Open Access. Powered by Scholars. Published by Universities.®
Articles 1 - 2 of 2
Full-Text Articles in Law
The Preemption Pentad: Federal Preemption Of Products Liability Claims After Medtronic [V. Lohr], Robert B. Leflar, Robert S. Adler
The Preemption Pentad: Federal Preemption Of Products Liability Claims After Medtronic [V. Lohr], Robert B. Leflar, Robert S. Adler
Robert B Leflar
Taking the language of the federal consumer protection statutes out of historical context and inattentive to those laws' original purposes, judges dissatisfied with the expansion of state products liability law have in recent years read preemption provisions of these federal statutes to bar a wide range of claims that would otherwise be viable under state law. In Medtronic v. Lohr, the Supreme Court (per Justice Stevens) severely constrained the scope of the federal preemption defense in the context of the federal medical device law. But the implications of the Medtronic decision for cases involving products in other regulatory categories remain …
Public Accountability And Medical Device Regulation, Robert B. Leflar
Public Accountability And Medical Device Regulation, Robert B. Leflar
Robert B Leflar
In enacting the Medical Device Amendments of 1976, Congress instituted a flexible system of regulatory controls over a vast array of health care products. Analyzing the complex statute and its legislative history, Professor Leflar finds at the law's core a structure designed to ensure the Food and Drug Administration's accountability to the public for its regulatory actions. Reviewing the history of FDA's implementation of the medical device law, however, the author demonstrates that FDA has strayed widely and, he contends, illegally from the congressionally mandated structure of public accountability. In particular, in its review of new-model medical devices in the …