Motion for Review of Special Master’s Decision; National Vaccine Injury Act, 42 U.S.C. § 300aa-l et seq.; Standard of Review; Tetanus-Diphtheria Vaccine; Guillain-Barré Syndrome; Molecular Mimicry.
OPINION
FINDINGS OF FACT
On August 26, 2008, Petitioner, LaKeysha Isaac, filed a timely petition for compensation with the National Vaccine Injury Compensation Program, pursuant to the National Childhood Vaccine Injury Act of 1986, Pub.L. 99-660, Title III, 100 Stat. 3755 (codified as amended at 42 U.S.C. § 300aa-l et seq. (2006)) (Vaccine Act). Following Special Master Lord’s July 30, 2012 decision, Petitioner filed a timely Motion for Review pursuant to Vaccine Rule 23 of the Rules of the United States Court of Federal Claims (RCFC) Appendix B (2012) (Vaccine Rules).
Petitioner received the tetanus-diphtheria
The hospital admission form at St. Dominic Hospital noted that Petitioner’s chief eom-
In the admission note at the Methodist Rehabilitation Center, Dr. Winkelmann stated: “Ms. LaKeysha Greer
She denies headache, fever, chills, cough, or sputum production. No abdominal pain, constipation, or diarrhea. No hesitancy or frequency. She does have the weakness with slow onset leading to her admission and the above-mentioned diagnosis. The culprit at this point in time, is felt to be the immunization, but this is an endemic area for West Nile, I would not rule out the same as an etiology of this condition.
The admission note concluded, under the heading “impression:” “At this point, my impression is that of a pleasant 30-year-old with what appeared to be Guillain-Barré. I would like to still rule out possible West Nile infection.” The West Nile test came back negative. On October 21, 2005, Petitioner underwent another electromyography and nerve conduction study. As part of taking the patient’s history, electromyographer Dr. Art Leis stated that Petitioner “[h]ad vaccination for TD [tetanus] and hepatitis [A] about 2 weeks before onset altered sensation.”
Petitioner was discharged home on October 27,2005, and began outpatient and physical therapy on November 2, 2005. In a January 5, 2009 affidavit filed in the above captioned case, Petitioner indicated that “[i]n January 2006, I was to be considered for a partner position at the law firm where I
As indicated above, on August 26, 2008, Petitioner filed a timely petition seeking compensation under the National Vaccine Injury Compensation Program, alleging that she suffers from Guillain-Barré Syndrome as a result of the tetanus vaccine and the hepatitis A vaccine. The ease was initially assigned to Special Master Abell and, on August 26, 2009, subsequently reassigned to Special Master Lord. On February 11, 2009, Respondent filed a response, pursuant to Vaccine Rule 4(c), opposing compensation to Petitioner. In the response, Respondent asserted that Petitioner was ineligible for compensation because Petitioner had “yet to offer a reputable medical or scientific theory causally connecting the Td and/or hep A vaccines to her GBS.”
On June 15, 2009, in response to an Order issued by Special Master Abell, Petitioner filed the Medical Expert Report of Dr. Carlo Tornatore, who, as noted in Special Master Lord’s July 30, 2012 decision, “is a neurologist at Georgetown University Hospital in Washington, D.C., and director of the Multiple Sclerosis Center there.” In the expert report, Dr. Tornatore concluded that there was a “logical sequence of cause of effect to explain the onset of an inflammatory demye-linating polyneuropathy (Guillain-Barre) following tetanus vaccination.” Included with Petitioner’s expert report were four articles on which Dr. Tornatore relied to support his conclusion. He cited to R. Lahesmaa et al., Molecular Mimickry between HLA B27 and Yersinia, Salmonella, Shigella and Klebsiel-la mthin the Same Region of HLA on-helix, Clin. Exp. Immunol. [Clinical & Experimental Immunology], 1991, vol. 86, at 399-404, to explain molecular mimicry, a process in which autoimmune responses occur if antigens in a vaccine share homology with host agents. Dr. Tornatore further cited to To-moko Komagamine and Nobuhiro Yuki, Ganglioside Mimicry as a Cause of Guil-lain-Barré Syndrome, CNS & Neurological Disorder — Drug Targets, 2006, vol. 5, at 391— 400, which, according to Dr. Tornatore discussed molecular mimicry in the context of Guillain-Barré Syndrome and Campylobac-ter jejuni.
On August 6, 2009, Respondent filed the Medical Expert Report of Dr. Thomas Leist, an expert in adult neurology and “an assistant professor of neurology at Thomas Jefferson University in Philadelphia and chief of the division of neuroimmunology,” who concluded that Petitioner’s Guillain-Barré Syn
It is my opinion that more likely than not the gastrointestinal illness was the proximate, causal event leading to Guillará Barre Syndrome. The elevated glucose during admission to Baptist Hospital can serve as evidence of impaired glucose tolerance as can be observed during infections particularly in persons with a diabetic condition. It is my opinion that Ms. Isaac did not suffer from any adverse effects of hepatitis A or Td other than possibly transient erythema at the injection sites whether such complications are listed in the Vaccine Injury Table or not contained therein. I hold this opinion to a reasonable degree of medical certainty.
Dr. Leist submitted six articles with his expert report to support his conclusions: S. Kuwabara et al., Does Campylobacter jejuni infection elicit “demyelinating” Guillain-Barré, Neurology, 2004, vol. 63(1), at 529-33; Steven Black et al., A post-licensure evaluation of the safety of inactivated hepatitis A vaccine (VAQTA, Merck) in children and adults, Vaccine, 2003, vol. 22, at 766-72; Mary Beth Koslap-Petraco et al., Hepatitis A: Disease Burden and Current Childhood Vaccination Strategies in the United States, J. Pediatr. Health Care, 2008, vol. 22(1), at 3-11; M. Koga et al., Antecedent symptoms in Guillainr-Barré syndrome: an important indicator for clinical and serological subgroups, Acta Neurol Seand [Seandinaviea], 2001, vol. 103, at 278-87; Tetsuo Nakayama & Kazumasa Onoda, Vaccine adverse events reported in post-marketing study of the Kita-sato Institute from 199j. to 2001, Vaccine, 2007, vol. 25, at 570-76; and Tuttle et al., The Risk of Guillainr-Barré Syndrome after Tetanus-Toxoid-Containing Vaccines in Adults and Children in the United States, Am. J. Pub. Health, 1997, vol. 87(12), at 2045-48. The Tuttle et. al. article explained that, while the forty-two-year-old man discussed in the Pollard and Selby article had suffered from Guillain-Barré Syndrome, he experienced those episodes following acute, viral illness. Following two subsequent “large, active surveillance studies,” the Tuttle et al. article concluded that, “on the basis of available data, no association of public health significance exists between tetanustoxoid-contain-ing vaccine and Guillain-Barré syndrome.”
Addressing molecular mimicry, Dr. Leist recognized that molecular mimicry can cause Guillain-Barré Syndrome in the presence of certain pathogens, notably, the bacterium C. jejuni. Dr. Leist noted, however, there are no scientific studies linking tetanus vaccine with the theory of molecular mimicry, and noted that the association between tetanus vaccination and Guillain-Barré Syndrome was only based on the Pollard and Selby article. He also stated that the article submitted by Dr. Tornatore, Komagamine and Nobuhiro Yuki, Ganglioside Mimicry as a Cause of Guillain-Barré Syndrome, describing C. jejuni as a cause of Guillain-Barré Syndrome by molecular mimicry, does not demonstrate that molecular mimicry explains how the tetanus vaccination can cause Guil-lain-Barré Syndrome.
On August 26, 2009, the above captioned case was reassigned to Special Master Lord, who held a causation hearing on July 27, 2010. The two experts who had submitted expert reports testified during the July 27, 2010 hearing: neurologist Dr. Carlo Torna-tore for Petitioner and neurologist Dr. Thomas Leist for Respondent. In his report, Petitioner’s expert, Dr. Tornatore, had raised the
[T]he white blood cells which are dutifully trying to get rid of whatever this antigen is will then start to try to remove the myelin, and so as they remove the myelin then patients end up with neurologic symptoms, and those are predominantly numbness, tingling, weakness, pain.... And then that’s in essence what Guillain-Barré is, and this affects the nerves of the peripheral nervous system.
Dr. Tornatore also referenced the Pollard and Selby article to explain the theory of ehallenge/rechallenge as a method to prove that a tetanus vaccine caused Guillain-Barré Syndrome, as opposed to another factor. The summary to the Pollard and Selby article begins: “A unique ease history is presented, of a 42-year-old patient who has suffered three episodes of demyelinating neuropathy, each of which followed an injection of tetanus toxoid.” Dr. Tornatore explained that “the Pollard and Selby article, although they [the authors] did not speak to molecular mimicry, spoke more to the idea that there is some specificity.” The specificity that Dr. Torna-tore referred to is the identification of individual components of a vaccine. Dr. Torna-tore tried to clarify that the Pollard and Selby article showed specificity because “somebody who was rechallenged with the same protein developed the same problem on three different occasions, and so that that [sic] antigenic stimulus was recognized as the inciting factor for causing the Guillain-Barré.” Under cross-examination at the July 27, 2010 hearing, Respondent asked Dr. Tornatore, “in order to apply the theory of molecular mimicry to this ease, don’t you have to be able to identify which antigens in the tetanus/diphtheria vaccine share homology with the host antigens?” Dr. Tornatore stated Petitioner did not, and testified:
Because you have the Pollard and Selby article where you had the positive reehal-lenge. And so all you need to know is that it’s the vaccine itself. The individual components it would be nice to know what those are specifically. However, that is for this case, that specificity is not required. The only specificity is that there was a challenge positive rechallenge case, the Pollard and Selby case, that the Institute of Medicine said, you don’t need to know the absolute molecular component but it’s teaching us that if something happens one time and you challenge a person a second time with that same entity, that entity is the case.
Although the Pollard and Selby article describes a single ease history from the 1970s, Dr. Tornatore concluded that “specificity was seen as evidence that, yes it’s a rare event, but rare if you can reproduce it is indeed true.” Dr. Tornatore testified that “in Ms. Isaac’s case the entity was the tetanus tox-oid, and she ended up with Guillain-Barré, which is exactly what Pollard and Selby described in that patient. So we’re not saying she got tetanus and had something else, her toe fell off, this is the same entity.” Dr. Tornatore also explained that the lack of epidemiologic studies following the thirty-two years since publication of the Pollard and Selby article was insignificant because the association between the tetanus vaccine and Guillain-Barré Syndrome had already been reported, and “the Institute of Medicine had spoken to this.”
Dr. Tornatore further testified that Guil-lain-Barré Syndrome can present itself in either a demyelinating form or an axonal form.
