VICP Registry Case Source Bundle Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_08-vv-00024 Package ID: USCOURTS-cofc-1_08-vv-00024 Petitioner: JG Filed: 2008-01-14 Decided: 2014-12-08 Vaccine: MMR Vaccination date: 2004-04-13 Condition: autism spectrum disorder (ASD) Outcome: dismissed Award amount USD: 5379 AI-assisted case summary: On January 14, 2008, Howard and Denise Greenberg filed a petition under the National Vaccine Injury Compensation Program on behalf of their son, JG, who was born on April 10, 2003. They alleged that JG developed autism spectrum disorder (ASD) as a result of a "Table Injury Encephalopathy" following an MMR vaccination administered on April 13, 2004. The respondent was the Secretary of Health and Human Services. The case was initially part of the Omnibus Autism Proceeding (OAP) due to the autism diagnosis. The petitioners' theory of causation evolved over time, initially alleging that the MMR vaccine and thimerosal-containing vaccines caused JG's condition. Later, they suggested the entire vaccine schedule was responsible. By January 2013, they filed an expert report from Dr. Kevin Passer, who opined that JG's symptoms were consistent with an acute attack of Encephalopathy or Encephalitis, based on a statement from Denise Greenberg recalling fever and sensitivity to light and sound. In January 2014, the Greenbergs filed an amended petition alleging only a Table Injury Encephalopathy from the MMR vaccination, abandoning any causation-in-fact claim. Special Master George L. Hastings dismissed the petition on December 8, 2014, on two grounds. First, the petition was time-barred. A Table Encephalopathy claim requires symptoms to appear within 5 to 15 days of the MMR vaccination, and the petition must be filed within 36 months of the first symptom. This meant the petition should have been filed by April 28, 2007, but it was filed on January 14, 2008. The Greenbergs argued for equitable tolling due to alleged government fraud regarding thimerosal studies, but the Special Master rejected this, noting the MMR vaccine does not contain thimerosal and the alleged fraud was irrelevant to a Table Encephalopathy claim following an MMR vaccine. Second, JG did not suffer a Table Encephalopathy. The definition requires a significantly decreased level of consciousness and response to the environment, lasting at least 24 hours. Denise Greenberg's statement described JG as "very sensitive to his surroundings," which the Special Master found to be the opposite of the required definition. Furthermore, JG's medical records for the year following the vaccination showed no neurological symptoms, with explicit notes of "no reactions to prior shots" at his 15-month and 18-month visits. Developmental concerns were not noted until his two-year visit, nearly a year after the MMR vaccine, and a chronic encephalopathy element also failed as JG was developing normally. The Greenbergs, acting pro se, filed a motion for reconsideration, which Special Master Hastings denied on March 20, 2015. They then filed a "Notice of Review" with the U.S. Court of Appeals for the Federal Circuit, which transferred the case back to the Court of Federal Claims. Judge Thomas C. Wheeler affirmed the Special Master's reconsideration order on November 2, 2015, finding no abuse of discretion. The $5,379 award noted in the database represents litigation costs awarded to the Greenbergs under § 15(e)(1) for expenses such as expert witness fees, filing fees, and mailing, not compensation for the injury itself, as the underlying petition was dismissed. Theory of causation field: Petitioners Howard and Denise Greenberg alleged that their son, JG, suffered a Table Injury Encephalopathy following an MMR vaccination on April 13, 2004, leading to autism spectrum disorder (ASD). The theory evolved from an initial claim involving MMR and thimerosal vaccines within the Omnibus Autism Proceeding, to a general vaccine schedule claim, and then specifically to a Table Encephalopathy claim, abandoning causation-in-fact. Expert Dr. Kevin Passer opined that JG's symptoms were consistent with acute encephalopathy. The Special Master dismissed the petition on two grounds: 1) Statute of Limitations: The petition was filed on January 14, 2008, which was untimely as it should have been filed by April 28, 2007, based on the 36-month limit and the 5-15 day window for Table Encephalopathy symptoms following the April 13, 2004 MMR vaccination. Equitable tolling was rejected as alleged fraud related to thimerosal-containing vaccines was irrelevant to the MMR vaccine. 2) No Table Encephalopathy: The evidence did not support a Table Encephalopathy diagnosis. Petitioner Denise Greenberg's description of JG as "very sensitive to his surroundings" was contrary to the required "decreased or absent response to environment." Medical records showed no neurological symptoms in the year following vaccination, and developmental concerns arose nearly a year after the MMR. The Special Master was George L. Hastings, and the decision was affirmed by Judge Thomas C. Wheeler. The $5,379 award was for litigation costs, not compensation. Public staged source text: ================================================================================ DOCUMENT 1: USCOURTS-cofc-1_08-vv-00024-0 Date issued/filed: 2015-01-07 Pages: 20 Docket text: PUBLIC DECISION (Originally filed: 12/08/2014) regarding 80 DECISION of Special Master. Signed by Special Master George L. Hastings. (tpj) Copy to parties. -------------------------------------------------------------------------------- Case 1:08-vv-00024-TCW Document 81 Filed 01/07/15 Page 1 of 20 ORIOI[\!A!. lln@'lte llHnite! Ststes @ourt of JFeleru[ Glsims OFFICE OF SPECIAL MASTERS FILED No.08-0024V Filed: Dccember 08, 2014 (Not for Publication) DEC - 8 2014 :t * * * * r. * * * *,t * * * :f ,f :f t U.S. COURT OF FEDERALCLAIMS IIOWARD GREENBERG and DENISE GREENBERG, * parents of JG, a minor, * Decision Dismissing "Table Encephalopathy" Claim; Statute * Petitioners, of Limitations SECRETARY OF HEALTH AND HUMAN SERVICES, Respondent. * * )t * :f :i :t,f :1. :t * * +,t * r. * t * * :1. :i Howard and Denise Greenberg, Kihei, HI, pro se petitioners. Lynn Ricciardella, U.S. Department oJ Justice, Washington, DC, for respondent' DECISION HASTINGS, Speciol Master This is an action in which Petitioners, Howard and Denise Greenberg, seek an award under the National Vaccine Injury Compensation Program (hereinafter "the Program"'), on account of their son JG's autism spectrum disorder ('ASD"), which they contend was the result ofa "Table Injury Encephalopathy" that occurred after an MMR vaccination on April 13,2004. Because (1) their "Table Encephalopathy" claim was not timely filed, and (2) they have failed to show the existence of a Table Encephalopathy in JG, I hereby dismiss this petition. I THE APPLICABLE STATUTORY SCHEME Under the National Vaccine Injury Compensation Program, compensation awards are made to individuals who have suffered injuries after receiving vaccines. In general, to gain an award, a petitioner must make a number of factual demonstrations, including showing that an individual received a vaccination covered by the statute; received it in the United States; suffered I l he appficable statutory proyisions defining the Program are found at 42 U.S.C. S 300aa-10 et seq. (2006 ed.). llereinafter, for case ofcitation, all $ references will be to 42 U.S.C. (2006 ed ). t Case 1:08-vv-00024-TCW Document 81 Filed 01/07/15 Page 2 of 20 a se ous, long-standing injury; and has received no previous award or settlement on account of the injury. Finally - and the key question in most cases under the Program - the petitioner must also establish a causal linkbelween the vaccination and the injury. In some cases, the petitioner may simply demonstrate the occurrence of what has been called a "Table Injury." That is, it may be shown that the vaccine recipient suffered an injury ofthe type enumerated in the "Vaccine Injury Table," corresponding to the vaccination in question, within an applicable time period following the vaccination also specified in the Table. If so, the Table Injury is presumed to have been caused by the vaccination, and the petitioner is automatically entitled to compensation, unless it is alfirmatively shown that the injury was caused by some factor other than the vaccination. g 300aa-13(a)(1)(A); $ 300aa-11(c)(lXC)(i); $ 300aa-14(a); $ 300aa-13(a)(1)(B). In other cases, the vaccine recipient may have suffered an injury nol of the type covered in the Vaccine Inj ury Table. In such instances, an altemative means exists to demonstrate entitlement to a Program award. That is, the petitioner may gain an award by showing that the recipient's injury was "caused-in-fact" by the vaccination in question. $ 300aa-13(a)(1)(B); $ 300aa-l l(c)(1)(C)(ii). In this case, however, the Petitioners eventually chose to allege only a Table Injury. Thus, the standards for proving a "causation-in-fact" case are not relevant. u THE OMNIBUS AUTISM PROCEEDING ("OAP") A. General This case is one of more than 5,600 cases filed under the Progtam in which petitioners alleged that conditions known as "autism" or "autism spectrum disorders" C'ASD') were caused by one or more vaccinations. A special proceeding known as the Omnibus Autism Proceeding ("OAP') was developed to manage these cases within the Olfice of Special Masters ('OSM). A detailed history of the controversy regarding vaccines and autism, along with a history ofthe development of the OAP, was set forth in the six entitlement decisions issued by three special masters as "test cases" for two theories of causation litigated in the OAP (see cases cited below), and will only be summarized here. A group called the Petitioners' Steering Committee was formed in 2002 by the many attorneys who represented Vaccine Act petitioners who raised autism-related claims. About 180 attorneys participated in the PSC. Their responsibility was to develop any available evidence indicating that vaccines could contribute to causing autism, and eventually to present that evidence in a series of "test cases," exploring the issue of whether vaccines could cause autism, and, if