Gassman v. United States

• Citation: 589 F. Supp. 1534
• Decision Date: 27 June 1984
• Docket Number: No. 79-314-Orl-Civ-06.,79-314-Orl-Civ-06.
• Parties: Emma GASSMAN and Julius Gassman, Plaintiffs, v. UNITED STATES of America, Defendant.
• Court: U.S. District Court — Middle District of Florida

589 F. Supp. 1534

Emma GASSMAN and Julius Gassman, Plaintiffs, v. UNITED STATES of America, Defendant.

No. 79-314-Orl-Civ-06.

United States District Court, M.D. Florida, Orlando Division.

June 27, 1984.

COPYRIGHT MATERIAL OMITTED

Christopher Wickersham, Daytona Beach, Fla., for plaintiff.

Gary Takacs, Asst. U.S. Atty., Tampa, Fla., for defendant.

MEMORANDUM OPINION

GEORGE C. YOUNG, Senior District Judge.

Plaintiff Emma Gassman brings this action under the Federal Tort Claims Act, 28 U.S.C. §§ 1346(b) and 2671 et seq., in connection with the National Swine Flu Immunization Program Act hereinafter "Swine Flu Act", 42 U.S.C. § 247b(j)-(1), seeking compensation for injuries allegedly resulting from her receipt of a swine flu innoculation. This action was filed on June 25, 1979, transferred as multi-district litigation to the District of Columbia for consolidated pretrial proceedings,¹ and remanded to this Court by an order dated November 3, 1980. A bench trial on the merits was held on October 11 and 12, 1983.

Mrs. Gassman contends that the swine flu vaccination caused her to develop inflammatory encephalitis and that the United States is liable for failure to obtain her informed consent in administering the vaccine.² The United States opposes Mrs. Gassman's claim, contending that there was no causal relation between the vaccination and Mrs. Gassman's condition, and that Mrs. Gassman has not established a theory of recovery which would render the government liable. The Court has fully considered the evidence and arguments of the parties and files this opinion which incorporates the Court's Findings of Fact and Conclusions of Law. For the reasons stated herein, the Court concludes that plaintiff's encephalitis was the proximate result of her swine flu innoculation and that she is entitled to compensation from the government.

1. Swine Flu Program

The Swine Flu Act of 1976 was a governmentally-undertaken attempt to innoculate the entire United States population, prompted by the discovery at Fort Dix, New Jersey of individuals having influenza of the "swine" type and the resulting concern that an epidemic would occur. Congress enacted implementing legislation on August 12, 1976, and vaccinations began on October 1, 1976. The program was discontinued on December 16, 1976, following reports linking the vaccine to the incidence of Guillain-Barre Syndrome, a disorder of the peripheral nervous system. In all, over forty-five million Americans were vaccinated for swine flu.

To ensure the success of the program, the Act created a cause of action against the United States for any personal injury or death arising out of the administration of the swine flu vaccine and based upon the act or omission of a program participant. 42 U.S.C. § 247b(k)(2)(A). This cause of action would be the exclusive remedy, 42 U.S.C. § 247b(k)(3), and would be governed by the procedures of the Federal Tort Claims Act. 42 U.S.C. § 247b(k)(1)(B). Liability could be based on any theory that would otherwise govern an action against such program participant under the law of the place where the act or omission occurred, including negligence, strict liability or breach of warranty. 42 U.S.C. § 247b(k)(2)(A)(i). The term "program participant" was defined to include anyone who manufactured, distributed or administered the swine flu vaccine. 42 U.S.C. § 247b(k)(2)(B).

History has demonstrated that no swine flu epidemic occurred during the winter of 1976-77.³ As one might expect, many people who were innoculated incurred illness or injury in a period relative to the vaccination. Lawsuits such as the instant one were filed throughout the country for illnesses allegedly resulting from the swine flu program.

2. Facts

On Friday, November 5, 1976, plaintiff received a swine flu innoculation⁴ at the Naval Reserve Training Center on City Island in Daytona Beach, Florida. The vaccination was administered by the Volusia County Health Department, a program participant under the Swine Flu Act.

At the time she took the vaccine, plaintiff appeared to be in relatively good health. She was 59 years old and was employed as a secretary/receptionist for an insurance agency. Her family physician, Dr. Edward Favis, had diagnosed her as hypertensive in January or February, 1976, and thereafter prescribed Hygroton and a mild dose of Valium. Mrs. Gassman had complained of occasional headaches, which abated once she was placed on the hypertension medication. During the two or three months preceding her vaccination, plaintiff experienced some intermittent numbness in the right upper and right lower extremities, which occasionally lasted a few hours and then cleared. She testified, however, that she did not recall any numbness during the period just before her innoculation, and that on the day she was vaccinated she "never felt better".

