Novak v. U.S.

• Decision Date: 28 February 1989
• Docket Number: Nos. 87-3404,87-3445,s. 87-3404
• Citation: 865 F.2d 718
• Parties: 27 Fed. R. Evid. Serv. 414 Barbara NOVAK, Plaintiff-Appellee, Cross-Appellant, v. UNITED STATES of America, Defendant-Appellant, Cross-Appellee.
• Court: U.S. Court of Appeals — Sixth Circuit

Page 718

865 F.2d 718

27 Fed. R. Evid. Serv. 414

Barbara NOVAK, Plaintiff-Appellee, Cross-Appellant, v. UNITED STATES of America, Defendant-Appellant, Cross-Appellee.

Nos. 87-3404, 87-3445.

United States Court of Appeals, Sixth Circuit.

Argued July 18, 1988.

Decided Jan. 10, 1989.

Rehearing and Rehearing En Banc Denied Feb. 28, 1989.

Verne K. Armstrong, Asst. U.S. Atty., Toledo, Ohio, Patrick M. McLaughlin (argued), U.S. Atty., Cleveland, Ohio, for defendant-appellant, cross-appellee.

Marcus L. Friedman, Friedman, Adler & Goldberg, Toledo, Ohio, Steven A. Fabbro (argued), Law Offices of Melvin M. Belli San Francisco, Cal., for plaintiff-appellee, cross-appellant.

Before MARTIN and WELLFORD, Circuit Judges; and GIBBONS, District Judge. ^*

WELLFORD, Circuit Judge.

There is no dispute that Joseph Novak, a young man of 37 who had previously been in good health, died of a rare disorder known as dermatomyositis on April 11, 1977. The plaintiff, his widow, sued the United States under the Federal Tort Claims Act (FTCA) and the Swine Flu Act claiming that her husband's untimely death was the result of his vaccination for swine flu on November 10, 1976.

The Swine Flu Act, enacted in 1976, was an attempt to inoculate the entire adult population of the United States to avoid a feared epidemic. This act marshalled the forces of public and private health care organizations to give free influenza inoculations to everyone requesting them. During the administration of this program, 45 million adults were vaccinated. Although the feared swine flu epidemic never materialized, several people suffered injuries or died as a claimed consequence of the vaccination. Foreseeing this potentiality, Congress permitted a cause of action in tort against the United States, and allowed recovery for all injuries proved to be the direct result of the vaccination. 42 U.S.C. Sec. 247b(k). For details of the reasons for its enactment, see generally Hasler v. United States, 718 F.2d 202 (6th Cir.1983), cert. denied, 469 U.S. 817, 105 S.Ct. 84, 83 L.Ed.2d 31 (1984), and Gicas v. United States, 508 F.Supp. 217 (E.D.Wis.1981).

Dermatomyositis (DM/PM), akin to polymyositis, is a "perplexing disease of unknown origin, thought to affect the body's auto-immune system which causes the immune system to destroy muscle and/or skin tissue." ¹ Then, and now, the scientific and medical community does not know the exact cause of DM/PM.

The district court found that Mr. Novak suffered from DM/PM within fifteen days of his inoculation with the swine flu vaccine. His wife testified that on November 25, 1976, around Thanksgiving, he complained of soreness in his leg and shoulder muscles, and was unable to engage in his normal athletic and other activities. She conceded that he became severely ill in January 1977, shortly after seeing a family doctor on December 27, 1976. His condition persisted, resulting in a hospital admission during January, at which time he was diagnosed as suffering from the DM/PM disorder. Mr. Novak unfortunately never recovered, and died within a few months.

A. Proximate Causation.

To support her claim that Novak's death was caused by the swine flu vaccination, Mrs. Novak relied primarily on the testimony of Dr. Joseph Bellanti, an expert in immunology and microbiology and a professor at Georgetown University Medical School. Dr. Bellanti gave an opinion that Mr. Novak's DM/PM "was related to the vaccine that he had received." In support of his conclusion, Dr. Bellanti drew inferences from the fact that Novak was in good health prior to the shot, that the lapse of time between the shot and the illness was relatively short, and that the disorder first manifested itself in the same arm in which Novak had received the shot. He also relied on research studies and his own experience. Dr. Bellanti believed clinical evidence showed that DM/PM may be caused by introducing a virus or virus-like particle into the body. In this respect, Bellanti's testimony was corroborated to some degree by other experts, Doctors Pearson and Lawry.

Based on this testimony, the district court found that the swine flu inoculation probably caused Novak's death, and entered judgment for the plaintiff. Looking to the "totality of circumstances," the judge concluded that causation was shown, although he was aware of and troubled by the problem and difficulty of demonstrating proximate cause. The district judge conceded that "the medical experts agree that no scientific data or epidemic logic data exists that DM/PM is a viral caused disease." The government appealed from the adverse judgment.