Dr. Leist, testifying as an expert for Respondent, agreed that Petitioner did suffer from Guillain-Barré Syndrome and had received a tetanus vaccination, but pointed out that she also “presented with GI [gastrointestinal] symptoms within a time frame consistent for an association with Guillain-Barré Syndrome.” In his expert report and in his testimony, Dr. Leist further indicated that the gastrointestinal symptoms, including nausea and vomiting, were reported in plaintiffs hospital records. Moreover, Dr. Leist testified on direct examination that, “two thirds of patients that come down with GBS indicate occurrence of an infection in the period of time prior to onset of the symptoms associated with Guillain-Barré Syndrome. And so obviously the occurrence of symptoms that are possibly indicative of an infection prior to her onset of Guillain-Barré Syndrome is important as this then could represent the proximate cause of her GBS.” Dr. Leist further testified that Petitioner’s elevated white blood cells and pre-diabetic condition did not rule out an infection. Moreover, Dr. Leist testified that since antibody testing was not done, an infection was never effectively evaluated as a possible cause for Petitioner’s Guillain-Barré Syndrome.
In his testimony, Dr. Leist also questioned the significance of the individual studied in the Pollard and Selby article, on which Dr. Tornatore had relied in his testimony. He explained that subsequent information following the Pollard and Selby article indicated that the symptoms of the individual referenced in the article were “independent of tetanus.” Therefore, Dr. Leist stated that because the 1994 Institute of Medicine Report had significantly relied on the Pollard and Selby article to conclude the tetanus vaccine could lead to Guillain-Barré Syndrome, he believed “if the Institute of Medicine will come around to look at this data again at some point in time, because I think these recommendations are living and breathing things, they will have to be reevaluated, then the opinion of the IOM [Institute of Medicine] probably will change.”
Subsequent to the causation hearing held in Petitioner’s ease, Special Master Lord filed an Order on September 23,2011, including as Court Exhibit 1, a prepublication
The epidemiologic evidence is insufficient or absent to asses an association between diphtheria toxoid-, tetanus toxoid-, or acel-lular pertussis-containing vaccines and GBS.
Mechanistic Evidence
The committee identified 10 publications reporting the development of GBS after the administration of vaccines containing diphtheria toxoid, tetanus toxoid, and acel-lular alone or in combination. The publications did not provide evidence beyond tem-porality, some too long or too short based on the possible mechanism involved.... Long latencies between vaccine administration and development of symptoms make it impossible to rule out other possible causes.
The symptoms described in the publications referenced above are consistent with those leading to a diagnosis of GBS. Au-toantibodies, complement activation, immune complexes, T cell and molecular mimicry may contribute to the symptoms of GBS; however, publications did not provide evidence linking these mechanisms to diphtheria toxoid-, tetanus toxoid-, or acel-lular pertussis-containing vaccine.
Under the heading “Causality Conclusion,” the pre-publication excerpt from the 2011 Report issued by the Institute of Medicine stated: “The evidence is inadequate to accept or reject a causal relationship between diphtheria toxoid-, tetanus toxoid-, or acellular pertussis-containing vaccines and GBS.” (internal citations omitted).
Pollard and Selby (1978) appear to present evidence of vaccine rechallenge leading to symptoms of peripheral neuropathy in a patient, subsequently diagnosed with a spontaneously relapsing remitting neuro-pathy, who developed symptoms in association with acute viral infections; however, the authors did not rule out other possible causes and did not provide evidence beyond a temporal relationship with vaccine administration. The spontaneous development of peripheral neuropathy makes it difficult to conclude that the tetanus toxoid vaccines were the causative agent.
In response to Court Exhibit 1, Petitioner filed Petitioner’s Exhibit 26, the preface to the 2011 pre-publication Institute of Medicine Report which indicated that, “the committee particularly counsels readers not to interpret a conclusion of inadequate data to accept or reject causation as evidence either that causation is either present or absent.” Petitioner alleged that the 2011 pre-publication Institute of Medicine Report provided weak circumstantial evidence because it neither accepted nor rejected whether a tetanus vaccine could cause molecular mimicry and Guillain-Barré Syndrome. Furthermore, Petitioner emphasized that she was “not required to satisfy any element of the Althen test [Althen v. Secretary of Health & Human Services,
Respondent replied in its own filing with the Special Master that the 2011 prepub-lication Institute of Medicine Report observations were consistеnt with the Respondent’s view that “the concept of whether or not Td vaccine actually induces GBS via molecular mimicry has not been established.” Therefore, the Respondent argued that Petitioner has not proven by a preponderance of the evidence that the tetanus vaccine, in fact, caused her Guillain-Barré Syndrome, for which reason Respondent requested a dismissal of Petitioner’s claim on the merits.
On May 24, 2012, Special Master Lord filed an Order, including as Court Exhibit 2, another excerpt from the 2011 pre-publication Institute of Medicine Report, Adverse Effects of Vaccines: Evidence and Causality 61-63. The Order again gave the parties thirty days to “file responses, if any, expressing the parties’ views on Court Exhibit 2.” The 2011 pre-publication Institute of Medicine Report excerpt, in relevant part, stated:
Molecular mimicry as a mechanism that can cause pathologic damage and disease has been demonstrated in several animal models, most notably experimental allergic encephalomyelitis (EAE) in mice and rabbits.
Proving that a particular human autoimmune disease is due to molecular mimicry is problematic_ A realistic and consistent temporal relationship between exposure to exogenous antigen and development of disease must be documented. This can be difficult in the case of a natural exposure to pathogen where infection may have been subclinical, making it impossible to define an exact temporal relationship.
The excerpt of the 2011 pre-publication Institute of Medicine Report continued: “While molecular mimicry is a well-estab
Some of the vaccine AEs [adverse events] under consideration by our committee share symptoms with human autoimmune diseases for which molecular mimicry has been hypothesized (i.e., arthritis, systemic lupus, erythematosus, insulin-dependant diabetes mellitus, central and peripheral nervous system demyelinating diseases). However, we found little clinical evidence (e.g., challenge/reehallenge), diagnostic evidence (e.g., presence of antigen or relevant immune complexes in affected tissue), or experimental evidence (e.g., in vitro evidence of cross-reactive T-cells derived from a site of tissue injury) that could be consistent with the hypothesis of molecular mimicry in rare and selected ease reports.
Based on the literature reviewed, molecular mimicry was not confirmed to be a mechanism leading to the development оf the adverse events postvaceination.
In response to Court Exhibit 2, Petitioner filed Exhibit 27, another pre-publication excerpt of the 2011 Institute of Medicine Report. Adverse Effects of Vaccines: Evidence and Causality 70-71, 77-78. The relevant portion of that 2011 pre-publication excerpt filed by Petitioner stated:
There are multiple uses of animal models in vaccine studies. It is possible to study each tissue of the body for microbial invasion and microbe-induced or immune-mediated damage.
With animal models it is possible to study whether particular genetic deficiencies or preexisting conditions attenuate, augment, or alter the immune response to infectious agents or microbial antigen, or whether the microbial or antigenic challenge exacerbates the preexisting condition or reveals otherwise unappreciated consequences of the genetic deficiency.
It is possible to look for molecular mimicry between vaccine antigen and self-antigen, although mimicry at the antibody level is more likely to translate to the human situation than molecular mimicry at the T cell level due to the diversity of histrocom-patibility molecules. Should molecular mimicry be found in an animal model, it still needs confirmation in humans.
Petitioner argued that while the excerpt of the 2011 pre-publication Institute of Medicine Report requires “direct evidence to prove the existence of molecular mimicry,” and is, therefore, unable to accept animal models, the Vaccine Program “allow[s] use [sic] indirect, circumstantial evidence.” Petitioner alleges that in order for the Institute of Medicine to accept the existence of molecular mimicry within humans, it would require “practices that do not and probably never will, occur in clinical practice.” Petitioner asserted that directly proving causation between molecular mimicry and vaccines with challenge/reehallenge is “highly unlikely, as it would require a medical practitioner to knowingly re-expose a patient to a potentially harmful circumstance.” Therefore, Petitioner concluded that it would go against the standard set forth in the Vaccine Program to force Petitioner to prove causation within a scientific certainty. Petitioner again argued she had shown causation by a preponderance of the evidence by providing a medical theory, logical sequence, and a proximate temporal relationship between the tetanus vaccination and her Guillain-Barré Syndrome.
In its response to Special Master Lord’s May 24, 2012 Order, Respondent argued that even with the lower threshold under the Vaccine Program standard, Petitioner had failed to satisfy her burden of proof because she did not provide the court with “ ‘a reputable medical or scientific explanation that pertains specifically to [her] case.’ ” (quoting Broekelschen v. Sec’y of Health & Human Servs.,
On July 27, 2012, Special Master Lord filed an Order, including as Court Exhibit 3, an excerpt of the 1994 Institute of Medicine Report. Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality 88-89. Special Master Lord entered the excerpt of the 1994 Institute of Medicine Report in order to complete the record because “both parties’ experts discussed this portion of the 1994 Institute of Medicine (TOM’) publication, but it was not previously in the record.”
There is a biologic plausibility for a causal relation between vaccines and demyelinat-ing disorders. The literature describing a possible association between GBS and tetanus toxoid, DT, or Td consists of case reports. The most convincing case in the literature is that reported by Pollard and Selby (1978), who described a 42-year-old man who developed GBS on three separate occasions (over a 13-year period) following receipt of tetanus toxoid. The relation between tetanus toxoid and GBS is convincing at least for that one individual, even though this man has subsequently experienced multiple recurrences of de-myelinating polyneouropathy, most following acute viral illnesses.
The relevant portion of the excerpt from the 1994 Institute of Medicine Report also stated that “[f]ew cases of GBS [Guillain-Barré Syndrome] following receipt of DT [tetanus] have been reported.” After examining two other cases, which the 1994 Institute of Medicine Report indicated did not include enough specific information to consider “the relation between tetanus toxoid, DT, or Td and the occurrence of GBS.” The 1994 Institute of Medicine Report continued:
However, because the ease by Pollard and Selby (1978) demonstrates that tetanus toxoid did cause GBS, in the committee’s judgment tetanus toxoid can cause GBS.
Conclusion
The evidence favors a causal relation between tetanus toxoid and GBS. If the evidence favors a causal relation between tetanus toxoid and GBS, then in the committee’s judgment the evidence favors a causal relation between vaccines containing tetanus toxoid (DT and Td) and GBS. Because the conclusions are not based on controlled studies, no estimate of incidence or relative risk is available. It would seem to be low.
(emphasis in original).
On July 30, 2012, Special Master Lord issued her decision on Petitioner’s case. As noted above, Special Master Lord dismissed Petitioner’s hepatitis A claim, finding that Petitioner had “effectively abandoned the allegation of causation by the Hep A vaccine” because, during the course of the hearing, Dr. Tornatore “did not opine that the Hep A vaccination caused Petitioner’s GBS.” Special Master Lord, therefore, focused on Petitioner’s tetanus vaccination claim. Special Master Lord stated that, in order to qualify for compensation, Petitioner had to prove causation of the tetanus vaccine and her Guillain-Barré Syndrome, “by a sound and reliable ‘medical or scientific explanation that pertains specifically to the petitioner’s case, although the explanation need only be “legally probable, not medically or scientifically certain.” ’ ” (quoting Moberly ex rel. Moberly v. Sec’y of Health & Human Servs.,
In arriving at her decision, Special Master Lord applied the three-prong causation analysis set forth in Althen v. Secretary of Health & Human Services,
Petitioner’s burden is to show 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 injury.”
