Hockett v. U.S., 83-5047

• Decision Date: 23 April 1984
• Docket Number: No. 83-5047,83-5047
• Citation: 730 F.2d 709
• Parties: Madeline Louise HOCKETT and Lowry Hockett, Plaintiffs-Appellees, v. UNITED STATES of America, Defendant-Appellant.
• Court: U.S. Court of Appeals — Eleventh Circuit

Page 709

730 F.2d 709

Madeline Louise HOCKETT and Lowry Hockett, Plaintiffs-Appellees, v. UNITED STATES of America, Defendant-Appellant.

No. 83-5047.

United States Court of Appeals Eleventh Circuit.

April 23, 1984.

Stanley Marcus, U.S. Atty., Miami, Fla., Mary McElroy Leach, Trial Atty., U.S. Dept. of Justice, Torts Branch, Civ. Div., Washington, D.C., for defendant-appellant.

Maguire & Friend, Michael P. Maguire, Coral Gables, Fla., for plaintiffs-appellees.

Appeal from the United States District Court for the Southern District of Florida.

Before GODBOLD, Chief Judge, TJOFLAT and HENDERSON, Circuit Judges.

GODBOLD, Chief Judge:

In this case we review the correctness of the trial court's findings, based on conflicting expert testimony, that a swine flu vaccination caused plaintiff's subsequent disease and complications. We affirm the judgment for the plaintiff.

I. Background

Plaintiff Madeline Hockett received a swine flu vaccination in October 1976. Six months later she was diagnosed as having Guillain-Barre Syndrome (GBS), a debilitating neurological disorder. She sued the government under the Federal Tort Claims Act, 28 U.S.C. Sec. 1346(b) (1976), and the National Swine Flu Immunization Program of 1976, 42 U.S.C. Sec. 247b (1976), alleging that she acquired GBS as a result of the vaccination. The parties stipulated that plaintiff had GBS and that she did not have to prove negligence or any other theory of liability; thus, she was required to prove only that the vaccination caused her GBS. The government contended that a flu-like illness she suffered several days prior to the onset of GBS, not the vaccination, caused the GBS.

Plaintiff's theory of causation centered on the testimony of Dr. Eylar, a biochemistry professor. Dr. Eylar described his work with laboratory animals and experimental allergic neuritis (EAN), a demyelinating disease generally recognized by the scientific community to be an excellent animal model for human GBS. A demyelinating disease attacks myelin, the component of a sheath surrounding the nerve that serves a function similar to that of insulation surrounding an electrical wire. Dr. Eylar found that EAN can be produced in animals by injection of a protein designated as P2 , when accompanied by a chemical adjuvant used to heighten the reaction. ¹ He also found that experimental monkeys could develop what he termed a chronic form of the disease and that some would not have a severe clinical attack until two or three months after the injection. Dr. Eylar determined that the blood sera of all the injected monkeys contained antibodies directed against P2 protein but that none of the control monkeys had any P2 antibodies.

Dr. Eylar tested a sample from the same lot of vaccine given to plaintiff and found that it contained chicken P2 protein. He also tested plaintiff's blood serum and found that it contained antibodies that reacted with chicken P2 . Dr. Eylar testified that he found P2 antibodies in the blood sera of approximately 50% of 30 people who had been vaccinated and had contracted GBS and that no P2 antibodies had ever been found in the blood sera of "conventional" GBS patients (those who had not received a swine flue vaccination).

Thus, under plaintiff's theory animal experiments suggest that P2 protein can play a causal role in GBS and that the presence of P2 in the vaccine and P2 antibodies in plaintiff's blood demonstrates that the vaccine did in fact cause plaintiff's GBS. Plaintiff contends that antibodies created by the human body in response to the foreign chicken P2 do not adequately discriminate chicken P2 protein from the human protein in the myelin sheath surrounding the peripheral nerves, and, therefore, the antibodies attack the myelin.

