The learned intermediary rule means that the duty imposed on pharmaceutical companies to warn about side effects associated with their prescription drug only runs to prescribing doctors, not patients. As such, the adequacy or sufficiency of the prescription drug’s warnings are judged by what the prescribing doctor, or so-called learned intermediary, is expected to know and understand.
Further, in many states part of this learned intermediary rule is that a prescribing doctor’s “independent knowledge” of a supposedly unwarned-of side effect risk breaks any causal connection between the drug warning’s inadequacy and the patient’s injury from that side effect.
Lastly, under most states’ legal proximate cause standard, in drug injury lawsuits the plaintiff patient must demonstrate that if a different, i.e., more adequate or sufficient, warning had been given to their prescribing doctor, this doctor would not have prescribed the drug to the patient in the same manner. Put otherwise, summary judgment in favor of the defendant pharmaceutical company is appropriate where a plaintiff fails to establish that this prescribing doctor’s decision to prescribe a particular drug would have changed if such a different warning been given.
The bottom line: If an alleged omission or understatement of a side effect risk would not have changed the prescribing doctor’s decision about use of the drug by a particular patient, this failure-to-warn drug injury lawsuit would result in a ruling in favor of the drug company.
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