so, in what circumstances. Ultimately, the PSC selected a group of attomeys to present evidence in two different groups of"test cases" during many weeks oftrial in 2007 and 2008' In the six test cases, the PSC presented two separate theories on the causation ofASDs' The first theory alleged rhat the measle.s portion of the measles, mumps, rubella (MMR) vaccine could cause ASDs. That theory was presented in three separate Program test cases during several weeks of trial in 2007. The second theory alleged that the mercury contained in thimerosal- conlaining vaccines could directly affect an infant's brain, thereby substantially contributing to Case 1:08-vv-00024-TCW Document 81 Filed 01/07/15 Page 3 of 20 the causation of ASD. That theory was presented in three additional test cases during several r.r.eeks of trial in 2008. Decisions in each ofthe three test cases pertaining to the PSC'slrs/ theory rejected the petitioners' causation theories. Cedillo v.l1I1E No. 98-916V, 2009 WL 331968 (Fed. Cl. Spec. Mstr. Feb. 12,2009),aff'd,89 Fed. Cl. 158 (2009),aff'd,617 F.3d 1328 (Fed. Cir.2010); Hazlehurst v. 11115, No. 03-654V, 2009 WL 332306 (Fed. Cl. Spec. Mstr. Feb. 12,2009), alf'd 88 Fed. Cl. 473 (2009), aff'd,604 F.3d 1343 (Fed. Cir. 2010); Snyder v. Hl1S, No. 01--162V, 2009 WL 332044 (Fed. Cl. Spec. Mstr. Feb. 12,2009), aff'd,88 Fed. Cl. 706 (2009).' Decisions in each ofthe three "test cases" pertaining to the PSC's second rheory also rejected the petitioners' causation theories, and the petitioners in each ofthose three cases chose not to appeal. Dwyer v. HHS, No. 03-1202V ,2010 WL 892250 (Fed. Cl. Spec. Mstr. Mar. 12,2010); King v. HHS, No. 03-584V, 2010 WL 892296 (Fed. Cl. Spec. Mstr. Mar 12,2010); Mead v. HI1S, No. 03-215V, 2010 WL 892248 (Fed. Cl. Spec. Mstr. Mar. 12,2010). The "test case" decisions were comprehensive, analyzing in detail all ofthe evidence presented on both sides. The three test case decisions conceming the PSC'sf,'sl theory (conceming the MMR vaccine) totaled more than 600 pages of detailed analysis, and were solidly affirmed in many more pages of analysis in three different rulings by three different judges of the United States Court of Federal Claims, and then in two rulings by two separate panels ofthe United States Court ofAppeals for the Federal Circuit. The three special master decisions conceming the PSC's second theory (conceming vaccinations containing the preservative "thimerosal") were similarly comprehensive. All told, the l1 lengthy written rulings by the special masters, the judges of the U.S. Court of Federal Claims, and the panels of the U.S. Court ofAppeals lor the Federal Circuit unanimously rejected lhe petitioners' claims, hnding no persuasive evidence that either the MMR vaccine or thimerosal-containing vaccines could contribute in any way to the causation of auttsm. Thus, the proceedings in the six "test cases" concluded in 2010. Thereafter, the Petitioners in this oase, and the petitioners in other cases within the OAP, were instructed to decide how to proceed with their own claims. The vast majority of those autism petitioners elected either to withdraw their claims or, more commonly, to request that the special master presiding over their case decide their case on the written record, uniformly resulting in a decision rejecting the petitioner's claim for lack ofsupport. However, a small minority of the autism petitioners have elected to continue to pursue their cases, seeking other causation theories and/or other expert witnesses. A few such cases have gone to trial before a special master, and in the cases ofthis type decided thus far, all have resulted in rejection ofpetitioners' claims that vaccines played a role in causing their child's autism. See, e.g.,Il'addell v. HI1S, No. 10-316V, 201,2 WL 482929 | (Fed. Cl. Spec. Mstr. Cambell-Smith Sept. 19, 2012) (autism not caused by MMR vaccination); Henderson v. Ir'HS, No. 09-616V, 2012WL 5194060 (Fed. Cl. Spec. Mstr. Vowell Sept. 28,2012) (autism not caused by pneumococcal vaccination); Franklin v. l/HS, No. 99-855V,2013 WL 3755954 (Fed. Cl. Spec. Mstr. Hastings May 16,2013) (MMR and other vaccines found not to contribute to autism): Coombs v. I1llS, No. 08-818V, 2014 WL 1677584 The petitioners in Snyder did not appeal the decision ofthe U.S. Court of Federal Claims. '] 3 Case 1:08-vv-00024-TCW Document 81 Filed 01/07/15 Page 4 of 20 (Fed. Cl. Spec. Mstr. Hastings April 8,2014) (autism not caused by MMR or Varivax vaccines). In addition, some autism claims have been rejected without trial, at times over the petitioners' objection, in light ofthe failure ofthe petitioners to file an expert repon raising an issue requiring a hearing. See, e.g., Geppert v. HIIS, No. 00-286V, 2012WL 2500852 (Fed. Cl. Spec. Mstr. Vowell Sept. 6, 2012); Fessnco v. I1HS, No. 02-1770,2010 WL 4955721 (Fed. Cl. Spec' Mstr. Hastings Nov. 9, 2010); Fresco v. I/FIS, No. 06-469V, 201 3 WL 364723 (Fed. Cl. Spec. Mstr. Vowell Jan.7,2013). Judges of this court have affirmed the practice of dismissal without trial in such a case. Eg., Fesanco v. HH9,2011 WL 1891701 (May 16, 2011) (Judge Braden). In none of the post-test case rulings has a special master orjudge found any merit in an allegation that any vaccine can contribute to causing autism. B. Relevunce of OAP to this case This case, however, is quite different from the cases cited in the OAP test cases and the other cases cited in the OAP discussion above. The issue here is nol whether vaccines "caused- in-tact" JG's autism, but whether JG suffered aTable Injury, namely "encephalopathy," with the first symptoms ofthat encephalopathy occurring within the Table time period after vaccination. I ultimately conclude below JG did nol suffer a "Table Encephalopathy. But it should be stressed that the evidence upon which I have relied in making my decisions is limited to the evidence set forth in fftis case. I include this section concerning the OAP only to show why this case, filed in 2008, was not processed in the usual manner ofnon-autism cases. Rather, because this case involved a child who had been diagnosed with autism, the processing of this case was delayed, along with the other 5,000 autism cases, to await the final outcome ofthe autism "test cases". Then, when the "test cases" were finalized in 2010, individual petitioners such as the Greenbergs were given a generous period of time to decide whether to abandon their claims or to develop a theory of their own case. Only after Petitioners filed their Amended Petition on January 21, 2014, did the focus of this case change to a Table Injury, namely a Table Inj ury Encephalopathy allegedly associated with JG vaccinations of April 13,2004. Thus this case does nol concem whether autism can be causedby the vaccinations that JG received, but only with whether JG suffered a Table Encephalopathy with the first symptoms of that encephalopathy within the Table time period after his MMR vaccination, and whether Petitioners' Table Encephalopathy claim was timely filed. III PROCEDURAL HISTORY OF THIS CASE On January 14, 2008, Petitioners filed a "Short-Form Autism Petition for Vaccine Compensation" under the National Vaccine Injury Compensation Program, on behalfoftheir son, JG. (See Petition ("Pet") at 1.) The case was originally assigned to Special Master Gary Golkiewicz. Q.,lotice of Assignment filed Jan. 14, 2008, ECF No. 2.) Case 1:08-vv-00024-TCW Document 81 Filed 01/07/15 Page 5 of 20 Respondent's counsel filed a response on Feb. 25, 2008, opposing the petition. Petitioners filed JG's medical records and other exhibits on March 20,2008, and many other exhibits on many dates thereafter.s By filing the "Short-Form Autism Petition", Petitioners in effect alleged that JG suflered from autism, and that his autism was caused by either or both (1) the MMR (measles, mumps, rubella) vaccine , and (2) vaccines containing "thimerosal", a mercury-based preservalive contained in a number of childhood vaccines until about 1999 (but removed from most childhood vaccines soon after that year). Autism General Order #1 , Exhibit A, Master Autism Peition for Vaccine Compensation,2002WL31696785, at *8 (Fed. Cl. Spec. Mstr. July 3,2002), available at http://www.usct'c.uscourts.eov/node/2718. They also were in effect, making their case part of the Omnibus Autism Proceeding (OAP). As a result, while the parties awaited the results of the "test cases" in the OAP, no formal proceedings were conducted to resolve the case for a considerable period of time. On June 3, 2008, the case was reassigned to Special Master John Edwards; on August l, 2008, the case was reassigned to Special Master Christian Moran; and then on Novemb er 7 ,2011 , the case was reassigned to the docket of Special Master Denise Vowell, one of the three special masters handling the OAP and the autism "test cases." As will be detailed below, in their many different documents filed in this case, Petitioners' theory of causation has varied. However, on January 9, 2013, Petitioners filed an expert report by Dr. Kevin M. Passer. (Pet. Ex. 23.) Dr. Passer stated that in his professional opinion, "the descriptions provided by IPetitioners] as to the observable reactions oftheir 12 month old are consistent with an acute attack of Encephalopathy or Encephalitis," and that JG's diagnosis ("PDD-NOS", a type of autism) is "a diagnosis which could apply to a child following a bout of Encephalopathy." (Pet. Ex. 23 aI3.) Although Dr. Passer did not specifically refer to the Vaccine Act, his report appears to allege that JG suffered a "Table Encephalopathy" as a result of his MMR vaccine at 12 months of age, on April 13, 2004. On June 14,2013, Petitioners expressed dissatisfaction with their attorney, Mr. Peck. Accordingly, Mr. Peck was relieved of the duties ofcounsel on June 21, 2013, and Petitioners proceeded pro .se thereafter. Because it was not clear to Chief Special Master Vowell on what theory or theories Petitioners wished to proceed, in an Order dated November 25,2013, she ordered Petitioners to file an amended petition that clearly stated the causation theory or theories they were alleging. Petitioners' Amended Petition, filed on January 21,2014, alleges only aT able Encephalopathy claim. That filing points to vaccinations of April 13, 2014, as injuring JG, and cites the regulatory language applicable to a Table Encephalopathy. Therefore, I will address only that allegation of a Table Encephalopathy.