In re Swine Flu Immunization Prod. Liability Lit., Civ. A. No. 78-F-452.

• Decision Date: 04 January 1982
• Docket Number: Civ. A. No. 78-F-452.
• Citation: 533 F. Supp. 703
• Parties: In re SWINE FLU IMMUNIZATION PRODUCTS LIABILITY LITIGATION. Verlin G. UNTHANK, Plaintiff, v. UNITED STATES of America, Defendant.
• Court: U.S. District Court — District of Utah

533 F. Supp. 703

In re SWINE FLU IMMUNIZATION PRODUCTS LIABILITY LITIGATION Verlin G. UNTHANK, Plaintiff, v. UNITED STATES of America, Defendant.

Civ. A. No. 78-F-452.

United States District Court, D. Utah.

January 4, 1982.

COPYRIGHT MATERIAL OMITTED

Clark W. Sessions, and Duane R. Smith, Sessions, Moore & Smith, Salt Lake City, Utah, for plaintiff Verlin G. Unthank.

Jeffrey Axelrad, Director, Torts Branch, U. S. Dept. of Justice, Emilia DeMeo, Trial Atty., Torts Branch, U. S. Dept. of Justice, Washington, D. C., Ronald L. Rencher, U. S. Atty., D. Utah, and Lawrence J. Leigh, Asst. U. S. Atty., D. Utah, Salt Lake City, Utah, for defendant United States of America.

MEMORANDUM OPINION AND ORDER

SHERMAN G. FINESILVER, District Judge:¹

Plaintiff Verlin G. Unthank claims that her neurological illness, transverse myelitis, resulted from the National Swine Flu Immunization Program of 1976. Further, she alleges that the defendant United States of America, sponsor of the program, is liable for damages.

In this suit, brought under the Federal Tort Claims Act ("FTCA"), 28 U.S.C. §§ 1346(b), 2671 et seq.,² plaintiff seeks recovery based on theories of negligence, strict liability and failure to warn her fully of the risks and benefits of the vaccine used in the immunization program. The government denied liability and contends there is no causal relation between the vaccination and Mrs. Unthank's condition. Additionally, it alleges that if a causal relation is proven, plaintiff has not established any theory of recovery which would render defendant liable.

I. PRELIMINARY STATEMENT

On October 18, 1976, plaintiff Verlin Unthank, age thirty-eight of Salt Lake City, Utah, received a swine flu vaccination administered pursuant to the National Swine Flu Immunization Program (Swine Flu Act) of 1976, Public Law 94-380; 42 U.S.C. § 247b(j)-(1). The program was designed to inouclate the country's adult population against the threat of a swine flu epidemic. On November 16, 1976, thirty days after her vaccination, plaintiff experienced a sudden onset of severe pain in her lower back, followed by tingling and numbness in her legs and torso. She was hospitalized and diagnosed as having a serious neurological disorder known as transverse myelitis. This disease rendered her extremely weak and immobile. She still has residual effects from transverse myelitis.

II. SUMMARY OF HOLDING

To summarize what we have concluded, we note that Mrs. Unthank developed transverse myelitis as the proximate result of her swine flu inoculation. Additionally, she is entitled to recover damages from the federal government incurred as a result of that neurological disorder.

In so holding, we do not find the government negligent nor do we rely for plaintiff's recovery on any theory of tort liability. Instead, we are interpreting the Swine Flu Act consistent with its clear and discernible legislative history, the policy expressed by former Secretary of Health, Education and Welfare Joseph A. Califano, Jr., and the stated position of the Department of Justice in other swine flu litigation.

In our view, the intent of Congress in passing the Swine Flu Act, and the expressed policy of the Department of Health, Education and Welfare, support just compensation for a plaintiff whose malady was predictable under the state of medical science in 1976 and was proximately caused by the swine flu vaccine. Our holding rests on narrow grounds and applies only to those vaccinees who meet the requisites of proof stated herein.

A recommendation is also documented calling for implementation of a national program to compensate victims of other national immunization programs predicated on no fault principles.

The following constitutes the court's findings and conclusions on the issue of liability.

III. PLAINTIFF'S MEDICAL HISTORY

Since injuries of a neurological nature are claimed, a detailed study of plaintiff's medical history is necessary.

Plaintiff is now forty-two years old. She is married and has two children. Prior to 1975 she was employed as a secretary and managed an apartment house. She is presently unemployed. Plaintiff testified that she was in extremely good health in the fall of 1976 but had experienced some health problems in the past.

In 1965 Mrs. Unthank suffered from peptic ulcers and the drug Aventyl was prescribed. She had periodic dizziness. Plaintiff was involved in an automobile accident in 1969 which required treatment for whiplash and pain in her head, right arm and neck. She was hospitalized again in 1970 for the surgical removal of a tumor from her right foot.

