Richardson v. Miller

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.

Facts. Cynthia Richardson (Plaintiff) went to Dr. James Miller (Defendant) for prenatal care.  The defendant referred Plaintiff to a cardiologist when she complained that she was experiencing times of palpitations, rapid heartbeats, and shortness of breath.  According to the cardiologist, Plaintiff did not require additional medical care.  When Plaintiff was 35 weeks pregnant, she went to Defendant for her last prenatal office visit.  She was admitted to the hospital in labor the next day.  Defendant gave medication to Plaintiff to stop her contractions by relaxing her uterine muscles, a process known as tocolysis.  When the contractions continued, Defendant ordered the drug terbutaline sulfate.  Terbutaline had been approved by the FDA only for treating bronchial asthma, but was also being widely used “off-label” as a tocolytic agent because it relaxes smooth muscles, including muscles of the uterus.  After taking terbutaline orally for a day, Plaintiff woke up with chest pain.  Defendant examined her and found that her chest pains subsided, but she was still in labor.  Plaintiff agreed when Defendant suggested using an infusion pump to infuse smaller, timed doses of terbutaline into her system.  Tokos Medical Corporation (Defendant) was contacted to procure a pump, and a nurse employed by Tokos (Defendant) showed Plaintiff and the hospital nursing staff how to use the pump.  After taking the drug for three days, her labor subsided, but she had a heart attack on that day.  Plaintiff’s baby was born that night.  She recuperated for several days and was discharged.  She then filed suit.  Just prior to trial, Defendant made a motion to prevent the Plaintiffs from introducing or using any information from either the terbutaline’s drug package insert or the PDR indicating that the drug had not been approved by the federal Food and Drug Administration for use in stopping premature labor.  The trial court granted the motion.  Plaintiff did not claim that Defendant was negligent for initially trying to use orally administered terbutaline to slow Plaintiff’s labor, an off-label use of the drug.  Rather, they claimed that Defendant breached the standard of care when he continued tocolysis using terbutaline after Plaintiff experienced chest pain while taking the drug orally and by choosing to administer the drug under the skin using an infusion pump.  The jury returned a verdict in favor of Defendants Miller and Tokos.

Issue. 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.