VICP Registry Case Source Bundle Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_10-vv-00243 Package ID: USCOURTS-cofc-1_10-vv-00243 Petitioner: ERICA FESTER, parent of B.A.B., a minor Filed: 2010-04-15 Decided: 2016-04-28 Vaccine: MMRV Vaccination date: 2007-04-18 Condition: Autism Spectrum Disorder (ASD) Outcome: dismissed Award amount USD: AI-assisted case summary: On April 15, 2010, Erica Fester, as the parent of B.A.B., a minor, filed a petition for compensation under the National Vaccine Injury Compensation Program. The petition alleged that the Proquad (MMRV) vaccine administered to B.A.B. on April 18, 2007, caused him to suffer encephalopathy, leading to developmental regression and delay. Petitioner was initially pro se but obtained counsel, Peter Sarda, on April 17, 2014. Respondent is the Secretary of Health and Human Services. The medical records and expert opinions submitted did not support the petitioner's claim. B.A.B. received the MMRV vaccine at his 12-month well-child visit. Medical records indicated that B.A.B. met all developmental milestones at his nine, 12, and 15-month well-child visits. Following the vaccination, B.A.B. was diagnosed with Autism Spectrum Disorder (ASD) by several physicians, including Dr. John Wilson, Dr. Lynn Wegner, and Dr. Christine Hook. Petitioner's expert, Dr. Karen Harum, a neurodevelopmental pediatrician, opined that B.A.B. suffered from "subclinical encephalopathy," which she defined as a subtle neurologic dysfunction manifesting as developmental regression, loss of language, and sensory processing deficits. Dr. Harum's theory evolved, initially suggesting acute or delayed infectious encephalitis, and later proposing a multi-faceted framework involving a prior viral illness (roseola infantum), granulocytopenia, immune dysregulation, and the vaccine's components (aluminum, glutamate, formaldehyde) contributing to microglial activation and worsening encephalopathy. The Special Master found Dr. Harum's theory lacked a sound medical basis and was not supported by the medical records or relevant literature. Specifically, the Special Master noted that B.A.B. was not diagnosed with encephalopathy or encephalitis, and his symptoms were more consistent with ASD. The court also found that Dr. Harum's theory of causation was similar to theories previously rejected in the Omnibus Autism Proceeding (OAP). Respondent's expert, Dr. Gregory Holmes, a pediatric neurologist, concluded that B.A.B. had ASD and that the MMRV vaccine had no bearing on his condition, stating there was no evidence of acute or subacute encephalopathy and that the MMR vaccine had no link to autism. The Special Master, Chief Special Master Nora Beth Dorsey, determined that petitioner failed to prove causation under the three prongs of the Althen test. The decision found no reliable medical theory connecting the vaccine to encephalopathy, no logical sequence of cause and effect, and no proximate temporal relationship. Consequently, the petition was dismissed for insufficient proof. Petitioner was represented by Peter Joseph Sarda, and respondent was represented by Voris Edward Johnson. The decision was issued by Chief Special Master Nora Beth Dorsey on April 28, 2016. Theory of causation field: Petitioner alleged that the MMRV vaccine administered on April 18, 2007, caused B.A.B. to suffer encephalopathy, leading to developmental regression and delay, diagnosed as Autism Spectrum Disorder (ASD). Petitioner's expert, Dr. Karen Harum, opined that B.A.B. suffered from "subclinical encephalopathy" and proposed a multi-faceted theory involving a prior viral illness (roseola infantum), granulocytopenia, immune dysregulation, and vaccine components (aluminum, glutamate, formaldehyde) contributing to microglial activation and worsening encephalopathy. Respondent's expert, Dr. Gregory Holmes, concluded that B.A.B. had ASD and the vaccine was not a cause. Chief Special Master Nora Beth Dorsey found Dr. Harum's theory lacked a sound medical basis, was not supported by the medical records or literature, and was similar to previously rejected theories. The Special Master determined that petitioner failed to prove causation under the Althen test, finding no reliable medical theory, logical sequence of cause and effect, or proximate temporal relationship between the vaccine and the alleged injury. The petition was dismissed for insufficient proof. The theory was classified as Off-Table. Public staged source text: ================================================================================ DOCUMENT 1: USCOURTS-cofc-1_10-vv-00243-cl-extra-2642517 Date issued/filed: 2013-08-27 Pages: 1 Docket text: Supplementary opinion from CourtListener cluster 2642517 -------------------------------------------------------------------------------- In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 10-243V Filed: August 27, 2013 To be Published1 **************************** ERICA FESTER, parent of * B.A.B., a minor, * * Advance Payment of Petitioner, * Interim Costs v. * * SECRETARY OF HEALTH * AND HUMAN SERVICES, * * Respondent. * * **************************** Erica Fester, Wrightsville Beach, N.C., pro se petitioner. Voris E. Johnson, Esq., U.S. Dept. of Justice, Washington, DC, for respondent. DECISION DENYING PETITIONER’S MOTION FOR ADVANCE PAYMENT OF INTERIM COSTS2 Vowell, Special Master: On April 15, 2010, Ms. Erica Fester [“Ms. Fester” or “petitioner”], acting pro se, filed a petition for Vaccine Compensation under the National Vaccine Injury 1 Because this published decision contains a reasoned explanation for the action in this case, I intend to post this decision on the United States Court of Federal Claims' website, in accordance with the E- Government Act of 2002, Pub. L. No. 107-347, § 205, 116 Stat. 2899, 2913 (codified as amended at 44 U.S.C. § 3501 note (2006)). In accordance with Vaccine Rule 18(b), petitioner has 14 days to identify and move to delete medical or other information, the disclosure of which would constitute an unwarranted invasion of privacy. If, upon review, I agree that the identified material fits within this definition, I will delete such material from public access. 2 In Shaw v. Sec’y, HHS, 609 F.3d 1372, 1375 (Fed. Cir. 2010), the Federal Circuit indicated that “a decision on attorneys’ fees and costs is a decision on compensation” and, following the terminology used by that court, my action in this case is thus characterized as a “decision,” albeit one not on the merits of the underlying petition. Compensation Program, 42 U.S.C. § 300aa-10, et seq.3 [the “Vaccine Act” or “Program”], on behalf of her son, B.A.B. Petitioner alleges that the combined measles, mumps, rubella, and varicella [“MMRV”] vaccine4 which B.A.B. received on April 18, 2007 caused B.A.B. to suffer “a fever, a rash, uncontrollable crying, and loss of language.” 5 Petition at 1. The petition was filed along with an application to proceed in forma pauperis. That application was granted on June 4, 2010. In this decision, I deny petitioner’s request for advance payment of interim costs in order to pay the retainer fee demanded by one of B.A.B.’s treating physicians before commencing work on an expert opinion regarding vaccine causation. I. Procedural History. In the 14 months between the filing of the petition and the unusual request that is the subject of this order, efforts of the court, petitioner, and respondent’s counsel in this case have focused on collecting a complete set of B.A.B.’s medical records, so that respondent and the special master could evaluate the merits of the case.6 Additionally, 3 National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755. Hereinafter, for ease of citation, all “§” references to the Vaccine Act will be to the pertinent subparagraph of 42 U.S.C. § 300aa (2006). 4 On April 18, 2007, B.A.B. received one dose of the vaccine Proquad which contains the measles, mumps, rubella, and varicella vaccines. Petitioner’s Exhibits [“Pet. Exs.”] 3, pp. 2-3; 6, p. 15. 5 Petitioner contends that B.A.B. “suffered an encephalopathy which was caused-in-fact by the MMRV vaccine” and resulted in B.A.B.’s “loss of prior skills and his current developmental delay.” Petition at 1. Although petitioner contends that she is not claiming that the MMRV vaccine causes autism spectrum disorders [“ASDs”], medical records indicate that B.A.B. has a diagnosis on the autism spectrum. Compare Petitioner’s Letter [“Letter”], filed Aug. 31, 2011, at 1-2 (reiterating that although B.A.B. has an autism diagnosis, her theory is that vaccines caused encephalopathy which resulted in a serious brain injury causing [B.A.B’s] regression and delay in development) with Pet. Ex. 12, p. 1 (referring to B.A.B.’s diagnosis of autism at 18 months of age). Based on my experience on what is often termed this court’s “autism docket,” I am aware that some petitioners chose, in spite of an ASD diagnosis, to characterize their children’s injuries as “encephalopathy,” “acute disseminated encephalomyelitis,” or as seizure disorders accompanied by developmental delay, based on a belief that claims alleging autism will not be compensated, but that claims alleging these other conditions may be compensated. Recharacterizing a condition as an “encephalopathy”—a term that can encompass conditions ranging from intoxication to a coma—when another diagnosis is more specific and appropriate does little to advance a vaccine injury claim. Whether the evidence supports vaccine causation of the actual condition from which the vaccinee suffers is the question before the special master in each case. In this case, petitioner acknowledges that her son has an autism diagnosis, but claims he has symptoms “uncharacteristic of a child with autism, and some may even be an (sic) impossible characteristics of a person with true autism.” Letter, filed Aug. 31, 2011, at 1. 6 Because the petition was filed without all the required medical records and an affidavit, the special master then assigned to this case ordered petitioner to complete the evidentiary record to support her claims. See Order, issued June 4, 2010. Petitioner filed some medical records and video evidence. See Pet. Exs. 1-15 (medical records), filed July 14, 2010; Pet. Exs. 16-17 (video evidence), filed Aug. 19, 2010. Two sets of records, those of Dr. Robert Perry and Dr. Karen Harum, were still missing at the time this case was reassigned to me on February 9, 2011. Petitioner filed Dr. Perry’s records on April 14, 2 petitioner has attempted to obtain representation, without success. The special master originally assigned to this case and I have conducted numerous status conferences with petitioner, respondent’s counsel, and B.A.B.’s father.7 The medical records are now largely complete. In her Vaccine Rule 4(c) report, respondent recommended against compensation. In support of her recommendation, respondent noted the statutory prohibition in § 13(a)(1) against a finding in favor of petitioner based on her claims alone, unsubstantiated by medical records or medical opinion, and pointed out that the medical records “do not contain a medical theory causally connecting vaccination and injury, nor do they provide a logical sequence of cause and effect showing that the vaccination was the reason for the injury.” Respondent’s Rule 4(c) Report [“Res. Report”], filed Sept. 10, 2010, at 9 (citing Althen v. Sec’y, HHS, 418 F.3d 1274, 1278 (Fed. Cir. 2005)). Respondent also noted the lack of a “reliable medical opinion demonstrating that [B.A.B.’s] MMRV vaccination either could be, or was the cause of [B.A.B.’s] alleged injuries.” Res. Report at 9. Petitioner responded to the Rule 4(c) report, providing her own recitation of B.A.B.’s medical history. She stated that “[i]t was the opinions of three doctors, Dr. Robert Perry, Dr. Karen Harum and Dr. Lynn Wagner [sic], that [B.A.B.] suffered from encephalopathy. All three could not rule out a vaccine injury, two stated that in their professional opinion, [B.A.B.] had received a vaccine injury.” Response to Respondent’s Rule 4(c) Report [“Response to Res. Report”], filed Feb. 8, 2011, at 3-4.8 However, none of the filed medical records reflects these opinions regarding causation. See Res. Ex. A (medical records from Dr. Karen Harum); Pet. Ex. 12 (medical records from Dr. Lynn Wegner); and Pet. Ex. 18 (medical records from Dr. Robert Perry). My own review of the evidence submitted to date discloses no evidence supportive of vaccine causation of B.A.B.’s condition. The records do not support petitioner’s assertions regarding symptoms in close temporal proximity to B.A.B.’s 12 and 18 month vaccinations. See infra Section III, Part C.2.a. No record from any treating health care provider attributes B.A.B.’s condition to a vaccine injury. 2011. See Pet. Ex. 18. Because Dr. Harum was not responsive to petitioner’s efforts to obtain B.A.B.’s medical treatment records (see Petitioner’s Status Report [“Pet. Status Report”], filed Apr. 14, 2011, noting no response to several phone calls, messages, and email messages to Dr. Harum), I authorized respondent’s counsel to sign and serve a subpoena in order to obtain and file those records. Doctor Harum is the same physician whose retainer fee is the subject of this order. Respondent filed Dr. Harum’s medical records on June 17, 2011. See Respondent’s Exhibit [“Res. Ex.”] A. 7 Although B.A.B.’s father is not named as a petitioner in this action, he has fully participated, at the request of Ms. Fester, in the telephonic status conferences in this case (most of which have been digitally recorded), and for this reason, some of my orders refer to “petitioners,” rather than to “petitioner.” Respondent has interposed no objection to his participation. 8 The pages of this document are unnumbered, but this quotation appears on the bottom of the third and the top of the fourth pages of the document. 