Hasler v. United States

• Citation: 517 F. Supp. 1262
• Decision Date: 15 July 1981
• Docket Number: Civ. A. No. 78-70130.
• Parties: Kathleen HASLER and Michael Hasler, Plaintiffs, v. UNITED STATES of America, Defendant.
• Court: U.S. District Court — Western District of Michigan

517 F. Supp. 1262

Kathleen HASLER and Michael Hasler, Plaintiffs, v. UNITED STATES of America, Defendant.

Civ. A. No. 78-70130.

United States District Court, E. D. Michigan, S. D.

July 15, 1981.

Tucker, Barbour & Mack, P.C. by James A. Tucker, David M. Barbour, Detroit, Mich., for plaintiffs.

Stuart Schiffer, Acting Asst. Atty. Gen., Richard A. Rossman, U. S. Atty., Detroit, Mich., Jeffrey Axelrad, Director, Torts Branch by Debra Newman, Thaddeus B. Hodgdon, Trial Attys., Torts Branch, Civil Division, U. S. Dept. of Justice, Washington, D. C., for defendant.

OPINION

GILMORE, District Judge.

This is an action by Kathleen Hasler and her husband Michael Hasler to recover for injuries allegedly suffered as a result of a swine flu injection received by Mrs. Hasler. Mr. Hasler derivatively sues for loss of consortium, loss of services and the like.

On November 24, 1976, plaintiff Kathleen Hasler received a swine flu vaccination under the National Swine Flu Immunization Program at the Penrickton Center for Blind Children in Taylor, Michigan. The swine flu vaccine administered to her was manufactured, formulated, processed, and sold by Merck, Sharp and Dohme, a division of Merck and Company, a program participant pursuant to 42 U.S.C. § 247b. The Penrickton Center for Blind Children was also a program participant pursuant to the statutory section cited above. Jurisdiction is conferred on the Court by the Federal Tort Claims Act, 28 U.S.C. § 1346(b), and the National Swine Flu Immunization Program Act, 42 U.S.C. § 247b.

Prior to her vaccination, plaintiff had seen and heard mass media advertisements that said there was a good possibility of a swine flu epidemic throughout the United States, and that the United States Government was attempting to vaccinate every man, woman, and child in the country. She testified that she saw President Ford on television telling the American people that everyone should get a swine flu shot, and that she heard nothing about the risks of taking the swine flu shot. She said she felt it was her duty to have a shot to help build immunity in the community, and she was especially concerned about it because she was employed as a receptionist at a pediatric clinic and she feared the possibility of infecting children in the clinic.¹

Immediately prior to receiving her shot, plaintiff was provided with a registration form which she scanned and signed. She did not read the form. The worker at the clinic told her that the only possible side effect would be some swelling at the site of the shot and perhaps a fever. This form, which was received as Defendant's Exhibit 30, said, with reference to side effects:

"Most people will have no side effects from the vaccine. However, tenderness at the site of the shot may occur and last for several days. Some people will also have fever, chills, headaches or muscle aches within the first forty-eight hours.

"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. ..."

At the time she took the shot, and prior to December 3, 1976, plaintiff was in excellent health, as was her husband.

Ten days after taking the shot, on December 3, 1976, plaintiff experienced a stabbing pain in the right knee while shopping. A stabbing pain in the left knee followed, and the pain subsequently went to all of her joints. A rash rapidly developed which covered 70 percent of her body. When she got home she was unable to bend her knees to get into the bathtub; she suffered severe pain all night and in the morning went to her employer, a physician, Dr. George Mills, who said she had some kind of serum sickness resulting from the swine flu vaccine.

Her condition continued to worsen and her fever rose to 102 degrees. On December 5, 1976, she was admitted to Oakwood Hospital, and remained there until January 29, 1977. Her symptoms, in addition to the pain, were a rash, spiking fever, sore throat, and limitation of motion of all major joints. Later she developed a heart murmur, anemia, and had protein and blood in her urine.

At Oakwood Hospital she was under the care of Dr. Edward M. Barbour, a board certified internist. In the hospital, her condition got progressively worse, and on her discharge on January 29, 1977, the diagnosis was acute rheumatoid arthritis (Still's Disease), suspected rheumatic fever, or fever of undetermined origin.