Prior to her vaccination, plaintiff had seen and heard television and newspaper advertisements which indicated there was a good possibility of a swine flu epidemic throughout the United States and that everyone should be vaccinated against it. Mrs. Gassman initially hesitated in taking the vaccine due to concerns about its safety. She decided to take it, however, because of media assurances — including a television statement by President Ford — that the shot was safe and "approved" and that "everyone should have it". Plaintiff also questioned two of her co-workers who had received the vaccine, each of whom told her they "felt fine".

Mrs. Gassman was accompanied by her husband and son when she went to the vaccination clinic on November 5, 1976. Shortly after arriving, plaintiff was handed a form which she was instructed to fill out. It was unclear from the evidence exactly which form she received. Plaintiff contends that she was given a form entitled "IMPORTANT INFORMATION ABOUT THE SWINE INFLUENZA (FLU) VACCINE (MONOVALENT)", which is reproduced in Appendix "A" to this opinion. (Plaintiff's Exhibit No. 4; M.D.L. Doc # 473). This is the form she should have been given, since she was innoculated with the Monovalent vaccine. (See Deposition of Muriel Edith Treen, PP. 22-25).⁵ On the other hand, the "REGISTRATION FORM" which plaintiff filled out and signed was the bottom half of a form entitled "IMPORTANT INFORMATION ABOUT SWINE AND VICTORIA INFLUENZA (FLU) VACCINE (BIVALENT)",⁶ which is reproduced in Appendix "B". (Defendant's Exhibit Nos. 2, 5; M.D.L. Doc. # 460). The Court finds these two forms to be identical in the respects which are material to this case.⁷

After receiving the form, Mrs. Gassman sat at a table and printed her name, address, etc. in the spaces provided and signed the form. Plaintiff testified that she did not remember much about the contents of the form because she "wasn't taking particular notice of it at the time". Plaintiff then returned the completed form and stood in line to receive her shot. The only question plaintiff remembered being asked by clinic personnel was whether she was allergic to eggs.

On Sunday, November 7, 1976, approximately two days after her innoculation, plaintiff developed aches and pains in her upper thighs. Believing these pains were merely temporary after-effects of the swine flu shot, plaintiff did not contact her physician and returned to work the following morning. The pains, however, increased each day during that week.

On Saturday, November 13, 1976, Mrs. Gassman experienced a sudden onset of difficulty in speaking. She intermittently could not make her mouth form words and what she said came out slurred. In addition, she began feeling weakness in both her upper and lower right extremities. At work the following Monday, Mrs. Gassman found she was unable to write memos clearly and had difficulty speaking while answering the phone. At times she suffered from blurred vision and had occasional lapses of memory. She also began to require more sleep than normal.

On the morning of November 19, 1976, after consulting with Dr. Favis' office, Mrs. Gassman went to Halifax Hospital in Daytona Beach for testing. Later that day, Dr. Favis informed her that based on the test results he felt she had suffered a stroke⁸, and advised her to go immediately to Ormond Beach Memorial Hospital where she was to see Dr. Kenneth Derbenwick, a neurologist. After Mrs. Gassman's admission to Ormond Beach Memorial Hospital, Dr. Derbenwick conducted several neurological tests. His positive findings included mild to moderate right hemiparesis of approximately equal degree in the right arm and leg, mild right lower facial weakness, spasticity and weakness in the right lower extremity, and marked reduction of rapid coordinative movements on the right side with mild to moderate reduction on the left. Based on these findings, Dr. Derbenwick's initial impression was that Mrs. Gassman had suffered a left cerebral infarction following apparently several spells of left cerebral transient ischemic attacks. However, a subsequent analysis of the plaintiff's cerebrospinal fluid revealed abnormally high levels of protein and white blood cells. Numerous subsequent tests were performed, the results of which led Dr. Derbenwick to conclude that Mrs. Gassman was inflicted with postvaccinal encephalitis resulting from the swine flu innoculation. Dr. Derbenwick's summary diagnosis upon plaintiff's discharge from Ormond Beach Memorial Hospital on November 29, 1976 was "probable viral encephalitis, probably with secondary transient cerebral ischemic episodes."

After being discharged, plaintiff was confined to her bed for approximately one month, and had difficulty walking alone for approximately two months. Plaintiff continued to suffer from weakness in her right extremities and pain in her upper legs. An electromyography examination performed in February, 1977 led Dr. Derbenwick to conclude that the lower extremity pains were caused by a viral-related generalized polyradiculopathy, an inflammation of multiple nerve roots. Plainti...