The United States Court of Appeals for the Federal Circuit provides the legal criterion for compensation for vaccine injuries not found in the table of vaccine injuries. The ruling provided the Althen Standard. In that ruling, the Court stated:
“Concisely stated, Althen’s burden is to show by preponderant evidence that the vaccination brought about her injury by providing:
(1) a medical theory causally connecting the vaccination and the injury;
(2) a logical sequence of cause and effect showing that the vaccination
was the reason for the injury; and
(3) a showing of a proximate temporal relationship between vaccination and
If Althen satisfies this burden, she is ‘entitled to recover unless the [government] shows, also by a preponderance of evidence, that the injury was in fact caused by factors unrelated to the vaccine.’” (Althen, at 5.)
Clearly the burden of proof is on the government (The HHS) to show that something other than the vaccine caused the injury. If the timing is right, and a plausible biological theory exists linking the vaccine to the injury, and the HHS cannot otherwise explain the injury, petitioners are to be awarded compensation.
Althen is foundational, and all Vaccine Act decisions are to follow it.
The Court also stated:
“If Althen satisfies this burden, she is ‘entitled to recover unless the [government] shows, also by a preponderance of evidence, that the injury was in fact caused by factors unrelated to the vaccine.’” Althen, 418 F.3d at 1278 (brackets in original).
Given the difficulty in assessing direct causality after-the-fact, and that the HHS could easily defeat any claim of vaccine injury merely by listing any number of alternative theories, the Althen decision properly places the burden of proof on the government’s for their alternative theories.
The Court emphasized additional important policies that Special Masters must apply in consideration of evidence and in fact finding:
“This [the government’s argument] prevents the use of circumstantial evidence envisioned by the preponderance standard and negates the system created by Congress, in which close calls regarding causation are resolved in favor of injured claimants. … While this case involves the possible link between TT [tetanus toxoid] vaccination and central nervous system injury [context: Athen case, not Tarsell case] a sequence hitherto unproven in medicine, the purpose of the Vaccine Act’s preponderance standard is to allow the finding of causation in a field bereft of complete and direct proof of how vaccines affect the human body.” Althen, 418 F.3d at 1280.
In earlier rulings, the Special Master had failed to follow the Althen standard, and on appeal, was ordered by the US Court of Federal Claims to reconsider the case. Upon reviewing the Althen standard, and abiding by the precedent, the Special Master found that the family had met that requirements of that standard:
-No medical record existed (i.e., no evidence existed) that Christina had cardiac arrhythmia prior to receiving the Gardasil vaccine, and speculation that it pre-existed but was “undetected” is mere speculation, and is not evidence;
-The HHS failed to provide any alternative cause for Chrisitina’s arrhythmia an death.
-The biologically plausible theory was provided by Dr. Yehuda Shoenfeld, who served as an expert witness, who posited that individuals exist who are more susceptible to serious adverse events from vaccines due to genetics that contributed to autoimmunity.
