This is Your Products Liability Restatement on Drugs
88 Pages Posted: 14 Jan 2009 Last revised: 21 Sep 2015
Date Written: December 15, 2008
This paper attempts to offer a comprehensive evaluation of the various facets of the Products Liability Restatement that relate to medical technologies, and it does so from a perspective rooted in the regulatory as opposed to the doctrinal challenges posed by these products. The special provisions applicable to prescription drugs and devices have provoked a great deal of scholarly commentary, and the few courts to consider the issue have uncritically relied upon the published critiques. I find little merit in most of these negative assessments, though I point out some flaws in section 6 of new Restatement that seemingly no one else has identified. Part II addresses production defects, focusing on the heated debate over what standards to use in deciding whether a prescription drug suffers from a defective design. Part III considers defects related to the information that accompanies prescription drugs, especially those advertised directly to consumers. Finally, Part IV touches on some of the peculiar issues raised by investigational products, generic drugs, prescription medical devices, and the duties of non-manufacturing sellers.
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