Richardson v. Miller

Cynthia Richardson became pregnant and sought prenatal care from Dr. James Miller (defendant). Thereafter, Richardson complained of rapid heartbeats, palpitations, and shortness of breath. Miller referred Richardson to Dr. James Ward, Jr., a cardiologist who placed Richardson on a heart monitor for 24 hours to monitor her heart rhythms. Nothing significant was found by Ward who reported to Miller that Richardson’s prenatal care did not need to be modified. When Richardson was 35-weeks pregnant, she went into labor and was admitted to the hospital. Miller ordered bed rest and administered drugs to stop the labor. When one particular medication failed to stop Richardson’s labor, Miller ordered the administration of terbutaline, a drug that had only been approved by the U.S. Food and Drug Administration (FDA) to treat asthma. After taking two doses of the drug, Richardson experienced chest pain and refused to take any further dose. Miller examined Richardson, noted that her labor had not stopped, and then recommended the use of an infusion pump to administer the terbutaline subcutaneously. Miller had little experience in the use of terbutaline infusion pumps. Tokos Medical Corporation (Tokos), the supplier of the infusion pump, sent a nurse to instruct Richardson and hospital nursing staff concerning the use of the pump. Over the next 48 hours, Richardson received regular subcutaneous doses of terbutaline, but the drug did not stop Richardson’s contractions initially. By the time Richardson’s labor had stopped, she complained of having a rapid heartbeat. Shortly thereafter, Richardson had a heart attack and then delivered a healthy baby. She required cardiac bypass surgery to alleviate heart damage. Richardson and her husband (plaintiffs) filed suit against the infusion pump supplier, Tokos and Miller (defendants) for his alleged negligence in using the terbutaline infusion pump as a treatment to stop premature labor. Prior to trial, Miller moved to prevent Richardson from introducing into evidence any information from terbutaline’s package insert and the Physician’s Desk Reference (“PDR”) indicating that the drug had not been approved by the FDA for use in stopping premature labor. The PDR is an encyclopedia of medications written from product inserts and published annually and provided to all practicing physicians. The trial court granted Miller’s motion and the jury subsequently found for Miller and Tokos. Richardson appealed.