Add to ORKGThis article attempts to reconcile the competing purposes of the MDA, and to offer one alternative to effectuate Congress\u27 purposes without preempting some claims and permitting others. First, this article will describe the arrangement of the MDA, including the classification provisions for medical devices and the preemption provision of the MDA. Next, this article will interpret the caselaw regarding preemption in general, and specifically preemption of state tort claims by the MDA. Finally, this article seeks to reconcile two competing purposes of Congress in enacting the MDA through implied preemption of state tort claims, with exceptions for devices which have never been subjected to the Food and Drug Administration\u27s (FDA) pre-ma...
The U.S. Supreme Court’s important ruling in Mutual Pharmaceutical Co., Inc. v. Bartlett concerns wh...
A mere five years ago, the Food and Drug Administration (the FDA ) began, for the first time in its...
The Supreme Court\u27s decision in Riegel v. Medtronic immunized medical device manufacturers from c...
This article attempts to reconcile the competing purposes of the MDA, and to offer one alternative t...
A circuit split regarding the preemptive scope of the Medical Device Amendments of 1976 (MDA) has wi...
Under the Medical Device Amendments of 1976 (MDA), Congress established a complex scheme for regulat...
Should manufacturers of cutting-edge medical devices ever be able to avoid liability from common law...
Imagine an individual who visits his or her doctor after developing a hernia. The doctor informs the...
This symposium was convened to address the growing and seemingly conflicting jurisprudence governing...
The 21st Century Cures Act introduced innovative changes to the Food and Drug Administration’s regul...
The purpose of this paper is to explore the relationship between federal medical device regulation a...
Perhaps the most dramatic indication that the courts have shifted attitudes on health and safety mat...
In Medtronic, Inc. v. Lohr, the United States Supreme Court, in a five-to-four split, held that the ...
I start with a brief history of the Medical Device Amendments of 1976 and explain why that history d...
This comment discusses the Medical Device Amendments of the Federal Food, Drug, and Cosmetic Act and...
The U.S. Supreme Court’s important ruling in Mutual Pharmaceutical Co., Inc. v. Bartlett concerns wh...
A mere five years ago, the Food and Drug Administration (the FDA ) began, for the first time in its...
The Supreme Court\u27s decision in Riegel v. Medtronic immunized medical device manufacturers from c...
This article attempts to reconcile the competing purposes of the MDA, and to offer one alternative t...
A circuit split regarding the preemptive scope of the Medical Device Amendments of 1976 (MDA) has wi...
Under the Medical Device Amendments of 1976 (MDA), Congress established a complex scheme for regulat...
Should manufacturers of cutting-edge medical devices ever be able to avoid liability from common law...
Imagine an individual who visits his or her doctor after developing a hernia. The doctor informs the...
This symposium was convened to address the growing and seemingly conflicting jurisprudence governing...
The 21st Century Cures Act introduced innovative changes to the Food and Drug Administration’s regul...
The purpose of this paper is to explore the relationship between federal medical device regulation a...
Perhaps the most dramatic indication that the courts have shifted attitudes on health and safety mat...
In Medtronic, Inc. v. Lohr, the United States Supreme Court, in a five-to-four split, held that the ...
I start with a brief history of the Medical Device Amendments of 1976 and explain why that history d...
This comment discusses the Medical Device Amendments of the Federal Food, Drug, and Cosmetic Act and...
The U.S. Supreme Court’s important ruling in Mutual Pharmaceutical Co., Inc. v. Bartlett concerns wh...
A mere five years ago, the Food and Drug Administration (the FDA ) began, for the first time in its...
The Supreme Court\u27s decision in Riegel v. Medtronic immunized medical device manufacturers from c...