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 …

“Danger Is My Business”: The Right To Manufacture Unsafe Products, Richard C. Ausness

Law Faculty Scholarly Articles

While no one would dispute that safety is a desirable objective, it may not always be an absolute priority. Rather, in some cases, other societal interests such as personal autonomy, consumer choice, product cost, and performance may trump legitimate safety goals. This is reflected in some of the doctrines and defenses that have evolved to protect the producers of unsafe products against tort liability. Some of these doctrines, such as those determining liability for the producers of optional safety equipment, inherently dangerous products, products with obvious hazards, and prescription drugs and medical devices, are part of the law of products …

A Prescription Warning, Carlton Lee Harpst

Pepperdine Law Review

No abstract provided.

“There's Danger Here, Cherie!”: Liability For The Promotion And Marketing Of Drugs And Medical Devices For Off-Label Uses, Richard C. Ausness

Law Faculty Scholarly Articles

Physicians often prescribe prescription drugs and other medications for uses that are not approved by the Food and Drug Administration ("FDA"), and such "off label" prescription is widely accepted within the medical community as a legitimate form of treatment. However, the federal government discourages off-label prescription and use in various ways. For example, the FDA restricts the dissemination of information by drug companies about potential off-label therapies. In addition, federally funded health insurance programs such as Medicaid do not reimburse health care providers for off-label uses. Because drug companies make large profits from off-label prescriptions, they are often tempted to …

The Battle Over Implied Preemption: Products Liability And The Fda, Mary J. Davis

Law Faculty Scholarly Articles

A mere five years ago, the Food and Drug Administration (the "FDA") began, for the first time in its 100-year history, to take the position that its prescription drug labeling regulations defeated the ability of injured plaintiffs to pursue common law tort claims based on the adequacy of the labeling. This position, radical to many and rational to others, places federal preemption of prescription drug labeling actions directly in the center of the debate over the proper roles of federal regulation and state tort laws in promoting product safety. The U.S. Supreme Court has contributed to this debate with several …

A Prescription For Drug Liability And Regulation, Victor E. Schwartz, Phil Goldberg

Oklahoma Law Review

No abstract provided.

Will More Aggressive Marketing Practices Lead To Greater Tort Liability For Prescription Drug Manufacturers?, Richard C. Ausness

Law Faculty Scholarly Articles

Manufacturers of prescription drugs have begun to market their products more aggressively than they did in the past. These marketing efforts are not confined to health care professionals alone; pharmaceutical companies now engage in extensive direct-to-consumer advertising on radio and television, in the print media, and even on the Internet. While these promotional efforts no doubt increase sales, they may also lead to greater tort liability for drug-related injuries. The most likely theories of liability are failure to warn and negligent marketing. Liability for inadequate warnings will almost certainly increase if courts abandon the learned intermediary rule and require drug …

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 …

Learned Intermediaries And Sophisticated Users: Encouraging The Use Of Intermediaries To Transmit Product Safety Information, Richard C. Ausness

Law Faculty Scholarly Articles

The general rule, under both negligence principles and strict products liability, is that a producer or supplier is required to warn users or consumers of its products. In most cases, this duty can be satisfied by placing a warning label on the product itself or by providing safety information in an owner's manual or in other literature attached to or enclosed with the product. However, there are some situations where it is difficult or impracticable to provide a direct warning to the ultimate user or consumer. In such cases, producers and suppliers should be able to satisfy their duty to …

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.

Generic Product Risks: The Case Against Comment K And For Strict Tort Liability, Joseph A. Page

Georgetown Law Faculty Publications and Other Works

The author considers whether strict liability should be imposed for injuries caused by products that pose generic risks--risks that do not derive from flaws in the manufacturing process but from product design or from the very nature of the product. He reviews the American Law Institute (ALI) debate that preceded adoption of section 402A of the Restatement (Second) of Torts and finds the ambiguous meaning of comment k, which deals with "unavoidably unsafe" products, of little use in determining whether section 402A applies to generic product risks. After examining the policy justifications for imposing strict liability in cases involving design …