(quoting Althen v. Sec’y of Health & Human Servs.,
Regarding to the first prong of the Althen test, “a medical theory causally connecting the vaccination and the injury,” Althen v. Sec’y of Health & Human Servs.,
Special Master Lord concluded that Dr. Tornatore had relied too heavily on the Pollard and Selby article as evidеnce of vaccine causation through challenge/rechallenge because the 2011 pre-publication Institute of Medicine Report “no longer characterized the individual reported on [in the earlier 1994 Institute of Medicine Report] as suffering from GBS, but from a reeurring/relapsing disorder called CIDP [Chronic Inflammatory Demyelinating Polyneuropathy].” She also noted that during the course of the proceedings, Special Master Lord introduced Court Exhibits 1 and 2 into evidence, and offered both parties an opportunity to respond: “Dr. Tornatore did not update his testimony when offered the opportunity to do so. By order dated September 23, 2011, the pertinent portion of the 2011 IOM [Institute of Medicine] report was entered into the record, without objection, and the parties were invited to comment on the new information. Dr. Tor-natore offered no supplementation of his report or his testimony, notwithstanding that the new IOM report indicated that his reliance on" Pollard and Selby to bolster his theory of causation in this case was misplaced.” (internal citation omitted).
Special Master Lord stated that she had relied on the 2011 pre-publication Institute of Medicine Report’s evaluation of the Pollard and Selby case only to find in Petitioner’s case that Dr. Tornatore’s report and testimony were “unreliable.” Special Master Lord further specified that she had not relied on the Report’s “non-conclusion” of Guillain-Barré Syndrome causation to reach her final conclusion. In a footnote, Special Master Lord stated:
This may be an appropriate point to note that Petitioner and her expert laid great emphasis on the conclusion from the 1994 IOM report of a causal link between Td and GBS. Now that the IOM has withdrawn its previous endorsement of a causal link, Petitioner urges that the IOM’s information should not be considered significant. I understand and appreciate the distinction between the proof that is required to establish entitlement to compensation in the Vaccine Program and the greater proof that may be required to satisfy the scientific community of vaccine injury causation, and I do not place undue reliance on the IOM’s causality conclusion (which is a non-conclusion, in any event). But I do rely on the IOM’s evaluation of the scientific significance of the Pollard and Selby report. That evaluation was undertaken and communicated to the public by a committee of scientific experts*756 assigned by law to evaluate scientific evidence. See Terran [ex rel. Terran v. Sec’y of Health & Human Servs.], 195 F.3d [1302,] 1313, 1315 [ (Fed.Cir.1999), cert. denied,531 U.S. 812 ,121 S.Ct. 45 ,148 L.Ed.2d 15 (2000) ] (noting that Congress “directed the Secretary to request that the Institute of Medicine of the National Academy of Sciences conduct studies exploring the link between childhood vaccines with certain illnesses”). The IOM’s latest evaluation of the significance of the Pollard and Selby report contradicts Dr. Torna-tore’s testimony at hearing. The argument that special masters should not rely on the opinion of the IOM concerning the significance of particular scientific evidence is unpersuasive.
(internal citations omitted).
In her decision, Special Master Lord stated “I am aware that in some earlier cases, GBS has been attributed to tetanus vaccination. See, e.g., Althen.”
Special Master Lord also found Dr. Torna-tore’s testimony unreliable because, relying on the process of molecular mimicry, he failed to link the tetanus vaccine and the Guillain-Barré Syndrome. Special Master Lord concluded that “[n]one of the medical literature submitted by Petitioner and her expert discusses molecular mimicry as a possible theory of causation linking Td vaccination and GBS.” (footnote omitted). Special Master Lord found that when Dr. Tornatore was asked to link the tetanus vaccination to Guillain-Barré Syndrome using the molecular mimicry theory, he, instead, switched to relying on the case history in 1978 Pollard and Selby article, and the multiple occurrences of Guillain-Barré Syndrome, the challenge/rechallenge, in the forty-two-year-old man described in that report after he received tetanus toxoid. The Special Master wrote:
Challenge/reehallenge in the Vaccine Program generally pertains to Prong 2 [of the Althen test], as it may furnish evidence that there was a logical chain of cause and effect linking vaccination to injury. In this ease, Dr. Tornatore testified that the case of challenge/reehallenge reported by Pollard and Selby supported his theory of molecular mimicry pertaining to Prong 1.1 agree in general that evidence that an injury did happen (even to someone other than the vaccinee) makes it more likely that it could happen. This is consistent with the principle established by the Federal Circuit that evidence adduced under one prong of the Althen test may be applied to satisfy the other prongs. See Capizzano v. Sec’y of Dep’t of Health & Human Servs.,440 F.3d 1317 , 1325-26 (Fed.Cir.2006). The problem, as discussed herein, is that it no longer appears that the Pollard and Selby case report represents a case of challenge/rechallenge.
(internal citations omitted).
In finding Dr. Tornatore’s testimony and expert report unreliable, Special Master Lord also noted that Dr. Tornatore failed to provide evidence to rebut Respondent’s “science-based evidence,” provided by Dr. Leist, and which countered Dr. Tornatore’s theory of causation. Special Master Lord indicated that “Dr. Leist pointed out that the medical literature Dr. Tornatore submitted involved a
Therefore, Special Master Lord concluded:
I find that Dr. Tornatore’s evidence is not sufficient to preponderate under Althen Prong 1. The theory that Td vaccination could cause GBS by molecular mimicry was effectively challenged by Respondent’s expert, without meaningful response. Seemingly unable to explain the basis for the theory of molecular’ mimicry as it might pertain to Td vaccination and GBS, Dr. Tornatore relied instead on the concept of ehallenge/reehallenge. That phenomenon, with respect to Td vaccination and GBS, no longer is accepted by scientific experts as a link between Td and GBS, as Dr. Leist indicated at hearing, and as was shortly thereafter confirmed by the IOM.
Finally, Special Master Lord found Dr. Tornatore’s expert report and testimony in Petitioner’s case unreliable because he relied on Dr. Winkelmann’s admission note to show causation. Dr. Winkelmann’s October 13, 2005 admission note to Methodist Rehabilitation Center stated: “It was felt that immunization series had been the trigger for the development of the Guillain-Barré.” (emphasis added). Special Master Lord explained that given Dr. Winkelmann’s specialty as a physiatrist, not a neurologist or an immunologist, “it seems odd that Dr. Tornatore would consider Dr. Winkelmann’s opinion of vaccine causation ‘important.’ ” As a physiatrist, Dr. Winkelmann is a specialist in the branch of medicine that deals with rehabilitation, “using physical agents such as light, heat, cold, water, electricity, therapeutic exercise, and mechanical apparatus, and sometimes pharmaceutical agents.’” (quoting Dorland’s Illustrated Medical Dictionary 1443). Special Master Lord also noted that Dr. Winkelmann was not Petitioner’s treating physician when she fell ill. Special Master Lord noted that, “[i]t would appear that at the time he [Dr. Winkelmann] made the statement on which Dr. Tornatore places importance, which was the time of Petitioner’s admission to the rehab facility, Dr. Winkelmann had not yet had a treating relationship with the Petitioner,” and “Dr. Winkelmann treated Petitioner only after this ‘important’ note concerning the cause of Petitioner’s condition was сreated.” (emphasis in original).
Special Master Lord concluded that Dr. Tornatore had improperly relied “on an isolated, ambiguous statement by a Physiatrist,” Dr. Winkelmann. Moreover, Special Master Lord also questioned Dr. Tornatore’s reliability based on his speculation that Dr. Winkel-mann examined the Petitioner’s medical history prior to wilting the note, when “this assumption is not based upon any evidence of record.” (footnote omitted). As indicated above, Special Master Lord found that Petitioner had failed to prove the first prong of the Althen test, demonstrating “a medical theory causally connecting the vaccination and the injury.” Althen v. Sec’y of Health & Human Servs.,
“[T]o provide additional context,” to her decision, Special Master Lord also examined the second prong of Althen, “a logical sequence of cause and effect showing that the vaccination was the reason for the injury.” Althen v. Sec’y of Health & Human Servs.,
Turning to the third prong of the Althen test, “a showing of a proximate temporal relationship between vaccination and injury,” Althen v. Sec’y of Health & Human Servs.,
Before this court, Petitioner objects to the decision of Special Master Lord on three grounds. First, Petitioner contends that Special Master Lord abused her discretion by arbitrarily and capriciously mischaracter-izing Dr. Tornatore’s testimony as “predomi-natly [sic] reliant” on the 1994 Institute of Medicine Report. Petitioner argues that Dr. Tornatore only briefly mentioned the 1994 Institute of Medicine Report once in his expert report, and only referred to the 1994 Institute of Medicine Report three times during his testimony. Petitioner alleges that Dr. Tornatore showed a plausible theory of causation between the Petitioner and the tetanus vaccine even by relying on three of the articles referred to in his expert report, namely, R. Lahesmaa et al., Molecular Mim-ickry between HLA B27 and Yersinia, Salmonella, Shigella and Klebsiella within the Same Region of HLA á\-helix, Clin. Exp. Immunol. 1991, vol. 86, Tomoko Komagamine and Nobuhiro Yuki, Ganglioside Mimicry as a Cause of Guillawr-Barré Syndrome, CNS & Neurological Disorder - Drug Targets, 2006, vol. 5, and Lawrence B. Schonberger et al, Guillainr-Barre Syndrome following Vaccination in the National Influenza Immunization Program, United States, 1976-1977, 110 Am. J. Epidemiology 105.
Second, Petitioner claims that Special Master Lord abused her discretion by finding that the Institute of Medicine reversed its position on causation from the 1994 Report to the 2011 pre-publication Report, and then used this allegedly mistaken belief that the Institute of Medicine had reversed its position as a reason to find Dr. Tornatore’s testimony unreliable. Petitioner argues that the 2011 pre-publication Institute of Medicine Report never reversed its position from the previous 1994 version of the Institute of Medicine Report conclusion that, “[t]he evidence favoi'S a causal relationship between tetanus toxoid and GBS.” Rather, according to Petitioner, the 2011 pre-publication Institute of Medicine Report took a neutral stance
Moreover, Petitioner alleges that Dr. Tornatore did not rely on the 1994 Institute of Medicine Report to prove his plausible theory of causation. Rather, according to Petitioner, to conclude that the tetanus vaccination caused Petitioner’s Guillain-Barré Syndrome, Dr. Tornatore relied on the specific facts of Petitioner’s case, the absence of another cause, and the three articles discussed in his expert report: R. Lahesmaa et al., Molecular Mimickry between HLA B27 and Yersinia, Salmonella, Shigellaand Klebsiella within the Same Region of HLA -helix, Clin. Exp. Immunol., 1991, vol. 86, Tomoko Komagamine and Nobuhiro Yuki, Ganglioside Mimicry as a Cause of Guil-lain-Barré Syndrome, CNS & Neurological Disorder — Drug Targets, 2006, vol. 5, and Lawrence B. Sehonberger et al., Guillain-Barre Syndrome following Vaccination in the National Influenza Immunization Program, United States, 1976-1977, 110 Am. J. Epidemiology 105. Petitioner also alleges that Dr. Tornatore explained how molecular mimicry causes Guillain-Barré Syndrome in his testimony.
