The U.S. Court of Appeals for the Federal Circuit recently considered the testimony of two expert witnesses who disagreed whether vaccinations caused a baby’s death. A majority of the panel that heard the case agreed with the Court of Claims that the parents’ expert witness failed to establish causation. A dissenting judge questioned whether the burden should instead be placed on the government to prove that the vaccinations did not cause the death.
Vaccine Injury Compensation
The National Vaccine Injury Compensation Program (VICP) is administered by the Department of Health and Human Services (HHS). The VICP is described as “a no-fault alternative to the traditional legal system for resolving vaccine injury petitions.” The government, rather than the vaccine manufacturer, pays compensation to individuals who are injured by a vaccination.
The “no-fault” label means that injury victims need not prove that the vaccine manufacturer was negligent. Victims must nevertheless prove that the vaccine caused an injury before compensation can be paid.
Congress created the VICP in the 1980s to protect the pharmaceutical industry from lawsuits that allegedly threatened to cause vaccine shortages. Congress intended VICP to assure adequate supplies of vaccines. Government production of vaccines would be an alternative to allowing drug companies to reap profits while taxpayers absorb risks, but substituting the government for a profit-making enterprise was not a politically palatable option.
In the last few years, the VICP has “paid out an average of $229 million a year to patients and their families.” That statistic is often quoted by conspiracy theorists who promote false claims about the dangers associated with vaccinations.
Facts of the Case
Individuals who believe they have been harmed by a vaccine can file a claim with the VICP. After reviewing the claimant’s medical records, a team of doctors will recommend that compensation be paid or denied. A denial can be litigated in “vaccine court,” the colloquial term given to the U.S. Court of Claims when it hears cases under the VICP. The court appoints a Special Master to recommend that the claim be approved or rejected.
Baby J.J. received several vaccinations during a well-baby examination at the age of four months. The next morning, J.J.’s parents discovered that J.J. was unresponsive. J.J. was rushed to the hospital, where he was pronounced dead.
According to the appellate opinion, the undisputed cause of J.J.’s death was Sudden Infant Death Syndrome (SIDS). As the dissent pointed out, SIDS is not a cause of death. It is “an announcement that the cause is unknown.”
J.J.’s parents petitioned for vaccine injury compensation. The case was eventually assigned to a Special Master who held an entitlement hearing. To receive compensation, J.J.’s parents needed to prove that a vaccine caused J.J.’s SIDS.
To prove causation, J.J.’s parents needed to present (1) a medical theory showing that one of the vaccines J.J. received is capable of causing SIDS; (2) “a logical sequence of cause and effect showing that the vaccination was the reason for the injury”; and (3) evidence that SIDS occurred in close proximity to the vaccination.
J.J.’s parents relied on the expert testimony of Dr. Douglas Miller. The claim was opposed by HHS, which relied on the expert testimony of Dr. Christine McCusker. Both doctors are well qualified, and both have testified in other VICP proceedings.
Dr. Miller relied on a medical theory known as the Triple Risk Model. It was undisputed that J.J. satisfied the first two prongs of that theory. J.J. was a vulnerable infant, in part because he had a defective brainstem. J.J. died during a critical developmental period of life.
The third prong of the Triple Risk Model requires evidence of an exogenous stressor. An exogenous stressor is an external factor that is capable of causing the patient’s injury. Dr. Miller testified that vaccines can cause SIDS by inducing the immune system to produce proteins known as cytokines, which impair the brain’s ability to rouse the body from sleep in response to elevated levels of carbon dioxide.
Dr. McCusker testified that Dr. Miller’s theory was unsupported by the current state of medical knowledge regarding the production, transportation, and effect of cytokines. She also testified that Dr. Miller’s theory was undermined by the fact that J.J. had a defective brainstem. She concluded that a normal brainstem is necessary for cytokines to affect the brain. Dr. Miller offered no alternative explanation for J.J.’s death.
The Special Master found that Dr. Miller failed to establish that a transport mechanism exists that would carry cytokines to the brain. The Special Master also agreed with Dr. McCusker than a normal brainstem would be required for Dr. Miller’s theory to operate.
Claims Court Decision and Appeal
The Claims Court reviews the decision made by the Special Master. In this case, the Special Master recommended a denial of compensation because J.J.’s parents did not prove that the vaccinations caused SIDS. The Claims Court accepted that recommendation. The court found that the Special Master made reasonable determinations regarding the credibility and reliability of the expert witnesses and applied the law correctly. It therefore dismissed the claim.
The Court of Appeals for the Federal Circuit noted that Dr. Miller had relied in an earlier case on the same Triple Risk Model to link vaccinations to SIDS. In that case, the court faulted the Special Master for accepting an “unsound and unreliable theory that constitutes a significant extension of the Triple Risk Model.”
The court rejected the argument that medical knowledge supporting a relationship between SIDS and vaccinations had advanced in the short time that passed between the court’s earlier rejection of Dr. Miller’s theory and his reliance on that theory in J.J.’s case. The court also accepted the Special Master’s finding that J.J.’s defective brainstem undercut Dr. Miller’s theory.
The court concluded that the Special Master acted reasonably in deciding that Dr. Miller failed to prove that a transport mechanism exists that allows cytokines to cross the blood-brain barrier. The Special Master gave greater weight to Dr. McCusker’s testimony than to Dr. Miller’s. Since the Special Master was in a better position to judge the credibility of the two experts, the court of appeals deferred to the Special Master’s findings.
Finally, the court acknowledged that suspicious timing — a SIDS death less than 24 hours after receiving vaccinations — raised a concern that the vaccinations caused the death. The court noted the “significant medical uncertainty surrounding SIDS” and acknowledged the possibility that vaccinations could have caused J.J.’s death. But possibilities and suspicions, the court held, do not meet the standard of proof required by the VICP.
The dissenting judge read the VICP to shift the burden of proof to the government when it is reasonably possible that a vaccination caused a harm. A healthy baby’s death within hours of receiving vaccinations creates a reasonable possibility that the vaccinations caused the death.
The dissent concluded that the purpose of the VICP (to award quick and generous compensation to victims of vaccine-related injuries) would best be advanced by requiring the government to prove that the vaccinations did not lead to J.J.’s death. In the dissent’s view, the statute requires the government to prove an “unrelated cause” of death when the claimant offers evidence of a causal relationship between the vaccination and a subsequent injury. Dr. McCusker offered no other cause to explain a healthy baby’s sudden death.
While scientific advances in the understanding of SIDS are encouraging, the dissenting judge recognized the continuing lack of concrete knowledge as to the specific mechanisms that cause the unexplained deaths of babies. The judge concluded that it is inconsistent with the purpose of the VICP to expect an expert to testify about the specific ways in which vaccines cause SIDS.
It is enough, in the dissenting judge’s view, for an expert to determine that the vaccine caused the death, an opinion that can be based on the absence of any other likely cause for a death that quickly follows the administration of a vaccine. If the government expert cannot establish a different cause of death, the claimant should prevail.
The unfortunate fact is that medical experts, for all their value, can only base opinions on the current state of medical knowledge. It may be that, some years from now, the opinions of either Dr. Miller or Dr. McCusker will be vindicated by further research. In the meantime, whether the burden should be on claimants to prove the specific means by which a vaccination caused a death, or on the government to prove that a vaccine did not cause a death that quickly followed a vaccination, is a question that will continue to divide judges unless and until it is resolved by the Supreme Court.