* r Petitioners filed exhibits numbered I through 8 on March 20,2008, and then a separate set ofexhibits numbered I through 7 on September 15,2008. Thus, when referring to any exhibits numbered I to7, I will refer to either the 3- 20-08 or 9- 15-08 filing dates. After September of2008, Petitioners filed exhibits numbered l6 through 142 on various dates. o On May 16,2014, this case was reassigned to the unde$igned liom Special Master Vowell. Case 1:08-vv-00024-TCW Document 81 Filed 01/07/15 Page 6 of 20 IV PETITIONERS' CAUSATION THEORY As previously noted, Petitioners' theory ofcausation in this case has varied over time. As noted, by filing a Short-Form Autism petition, on January 14,2008, Petitioners automatically elected to be part of the Omnibus Autism Proceeding ["OAP"]. Additionally, by filing a Short- Form Autism petition, Petitioners were deemed to be alleging that: [a]s a direct result ofone or more vaccinations covered under the National Vaccine Injury Compensation Program, [JG] developed a neurodevelopmental disorder, consisting ofan Autism Spectrum Disorder or a similar disorder. This disorder was caused by a measles-mumps-rubella (MMR) vaccination; by the "thimerosal" ingredient in certain Diphtheria-Tetanus-Pertussis (DTP), Diphtheria-Tetanus-acellular Pertussis (DTaP), Hepatitis B, and Hemophilus Influenza[e] Type B (HIB) vaccinations; or by some combination of the two. Autism General Order #1, Exhibit A, Master Autism Petition for Vaccine Compensation, 2002 *8 WL 31696785, at (Fed. Cl. Spec. Mstr. July 3,2002),available at http ://www. uscfc.uscourts. gov/no de 127 I 8. In their March 2008 filings, Petitioners stated that their claim "is not solely based on" JG's receipt ofvaccines containing thimerosal, but rather that he was injured because ofhis inability to "digest" the vaccines. (Petitioners' Statement Regarding Respondent's Report, filed as Petitioners' Exhibit ["Pet. Ex."] I on March 20, 2008.) They noted that "a recent hair test [showedl mercury toxicity along with other toxic metals and deranged minerals," and that results of other testing led them to believe that JG's "autism is directly correlated to his inability to digest the contents of the vaccines." (Statement Regarding Onset, filed as Pet. Ex. 2.) Their filings also suggested that JG has symptoms associated with mitochondrial disorders and that *"* working with doctors to confirm whether he has such a disorder. (See Pet. Exs. 1 and f;t Petitioners' February 2012 Iheory of causation statement (Pet. Ex. I 7) noted that they "do not believe that any one vaccine caused [JG] to become autistic," but that "it was the vaccine schedule meaning all ofthe vaccines he received contributed to him becoming autistic." However, on January 9,2013, Petitioners seemed to change and narow their causation theory in this case, when they filed an expert report by Dr. Kevin M. Passer. (Pet. Ex. 23.) Dr. Passer stated that in his professional opinion, "the descriptions provided by [Petitioners] as to the observable reactions oftheir 12 month old boy are consistent with an acute attack of Encephalopathy ot Encephalitis," and that JG's diagnosis (PDD-NOS, a form of autism) is "a diagnosis which could apply to a child following a bout of Encephalopathy." (Pet. Ex. 23 at 3.) Although Dr. Passer did not specifically refer to the Vaccine Act, his report appears to be alleging that JG suffered a "Table Encephalopathy" as a result ofhis MMR vaccine, at l2 months ofage, on April 13,2004. Case 1:08-vv-00024-TCW Document 81 Filed 01/07/15 Page 7 of 20 Because it was not clear to Chief Special Master Vowell on what theory or theories Petitioners wished to proceed, in an Order dated November 25,2013, she ordered Petitioners to file an amended petition that clearly stated the causation theory or theories they were alleging. Petitioners' Amended Petition, filed on January 21,2014, alleges only a Table Encephalopathy claim. That filing points to vaccinations of April 13,2004, as injuring JG, and cites the regulatory language applicable to aTable Encephalopathy. Therefore, I will address only that allegation of a Table Encephalopathy.) V SUMMARY OF F'ACTS AND EVIDENCE RELEVANT TO PETITIONERS' TABLE ENCEPHALOPATHY CLAIM A. Medical records JG was bom on April 10,2003. JG had his one-year well-child visit on April 13,2004, three days after his first birthday. (Pet. Ex. 3, filed 3-20-08, p. 1l.) He passed all ofthe applicable developmental milestones, and was assessed as a well child. He received the allegedly causal vaccine at this visit: MMR as well as a Varivax vaccine. (ld.,pp. 1-2, 11.) The pediatric records indicate that between JG's one-year and 18-month well-child visits, Petitioners made three phone calls to his pediatrician. On April 23,2004, Mrs. Greenberg called and conveyed that JG was very fussy with swollen gums due to his molars coming in. He did not have a fever, and Petitioners were advised to give him Advil. (,ld, p. 15.) The next call occurred on May 28,2004, and was initiated by Mr. Greenberg. He reported that JG was having a reaction due to an overload of vitamin C. JG had non-itchy, little bumps on his leg, stomach, and arms. Petitioners were advised to monitor his condition and decrease his vitamin C intake. Additionally, if his skin looked dry, Petitioners were to apply moisturizer. (ld.) The final call was placed on June 4, 2004. After having a small amount of peanuts, JG began wheezing and his mother was concemed it was an allergic reaction. (ld ,p.9.) Petitioners were instructed to obtain albuterol syrup and told to have JG avoid all nuts, including peanut butter. (1d ) On July 13, 2004, at his fifteen-month well-child visit, JG was described as a well-child with a history of bronchospasms. He received his fourth Hib vaccine at this visit. The history indicates there were no reactions to his prior shots, and that he had been experiencing wheezing for six weeks, which corresponds to the possible allergic reaction to peanuts. JG was reported to be walking without support, drinking from a cup, self-feeding, stacking blocks, and indicating wants without crying. (1d, p. I 1.) 5 In the version ofthe Vaccine Injury Table applicable to this case, there is a Table Injury of "Encephalopathy" for the MMR yaccine,but no Table lnjury ofany kind listed for the varicella vaccine, which JG received on April 13, 2004, along with his MMR vaccination. Thus, obviously, Petitioners' only potential Table Injury claim is a Table Encephalopathy refated to the MMRvaccine. 42 C.F.R. $ 100.3(a). Case 1:08-vv-00024-TCW Document 81 Filed 01/07/15 Page 8 of 20 JG's eighteen-month well-child visit occuned on October 13,2004. The history reported that he was doing well and, again, that he had experienced no reaction to his prior shots. He received his fourth DTaP and pneumococcal vaccines at this visit. Petitioners refused consent for the influenza vaccination. JG was assessed as a well-child, who walked well, kicked and threw balls, and used 3 words other than mama and dada. (1d., p. 10.) At his two-year well-child visit on April 12,2005, JG was assessed as a well child, but ooncerns were raised about his development. It was noted that he only sometimes used two- word phrases, had tantrums, and exhibited screeching. Petitioners were instructed to schedule a re-evaluation of his speech and behavior in six months if no progress had been made. (1d., p. 10.) By the time of a developmental evaluation on January 5, 2006, JG's development was clearly significantly abnormal. He was diagnosed with "Pervasive Developmental Disorder - Not Otherwise Specified" (PDD-NOS), a form of autism. (Pet. Ex. 5, p. 5, filed on March 20, 2008.) B. Parental statements and afJidavits I. Statement of March 13,2008, regarding onset In their statement regarding onset, Petitioners stated that they "first noted a delay in [JG's] development at his 2 year immunization check up." (Pet. Ex. 2 at l, filed March 20, 2008.) The pediatrician assured them at that time that JG "still had good eye contact, was by no means autistic, but was just developing verbally slowly." (1d ) Petitioners thought that the regression or stalling in his development might be a psychological reaction to the birth of his younger sister, who at the time was 4 months old, but they nevertheless sought assistance from an early intervention program. (/d. ) Petitioners did not allege any relevant symptoms in JG any earlier than at the time of his two-year check-up. Ultimately, the symptoms first noted by Petitioners at around the time of JG's two-year visit proved to be early symptoms of autism-he was later diagnosed with PDD-NOS, a form of autism. (Ex. 5, p. 5, filed on March 20,2008.) 2. Letter of Dr. Frank Baum, dated July 20, 2008 On September 15, 2008, Petitioners submitted exhibits numbered i though 7 . InEx. 2, Doctor Baum, JG's pediatrician, wrote a "to whom it may concem" letter dated July 20,2008. Doctor Baum stated that no "red flags" were raised during the modified Denver Developmental evaluation performed at JG's 18-month well-child visit. (Pet. Ex. 2, fiIed 9-15- 08, p. 1.) In contrast, wrote Dr. Baum, at JG's two-year well-child visit, Dr. Baum found disturbing symptoms, including JG's failure to play with other children and JG's tendency to screech and make lots of sounds. (1d ) Doctor Baum noted that he had suggested a re-evaluation ofJG in six months, a|2.5 yearc ofage, if no further progress had been made in his speech and Case 1:08-vv-00024-TCW Document 81 Filed 01/07/15 Page 9 of 20 behavior skills. (/d) Additionally, Dr. Baum noted that he had"no notations inJG's medical record ofany unusual vaccine resctions." (ld. at2, emphasis added.) 