Third, Petitioner alleges that “[rjejecting an expert’s opinion based on whether his theory of causation is supported by the weight of epidemiological evidence is an erroneous legal standard.” (emphasis in original). Petitioner quotes from the Federal Circuit’s decision in Andreu ex rel. Andreu v. Secretary of Department of Health & Human Services,
In the instant matter the Special Master repeatedly denigrates Dr. Tornatore’s testimony due to what is characterized as a “lack of reliability,” in particular because the articles he submitted may nоt say that a causal relationship to a degree of scientific certainty has been established, or because articles they have submitted indicate either that there is not enough evidence or that there is no association, and most significantly that the 2011 IOM report that the Court submitted “reversed” its position on causation between the Td vaccination and GBS.
Petitioner also contends that, “[djespite the Federal Circuit’s clear directive that Petitioners are not required to submit literature, the standard of scientific certainty in
Epidemiology cannot be used to disprove causation. Yet, the Special Master used the ambivalent conclusions of the 2011 IOM report to attack Dr. Tornatore, and to hold that since his theories are not generally accepted in the medical community, they are not “reliable.” This argument was also in front of the Federal Circuit in Althen in the guise of Prong 2 of Stevens . This argument was also explicitly rejected by the Circuit as contrary to law and imposing an impermissible burden of proof on Mrs. Althen. By requiring this objective confirmation the Special Master in Althen acted contrary to law.
(emphasis in original).
Petitioner argues that Special Master Lord erroneously changed the legal standard by requiring Dr. Tornatore to rebut Dr. Leist’s testimony with objective medical theories in order to be found credible. Petitioner also takes issues with Special Master Lord’s finding that Dr. Tornatore’s “‘reliance’ on the statements of Dr. Winkelmann in LaKeysha’s contemporaneous medical records is ‘misplaced.’ Dr. Tornatore did find it important that Dr. Winkelmann related the Td vaccination to LaKeysha’s GBS. He never testified that it was necessary for his opinion.” (emphasis in original). Petitioner, therefore, moves for this court to set aside Special Master Lord’s decision, to enter a decision in her favor, and to remand her case for a determination of damages.
In response, Respondent asks the court to dismiss Petitioner’s Motion for Review. According to Respondent, “Petitioner has not shown that the special master’s determination was arbitrary, capricious, or an abuse of discretion. Thus, she has not established reversible error, and the special master’s decision must be affirmed.” First, Respondent argues that Special Master Lord did not mischaraeterize Dr. Tornatore’s reliance on the 1994 Institute of Medicine Report when he tried to establish causation. Rather, Respondent emphasizes:
Dr. Tornatore relied upon the 1994 IOM report and its prior endorsement of Pollard & Selby as the linchpin to support his conclusion that tetanus-toxoid containing vaccines can cause GBS. He offered no other evidence to support this assertion (including his own knowledge of Td vaccine, his experience with other GBS cases, or other case reports, studies, or medical literature), and otherwisе failed to explain the putative link between Td vaccine and GBS (whether by molecular mimicry or otherwise) when offered the opportunity to do so at the hearing and thereafter,
(internal citations and footnote omitted).
Respondent continues: “Indeed, the special master acknowledged that, if she were to have found that Dr. Tornatore’s testimony supplied preponderant reliable evidence of a causal connection between Td vaccine and GBS, she would have held that petitioner satisfied Althen prong 1, ‘notwithstanding the lack of supporting evidence elsewhere in the record.’ ” Therefore, Respondent argues that Special Master Lord was warranted in finding Dr. Tornatore’s expert report and testimony unreliable because he depended on the 1994 Institute of Medicine Report to support his theory, and based his theory in such general terms, that it “ ‘seemed to be that any vaccine can cause any demyelinating disorder.’” Respondent also argues that “[th]e special master found Dr. Tornatore’s inability to independently express or explain the concept of molecular mimicry in the context of Td vaccine as illustrative of the tenuous and circular nature of his opinion in this case.”
According to Respondent, although Special Master Lord used the Institute of Medicine Report to explain inconsistencies in Dr. Tor-natore’s theory, she never concluded that the Institute of Medicine had reversed its position from their 1994 Report to the 2011 pre-publication version of the Report. Respondent contends, “the special master was careful to articulate that her discussion of the 2011 IOM report [2011 prepublieation Institute of Medicine Report] was to explain the contradiction between Dr. Tornatore’s reliance on Pollard & Selby at the hearing, and the IOM’s re-evaluation of the ‘significance’ of that evidence — not to raise the bar of what is required to establish compensation under
[T]he special master acknowledged that “the standard of proof to demonstrate causation in the scientific community requires more and different evidence than is required in the Vaccine Program.” Thus, she did not simply adopt the IOM’s new findings, or find that “the absence of evidence” is “evidence of absence,” as petitioner contends. Rather, the special master was careful to articulate that her discussion of the 2011 IOM report was to explain the contradiction between Dr. Tornatore’s reliance on Pollard & Selby at the hearing, and the IOM’s re-evaluation of the “significance” of that evidence — not to raise the bar of what is required to establish compensation under the Act to the scientific standard.
(internal citations omitted).
Accordingly, Respondent argues Special Master Lord did not use epidemiology studies to establish credibility between the expert witnesses, but instead found Dr. Tornatore’s testimony unreliable because it was “essentially unsupported by other evidence in the record.” Respondent notes that, although Petitioner argues that it was “absolutely appropriate” that Dr. Tornatore relied “on other evidence in reaching his conclusion that the Td vaccine caused her GBS, including that the timeframe between vaccination and the onset of symptoms,” and that testing ruled out other causes, “it is well settled that ‘neither a mere showing of a proximate temporal relationship between vaccine and injury, nor a simplistic elimination of other potential causes of the injury suffices, without more, to meet the burden of showing actual causation.’ ” (quoting Moberly ex rel. Moberly v. Sec’y of Health & Human Servs.,
Furthermore, the Respondent points out that Special Master Lord concluded that Dr. Tornatore’s entire testimony was filled with “ ‘apparent contradictions, gaps, vagueness and illogic.’ ” Respondent contends that for numerous reasons, Special Master Lord properly did not find Dr. Tornatore’s expert report and testimony in Petitioner’s case reliable, and more heavily relied on Dr. Leist’s expert report and testimony, when she held that Petitioner failed to meet her burden of proof. Accordingly, Respondent requests that this court deny Petitioner’s Motion for Review, and dismiss her petition for compensation.
DISCUSSION
When reviewing a Special Master’s decision, the assigned Judge of the United States Court of Federal Claims shall:
(A) uphold the findings of fact and conclusions of law of the special master and sustain the special master’s decision,
(B) set aside any findings of fact or conclusions of law of the special master found to be arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law and issue its own findings of fact and conclusions of law, or
(C) remand the petition to the special master for further action in accordance with the court’s direction.
42 U.S.C. § 300aa-12(e)(2); see also Vaccine Rule 27. The legislative history of the Vaccine Act states: “The conferees have provided for a limited standard for appeal from the [special] master’s decision and do not intend that this procedure be used frequently, but rather in those eases in which a truly arbitrary decision has been made.” H.R.Rep. No. 101-386, at 517 (1989) (Conf.Rep.), reprinted in 1989 U.S.C.C.A.N. 3018, 3120.
In order to recover under the Vaccine Act, a petitioner must prove that the vaccine caused the purported injury. See Hibbard v. Sec’y of Health & Human Servs.,
As recently noted by the United States Court of Appeals for the Federal Circuit:
The role of appellate review of a special master’s decision under the arbitrary and capricious standard “is not to second guess the Special Master’s fact-intensive conclusions; the standard of review is uniquely deferential for what is essentially a judicial process.” Locane v. Sec’y of Health & Human Servs.,685 F.3d 1375 , 1380 (Fed.Cir.2012), quoting Hodges v. Sec’y of Health & Human Servs.,9 F.3d 958 , 961 (Fed.Cir.1993); Doe v. Sec’y of Health & Human Servs.,601 F.3d 1349 , 1355 (Fed.Cir.2010)[, cert. denied, — U.S.-,131 S.Ct. 573 ,178 L.Ed.2d 414 (2010) ]. If the special master’s conclusion is “based on evidence in the record that [is] not wholly implausible, we are compelled to uphold that finding as not being arbitrary and capricious.” Cedillo v. Sec’y of Health & Human Servs.,617 F.3d 1328 , 1338 (Fed.Cir.2010), quoting Lampe v. Sec’y of Health & Human Servs.,219 F.3d 1357 , 1360 (Fed.Cir.2000). Put another way, if the special master “has considered the relevant evidence of record, drawn plausible inferences and articulated a rational basis for the decision, reversible error will be extremely difficult to demonstrate.” Hines [ex rel. Sevier] v. Sec’y of the Dep’t of Health & Human Servs.,940 F.2d 1518 , 1528 (Fed.Cir.1991).
Hibbard v. Sec’y of Health & Human Servs.,
These standards vary in application as well as degree of deference. Each standard applies to a different aspect of the judgment. Fact findings are reviewed by us, as by the Claims Court judge, under the arbitrary and capricious standard; legal questions under the “not in accordance with law” standard; and discretionary rulings under the abuse of discretion standard. The latter will rarely come into play except where the special master excludes evidence.
Munn v. Sec’y of Health & Human Servs.,
As indicated by the Federal Circuit in Althen v. Secretary of Health & Human Services:
The [Vaccine] Act provides for the establishment of causation in one of two ways: through a statutorily-prescribed presumption of causation upon a showing that the injury falls under the Vaccine Injury Table (“Table injury”), see 42 U.S.C. § 300aa-14(a); or where the complained-of injury is not listed in the Vaccine Injury Table (“off-Table injury”), by proving causation in fact, see 42 U.S.C. §§ 300aa-13(a)(l), -ll(c)(l)(C)(ii)(I).
