Law Commons^™

Renovations Needed: The Fda's Floor/Ceiling Framework, Preemption, And The Opioid Epidemic, Michael R. Abrams

Michigan Law Review

The FDA’s regulatory framework for pharmaceuticals uses a “floor/ceiling” model: administrative rules set a “floor” of minimum safety, while state tort liability sets a “ceiling” of maximum protection. This model emphasizes premarket scrutiny but largely relies on the state common law “ceiling” to police the postapproval drug market. As the Supreme Court increasingly holds state tort law preempted by federal administrative standards, the FDA’s framework becomes increasingly imbalanced. In the face of a historic prescription medication overdose crisis, the Opioid Epidemic, this imbalance allows the pharmaceutical industry to avoid internalizing the public health costs of their opioid products. This Note …

Regulating Black-Box Medicine, W. Nicholson Price Ii

Michigan Law Review

Data drive modern medicine. And our tools to analyze those data are growing ever more powerful. As health data are collected in greater and greater amounts, sophisticated algorithms based on those data can drive medical innovation, improve the process of care, and increase efficiency. Those algorithms, however, vary widely in quality. Some are accurate and powerful, while others may be riddled with errors or based on faulty science. When an opaque algorithm recommends an insulin dose to a diabetic patient, how do we know that dose is correct? Patients, providers, and insurers face substantial difficulties in identifying high-quality algorithms; they …

Medicine As A Public Calling, Nicholas Bagley

Michigan Law Review

The debate over how to tame private medical spending tends to pit advocates of government-provided insurance—a single-payer scheme—against those who would prefer to harness market forces to hold down costs. When it is mentioned at all, the possibility of regulating the medical industry as a public utility is brusquely dismissed as anathema to the American regulatory tradition. This dismissiveness, however, rests on a failure to appreciate just how deeply the public utility model shaped health law in the twentieth century— and how it continues to shape health law today. Closer economic regulation of the medical industry may or may not …

How Many Libertarians Does It Take To Fix The Health Care System?, Thomas L. Greaney

Michigan Law Review

There's an old joke about a Southern preacher who is asked whether he believes in the sacrament of infant baptism. "Believe in it?" thunders the preacher. "Hell, son, I've seen it done." In Mortal Peril: Our Inalienable Right to Health Care?, Richard Epstein gives testimony that markets should be left unfettered to distribute health care services. Arguing from first principles, he aims to persuade that the messy, confusing business of health care is best dealt with by simple legal rules: permit free contracting, countenance no government-induced subsidies, recognize no positive rights. One leaves this particular revival tent feeling he …

Cumulative Trauma Disorders: Osha's General Duty Clause And The Need For An Ergonomics Standard, David J. Kolesar

Michigan Law Review

This Note argues that neither the Act nor its underlying policies supports OSHA's current use of the general duty clause to prosecute alleged ergonomics violations and that the only way to protect workers from CTDs fairly and effectively is through the promulgation of an ergonomics standard. Part I examines the purposes of the Act, as well as the function of the Act's general duty clause. Part II analyzes the four requirements of the general duty clause in the context of CTDs and finds that the clause does not apply to CTDs. Part III argues that the Act's intended policies support …

In The Regulation Of Manmade Carcinogens, If Feasibility Analysis Is The Answer, What Is The Question?, Christopher H. Schroeder

Michigan Law Review

A Review of Environmentally Induced Cancer and the Law by Frank B. Cross

Of Foxes And Hen Houses: Licensing And The Health Professions, Michigan Law Review

Michigan Law Review

A Review of Of Foxes and Hen Houses: Licensing and the Health Professions by Stanley J. Gross

Regulation Through The Looking Glass: Hospitals, Blue Cross, And Certificate-Of-Need, Sallyanne Payton, Rhoda M. Powsner

Michigan Law Review

A clear focus on the commitment of the public health and hospital establishments to the large teaching hospital and their belief in rationalizing the health care system through community-based planning allows us to understand the ideas and institutions that have produced our present system of hospital regulation. It can also help us to understand the structure and behavior of the hospital industry and can illuminate current controversies over health care policy.

What follows is a narrative account of the development of regional planning and certificate-of-need legislation. As part of that story, we trace the evolution of the Blue Cross, explain …

International Control Of The Safety Of Nuclear-Powered Merchant Ships, William H. Berman, Lee M. Hydeman

Michigan Law Review

In recent years we have witnessed the transition of nuclear-powered ships from an imaginative dream to an engineering reality. This vast step from the drawing board to successful operation on the high-seas has taken place in a remarkably short span of time. Nevertheless, in the :flush of enthusiasm over the technological achievement, we must not lose sight of the fact that the promise of nuclear power for the propulsion of ships will not have been fulfilled until nuclear vessels are operating safely and economically over the maritime trade routes of the world. It would be unrealistic to assume that further …