Citation. Tenn. Ct. App., 44 S.W.3d 1 (2000)
Brief Fact Summary. An infusion pump was used by a doctor to give a drug to a pregnant woman to stop her premature labor. The use as prescribed was off-label and was not included in the drug’s reference in the Physician’s Desk Reference (PDR). The woman suffered a heart attack, and after she gave birth to a healthy baby, she brought suit claiming malpractice against the doctor and the supplier of the infusion pump.
Synopsis of Rule of Law. The labeling of a prescription drug or parallel PDR reference is admissible regarding the standard of care for using and administering the drug, so long as other expert evidence is also introduced regarding the standard of care.
Establishing the professional standard of care requires expert testimony.
View Full Point of LawIssue. Is the labeling of a prescription drug or parallel PDR reference admissible regarding the standard of care for using and administering the drug, so long as other expert evidence is also introduced regarding the standard of care?
Held. (Koch, J.) Yes. The labeling of a prescription drug or parallel PDR reference is admissible regarding the standard of care for using and administering the drug, so long as other expert evidence is also introduced regarding the standard of care. In this case, Plaintiffs intended to call expert witnesses on the issue of the applicable standard of care, in addition to presenting evidence regarding terbutaline’s labeling as approved by the Food and Drug Administration or the parallel PDR reference. Their testimony, when added to the evidence that Miller (Defendant) should not have continued terbutaline on Plaintiff after she began experiencing chest pain, would have been sufficient to require Miller (Defendant) to explain why he continued the administration of terbutaline once she began to experience severe chest pain, as well as the basis for his decision to use an infusion pump and how he determined the proper dose. Reversed and remanded.
Discussion. The ruling is straightforward in this case: the labeling, off-label uses, and PDR reference of a drug are admissible to show the standard of care for using and administering the drug, on the condition that other evidence is also introduced to show the standard of care. The opinion is particularly useful for its description regarding the process of the Food and Drug Administration to approve drugs, and for its primer on the drug industry dictionary. Note also that off-label uses of drugs are not necessarily negligent—they are actually common in the practice of medicine.