Richardson v. Miller

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.