Clinical Trials And The Learned Intermediary Doctrine

Law360, New York (June 30, 2010, 1:34 PM EDT) -- While the range of claims brought against manufacturers of marketed drugs and medical devices are also alleged in actions arising out of clinical trials, clinical trials are unique in a variety of ways which support the assertion of certain defenses, particularly the learned intermediary doctrine.

Clinical trials involve experimental prescription medicine or medical devices with less knowledge of the therapeutic benefit or risks of the medicine or device and a unique relationship between the manufacturer/sponsor (“sponsor”) and the investigator/doctor (“investigator”).

Surely in phase I and II...
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