After her discharge, plaintiff was bedridden and unable to care for herself. Her condition remained unchanged until the summer of 1977, when she was admitted to Harper Hospital, Detroit, for further diagnostic studies by Dr. Barbour. During the period from her discharge from Oakwood Hospital in January until her admission to Harper Hospital in August, she remained totally immobile. She could do no housework, and had to stay in bed 90 percent of the time.

Mrs. Hasler was an inpatient at Harper Hospital from August 18, 1977, through August 25, 1977, when she was discharged with a diagnosis by Dr. Barbour of acute rheumatoid arthritis secondary to swine flu vaccination. This discharge diagnosis was concurred in by other attending physicians, including interns and residents on the staff at Harper Hospital.

Plaintiff had no hospitalization during 1978, but she was in bed most of the time and her condition worsened. Her sister and her mother took over all of her household chores and she was in constant pain. She had no outside activity.

In February of 1979, Mrs. Hasler was readmitted to Harper Hospital and was told that her right hip had completely deteriorated and would have to be replaced. She was discharged, and the next month, March 1979, returned to Harper Hospital for a total replacement of her right hip. The next year, in August 1980, she returned to the hospital and had a total left hip replacement.

At the time of trial, plaintiff testified that she spends 90 percent of her time in bed. She has been unable to return to work or to do the simplest household chores. She cannot properly care for her 11-year-old daughter. She faces the prospect of a joint replacement in her knees, and surgery on her hands and ankles. She has constant pain in her neck, back and shoulders. The rash and fever are persistent. Her family relationship has deteriorated terribly and life with her husband has drastically changed.

Mrs. Hasler was determined to be totally and permanently disabled by the Social Security Administration, which assigned the onset date of December 3, 1976 for her disability.

Mr. Hasler, who had been in excellent health prior to the illness of his wife, has developed ulcerative colitis, etiology unknown. His ulcerative colitis has been exacerbated by the condition of his wife.

I

In January of 1976, a number of cases of respiratory disease developed at Fort Dix, New Jersey, and the Center for Disease Control Virology Laboratory identified two of eight throat washings from Fort Dix as swine-like virus, type A/NJ/76. Investigation of the swine flu at Fort Dix revealed five patients in which the swine flu virus was isolated. A total of four cases of A/NJ/76 outside of Fort Dix were diagnosed by serological testing and/or by virus isolation in 1976 in the United States, and two cases were diagnosed in 1977. In February and March of 1976, surveys at Fort Dix were conducted. The Center for Disease Control conducted similar surveys in surrounding civilian populations to determine the spread of the swine flu virus. The survey results produced no recorded evidence of a community spread of swine flu from March 1976 through December 1976.

Throughout February and March 1976, various health officials from the Center of Disease Control began planning swine flu immunization programs aimed at inoculating the entire population. A meeting of these officials and other distinguished medical persons was held at the White House in March 1976, with President Ford in attendance. Following this meeting, the President announced that he was recommending a mass vaccination program for all Americans. In this announcement, President Ford stated he would request the Congress to appropriate money so that every man, woman, and child could be vaccinated against the swine flu. The special appropriation was authorized by the Congress, and on April 15, 1976, President Ford signed the legislation appropriating $135,000,000 for the Swine Flu Program.

On April 21, 1976, swine flu clinical trials began and a total of 7,590 subjects were enrolled. Field trials indicated that single doses of the vaccine did not work well on children, who had a number of reactions, including high fever. There was much discussion in Washington and elsewhere about the potential liability of drug manufacturers and insurance companies if there was to be mass immunization. Legislative hearings were held and many prominent physicians, including Dr. Albert Sabin and the Health Research Group, opposed the program. They proposed that the vaccine be manufactured and stored until there was evidence of a significant outbreak of the swine flu.

Liability issues were eventually resolved by the Government's assumption of liability for adverse reactions of the vaccine, and on August 12, 1976, President Ford signed into law "The National Swine Flu Immunization Program of 1976."

II

Plaintiff relies upon both the Federal Tort Claims Act, 28 U.S.C. § 1346(b) et seq. and the National Swine Flu Immunization Program Act of 1976, 42 U.S.C. § 247(b), (hereinafter the Swine Flu Act), to establish liability. However, this Court concludes that liability can be predicated upon the Swine Flu Act alone; therefore, it is not necessary to consider the Federal Tort Claims Act to arrive at a decision.

The Swine Flu Act has as one of its purposes the protection of "program participants'" liability. The Act establishes exclusive...