3 Nevertheless, in numerous status conferences and in her written filings, petitioner has expressed her firm belief that B.A.B.’s condition is the result of his MMRV vaccine at 12 months of age, and possibly the DTaP vaccine he received at 18 months of age. See, e.g., Letter, filed Aug. 31, 2011, at 1-2. Petitioner acknowledges that the report of a medical expert is necessary in order to prove her case,9 and has suggested on several occasions that an expert should be provided for her. In my initial status conference, held on March 1, 2011, petitioner inquired about government funding of an expert, and seemed to expect that funding for an expert would be made available or that an expert would be appointed for her. I explained that, while interim costs were available and “costly experts” were one of the examples our appellate court had given as warranting an interim award, all of the decisions awarding interim fees and costs involved reimbursement, not advancement, of fees and costs. That is, interim costs had been awarded only after the expert had submitted a bill for services actually rendered, and had been paid by petitioners or their attorneys. I noted that the issue of advancing costs had arisen in one of my other cases, and in that case, respondent had objected to any award of costs in advance of petitioner’s payment of such costs. In a July 7, 2011 status report, petitioner reported her lack of success in finding an attorney.10 She tied her lack of representation to lack of an expert evaluation, stating: “I believe it would be helpful in my search for legal representation to have an objective expert witness, who has examined [B.A.B.] and his medical records, write up a report complete with a summary indicating a probability of a specific cause for [B.A.B.’s] injury. I would imagine that at some point a similar witness for the Respondent will be provided by public funding or via the Court to review [B.A.B.’s] medical records.” Status Report, filed July 7, 2011, at 1. “We are unable to pay for an expert witness and would hope that the Court could assist in this.” Id. Much of the ensuing July 28, 2011 status conference was focused on petitioner’s status report comments. Petitioner confirmed that her status report statement should be construed as a request for the court to appoint an expert witness to assist her. I explained that it was petitioner’s burden to support her claim of a vaccine injury. I also explained that independent medical examinations were occasionally performed, but their use was generally limited to resolving disputes among experts concerning a 9 In my initial status conference with petitioner on March 1, 2011, I explained that once missing medical records were filed, petitioner would need to find an expert willing to opine on vaccine causation, and that a causation hearing would likely be necessary if she was successful in finding a doctor to opine. See, e.g., Order, issued July 28, 2011, at 1. 10 Petitioner indicated that she was looking for an attorney within a two-hour drive of her home because “it would be much more productive to have face to face meetings rather than phone conversations. . . .” Status Report, filed July 7, 2011, at 1. In a status conference on July 28, 2011, I encouraged her to broaden her search, noting that many, if not most, Vaccine Act petitioners are represented by attorneys who do not practice in the same geographical location as their clients. 4 diagnosis or the nature and extent of injuries for purposes of determining damages. I indicated that, based on the posture of her case,11 I would not appoint an expert to conduct an evaluation of B.A.B. During this status conference, we also discussed the use of interim costs to pay for an expert and how to go about finding an expert willing to opine. I noted that the law on payment of interim costs was not yet well-developed, and that there was no precedent in the Vaccine Program supporting payment of those costs in advance, but that I would hear any arguments she might make concerning such payment. Although none of B.A.B.’s treating physicians had indicated that B.A.B.’s problems were vaccine-caused, I suggested that petitioner begin her search for an expert by approaching those physicians to see if they could suggest an expert who might be willing to review the case. If petitioner found an expert willing to review the case, she was to provide the court with information regarding the expert’s qualifications, the expert’s hourly rate, and how many hours the expert would expect to need to formulate an opinion. If the expert required some payment in advance of reviewing the case (a retainer fee), petitioner was directed to provide evidence concerning her inability to pay a retainer.12 Finally, I indicated that I had no doubt about petitioner’s good faith belief that vaccines were somehow responsible for B.A.B.’s condition, but the law required that I also find a reasonable basis for the claim in order to award any costs. See Order, issued July 28, 2011. II. The Request for Advance Funding. A. Petitioner’s Request for Advance Funding. On September 26, 2011, petitioner notified the court that Dr. Harum had agreed “to develop an opinion as to the cause of” B.A.B.’s injury. Notice, filed Sept. 26, 2011, at 2. Petitioner indicated that Dr. Harum’s requested rate was $300 per hour and that Dr. Harum had estimated it would take 30 to 40 hours to develop her expert report. Id. Petitioner requested that the court provide the funds necessary to pay Dr. Harum. Id. 11 As discussed more completely in Section III, Part C.2 below, the filed medical records are not supportive of petitioner’s claims of a reaction to the April 17, 2007 vaccinations. Her own statements, made prior to filing this claim, initially attributed B.A.B.’s condition to causes other than the MMRV vaccine, and first mentioned the measles vaccination as a cause in 2009. See Pet. Ex. 12, p. 6. 12 Petitioner failed to provide this evidence until January 26, 2012 when she filed a response to my December 13, 2011 Order. In her response, petitioner indicated that she filed for bankruptcy on October 14, 2010, reported $4,792.00 in income on her 2010 income tax return, expected to report income of less than $10,000.00 on her 2011 income tax return, and was currently caring for B.A.B. full time as he could not attend school due to behavioral issues. Response, filed Jan. 26, 2012, at 2. Petitioner added that B.A.B.’s father once provided generous support but he had “suffered a life threatening injury at the end of 2010,” was unable to work for a year, and was currently unemployed. Id. 5 I ordered petitioner to file Dr. Harum’s curriculum vitae, as well as a statement from Dr. Harum indicating: (1) her willingness to opine; (2) the amount of any required retainer fee; (3) the date when Dr. Harum could complete her expert report; and (4) Dr. Harum’s hourly rate for expert services in other cases. Order, issued Sept. 28, 2011, at 1. During a status conference on December 9, 2011, I reiterated that petitioner needed to file all of the information concerning Dr. Harum identified in my September 28, 2011 Order, as well as evidence demonstrating petitioner’s inability to pay for an expert. On January 26, 2012, petitioner filed additional medical records, a statement of completion, and the information concerning Dr. Harum. See Pet. Exs. 20-22. In petitioner’s exhibit 22, Dr. Harum indicated that: (1) she was willing to opine in this case; (2) she charges $300 per hour to testify as an expert or to prepare an expert report; (3) she estimated an expert report in this case would require approximately 20 hours of her time; and (4) she would charge a retainer fee of $600 (10% of the total anticipated fee). Pet. Ex. 22 at 7. In a February 24, 2012 status conference, respondent’s counsel indicated that respondent would oppose an award of interim costs covering the requested retainer. I therefore urged petitioner to exhaust all other options for obtaining funds for the $600 retainer fee. Respondent filed her written opposition to petitioner’s request for advance payment of expert costs on March 8, 2012. See Respondent’s Opposition to Petitioner’s Request for an Advance of Interim Expert Costs [“Res. Opp.”] at 1. On April 13, 2012, petitioner reported that she was unable to secure funds for the retainer fee. Response to Respondent’s Opposition to Petitioner’s Request for an Advance of Interim Expert Costs [“Response to Res. Opp.”] at 2. Petitioner reiterated her request for advance payment of interim costs. Id. at 5. B. Arguments Advanced by the Parties Regarding Petitioner’s Request. 1. Petitioner’s Position. In essence, petitioner’s arguments are equitable. She acknowledges that she cannot prevail in her claim without an expert opinion. Based on her financial need, she contends that the Program should provide advance funding of costs because there are no other alternatives available to her. Reading between the lines of her request, petitioner appears to be arguing that because respondent has access to tax-supported experts, she should as well, in the interest of fairness. Petitioner argues that “[t]he need for detailed affidavits by a medical expert is clear” and asserts that she is “unable to afford an expert witness.” Response to Res. Opp. at 2. Furthermore, she claims that her ability to find an attorney to represent her is affected by the lack of an expert’s 6 review. She asserts that she has “made every attempt to retain legal representation”13 and to secure the funds necessary to obtain an expert report.14 Id. Petitioner believes that “respondent’s use of the term ‘scant evidence’ [indicates] that [respondent] has made some kind of informed opinion as to the scientific authentication of the petitioner’s claim.” Response to Res. Opp. at 2. Petitioner requests a copy of “any such scientific evidence the respondent has obtained on her behalf in order to make such an opinion” and any expert report that respondent has. Id. at 2-3. Finally, petitioner questions “what the respondent believes a reasonable cost for an expert opinion might be” and argues that advance payment of Dr. Harum’s $600 retainer is reasonable. Id. at 2. 2. Respondent’s Position. In opposing petitioner’s request, respondent contends that interim fees and costs are not authorized until entitlement to compensation has been either awarded or denied; that costs must be actually incurred before they can be paid by the Program; that the record before me does not support a reasonable basis for this claim; that Dr. Harum’s qualifications to provide an expert report are lacking; and that fees she proposes to charge have not been established to be reasonable. Res. Opp. at 1. Respondent does not address petitioner’s position that the government’s access to experts mandates a level playing field nor does she address the request for disclosure of the results of any medical review performed by respondent.15 13 Whether petitioner has truly exhausted all efforts to obtain representation is not easily determined. With regard to her position that no attorney will take her case because of the lack of an expert report, I note that Vaccine Act practitioners routinely accept cases lacking an expert’s report. Although, it is true that most of the attorneys who once represented autism petitioners have withdrawn from representation of clients who continue to pursue autism claims, the refusal to pursue these cases is not universal. Based on my own docket, which includes about one-half of the autism or similar neurological injury claims still pending in the Program, I am aware that at least half a dozen attorneys are still pursuing such claims. Several of these attorneys have taken over cases for pro se litigants. Nevertheless, for purposes of determining whether I have the authority to order advance payment of her expert’s retainer fee, I will treat petitioner’s statements regarding her efforts to obtain representation as correct. 14 Petitioner explained her financial circumstances in a response filed on January 26, 2012. See supra at note 12. Petitioner also claims that she “has made every attempt to secure the necessary funds to produce an expert witness’ opinion . . . [and] has been unable to do so,” but fails to describe her efforts in any detail. Response to Res. Opp. at 2. 15 Petitioner’s request for disclosure of any medical review performed by respondent is DENIED. Until filed with the court as an exhibit or as an attachment to a Vaccine Rule 4(c) report, any medical review by respondent’s expert would not be discoverable under the Rules of the United States Court of Federal Claims [“RCFC”]. RCFC 26(b)(3)(A)&(B); see also RCFC 26(b)(4)(B) (discussing draft reports); Deseret Mgmt. Corp. v. U.S., 76 Fed. Cl. 88, 92-93 (2007) (discussing the application of the work-product privilege to RCFC 26(b)(3)). 7 III. Analysis of the Arguments. The Vaccine Act is extraordinarily generous in its provisions for payment of fees and costs. Motivated by a desire to ensure that petitioners have adequate assistance from counsel when pursuing their claims, Congress determined that attorneys’ fees and costs may be awarded even in unsuccessful claims. H.R. REP. NO. 99-908, at 22 reprinted in 1986 U.S.C.C.A.N. 6344, 6363; see also Cloer v. Sec’y, HHS, 133 S.Ct. 1886, 1895 (2013); Saunders v. Sec’y, HHS, 25 F.3d 1031, 1035 (Fed. Cir. 1994). As Judge Lettow noted in Davis, “the Vaccine Program employs a liberal fee-shifting scheme.” Davis v. Sec’y, HHS, 105 Fed. Cl. 627, 634 (2012). It may be the only federal fee-shifting statute that permits unsuccessful litigants to recover fees and costs. In more than 24 years of Vaccine Act litigation, very few unsuccessful litigants have been denied fees and costs awards, so long as jurisdictional requirements for payment were met.16 Ms. Fester seeks to extend that generosity by asking me to provide advance funding for the expert she has chosen. In essence, petitioner is saying that, because she cannot establish causation of B.A.B.’s case without an expert opinion and cannot afford to pay an expert, the Program should provide the funds in advance to enable her to retain an expert. I analyze Ms. Fester’s request by looking to the statute itself, its legislative history, the arguments of the parties, the requirements for an interim award of fees and costs, and the effects of granting or denying petitioner’s request. I conclude that although the evidence supporting a reasonable basis for this claim is not strong, it is sufficient to support an award of interim costs once the costs have been incurred, but that I lack the authority to advance Program funds to petitioner for the purpose of retaining an expert. A. The Statutory Compensation Scheme. The Vaccine Act provides: If the judgment of the United States Court of Federal Claims on such a petition does not award compensation, the special master or court may award an amount of compensation to cover petitioners’ reasonable attorneys’ fees and other costs incurred in any proceeding on such petition if the special master or court determines that the petition was brought in good faith and there was a reasonable basis for the claim for which the petition was brought. 