Althen v. Sec’y of Health & Human Servs.,
Petitioner claims that, as a result of the tetanus vaccine she received in 2005, she developed Guillain-Barré Syndrome, which is not listed as an injury on the Vaccine Table. See 42 U.S.C. § 300aa-14. Under the off-Table theory of recovery, a petitioner is entitled to compensation if she can demonstrate, by a preponderance of the evidence, see 42 U.S.C. § 300aa-13(a)(l)(A), that the recipient of the vaccine sustained, or had significantly aggravated, an illness, disability, injury, or condition not set forth in the Vaccine Injury Table but which was caused by a vaccine that is listed on the Vaccine Injury Table. 42 U.S.C. § 300aa-11(c)(1)(C)(ii)(I); see also Althen v. Sec’y of Health & Human Servs.,
Since Petitioner’s condition does not meet the requirements of a presumptively on-Table, vaccine-related condition, to prove entitlement for an off-Table injury, petitioner must
prove causation-in-fact. Grant [v. Sec’y of Health & Human Servs.], 956 F.2d [1144,] 1147-48 [(Fed.Cir.1992)]. [The United States Court of Appeals for the Federal Circuit has] held that causation-in-fact in the Vaccine Act context is the same as the “legal cause” in the general torts context. Shyface v. Sec’y of Health and Human Servs.,165 F.3d 1344 , 1352 (Fed.Cir.1999). Therefore, drawing from the Restatement (Second) of Torts, the vaccine is a cause-in-faet when it is “a substantial factor in bringing about the harm.”
de Bazan v. Sec’y of Health & Human Servs.,
The petitioner must prove her ease by a preponderance of the evidence. See 42 U.S.C. § 300aa-13(a)(l)(A). According to the United States Court of Appeals for the Federal Circuit, the preponderance of evidence standard is “one of proof by a simple preponderance, of ‘more probable than not causation.’ ” Althen v. Sec’y of Health & Human Servs.,
The court in Althen defined a three-prong test which a petitioner must meet to establish causation in an off-Table injury case:
To meet the preponderance standard, [petitioner] must “show a medical theory causally connecting the vaccination and the injury.” Grant v. Sec’y of Health & Human Servs.,956 F.2d 1144 , 1148 (Fed.Cir.1992) (citations omitted). A persuasive medical theory is demonstrated by “proof of a logical sequence of cause and effect showing that the vaccination was the reason for the injury[,]” the logical sequence being supported by “reputable medical or scientific explanation[,]” i.e., “evidence in the form of scientific studies or expert medical testimony[.]” Grant,956 F.2d at 1148 . [Petitioner] may recover if she shows “that the vaccine was not only a but-for cause of the injury but also a substantial factor in bringing about the injury.” Shyface,165 F.3d at 1352-53 . Although probative, neither a mere showing of a proximate temporal relationship between vaccination and injury, nor a simplistic elimination of other potential causes of the injury suffices, without more, to meet the burden of showing actual causation. See Grant,956 F.2d at 1149 . Concisely stated, [petitioner’s] burden is to show by preponderant evidence that the vaccination brought about [the] 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 injury.
Althen v. Sec’y of Health & Human Servs.,
With regard to the first Althen prong, “a medical theory causally connecting the vaccination and the injury,” Althen v. Sec’y of Health & Human Servs.,
[t]he Court of Federal Claims is therefore not to be seen as a vehicle for ascertaining precisely how and why DTP and other vaccines sometimes destroy the health and lives of certain children while safely immunizing most others. This research is for scientists, engineers, and doctors working in hospitals, laboratories, medical institutes, pharmaceutical companies, and government agencies. The special masters are not “diagnosing” vaccine-related injuries. The sole issues for the special master áre, based on the record evidence as a whole and the totality of the ease, whether it has been shown by a preponderance of the evidence that a vaccine caused the [petitioner’s] injury or that the [petitioner’s] injury is a table injury, and whether it has not been shown by a preponderance of the evidence that a factor unrelated to the vaccine caused the child’s injury. See 42 U.S.C. § 300aa-13(a)(l), (b)(1).
Knudsen ex rel. Knudsen v. Sec’y of Health & Human Servs.,
Although a finding of causation “must be supported by a sound and reliable medical or scientific explanation,” causation “can be found in vaccine eases ... without detailed medical and scientific exposition on the biological mechanisms.” Knudsen v. Sec’y of the Dep’t of Health & Human Servs.,35 F.3d 543 , 548-49 (Fed.Cir.1994). It is not necessary for a petitioner to point to conclusive evidence in the medical literature linking a vaccine to the petitioner’s injury, as long as the petitioner can show by a preponderance of the evidence that there is a causal relationship between the vaccine and the injury, whatever the details of the mechanism may be.
Simanski v. Sec’y of Health & Human Servs.,
The second prong of the Althen test requires the petitioner to demonstrate “a logical sequence of cause and effect, showing that the vaccination was the reason for the injury” by a preponderance of the evidence. Althen v. Sec’y of Health & Human Servs.,
The third prong of the Althen test requires the petitioner to demonstrate, by a preponderance of evidence, “a proximate temporal relationship between vaccination and injury.” Althen v. Sec’y of Health & Human Servs.,
[i]f, for example, symptoms normally first occur ten days after inoculation but petitioner’s symptoms first occur several weeks after inoculation, then it is doubtful the vaccination is to blame. In contrast, if symptoms normally first occur ten days after inoculation and petitioner’s symptoms do, in fact, occur within this period, then the likelihood increases that the vaccination is at least a factor. Strong temporal evidence is even more important in cases involving contemporaneous events other than the vaccination, because the presence of multiple potential causative agents makes it difficult to attribute “but-for” causation to the vaccination. After all, credible medical expertise may postulate that any of the other contemporaneous events may have been the sole cause of the injury.
Id. at 1358.
According to the court in Capizzano v. Secretary of Health & Human Services, evidence used to satisfy one of the Althen prongs may overlap with and be used to satisfy another prong. Capizzano v. Sec’y of Health & Human Servs.,
At oral argument, Petitioner stated that “even if there had never been a Pollard and Selby article, even if there had never been a 1994 [Institute of Medicine] report, this case would be on all fours with the Althen decision.” As noted above, the Federal Circuit in Althen defined the three-prong test by which a petitioner must meet to establish causation in an off-Table injury case. Although Petitioner in this ease has claimed, on multiple occasions, that Petitioner’s case was “on all fours” with the Federal Circuit’s decision in Althen, as Respondent correctly observes, “Althen’s a different case. It’s a different injury. It’s a different medical presentation, a different clinical presentation, just different evidence, different expert.”
In Althen, the petitioner, a forty-nine-year-old woman with pre-existing diagnoses of hypothyroidism and Duane’s Syndrome,
The United States Court of Federal Claims reversed, concluding that Ms. Althen had proven causation in fact under the preponderant evidence standard set forth in the Vaccine Act, and the Federal Circuit affirmed the Court of Federal Claims decision. Aside from the fact that the petitioner in Althen and the current petitioner are both female, and that both received tetanus toxoid and hepatitis A vaccinations, it is difficult to draw many other comparisons between the two cases. A footnote to the original Althen decision by the Special Master did note that Dr. Smith referenced the “IOM’s 1994 findings of a probable causal relation between tetanus toxoid and two injuries, brachial neuritis and acute inflammatory demyelinating polyradiculoneuropathy, also known as Guil-lain-Barre Syndrome.” Althen v. Sec’y of Health & Human Servs.,
Moreover, the discussion in Althen was focused on the Special Master’s use of the test from Stevens v. Secretary of Health & Human Services,
The disputed Stevens test requires that a claimant provide proof of: (1) medical plausibility; (2) confirmation of medical plausibility from the medical community and literature; (3) an injury recognized by the medical plausibility evidence and literature; (4) a medieally-aeceptable temporal relationship between the vaccination and the onset of the alleged injury; and (5) the elimination of other causes.
Althen v. Sec’y of Health & Human Servs.,
Petitioner alleges that she has met her burden of proving by a preponderance of the evidence that the tetanus vaccina
Petitioner argues that “Special Master Lord arbitrarily and capriciously mischarac-terized Dr. Tornatore’s testimony as being predominantly reliant upon findings of the [1994 Report issued by the] Institute of Medicine.” Petitioner claims that Special Master Lord “then abused her discretion by finding that the IOM had reversed its position on causation related to the Td vaccine and GBS when, in fact, the IOM’s finding was that ‘the evidence is inadequate to accept or reject a causal relationship.’ This abuse of discretion led directly to the Special Master requiring Lakeysha to prove an elevated evidentiary burden expressly rejected in Althen v. HHS,
In his expert report, Dr. Tornatore concluded that, “[i]t is my opinion, to a reasonable degree of medical certainty, that the vaccinations of September 15, 2005, specifically the tetanus vaccination, resulted in the development of Ms. Isaac’s inflammatory
Special Master Lord determined in her decision that in Petitioner’s case, “none of the medical records support molecular mimicry or any other theory of possible vaccine causation. Petitioner’s case therefore rests on the reliability of her [Petitioner’s] expert’s conclusion.” Special Master Lord noted in a footnote that “Petitioner’s expert’s theory seemed to be that any vaccine can cause any demyelinating disorder. Accordingly, Petitioner submitted evidence of data derived from the 1970s swine flu vaccination campaign to show that that flu vaccination can cause GBS. I find no reliable evidence in this material supporting a broad hypothesis causally linking any and all vaccinations with any and every demyelinating disorder.” (internal citation omitted).
After reviewing the expert testimony offered by Dr. Tornatore, the Special Master found it insufficient to support Petitioner’s claim to compensation. Petitioner argues that Special Master Lord’s miseharacterization of Dr. Tornatore’s expert testimony was overly reliant on the 1994 Institute of Medicine Report and that her decision was arbitrary and capricious. Petitioner alleges that Dr. Tornatore demonstrated a plausible theory of causation between the Petitioner’s Guil-lain-Barré Syndrome and the tetanus vaccine by relying on three articles he submitted in addition to the Pollard and Selby article. Petitioner also argues that Dr. Tornatore did not overly rely on the 1994 Institute of Medicine Report because he briefly mentioned it only once during his expert report, and referred to the 1994 Institute of Medicine Report only three times during his testimony, “the last two in the same-answer to a single question.” Of the four academic articles provided in his expert report, Dr. Tornatore relied on the Pollard and Selby article and the Sehonberger et al. article for support that Tetanus is a vaccine “resulting in inflammatory demyelinating polyneuropathies.” In his expert report, however, Dr. Tornatore continued: “Indeed, the Institute of Medicine has recognized that tetanus vaccination can be a cause of Guillain-Barre based on the article by Pollard and Selby,” without mentioning the Sehonberger et al. article, or any other article. In addition, the 1978 Pollard and Selby article is the article on which Dr. Tornatore most extensively relied on during his testimony at the June 27, 2010 hearing.