3. Aljidavit of Petitioners, dated September 13, 2008 Another of the seven documents filed on September 15, 2008, was Ex. I , a joint affidavit of the Petitioners executed on September 3,2008. In their affidavit, Petitioners indicated that they first experienced concems about JG's lack of speech development around the time ofhis two-year well-child visit. (Ex. 1 at 1.) They stated that a report prepared by Dr. Galler-Rim, following an evaluation ofJG when he was 2 years and 9 months ofage, incorrectly placed onset of his developmental delay at 18 months. Petitioners stressed that JG was "still progressing normally" at 1 8 months. (/d.) 4. Petitioners' Interrogatory Responses executed on January 15,2009 On December 9, 2008, Respondent's counsel mailed Petitioners a list ofeight questions. Petitioners' responses to the questions were filed by Respondent on February 5,2009. (See Ex. A and Ex. B, filed Feb. 5,2009.) Petitioners indicated that they first thought their son might be autistic after seeing an episode of the "Super Nanny" television show that featured an autistic child. The child in the episode had behaviors similar to those they were observing in JG. Because they saw the episode about a week or ten days before his already-scheduled two-year well-child visit, they did not schedule a special appointment with their pediatrician to discuss their concems. (lnterogatory No. 2.) Petitioners reported that JG was able to easily repeat words at his 18-month check up, and believed that his inability to do so was a concern at his 2-year check up. (Intenogatory No. 4.) C, Expert rcports L Dr. Kevin Passer As previously noted, Petitioners filed the expert repofi ofDr. Kevin Passer on January 9, 2013. (Pet. Ex. 23.) Dr. Passer is a board-certified child and adolescent psychiatrist based in Hattiesburg, MS. He completed his fellowship training at Johns Hopkins. (ld. at l) His expert report addressed four specific questions: (l) "How is PDD-NOS diagnosed in a 2 year old patient?" (2) "What are the ranges of OBSERVABLE symptoms for an acute attack of Encephalopathy or encephalitis in a 1 year old child?" (3) "Can long-term injury that results lrom an acute attack of Encephalopathy or encephalitis result in observable symptoms that could be diagnosed as PDD-NOS?" and (4) "Does the parent statement of Denise Greenberg, dated December 12,2012, fit within descriptive parameters for an attack ofacute Encephalopathy or encephalitis, by a parent without medical knowledge?" (ld. at l-3.) After providing short answers to the lour questions that he posed, Dr. Passer concluded that in his "professional opinion, the descriptions provided by the parent as to the observable Case 1:08-vv-00024-TCW Document 81 Filed 01/07/15 Page 10 of 20 reactions oftheir 12 month old boy are consistent with an acute attack of Encephalopathy or Encephalitis." (Pet. Ex. 23 at3.) In reaching his conclusion, Dr. Passer stated, he relied upon a statement of Ms. Greenberg dated December 12,2012, in which she wrote that Petitioners "first noticed that JG was sick when he had a fever and seemed very sensitive to his sunoundings Iike to light and sound. He just seemed weak and out of it and very initable." (,Li. A copy ofthe f)ecember 12,2012, statement was filed in this case on January 27,2014, as Petitioners' Exhibit 140.) That statement, by Ms. Greenberg, however, does r?ol associate her observations with a particular date or timeframe. It does note that "JG remained in this state of delirium for over a day." (Ex. 140 at 1.) III 2. Dr, John Green, Dr. Green is a physician who specializes in Allergy & Environmental Medicine and Childhood Disorders. His clinic, EverGreen Center PC, is located in Oregon City, OR. (Pet. Ex. 141, filed on January 17,2014,at 1.) In April 2010, Dr. Green wrote a "disability letter" in which he stated that "[JG] is disabled by inability to communicate effectively, by inordinate, intractable behaviors, and by multiple complex metabolic problems resulting in metabolic cncephalopathy." (ld.) In that letter, however, Dr. Green did r?o/ state any opinion as to the cause of JG's "metabolic encephalopathy," nor did he state that JG's encephalopathy followed his MMR vaccine. Thus, this expert report provides no support to Petitioners' Table Injury claim in this case. VI PETITIONERS'"TABLE INJURY" CLAIM IS CLEARIY TIME-BARRED As noted above, under the Vaccine Act, the petitioner bears the burden ofproving a vaccine-caused injury.6 There are two ways causation may be demonstrated. Firsi, a petitioner may establish a "Table Injury."' Altematively, a petitioner may prove that a vaccine listed on the Table actually caused or significantly aggravated an injury (an "off-Table" injury). In this case, Petitioners allege only that JG suffered a "Table Encephalopathy" lollowing his MMR vaccination on April 13,2004. (See Amended Petition filed on January 27,2014; pet. Ex. 23.) To succeed with their Table Encephalopathy claim, petitioners must demonstrate (1) that their petition was timely filed, and (2) that JG's symptoms satisfl' the statutory definition for a Table Encephalopathy. Petitioners are able to do neither, as I will demonstrate in this Section VI of this Decision, plus the following Section VIL " Petitioners have the burden of demonstrating the facts necessary to show their entitlement to an award by a "preponderance ofthe cvidence." $ 300aa- 12(aX l XA). Under that standard, the existence ofa fact must be shown to be "more probable than its nonexistence." In re llinship,391 u.s. 358, 371 (1970) (Harlan, J., concurring). 7 See 5 lt1c1t1C;;42 C.F.R. g 100.3 (2010). IO Case 1:08-vv-00024-TCW Document 81 Filed 01/07/15 Page 11 of 20 A. Legol standard: Statute of Limilations The Vaccine Act's statute of limitations provides that, in the case oi a vaccine set forth in the Vaccine Injury Table which is administered after October l, 1988, if a vaccine-related injury occurred as a result of the administration of such vaccine, no petition may be filed for compensation under the Program for such injury after the expiration of 36 months after the date ofthe occurrence of the first symptom or manifestation ofonset or ofthe significant aggravation of such injury . . . $ l6(a)(2). The date ofoccurrence "is a statutory date that does not depend on when a petitioner knew or reasonably should have known anything adverse about her condition." Cloer v. HHS, 654 1".3d 1322, 1339 (Fed. Cir. 201 l) (en banc), cert. denied, Cloer v. Sibelius,132 S. Ct. 1908 (2012). Additionally, the date "does not depend on the knowledge of a petitioner as to the cause ofan injury." (1d. at 1338.) When drafting the Vaccine Act, Congress rejected a "discovery rule"-based statute oi limitations, in favor of one that does nol consider knowledge, and runs solely from the date ofan event, the first symptom or manifestation ofonset. (1d./ In Cloer, the Federal Circuit acknowledged that "equitable tolling"8 applies in Vaccrne Act cases, but under very limited circumstances, such as when a petitioner was the victim of fraud or duress, or when a procedurally deficient pleading was timely filed. Cloer,654F.3dat 1344-45. It squarely rejected the applicability ofequitable tolling "due to unawareness ofa causal link between an injury and administration ofa vaccine." Id. at1345. B. Application of statute of limitations to Petitioners' Table Encephalopathy claim Combining the Vaccine Act's 36-month statute of limitations, with its requirement that the first symptoms of an MMR-caused "Table Encephalopathy" must occur within 15 days of the vaccination (42 C.F.R. $ 100.3(a)), to be considered timely-filed the petition in this case must have been filed by April 28,2007--i.e.,3 years and l5 days after the MMR in question. Because the petition was not filed until January 14, 2008, it was untimely filed. Petitioners argue that the late filing of their petition should be excused because of misrepresentations and fraud committed by the United States Govemment. (Petitioners' Response to Respondent's Motion to Dismiss, filed June 14,2013, at 2; see aiso Amended Petition, filed Jan. 27 ,2014, aI3.) In reviewing their allegation, Special Master Vowell noted that the documents which Petitioners filed conceming the alleged fraud (Exs. 25-139) were generally focused on studies exploring thimerosal, a mercury-based preservative contained in sorze vaccines, its possible role in autism, and the govemment's alleged misconduct in certain published anicles and the study " 1'he doctrine ofequitable tolling is a legal principle that acts to overcome a statute of limitations problem in certain situations. Ifa case is untimely filed and the doctrine ofequitable tolling applies, then the case will be permitted to conttnue. lt Case 1:08-vv-00024-TCW Document 81 Filed 01/07/15 Page 12 of 20 results conceming thimerosal that such articles contained. (Order, issued Nov. 25,2013, aI5.) She conceded that a few of the documents refer to MMR and autism, but that on their own such articles could not support an allegation of fraud pertinent to a Table Encephalopathy claim. (1d ) Petitioners were cautioned that if they intended to pursue a Table claim and assert that it should be considered timely-filed because offraud, they must establish that the alleged fraud is relevant to the claim. Additionally, because their filed evidence focused primarily on research involving thimerosal-containing vaccines, Special Master Vowell advised that, if Petitioners intended to rely on those documents, they must establish that the MMR vaccine that JG received contained thimerosal. (1d ) In their Amended Petition, filed on January 2't,2014, Petitioners replied that "their son's HIB, DTaP, IPV, and Hep B contained thimerosal." (Amd. Pet. at 3.) Petitioners did nol argue, much less establish, that the MMR vaccination JG received contained thimerosal.' Nor did Petitioners link the alleged fraud to their own Table Encephalopathy claim. Asserting a "Table Encephalopathy" claim is different than a causation-in-fact claim regarding vaccines and autism, as Chief Special Master Vowell explained to Petitioners during the November 2013 status oonference and in her subsequent order. (Order ofNovember 25, 2013.) Establishing fraud regarding thimerosal and autism, as Petitioners assert occuned via Paul Thorsen and a 2002 Danish study (see Amd. Pet. at 2-3),'0 does ndl warrant an application of equitable tolling to petitioners' MMR Table Encephalopathy claim. As discussed in Section VII ofthis Decision below, the/acfs ofthis case do not in uty event meet the Vaccine Act's standard for demonstrating a Table Encephalopathy. Therefore, I technically need not determine whether Petitioners have established that fraud occurred or if it is ' ln fact, I am aware, from the autism "test cases" cited above, that the MMR vaccine does ,oI contain thimerosal. E.g.,Dwyerv. HHS, No.03-1202V, l0l0 WL 892250, at.'171, tu. 635. 