16 See Jessen v. Sec’y, HHS, No. 94-1029V, 1997 WL 48940, at *4-5 (Fed. Cl. Spec. Mstr. Jan. 17, 1997) (providing a detailed discussion of the fee structure under the Vaccine Act and its effect on the behavior and motivation of attorneys practicing in the Vaccine Program). 8 § 15(e)(1). The statute explicitly provides for payment of reasonable attorney fees. Although it does not explicitly state that costs must be reasonable as well, context suggests, and caselaw mandates, that only reasonable costs may be paid. See Perreira v. Sec’y, HHS, 27 Fed. Cl. 29, 34 (1992), aff’d, 33 F.3d 1375 (Fed. Cir. 1994) (indicating the description of reasonable applies to both costs as well as attorneys’ fees); Gruber ex rel. Gruber v. Sec’y, HHS, 91 Fed. Cl. 773, 796 (2010) (citing § 15(e)(1) and specifying that “[p]etitioners are entitled to compensation for reasonable costs incurred in bringing their Vaccine Act petition”). Special masters determine reasonable hourly rates for experts (a “cost”) in the same manner in which reasonable hourly rates for attorneys are determined. Sabella v. Sec’y, HHS, 86 Fed. Cl. 201, 206 (2009). The statute also requires unsuccessful litigants to demonstrate that their claim was brought in good faith,17 a subjective standard, and upon a reasonable basis, an objective standard. Perreira v. Sec’y, HHS, No. 90-847V, 1992 WL 164436, at *1 (Cl. Ct. Spec. Mstr. June 12, 1992) (describing good faith as subjective and reasonable basis as objective), aff’d, 27 Fed. Cl. 29 (1992), aff’d, 33 F.3d 1375 (Fed. Cir. 1994). The third statutory requirement, that the fees and costs must be “incurred in any proceeding on such petition,” has been invoked to deny compensation for work performed on litigation in other courts, such as when a petitioner files a civil suit for a vaccine injury before filing a petition under the Vaccine Act. See Stewart ex rel. Stewart-Sotelo v. Sec’y, HHS, No. 06-287V, 2011 WL 5330388, at *22-25 (Fed. Cl. Spec. Mstr. Oct. 17, 2011) (citing § 15(e)(1)(b) and determining that “costs associated with previous, civil litigation unrelated to [the proceedings under the Vaccine Act] are not compensable”). Special Master Golkiewicz also discussed the meaning of incurred when he denied a fee award for research and legal work performed by a petitioner’s spouse (an attorney) prior to retaining counsel familiar with the Vaccine Program. Kooi v. Sec’y, HHS, No. 05-438V, 2007 WL 5161800 (Fed. Cl. Spec. Mstr. Nov. 21, 2007). The main issue in the decision was whether the work done by Mr. Kooi was an “incurred" cost or unreimbursable “self-help” work. Id. at 1-2, 5. Both decisions involved requests for final fees and costs. Here, respondent focuses on the word “incurred” to argue that costs may not be advanced before the work on the case is performed. The definition of “incurred” as used in § 15(e)(1) and applied to an application for interim costs appears to be an issue of first impression. This argument is addressed in more detail in Part E below. B. May Interim Awards be Made before Entitlement is Determined? 17 Absent some evidence to the contrary, good faith is presumed. Grice v. Sec’y, HHS, 36 Fed. Cl. 114, 121 (1996). 9 1. Interim Awards in General. Although the statute itself is silent regarding interim awards, the Federal Circuit has held that such awards are permissible. See Shaw v. Sec’y, HHS, 609 F.3d 1372 (Fed. Cir. 2010); Avera v. Sec’y, HHS, 515 F.3d 1343 (Fed. Cir. 2008). To be eligible for an interim award, a petitioner must demonstrate not only the good faith and reasonable basis required of unsuccessful claimants, but such factors as “protracted proceedings,” “undue hardship,” and that the fees and costs sought are substantial. Avera, 515 F.3d at 1352. In Shaw, the Federal Circuit ruled that interim fees could be awarded in advance of a decision on the merits of the petition so long as the need for an interim award could be demonstrated and there was sufficient evidence for the special master to conclude that good faith and a reasonable basis existed. Shaw, 609 F.3d at 1375. The court further indicated that “[w]here the claimant establishes that the cost of litigation has imposed an undue hardship and that there exists a good faith basis for the claim, it is proper for the special master to award interim attorneys’ fees.” Id. In both Avera and Shaw, the Federal Circuit noted that interim fees and costs need not be awarded in all circumstances. Shaw, 609 F.3d at 1375; Avera, 515 F.3d at 1352. The Federal Circuit explained that “[t]he special master may determine that she cannot assess the reasonableness of certain fee requests prior to considering the merits of the vaccine injury claim.” Shaw, 609 F.3d at 1377. Even if a petitioner can establish the statutory good faith and reasonable basis requirements for payment of fees for her as yet unadjudicated claim, the petitioner still must show why an interim award is appropriate. See Avera, 515 F.3d at 1352 (holding that although the Vaccine Act allows for interim awards, an award was not appropriate in that case). The factors that delineate when an interim award is appropriate remain somewhat amorphous. The Federal Circuit has indicated only that an interim award is appropriate when, as stated in Shaw, “the cost of litigation has imposed an undue hardship,” or, as stated in Avera, “proceedings are protracted” or “costly experts must be retained.” Shaw, 609 F.3d at 1375; Avera, 515 F.3d at 1352. 2. Revisiting Shaw. In spite of Shaw, respondent contends, citing § 15(e)(1), that interim fees and costs are not authorized under the Vaccine Act unless entitlement to compensation has been either awarded or denied. Res. Opp. at 3. Respondent bases her argument on the language “[i]f the judgment . . . on such a petition does not award compensation” (emphasis added), contained in § 15(e)(1) and refers to this argument as her statutory argument. Res. Opp. at 3-4. Respondent contends that the Federal Circuit’s holding in Avera is consistent with her position because a decision on entitlement had been made in that case. Res. Opp. at 4-6. The first line of the statute appears to support respondent’s position that such awards may not be made until after judgment on the merits, implying that the discretion to award fees and costs to unsuccessful litigants does not attach until after judgment 10 has issued. By implication, a petitioner is not “unsuccessful” until a determination of the merits of a petition has occurred. However, this reading cannot be reconciled with the panel decision in Shaw in which the Federal Circuit held that “the Court of Federal Claims has jurisdiction to review interim fee decisions prior to the decision on the merits of the underlying claim.” Shaw, 609 F.3d at 1376. Thus, the Circuit rejected implicitly respondent’s position here that a judgment on the merits is necessary before fees and costs can be awarded. Respondent acknowledges that “a number of special masters” and Judge Bruggink at the Court of Federal Claims [“CFC”] have relied on the Federal Circuit’s holding in Shaw to reject respondent’s statutory argument, but she contends that she failed to present this statutory argument to the Federal Circuit in Shaw. Res. Opp. at 6. Respondent further contends that her failure to raise this statutory interpretation argument in Shaw does not prohibit her from raising it in this case. Res. Opp. at 6 (citing United States vs. Mendoza, 464 U.S. 154, 162 (1984)). Respondent also argues that the panel in Shaw failed to address an earlier decision by another panel (Martin v. Sec’y, HHS, 62 F.3d 1403 (Fed. Cir. 1995)), a decision which respondent interprets as requiring a judgment on the merits before a special master can award fees and costs. Res. Opp. at 7. 3. Conclusion on Interim Awards in the Absence of an Entitlement Decision. I reject respondent’s position that a decision on entitlement is required before interim costs may be awarded. Notwithstanding respondent’s arguments, I read Avera and Shaw together as indicating that interim fees may be awarded before entitlement is determined, provided that good faith and a reasonable basis for the claim are demonstrated on the record and adequate justification for making an interim award exists. C. Has Petitioner Established Adequate Justification for an Interim Award? To justify an interim award of fees and costs, a petitioner must demonstrate that her claim was brought in good faith and upon a reasonable basis. Additionally, because she is seeking an interim award, she must demonstrate circumstances warranting an interim award. Although the precise parameters of these circumstances have not yet been defined, the Federal Circuit has referred to “protracted proceedings,” “costly experts,” and “undue hardship.” Avera, 515 F.3d at 1352; Shaw, 609 F.3d at 1375. Whether these factors are absolute requirements or merely examples of circumstances warranting an award of interim costs (a process that, of necessity, competes for time and attention with the process of deciding entitlement to compensation and awarding damages to petitioners who prevail, and which largely benefits the attorney rather than the petitioner) remains unclear. I need not address this issue in Ms. Fester’s case because she is clearly asserting that she is experiencing “undue hardship.” 11 1. Good Faith. Respondent “does not dispute that petitioner filed the claim in good faith.” Res. Opp. at 9 n.7. I agree that petitioner has a good faith belief in the merits of her case. 2. Reasonable Basis. Whether this claim has a reasonable basis is more difficult to ascertain. Respondent argues that it does not, Res. Opp. at 9-10, and has moved to dismiss the case because the evidentiary record does not support petitioner’s contentions. Res. Report at 8-9. For purposes of this motion, respondent also contends that I cannot yet determine if a reasonable basis for this claim exists. Res. Opp. at 10. Respondent points out that the medical records do not support petitioner’s claim that B.A.B. suffered an encephalopathy caused by his MMRV vaccination. Id. at 9. Although petitioner has indicated that Dr. Harum’s expert opinion will support her claim, respondent argues that, in the absence of such a report, “it is premature” for me to determine that a reasonable basis exists. Id. at 9-10. I agree there is scant evidence to support a reasonable basis for this claim, based on the evidence filed to date. The following summary of the medical records illustrates the contradictions between the assertions made in the petition and the records filed. a. Analyzing Petitioner’s Assertions in Light of the Filed Medical Records. Petitioner contends that the MMRV vaccine which B.A.B. received on April 18, 2007 caused B.A.B. to suffer “a fever, a rash, uncontrollable crying, and loss of language.” She also alleges that B.A.B. “suffered an encephalopathy which was caused-in-fact by the MMRV vaccine” and resulted in B.A.B.’s “loss of prior skills and his current developmental delay.” Petition at 1. The medical records present a different picture. After the April 2007 vaccinations, B.A.B. was next seen by health care providers some three months later in the emergency room for a laceration to his upper lip.18 No mention was made of any health or behavior concerns since his last health care visit, but, given the nature of the treatment sought, behavioral concerns might not be raised. 18 Although petitioner characterized this laceration as “gaping,” the ER staff described a one cm superficial laceration which was closed using steri-strips. Pet. Exs. 4, p. 17; 5, pp. 1, 5. The next day, B.A.B. was seen by his pediatrician who described the injury as a shallow laceration with a scab already formed, adding “[t]here is no evidence that it was ever gaped open.” Pet. Ex. 6, p. 3. 12 B.A.B. was next taken to his primary care provider in mid-August 2007, when he was about 15 months of age, for a high fever the night before and some increased fussiness. He was diagnosed with a viral syndrome. Pet. Ex. 6, p. 3. No mention was made of any earlier high fever, uncontrollable crying, or loss of language or other skills. Ms. Fester called the pediatrics office in mid-September, 2007 complaining of B.A.B.’s fever19 and two weeks of bloody nasal discharge. She indicated that B.A.B. was acting normally, but had less appetite. Pet. Ex. 4, pp. 13-15. B.A.B. was seen at the practice two days later. His eardrums were red, but there was no discharge. Once again, he was diagnosed with a probable viral syndrome. Pet. Ex. 6, p. 4. At B.A.B.’s 18 month well child visit on October 19, 2007, he was noted to say at least three words, in addition to “mama” and “dada,” but his mother was concerned about his speech development. She reported that his speech was at the same level as it was at one year of age. B.A.B. was “[s]aying quite a few words,” Pet. Ex. 6, p. 4, but they were the same words he had previously used and he did not seem to be interested in acquiring new words. She also reported that although he appeared to have normal hearing, B.A.B. was not responding to his name.20 Id., p. 4. The pediatrician suggested waiting until January, 2008, before taking any further action. Id. No prior side effects following immunizations were noted, and B.A.B. received a DTaP vaccination at this visit. Pet. Exs. 3, pp. 2-3; 6, p. 16. B.A.B.’s records contain a handwritten entry for November 6, 2007, but I cannot decipher it. Pet. Ex. 6, p. 4. On November 23, 2007, B.A.B. was scheduled for an influenza booster, but he had a fever the night before, with a temperature of 104° Fahrenheit, and he seemed lethargic. On examination, B.A.B. was cranky but easily consoled, and his right ear was normal except for a slight redness. Id. During the visit, the pediatrician questioned petitioner about B.A.B.’s speech because he did not speak at all during the examination. Ms. Fester reported that B.A.B. did not point and did not try to show things to his parents.21 This pediatrician suggested investigating the possibility of ASD. Pet. Ex. 6, p. 4. Later that same day, Ms. Fester called to report that B.A.B. was running a fever of 103.5°, had blotchy skin, an intermittent blue tinge to his lips, and a runny nose. Pet. 19 She indicated it had been 102° in the morning, and reduced to 99° after she gave B.A.B. Motrin. 