CHAPTER 21

• Jurisdiction: United States

CHAPTER 21 THE DIFFERENCE IN BURDENS OF PROOF

Compared to the typical tort plaintiff, the burden of proof in a federal administrative vaccine claim is noticeably different. Although a petitioner in a vaccine program has the same "preponderance of the evidence" burden as in tort claims, the elements a petitioner needs to prove are vastly different.¹

VICP Claims

The 1986 National Childhood Vaccine Injury Act process requires the claimant to show that she is the real party in interest, that the vaccine is covered in the injury table (see Appendix A), that the vaccine was administered in the United States, that no prior award of settlement has been given for this person's injury, and that no previous civil action had been filed.²

The 1986 Act provided two ways for the claimant to prove entitlement to damages. The first is based on a table initially established in the law, but subject to revision by the HHS Secretary, that lists:

• the covered vaccines,
• the covered illnesses related to that vaccine, and
• the time frame from vaccination to first symptom of the illness.³

The key concept here is whether one's evidence supports a "Table Injury" (i.e., an injury listed on the Vaccine Injury Table, in the federal compensation rules, that occurred within the time period provided by the Table) (see Appendix A). If so, then causation is presumed, and the petitioner is entitled to compensation, so long as the federal agency "respondent" cannot prove by a preponderance of the evidence that the injury had been due to other factors unrelated to the vaccine.⁴ The 21st Century Cures Act amended the National Childhood Vaccine Injury Act to require that HHS must revise the Vaccine Injury Table to include vaccines recommended by the CDC for routine administration in pregnant women.⁵

The burden is much more difficult if the injury does not fall within the description of a "Table Injury." In those cases, causation is not presumed, and the petitioner must prove that he or she suffered an injury that had been actually caused by a vaccine (i.e., a "Non-Table Injury").⁶

To prove a Non-Table claim, the petitioner must show the vaccine was both a but-for cause of the injury and a substantial factor in bringing about the injury.⁷ In doing so, the petitioner's burden is to satisfy three elements established in Althen v. Secretary of Health & Human Services:⁸

1. establishing "a medical theory causally connecting the vaccination and the injury,"
2. providing "a logical sequence of cause and effect showing that the vaccination was the reason for the injury," and
3. showing a "proximate temporal relationship between vaccination and injury."⁹

Stated another way, under the first prong of the 2005 Althen appellate precedent, petitioner must provide a reputable medical theory demonstrating that the vaccine received by the claimant can cause the type of injury alleged.¹⁰ Under the second Althen prong, petitioner must show the vaccine caused her injury.¹¹ Under the third Althen prong, petitioner must prove that the onset of symptoms occurred within a time frame from which it is medically acceptable to infer causation in fact given the medical understanding of the disorder's etiology.¹² These cases are harder to build and more complex to assemble and require more help from medical experts.

Note that the 1986 vaccine compensation system created no presumption of injury causation. The general tort concept of "legal cause" remains.¹³ So the vaccine must have been a substantial factor in causing harm. The differences in burden of proof between a Table Injury and Non-Table Injury has a profound effect on the need for expert witnesses. Since causation is presumed for a Table Injury claim, such claims rarely require an expert. As causation is not presumed in Non-Table Injuries, those claims nearly always require an expert. Counsel should carefully evaluate the potential claimant's assertions against the HHS regulation¹⁴ that defines the Table Injury category. Either way is simpler than with the 2005 Act's vaccines for "countermeasures," including claims about COVID vaccines.

CICP Claims

Similar to the VICP process, the CICP has developed a table that lists the covered vaccines, shown in Appendix B, and if one submits evidence that supports a "Table Injury" (i.e., an injury listed on the official agency regulations' Vaccine Injury Table and that occurred within the time period provided by the Table), then causation is presumed.¹⁵ However, that presumption is rebuttable. If the HHS Secretary determines that a source other than the countermeasure more likely caused the injury, then the claim will be denied.¹⁶ This can be pursued on appeal.¹⁷ And the COVID vaccine recipient receives a statement of cautions; failure of the vaccine maker to warn cannot be the predicate for a claim, because of VICP preemption.¹⁸

If the injury is a Non-Table injury (i.e., is not included on the Table or does not meet the requirements set out on the Table), then the petitioner "must demonstrate that the injury occurred as the direct result of the administration or use of a covered countermeasure."¹⁹ A temporal association alone is not sufficient to establish causation.²⁰ The petitioner must submit "compelling, reliable, valid, medical and scientific evidence" as proof of causation.²¹ Unlike the VICP,²² however, the CICP does not publish its decisions, so it is not clear what evidence the agency considers sufficient proof of causation. Presumably, however, an expert would be needed to be used in Non-Table claims. If at this point, the reader is confused, we note that the countermeasures system is not easy to navigate; that is the way the vaccine maker lobbyists wanted it to be in their 2005 drafting efforts.

Evidence in the Statutory Vaccine Claims Process

The claim processes are quite unusual for the typical tort lawyer's experience. Since CICP and VICP are administrative programs, with no jury, they are not subject to the formalities of a traditional tort case. One major example of this exceptional distinction is in discovery: there is no discovery as a matter of right in a vaccine case.²³ Did your client receive a dose that had been mixed badly or preserved poorly or allowed to thaw too much? Each of the two federal vaccine compensation programs, however, handles evidence differently. Case decisions of VICP are accessible on Westlaw.

CICP

Let us walk through the typical COVID vaccine recipient's claims process. When a petitioner submits a CICP claim, he or she does so by submitting a Request for Benefits form (available online from HRSA's CICP website²⁴ ), along with documentation that the injured petitioner had used or had been administered a "countermeasure" vaccine or drug, designated as such by HHS, and was injured thereby; and this submission must include an authorization for the disclosure of health information by each healthcare provider from whom he or she sought treatment.²⁵

If this injury is listed in the "Table" shown in the federal regulation,²⁶ the claim proceeds. For a Non-Table Injury, the petitioner's documentation should include scientific studies or other information necessary to prove causation. Since the CICP does not set a hard deadline for submission of records, a petitioner should submit this evidence with their application. Otherwise, the petitioner could risk the HHS Secretary making an adverse decision before that full set of information is submitted.

VICP

Unlike the CICP, the VICP does not use a standard administrative form to request payment of the requested benefit. Instead, to apply, the petitioner must file a formal petition for compensation in the United States Court of Federal Claims.²⁷ That court's rules for vaccine cases are found in title 42 of the Code of Federal Regulations.²⁸ Additionally, all the information needed for the respondent to respond to the claim for compensation should be included in the petition and the attachments thereto.²⁹ These are printed out and delivered in paper form to the VICP. (During background interviews for this text, federal employees emphasized paper copies, rather than electronic transmissions, should be delivered to VICP in order to assure they will be all be considered together by the contract medical review team.)

Specifically, in the petition itself, the petitioner must state the name of the individual to whom the vaccine was administered, the date and place of the vaccination, a specific description of the injury alleged, whether the injury alleged is contained in the Vaccine Injury Table, and a specific demand for relief or a statement that such a demand will be deferred.³⁰ Additionally, attached to the petition, the petitioner must include all available medical records supporting the allegations in the petition, including records of:

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