'u ln their many exhibits filed in this case, Petitioners allege fraud by a Danish vaccine researcher named Thorsen, and by others, in regard to the controversy conceming whether thimerosql-conlqining yaccines ("TCVs") can cause autism. As noted above, this alleged fraud has proven to be irrelevqnl lo this case, in which Petitioners ultimately relied only upon a theory of a "Table Encephalopathy" after an MMR vaccination of April 13, 2004, since MMR vaccines do rr.)/ contain thimerosal. Nevertheless, I do not wish to leave the impression in this Decision that Petitioners havepi'ove, fiaud conceming the theory that TCVs can cause autism. To the contrary, I note that after weeks oftrial in which some ofthe world's top autism experts testified, in the "test case" decisions, three different special masters ofthis court, in three separate rulings combining to stretch hundreds ofpages in length, each stongly rejectedthe idea ofany causal connection between TCVS and autism. See Kirgv. l/11S, No.03-584V, 2010 WL 892296 (Fed. Cl. Spec. Mstr. March 12, 2010) (my own ruling\ Mead v. gHS, No. 03-215V, 2010 WL 892248 (Fed. Cl. Spec. Mstr. March 12, 2010) (ruling by Special Master Campbell-Smith, now ChiefJudge ofthis Court); and Dwyer v. //l/S, No. 03- 1202V, 2010 WL 892250 (Fed. Cl. Sec. Mstr. March 12, 2010) (ruling by Special Master Vowell, now ChiefSpecial Master). Each ofthe three opinions rejected the alleged causal connection for many dllerenl reasons, n addition to the negative epidemiologic studies as to which the Petitioners in this case allege liaud, And even in the single area of epidemiologic studies, each ofthe three special masters relied upon zaay epidemiologic studies by different researchers flom different countries. (E.g., King,2010WL *63-*67.) 892296, at Thus, even ifone oreven a few ofthose epidemiologic studies were discredited-and I have made no ruling concerning that irreleyant assertion in this case-such discrediting clearly would ,?o, discredit the overqll overwhelming weight of the evidence cited in three test cases cited above, which found no merit to the alleged fCV-autism connection, based not only upon zary epidemiologic studies, but also upon many other vtays in which the alleged causal connection was shown to be scientifically highly unlikely. l2 Case 1:08-vv-00024-TCW Document 81 Filed 01/07/15 Page 13 of 20 the type of fraud contemplated by the Federal Circuit in Cloer as invoking equitable tolling in ifl Vaccine Act cases. Even were to accept petitioners' arguments and apply equitable tolling (and thus not dismiss their petition for untimely filing), their Table claim would still have to be dismissed for failing to meet the Table's injury requirements. I{owever, it is quite clear that this petition, which Petitioners, in their Amended Petition, have now narrowed to a Table Encephalopathy claim with respect to the MMR vaccination of April 13, 2004, was filed far out of time with respect to that April 2004 Table Encephalopathy claim. Nor, even assuming Ihat the Danish study by Thorsen was a fraudulent study, would that extend the statute of limilations for Petitioners' claim, since that alleged fraud concems the issue of thimerosal-containing vaccines, and has nothing to do with the issue of whether an MMR vaccine, which does not contain thimerosal, could cause autism.ll VII PETITIONERS CLEARLY HAVE FAILED TO DEMONSTRATE THAT JG SUFFERED A "TABLE ENCEPHALOPATHY" A. Introduction As noted above, I could dismiss this claim either because it was not timely filed, or because Petitioners have failed to demonstrate that JG suffered a Table Encephalopathy. Thus, having found in Section VI of this Decision that their petition clearly was not timely filed with respect to their I'able Encephalopathy claim, I could end my analysis at that point. However, in the interest ofcompleteness, I will now analyze the merits of the Table Encephalopathy claim. I llnd that JG drd not suffer a Table Encephalopathy, for the reasons set forth below. B. Legal standard: Table Encephalopathy For petitions, such as this one, filed after the modifications to the Vaccine Injury Table that went into effect on March 24, 1997, "encephalopathy" exists as a Table Injury for MMR vaccinalions. I will set tbrth the relevant Table Iniurv definition below.'" ' ' Since this case was transferred to me, on May I 6, 2014, I have examined the many documents fi led by Petilioners. I agree completely with the analysis of Special Master Vowell, in her Order issued on November 25,2013, conceming Petitioners' Exs. 25-139 and Petitioners' allegations conceming "liaud." As Special Master Vowell concluded, the allegations in those documents conceming fiaud in the medical community's analysis of thimerosal- contdining vaccines is irrelevanl to the o/i/.), claim that Petitioners have raised in their Amended Petition, that JG's MMR vaccination caused a Table Encephaiopathy in April of 1994. Irunher, I have examined the other documents filed by Petitioners in this case, including, but not limited to, Exhibits l40 and l4l filed on Januaty 27 ,2014, with theI Amended Petition, and the additional exhibits filed on September 12, 2014, with duplicative exhibit numbers, Exs. 140-42. Again, I find no evidence of fiaud by anyone relating to Petitioners"'Table Encephalopathy" claim. D The statute itself contains a version of the Vaccine lnjury Table that applied to vaccinations administered prior to the enactment ofthe Program and for several years after that enactment. See $ 300aa-14(a). However, the Vaccine Injury Table was administratively modified with respect to Progam petitions, such as this one, that were filed after March 24, 1997, See 62 Fed. Reg. 7685,7633 (1997); O'Connell v. Shalqlq,'l9F.3d 170(l'rCir. 1996). That l3 Case 1:08-vv-00024-TCW Document 81 Filed 01/07/15 Page 14 of 20 $ 100.3 Vaccine injury table. (a) In accordance with section 312(b) of the National Childhood Vaccine Injury Act of 1986, r' + * the following is a table of vaccines, the injuries, disabilities, illnesses, conditions, and deaths resulting from the administration of such vaccines, and the time period in which the first symptom or manilestation of onset or of the significant aggravation of such injuries, disabilities, illnesses, conditions, and deaths is to occur after vaccine administration for purposes of receiving compensation under the program: VACCINE INJURY TABLE Vaccine lllness, disabiliry, Time period for first symptom or injury or condition manifestion ofonset or of covered signifi cant aggravation afler vaccine administration Measles, mumps, A. Anaphylaxis or 4 hours of rubella, or any anaphylactic shock its components B. Encephalopathy (or 5-15 days (not less than 5 days (e.9, MMR, MR, encephalitis) and not more than l5 days). R) M, C. Any acute Not applicable complication or sequela (including death) ofan illness, disability, injury, or condition referred to above which illness, disability, injury, or condition arose within the time period prescribed (b) dnd aids to interpretation. The following Qualifications qualifications and aids to interpretation shall apply to the Vaccine Injury Table to paragraph (a) ofthis section: (2) Encephalopathy. For purposes of paragraph (a) of this section a vaccine recipient shall be considered to have suffered an encephalopathy only if such Table modification, along with an earlier administrative modification ofthe Table in 1995 (see 60 Fed. Reg. 7678 (1995)), significantly altered the "Table Injury" categories with respect to the MMR vaccination fiom the version of the Table contained in the statute. The portion ofthe new Table applicable to this case, Iisting "encephalopathy" as a Table lnjury for the MMR vaccination, appears at 42 C.F.R. $ 100.3(a)(IUXB) ( l0- l -97 edition of C F.R.-all C.F.R. references in this Decision will be to the l0-l-97 edition of the C.F.R) t4 Case 1:08-vv-00024-TCW Document 81 Filed 01/07/15 Page 15 of 20 recipient manifests, within the applicable period, an injury meeting the description below of an acute encephalopathy, and then a chronic encephalopathy persists in such person for more than 6 months beyond the date ofvaccination. (i) An acute encephalopathy is one that is sufficiently severe so as to require hospitalization (whether or not hospitalization occurred). (A) For children less than 18 months of age who present without an associated seizure event, an acute encephalopathy is indicated by a significantly decreased level oi consciousness lasting lor at least 24 hours. Those children less than l8 months of age who present following a seizure shall be viewed as having an acute encephalopathy if their significantly decreased level of consciousness persists beyond 24 hours and cannot be attributed to a postictal state (seizure) or medication. (D) A "significantly decreased level of consciousness" is indicated by the presence of at least one of the following clinical signs for at least 24 hours or greater (see paragraphs (bX2)(iXA) and (b)(2)(i)(B) of rhis section lor applicable timeframes): (1) Decreased or absent response to environment (responds, if at all, only to loud voice or painful stimuli); (2) Decreased or absent eye contact (does no1 fix gaze upon family members or other individuals); or (3) Inconsistent or absent responses to extemal stimuli (does not recognize familiar people or things). (E) The following clinical features alone, or in combination, do not demonstrate an acute encephalopathy or a significant change in either mental status or level of consciousness as described above: Sleepiness, initability (fussiness), high-pitched and unusual screaming, persistent inconsolable crying, and bulging fontanelle. Seizures in themselves are not sufficient to constitute a diagnosis of encephalopathy. In the absence of other evidence of an acute encephalopathy, seizures shall not be viewed as the first symDtom or manilestation of the onset ofan acute encephalopathy. (il) Chronic Encephalopathy occurs when a change in mental or neurologic status, first manif'ested during the applicable time period, persists for a period of at least 6 months from the date ofvaccination. 