20 Both the plateau in language development and the lack of response to his name are early symptoms of an ASD, and are often the first symptoms noticed by parents or other caregivers. See White v. Sec’y, HHS, No. 04-337V, 2011 WL 6176064 (Fed. Cl. Spec. Mstr. Nov. 22, 2011) (discussing symptoms of ASDs). 21 Lack of pointing to share, as opposed to pointing to express wants or needs, is an early symptom of ASD often noted by caregivers or health care providers. See White, 2011 WL 6176064, at *7 (discussing this early symptom of ASDs). 13 Ex. 4, pp. 11-12. He was seen in the office that evening. His pulse oxygen level was 96-98% on room air, and he was described as alert and interactive, but crying. He was assessed as having a possible reaction to the antibiotic given for treatment of his otitis media. Pet. Ex. 6, p. 5. B.A.B. continued to run a fever and was seen again on November 29, 2007. Ms. Fester also shared concerns about his behavior, and reported that she had been in touch with an ASD diagnosis and treatment program to arrange for an evaluation. Pet. Ex. 6, p. 5. With regard to his fevers, she was worried that B.A.B. might have leukemia instead of otitis media or a viral illness. She reported that he seemed to be feeling well in general and was eating and drinking well. She also expressed concern about possible seizure activity, as he sometimes stiffened and appeared unresponsive, but he did not shake and was not incontinent after the episodes. She observed that B.A.B. would wake up screaming during the night and during naps. She wondered if his history of high fevers might have affected his brain. Id. The physician noted that many of Ms. Fester’s numerous concerns appeared to have been prompted by her internet research and that she was quite preoccupied with what she saw as B.A.B.’s behavioral disorders. Pet. Ex. 6, p. 5. He explained that a temperature of under 100.4° was not considered a fever and that the complete blood count performed in April had been normal. Id., p. 6. He reassured petitioner that B.A.B.’s behavior was “alert and energetic” and he was not exhibiting “any signs of systemic illness.” Id. He encouraged petitioner to rely only on resources recommended by “reliable health care professionals.” Id. B.A.B. was evaluated for possible autism by North Carolina’s Children’s Developmental Services Agency [“CDSA”] on December 6, 2007. Ms. Fester reported that he had reached most milestones early, that he was able to identify shapes and colors at three months of age,22 and that he was talking in two to three word phrases23 22 In a short video clip filed as Pet. Ex. 16, B.A.B., then six months of age, was shown pointing to the green card when presented with both a red and green card. However, Ms. Fester was required to make her request several times before B.A.B. pointed and, there is no evidence that the way the cards were presented to B.A.B. was ever varied. Thus, other than this parental report, there is no indication that B.A.B. knew his colors at three months of age. 23 Later, in the same report from B.A.B.’s December 6, 2007 evaluation, it is recorded that B.A.B. was using two to three words at eight to nine months of age, rather than using two to three word phrases. Pet. Ex. 7, p. 1. The report of two to three words, rather than the use of phrases, is more consistent, with both normal child development and petitioner’s report to B.A.B.’s pediatrician about his failure to progress in language at B.A.B.’s 18 month well child visit. NELSON TEXTBOOK OF PEDIATRICS (19th ed. 2011) [“NELSON’S”], at 28, 30-31, 34 (noting that the average child begins using repetitive consonant sounds by 10 months of age and uses a few words other than “mama” and “dada” by one year of age, four to six words by 15 months of age, and multiple word phrases beginning at two years of age). The number of words in a sentence generally equals the age of the child in years. Id. at 34. Although B.A.B. was reported to have “lots of words” at his nine month checkup, Pet. Ex. 6, p. 14, a later report suggests that he was echoing words rather than using them independently and spontaneously at this point. See Pet. Ex. 7, p. 5. 14 at eight to nine months of age. Pet. Ex. 7, p. 1. She also reported that he stopped talking at all at around 10 months of age. Id. Based on her report, B.A.B.’s plateau in language occurred about two months before the allegedly causal MMRV vaccine. B.A.B.’s parents attributed his loss of verbal and social skills to a sudden high fever24 of 107.5°. Pet. Ex. 7, p. 1. B.A.B.’s father expressed concern about his son’s fascination with the ceiling fan, pulling books off shelves, and inability to cease an activity until physically stopped. Id., p. 2. Ms. Fester noted that he was a picky eater. Based on their internet research on autism, they had recently placed B.A.B. on a gluten-free diet, with improvement in social behavior and talking as a result. Id., p. 1. B.A.B. was assessed with delays in social skills and language, but was not definitively diagnosed with ASD. Id., p. 3. Later that same day, B.A.B. was seen by his pediatrician. The reason for the visit was a red to pink rash on his torso, and a red, dry, scaly rash on his thighs.25 Ms. Fester reported that she had placed B.A.B. on a gluten-free diet, and that an evaluation earlier that day had assessed B.A.B. as on “the low end” of autism spectrum disorders, with speech at an eight-month level. Pet. Ex. 6, p. 6. The rash was assessed as likely eczema. Id. 24 There were no fevers reported for almost four months after B.A.B.’s April 2007 vaccinations, administered when he was one year old. However, a fever that allegedly reached 107° occurred when B.A.B. was about eight and one half months old, more than three months before B.A.B.’s MMRV vaccination. Ms. Fester called the afterhours service at the pediatrician’s office on December 31, 2006, reporting that a fever began at about 8:20 PM and reached a peak at 102.5° measured tympanically. B.A.B. was drinking, eating, and urinating normally, and had not been vomiting or experiencing diarrhea, and had no rash. His father had been ill recently. Pet. Ex. 4, pp. 22-26. The next day, B.A.B.’s father placed a call to the pediatric practice’s afterhours number, indicating that he was at the emergency room with B.A.B., who had a fever of 107°. He wanted one of the pediatricians to meet him in the emergency room. Id., pp. 19-21. At the emergency room, B.A.B.’s temperature was recorded as 105.9°, and he was observed to have decreased activity, excessive crying, congestion, and nasal discharge. Tylenol and Motrin were administered. Pet. Ex. 5, pp. 6-8. B.A.B.’s father reported that his pediatrician had agreed to meet them at his office, and he and the child left the emergency room against medical advice. B.A.B. was then seen at the pediatrician’s office. He had a minimal runny nose and cough. He was well-appearing, but tired and sleepy. The physician assessed B.A.B. as likely having a viral fever. Pet. Ex. 6, p. 2. On January 3, B.A.B. was seen again by the same physician. B.A.B. continued to have a runny nose, but was well-appearing and in no apparent distress. A complete blood count confirmed the physician’s suspicion that the fever was viral in nature, as the blood results were “reassuringly viral.” B.A.B. had an ulcer on his tongue and one papule on his wrist. Id. 25 Although petitioner contends that B.A.B. experienced a rash as the result of his April 2007 MMRV vaccination, this was the first report of any rash after the 12 and 18 month immunizations. His mother also indicated that he routinely developed rashes after fevers. Pet. Ex. 6, p. 6. 15 In histories provided to specialists diagnosing, evaluating, or treating B.A.B. from January 2007 to July 2008, his parents never attributed his speech stagnation or regression to his vaccinations. See, e.g., Pet. Exs.10, p. 3 (speech therapy evaluation on January 17, 2008, in which his parents reported that B.A.B. was using more words at one year of age, but had since stopped using them and indicating that there were no significant events or changes at the time); 7, pp. 5-6 (CDSA evaluation on January 24, 2008, in which his parents reported a history of mimicking words at six months of age, and regression beginning “after roseola fever with temperature of 107.5°”); Res. Ex. A, p. 113 (an email message to Dr. Harum on July 18, 2008, in which B.A.B.’s father reported that B.A.B. went from being able to say “I love you” at 10 months of age to only one or two words in November 2007, and which indicated that he had no problems after the 107.5° fever, but had developed changes five to six months later). The first mention of any fever or regression associated with his MMRV vaccination did not occur until April 14, 2009. See Pet. Ex. 12, p. 6. b. Determining if a Reasonable Basis Exists. Whether these deficiencies in petitioner’s case are sufficient to conclude that the claim lacks a reasonable basis is a difficult call. Certainly, there is nothing in the record to date to suggest vaccine causation. However, I have seen many cases in which an expert opined in favor of vaccine causation, in spite of the lack of such indications in the medical records, and it is not uncommon for fees and costs to be awarded at the conclusion of a case in that procedural and evidentiary posture. Petitioner filed B.A.B.’s claim a few days before the statute of limitations would have expired, assuming that B.A.B. had the relatively immediate reaction to his April 18, 2007 vaccinations claimed.26 Thus, giving petitioner the leeway normally accorded to petitions filed on the eve of the expiration of the statute of limitations, it is appropriate to conclude that petitioner had a reasonable basis to file the petition. See Hamrick v. Sec’y, HHS, No. 99-683V, 2007 U.S. Claims LEXIS 415, at *14 (Fed. Cl. Spec. Mstr. Nov. 19, 2007) (discussing the more liberal standard for finding a reasonable basis for petitions filed just prior to the expiration of the Vaccine Act’s statute of limitations). However, the Federal Circuit has required something more than “unsupported speculation” to continue to pursue a petition. Perreira v. Sec’y, HHS, 33 F.3d 1375, 1377 (Fed. Cir. 1994); see also Hamrick, 2007 U.S. Claims LEXIS 415, at *15 (distinguishing reasonable basis needed to file a petition from that needed to continue a claim). If petitioner’s causation theory is not premised on facts supported by the record, or is not grounded in reputable medical evidence, his (or his expert’s) espousal of that theory is insufficient to maintain a reasonable basis. See Perreira, 27 Fed. Cl. at 33-34, 26 The petition was filed on April 15, 2007, just three days short of 36 months after administration of the allegedly causal vaccinations. 16 aff’d, 33 F.3d 1375 (Fed. Cir. 1994); Stevens v. Sec’y, HHS, No. 90-221V, 1992 WL 159520, at *4 (Cl. Ct. Spec. Mstr. June 9, 1992). Many cases filed in the Vaccine Program suffer from the same infirmities as does this one. That is, most petitions, like the one in the instant case, are filed based on a belief in vaccine causation, unsupported by the medical records or by expert opinion. In the typical Vaccine Act case, it takes months for petitioners to produce sufficient medical records to allow respondent and the special master to assess whether the claim is colorable. Only rarely is a petition accompanied by sufficient medical records to permit respondent to file a substantive report as contemplated by Vaccine Rule 4(c) within 90 days of the petition’s filing. Even more rarely is a petition accompanied by an expert report or a statement from a treating physician regarding vaccine causation. Yet, in the vast majority of cases, respondent does not challenge the reasonable basis for the claim when petitioners seek payment of final fees and costs for an unsuccessful claim. Fees and costs have been paid, often without opposition by respondent, in cases in which petitioners have been unable to find an expert willing to opine as well as in those in which petitioners have obtained an unfavorable opinion. Experts have been paid simply to review and summarize the medical records. Savin v. Sec’y, HHS, No. 99-537V, 2008 WL 2066611, at *3-4 (Fed. Cl. Spec. Mstr. Apr. 22, 2008); Lamar v. Sec’y, HHS, No. 99-583V, 2008 WL 3845165, at *12-13 (Fed. Cl. Spec. Mstr. July 30, 2008). In this case, a physician who has seen and treated B.A.B. in the past has agreed to opine on whether vaccines are responsible for his condition.27 In the absence of any evidence that she is doing so for reasons unrelated to the vaccine injury claim process, I cannot distinguish this case from hundreds of those in the posture of final fees in which fees and costs have been paid, in spite of the lack of an expert report or evidence of vaccine causation in the medical records filed. 3. Is the Cost Reasonable? Respondent asserts that I cannot determine if the interim costs sought by petitioner are reasonable. Res. Opp. at 10; see also § 15(e)(1). According to respondent, the petitioner is, in essence, asking me to pre-certify Dr. Harum as an expert and pre-approve her rate. Res. Opp. at 10-11 and n.9. Respondent contends that I do not have enough evidence to make such a determination without seeing Dr. Harum’s report. Id. at 11. 27 It is a matter of some concern to me that this particular physician, Dr. Harum, earlier refused to provide petitioner with a copy of B.A.B.’s medical records. To obtain Dr. Harum’s records after she was not responsive to petitioner’s requests, I authorized respondent’s counsel to sign and serve a subpoena on Dr. Harum. See Order, issued Apr. 21, 2011. 