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Is It Worth The Trouble? The New Policy On Dissemination Of Information On Off-Label Use Under The Food And Drug Administration Modernization Act Of 1997, Elizabeth Weeks Leonard Jan 1999

Is It Worth The Trouble? The New Policy On Dissemination Of Information On Off-Label Use Under The Food And Drug Administration Modernization Act Of 1997, Elizabeth Weeks Leonard

Scholarly Works

On January 14, 1998 the Food and Drug Administration (FDA) approved the use of a product previously marketed as Excedrin Extra Strength® for use in treating migraine headaches. As part of the approval for the new use of the product, FDA required the pharmaceutical manufacturer of Excedrin®, Bristol-Myers Squibb, to relabel and repackage the product. The new product is called “Excedrin Migraine®” and is sold side-by-side with Excedrin Extra Strength®. Both over-the-counter (OTC) products contain the same active ingredients: 250 milligrams of acetaminophen, 250 milligrams of aspirin, and sixty-five milligrams of caffeine. Many …


Genetic Test Results And The Duty To Disclose: Can Medical Researchers Control Liability?, Richard L. Furman, Jr. Jan 1999

Genetic Test Results And The Duty To Disclose: Can Medical Researchers Control Liability?, Richard L. Furman, Jr.

Seattle University Law Review

This Comment examines research on the human genome and explores the existence of a duty to disclose genetic test results in clinical and research settings. Part II begins with a hypothetical describing how such a duty to disclose can arise. Part III (A-C) describes advances in the sequencing of the human genome, the development of reliable tests for genetic disorders, and issues regarding access and control of genetic test samples and results. Part III (D) looks at the tort law basis for a general duty of physicians to disclose medical information, the specific duty of clinical physicians to disclose the …