42 C.F.R. g 100.3 (10-l-97 edition of C.F.R.). l5 Case 1:08-vv-00024-TCW Document 81 Filed 01/07/15 Page 16 of 20 Thus, to establish their Table Encephalopathy claim, under the regulatory Ianguage set forth above, Petitioners must demonstrate that JG manifested an injury encompassed in the deflnition of an "acute encephalopathy" within 5 to 15 days of his MMR vaccination, and that a "chronic encephalopathy" was then present for more than 6 months after the acute encephalopathy. 42 C.F.R. $ 100.3(bX2).'' For a child younger than 18 months, presenting without an associated seizure event, an acute encephalopathy is indicated "by a significantly decreased level ofconsciousness . . . lasting for a1 least 24 hours." $ 100.3(bX2Xi)(A). A significantly decreased level ofconsciousness is demonstrated by the presence ofone ofthree clinical signs for a period ofat least 24 hours: "(1) Decreased or absent response to environment (responds, if at all, only to loud voice or painful stimuli); (2) Decreased or absent eye contact (does not fix gaze upon family members or other individuals); or (3) Inconsistent or absent responses to external stimuli (does not recognize familiar people or things)." $ 100.3(bX2Xi)(D). Sleepiness, initability (fussiness), high-pitched and unusual screaming, persistent inconsolable crying, and bulging fontanelle are not, alone, or in combination, a demonstration ofan acute encephalopathy. $ 100.3(bX2XE). An acute encephalopathy is an event "that is sufficiently severe so as to require hospitalization (whether or not hospitalization occuned)." S 100.3(bX2XD." A chronic encephalopathy is defined in the QAI as "a change in mental or neurologic status, first manifested during the applicable time period, [that] persists for a period ofat least 6 months from the date of vaccination." $ 100.3(b)(2xii). The clinical signs and symptoms ofan acute encephalopathy were incorporated into the QAI to "clearly distinguish infants and children with brain dysfunction from those with transient 'lethargy."' Revision of the Vaccine Injury Table, 60 Fed. Reg. at7687. As noted in lttaddell, by then-Chief Special Master Campbell-Smith,'' the QAI definition of "significantly decreased levcl of consciousness" implies "a state of diminished alertness that is much more than mere sleepiness or inattentiveness . . . . [t] requires markedly impaired--or strikingly absent-- responsiveness to environmental or external stimuli, for a sustained period ofat least twenty-four hours." ll/addell v. HHS, No. 10-316V, 2012WL4829291, at *7 (Fed. Cl. Spec. Mstr. Sept. 19, 20t2). '' The qAI section of the Vaccine Injury Table, 42 C.F.R. $ 100.3(b), conlains dertnitions for the terms, such as "encephalopathy," used in the Table. See Althen v. l1F1S, 5 8 Fed. Cl. 270, 280 (2005) , affd, 418 F.3d 1274 (Fed. Cir. 2005) (noting that the QAI should be used to interpret key terms found in the Table). 'a When revising the QAI definition, it was noted that the hospitalization requirement was not intended "as an absolute requirement to establish an acute encephalopathy, but rather as an indicator ofthe severity ofthe acute event." Revision ofthe Vaccine Injury Table, 60 Fed. Reg. 7685,7681 (Fed.20, 1997) (preamble to final rule) 15 On September 19, 2013, ChiefSpecial Master Campbell-Smith was appointed Judge ofthe U.S. Court ofFederal Claims. On October 21,2013, Judge Campbell-Smith was designated as the ChiefJudge ofthe U S. Court of Federal Claims. 16 Case 1:08-vv-00024-TCW Document 81 Filed 01/07/15 Page 17 of 20 The revised QAI definition aimed to differentiate between the "diminished alertness and motor activity [] which characterize [a] lethargic infant or child" and the "more serious impairment of consciousness that is the hallmark of encephalopathy (i.e., obtundation, stupor and coma)." Revision ofthe Vaccine Injury Table, 60 Fed. Reg. at7687; see also Romano v. HHS, No.90-1423, 1993WL472879,at *6(Fed. Cl. Spec. Mstr.Nov. l,1993). Therefore, dramatic or severe symptoms must be present to meet the Table Encephalopathy definition.'" C. Analysis of Petitioners' Table Encephalopathy claim Petitioners have clearly failed to show that JG suffered an "acute encephalopathy" as defined by the regulatory language set forth above, and have also failed to show that he suffered a "chronic encephalopathy" thereafter. Accordingly, they have clearly failed to show that JG experienced a "Table Encephalopathy." I. Acute Encephalopathy 'fhe evidence in the record clearly contradicts the Petitioners' claim that JG suff'ered an "acute encephalopathy," with onset of symptoms 5 to 15 days after his MMR vaccination of April I 3, 2004. As noted, Dr. Passer based his diagnosis of an acute encephalopathy, after the MMR vaccination of April 13,2004, upon a statement of Petitioner Denise Greenberg dated December 12.2012. which stated that "we first noticed that Joshua was sick when he had a fever and seemed very sensitive to his sunoundings like to light and sound. He just seemed weak and out of it and very initable." (Pet. Ex. 23,p.3.) That statement of Ms. Greenberg was later filed as an atlachment to Petitioners' Amended Petition on January 27,2014. But that statement, does nol say Ihat such fever and other symptoms occurred at any particular time, much less soon after the MMR vaccination of April 13,2004. (Amended Petition, Jan.27,2014, p. 5.) Second, even if those symptoms did occur 5 to I 5 days after the MMR vaccination in question, in fact the above description by Ms. Greenberg clearly does not match the regulatory definition ofan acute encephalopathy, set forth above, which requires a "significantly decreased level ofconsciousness lasting for at least 24 hours," with "decreased or absent response to environment," "decreased or absent eye contact", or "inconsistent or absent response to external stimuli." (42 C.F.R. $ 100.3(bX2).) To the contrary, to the extent that Ms. Greenberg describes JG as "very sensitive to his sunoundings," and "very irritable," her description is in fact the exacl opposite ofthe Table Encephalopathy definition quoted above--i.e. "decreased or absent response to environment." 'o See, e.g., ,lay v. HHS,998 F.2d 9'79,981,984 (Fed. Cir. 1993) (noting the Special Master's comment that "[w]ith an encephalopathy we typically seen at least one dramatic aspect. This aspect is what separates the events liom the normal range of DTP reactions"; and concluding that the "dramatic aspect" in the case was the child's death): Gamqche v. HHS, 2'l Fed. Cl. 639,642 ( 1993) (upholding a dismissal decision in which the special master had concluded that "screaming and crying in and ofthemselves are not conclusive evidence of encephalopathy. IThe vacinee'sl high-pitched and unusual screaming and inconsolable crying are explainable as a local, systemic reaction to the DPT vaccine rather than as indicia of encephalopathy.") Watt v. H HS,N}.99-25V,2001 WL 166636, ar *8 (Fed. Cl. Spec. Mstr. Jan. 26, 2001) (citing expert testimony that the symptoms relied upon to establish a Table Encephalopathy "cannot merely be crying, it cannot--inconsolable crying; it cannot merely be crankiness; it cannot merely be a nurnber ofthings."). l'7 Case 1:08-vv-00024-TCW Document 81 Filed 01/07/15 Page 18 of 20 Moreover, JG's medical records at Ihe time of the alleged "acute encephalopathy" show no indication at all of an acute encephalopathy. The records ofthe visit on April 13, 2004, show no reaction to the vaccination. (Ex. 3, p. I l, filed March 20, 2008.) The pediatric records do nol show any return visit by JG to his pediatrician in the following weeks. Over the three-month period after the April 2004 MMR, the records show only three phone calls by his parents. On April 23,2004, Mrs. Greenberg called and conveyed that JG was very fussy with swollen gums due to his molars coming in. He did not have a fever, and Petitioners were advised to give him Advil. (1d, p. 15.) The next call occurred on May 28, 2004, and was initiated by Mr. Greenberg. He reported that JG was having a reaction due to an overload of vitamin C. JG had non-itchy, little bumps on his leg, stomach, and arms. Petitioners were advised to monitor his condition and decrease his vitamin C intake. (ld.) The final call was placed on June 4,2004. Alier having a small amount of peanuts, JG began wheezing and his mother was concemed it was an allergic reaction. (ld.,p 9.) Petitioners were instructed to obtain albuterol syrup and told to have JG avoid all nuts, including peanut butter. (1d.) JG's next visit to the pediatrician was on July 13,2004, for his fifteen-month well-child visit. (/z/., p. 11.) At that visit, JG was described as a well-child with a history of bronchospasms. The history indicates there were no reactions to his prior shots, and that he had been experiencing wheezing for six weeks, which corresponds to the possible allergic reaction to peanuts. JG was repofied to be walking without support, drinking from a cup, self-feeding, stacking blocks, and indicating wants without crying. (ltl.) JG's next pediatrician visit, his eighteen-month well-child visit, occurred on October I 3, 2004. (1d., p. 10.) The history reported that he was doing well and, again, had no reaction to his prior shots. JG was assessed as a well-child, who walked well, kicked and thew balls, and used 3 words other than mama and dada. (1d.) JG's next pediatrician visit was at his two-year well-child visit on April 12,2005. (1d., p. I 0.) It was only at that two-year visit that concerns were raised about his development. (1d.) In sum, JG's medical records for the full year f,ollowing his MMR vaccination offer r4o evidence whatsoever lfral he suffered a Table Encephalopathy after that vaccination. To the contrary, the records from both his 15-month and 18-month checks state plainly that he had no reaction to his prior shots. In addition, even the first statement about JG made by Petitioners themselves in this case makes no mention whatsoever of an encephalopathic reaclion or any reaction to the MMR vaccination of April 2004. On March 20,2008, Petitioners filed their Ex. 2, a Statement Regarding Onset by Petitioner Denise Greenberg. (Ex. 2.) That statement reports no problems with JG until shortly before his two-year check-up. (ld.) In sum, when I evaluate the record of this case as a whole, it becomes completely clear that JG did ,?ot suffer an "acute encephalopathy." 