17 It is true that Dr. Harum does not have a “track record” as an expert in the Vaccine Program, and based on the somewhat vague statements in the Notice filed September 26, 2011 and Pet. Ex. 22, I cannot determine if she has ever testified as an expert witness regarding causation of an injury or has filed an expert report in any other court. She is, however, a board certified pediatrician, Pet. Ex. 22 at 3, and has seen and treated B.A.B. There is no prohibition in the Vaccine Program against treating physicians testifying as experts. In fact, special masters are abjured to carefully consider the opinions of treating physicians when considering whether vaccine causation has been established. Althen, 418 F.3d at 1280; Capizzano v. Sec’y, HHS, 440 F.3d 1317, 1326 (Fed. Cir. 2006). While her training and experience appear to be less than that of most experts who have testified regarding vaccine causation of ASDs or encephalopathies, generally speaking, her qualifications would affect the weight given her opinion under Daubert v. Merrell Dow Pharmaceuticals, 509 U.S. 579 (1993) rather than its admissibility.28 Her training and experience would certainly be a factor in assessing the hourly rate to be awarded. Based on my experience in the Vaccine Program, most experts who require retainers before rendering an opinion request more money in advance than does Dr. Harum. The average retainer amount in the fees and costs applications I have reviewed, which involve experts in a variety of disciplines, is nearly twice what Dr. Harum is requesting. The requested retainer is, therefore, quite reasonable. Respondent argues that paying the retainer amount would equate to pre- approval of Dr. Harum and her rate. I do not agree. Approving payment of the retainer sought by Dr. Harum does not commit me to accept Dr. Harum’s hourly rate or her estimate of the total cost involved. Thus, should Dr. Harum’s report be of poor quality or the additional hours requested be unreasonable, advance payment of a retainer does not commit the court to approve additional funds. However, whether Dr. Harum’s hourly rate and the number of hours sought are reasonable is secondary to determining whether petitioner can receive Program funds for Dr. Harum’s services in advance of expending payment to acquire those services. 28 Although special masters can decline to consider an expert’s opinion based on lack of qualifications and other factors, such cases are rare. Veryzer v. Sec’y, HHS, No. 06-522V, 2010 WL 2507791 (Fed. Cl. Spec. Mstr. June 15, 2010) (granting respondent’s motion to exclude petitioner’s expert report). More frequently, special masters consider all of the evidence and testimony produced by the parties, and rather than using the Daubert criteria to screen out evidence at the gate to the courthouse, they use the non- exhaustive Daubert criteria to determine what, if any, weight to give to expert opinions. Terran v. Sec’y, HHS, 195 F.3d 1302, 1316 (Fed. Cir. 1999) (approving a special master’s use of the Daubert factors “as a tool or framework for conducting the inquiry into the reliability of the evidence”); Cedillo v. Sec’y, HHS, 617 F.3d 1328, 1339 (Fed. Cir. 2010) (noting that special masters are to consider all relevant and reliable evidence filed in a case and may use Daubert factors in their evaluation of expert testimony); Davis v. Sec’y, HHS, 94 Fed. Cl. 53, 67 (2010) (describing the Daubert factors as an “acceptable evidentiary- gauging tool with respect to persuasiveness of expert testimony already admitted . . . by special masters in vaccine cases”). 18 D. Do the Circumstances of this Case Justify an Interim Award? 1. Protracted Proceedings. This petition has been pending for about 40 months. During the first 15 months, the focus of the efforts of petitioner, respondent, and two special masters was on obtaining sufficient medical records to evaluate the claim. The focus then shifted to petitioner’s efforts to obtain representation and to find an expert willing to opine. Twenty-four months after filing her claim, petitioner reported that she had exhausted her effort to obtain funding for her expert’s retainer fee, and requested that I rule on her application for interim costs.29 In Avera, the Federal Circuit included “protracted proceedings” as a basis for awarding interim fees and costs but did not elaborate on what amount of time would be considered protracted. Avera, 515 F.3d at 1352. The Circuit held that an interim award was not warranted in that case in part because petitioners only sought the award pending appeal. Following the Federal Circuit’s logic, I have awarded interim fees and costs in cases in which further proceedings were likely to be protracted, such as those involving withdrawal of an attorney, and when the damages phase is expected to take some time. Other special masters have awarded interim fees and costs in cases pending for shorter periods of time. See, e.g., Bear v. Sec’y, HHS, No. 11-362V, 2013 WL 691963 (Fed. Cl. Spec. Mstr. Feb. 4, 2013) (awarding interim fees in a case pending for 19 months). In these cases, the request for interim fees and costs accompanied a motion to withdraw as attorney of record.30 While petitioner’s claim has been pending for longer than the statutory “opt out” period, whether this case qualifies as “protracted” is not clear. See § 21(b) (for a description of the statute’s “opt out” period). 2. Undue Hardship and Costly Experts. Before an interim award is appropriate, petitioners must show “that they have suffered undue hardship.” Avera, 515 F.3d at 1352; accord. Shaw, 609 at 1375. Although neither Avera or Shaw contains an example of what undue hardship would entail, the Federal Circuit in Avera specifically held that undue hardship did not exist 29 Unfortunately, my decision on her application has been unduly delayed by entitlement hearings in other cases and efforts to resolve informally approximately 1,000 outstanding final attorney fee applications in the “Cloer hold cases” (cases in which respondent had challenged the award of fees and costs because the claims were untimely filed). At the February 24, 2012 status conference, I did inform petitioner that adjudication of her interim costs application was likely to be delayed. I regret this decision was delayed longer than I had anticipated. 30 The fact that an attorney has filed a motion to withdraw has been viewed as circumstances which warrant an interim fee award. Wood v. Sec’y, HHS, 105 Fed. Cl. 148, 154 (2012). But cf. McKellar v. Sec’y, HHS, 101 Fed. Cl. 297, 302 (2011) (holding that “the mere fact that an attorney plans to withdraw is not necessarily a hardship that triggers an award of interim attorneys' fees and costs”). 19 because “the amount of the fees here was not substantial; appellants had not employed any experts; and there was only a short delay in the award pending the appeal.” Avera, 515 F.3d at 1352. Thus, the Circuit appeared to focus on the hardship of carrying unreimbursed costs for extended periods rather than the financial situation of the petitioner or counsel. Whether expert costs are “expensive” can be evaluated either objectively, i.e., considered in light of other expert costs in the Program, or subjectively, i.e., based on petitioner’s counsel or a pro se petitioner’s ability to carry those costs until final resolution of the case. It makes considerable practical sense to evaluate such costs on an objective basis. A petitioner or petitioner’s counsel who has expended $100,000 in expert costs in a case that may be on review or appeal for several more years certainly presents a more compelling case for an interim award than one who has only a $1,000 expert retainer cost outstanding.31 To look at such cases subjectively would require delving into a law firm’s or expert’s financial situation,32 a requirement that would likely be repellant to the court and law firm alike.33 Using an objective standard, the cost of Dr. Harum’s retainer is not expensive. It does, however, represent a hardship to petitioner.34 Whether it constitutes an “undue” hardship is less clear, particularly when viewed in light of the statutory requirement to file a petition supported by evidence of vaccine causation. 31 In more than seven years of experience as a special master, I am aware that a retainer is often the only expert witness expenditure actually paid at the time a case is resolved without the need for testimony. Because of the relative certainty that expert costs will ultimately be paid even in cases where causation is not established, some experts have been willing to opine based on only a retainer payment, and await the award of fees and costs at a later date in order to collect the remainder of their expert fee. 32 When considering the hourly rate which should be awarded to an attorney, the argument that a law firm’s profitability should be examined has been rejected on the grounds that this further examination was not relevant to that issue. Masias v. Sec’y, HHS, 2009 WL 1838979, at *29 (Fed. Cl. Spec. Mstr. June 12, 2009), aff’d 634 F.3d 1283 (Fed. Cir. 2011). 33 A law firm’s bottom line is not only affected by income but by expenditures and an evaluation of “need” could involve a close look at salaries, benefits, and highly discretionary expenditure decisions. 34 I do realize that because of her financial situation, petitioner’s application to proceed in forma pauperis was granted on June 4, 2010. However, the waiver of a filing fee or court costs required for an indigent person to obtain access to the courts does not thereby compel a court to authorize payment of the expert witness costs necessary to obtain relief. See, e.g., Victor v. Lawler, 2011 WL 722387, at *2 (M.D.Pa.); see also infra Section III, Part F.3. The statute that authorizes me to waive a filing fee does not similarly authorize me to waive expert costs or to provide funding for expert assistance. 28 U.S.C. § 1915 (1996); see also Wiley v. United States, 69 Fed. Cl. 733, 734 (2006) (reiterating the special master’s ruling that although he waived the filing fee, allowing the petitioner in that case to proceed in forma pauperis, he did not have the authority to appoint an attorney for the petitioner). 20 E. The “Incurred” Costs Issue. Respondent’s strongest argument is that the Vaccine Act requires a petitioner to have actually incurred costs before such costs can be paid as part of an interim award. Res. Opp. at 8; see also § 15(e)(1). Respondent defines “incur” to mean become “legally liable to pay.” Res. Opp. at 8 (citing Black v. Sec’y, HHS, 33 Fed. Cl. 546, 550 (1995)). Respondent contends that “petitioner has not incurred any costs for Dr. Harum’s services [as an expert], because Dr. Harum has yet to perform those services.” Res. Opp. at 8. 1. Meaning of “Incurred” within the Vaccine Act. The statute uses the term “incurred,” but does not define it. The common rule of statutory construction is that words are given their plain and ordinary meaning in the absence of any indication otherwise. See Cloer, 133 S.Ct. at 1893 (quoting BP America Production Co. v. Burton, 549 U.S. 84, 91 (2006)). Black’s Law Dictionary defines the word “incur” to mean “[t]o suffer or bring on oneself (a liability or expense).” Black’s Law Dictionary 771 (7th ed. 1999). The Court of Federal Claims has interpreted the word “incur” as it was used in § 11(c)(1)(D)(i), a subsection of the Act that has since been amended to omit the provision containing the word. See Black, 33 Fed. Cl. at 546 (discussing the provision requiring that a petitioner “has incurred in excess of $1,000 in unreimbursable expenses” as a prerequisite for bringing a claim). The court indicated that “[o]ne incurs an expense, therefore, at the moment one becomes legally liable, not at the moment one pays off the debt, nor at the moment when one decides that an expense will become necessary one day in the future.” Id. at 550. In quoting another case, the court observed that “‘[t]o incur means to become liable for or subject to; it does not mean to actually pay for.’” Id. (quoting Quarles Petroleum Co. v. United States, 213 Ct. Cl. 15, 22 (1977)). In 1996, the Federal Circuit heard a combined appeal that included the petitioner from Black and petitioners from two other cases in which the court considered the application of § 11(c)(1)(D)(i). See Black v. Sec’y, HHS, 93 F.3d 781 (Fed. Cir. 1996). In the appeal, petitioners relied on the definition of “incur” found in the Webster’s Dictionary, “to become liable or subject to,” to argue for reversal of the dismissal of their petitions for failing to have satisfied the $1,000 expense prerequisite. Id. at 785 (quoting Webster’s Third New International Dictionary 1146 (1968)). Petitioners argued that given the severity of their injuries they faced the “near-certain prospect of ultimately suffering unreimbursable expenses of more than $1000,” and thus “had incurred” $1,000 in expenses at the time of their injury. Black, 93 F.3d at 785. The Federal Circuit rejected petitioners’ interpretation of “incurred” and held that incurred costs meant “expenses for which payment has been made or for which liability has attached.” Id. at 786. The Court noted that § 15(a)(1)(A) distinguished between 21 unreimbursable expenses incurred at a certain time and those “reasonable projected unreimbursable expenses that have been or will be incurred,” and that adoption of petitioners’ definition would therefore result in superfluous language in § 15 because there would be no difference between the projected expenses that “have been” or “will be” incurred. Id. 2. Application of Definition to Dr. Harum’s Retainer. It does not appear from the documents submitted35 that petitioner is currently obligated or legally liable to pay Dr. Harum. Conversely, Dr. Harum is not legally obligated to begin performance (review of B.A.B.’s case and preparation of an expert report to be filed with the court) until the retainer is paid. Doctor Harum has offered to serve as an expert in this case, but has made payment of the $600 retainer a condition precedent36 for her to begin reviewing the medical records. As Dr. Harum indicated in her letter, she can “have a document prepared within 90 days from the date that I am retained. A retainer fee of $600 will be accepted . . . .” Pet. Ex. 22 at 8 (emphasis added). Until petitioner pays the retainer, Dr. Harum is not obligated to begin performance. Because petitioner has neither made a payment to Dr. Harum nor become legally liable for a payment at this time, petitioner cannot be considered to have incurred a cost. F. Is a Request for Advance Funding Distinguishable from Interim Awards of Fees and Costs? Assuming, arguendo, that petitioner has met all the requirements for payment of interim costs, there are three factors that could militate against advancing payment in this case. First, the legislative history for § 15 of the Act suggests that the provision for payment of fees and costs in unsuccessful cases was included in order to ensure that those seeking compensation for a vaccine injury would have ready access to a competent attorney to represent them, not to ensure that funding would be available to obtain experts. Second, the contemporaneous records and the early reports by petitioner and her husband to health care providers about the onset of B.A.B.’s symptoms differ markedly from the claims now made regarding vaccine causation. Comments by petitioner and B.A.B.’s father suggest that part of the reason for filing and 35 Only the January 22, 2012 letter Dr. Harum wrote regarding her willingness to serve as an expert has been filed. See Pet. Ex. 22. A copy of any formal retainer agreement between Ms. Fester and Dr. Harum has not been provided to the court. 