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Food and Drug Law

Michigan Law Review

Informed consent

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From The Wrong End Of The Telescope: A Response To Professor David Bernstein, Margaret A. Berger, Aaron D. Twerski Aug 2006

From The Wrong End Of The Telescope: A Response To Professor David Bernstein, Margaret A. Berger, Aaron D. Twerski

Michigan Law Review

On the pages of this law review, in an article entitled Uncertainty and Informed Choice: Unmasking Daubert, the authors argued for the recognition of a new product liability cause of action when drug companies fail to warn about uncertain risks attendant to the use of non-therapeutic drugs whose purpose is to enhance lifestyle. We noted that in the post-Daubert era, plaintiffs have faced increasing difficulty in proving that a given toxic agent was causally responsible for the injuries suffered after ingesting a drug. That plaintiffs cannot overcome the barriers to proving injury causation does not mean that defendants have met …


Learning The Wrong Lessons From "An American Tragedy": A Critique Of The Berger-Twerski Informed Choice Proposal, David E. Bernstein Aug 2006

Learning The Wrong Lessons From "An American Tragedy": A Critique Of The Berger-Twerski Informed Choice Proposal, David E. Bernstein

Michigan Law Review

Margaret Berger and Aaron Twerski are among the leading scholars in their respective fields of Evidence and Products Liability. I have benefited from their work on many occasions. Precisely because of the deserved respect and esteem in which Berger and Twerski are held-not to mention the prominence of their forum, the Michigan Law Review-their proposal to create a new "informed choice" cause of action in pharmaceutical litigation is likely to receive sympathetic attention. Because I believe that their proposal is ill-conceived and dangerous, I feel compelled (with some trepidation) to write this response. Berger and Twerski propose that courts recognize …


Uncertainty And Informed Choice: Unmasking Daubert, Margaret A. Berger, Aaron D. Twerski Nov 2005

Uncertainty And Informed Choice: Unmasking Daubert, Margaret A. Berger, Aaron D. Twerski

Michigan Law Review

This Article will first examine why it is that plaintiffs have been unable to prove causation under the Daubert guidelines in toxic tort litigation. Second, it will look at the two existing models for informed choice litigation medical malpractice and products liability-and demonstrate why neither of these models gives toxic tort plaintiffs a fair opportunity to recover for the deprivation of patient autonomy against drug manufacturers who have breached their duty to warn of known or knowable risks. Finally, this Article will explore the elements of a causation-free informed choice cause of action. It will suggest the appropriate standard for …