces an increasing prescription opioid crisis, resulting in addiction, heroin use, and accidental overdose deaths. While other states are certainly experiencing this same problem, former Massachusetts Governor Deval Patrick declared the problem a Public Health Emergency in 2014. By declaring the opioid epidemic a Public Health Emergency, Governor Patrick took "extraordinary legal action[]," which is normally only invoked for public health issues such as acts of terrorism, epidemics of serious, contagious diseases, and natural disasters. Massachusetts does not define a public health emergency, granting the governor discretion in deciding when to declare such an event.
Recent Court Decisions
Recent Case Development: Supreme Court Strikes Down Abortion Regulations; Texas Bill Found Unconstitutional
Melissa Kraus - [PDF]

In Whole Woman's Health v. Hellerstedt, the Supreme Court considered the constitutionality of two provisions of Texas' House Bill 2. Texas passed the bill in 2013 amid significant controversy, most notably when State Senator Wendy Davis filibustered the bill for over eleven hours. Governor Rick Perry then called a second special session of the state legislature in his effort to make abortion "a thing of the past," or to at least impose more safety restrictions on abortion providers. Many other states had passed similar restrictions, often referred to as Targeted Regulation of Abortion Providers, or TRAP laws, which were all struck down by this ruling. The first provision required that any physician performing an abortion, "have active admitting privileges at a hospital . . . . located not further than 30 miles from the location at which the abortion is induced . . . ." Previously, Texas required facilities to have a written protocol describing what to do in the event of a medical emergency and a working arrangement with a physician with admitting privileges at a hospital. The second provision required "the minimum standards for an abortion facility [to] be equivalent to the minimum standards . . . for ambulatory surgical centers." Texas abortion providers opposed both of these provisions, claiming they violated the Fourteenth Amendment under the Casey standard. The district court enjoined both provisions from being enforced and found them to be unconstitutional. Texas appealed the judgment. The Fifth Circuit then reversed the district court's decision. The Fifth Circuit determined that the plaintiffs had not provided sufficient evidence to prove the two provisions placed a substantial obstacle in the path of women's access to abortions.
Recent Case Development: Supreme Court Reshapes the Landscape of False Claims Act Litigation
Eugenie Reich - [PDF]

On June 16, 2016, the Supreme Court clarified the basis of False Claims Act (FCA) liability in a health care fraud case brought qui tam by respondents. The Court upheld the implied certification theory under which any statutory, regulatory, or contractual noncompliance can be a basis for liability, but also cabined liability by reading a "rigorous" materiality standard into the FCA. Both plaintiffs' and defense lawyers have claimed the opinion as a victory.