36 As the Court of Federal Claims has noted, “[a] condition precedent is either an act of a party that must be performed or a certain event that must happen before a contractual right accrues or contractual duty arises.” Haddon Housing Assoc., LLC v. U.S., 99 Fed. Cl. 311, 326 (2001) (quoting R. Lord, 13 Williston on Contracts § 38:7 (4th ed. 2000)). 22 pursuing this claim was to obtain a definitive diagnosis and the probable etiology of B.A.B.’s disorder. Payment of fees and costs in advance could encourage the filing of cases in order to obtain expert evaluations that might not otherwise be affordable. Finally, court involvement in the “pre-selection and payment” of experts could greatly burden the Vaccine Program and complicate a process meant to be a quick and less complex means to compensate those injured by vaccination. See H.R. REP. NO. 99- 908, at 3 reprinted in 1986 U.S.C.C.A.N. 6344, 6344. 1. Legislative History - Encouraging Involvement by Competent Counsel. By paying attorneys’ fees to unsuccessful litigants, the Act encourages counsel to represent petitioners in Vaccine Act cases and, in particular, the off-Table injury claims where petitioners must perform the “heavy lifting” to demonstrate that a vaccine is more likely than not responsible for their injuries. H.R. REP. NO. 99-908, at 22 reprinted in 1986 U.S.C.C.A.N. 6344, 6363; see also Hodges v. Sec’y, HHS, 9 F.3d 958, 961 (Fed. Cir. 1993) (referring to the heavy burden placed on petitioners presenting causation in fact claims). An attorney representing petitioners in Vaccine Act cases performs many roles and, sometimes, after a careful examination of the evidence and the law, the most important of those is providing a candid assessment of the merits of a case to a petitioner whose firm, fixed belief in vaccine causation is unsupported by evidence. In these cases, fees are almost invariably awarded in order to effectuate the policy behind the fees provisions of the Act. It is clear from the legislative history of the Vaccine Act that Congress wanted to provide an incentive to attorneys to represent Vaccine Act petitioners. H.R. REP. NO. 99-908, at 22 reprinted in 1986 U.S.C.C.A.N. 6344, 6363; see also Cloer, 133 S.Ct. at 1895; Saunders, 25 F.3d at 1035. Interim fees help effectuate this purpose. However, it is by no means clear that Congress intended to advance funds from the Vaccine Trust Fund to allow petitioners to establish a prima facie case. To the contrary, the statutory scheme requires that petitioners present a comprehensive case for entitlement to compensation at the time the petition is filed.37 See § 11(c) (specifying the contents of a petition filed under the Program). Advance payment of costs could encourage the filing of “bare bones” petitions, with the expectation that the court will approve advance payment for obtaining the statutorily-required records and opinions necessary to demonstrate causation, only to be followed by the dismissal of a jurisdictionally defective or meritless petition. 37 I recognize that this provision is more honored in the breach than in the practice. It is not uncommon for petitioners to file a “bare bones” petition, unaccompanied by medical records or medical opinions as to causation, although that practice is now discouraged by special masters. The autism and hepatitis B omnibus proceedings have demonstrated the importance of locating and filing all relevant medical records at the earliest possible point in the proceedings. Past practice does not, however, negate the clear expressed intent of the legislature that petitioners file the evidence showing vaccine causation at the time of filing the petition itself. In most cases filed in the last four to five years, at least some medical records are filed either with the petition or as soon as the case is converted to electronic filing. 23 In this case, petitioner has yet to find an attorney who meets her requirements. She claims that the lack of an expert opinion is one of the reasons no attorney has yet been willing to take her case. However, the evidence filed to date suggests another reason: the filed evidence simply does not support petitioner’s claim that B.A.B. experienced fever, a rash, uncontrollable crying, and loss of language, constituting an “encephalopathy” after his MMRV vaccination at one year of age. Although the records reflect several high fevers and rashes at periods of time both before and after the April, 2007 vaccinations as well as numerous calls and visits to the pediatrician for other more minor concerns,38 they do not reflect any visits or telephone calls reporting such concerns after the April 2007 vaccinations. 2. Motivation in Seeking Expert Review. I have discussed the conflicts between the petition and B.A.B.’s records regarding onset and cause of his condition, whether it is characterized as an ASD or an encephalopathy, with petitioner at several status conferences. In her response to respondent’s motion to dismiss, petitioner argued about what various physicians have said regarding vaccine causation, but failed to identify anywhere in the medical records filed that such statements appear. It is true that an expert could base a causation opinion on something other than the medical records filed. Such opinions are unlikely to be persuasive to a special master unless there are reasons to reject the contemporaneous records (or lack of such records when the severity of symptoms would suggest that caring and concerned patients would seek treatment). See Burns v. Sec’y, HHS, 3 F.3d 415, 417 (Fed. Cir. 1993) (holding that “the special master did not err in accepting the contemporaneous medical records over the testimony of fact witnesses”). Our caselaw suggests that contemporaneous records are strongly favored over affidavits or testimony elicited years later. See, e.g., Cucuras v. Sec'y, HHS, 993 F.2d 1525, 1528 (Fed. Cir. 1993). B.A.B.’s parents were not shy about contacting the afterhours number when he was ill, and during the illness in which B.A.B.’s fever was reported as 107°, they induced their pediatrician to meet B.A.B. and his father at the pediatrician’s office in the late evening of New Year’s Day or in the early morning hours of the day following. Reading between the lines, it appears that petitioner’s financial difficulties have interfered with her ability to have B.A.B. continue treatment with Dr. Harum, and what she and B.A.B.’s father really seek is a firm diagnosis and an identified cause for B.A.B.’s condition. This would be a matter of high priority for nearly any parent, and the record establishes that both of B.A.B.’s parents are caring and concerned and seek only the best for their child. A lawsuit, however, is not a vehicle for seeking medical care or such answers. Unsophisticated in the law as they are, their statements indicating their 38 See, e.g., Pet. Exs. 4, pp. 4, 13-15; 6, pp. 6-7. 24 expectation that the court would appoint an expert or that it should provide them with the funds necessary to evaluate B.A.B.’s condition strongly suggest that they did not understand their legal obligation to present a case for entitlement at the time B.A.B.’s case was filed. See Status Conference held July 28, 2011 (asking for an expert evaluation of B.A.B.); Status Conference held Dec. 9, 2011 (requesting an order be issued or letter provided to Dr. Harum telling her she will be paid at the end of the case). 3. Practical and Policy Concerns. If funds are advanced, there is no way of ensuring that the funds are used for their intended purpose.39 When reimbursement is sought for funds already expended, there is a motivation to exercise judgment in selecting the expert and in monitoring that expert’s work and expenditures. When a petitioner (or his or her attorney) expends funds or time on the case to secure an expert opinion, someone other than the court is monitoring the hourly rate paid and the hours authorized. See Perreira, 1992 WL 164436, at *4, aff’d, 27 Fed. Cl. 29 (1992), aff’d, 33 F.3d 1375 (Fed. Cir. 1994) (referring to counsel’s obligation to monitor expert costs). In contrast, when advance payment is sought, the court must, of necessity, insert itself in such matters. What happens when the court determines that the hourly rate requested is too high, that the hours proposed are excessive, or that the expert is not sufficiently qualified to opine? Petitioners may be denied thereby the only expert who is willing to favorably opine on their case. Of course, when final or interim costs are requested, the court may well come to similar conclusions, but it does so at a time when the expert’s bill is before the court, his or her qualifications have been presented and challenged (either in a hearing or a motion) and, most importantly, the expert’s work product is available for review. Advance payment of costs would open the door to advance payment of fees. It would not be unreasonable to expect that an attorney, experiencing cash flow problems, might request an advance payment for work he or she expects to do on a case to prepare it for a hearing, to answer a motion to dismiss, or simply to collect and file the medical records expected to accompany the petition itself. If financial hardship is a consideration in advancing costs for this pro se petitioner, then should not the court consider the financial hardship for an attorney representing a petitioner? In other contexts, courts do authorize payment for expert witnesses. In criminal cases, there is a due process right, grounded in the Fourteenth Amendment, for an 39 While the government might institute proceedings to recoup payment, an impecunious defendant is effectively judgment-proof. I do not imply that I think this petitioner is likely to misuse funds provided to her for purposes of securing an opinion on vaccine causation, but a determination that advance payment of costs is available would impact on more cases than B.A.B.’s claim alone. 25 indigent defendant to obtain expert assistance at trial40 or materials necessary to prepare an appeal.41 However, the state must provide only the assistance needed to satisfy due process. See Ross v. Moffitt , 417 U.S. 600, 601 (1974) (determining that an indigent defendant must be given “an adequate opportunity to present his claims fairly in the context of the State's appellate process,” but need not be given the same resources available to a wealthier defendant); United States ex rel. Smith v. Baldi, 344 U.S. 561, 570 (1953) (finding that although the defense was not provided with an expert witness, due process was not violated because a neutral psychiatrist had examined the defendant). A specific level of remedy is not dictated, but a variety of approaches may be used to satisfy a defendant’s due process right. Griffin, 351 U.S. at 20 (indicating a variety of methods to provide defendants with a report of trial proceedings could be employed). For example, in a case before the Third Circuit, the Department of Justice was not required to reimburse a defendant for all expert costs, only those costs associated with determining his competency to stand trial as required under 18 U.S.C. § 4244 (1976). United States v. Rogalsky, 575 F.2d 457, 461 (3d Cir. 1978). The expert costs stemming from examinations used to establish his defense of insanity were deemed more appropriately paid from the public defender’s budget. Id.; see also 18 U.S.C. § 3006A(e) (1976). The Supreme Court has also applied a Fourteenth Amendment due process right in the context of the “quasi-criminal” proceedings of a paternity suit. The Supreme Court held that to determine paternity, Connecticut should have provided blood tests without cost to an indigent putative father. Little v. Streater, 452 U.S. 1, 10 (1981). The Supreme Court reasoned that the putative father’s future costs for child support would be a taking of property under the Fourteenth Amendment. Little, 452 U.S. at 6. However, the right has not been extended to civil litigation to recoup damages, even when the damages sought were for an alleged due process violation. See Boring v. Kozakiewicz, 833 F.2d 468 (3d Cir. 1987) (finding no right to public funding of an expert witness for former pretrial detainees suing the county for medical malpractice while incarcerated); see also Crawford Fitting Co. v. J.T. Gibbons, Inc., 482 U.S. 437 (1987) (prevailing party in a civil rights suit may not claim expert witness fees as costs). I note that in Avera when the Federal Circuit ruled that interim fees were available in Vaccine Act cases, the Court looked to other fee-shifting statutes in which interim fees had been authorized in spite of the statutes’ silence. Avera, 515 F.3d at 1351-52. The Circuit examined cases involving the Emergency School Aid Act, the Civil Rights Attorney's Fees Awards Act of 1976, the Freedom of Information Act, and Title 40 Ake v. Oklahoma, 470 U.S. 68, 86-87 (1985) (explaining that “mere access to the courthouse doors does not by itself assure a proper functioning of the adversary process”). 41 Griffin v. Illinois, 351 U.S. 12, 17 (1956) (holding that “due process and equal protection both call for procedures in criminal trials which allow no invidious discriminations between persons and different groups of persons”). 