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“Danger Is My Business”: The Right To Manufacture Unsafe Products, Richard C. Ausness
“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 …
“There's Danger Here, Cherie!”: Liability For The Promotion And Marketing Of Drugs And Medical Devices For Off-Label Uses, Richard C. Ausness
“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
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 …
Will More Aggressive Marketing Practices Lead To Greater Tort Liability For Prescription Drug Manufacturers?, Richard C. Ausness
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 …
Learned Intermediaries And Sophisticated Users: Encouraging The Use Of Intermediaries To Transmit Product Safety Information, Richard C. Ausness
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 …