Federal Rule of Civil Procedure 52(a) applies in this case, and the district court's causation finding is reviewed under the clearly erroneous standard. Hasler v. United States, 718 F.2d 202 (6th Cir.1983), cert. denied, 469 U.S. 817, 105 S.Ct. 84, 83 L.Ed.2d 31 (1984). We may not overturn the decision, therefore, unless we are "left with a definite and firm conviction that a mistake has been committed." United States v. United States Gypsum Co., 333 U.S. 364, 395, 68 S.Ct. 525, 541, 92 L.Ed. 746 (1948). The plaintiff must make out her case under Ohio tort law, the place of the inoculation and the death of Mr. Novak. 42 U.S.C. Sec. 247b(k)(2). In actions of this type, we construe the state law in favor of the plaintiff, the intended beneficiary. See Unthank v. United States, 732 F.2d 1517, 1521 (10th Cir.1984). A judgment, however, based upon speculation or supposition cannot be sustained. We have considered the standards applied in Hasler v. United States, 718 F.2d 202 (6th Cir.1983), cert. denied, 469 U.S. 817, 105 S.Ct. 84, 83 L.Ed.2d 31 (1984). The issue there, as here, was proximate cause, and we found it necessary in Hasler to reverse the lower court's judgment rendered for the plaintiff in a swine flu vaccination case.

Hasler involved the plaintiff's claim that her swine flu inoculation caused her affliction with a type of rheumatoid arthritis known as Still's Disease. 718 F.2d at 204. The district court found for the plaintiff in Hasler because 1) she was in good health shortly before her inoculation; 2) she contracted Still's Disease just ten days after the vaccination; and 3) the experts agreed that a reaction to the vaccine could cause the affliction. Id. at 204-05. We reversed the judgment of the district court, holding:

Given these facts, to conclude that the swine flu vaccination was the cause in fact of Ms. Hasler's injuries would be mere conjecture. * * * While an antibody antigen reaction can cause rheumatoid arthritis, there is no showing that it did cause the plaintiff's disease in this case. Moreover, the plaintiff must show that any antigen reaction she may have had was a reaction to the swine flu shot.

Id. at 205 (emphasis in original).

This ruling parallels the position of our court that an expert's opinion must be based on a theory that is generally accepted in the relevant scientific community. In addition, it must not be based on speculation or surmise. Sterling v. Velsicol Chemical Corp., 855 F.2d 1188 (6th Cir.1988); United States v. Kozminski, 821 F.2d 1186 (6th Cir.), aff'd, --- U.S. ----, 108 S.Ct. 2751, 101 L.Ed.2d 788 (1988). This is also the standard in Ohio. State v. Thomas, 66 Ohio St.2d 518, 423 N.E.2d 137 (1981); State v. Whitman, 16 Ohio App.3d 246, 475 N.E.2d 486 (1984). In Sterling, we reversed a district court's verdict for the plaintiffs because there were no scientific studies linking pollution of area waterways to damage of the plaintiffs' immune systems. Despite the experts' opinions that pollution did cause bodily damage, we reversed on the causation question, stating:

Without the requisite clinical tests and a widely accepted medical basis for reaching its conclusions, plaintiffs' experts' opinions are insufficient to sustain plaintiffs' burden of proof that the contaminated water damaged their immune system.

855 F.2d at 1209. This position mirrors the view of the Ohio courts. E.g., Shumaker v. Oliver B. Cannon & Sons, Inc., 28 Ohio St.3d 367, 504 N.E.2d 44 (1986).

Experts presented by Mrs. Novak thought that the swine flu vaccine was a probable cause of Novak's death, reasoning that there was a "discovered link" between the vaccine in question and a disease of the nervous system known as Guillain-Barre Syndrome (GBS), which causes the immune system to attack the myelin sheaths covering the nerves. ² They believed that the swine flu vaccine contained chemicals closely resembling myelin, and that this substance caused the body to attack its own nerves as it tried to attack the virus. The government and its experts conceded that the Center for Disease Control reported an increase in the number of reported cases of GBS for a limited period at or about the time of the swine flu vaccination program. There is, however, no direct relationship between GBS and DM/PM. ³ See Hixenbaugh v. United States, 506 F.Supp. 461 (N.D.Ohio 1980), for a discussion concerning various side effects associated with GBS.

The plaintiff's experts submitted that, like GBS, DM/PM could be caused by a virus. They testified that analysis of those suffering from the DM/PM disorder indicates the presence of virus-like particles in their bodies, and that certain experiments performed on animals show that when injected with such particles, the animals develop symptoms resembling DM/PM. Finally, they pointed to evidence that children who were twice injected with a "killed measles vaccine" developed an irritation in their muscles, suggesting that a "killed virus" vaccine, such as swine flu, could at least theoretically cause a reaction leading to DM/PM.

In summary, based on this reasoning, and an assumption that DM/PM is caused by a virus, the plaintiff's experts testified that the swine flu vaccine could have been the cause of Novak's death. They relied heavily on the relatively short period between Novak's inoculation and development of his sickness...