Plaintiff's testimony and medical records revealed other less severe medical problems prior to 1976. Although she experienced fatigue due to depression from 1970 to 1973, Mrs. Unthank testified that her energy level returned prior to November 1976. Her medical records indicate that she had fallen accidently on two occasions and sustained minor broken bones. Plaintiff first fell while she was in the mountains collecting rocks and the second fall occurred while she was carrying one of her children.

Other recitals in the medical records relevant to a neurological diagnosis include complaints in 1973 of instances of incoordination and weakness between 1969 and 1973. The medical records from 1973 to 1976 (time of her swine flu shot) indicate that plaintiff had no significant neurological disorders.

Several items in plaintiff's medical history were the subject of conflicting interpretation by doctors. In 1970 plaintiff complained of vertigo³ to a family physician. The incident occurred the previous day. Plaintiff testified that she used the term "vertigo" to describe a light sensation on the top of her head. At trial, Charles M. Poser, M.D., a neurologist, testified that her complaint was not medically recognized as vertigo. He explained that vertigo involves a rotatory component and the patient feels that either she or her environment is spinning.

Another item of controversy in plaintiff's medical records was a reported incident of blurred vision in September 1976.⁴ There are three separate reports of this single episode, each indicating that it lasted for a different period of time. One states four hours, another twelve hours, and the last report twenty-four hours. Plaintiff testified that the incident lasted for about forty-five minutes commencing when she awoke in the morning.

As noted, on October 18, 1976 plaintiff received a swine flu vaccination. She encountered no noticeable medical problems for the first thirty days. However, on the evening of November 16, 1976 plaintiff took a hot bath. Upon lifting herself from the bath tub she began experiencing a sharp pain in her lower back. She related that at first the pain felt like gas, but the intensity increased and the pains persisted. Within a few minutes Mrs. Unthank began experiencing numbness in her right leg which quickly spread to her left leg and torso. At about 10:15 p. m., when she called for the paramedics, she was unable to support herself on her right leg. By the time she arrived at the hospital, about 11:00 p. m., she could not walk, even with the help of two paramedics.

She remained hospitalized from November 17 to December 8, 1976. During that interval she was unable to walk without assistance and had no feeling in her legs. On December 8, 1976 she was transferred to the University of Utah Hospital for rehabilitation. She remained there until January 22, 1977.

Plaintiff still experiences weakness and has difficulty standing and walking. In addition, she has minimal sensation in the lower half of her body which presents problems when she walks in the dark. She suffers from bowel and bladder incontinence.

IV. MALADIES INVOLVED

The primary issue in this case involves a determination of whether the swine flu vaccination was the proximate cause of the neurological disorder suffered by plaintiff. While plaintiff claims her illness is transverse myelitis, testimony indicates three conflicting medical diagnoses. In addition to transverse myelitis, other diagnoses are multiple sclerosis and spinal cord infarction. We expressly find that her illness is transverse myelitis. We reject differential diagnoses of multiple sclerosis and spinal cord infarction. A brief discussion of these three maladies is necessary.

A. Transverse Myelitis

Transverse myelitis or myelopathy⁵ has reference to internal processes in which a spinal cord lesion is produced. This lesion is limited vertically to one or a few spinal segments, but extends horizontally across the spinal cord. It is defined as an inflammation of the spinal cord across a horizontal segment resulting in lesions in the white-matter of the spine in certain areas. Accordingly, transverse myelopathy is a term denoting functional disturbances and/or pathological changes in the brain. The term is often used to designate nonspecific lesions, in contrast to inflammatory lesions. Dorland's Illustrated Medical Dictionary, 24th edition (1965).

Transverse myelitis most frequently occurs in the mid thoracic or high thoracic segments of the spinal cord. The first symptom of neurologic involvement often consists either of diffuse tingling sensations in the lower extremities, a burning sensation in the girdle surrounding the affected spinal cord segment, or severe back pain. Plum and Olson, Myelitis and Myelopathy, Chapter 36 in CLINICAL NEUROPATHY (Baker & Baker, ed. 1973), p. 26.

At trial, Barry Arnason, M.D., a neurologist, defined transverse myelitis as follows:

Transverse Myelitis is less clearly delineated in medical terms, but really means a relatively rapid or sudden interference with the spinal cord function for which no evidence of obstruction is found, and is thought to be inflammatory in nature, and may or may not be associated with recovery. I realize this definition leaves something to be desired but the area is a murky one.⁶ (Testimony of Dr. Aranson)

There...