The Appeals Court remanded the incorrect decision back to the Special Master, who had utterly confused which rules applied to which levels of causality under Althen:
In finding that Petitioner failed to demonstrate that Christina’s vaccine preceded her arrhythmia, the Special Master did not assess whether Petitioner demonstrated, by a preponderance of the evidence, a “proximate temporal relationship between the vaccination and the injury” in the traditional manner required to satisfy Althen Prong Three. The requirement of a “‘temporal relationship’ between the vaccination and the injury is designed to ensure that it is ‘medically acceptable to conclude that the vaccination and the injury are causally linked.’” Simanski v. Sec’y of Health & Human Servs.,
, 1384 (Fed. Cir. 2012) (quoting de Bazan, 539 F.3d at 1352). Petitioner can meet her burden of proving that Christina’s arrhythmia arose within an acceptable time frame after she received the Gardasil vaccines via medical-record evidence or expert opinion. Althen, 418 F.3d at 1279. The Special Master is instructed to re-evaluate Althen Prong Three consistent with Althen, de Bazan and W.C. The Special Master shall consider the totality of the evidence to determine whether it is more likely than not that the onset of Christina’s arrhythmia predated her first Gardasil vaccine and if not, whether Christina’s arrhythmia and cardiac arrest occurred within a medically appropriate time after her vaccines. Althen Prong One: The Special Master Impermissibly Elevated Petitioner’s Burden to Provide a Medical Theory Causally Linking Gardasil to Arrhythmia In analyzing Althen Prong One, the Special Master required that Petitioner prove that her theory of how Gardasil “can cause” cardiac arrhythmia was “more likely than not,” instead of requiring that Petitioner provide a “medical theory of causation linking the vaccine to the injury.” Petitioner presented a theory connecting Gardasil to Christina’s development of a cardiac arrhythmia and subsequent death, which can be summarized as follows: Christina Tarsell died from an arrhythmia induced by autoantibodies to the L-type calcium channel receptor. Homology (molecular mimicry) between proteins is the first step required for cross- reactivity. According to peer-reviewed literature, L1 protein of HPV 16 antigen shares homology with human proteins associated with cardiac function. In our case, the L-1 protein shares similarity with the L-type calcium channel receptor. In genetically susceptible individuals like Christina, the body mounts an immune 11 system response to both the L-1 protein and the L-type calcium channel receptor resulting in cross-reactivity. Autoantibodies bound to the L-type calcium channels in Christina’s heart making them dysfunctional resulting in an influx of calcium into the heart cells. The increased concentration of calcium in the heart cells caused her premature ventricular contractions. After each additional Gardasil vaccination, more calcium entered the heart cells resulting in a worsening of her arrhythmia and ultimately her death. Mot. for Rev. 16.11 The Special Master interpreted Moberly ex rel. Moberly v. Secretary of the Department of Health & Human Services,
(Fed. Cir. 2010), to require Petitioner to demonstrate her theory by a preponderance of the evidence, reasoning: The Federal Circuit has stated that petitioner’s burden of proof is “more likely than not,” not mere plausibility. Moberly,
, 1322 (Fed. Cir. 2010). Decisions from the Court of Federal Claims have followed Moberly. M.S.B. by Bast v. Sec’y of Health & Human Servs.,
, 123 (2014), appeal dismissed, 579 Fed.Appx. 1001 (Fed.Cir.2014); Taylor v. Sec’y of Health & Human Servs.,
, 819 (2013). Decision at *15 (internal footnote omitted). However, the phrase “more likely than not” that the Special Master quotes from Moberly addresses the petitioner’s overall burden of proving causation-in-fact under the Vaccine Act, not a petitioner’s burden to provide a medical theory causally linking the vaccine to the injury. In this passage that the Special Master quotes from Moberly, the Federal Circuit stated: While the petitioners acknowledge that the statute requires proof of causation by a preponderance of the evidence, they appear to be arguing for a more relaxed standard. They repeatedly characterize the test as whether Molly’s condition was “likely caused” by the DPT vaccine. By that formulation, however, they appear to mean not proof of causation by the traditional “more likely than not” standard, but something closer to proof of a “plausible” or “possible” causal link between the vaccine and the injury, which is not the statutory standard. Similarly, the petitioners object to the use of the term “causation in fact” by the special master and the Court of Federal Claims, because they claim that proof that a vaccine “in fact” caused an injury would require conclusive scientific evidence. But this court has regularly used that term to describe the causal requirement for off-Table injuries and has made clear that the applicable level of proof is not certainty, but the traditional tort standard of “preponderant evidence.”
The new ruling is consistent with the standard implementation of Althen. In murder trials, the body counts as evidence. For those who try to claim that The Christina Tarsell Estate failed to provide a preponderance of evidence, go back and read the Althen criteria and decision, and ask whether the HHS provided a sufficiently plausible alternative explanation for Christina’s death. They did not.
Detractors will similarly claim that large epidemiological studies have found no link between HPV vaccines and autoimmune conditions. But those studies are utterly irrelevant because were not designed to, and did not test, for increased risk in a genetically susceptible subpopulation.
Dr. Shoenfeld’s theory of autoimmunity is highly compelling, as he reported that a five amino acid sequence – LQAGL (Leu-Gln-Ala-Gly- Leu) – found near the C-terminus of the HPV strain 16 L1 capsid protein antigen present in the HPV virus proteins in the Gardasil vaccine is identical to the the amino acid sequence of the L-type calcium channel protein spanning the membrane of heart muscle cells.