The government's expert, Dr. Brostoff, testified that he tested plaintiff's lot of swine flu vaccine and that it did not contain any P2 antibodies. Dr. Eylar disputed the reliability of Dr. Brostoff's vaccine test, and the district court, based on the testimony of both, concluded that Eylar's test, not Brostoff's, was credible. The government never tested plaintiff's blood for P2 antibodies; Eylar's testimony that plaintiff's blood contained these antibodies therefore remained unrefuted. Even assuming the P2 antibodies were present in plaintiff's blood, Dr. Brostoff offered an alternative explanation for their presence. Hockett was "primed" with swine flu vaccine (i.e., chicken P2 ) and then suffered a viral infection that caused GBS. Her peripheral nervous system was damaged as a result of the disease process, and P2 protein (a component of the peripheral nerve) leaked into the blood stream, causing antibodies to form in response to the presence of P2 . Because Hockett had chicken P2 in her body (as a result of the swine flu vaccination but having nothing to do with the GBS), antibodies also formed in response to chicken P2 . Thus, when examined plaintiff's blood contained antibodies to chicken P2 . The antibodies to chicken P2 , according to Dr. Brostoff, were a result of the disease process, not the cause. The district court rejected this rationalization in favor of Dr. Eylar's testimony that his theory explained the only cause for the presence of chicken P2 antibodies in plaintiff's blood.

The government further attempted to rebut Dr. Eylar's evidence of causation through a statistical study tending to show that vaccination-caused GBS occurred within four to five weeks after the vaccination and that the incidence of GBS in vaccinated patients after ten weeks equaled that in the unvaccinated population. GBS occurring more than ten weeks after vaccination, the government's experts testified, is more likely to be caused by a flu-like illness than by the vaccination.

Following a bench trial the court entered judgment for plaintiff for $324,275.61. The government asserts three errors on appeal: (1) the court erroneously shifted the burden to the government to disprove causation; (2) the court's finding that the vaccination caused plaintiff's GBS is clearly erroneous; and (3) the court's finding that the GBS caused plaintiff's subsequent pulmonary disease is clearly erroneous.

II. The burden of proof in the district court

The district court correctly stated that the plaintiff had the burden of proving causation by a preponderance of the evidence, i.e., that the vaccination was a substantial factor in the onset of GBS. See, e.g., Cassel v. Price, 396 So.2d 258, 266 (Fla.Dist.Ct.App.1981) (to prove causation plaintiff must show more likely than not that defendant's conduct was a substantial factor in bringing about the result). Thus the court did not as a preliminary matter choose the wrong burden of proof.

The government contends that a portion of the district court opinion discussing the weight to be given to the government's statistical evidence shows that the district court erroneously shifted the burden to the government to disprove that the vaccination caused plaintiff's GBS:

It appears from the evidence that the state of the scientific and medical knowledge about GBS is that some of those people who received a swine flue vaccination later developed GBS, but most did not. Of those who did, it usually took two to three weeks for the symptoms to appear. However, the mere fact that the time interval in plaintiff's case was significantly longer is not dispositive. The statistics reveal a skewed bell curve relationship between the vaccinations and the onset of GBS; that does not rule out the possibility of a causal relationship between the two. Dr. Daniel Bader pointed out in his deposition that the existence of a bell curve relationship doesn't mean that things that fall outside the middle part of the curve, on either side, are not associated. After ten weeks, the incidence of GBS in the vaccinated population does not fall to zero--it drops to the background incidence rate. That background rate reflects unknown causal factors. As Dr. Barry Arnason stated in his deposition, some 60% of the cases of GBS can be associated with a history of infections [sic] illness in the prior four weeks and another 5-10% with a surgical operation in the prior month or so. Even if those were known to be causal relationships rather than mere associations, that would still leave the cause of 30-35% of the cases unexplained.

Dr. Bader's observation that one shouldn't throw away the outside margins of the bell curve just because the majority of things occur in the middle of the bell curve is well taken. We know that the overall risk of GBS in the vaccinated population is approximately four times greater than normal, and that some of those in the vaccinated population do in fact develop GBS more than nine or ten weeks later; we also know that not all of the cases of GBS can even be explained with associations, much less proven causes. If cases such as this were to be decided on the bell curve statistics alone, no plaintiff who contracted GBS more than nine weeks after his vaccination would ever be able to recover. While such a result might be justified in a case where there was no other evidence, in this case there is additional evidence which this Court must consider.

Manuscript op. at 6-7 (emphasis added) (footnotes omitted).

The government contends that another passage further confirms that the district court improperly placed the burden on the government to disprove that the vaccination caused the GBS:

A crucial item of additional evidence in this case is Dr. Eylar's finding that plaintiff's blood serum contained antibody to chicken P2 protein. There is no contrary evidence; defendant's experts did not test plaintiff's blood. The experts agreed that if in fact plaintiff's blood contained such antibodies, she must have somehow been exposed to chicken P2 protein, because those specific antibodies are not naturally found in the human body. Defendant has no explanation for such exposure, but plaintiff claims it was due to the...