Law Commons^™

Fda In The Time Of Covid-19, Elizabeth Mccuskey

Faculty Scholarship

Over the past century, Congress has made the Food & Drug Administration (FDA) responsible for regulating the safety and efficacy of drugs and devices being deployed in the fight against the COVID-19 pandemic. The FDA’s regulatory infrastructure was built for public health threats and to combat manufacturers' misinformation about treatments.

This article spotlights the ways in which FDA has been adapting to a new challenge during the COVID-19 pandemic: combating misinformation emanating from within the executive branch.

The Argument That Wasn't' And 'King, Chevron, And The Age Of Textualism, Abigail Moncrieff

Faculty Scholarship

In these two short essays, I examine the somewhat bizarre — and potentially harmful — ways that Chief Justice John Roberts escaped the tension between legalism and realism in King v. Burwell, the Court’s latest Obamacare case. King presented a close legalistic case but a slam-dunk realist case in favor of an IRS interpretation of Obamacare. Roberts opted for the realistic result, but he got there through a bizarre combination of legalistic maneuvers. In “The Argument that Wasn’t,” I note that Roberts refused to make the full legalistic argument in the government’s favor, ignoring an invocation of the constitutional avoidance …

The Inclusion Of Pregnant Women In Clinical Research, Barbara A. Noah

Faculty Scholarship

In the past three decades, there has been unprecedented growth in medical research utilizing human subjects, with much promise for new treatments that extend life, improve quality of life, and prevent disease and disability. Safe prescribing of drug therapies requires that researchers design clinical trials to test products for the benefit of all persons who are likely to utilize them, not just a limited population. For this reason, it is essential that clinical trials include women, pregnant women, children, and racial minorities, as appropriate, because these populations sometimes exhibit different patterns of response or adverse reactions.

Despite some significant progress …

Price And Pretense In The Baby Market, Kimberly D. Krawiec

Faculty Scholarship

Throughout the world, baby selling is formally prohibited. And throughout the world babies are bought and sold each day. As demonstrated in this Essay, the legal baby trade is a global market in which prospective parents pay, scores of intermediaries profit, and the demand for children is clearly differentiated by age, race, special needs, and other consumer preferences, with prices ranging from zero to over one hundred thousand dollars. Yet legal regimes and policymakers around the world pretend that the baby market does not exist, most notably through prohibitions against “baby selling” – typically defined as a prohibition against the …

The Supreme Court's Assault On Litigation: Why (And How) It Could Be Good For Health Law, Abigail Moncrieff

Faculty Scholarship

In recent years, the Supreme Court has narrowed or eliminated private rights of action in many legal regimes, much to the chagrin of the legal academy. That trend has had a significant impact on health law; the Court’s decisions have eliminated the private enforcement mechanism for at least four important healthcare regimes: Medicaid, employer-sponsored insurance, and medical devices. In a similar trend outside the courts, state legislatures have capped noneconomic and punitive damages for medical malpractice litigation, weakening the tort system’s deterrent capacity in those states. This Article points out that the trend of eliminating private rights of action in …

Abortion, Equality, And Administrative Regulation, Gillian E. Metzger

Faculty Scholarship

Abortion and equality are a common pairing; courts as well as legal scholars have noted the importance of abortion and a woman's ability to control whether and when she has children to her ability to participate fully and equally in society. Abortion and administrative regulation, on the other hand, are a more unusual combination. Most restrictions on abortion are legislatively imposed, while guarantees of reproductive freedom are constitutionally derived, so administrative law does not frequently figure in debates about access to abortion.