Christina’s amino acid sequence in unknown, but as I have argued from the beginning of my journey into vaccine safety science, her specific genetic variant could be in the form of a non-synonymous substitution in the five-amino sequence, or next to the amino sequence, creating a six-amino acid epitope with enhanced immunogenicity. The increased genetic risk could also be a frame-shift deletion that changed her amino L-type calcium channel protein sequence into a much larger epitope. Any number of types of mutations in the part of the L-type calcium channel protein could have made her L-type calcium channel protein more similar to the amino acid epitope that includes the five amino acid sequence.
Thus, this study that shows that typical L1 capsid proteins from four types of HPV do not bind to the five amino acid sequence cannot rule out a specific risk for Christine. Population risk is irrelevant when genetic susceptibility is in play.
The HHS presented data from the CDC (that is, the Defendant in this case, HHS runs CDC) that failed to find any histological evidence of infiltrating immune cells. Consider the source. CDC has consistently failed to find a lot of things, including association between vaccines and autism by conveniently leaving out positive association results. The consideration of infiltrates by the witnesses, and ultimately by the Special Master, went as follows:
While the sequence of interest is found in other tissues, and no sign of autoimmunity against those tissues had presented in Christina, they are found by proteins encoded by other genes. I would be unlikely (as in, statistically impossible) that those genes would have the identical mutation that led to increased homology. More importantly, the immunogenicity of the LQAGL sequence and related sequences is determined by the shape of the protein (whether viral or human), not just its sequence.
What Should be Done?
(1) FDA Should Issue a Caution of Arrhythmia Due to HPV Vaccine
Christina’s case is so compelling that FDA should put out a caution on HPV vaccine due to concerns over arrhythmia, just as they have done for Azithromycin (Zithromax or Zmax), and Bella Diet Capsules. They should force Merck to update the Gardasil package insert.
(1) Doctors Should Stop Staying “The HPV Vaccine ‘Is Safe'”.
Clearly, that is not the case for everyone. Such generalizations are not biologically, scientifically, medically, or legally supported. Denial of informed consent must end.
(2) The Congressional Mandate of 1986 Should be Fully Funded
The National Vaccine Childhood Injury Act of 1986 mandated that genetically susceptible subgroups be identified. That means objective science that studies vaccines AND genetics in the same study. Thirty-two years of vaccine risk denialism and studies that test the wrong hypotheses do not fulfill the mandate.
(3) Vaccine Mandates Should Have “No Questions Asked” Exemptions, or Should Not Exist At All
If any individual patient or parent has a concern over the incompletely specific risk, they should be able to opt out. Bills for HPV Vaccine Mandates are failing all around the country. HPV vaccine injuries rank #1 out of all vaccines in vaccine safety databases.
(4) Merck Should Be Investigated for Fraud
As outlined in this investigative report, Merck did not report all adverse events that occurred during pre-clinical license clinical studies. Instead of allowing the study to tell them what adverse events resulted from Gardasil, they assumed that newly emerging medical conditions that occurred after any of the doses of the vaccine were NOT due to the vaccine, and buried them in “New Medical Files”. That is not science; that’s not ethical; that’s wrong and those data should be completely re-analyzed including New Medical Conditions by truly independent scientists with no conflicts of interest to determine if adverse events that could be due to the vaccine were higher in the vaccinated group compared to the group that was injected with the aluminum “placebo” (aluminum hydroxyphosphate sulfate).
(5) Merck: Take it Off the Market – Your Science is FRAUD
Merck should do the right thing. If not, FDA should de-license Gardisil, and then truly independent randomized clinical trials should be conducted. They should include an assessment of the claims of the benefit of vaccination against 4 or 9 types of HPV when the preponderance of the evidence in the scientific literature shows that type replacement (replacement of the common, vaccine-targeted types with rarer, potentially more lethal types results from mass vaccination).
James Lyons-Weiler, PhD
April 10, 2018
Allison Park, PA