Factual determination that SIRVA injury more likely caused by influenza vaccine than uncovered vaccine
In this SIRVA case, the petitioner received an uncovered pneumococcal vaccine and a covered influenza vaccine in the same arm at the same time. The court concluded that there was preponderant evidence for a finding that petitioner’s right shoulder injuries resulted from the influenza vaccination and not the pneumococcal vaccination. At the time of the fact hearing, petitioner was no longer able to recall which vaccination he received first or where each vaccination was given. However, the chief special master relied on four contemporaneous reports by petitioner to various medical providers that his pain began after getting the flu vaccine too high in his arm. Zebofsky v. HHS, (Fed. Cl. Spec. Mstr. Dec. 15, 2016) (Dorsey, CSM)
Ruling on the record, finding in favor of entitlement, in a case involving autoimmune NMDA encephalitis following Gardasil vaccine
Petitioner’s immunology expert applied the eight Miller elements to determine whether the evidence supported vaccine causality. This is the second decision in which I’ve seen this criterion successfully used recently. They are:
- Temporal association consistent with known biologic effects.
- Lack of likely alternative explanations.
- Dechallenge – did the defining aspects of the disorder disappear or improve when the exposure was removed.
- Rechallenge – did the disorder reappear or worsen when the exposure was reintroduced.
- Biologic plausibility-is the disorder plausible based upon the known in vivo or in vitro effects of the exposure. Id.
The secondary elements are:
- Analogy- are there prior published or unpublished reports of a similar disorder developing after the exposure in question or after a similar exposure
- Dose responsiveness-is there evidence that the dose or extent of the exposure is related to the likelihood of developing the disorder or to the disorder’s severity.
- Specificity- are the defining symptoms, signs, and laboratory features of the disorder the same as those seen in previous cases after exposure to the same environmental agent.
This reminds me of bit of the Stevens criteria, which were previously promulgated in the program by judicial fiat, and ultimately determined to have created too high a bar for petitioners in the Althen case, which set the evidentiary standard we still use today. But, I suppose if your expert is able to make an argument that these criteria are satisfied then that’s obviously helpful for your case. But let’s be sure that these criteria are not used against petitioners in an unlawful way, by elevating the burden.
Ultimately, the special master concluded that petitioner’s proposed causation theory, epitope spreading, was “not particularly robust but it has just enough validity and reliability from a legal standpoint to meet the relatively lenient preponderance standard applied in Program cases.” It was also quite helpful that there was a treating physician report.
This case also features one of my favorite excerpts from the IOM report which supports short onset cases, and ironically had been cited by respondent’s expert “[d]ue to the development of memory B and T cells during the primary immune response, the latency between subsequent exposure to the antigen and development of the immune response will usually be shorter. The lag phase is generally 1 to 3 days; the logarithmic phase of the secondary antibody response occurs over the next 3 to 5 days.”
The special master recognized that close calls are to be resolved in favor of injured claimants. Al-Uffi v. HHS, Fed. Cl. Spec,. Mstr. Feb. 22, 2017) (Corcoran, SM)
Denial of entitlement in a case alleging pneumococcal pneumonia caused by MMR vaccine
In a drastic departure from the norm, respondent’s expert conceded, in this case, that the MMR vaccine is immunosuppressive for a period of weeks, in the same way as wild measles infection. However, the court found that the MMR vaccine does not alter the effectiveness of the innate immune system, thus the ability to produce antibodies against pneumococcus, and could not have contributed to the development of pneumonia. Two lessons to be learned from this case are 1) murine models do not necessarily apply to humans because mice are not people, and, 2) an immunologist beats a pulmonologist where the dispute is over immunology. DePena v. HHS¸ (Fed. Cl. Spec. Mstr. Feb, 22, 2017) (Moran, SM)
Ruling in favor of entitlement in a case alleging HLH and death in a newborn caused by Hepatitis B vaccine
HLH is hemophagocytic lymphohistiocytosis, which is essentially an immune attack on the entire body leading to death. One of the primary issues in the case, whether the HLH existed in utero, was resolved in petitioner’s favor. With respect to prong one, the special master found that it was more likely than not that hepatitis B vaccine could activate the innate immune system, causing a release of proinflammatory cytokines, triggering a cytokine storm and resulting in the development and/or triggering of HLH. Petitioner prevailed on prongs two and three as well. Finally, the special master held that respondent did not meet its burden of showing an alternative cause in contending that the HLH was present in utero. Although any infectious agent, bacteria, fungi, virus can cause HLH, there was no evidence that the child suffered from any of these conditions in utero or after birth. Respondent essentially proffered a theory that the HLH was idiopathic or a disease of unknown cause, and this is legally insufficient to constitute a “factor unrelated” defense under the Vaccine Act. Sajbel v. HHS, (Fed. Cl. Spec. Mstr. Mar. 31, 2017) (Roth, SM)
Denial of entitlement in case alleging afebrile seizures caused by HPV vaccine
Petitioner did not prevail on any of the Althen prongs. The special master noted that petitioner’s expert, a general neurologist, was ill-qualified to testify regarding immunological concepts. K.L. v. HHS, (Fed. Cl. Spec. Mstr. Mar. 17, 2017) (Corcoran, SM)
Denial of entitlement in a case alleging ITP caused by HPV vaccine – onset- molecular mimicry
