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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 …
The Application Of A Due Diligence Requirement To Market Share Theory In Des Litigation, Thomas C. Willcox
The Application Of A Due Diligence Requirement To Market Share Theory In Des Litigation, Thomas C. Willcox
University of Michigan Journal of Law Reform
This Note argues that courts should impose a due diligence requirement on plaintiffs as a prerequisite to the use of market share theory. Part I examines traditional products liability theories along with alternative theories and explains the relationship of due diligence to market share theory. Part II argues that due diligence should be a prerequisite to market share liability. Part III discusses the nature of due diligence in this context. Finally, Part IV considers various objections to a due diligence requirement and argues that they are essentially without merit.