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Renovations Needed: The Fda's Floor/Ceiling Framework, Preemption, And The Opioid Epidemic, Michael R. Abrams
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 …
Radiation Injuries And Statistics: The Need For A New Approach To Injury Litigation, Samuel D. Estep
Radiation Injuries And Statistics: The Need For A New Approach To Injury Litigation, Samuel D. Estep
Michigan Law Review
The emphasis given by the mass media of communication to some of the dramatic problems arising from the use of nuclear energy unfortunately has diverted attention from some of the matters about which something can be done by lawyers, administrators, and legislators without the necessity of complicated international negotiations between various parties to the "Cold War." The headlines leave the uninformed, and perhaps often also the informed, public with the impression that even for radiation injuries the important problems all deal with such questions as: (1) Will only a few or many millions of people survive an all-out nuclear war? …