June 22, 2021

Southern District of Texas Holds Learned Intermediary Doctrine Applies to Clinical Trials

Faegre Drinker on Products Blog

Does the learned intermediary doctrine apply in the context of a clinical trial? According to the Southern District of Texas, it does. The case in question is Butler et al. v. Juno Therapeutics, Inc., a tragic case involving the death of a 19-year-old woman with terminal leukemia who died within days of receiving an experimental cancer drug as a participant in a clinical trial.

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