The other three articles in Dr. Tornatore’s expert report were: R. Lahesmaa et al., Molecular Mimickry between HLA B27 and Yersinia, Salmonella, Shigella and Klebsiel-la within the Same Region of HLA ai-helix, Tomoko Komagamine and Nobuhiro Yuki, Ganglioside Mimicry as a Cause of Guil-lain-Barré Syndrome, and Lawrence B. Sehonberger et al., Guillain-Barre Syn-dromefollowing Vaccination in the National Influenza Immunization Program, United States, 1976-1977. These three other articles were used by Dr. Tornatore generally to explain molecular mimicry, how molecular mimicry applies in the general context of Guillain-Barré, and how various vaccines cause molecular mimicry. The entire sum of Dr. Tornatore’s reliance on the article titled Molecular Mimickry between HLA B27 and Yersinia, Salmonella, Shigella and Klebsiel-la within the Same Region of HLA ai-helix, was the general statement in his expert report that “[t]he concept that viral or bacterial antigens share homology with host antigens, also known as molecular mimicry, is a well established concept in immunology.” At the July 27, 2010 hearing, the extent of Dr. Tor-natore’s testimony on the same article was limited to the statement that “this is a paper that was trying to find similarities between those microorganisms and a protein called HLAB27, it’s an immune protein.” Additionally, under cross-examination, Dr. Toratore explained that although the article he submitted by Tomoko Komagamine and Nobuhi-ro Yuki, Ganglioside Mimicry as a Cause of Guillairtr-Barré Syndrome referenced C. je-juni. Dr. Toratore stated the article “was just submitted as, you know, the concept that you can have, just to support the argument that molecular mimicry can be a pathogenetic mechanism in Guillain-Barré. It was not
Schonberger article really was to demonstrate the kinetics of the onset of the Guil-lain-Barré following a vaccination. It’s a large number of patients and so it’s our best example of what one might expect as far as timing goes. But in that article the peak time of Guillain-Barré following vaccination was approximately two weeks, and that’s about the time frame for the Pollard and Selby article, and in this case is approximately two weeks from when the vaccination occurred to when really the first manifestations of Guillain-Barré happened, so everything kind of fits together.
Dr. Tornatore also used the Pollard and Selby article to develop his theory on ehal-lenge/rechallenge and specificity. At the July 27, 2010 hearing Dr. Tornatore testified that “the Pollard and Selby article, although they did not speak to molecular mimicry spoke more to the idea that there is some specificity to this in that somebody who was rechallenged with the same protein developed the same problem on three different occasions, and so that that antigenic stimulus was recognized as the inciting factor for causing the Guillain-Barré. And in the early ‘90s the Institute of Medicine recognized that concept of challenge rechallenge as a valid biological model for looking at this idea.”
Additionally, Dr. Tornatore used the 1994 Institute of Medicine report to bolster his reliance on the Pollard and Selby article, and the 1994 Institute of Medicine Report to indicate that the Institute of Medicine approved of his theory of causation, reasoning that, “[i]ndeed, the Institute of Medicine has recognized that tetanus vaccination can be a cause of Guillain-Barré based on the article of Pollard and Selby.” Dr. Tornatore stated at the July 27, 2010 hearing:
Because you have the Pollard and Selby article where you had the positive rechal-lenge. And so all you need to know is that it’s the vaccine itself. The individual components it would be nice to know what those are specifically. However, that is for this case, that specificity is not required. The only specificity is that there was a challenge and positive rechallenge case, the Pollard and Selby ease, that the Institute of Medicine said, you don’t need to know the absolute molecular component.
Dr. Tornatore further explained that a lack of subsequent studies relating to Guillain-Barré Syndrome and tetanus vaccinations were explained by the fact that “the Institute of Medicine has spoken to this.” Dr. Torna-tore continued: “Science is sсience. That’s a very interesting case. If it happened and you have a patient that demonstrates a very peculiar process you don’t discard it just because, oh that happened some time ago. What difference does that make?”
Special Master Lord’s conclusion that Dr. Tornatore “described the Pollard and Selby report as a ease of GBS caused by tetanus vaccination and indicated that the IOM recognized it as such” was not a mischaracteri-zation of the testimony of Dr. Tornatore, offered in his expert report and at the hearing. As noted by the Respondent, “Dr. Tor-natore relied upon the 1994 IOM report and its prior endorsement of Pollard & Selby as the linchpin to support his conclusion that tetanus-toxoid containing vaccines can cause GBS. He offered no other evidence to support this assertion (including his own knowledge of Td vaccine, his experience with other GBS eases, or other case reports, studies, or
After the July 27, 2010 hearing Special Master Lord took note of the 2011 prepub-lieation Institute of Medicine Report, which called into question the conclusions of the 1994 Institute of Medicine Report, and introduced two excerpts into the record as Court Exhibit 1 and Court Exhibit 2, on September 23,2011 and May 24, 2012, respectively. The Special Master gave both parties an opportunity to address each of the excerpts. In her decision, Special Master Lord noted that, “[b]y order dated September 23, 2011, the pertinent portion of the 2011 IOM report was entered into the record, without objection, and the parties were invited to comment on the new information,” and “[o]n May 24, 2012, the parties were invited to comment on and file responses to Court Exhibit 2, the excerpt from the 2011 IOM report on the theory of molecular mimicry.”
As indicated by a Judge of the United States Court of Federal Claims, “a special master must act on the record after adequate notice.” Davis v. Sec’y of Health & Human Servs.,
The requirement to decide on the record is specifically stated in 42 U.S.C. § 300aa-13(a)(1), which provides in pertinent part that “[compensation shall be awarded under the Program to a petitioner if the special master or court finds on the record as a whole [that the petitioner is entitled to relief].” See also 42 U.S.C. § 300aa-13(e) (defining “record”); RCFC Appendix B, Rule 8(b)(1) (requiring the special master to consider “all relevant and reliable evidence”). The correlative requirement that a special master provide adequate notice to the parties of evidentiary issues and matters stems from 42 U.S.C. § 300aa-12(d)(3)(B)(iv), (v) (a special master “shall afford all interested persons an opportunity to submit relevant written information” and “may conduct such hearings as may be reasonable and necessary”), as well as RCFC Appendix B, Rule 8(b)(1) (a “[special master ... must consider all relevant and reliable evidence governed by principles of fundamental fairness to both parties”).
Davis v. Sec’y of Health & Human Servs.,
Generally, as to the use of an Institute of Medicine Report, a Judge of the United States Court of Federal Claims appropriately wrote:
The Institute of Medicine (IOM), a branch of the National Academy of Sciences, was charged by the Vaccine Act with reviewing medical and scientific literature on risks associated with certain vaccines covered by the Act. See Watson v. Sec’y of Health & Human Servs., No. 96-639V,2001 WL 1682537 , at *5 n. 11 (Fed.Cl.Spec.Mstr. Dec. 18, 2001). Special masters “frequently rely” on the IOM’s 1994 report, Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality, (1994 IOM Report) “as a sound source for answering difficult issues of medical plausibility and causation.” Althen,2003 WL 21439669 , at *11 n. 28. “Due to the IOM’s statutory charge, the scope of its review, and the cross-section of experts making up the committee reviewing the adverse events associated with vaccines, the court*772 considers their determinations authoritative and subject to great deference.” Id.
Kelley v. Sec’y of Health & Human Servs.,
The 2011 pre-publication excerpts from the Institute of Medicine Report backed off from the 1994 Institute of Medicine Report’s earlier conclusion of a link between the tetanus vaccine and Guillain-Barré Syndrome and concluded that “[t]he evidence is inadequate to accept or reject a causal relationship between diphtheria toxoid-, tetanus toxoid-, or acellular pertussis-containing vaccines and GBS.” (internal citations omitted). The 2011 pre-publication Institute of Medicine Report reached this result because of changing views on the Pollard and Selby article. Regarding the Pollard and Selby article, Special Master Lord repeated that the man studied in the “Pollard and Selby report no longer is rеgarded by the IOM as evidence of vaccine causation,” because he was ‘“subsequently diagnosed with a spontaneously relapsing remitting neuropathy and experienced episodes in association with acute viral infections.’” Therefore, it was appropriate for Special Master Lord to conclude that the “IOM no longer characterized the individual reported on as suffering from GBS, but from a reeurring/relapsing disorder called CIDP [Chronic Inflammatory De-myelinating Polyneuropathy].” In addition, referring to the concept of challenge/reehal-lenge, from the Pollard and Selby article, which was relied upon by Dr. Tornatore, Special Master Lord noted that challenge/rechallenge “may furnish evidence that there was a logical chain of cause and effect linking vaccination to injury,” but, “[i]n this case, Dr. Tornatore testified that the case of challenge/reehallenge reported by Pollard and Selby supported his theory of molecular mimicry pertaining to Prong 1 [of the Althen test].” Special Master Lord correctly recognized that: “The problem, as discussed herein, is that it no longer appears that the Pollard and Selby ease report represents a case of challenge/rechal-lenge.” Moreover, Special Master Lord found that the individual studied in the Pollard and Selby article “was not linked with ‘specificity’ to [the tetanus] vaccination” because the Institute of Medicine established that his “relapsing/remitting neuropathies had only ‘a temporal relationship with vaccine administration.’ ”
Unlike the 1994 Institute of Medicine Report, the Guillain-Barré Syndrome section of the 2011 pre-publication Institute of Medicine Report does not include any mention of the Pollard and Selby article. Rather, the only mention of the Pollard and Selby article falls in the Chronic Inflammatory Disseminated Polyneuropathy section of the 2011 pre-publication Institute of Medicine Report. That section includes a conclusion that the Pollard and Selby article “did not provide evidence beyond a temporal relationship between administration of the vaccine and development of symptoms after vaccination.” Special Master Lord stated in a footnote to her decision that she did “not place undue reliance on the IOM’s causality conclusion (which is a non-conclusion, in any event).” In the same footnote, Special Master Lord explained:
This may be an appropriate point to note that Petitioner and her expert laid great emphasis on the conclusion from the 1994 IOM report of a causal link between Td and GBS.... Now that the IOM has withdrawn its previous endorsement of a causal link, Petitioner urges that the IOM’s information should not be considered significant_ I understand and appreciate the distinction between the proof that is required to establish entitlеment to compensation in the Vaccine Program and the greater proof that may be required to satisfy the scientific community of vaccine injury causation, and I do not place undue reliance on the IOM’s causality conclusion (which is a non-conclusion, in any event). But I do rely on the IOM’s evaluation of the scientific significance of the Pollard and Selby report. That evaluation was undertaken and communicated to the public by a committee of scientific experts assigned by law to evaluate scientific evidence.
