Package inserts and the standard of care

Russell G. Thornton, JD

A number of pending and new claims involve diet drugs, hormone replacement therapy, cerivastatin (Baycol), oxycodone (OxyContin), troglitazone (Rezulin), thimerosal, and nefazodone hydrochloride (Serzone). One issue is intertwined in all of these claims: the relation between a medication's package insert (also referred to as product information, prescribing information, or Physicians' Desk Reference [PDR] listing) and the standard of care applicable to a prescribing physician. In a lawsuit, the manufacturer will attempt to use this information to deflect blame away from it and toward the prescribing physician as part of a general defense strategy or to establish the applicability of the "learned intermediary" doctrine. In addition, juries often attach a great deal of significance to package insert information and can be led to believe that this information sets forth a standard of care or practice guideline. Therefore, package insert information is used by claimants in drug litigation claims and mainstream malpractice cases to establish and/or support opinions about the applicable standard of care and deviations from that standard.
For these reasons, the purpose of package insert information (whether in the form of product information, prescribing information, or PDR entry) and its relation to the practice of medicine needs to be understood and communicated to the court and jury throughout the defense of a claim that centers on the use of a medication. Otherwise, the prescribing physician runs a risk of being unfairly judged on information that is not meant to establish or reflect the applicable standard of care, does not contain or set forth a standard of care, and is not a practice guideline.