Petitioner’s claim failed because of the inability to establish the onset of the ITP, there were never any symptoms of ITP, only an abnormal platelet count discovered incidentally, post-vaccine. Discovery of the condition did not equate to proof of onset of the condition. The special master did find that petitioner would otherwise have prevailed on Althen prong one, by proposing molecular mimicry, even though that theory is more often utilized with MMR in ITP cases. Importantly, the special master noted that it was unnecessary for petitioner to show exactly which antigen would be involved in the proposed cross-reactivity process, or to offer any studies showing molecular mimicry could happen between ITP and HPV, because that would impermissibly heighten the burden of proof (not every SM agrees). Johnson v. HHS, (Fed. Cl. Spec. Mstr. Jan. 6, 2017) (Corcoran, SM)
Motion for review granted; entitlement found by reviewing court in case alleging seizures, autoimmune encephalopathy, and cognitive and motor decline post-MMR vaccine
This case has a long procedural history and had previously been all the way to the Federal Circuit. The Circuit had remanded the case to the special master with instructions to reconsider certain parts of the record. On remand, the special master changed his mind and found that prong one had been proven, but again found that petitioners had failed to prove prong two. Petitioners filed their second motion for review, and the court concluded:
…instead of following the Federal Circuit’s direction, the special master prepared a 60-page, single-spaced decision finding that Petitioners had failed to satisfy prong two of the Althen test. Indeed, the special master explained away or dismissed virtually every argument offered in Petitioner’s favor. In performing this analysis, the special master imposed too great of a burden on Petitioners that could not reasonably or possibly be met. Even if this case could be regarded as a “close call,” the Federal Circuit has held that “close calls regarding causation are resolved in favor of injured claimants.” Althen, at 1280, citing Knudsen v. Sec’y of Health & Human Servs., 35 F.3d 543, 549 (Fed. Cir. 1994). Application of this principle results in Petitioners’ recovery. Moriarty v. HHS, (Fed. Cl. Feb. 10, 2017) (Wheeler, J)
Denial of entitlement in a post-MMR mitochondrial autism case
Following the trend of all post-OAP cases alleging the existence of a mitochondrial disease or dysfunction, the special master found none to exist, a necessary prerequisite to the medical theory. Moreover, the special master found that none of the Althen prongs were satisfied. Anderson v. HHS, (Fed. Cl. Spec, Mstr. Nov. 1, 2016) (Corcoran, SM), aff’d (Fed. Cl. May 5, 2017) (Braden, CJ)
Denial of entitlement in a post-MMR mitochondrial autism case with a genetic mutation
This case presented an interesting twist on the mitochondrial autism theme, in that the child had a mutation in a calcium channel gene which purportedly created a susceptibility factor in addition to his mitochondrial dysfunction. The claim failed because the special master found that the child did not suffer from mitochondrial dysfunction, that his mutation was not a susceptibility factor and that none of the Althen prongs had been satisfied. Dempsey v. HHS, (Fed. Cl. Spec. Mstr. Feb. 23, 2017) (Hastings, SM)
ATTORNEYS FEES AND COSTS DECISIONS
Hourly rates and billing judgment
In this fees case, the special master ordered the law firm to follow the Guidelines and, in the future, identify paralegals by names or initials and provide information about their qualifications and experience, so that the court could properly assess the reasonableness of the hourly rate charged. This is so even if the firm charges the same hourly rate for every paralegal.
The court also held that it was unreasonable to bill .1 hours each for drafting an email, reading its response, and replying and that these three tasks should have been combined into one entry. Floyd v. HHS, (Fed. Cl. Spec. Mstr. Mar. 2, 2017) (Moran, SM)
Denial of fees and costs, no reasonable basis in a case alleging headaches post HPV vaccine
This case contains a very detailed explanation of the development of reasonable basis law over the years and where it currently stands. There are two cases currently on appeal to the Federal Circuit which will hopefully set forth a more definitive test for what amount of evidence is needed to establish a reasonable basis for a claim, and whether other circumstances, such as statute of limitations, are properly considered in the reasonable basis analysis or not. Cottingham v. HHS, (Fed. Cl. Spec. Mstr. Mar. 30, 2017) (Moran, SM)
Denial of interim fees and costs request, in part due to reasonable basis concerns
The special master observed that she did not expect to know whether the case had a reasonable basis until after the case was tried. Purvis v. HHS, (Fed. Cl. Spec. Mstr. Feb. 28, 2017) (Millman, SM)
In this interim fees proceeding, petitioner requested compensation for a pediatric pulmonologist at an hourly rate of $500, for 221 hours. In the context of discussing whether or not these hours were excessive, the special master suggested that the HHS expert’s timesheets be submitted. HHS opposed doing so. The special master noted that “[a]t first glance, this amount of time shockingly exceeds the amount of time that experts usually spend on a case that included two days of hearing.” Yet, after considering that the expert had summarized the medical records, written six expert reports, (likely most were at the special master’s behest), reviewed more than 70 articles, reviewed respondent’s expert reports and prepared for and attended two days of hearing, the special master concluded that the hours were reasonably spent. This rendered moot the issue of whether respondent’s expert’s invoices should be sought by the court.
Further, the expert’s hourly rate was reduced to $325 per hour, because he was a first-time vaccine program expert, thus inefficient; his expertise did not match the relevant subject matter; and his credentials were not particularly impressive in that he did not have a significant teaching position, was not conducting research and was not an editor of any journals.
Finally, the expert’s $900 first-class plane ticket was reduced by 50%. DePena v. HHS¸ (Fed. Cl. Spec. Mstr. Mar. 30, 2017) (Moran, SM)