Richardson v Miller

• Decision Date: 16 August 2000
• Docket Number: 97-00205
• Citation: 44 S.W.3d 1
• Parties: CYNTHIA RICHARDSON, ET AL. v. JAMES MILLER, M.D., ET AL.IN THE COURT OF APPEALS OF TENNESSEE AT NASHVILLE March 1998 Session Filed
• Court: Tennessee Court of Appeals

CYNTHIA RICHARDSON, ET AL. v JAMES MILLER, M.D., ET AL.

No. M1997-00205-COA-R3-CV

IN THE COURT OF APPEALS OF TENNESSEE AT NASHVILLE

March 1998 Session

Filed August 16, 2000

Appeal from the Circuit Court for Davidson County No. 94C-1993

Marietta M. Shipley, Judge

This appeal involves a medical malpractice action stemming from the use of an infusion pump to administer terbutaline sulphate subcutaneously to arrest a pregnant woman's labor. After suffering a heart attack shortly before giving birth to a healthy child, the woman and her husband filed suit in the Circuit Court for Davidson County against her attending physician, the supplier of the infusion pump, and others alleging that their negligence had caused her heart attack. The woman's medical insurance carrier intervened to assert its contractual reimbursement rights based on the payments it had advanced for the woman's medical expenses. The trial court dismissed the insurance carrier's complaint, and a jury returned a verdict for the physician and the pump supplier. Among their issues on this appeal, the woman and her husband take issue with the exclusion of evidence regarding the FDA-approved uses of terbutaline and with the trial court's refusal to give their requested missing evidence instruction. The physician and the pump supplier assert that they were entitled to a directed verdict at the close of all the proof. Finally, the medical insurance carrier takes issue with the dismissal of its reimbursement claim. While we have determined that the trial court correctly overruled the motions for directed verdict, we conclude that the trial court erred by excluding the evidence regarding the off-label use of terbutaline and by declining to give the requested instruction. The trial court also erred by dismissing the medical insurance carrier's claim. Accordingly, we vacate the judgment for the physician and manufacturer of the pump and remand the case for a new trial.

Tenn. R. App. P. 3 Appeal as of Right; Judgment of the Circuit Court Vacated and

Remanded

Mary A. Parker and C. Michael Lawson, Nashville, Tennessee, for the appellants, Cynthia Richardson and William Richardson.

Douglas Berry, Nashville, Tennessee, for the appellant, Principal Mutual Life Insurance Company.

Thomas A. Wiseman, III, Nashville, Tennessee, for the appellee, James Miller, M.D.

Thomas Pinckney, Nashville, Tennessee, for the appellee, Tokos Medical Corporation.

WILLIAM C. KOCH, JR., L., delivered the opinion of the court, in which HENRY F. TODD, P.J., M.S., joined. BEN H. CANTRELL, J., filed a dissenting opinion.

OPINION

Cynthia Richardson married William Richardson in 1991. Ms. Richardson was a 26-year-old physical therapist, and Mr. Richardson was four years her junior. Ms. Richardson loved children, and the couple decided not to delay starting a family because Ms. Richardson, as she put it later, felt her "biological clock ticking." Ms. Richardson learned that she was pregnant with the couple's first child on Thanksgiving Day 1992. Her estimated due date was July 28, 1993.

Ms. Richardson sought her prenatal care from Dr. James Miller. In early January 1993, Ms. Richardson complained that she was experiencing periods of palpitations, rapid heartbeats, and shortness of breath. Dr. Miller referred her to Dr. James W. Ward, Jr., a cardiologist who had previously evaluated Ms. Richardson in 1987 for a similar complaint. Dr. Ward placed Ms. Richardson on a 24-hour heart monitor that showed only benign changes in her heart rhythm. Accordingly, Dr. Ward reported to Dr. Miller that he recommended no additions to Ms. Richardson's medical care. Ms. Richardson made no other cardiac complaints during subsequent office visits with Dr. Miller.

Ms. Richardson made her last prenatal office visit to Dr. Miller on June 23, 1993, when she was approximately thirty-five weeks pregnant. The checkup was routine and ended with the doctor's office scheduling her for a return visit the following week. Events, however, brought the parties together sooner. On the afternoon of the very next day, Ms. Richardson was admitted to Nashville Memorial Hospital in labor. Dr. Miller was immediately concerned that the labor was premature and that there could possibly be complications for the baby if born at thirty-five weeks. He ordered bed rest and hydration and tested Ms. Richardson to rule out mere uterine irritability. When the contractions showed no signs of abating, Dr. Miller opted to affirmatively retard Ms. Richardson's premature labor by tocolysis, i.e., giving her medication to stop her contractions by relaxing her uterine muscles.