26 VII of the Civil Rights Act of 1964. Although all statutes were found to allow for interim awards, I could find no case in which litigation costs were advanced. Similarly, when expanding my research to statutes such as the Black Lung Benefits Act, I could find no instance of advance payment of attorney fees or costs.42 IV. Conclusion. Approximately a quarter century ago, Congress authorized an experiment in tort reform. It created a no-fault compensation scheme in which petitioners had only to prove vaccine causation of their injury in order to obtain generous compensation.43 In some cases, based on the vaccine, the timing, and the nature of the injury, compensation was presumed. To ensure that vaccine-injured claimants had ready access to attorneys willing to take their cases, Congress did something unprecedented. It authorized attorneys’ fees and costs even when petitioners do not prevail. Congress also mandated that petitioners present a documented and supported case for vaccine causation at the time the claim was filed. Read in pari materia, these statutory provisions do not support granting the relief petitioner seeks. Petitioner’s request for advance funding of interim expert costs is DENIED. Petitioner shall file by no later than Thursday, September 26, 2013, a status report informing the court how petitioner intends to proceed. The clerk of the court shall forward a copy of this Decision to petitioner by certified mail, return receipt requested and a second copy by regular mail. IT IS SO ORDERED. Denise K. Vowell Special Master 42 Although this is the first case in which I decide the issue of advancement of costs to an indigent pro se litigant, the issue of advance payment of litigation costs has been raised in at least two recent rulings, Klein and Mostovoy. See Klein v. Sec’y, HHS, No. 12-560V (soon to be posted on the Court’s website) (denying petitioners’ request for $500, the fee required to obtain autopsy slides); Mostovoy v. Sec’y, HHS, No. 02-10V, 2013 WL 3368236, at *27 (denying petitioners’ request for advance funding of expert costs and research). From informal discussions with my colleagues, I also am aware of two other cases with pending requests for advance funding of expert fees and testing. 43 Although there are statutory “caps”: on pain and suffering, § 15(a)(4), and on lost wage claims for those who were minors at the time of injury, § 15(a)(3)(B), the statute authorizes full payment for actual or projected unreimbursable expenses, § 15(a)(1). Moreover, in civil tort suits filed on a contingent fee basis, an attorney may take between 25%-50% of the damages awarded as attorney fees, effectively wiping out the higher pain and suffering awards received in civil litigation. 27 ================================================================================ DOCUMENT 2: USCOURTS-cofc-1_10-vv-00243-0 Date issued/filed: 2016-04-28 Pages: 34 Docket text: PUBLIC ORDER/RULING (Originally filed: 04/07/2016) regarding 87 DECISION of Special Master Signed by Chief Special Master Nora Beth Dorsey. (tlf) Copy to parties. -------------------------------------------------------------------------------- Case 1:10-vv-00243-UNJ Document 88 Filed 04/28/16 Page 1 of 34 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS Filed: April 7, 2016 * * * * * * * * * * * * * * * PUBLISHED ERICA FESTER, parent of * B.A.B., a minor, * * No. 10-243V Petitioner, * * v. * Chief Special Master Dorsey * * Proquad (“MMRV”) Vaccine; SECRETARY OF HEALTH * Autism (“ASD”); Encephalopathy; AND HUMAN SERVICES, * Subacute Encephalopathy; * Subclinical Encephalopathy; Respondent. * Insufficient Proof. * * * * * * * * * * * * * * * * Peter Joseph Sarda, Creech Law Firm, Raleigh, NC, for petitioner. Voris Edward Johnson, U.S. Department of Justice, Washington, D.C., for respondent. DECISION ON PETITIONER’S MOTION FOR RULING ON THE RECORD1 I. Introduction On April 15, 2010, Erica Fester (“petitioner”), parent of B.A.B., a minor, filed a petition for compensation under the National Vaccine Injury Compensation Program (“the Program”),2 alleging that the combined measles, mumps, rubella, and varicella (“MMRV” or “Proquad”) vaccine3 that B.A.B. received on April 18, 2007, caused him to suffer encephalopathy. Petition 1 Because this decision contains a reasoned explanation for the undersigned’s action in this case, the undersigned intends to post this ruling on the website of the United States Court of Federal Claims, in accordance with the E-Government Act of 2002, 44 U.S.C. § 3501 note (2012)(Federal Management and Promotion of Electronic Government Services). As provided by Vaccine Rule 18(b), each party has 14 days within which to request redaction “of any information furnished by that party: (1) that is a trade secret or commercial or financial in substance and is privileged or confidential; or (2) that includes medical files or similar files, the disclosure of which would constitute a clearly unwarranted invasion of privacy.” Vaccine Rule 18(b). 2 The Program comprises Part 2 of the National Childhood Vaccine Injury Act of 1986, 42 U.S.C. §§ 300aa-10 et seq. (hereinafter “Vaccine Act” or “the Act”). Hereafter, individual section references will be to 42 U.S.C. § 300aa of the Act. 3 B.A.B. received one dose of the vaccine Proquad, which contains the measles, mumps, rubella, 1 Case 1:10-vv-00243-UNJ Document 88 Filed 04/28/16 Page 2 of 34 at ¶ 5. Petitioner contends that B.A.B.’s “loss of prior skills and his current developmental delay is [sic] the sequela of that brain injury.” Id. The medical records and other information in the record, however, do not support a finding that petitioner is entitled to compensation. Under the Program, petitioner may not receive compensation based solely upon her claims, as the petition must be supported by either medical records or by the opinion of a qualified physician proving a causal relationship. See § 13(a)(1). Here, the medical records do not support petitioner’s claims, so a medical opinion is required. Petitioner has offered the opinion of Dr. Karen Harum.4 However, Dr. Harum’s opinion fails to provide support for the elements necessary to prove causation. For these reasons, and the reasons discussed below, petitioner has failed to demonstrate that she is entitled to compensation. I. Procedural History Petitioner filed her case pro se on April 15, 2010. In support of her claim, petitioner filed medical records labeled as exhibits 1-12. Approximately three months later, she filed additional medical records and videotapes. See Pet’r’s Exs. 16-17 filed Aug. 19, 2010 (ECF Nos. 10).5 On September 10, 2010, respondent filed her Rule 4(c) Report, stating that the case was not appropriate for compensation. Petitioner filed a response to the Rule 4(c) Report on February 8, 2011. Although petitioner argued that three of B.A.B.’s treating doctors believed B.A.B. suffered an encephalopathy and two believed that B.A.B. “had received a vaccine injury,” she agreed that she needed the report of a medical expert to support her claim. Pet’r’s Response to Respondent’s Rule 4(c) Report at 3-4 (ECF No. 20).6 Because B.A.B. was diagnosed with autism by at least one treating doctor, the case was reassigned, over petitioner’s objection,7 to former Chief Special Master Vowell, one of the and varicella vaccines. Petitioner’s Exhibits (“Pet’r’s Exs.”) 3 at 2-3; 6 at 15. 4 See Pet’r’s Exs. 19, 26, 29 (initial and two supplemental reports). Dr. Harum is a neurodevelopmental pediatrician who began treating B.A.B. in September 2008. See Respondent’s Exhibit (“Resp’s Ex.”) A at 1 (ECF No. 27) (medical records from Dr. Harum). Because the documents submitted as Ex. A were not electronically filed and do not have ECF numbers, the undersigned refers to the handwritten page numbers on the bottom of the document. 5 Exhibit 16 is comprised of several photographs and movies of B.A.B as a young child. Exhibit 17 is a video clip of B.A.B. saying, “I love you.” 6 The pages of Petitioner’s Response to Respondent’s Rule 4(c) Report are unnumbered, but this quotation appears on the bottom of the third and the top of the fourth pages of the document. 7 See Motion dated Feb. 23, 2011 (ECF No. 18). See also Order dated Feb. 28, 2011 (ECF No. 19). 2 Case 1:10-vv-00243-UNJ Document 88 Filed 04/28/16 Page 3 of 34 special masters involved in the Omnibus Autism Proceeding (“OAP”).8 During this time, petitioner continued to file medical records. See Pet’r’s Ex. 18 filed Apr. 14, 2011. Because petitioner experienced difficulty obtaining the medical records from Dr. Harum, one of B.A.B.’s treating physicians, respondent was authorized to issue a subpoena and then obtained and filed Dr. Harum’s records on June 17, 2011. See Resp’s Ex. A; Order dated July 14, 2010 (ECF No. 9). After Dr. Harum agreed to provide an expert report, petitioner made numerous filings supporting a request for advance payment of her fees. On January 26, 2012, petitioner filed additional medical records. See Pet’r’s Exs. 20a-20d.9 On August 27, 2013, a decision was entered denying petitioner’s request for interim advanced costs for expert fees. Decision dated Aug. 27, 2013 (ECF No. 46). 8 The OAP was created to manage more than 5,400 petitions alleging that autism or autism spectrum disorder (“ASD”) was caused by either the measles, mumps, and rubella (“MMR”) vaccine or thimerosal, an ethylmercury preservative used in multi-dose vials of vaccines. See Autism General Order #1, dated July 3, 2002 (found at 2002 WL 31696785, 2002 U.S. Claims LEXIS 365; also available at http://www.uscfc.uscourts.gov/sites/default/files/autism/Autism+General+Order1.pdf (last visited on February 16, 2016)). Three special masters conducted separate proceedings in test cases involving the two theories of autism causation mentioned above. All found petitioners had not provided preponderant evidence of causation, indicating the cases were “not a close case.” King v. Sec’y of Health & Human Servs., No. 03-584V, 2010 WL 892296, at *90 (Fed. Cl. Spec. Mstr. Mar. 12, 2010) (emphasis removed). All three decisions were affirmed on appeal. Two of the three decisions in the Theory 1 test cases were appealed to the Federal Circuit. Cedillo v. Sec’y of Health & Human Servs., 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); Hazelhurst v. Sec’y of Health & Human Servs., No. 03-654v, 2009 WL 332306 (Fed. Cl. Spec. Mstr. Feb. 12, 2009), aff’d, 88 Fed. Cl. 473 (2009), aff’d, 604 F.3d 1343 (Fed. Cir. 2010). Petitioners in the third test case did not appeal the Court of Federal Claims’ decision. Snyder v. Sec’y of Health & Human Servs., No. 01-162v, 2009 WL 332044 (Fed. Cl. Spec. Mstr. Feb. 12, 2009), aff’d, 88 Fed. Cl. 706 (2009). Petitioners did not seek review of the special masters’ decisions in the Theory 2 test cases. Dwyer v. Sec’y of Health & Human Servs., No. 02-1202v, 2010 WL 892250 (Fed. Cl. Spec. Mstr. Mar. 12, 2010); King v. Sec’y of Health & Human Servs., No. 03-584v, 2010 WL 892296 (Fed. Cl. Spec. Mstr. March 12, 2010); Mead v. Sec’y of Health & Human Servs., No. 03-215v, 2010 WL 892248 (Fed. Cl. Spec. Mstr. March 12, 2010). For further information and a comprehensive discussion of the OAP and proceedings after the conclusion of the test case litigation, see Sturdivant v. Sec’y of Health & Human Servs., No. 07-788, 2016 WL 552529 (Fed. Cl. Spec. Mstr. Jan 21, 2016). 9 Although there is a later filed exhibit also labeled as exhibit 20, the undersigned will continue to use the exhibit numbers 20a-20d for the medical records filed on January 26, 2012, and exhibit number 20 for the later filed record. See Pet’r’s Ex. 20 filed Sept. 23, 2014 (ECF No. 64). 3 Case 1:10-vv-00243-UNJ Document 88 Filed 04/28/16 Page 4 of 34 Petitioner obtained counsel on April 17, 2014, and has since been represented by Mr. Peter Sarda. On September 23, 2014, petitioner filed Dr. Harum’s expert report, curriculum vitae (“CV”), and medical literature. See Pet’r’s Exs. 19-25 (ECF Nos. 63-64). Respondent filed a responsive expert report, CV, and medical literature from Dr. Gregory Holmes on December 17, 2014. See Resp’s Exs. B-P (ECF No. 66). After Special Master Vowell raised specific criticisms of Dr. Harum’s initial expert report,10 petitioner filed the first supplemental report from Dr. Harum on March 9, 2015. See Pet’r’s Ex. 26 (ECF No. 73). Petitioner also filed six of the references cited by Dr. Harum as one exhibit.11 The case was reassigned to the undersigned on February 5, 2015. On March 26, 2015, the undersigned held a status conference to discuss the current status of the case. Petitioner’s counsel stated that he had been counsel of record in this case for less than one year. Although he admitted that Dr. Harum’s report had, in certain parts, characterized this as an autism case, he reiterated petitioner’s early arguments that her theory of causation involves encephalopathy as the injury, not autism. Order dated Mar. 30, 2015, at 1 (ECF No. 76). Counsel for respondent stated that as long as petitioner’s expert characterized the child’s injury as one that falls on the autism spectrum, the case could not be informally resolved. Id. The undersigned then inquired about the status of testing results and medical records from the University of North Carolina (“UNC”), where B.A.B. was evaluated and underwent genetic testing. Order dated Mar. 30, 2015, at 1 (ECF No. 76). Specifically, when B.A.B. was seen at UNC, a report from Dr. Doreswamy questioned whether he had developmental impairment associated with a CIAS-1 mutation, with an incomplete clinical expression of neonatal onset multisystem inflammatory disease (“NOMID”).12 See Pet’r’s Ex. 12 at 8-9. Dr. Doreswamy wrote, “Since the range of clinical CIAS-1 expression is broad, I will likely 10 See Order dated Jan. 9, 2015 (ECF No. 68). 11 See Amended Notice dated Mar. 10, 2015 (ECF No. 75) (providing the list of articles comprising Pet’r’s Ex. 27 filed by CD on Mar. 11, 2015). Two of these articles were incomplete, containing only the first few pages, but petitioner re-filed the complete articles approximately three months later as Exhibit 28. See Notice dated June 8, 2015 (ECF No. 83) (providing the list of articles comprising Pet’r’s Ex. 28, which was filed by CD on June 12, 2015.) It should be noted that petitioner filed multiple articles as one exhibit in both exhibits 27 and 28. The undersigned thus refers to all of these articles with the exhibit number to which petitioner assigned them, and the ECF page numbers have been provided for ease of reference. 