Richardson v. Miller
Court of Appeals of Tennessee
44 S.W.3d 1 (2000)
During Cynthia Richardson's pregnancy, Dr. James Miller (defendant) administered terbutaline -- an FDA-approved asthma drug, used off-label here to stop premature labor -- first orally and then, after Richardson developed chest pain and refused further doses, via an infusion pump Miller had little experience using. Richardson later suffered a heart attack requiring bypass surgery. She and her husband (plaintiffs) sued Miller and the pump's supplier for negligence, and before trial, the court granted Miller's motion to exclude the drug's package insert and its PDR entry showing it wasn't FDA-approved for stopping labor. The jury found for the defendants, and Richardson appealed.
Whether a prescription drug's labeling or its PDR reference, when introduced along with other expert evidence on the standard of care, is admissible to help the factfinder determine whether the drug presented an unacceptable risk to the patient.