Special Master Lord also specifically noted that, “I agree that the standard of proof to demonstrate causation in the scientific community requires more and different evidence
As noted above, Dr. Tornatore has testified extensively for petitioners in vaccine cases. His conclusions have been rejected, but he also has been an expert in several notable eases in which petitioners were deemed entitled to compensation based on the facts of those particular cases. The United States Court of Appeals for the Federal Circuit, sustaining a Court of Federal Claims decision, reversing a special master’s decision which сriticized Dr. Tornatore, observed: “As the Court of Federal Claims correctly recognized, [Doctor] Tornatore has ‘excellent medical credentials.’ ... He is director of the residency program in the neurology department at Georgetown University, has done research at the National Institutes of Health on the toxic effect of bacterial and viral products on cells, and is an expert in the pathogenesis of brain injury.” Andreu ex rel. Andreu v. Sec’y of Health & Human Servs.,
In the ease currently before this court, Petitioner claims that “[a]s is becoming painfully expected in the Vaccine Program the Special Master ultimately reduced her decision to a comparison of experts, specifically the reliability of experts. As noted above she favored Dr. Leist’s ‘science-based’ testimony over Dr. Tornatore’s ‘advocacy.’ ” (emphasis in original). In a footnote, Petitioner quotes from a footnote in Special Master Lord’s decision, in which Special Master Lord indicated that Dr. Tornatore “ ‘appeared to be more of an advocate than an objective expert.... To the extent that Dr. Tornatore’s opinion appears to be that of a partisan rather than an objective expert, his opinion carries less weight.’” (omission in original). Based on this statement, Petitioner’s counsel tries to inflame the issue when stating, “[w]hile Special Master Lord stops short of calling Dr. Tornatore a ‘hired gun’ as some of her colleagues have done — and been rebuked for doing, she nevertheless attacks his ‘credibility under the guise of his ‘relia
Special Master Lord’s observation that Dr. Tornatore was “more of an advocate than an objective expert,” in the case under review, was based on her conclusion that Dr. Tornatore made assumptions not based on evidence in the record before her. She questioned Dr. Tornatore’s relianсe on Dr. Winkelmann’s statement that, “ ‘[i]t was felt that immunization series had been the trigger for the development of the Guillain-Barré,’ ” because Dr. Winkelmann was not a neurologist or an immunologist. Special Master Lord wrote: “Dr. Tornatore explained that he credited Dr. Winkelmann’s statement because, unlike the physicians who did not identify vaccination as causative, or who identified an infectious cause, ‘Dr. Winkelman[n] has the retrospectoscope where he can look back, he knows everything that happened.’ ... Dr. Tornatore assumed that ‘obviously he [Dr. Winkel-mann] must have gone through the previous records and come up with something.’ This assumption is not based upon any evidence of record.” (footnote omitted).
Respondent suggests that Special Master Lord found Dr. Tornatore unreliable not only due to the lack of evidence provided by Petitioner, but also because of “‘significant weaknesses’ in his [Dr. Tornatore’s] testimony.” In Petitioner’s ease, Special Master Lord supported her consideration of Dr. Tor-natore’s testimony as unreliable because his testimony had “apparent contradictions, gaps, vagueness, and illogic.” Special Master Lord explained that Dr. Tornatore provided contradictory testimony by identifying Dr. Winkelmann’s statement, “ ‘[i]t is felt that immunization series had been the trigger for the development of the Guillain-Barré,’ ” as important, although dismissing Dr. Moore’s statement that petitioner’s injury “ ‘is likely related to gastrointestinal illness.’ ”
In an attempt to bolster the credibility of Dr. Tornatore, Petitioner contends that Dr. Tornatore based his testimony on more than just timing and the elimination of other causes by also relying on clinical facts, such as “statements by her treating doctors [that] certainly add weight to Dr. Tornatore’s opinion,” including the entry by Dr. Leis, one of Petitioner’s treating physicians, which indicates that Petitioner “[h]ad vaccination for DPT [tetanus vaccination] and hepatitis about 2 weeks before onset of altered sensation,” similarly, the statement by Dr. Winkel-mann that “patient states that she started experiencing the symptoms a couple of weeks after having some injections_”
In his testimony, Respondent’s expert, Dr. Leist, who the Special Master noted is an expert in adult neurology,” and “is an assistant professor of neurology at Thomas Jefferson University in Philadelphia and chief of the division of neuroimmunology,” relied on the facts in Petitioner’s medical records to reach his expert opinion that Petitioner’s injury was caused by a gastrointestinal illness, including Petitioner’s symptoms of nausea and vomiting. Special Master Lord noted that in his expert report, “Dr. Leist opined that the presence of ‘nausea and vomiting is compatible with an acquired gastrointestinal illness including a gastrointestinal infection,’” Special Master Lord also observed that “Dr. Leist reviewed Petitioner’s medical history, including her Hep A and tetanus vaccinations on September 15, 2005. He noted Petitioner’s symptoms when she presented to Baptist Health System on September 28, 2005 — chest pressure, headache, nausea and emesis, as well as numbness and tingling in the fingers and toes_ Dr. Leist pointed out that Petitioner reported ‘that she had experienced headache, stiff neck, nausea and vomiting 2 weeks before which resolved after one week.’ ”
Special Master Lord correctly concluded that, “[t]he medical record discloses very little by way of treating physician opinions concerning whether vaccination was the cause of Petitioner’s GBS.” Special Master Lord concluded that “[ujpon careful consideration of the record, I find that none of the notations, other than Dr. Moore’s single
In addition, Special Master Lord took issue with Dr. Tornatore’s testimony regarding molecular mimicry. Special Master Lord indicated that, “somewhere between what the IOM would require to establish molecular mimicry as a theory of vaccine injury causation, and what we have in this case, which is the bare speculation of an expert, there is scope for a special master to decide whether there is sufficient evidence tо preponderate under Prong 1 of Althen.” Again, Special Master Lord was not discrediting Dr. Torna-tore, rather, she was acknowledging that Dr. Tornatore had relied on the 1994 Institute of Medicine Report and the Pollard and Selby article to support his molecular mimicry argument, with little or no additional support. Special Master Lord explained in her decision:
Dr. Tornatore stated that molecular mimicry explained how the vaccine could have caused GBS- He said it was not necessary to know which component of the vaccine shared homology with the host antigens that theoretically caused GBS, “Because you have the Pollard and Selby article where you had the positive rechal-lenge.”
Dr. Tomatore’s testimony in this respect is essential to my decision in this case. He stated:
And so all you need to know is that it’s the vaccine itself. The individual components it would be nice to know what those are specifically. However, that is for this case, that specificity is not required. The only specificity is that there was a challenge and positive re-challenge case, the Pollard and Selby case, that the Institute of Medicine said, you don’t need to know the absolute molecular component but it’s teaching us that if something happens one time and you challenge a person a second time with that same entity, that entity is the ea[u]se.
Dr. Tornatore testified that the absence of epidemiological studies showing an association between tetanus vaccine and GBS was not significant, because “epidemiologic studies are not meant to identify rare events.” He indicated that there may have been no subsequent case reports in the more than three decades since the*776 Pollard and Selby article was published only because “it’s already been reported.”
(internal citations omitted, bracket in original). Special Master Lord determined “I find that Dr. Tornatore’s evidence is not sufficient to preponderate under Althen Prong 1. The theory that Td vaccination could cause GBS by molecular mimicry was effectively challenged by Respondent’s expert, without meaningful response.” Special Master Lord also found that Dr. Tornatore had gaps in his testimony, and, therefore, was unreliable. Special Master Lord noted that “[sjeemingly unable to explain the basis for the theory of molecular mimicry as it might pertain to Td vaccination and GBS, Dr. Tornatore relied instead on the concept of challenge/reehallenge.” Although Dr. Torna-tore did describe the process of molecular mimicry as it relates to Guillain-Barré Syndrome, he failed to show how the tetanus shot in particular could incite molecular mimicry and cause Guillain-Barré Syndrome, other than through the process of ehal-Ienge/rechallenge found in the Pollard and Selby article. Special Master Lord, therefore, determined that “none of the medical records support molecular mimicry or any other theory of possible vaccine causation. Petitioner’s case therefore rests on the reliability of her expert’s conclusion.”
Special Master Lord observed that Respondent’s expert, Dr. Leist provided evidence that ran counter to Dr. Tornatore’s theory of causation. Special Master Lord noted that “Dr. Leist pointed out that the medical literature Dr. Tornatore submitted involved a cross-reaction based on a particular component of an organism known to cause GBS_ Evidence that C. jejuni causes GBS by molecular mimicry does not constitute preponderant evidence that molecular mimicry is a possible explanation for vaccine causation. Further, AIDP [Acute Inflammatory Demyelinating Polyneuropa-thy], the form of GBS at issue in this case, has been found not to be caused by cross-reaction with C. jejuni.” Dr. Tornatore admitted that Petitioner was not tested for C. jejuni bacteria (or other virases associated with Guillain-Barré Syndrome such as cyto-megalovirus or Epstein-Barr virus), and testified that she was not tested because her symptoms did not warrant it. Respondent further explained that “Dr. Tornatore also conceded that two-thirds of GBS patients have a history of preceding infection, and while Campylobacter jejuni is a common pro-drome
Despite having been given the opportunity, Dr. Tornatore, as Petitioner’s expert, did not respond to the excerpts from the 2011 pre-publication Institute of Medicine Report which the Special Master placed in the record and regarding which she offered the parties an opportunity to comment. Although counsel for Petitioner and for the Respondent both responded on behalf of their clients, at oral argument before this
I find that Dr. Tornatore’s evidence is not sufficient to preponderate under Althen Prong 1. The theory that Td vaccination could cause GBS by molecular mimicry was effectively challenged by Respondent’s expert, without meaningful response. Seemingly unable to explain the basis for the theory of molecular mimicry as it might pertain to Td vaccination and GBS, Dr. Tornatore relied instead on the concept of ehallenge/reehallenge. That phenomenon, with respect to Td vaccination and GBS, no longer is accepted by scientific experts as a link between Td and GBS, as Dr. Leist indicated at hearing, and as was shortly thereafter confirmed by the IOM.
Finally, Petitioner argues that Special Master Lord elevated Petitioner’s evidentia-ry burden of proof from a preponderance of the evidence to a scientific certainty, thereby not acting in accordance with the law. In response, Respondent disputes Petitioner’s contention that Special Master Lord elevated the required standard of proof. In Respondent’s view, Special Master Lord “articulated and applied the proper legal standard,” and acted in accordance with the applicable law. Respondent also asserts that Special Master Lord understood the difference between the standard of proof required by the scientific community to show causation and the preponderance evidence standard established in the Vaccine Act.