2. Chronic Encephalopathy l8 Case 1:08-vv-00024-TCW Document 81 Filed 01/07/15 Page 19 of 20 Petitioners assert that JG suffered an acute encephalopathy after his April 2004 MMR vaccine. Therefore, a chronic encephalopathy must have persisted in JG from then until at least October 2004, to meet the statutory definition for a Table Encephalopathy. The evidence, however, clearly demonstrates that JG did not suffer a chronic encephalopathy that lasted more than six months after his alleged acute encephalopathy. The medical records from JG's 1S-month well child visit (July 13, 2004) and his l8-month well-child visit (October 13,2004) indicate that he was a well child, who was developing normally. (Ex.3, pp. l0-11.) Concems about his development were not raised with his pediatrician until his two- year well-child visit in April 2005. (Pet. Ex. 3, hled 3-20-08, p. 10.) Additionally, Petitioners' written statements, affidavit, and interrogatory responses, as well as Dr. Baum's affidavit, all convey that JC was developing normally up until_sometime around his second birthday, or at least until sometime after he was l8 months old." (See evidence discussed at pp. 8-9, above.) In sum, because JG's medical records indicate no neurologic abnormalities in the six- month period after the vaccination in question, as demonstrated by his routine 15-month and l8- month well-child visits, he cannot be considered to have suffered a "chronic encephalopathy" fbllowing the alleged acute encephalopathy triggered by his MMR vaccination. Thus, petitioners cannot establish that JG meets the Vaccine Act's requirements for a Table Encephalopathy injury claim. VIII CONCLUSION Petitioners' "Table Encephalopathy" claim is hereby dismissed, because (1) that claim was not timely filed, and (2) Petitioners have failed to introduce evidence that would establish that a "Table Encephalopathy" occuned. Further, Chief Special Master Vowell ordered Petitioners to include in their amended petition, all of the causation theories on which they wished to proceed. (Order, issued Nov. 25, 2013, at 4-5.) Because Petitioners, in response, filed an Amended Petition that included only an allegation of a Table Encephalopathy, and they have failed Io establish either that a Table Encephalopathy occurred or that their Table Encephalopathy claim was timely filed, I must dismiss this claim.rs " Petitioners' expert reports do not address whether JG exhibited behaviors consistent with a chronic encephalopathy. Doctor Passer's report only addresses the presence ofan acute encephalopathy, while Dr. Green's repo( opines that JG suffered liom a metabolic encephalopathy, and does not identiry such encephalopathy as caused by or occurring soon after any particular vaccine. Further, as to Dr, Green's report, which opined that JG suffered a "metabolic encephalopathy," the QAI specifies that "an encephalopathy shall not be considered to be a condition set forth in the Table if. . . the encephalopathy was caused by an infection, a toxin, a metqbolic disturbance . . . ." ($ 100.3(bX2)(iii), emphasis added.) 't Because, as demonstrated in Section Vl ofthis Decision, it is clear that Petitioners' Table Encephalopathy claim is time-b.trred, ar4 as demonstrated in Section VII ofthis Decision, it is clear that Petitioners' Table Encephalopathy clatm tswithout mellr, it is appropriate for me to decide this case without an evidentiary hearing. $99 Vaccine Rule 8(d) (a special master has discretion to decide a case without an evidentiary hearing when appropriate under the crrcumstances). l9 Case 1:08-vv-00024-TCW Document 81 Filed 01/07/15 Page 20 of 20 Some additional comments. however. are also in ordcr. The record ofthis case demonstrates plainly that JG and his family have been through a tragic ordeal. I have noted the records describing JG's medical history, and the efforts ofhis family in caring for him. The dedication of JG's family to his welfare is readily apparent to me. I have no doubt that JG's parents are sincere in their beliefthat vaccines played a role in causing JG's autism. JG's parents obviously have read the writings ofphysicians who profess to believe in a causal connection between vaccines and autism. After studying the evidence in this case, and many other cases (see "test cases" mentioned at p. 3 below), I have seen no persuasive evidence whatsoever of such a causal connection. Nevertheless, I can understand why JG's parents found such opinions to be believable under the circumstances. I conclude that the Petitioners filed this Program claim in good faith. Thus, I feel deep sympathy for the Greenberg family. Further, I find it unfortunate that my ruling in this case means that the Program will not be able to provide funds to assist this family, in caring for their child who suffers from a serious disorder. It is my view that our society does not provide enough assistance to the families of a// autistic children, regardless of the cause oltheir disorders. And it is certainly my hope that our society will find ways to ensure that in the fulure much more generous assistance is available to all such children. Such families must cope every day with tremendous challenges in caring for their autistic children, and all are deserving of sympathy and admiration. However, I must decide this case not on sentiment, but by analyzing the evidence. Congress designed the Program to compensate only the families of those individuals whose injuries or deaths can be linked causally, either by a Table Injury presumption or by a preponderance of "causation-in-fact" evidence, to a listed vaccine. In this case, the evidence advanced by the Petitioners has fallen far short of demonstrating such a link. Accordingly,^l conclude that the Petitioners in this case are,lol entitled to a Program award on '' .lG's behalf. In the absence ofa timely-filed motion for review of this Decision, the Clerk ofthe Court shall enter j udgment accordingly. IT IS SO ORDERED. Geoige L. Hastings, rs I also note that the Petitioners filed this case nearly seven years ago. Yet in all that time Petitioners have failed to file a viablc expen report. They have been given a fair chance to prove that JG's autism was connected to a vaccination, but have failed to do so. ================================================================================ DOCUMENT 2: USCOURTS-cofc-1_08-vv-00024-1 Date issued/filed: 2015-08-07 Pages: 2 Docket text: PUBLIC DECISION (Originally filed: 7/16/15) regarding 105 DECISION of Special Master Signed by Special Master George L. Hastings. (jtl) Copy to parties. -------------------------------------------------------------------------------- I Case 1:08-vv-00024-TCW Document 107 Filed 08/07/15 Page 1 of 2 ORIGINAL In tyt WLnittb states Court ofUreteral Claims OFFICE OF SPECIAL MASTERS No. 08-24V (Not for publication) FILED JUL 16 2015 * HOWARD GPvEENBERG and DENISE * U.S. COURT OF GREENBERG, parents ofJ.G., a minor, * Filed: July 16, 2015 FEDERALCLAIMS * Petitioners, * Vaccine Act; Costs v. SECRETARY OF HEALTH AND * HUMAN SERVICES * Respondent. * * ************************* Howardand Denise Greenberg, Kihei, HI pro se petitioners. Lynn E. Ricciardella, U.S. DepartmentofJustice, Washington, DC,for respondent. DECISION AWARDING COSTS Inthiscase under theNational Vaccine Injury Compensation Program,1 Iissued a decision on December 8, 2014. On March 30, 2015, Petitioners, actingpro se, filed an application forreimbursement oftheircosts incurred inprosecuting theirVaccine Actpetition before me. AsstatedinmyOrderfiledonJuly 13, 2015,1 amrelying uponfivefilings to understand the Petitioners' costs request: (1) Petitioners' application filed on 3-30-15, with attachments; (2) Petitioners'filingof5-19-15; (3)Attorney Peck's filingof6-8-15; (4)Attorney Peck's filingof 6-15-15; and (5) Petitioners' filing of6-30-15. As Iunderstand the filings mentioned above, the Greenbergs sent a check to Attorney Peckfor$4,685.00. He usedmostofthatamountto payanexpertwitness(AmericanMedical Experts), butrefunded $555.25 thereoftoPetitioners. So, ineffect, theGreenbergs seek $4,129.75 (thatis,$4,685 less$555.25) forpaying anexpertwitness, plustheothersmall amounts claimed intheir application filed on 3-30-15. Theapplicable statutoryprovisions definingtheprogramarefound at42U.S.C. §300aa-10 etseq. (2006). Case 1:08-vv-00024-TCW Document 107 Filed 08/07/15 Page 2 of 2 InmyOrder filed onJuly13, 2015,1 also indicated mypreliminary approval of compensation for the$4,129.75 mentioned above, plus the other small amounts requested. In response, onJuly 14, 2015, Respondent's counsel contacted my law clerk byemail toreport that Respondent would notbefiling anopposition tosuch anaward. Accordingly, Iwill compensate Petitioners for the following costs: FilingFee $ 250.00 AmountpaidtoAttorney Peck $4,129.75 Amountpaidto expertDr.Megson $ 247.00 MailingandFedExfees(total) $ 722.27 Audiorequest12/18/13 $ 30.00 Total costs awarded $5,379.02 Anawardforfeesandcostsisappropriateatthistime,pursuantto42U.S.C. §300aa- 15(b) and (e)(1). Further, the proposed amounts seem reasonable and appropriate. Accordingly, Ihereby award the following attorneys' fees and costs pursuantto42 U.S.C. §300aa-15(b) and (e)(1): alump sumof$5,379.02, intheform ofacheckpayable toPetitioners, whichrepresents Petitioners' ownlitigation expenses inthiscase. Intheabsence ofatimely-filed motion forreview filed pursuant toAppendix Bofthe Rules ofthe U.S. Court ofFederal Claims, the clerk ofthe court shall enter judgment in accordance herewith.2 IT IS SO ORDERED George L. Hasting Special Master 2PursuanttoVaccine Rule 11(a),thepartiesmayexpediteentryofjudgmentbyfiling