ON APPEAL FROM THE UNITED STATES DISTRICT COURT FOR THE WESTERN DISTRICT OF PENNSYLVANIA
Before: ADAMS and SLOVITER, Circuit Judges, and VANARTSDALEN, District Judge*fn*
VANARTSDALEN, District Judge.
This is an appeal from a judgment entered in favor of the plaintiffs, Lonnie F. Titchnell and Ella Titchnell, his wife, on a medical malpractice cause of action for negligent administration of a swine flue immunization inoculation provided to Mr. Titchnell pursuant to the National Swine Flue Immunization Program of 1976, 42 U.S.C. §§ 247(j)-247(l) (1976). The judgment will be affirmed.
Pennsylvania case law requires a plaintiff in a medical malpractice action to prove by expert testimony (1) the pre-ailing standard of medical care accepted by the medical profession, and (2) that the care provided plaintiff deviated from a fell below such accepted standard. Among the witnesses who testified in this case as to medical practices were the following: (1) the supervising nurse at the Suismon Street Clinic, where Mr. Titchell received the inoculation; (2) a district health officer of the Allegheny County Health Department who had administrative and supervisory duties in respect to the swine flu immunization program provided at several Allegheny County Public Health Clinics, including the Suismon Street Clinic; (3) a psychiatrist; (4) an internist-pathologist; and (5) a neurologist. In addition, the Allegheny County Health Department's Guidelines for Mass Clinics for the General Population and District Office Clinics for the High Risk Population (Guidelines ) applicable to the swine flu immunization program were received in evidence.
Although no physician or other witness testified by was of expert opinion as to the precise standard of medical care or practice that was due to Mr. Titchnell in the administration of the inoculation, we conclude that the cumulative testimony of expert and nonexpert witnesses as to prevailing practices was sufficient for a fact finder to ascertain the degree of care required by those administering swine flu inoculations, and to further find that the care provided deviated from and fell below standard practice.
On November 15, 1976, plaintiff Lonnie Titchnell, age 71, and his wife, plaintiff Ella Tichnell, age 61 drove to the nearby Suismon Street Clinic, operated by the Allegheny County Health Department, to receive swine flu vaccine inoculations pursuant to the National Swine Flu Immunization Program of 1976.
Mr. Titchnell, at the time of the clinic visit, was being treated regularly by his own physician, Lawrence Brent, M.D., for a rapid pulse and high blood pressure. Mr. Titchnell had suffered two minor cerebrovascular accidents (commonly referred to as "strokes") but had successfully recovered from both. In addition, he had both coronary and cerebral arteriosclerosis. He was apprehensive about receiving the swine flu vaccine, but Dr. Brent had told him it "was advisable."
On arrival at the clinic, the Titchnells entered a reception room where they were given a sheet of paper entitled "Important Information about Swine and Victoria Influenza (Flu) Vaccine (Bivalent)." The form described the symptoms of the flu, the function and possible side effects of the vaccine, and contained a section entitled "Special Precautions" which provided:
As with any vaccine or drug, the possibility of severe or potentially fatal reactions exists. However, flu vaccine has rarely been associated with severe or fatal reactions. In some instances people receiving vaccine have had allergic reactions. You should note very carefully the following precautions:
Children under a certain age should not routinely receive flu vaccine. Please ask about age limitations if this information is not attached.
People with known allergy to eggs should receive the vaccine only under special medical supervision.
People with fever should delay getting vaccinated until the fever is gone.
People who have received another type of vaccine in the past 14 days should consult a physician before taking the flu vaccine.
If you have any questions about flu or flu vaccine, please ask.
The receptionist asked Mr. and Mrs. Titchnell whether they were allergic to eggs. She did not ask any other questions or take any medical history from them. She handed them a paper entitled "Registration Form" which provided:
I have read the above statement about swine flu, the vaccine, and the special precautions. I have had an opportunity to ask questions, including questions regarding vaccination recommendations for persons under age 25, and understand the benefits and risks of flu vaccination. I request that it be given to me or to the person named below of whom I am the parent or guardian.
After receiving the forms, Mr. and Mrs. Titchnell sat down and signed them. They then entered another room where there were two lines of people. The plaintiffs stood in one of the lines for about ten minutes awaiting their turn. Chairs were available had they chosen to sit down, but Mr. and Mrs. Titchnell did not do so. The plaintiffs could view the vaccine being administered to those people waiting ahead of them. While in line, Mr. Titchnell expressed some reservations, but his wife insisted that he receive the injection.
The nurse who administered the vaccine did not ask any questions of the plaintiffs. There was no physician in attendance. The nurse took the signed forms from the Titchnells and administered the vaccine while the plaintiffs were standing. Each received the bivalent vaccine in the left arm by hypodermic injection.*fn1 The nurse instructed the plaintiffs to proceed to another room -- the resting room -- and to wait there for a period of time.
During the waiting period, the Tichnells were upset by off-hand comments made by another person who had been inoculated. They also observed an episode of fainting by a young man who had received the vaccine. After waiting a short period of time, Mrs. Titchnell suggested that they leave the clinic. Mr. Titchnell said "No," that he wanted to sit a while longer because his head felt numb. They sat for approximately ten more minutes, whereupon Mrs. Titchnell repeated her suggestion. The couple left the clinic and took a five-to-ten minute walk outside the clinic because Mr. Titchnell wanted "to get his blood circulating." Following the walk, Mr. Titchnell drove the car home with his wife as a passenger.
The next day Mr. Titchnell was admitted to Allegheny General Hospital, having suffered during the night or early morning a third cerebrovascular accident which was severe in its consequences. Following a long course of hospitalization and rehabilitation, Mr. Titchnell remains severely impaired. He is confined for the most part to a wheelchair and is unable to speak.
The plaintiffs filed this action in the United States District Court for the Western District of Pennsylvania, seeking recovery on theories of negligence and the government's alleged failure to obtain a proper informed consent. The action was transferred by the Judicial Panel on Multidistrict Litigation to the United States District Court for the District of Columbia for coordinated and consolidated pretrial proceedings. Following completion of those proceedings, the action was remanded to the Western District of Pennsylvania for local discovery and trial.
Trial was held nonjury and judgment entered on May 19, 1981, in favor of the plaintiffs. The trial court determined that the clinic personnel were negligent in not taking a medical history from Mr. Titchnell or ascertaining his past medical history. If such a history had been obtained, the court found that good medical practice would have dictated that the vaccine by administered, if at all, while Mr. Titchnell was lying down. Failure to do so, the court held, was the proximate cause of Mr. Titchnell's cerebrovascular accident. The court did not decide the issue of informed consent. The plaintiffs were awarded $219,858.62 in damages. The government appeals that judgment and award.
Under the National Swine Flu Immunization Program of 1976 (Swine Flu Act), Pub. . No. 94-380, § 2, 90 Stat. 1113 (codified at 42 U.S.C. §§ 247b(j) - 247(l) prior to the enactment of the Health Services and Centers Amendments of 1978, Pub. L. No. 95-626, § 202, 92 Stat. 3574), Congress established a procedure for the filing and determination of all claims alleging personal injury or death arising out of the administration of the swine flu vaccine.*fn2 The Swine Flu Act provides that the United States shall be liable for all such claims based upon the act or omission of a program participant*fn3 in the same manner and to the same extent as the United States would be liable in any action brought against it under 28 U.S.C. § 1346(b) (1976) and the ...