As noted above, under the off-Table theory of recovery, a petitioner is entitled to compensation if she can demonstrate, by a preponderance of the evidence, see 42 U.S.C. § 300aa-13(a)(l)(A), that the recipient of the vaccine sustained, or had significantly aggravated, an illness, disability, injury, or condition not set forth in the Vaccine Injury Table but which was caused by a vaccine that is listed on the Vaccine Injury Table. 42 U.S.C. § 300aa-ll(c)(l)(C)(ii)(I); see also Althen v. Sec’y of Health & Human Servs.,
In her decision, Special Master Lord specifically stated that in order to qualify for compensation, Petitioner had to prove causation by the tetanus vaccine and her Guillain-Barré Syndrome, “by a sound and reliable ‘medical or scientific explanation that pertains specifically to the petitioner’s case, although the explanation need only be “legally probable, not medically or scientifically certain.” ’ ” (quoting Moberly ex rel. Moberly v. Sec’y of Health & Human Servs.,
A Special Master’s decision will be upheld if the Special Master acted in accordance with the law, if the Special Master weighed all the evidence submitted by both parties, and if the Special Master did not base his or her conclusion on a lack of
In the easе currently before this court, Special Master Lord undertook significant efforts to review Petitioner’s claim and wrote a lengthy opinion explaining her conclusions. Special Master Lord repeatedly invited the parties to comment on medical information, even after the hearing. As indicated above, although Respondent’s and Petitioner’s counsel offered responses, Dr. Tornatore did not did not take the opportunity to rebut the information Special Master Lord put into the record, including the excerpts from the 2011 pre-publication Institute of Medicine Report. The Special Master also analyzed Petitioner’s medical records, reviewed the medical literature, and considered the testimony provided by both parties before making her decision. Special Master Lord’s decision considered all of Petitioner’s claims, as well as all of the expert reports and testimony before determining, for the reasons described throughout this opinion, that Petitioner had “not presented preponderant evidence to support her claim under the Vaccine Act that the Td vaccination was the cause of her injuries.”
As indicated above, Petitioner’s counsel frequently cited to Althen v. Secretary of Health & Human Services,
Contrary to Petitioner’s suggestion, Special Master Lord did not require objective confirmation of Dr. Tornatore’s theory of causation, or that the articles he submitted had to establish that there existed “a causal relationship to a degree of scientific certainty.” At oral argument before this court, Petitioner failed to identify where in Special Master Lord’s decision she required such objective confirmation. Moreover, as discussed at length above, Special Master Lord did not find Dr. Tornatore’s testimony unreliable because she required scientific certainty, instead she found him unreliable because the scientific evidence he heavily relied on to draw a connection between the tetanus vaccine and Petitioner’s Guillain-Barré Syndrome had been discredited or at least called into question by the 2011 pre-publication excerpts from the Institute of Medicine Report and because he was unable to articulate and support the basis for molecular mimicry and how it related to Petitioner’s Guillain-Barré Syndrome. For all the reasons cited above, Special Master Lord’s found that Dr. Torna-tore had failed to show causation between the Petitioner’s tetanus vaccination and her Guil-lain-Barré Syndrome, and had failed to rebut Respondent’s expert testimony. See generally Viscontini v. Sec’y of Health & Human Servs.,
CONCLUSION
Upon review of the record before this court, including the transcripts, medical records, exhibits, conflicting expert reports, and Special Master Lord’s decision, this court finds that Special Master Lord employed the proper standard of proof. Despite a few inconsistencies, Special Master Lord’s conclusion that Petitioner failed to prove, by a preponderance of the evidence, a medical theory of causation between the tetanus vaccination and Petitioner’s Guillain-Barré Syndrome, was not arbitrary or capricious. The Special Master’s Ruling on Entitlement denying compensation to Petitioner is AFFIRMED.
IT IS SO ORDERED.
Notes
. The Motion for Review, however, was not in compliance with the RCFC, as the Motion did not include a table of contents or a table of authorities. The court ordered Petitioner to refile the Motion for Review, which Petitioner accomplished on August 31, 2012 by filing a corrected Motion for Review.
. The Special Master's decision, the parties' filings, and the experts generally refer to the vaccination received by Petitioner simply as “tetanus” and not "tetanus-diphtheria.” In order to be consistent, this оpinion will likewise refer to the vaccine as tetanus.
.In her July 30, 2012 decision, Special Master Lord dismissed Petitioner’s hepatitis A claim, finding that Petitioner "effectively abandoned the allegation of causation by the Hep A [hepatitis A] vaccine” because, during the course of the hearing, Petitioner’s expert, Dr. Carlo Tornatore, "did not opine that the Hep A [hepatitis A] vaccination caused Petitioner's GBS [Guillain-Barré Syndrome].” Petitioner does not allege that Special Master Lord improperly dismissed Petitioner’s hepatitis A claim, nor does Petitioner now claim entitlement to compensation under the Vaccine Act pursuant to the hepatitis A claim. Therefore, this opinion addresses only Petitioner's tetanus vaccine claim.
. According to Dorland's Illustrated Medical Dictionary, inflammation is "characterized in the acute form by the classical signs of pain (dolor), heat (calor), redness (rubor), swelling (tumor), and a loss of function (function laesa).” Dor-land's Illustrated Medical Dictionary 936 (32nd ed. 2012). The Merck Manual of Diagnosis and Therapy notes that "some myelin disorders (eg Guillain-Barré syndrome, chronic inflammatory disseminated polyneuropathy ...) tend to affect primarily the peripheral nerves_” The Merck Manual of Diagnosis and Therapy ¡887. Moreover, it also defines polyneuropathy as "a diffuse peripheral nerve disorder not confined to the distribution of a single nerve or a single limb.” Id. at 1904.
. According to Dorland's Illustrated Medical Dictionary, Guillain-Barré Syndrome is a "rapidly progressive ascending motor neuron paralysis of unknown etiology, frequently seen after an enteric or respiratory infection.” Dorland's Illustrated Medical Dictionary 1832. Enteric is defined as "1. Intestinal. 2. Within the small intestine.” Dorland's Illustrated Medical Dictionary 624.
.Despite the different last name on the admission notes, both parties cite to, and quote from, the admission notes in the filings, and Petitioner included the admission note as Petitioner's Exhibit 6 in Petitioner's petition for compensation. Moreover, both experts discussed the admission note at the July 27, 2010 hearing, and Special Master Lord discussed the admission note at length in her July 30, 2012 decision.
. Campylobacter jejuni is a bacterial infection that causes axonal degeneration. According to Dorland's Illustrated Medical Dictionary, axons are "[t]he process of a neuron by which impulses travel away from the cell body,” and degeneration is defined as “deterioration; change from a higher to a lower form; especially [a] change of tissue to a less functionally active form.” Dor-land’s Illustrated Medical Dictionary 186, 479.
. In his expert report, Dr. Leist stated that "Dr. Moore diagnosed Ms. Isaac with early acute inflammatory demyelinating polyneuropathy (AIDP form of GBS) likely caused by a gastrointestinal illness." Dr. Moore’s statement actually indicated that: “AIDP is likely related to gastrointestinal illness.” (emphasis added). Special Master Lord correctly identified Dr. Moore's statement as “likely related to gastrointestinal illness,” in her decision, except when, citing Dr. Leist’s expert report, she stated: "He [Dr. Leist] noted that Dr. Moore, the neurology consultant who evaluated Petitioner at St. Dominic-Jackson, commented that she had a form of GBS likely caused by a gastrointestinal illness.” In her Motion for Review, Petitioner also refers to Dr. Moore’s note as stating "AIDP is likely caused by gastrointestinal illness,” with a reference to Petitioner's own exhibit, which is a copy of Dr. Moore's original statement, and which, as noted above, stated "AIDP is likely related to gastrointestinal illness.”
. The 1994 Institute of Medicine Report referenced by Dr. Tornatore, titled Adverse Events
. According to Borland’s Illustrated Medical Dictionary, axons are the "process of a neuron by which impulses travel away from the cell body,” and demyelination is the "destruction, removal, or loss of the myelin sheath of a nerve or nerves.” Borland's Illustrated Medical Dictionary 186, 486.
. The final version of the Institute of Medicine Report was published in 2012. Special Master Lord in her Ruling on Entitlement, issued on July 30, 2012, however, only referred to the 2011 pre-publication Institute of Medicine Report, Adverse Effects of Vaccines: Evidence and Causality. There are no material differences in the relevant sections introduced into the record by Special Master Lord between the pre-publication and final versions, only typographic and minor clarifying changes which do not affect the issues raised in this case. Therefore, the court also refers to the pre-publication version in this opinion.
. Unlike the two previous exhibits, the parties did not respond to the Special Master’s filing. As Special Master Lord noted, "I am entering the excerpt to complete the record.”
. The United States Court of Federal Claims decision in Althen v. Secretary of Health & Human Services,
. In this respect, the Special Master may have overstated the facts, although her decision remains valid overall, given the othеr factors on which she relied. As noted above, although Dr. Moore described Petitioner’s AIDP as "likely related to related to gastrointestinal illness.” The next day he also indicated that the nerve study was "consistent with early GBS.”
. Petitioner argues that ”[a]fter improperly characterizing Dr. Tornatore’s theory of causation as emphatically relying upon the 1994 IOM
. At oral argument, counsel for the Respondent elaborated on the differences between Althen and the above captioned case, stating:
There’s no collateral estoppel in the program because each case is unique. Even though the injuries may be the same, each patient’s or petitioner’s medical presentation is different. The Federal Circuit in Althen was not opining as to the theory. The Federal Circuit in Althen took issue with the Special Master’s sort of styled Stevens [v. Secretary of Health & Human Services, No. 99-594V,2001 WL 387418 (Fed. Cl. March 30, 2001)], test where the Special Master required objective evidence of the petitioner and found that was inappropriate, and the Special Master basically said unless you can show me epidemiological studies or some proof in the medical literature, you automatically lose. That’s not what Special Master Lord did here. In fact, she was very clear in her opinion.
. The Federal Circuit in Althen explained that "Duane’s Syndrome is a hereditary eye movement disorder which limits the ability to move the eye outward toward the ear (abduction) and, in most cases, the ability to move the eye inward toward the nose (adduction). This ailment caused Althen to experience double vision when looking to the left:” Althen v. Sec'y of Health & Human Servs.,
. Dr. Tornatore, has testified as an expert in roughly sixty cases regarding the Vaccine Act. Among those cases, Dr. Tornatore's testimony has been both helpful to prove some claimants' claims, but his expert opinion also has been found insufficient or unreliable as support in other petitioners’ cases.
. As a Judge of the United States Court of Federal Claims noted: "Ipse dixit is Latin for 'he himself said it.’ Black's Law Dictionary 847 (8th ed. 2004). The term means ‘[s]omething asserted but not proved.’ ” Banks v. United States,
.The abuse of discretion standard is " 'ordinarily used where the tribunal under review had a finite range of discretion (e.g. to select a penalty, or to award a specific sum as damages, from within a range of permissible alternatives).’ ” Moberly ex rel. Moberly v. Sec’y of Health & Human Servs.,
. The court has noted that Dr. Moore’s notes included conflicting information. At first, he indicated that Petitioner's acute inflammatory de-myelinating polyneuropathy "is likely related to gastrointestinal illness.” The next day, Dr. Moore also noted that the nerve study was "consistent with early GBS.”
. As described above, Special Master Lord also questioned the reliance on Dr. Winkelmann, given that he was not a neurologist or an immunologist, nor was he Petitioner’s treating physician when she fell ill.
. As noted above, Dr. Moore made two conflicting statements on successive days.
. According to Dorland’s Illustrated Medical Dictionary, prodrome is defined as "a premonitory symptom or precursor; a symptom indicating the onset of a disease.’’ Dorland’s Illustrated Medical Dictionary 1522.