ajointnotice renouncingthe rightto seekreview. ================================================================================ DOCUMENT 3: USCOURTS-cofc-1_08-vv-00024-2 Date issued/filed: 2015-11-02 Pages: 4 Docket text: JUDGE VACCINE OPINION AND ORDER affirming the Special Master's 86 Order of Reconsideration denying relief from the judgment entered in this case on January 8, 2015. Signed by Judge Thomas C. Wheeler. [Docketed for Administrative Purposes Only](ar) Copy to parties. -------------------------------------------------------------------------------- Case 1:08-vv-00024-TCW Document 112 Filed 11/02/15 Page 1 of 4 ORIGINAL 3Jn tbe Wniteb Qeourt of jfe beral Qelaims ~tates No. 08-24V (Filed Under Seal: October 13, 2015) (Refiled for Public Availability: November 2, 2015)1 **************************************** * HOWARD GREENBERG AND DENISE * GREENBERG, parents of JG, a minor, * * Petitioners, * v. * * SECRETARY OF HEALTH AND * HUMAN SERVICES, * * Respondent. * * **************************************** * OPINION AND ORDER This case comes to the Court under unusual circumstances. This is a case seeking compensation under the National Childhood Vaccine Injury Act (42 U.S.C. §§ 300aa-1 to 300aa-34, the "Vaccine Act"), which is administered judicially in the U.S. Court of Federal Claims. This Court's Rules (RCFC), including the "Vaccine Rules" found in Appendix E, contain the procedural requirements for actions seeking compensation for vaccine injuries. Petitioners are acting without legal representation and have sought review of the Special Master's decision in the U.S. Court of Appeals for the Federal Circuit, without first seeking the required review in this Court. The Circuit Court has now transferred Petitioner's "Notice of Review" back to the Court of Federal Claims. The question presented is whether this Court has jurisdiction to review the Special Master's order on reconsideration given the procedural setting, and if so, whether the Special Master's reconsideration of his decision and denial of relief was an abuse of discretion sufficient to justify a reversal of the judgment in this case. 1 This opinion was originally filed on October 13, 2015 and held under seal for fourteen days during which the parties had the opportunity to consult and indicate to Chambers any appropriate redactions. No redaction requests were received, and this Opinion is now public. Rules of the Court of Federal Claims ("RCFC"), App. B, Rule 18(b). Case 1:08-vv-00024-TCW Document 112 Filed 11/02/15 Page 2 of 4 BACKGROUND Petitioners originally filed this case in the Court of Federal Claims in January 2008 in the form of a Short-Form Autism Petition, which was delayed pending the outcome of the Omnibus Autism Proceeding (OAP) examining the connection between vaccines and autism. In January 2014 Petitioners filed an amended petition claiming that their child JG suffered a "Table Encephalopathy" following a vaccination in April 2004. On December 8, 2014, the Special Master issued a decision denying relief to Petitioners. (Dkt. No. 80). Petitioners neither moved for reconsideration of the decision by the Special Master under Vaccine Rule 10 ( e ), nor sought review of the decision by a judge of this Court under Vaccine Rule 23. Without further action by Petitioners, judgment became final and was entered on January 8, 2015. On February 3, 2015, Petitioners filed a motion for reconsideration of the decision by the Special Master. On March 20, 2015, the Special Master issued an order on reconsideration denying relief (the "Reconsideration Order", Dkt. No. 86). He noted Petitioners' "problematic" use of the procedural rules in requesting reconsideration at this stage, but went on to review the merits. On March 12, 2015, a week before that decision was issued, Petitioners filed a "Notice of Review" with the U.S. Court of Appeals for the Federal Circuit, bypassing the required appeal to the Court of Federal Claims. The Court of Appeals issued an Order on June 10, 2015 (Court of Federal Claims Dkt. No. 106), finding that there was no right to further review in any court, of the January 8, 2015 judgment denying compensation. However, the Court of Appeals transferred the case back to this Court for a determination of whether Petitioners' March 12, 2015 Notice of Review filed in error with the Court of Appeals, gives this Court jurisdiction to review the March 20 Reconsideration Order. The Court of Appeals noted that the Notice of Review "may be considered to be timely (however premature)" even though it was filed a week before the Reconsideration Order, drawing an analogy to Appellate Rules which permit ripening of a premature appeal after a subsequent event. Petitioners and Respondent have now filed their Memoranda outlining their positions, as requested by this Court's June 18, 2015 Order (Dkt. No. 99). DISCUSSION The Rules of our Court and the accompanying Vaccine Rules can at times present a difficult challenge to a petitioner pursuing a vaccine claim without the help of legal counsel. For example, the distinction between a judge of this Court and a Special Master may not be readily apparent. Petitioners cite Vaccine Rule 31 to support the timeliness of their motion for reconsideration filed after judgment was entered, when in fact Rule 31 does not apply because it speaks to "the assigned judge's decision," rather than to a Special Master's decision. In his Reconsideration Order the Special Master looked instead to Vaccine Rule 36, "Relief from a Judgment" to find support for reconsidering his original opinion even after judgment was entered. Rule 36 applies the guidelines of our Court Rules 2 Case 1:08-vv-00024-TCW Document 112 Filed 11/02/15 Page 3 of 4 59 and 60 in assessing a motion for relief from a judgment. However, as noted by the Special Master, the relief provided in Vaccine Rule 36 is not intended as a substitute for appeal. Vessels v. HHS, 65 Fed. Cl. 563, 569 (2005), Lemire v. HHS, 60 Fed. Cl. 75, 78 (2004 ). Nevertheless, this Court will, in the interest of justice, undertake a review of the Reconsideration Order using the guidelines of Vaccine Rule 36(b )(7), which provide that "the assigned judge may set aside the ruling only if it is found to be arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law." In their Memorandum, Petitioners first claim that the Special Master disregarded the principle of equitable tolling in determining that their petition was filed late and thus was barred by the relevant statute of limitations. Pet'rs Mem. 5. As Respondent pointed out in its Memorandum at page 5, the Special Master did discuss equitable tolling in his Reconsideration Order, noting Petitioners' claims of fraudulent information provided by the Department of Health & Human Services. He found those claims to be "unpersuasive." He also noted that, even if the statute of limitations had not barred the petition, he had found in his original decision that "the record clearly showed that JG did not experience a Table Encephalopathy after the vaccines .... " Reconsideration Order 6. Since a table injury was Petitioners' only theory of recovery, application of equitable tolling principles to cancel the statute of limitations bar would not change the result in this case. Petitioners also claim that they were not granted a fair evidentiary hearing before the Special Master issued his decision. During the six-year pendency of this case, Petitioners filed 140 exhibits, and the Special Masters conducted a total of eight status conferences with Petitioners and counsel for Respondent. Resp 't Mem. 10-11. All of this information was available to the Special Master when he was assigned the case in May 2014. He then gave Petitioners an opportunity to file additional evidence, which they did. Vaccine Rule 8( d) specifically provides that a special master is not required to conduct an evidentiary hearing before a decision is made. Petitioners have not identified any evidence that was not already before the Special Master without a hearing. Thus, there is no reason to set aside the Special Master's decision not to conduct a hearing in this case. Petitioners point to the Special Master's refusal to permit electronic filing of their documents as a denial of "fundamental fairness." Pet' rs Mem. 5-6. However, use of the electronic filing system is not available to parties acting without legal representation under our Court's Rules (see RCFC, Supplement to Appendix B, Electronic Filing Procedure in Vaccine Act Cases). The Special Master has no authority to grant a variance from these rules. Further, Petitioners offered no evidence to show that filing by mail was inadequate to afford enough time to meet filing deadlines. The Vaccine Act defines a petitioner's burden of proof when alleging a "table injury", which refers to specific injuries and vaccines occurring in a specified time period, as described in the "Vaccine Injury Table'', 42 C.F.R. § 100.3. If the injury and the stated time period can be proven, the petitioner is entitled to a presumption that the injury was 3 Case 1:08-vv-00024-TCW Document 112 Filed 11/02/15 Page 4 of 4 caused by the vaccine. In this case Petitioners claimed a table injury of encephalopathy following measles, mumps and rubella (MMR) vaccination. Their Memorandum disputing the Reconsideration Order argues that the Special Master ignored their medical evidence showing injury within the time frame required by the Vaccine Injury Table. However, a review of the Reconsideration Order reveals an extensive analysis of the evidence presented for both an "acute encephalopathy" and a "chronic encephalopathy'', both of which are required for proof of a Table Encephalopathy. Reconsideration Order 6-10. The injury claimed was simply not proven, and this Court can find no reason to rule that the Special Master's Order of Reconsideration should be set aside as "arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law", as required by the Vaccine Rules. Accordingly, the Special Master's Order of Reconsideration of March 20, 2015, denying relief from the judgment in this case entered on January 8, 2015, is AFFIRMED. IT IS SO ORDERED. THOMAS C. WHEELER Judge 4