Dr. Miller first prescribed and administered magnesium sulfate with limited success. On June 24, 1993, when the frequency of Ms. Richardson's contractions did not decrease, Dr. Miller ordered a different tocolytic drug - terbutaline sulfate ("terbutaline"). While terbutaline had been approved by the FDA only for treating bronchial asthma, it was also being widely used as a tocolytic agent because it relaxes smooth muscles, including the muscles of the uterus.

Ms. Richardson received her first oral dose of terbutaline at approximately 8:30 p.m. on June 24 and her second dose, again by mouth, four hours later. Sometime during the early morning hours of June 25, she awoke with a "horrible pain" in her chest. Ms. Richardson had not gone back to sleep when a nurse came in at approximately 4:00 a.m. with a third oral dose of terbutaline. Ms. Richardson refused the drug, telling the nurse, as the nurse's notes reflect, that her chest hurt. Said Ms. Richardson, "I'm not taking that. . . . [M]y chest is killing me. I don't want any more of that stuff."

The next morning, the nursing staff informed Dr. Miller that Ms. Richardson had complained of chest pain and had refused to take the third dose of terbutaline. When Dr. Miller examined Ms. Richardson, he discovered that her chest pains had subsided but that she was still in labor. At that point, Dr. Miller suggested using an infusion pump to subcutaneously infuse smaller, timed doses of terbutaline into Ms.Richardson's system. Ms. Richardson may not have understood that the pump would be used to give her the very same drug that she had earlier refused to take orally, but she understood that the whole purpose of the pump was to give her medication to retard her labor and that it was Dr. Miller's intention to stabilize her contractions and then to send her home with the infusion pump in place until her pregnancy was full term.

Dr. Miller had little prior experience with terbutaline infusion pumps other than attending a 1989 seminar, conversing with a manufacturer's representative, and reading professional articles. After completing his examination of Ms. Richardson, Dr. Miller directed the attending nurses to contact Vanderbilt University Hospital about arranging for a terbutaline pump. Nurse Gail Harris was eventually directed to Tokos Medical Corporation ("Tokos"), a California-based medical services and drug provider, who arranged to supply a tocolytic pump designed and programmed to infuse terbutaline subcutaneously in set doses. Other than deciding to start Ms. Richardson on the pump, Dr. Miller was not directly involved with installing the pump or determining the dosage of terbutaline Ms. Richardson would receive while on the pump.

On the afternoon of June 25, Christine Evans, a nurse employed by Tokos, arrived at Memorial Hospital with the infusion pump ordered by Dr. Miller. She did not confer with Dr. Miller, but instead, she reviewed Ms. Richardson's medical records, talked with Ms. Richardson, and then gave Ms. Richardson and the hospital nursing staff instructions concerning the use of the pump. After conferring with one of Tokos's staff pharmacists, Ms. Evans also established the dosage of terbutaline that Ms. Richardson would receive. The hospital staff then obtained the terbutaline from the hospital pharmacy, filled the infusion pump, inserted the needle that would deliver the medication, and activated the pump. As Ms. Richardson remembers it, "[t]hey initially set it up, and the [hospital] nurse put the needle in. And I remember that every four hours the machine would give [me a] dose [of medicine]. And before [each] time I was to check my pulse rate to see if it was in the range - I don't remember the range that they gave me."

Ms. Richardson received regular subcutaneous doses of terbutaline for approximately the next forty-eight hours. Her labor contractions did not stop immediately; however, they eventually began to decrease. By around noon on June 27, three days after their onset, the contractions stopped. Although Ms. Richardson experienced shakiness and what she characterized as a "rapid heart rate," the nurses' notes stated that Ms. Richardson's vital signs were "stable" around the time her contractions stopped.

Ms. Richardson visited with her sister at approximately 3:00 p.m. on June 27. She became upset when her sister told her that their mother's dog had died. At that time, Ms. Richardson's chest, arm, jaw, and head began hurting. When a nurse arrived, Ms. Richardson exclaimed that she was having a heart attack and insisted that she be removed from the terbutaline pump. After some confusion and hesitation, the nurses disconnected Ms. Richardson from the pump, and she was subsequently transferred to a critical care unit where an electrocardiogram confirmed that she had, in fact, experienced a heart attack.

That night Ms. Richardson gave birth to a healthy, six-pound boy. A few days later, Ms. Richardson underwent open-heart by-pass surgery to repair a tear in her coronary artery associated with her heart attack. After recuperating for several days, Ms. Richardson and her baby were discharged from Memorial Hospital.

On June 23, 1994, the Richardsons filed a medical malpractice and products liability action in the Circuit Court for Davidson County seeking $3,500,000 in compensatory and...