Law Commons^™

The Opioid Litigation: The Fda Is Mia, Catherine M. Sharkey

Dickinson Law Review (2017-Present)

It is readily agreed that federal preemption of state tort law alters the balance between federal and state power. Federal preemption is a high-profile defense in almost all modern products liability cases. It is thus surprising to see how little attention has been given to federal preemption by courts and commentators in the opioid litigation. Opioid litigation provides a lens through which I explore the role of state and federal courts and the Food and Drug Administration (FDA) in striking the right balance of power. My purpose here is not to resolve the divide among the few courts that have …

Reflections On The Effects Of Federalism On Opioid Policy, Matthew B. Lawrence

Dickinson Law Review (2017-Present)

No abstract provided.

Encouraging Maternal Sacrifice: How Regulations Governing The Consumption Of Pharmaceuticals During Pregnancy Prioritize Fetal Safety Over Maternal Health And Autonomy, Greer Donley

Articles

Pregnant women are routinely faced with the stressful decision of whether to consume needed medications during their pregnancies. Because the risks associated with pharmaceutical drug consumption during pregnancy are largely unknown, pregnant women both inadvertently consume dangerous medications and avoid needed drugs. Both outcomes are harmful to pregnant women and their fetuses. This unparalleled lack of drug safety information is a result of ill-conceived, paternalistic regulations in two areas of the law: regulations governing ethical research in human subjects and regulations that dictate the required labels on drugs. The former categorizes pregnant women as “vulnerable” and thus precludes them from …

A System Of Men And Not Of Laws: What Due Process Tells Us About The Deficiencies In Institutional Review Boards, Greer Donley

Articles

Governmental regulation of human subjects research involves unique agency action. It delegates power to non-expert committees, Institutional Review Boards, to decide whether research protocols are "ethical" according to vague federal regulations. Without IRB approval, the protocol cannot be investigated. The empirical evidence regarding this system demonstrates that IRBs render deeply inconsistent and inaccurate outcomes. This Article argues that the lack of due process in the IRB system is to blame for such arbitrary agency action. By juxtaposing the levels of process required for IRB approval or research with FDA new drug approval--agency action involving similar interests--this Article highlights that IRBs …

A Cost-Benefit Interpretation Of The "Substantially Similar" Hurdle In The Congressional Review Act: Can Osha Ever Utter The E-Word (Ergonomics) Again?, Adam M. Finkel, Jason W. Sullivan

All Faculty Scholarship

The Congressional Review Act permits Congress to veto proposed regulations via a joint resolution, and prohibits an agency from reissuing a rule “in substantially the same form” as the vetoed rule. Some scholars—and officials within the agencies themselves—have understood the “substantially the same” standard to bar an agency from regulating in the same substantive area covered by a vetoed rule. Courts have not yet provided an authoritative interpretation of the standard.

This Article examines a spectrum of possible understandings of the standard, and relates them to the legislative history (of both the Congressional Review Act itself and the congressional veto …

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 …

Public Health Law As Administrative Law: Example Lessons, Edward P. Richards

Journal of Health Care Law and Policy

No abstract provided.

Beyond Compensation: Using Torts To Promote Public Health, Elizabeth A. Weeks

Journal of Health Care Law and Policy

No abstract provided.