Law Commons^™

(Almost) No Bad Drugs: Near-Total Products Liability Immunity For Pharmaceuticals Explained, Anita Bernstein

Washington and Lee Law Review

This Article explores four beliefs about supposed pharma-benevolence that appear to be shared by more than the industry, reaching the level almost of conventional wisdom. These figurative pillars help support one-sided results in court. However, each of the pillars on examination turns out at least a bit shaky. This Article puts them forward for review to start a necessary discussion.

The locus of this Article is products liability, where a court concludes that a manufactured object is defective or could be called defective by a factfinder following a trial. Drug manufacturers enjoy near-immunity from this consequence. Modern products liability identifies …

The Informational And Institutional Theories Of Off-Label Promotion, Miguel A. Lopez

San Diego Law Review

This Article contends that there are two distinct theories of the offense of off-label promotion—the informational theory and the institutional theory. One is concerned with controlling the flow of medical knowledge and the other is concerned with protecting regulatory legitimacy. Different kinds of evidence are key under each theory. I argue that although the Federal Food, Drug, and Cosmetic Act (FD&C Act) and its accompanying regulations emphasize the informational theory, federal prosecutors rely more heavily on the legal arguments that underpin the institutional theory of enforcement. A corollary to this contention is that the informational theory of off-label promotion does …

Internet Pharmacies And The Need For A New Federalism: Protecting Consumers While Increasing Access To Prescription Drugs, Linda C. Fentiman

Elisabeth Haub School of Law Faculty Publications

In this article I will argue that Internet pharmacies pose a significant public health problem, as they raise the classic eternal triangle of health care issues--access, quality, and financing--in a new technological context. Part II describes the phenomena of Internet pharmacies, and Part III reviews the present regulatory scheme. Part IV explains why the current legal framework is inadequate to address the public health and safety problems posed by Internet pharmacies, focusing particularly on the jurisdictional, constitutional, and practical obstacles to effective state oversight of Internet pharmacies. Part V argues that comprehensive federal oversight of Internet prescribing and dispensing is …

Direct-To-Consumer Advertising Of Prescription Drugs: After A Decade Of Speculation, Courts Consider Another Exception To The Learned Intermediary Rule, Mae Joanne Rosok

Seattle University Law Review

This Comment will explore whether Washington courts should recognize direct-to-consumer advertising as an exception to the learned intermediary rule. With the ultimate goal of advocating the best protection for the consumer, the discussion will suggest that Washington courts should not create an exception. A review of other exceptions to the learned intermediary rule does not support abandoning the doctrine when a drug company advertises its product directly to consumers. Nevertheless, advertising does affect consumer purchases and does influence consumer choices, and drug companies should accept the responsibility to present balanced information. This responsibility should encompass more than meeting the minimum …

Will A New Restatement Help Settle Troubled Waters: Reflections, James A. Henderson Jr., Aaron Twerski

Cornell Law Faculty Publications

No abstract provided.

A Proposed Revision Of Section 402a Of The Restatement (Second) Of Torts, James A. Henderson Jr., Aaron Twerski

Cornell Law Faculty Publications

No abstract provided.

Consumer Protection And Prescription Drugs: The Generic Drug Substitution Laws, Jillena A. Warner

Kentucky Law Journal

No abstract provided.