12 NOMID is a “very rare” disorder, which “causes persistent inflammation and tissue damage primarily affecting the nervous system, skin, and joints.” https://ghr.nlm.nih.gov/condition/neonatal-onset-multisystem-inflammatory-disease (last visited Mar. 11, 2016). Individuals with the disorder have “a skin rash that is usually present from birth” and joint and skeletal abnormalities. Id. They “often have headaches, seizures, and vomiting resulting from chronic meningitis, which is inflammation of the tissue that covers and protects the brain and spinal cord (meninges).” Id. They may experience “[r]ecurrent episodes of mild fever,” “[i]ntellectual disabilities,” “[h]earing and vision problems,” and “progressive kidney damage.” Id. 4 Case 1:10-vv-00243-UNJ Document 88 Filed 04/28/16 Page 5 of 34 advocate obtaining genetic analysis.” Id. at 8-9. Petitioner was ordered to advise whether the testing was done, and if so, she was ordered to obtain and file the results. Order dated Mar. 30, 2015 at 1 (ECF No. 76). Moreover, in Dr. Harum’s medical records filed by respondent, there is a reference to a C677Y mutation. Resp’s Ex. A at 102. Petitioner was asked to investigate this question and file any records related to this gene mutation. Order dated Mar. 30, 2015 at 1 (ECF No. 76). Also during the status conference on March 26, 2015, the undersigned addressed the fundamental flaw in Dr. Harum’s expert reports: the lack of a foundational basis for her opinions. Order dated Mar. 30, 2015, at 2-3 (ECF No. 76). Petitioner was asked to provide a supplemental report by Dr. Harum addressing the basis for her opinion that B.A.B. had encephalopathy and to provide references from the medical records to support her claims. A review of B.A.B.’s medical records showed that he was developing normally at his nine, 12 and 15 month well-child visits. The Order stated that if petitioner was pursuing a claim that the vaccines B.A.B. received at his 12 month visit either caused or significantly aggravated an underlying condition, then petitioner would need to provide evidence that B.A.B. suffered an injury in the appropriate time frame in relation to his 12 month vaccinations. Lastly, the undersigned stated that if Dr. Harum was unable to substantiate her expert report, petitioner should consider dismissing her claim. Id. at 3. On April 27, 2015, petitioner filed a status report indicating that she would be filing a motion for judgment on the record but that she needed additional time to obtain and file Dr. Harum’s supplemental report, which would address the issues raised in the March 30, 2015 Order. Pet’r’s Status Report dated Apr. 27, 2015 (ECF No. 77). Petitioner’s request for additional time was granted. Scheduling Order dated Apr. 28, 2015 (ECF No. 78). A similar request for additional time was made on May 27, 2015, and again that request was granted. Order dated May 28, 2015 (ECF No. 80). On June 3, 2015, petitioner filed a second supplemental expert report by Dr. Harum. See Pet’r’s Ex. 2913 (ECF No. 81). She also filed a motion for judgment on the record. Motion for Judgment on the Administrative Record (“MJR”) dated June 3, 2015 (ECF No. 82).14 In the motion, petitioner stated, “Because the medical records tell the story of [B.A.B.] since his birth, and the professional opinions support their respective positions, . . . no benefit to the parties would accrue by conducting a trial.” MJR at 1. A few days later, petitioner filed medical literature cited by Dr. Harum.15 13 Petitioner did not provide an exhibit number for this filing. Because she designated medical literature filed five days later as exhibit 28 (the next available exhibit number), the undersigned designates Dr. Harum’s second supplemental report as exhibit 29. This report was also filed along with petitioner’s motion for ruling on the record, as Tab 3. See Motion for Judgment on the Administrative Record dated June 3, 2015 (ECF No. 82). 14 Along with her motion, petitioner filed copies of the previously filed expert reports: three by petitioner’s expert, Dr. Harum, and one by respondent’s expert, Dr. Holmes, as attachments 1-4. See also Pet’r’s Exs. 19, 26, 29; Resp’s Ex. B. 15 See Notice dated June 8, 2015 (providing the list of articles comprising Pet’r’s Ex. 28 filed by 5 Case 1:10-vv-00243-UNJ Document 88 Filed 04/28/16 Page 6 of 34 Respondent filed her response on June 17, 2015, asserting that “[t]he [p]etition should be dismissed.” Resp’s Response dated June 17, 2015, at 13 (ECF No. 84). Respondent argued that “[p]etitioner has failed to provide any credible evidence that B.A.B. suffered an encephalopathy as defined by the Act, or that his neurological symptoms were in any way caused by the Proquad vaccine.” Id. In accordance with the undersigned’s August 19, 2015 Order, respondent filed a supplemental expert report by Dr. Holmes and additional medical literature on October 2, 2015. See Resp’s Exs. Q, R (ECF No. 86). This case is now ripe for adjudication of petitioner’s motion for a ruling on the record. II. Summary of Relevant Medical Records and Affidavits a. Summary of Medical Records B.A.B. was born on April 17, 2006. Pet’r’s Ex. 2 at 1. He had a normal physical examination and his APGAR scores16 were nine and nine. Id. His newborn screening tests and hearing examination were normal, and he was discharged home on April 19, 2006. Id. at 1-4. On May 20, 2006, petitioner called B.A.B.’s pediatrician complaining that B.A.B. had been crying for twelve hours, he was wheezing, and he seemed to be in pain. Pet’r’s Ex. 4 at 27-28. On June 16, 2006, B.A.B. was noted to be spitting up and fretful. He was diagnosed with possible gastroesophageal reflux disease (“GERD”) and mild reflux esophagitis. Pet’r’s Ex. 6 at 1. The treating physician ordered Prevacid. Id. at 1-2. On June 23, 2006, at his two month well- child visit, he was noted to have nasal congestion. Pet’r’s Ex. 6 at 11. During this visit, B.A.B. received the DTap, IPV, Hib, Prevnar, and Hepatitis B vaccinations. Pet’r’s Ex. 3 at 2-3. No adverse reaction was noted. At his four month well-child visit on August 22, 2006, B.A.B. met all his developmental milestones. Pet’r’s Ex. 6 at 12. On September, 21, 2006, he was diagnosed with an upper respiratory infection. Pet’r’s Ex. 6 at 2-3. At his six month well-child visit on October 25, 2006, B.A.B. again met all his developmental milestones. Pet’r’s Ex. 6 at 13. B.A.B. received his DTap, IPV, Hib, Prevnar, and Hepatitis B vaccinations. Pet’r’s Ex. 3 at 2-3. No adverse reactions were documented. On December 31, 2006, at about eight months old, B.A.B. had a fever of 102.5 but showed no other signs of serious infection. Pet’r’s Ex. 4 at 22-26. On January 1, 2007, B.A.B. presented to the emergency department (“ED”) of Central Carolina Hospital (“CCH”) with a fever of 105.9, decreased activity, excessive crying, CD on June 12, 2015). Petitioner re-filed five of the articles previously filed as part of exhibit 27, this time filing the complete articles for the two partially filed on March 11, 2015. Petitioner also included eight additional references, filing only the abstract or summary for three of these articles. See Pet’r’s Ex. 28 at 48, 134-36. 16 Appearance, Pulse, Grimace, Activity, and Respiration (“APGAR”) score is a method of evaluating newborns to determine their overall health. See NELSON TEXTBOOK OF PEDIATRICS (19th ed. 2011) at 536-37. 6 Case 1:10-vv-00243-UNJ Document 88 Filed 04/28/16 Page 7 of 34 congestion, and nasal discharge. Pet’r’s Ex. 5 at 7-8. His oxygen saturation was excellent at 100 percent, he was otherwise well-appearing, he did not have a rash, and no speech or neurological problems were noted. Id. B.A.B.’s treating physicians diagnosed him with a fever, likely due to a virus. Pet’r’s Ex. 6 at 2. While B.A.B. was in the ED, his father called the pediatrician’s after hours telephone line, “agitated [and] demanding [that a] doctor meet [B.A.B.] in [the emergency room] as they do not know any of the doctors.” Pet’r’s Ex. 4 at 19. B.A.B.’s father further reported that his son had a “fever of 107.” Id. Ultimately, B.A.B. left the ED against medical advice (“AMA”), and his father reported that he was taking his son to the pediatrician’s office. Pet’r’s Ex. 5 at 6. B.A.B. was seen on January 2, 2007, by his pediatrician, Dr. A.M. Hess. Dr. Hess documented that B.A.B. had fever up to 106, with minimal runny nose and cough. Pet’r’s Ex. 6 at 2. His impression was that B.A.B. was experiencing a “fever, [which was] likely viral.” Id. Dr. Hess saw B.A.B. the next day, January 3, 2007. Although he had experienced a fever for four days, B.A.B. appeared well during the visit and was in no distress. He had an ulcer on his tongue and one papule on his wrist, but otherwise, no rash was noted. His hemoglobin level was normal, and his complete blood count (“CBC”) was “reassuringly viral.” Id. At B.A.B.’s nine month well-child visit on January 23, 2007, he again met all his developmental milestones, and his developmental assessment was normal. Pet’r’s Ex. 6 at 14. He was using “lots of words” and was able to name colors. Id. On February 5, 2007, he had chapped cheeks and was diagnosed and treated for facial eczema. Id. at 3. On April 18, 2007, B.A.B. presented for his 12 month well-child visit and again met all of his developmental milestones. Id. at 15. His developmental assessment was normal. Id. He received the Prevnar, MMR, and Varicella vaccines,17 and his physician did not note any adverse reaction. Pet’r’s Ex. 3 at 2-3. There are no entries in the medical record that indicate B.A.B. had any abnormal neurological condition or symptoms following his 12 month vaccinations. On July 13, 2007, B.A.B. presented to CCH for treatment of a lip laceration. Pet’r’s Ex. 5 at 1. His past medical history was noted to be negative, and he appeared alert upon physical examination. Id. Neurological examination documented that he was oriented, that his mood and affect was normal, and that he had no sensory or motor deficit. Id. at 2. The nursing record from that admission notes that his mental status was alert and oriented and that his behavior was cooperative. Id. at 4. B.A.B.’s parents made several follow up calls to the pediatrician’s office about the laceration on his face, but no pre-existing conditions or evidence of any problems, other than the concern about the small laceration on his face, were noted. See Pet’r’s Ex. 4 at 16; Pet’r’s Ex. 6 at 3. During this time, there is no indication in the medical records that B.A.B. experienced any neurological problems, especially not any signs or symptoms of encephalopathy or encephalitis. B.A.B. was 15 months old on July 17, 2007. The record does not indicate that he experienced any medical problems at this time. On August 15, 2007, at about 16 months of age, B.A.B. had a fever of 103.8, but he had no other symptoms. Pet’r’s Ex. 6 at 3. He looked well hydrated and was not in acute distress. Other than some pharyngitis and nasal congestion, he appeared normal and had no other symptoms. Id. A month later, on September 15, 2007, B.A.B. had a fever with congestion. Pet’r’s Ex. 4 at 13-15; Pet’r’s Ex. 6 at 4. His doctor observed on September 17, 2007, that B.A.B. was “cranky” but easily consoled, and he appeared well. 17 These are the vaccinations at issue. 7 Case 1:10-vv-00243-UNJ Document 88 Filed 04/28/16 Page 8 of 34 Pet’r’s Ex. 6 at 4. His tympanic membranes were red, but there was no pus or bulging, and he was diagnosed with a viral syndrome. Id. During these visits, there were no symptoms to suggest that B.A.B. had encephalopathy or encephalitis, nor is there anything in the record to suggest that the pediatrician even considered either of these diagnoses. B.A.B. had his 18 month well-child visit on October 19, 2007. At that visit, petitioner expressed concerns about B.A.B.’s speech development. She stated that he still had the “same speech” and “level of skills” that he had at 12 months of age, and that while he was saying quite a few words, he was not saying new words. He did not seem interested in acquiring new words, did not respond to his name, but did seem to hear normally. Pet’r’s Ex. 6 at 4. B.A.B. did meet all of his developmental milestones. Id. at 16. He was drinking from a sippy cup, was able to say three words plus “mama” and “daddy,” and was able to walk, run and climb. He was able to scribble, play games, and he tried to use a spoon and fork. Id. His gross motor development was normal. The pediatrician and petitioner decided to monitor B.A.B.’s developmental progress. The pediatrician reported, “mom will call [on the] first of the year if [B.A.B.] seems to have progressed no further.” Id. at 4. During this visit there was no mention of or suggestion that B.A.B. had encephalopathy or encephalitis, or that he had any prior history of either of these conditions. Approximately one month later, on November 23, 2007, B.A.B. presented to his pediatrician with fever, lack of appetite, and lethargy. He was diagnosed with right otitis media, and antibiotics were prescribed. Pet’r’s Ex. 6 at 4. During that visit, the pediatrician noted that B.A.B. did not speak during the examination, that he did not point, and that he does not “bring mom into his world if he sees something.” The pediatrician questioned “possible Autism Spectrum Disorder.” Id. Later that same day, however, when B.A.B. was seen for a possible allergic reaction to amoxicillin, he was noted to be “doing well” and was running around the clinic, looking at pictures, and pointing to baby pictures on the walls. Id. at 5. In a follow-up visit on November 29, 2007, B.AB.’s pediatrician noted that he appeared healthy, playful, and was eating and drinking normally. Id. at 5-6. The pediatrician further observed that B.A.B. “seems to exhibit age appropriate behavior, maybe a litlte [sic] bit on the hyperactive side,” and that “he does not exhibit any signs of systemic illness.” Id. However, his doctor reported that petitioner was “clearly very preoccupied with what she perceives to be [B.A.B.’s] behavioral disorder.” Id. at 5. The doctor further recommended “let[ting] the evaluation from TEACCH18 occur first before we make any pronouncement as to whether B.A.B. does have any behavior abnormalities.” Id. B.A.B.’s pediatrician noted that a lot of petitioner’s concerns “have been prompted by her reading … on the internet.” Id. at 6. The pediatrician recommended that petitioner “stick to only resources recommended to her by TEACCH or other reliable healthcare professionals.” During these visits, there was no reference to any prior history of encephalopathy or encephalitis, or any prior or current diagnosis of either condition. 18 Treatment and Education of Autistic and Related Communication Handicapped Children (“TEACCH”) is a program that provides training and services to families with autistic children. The program was developed by the University of North Carolina at Chapel Hill. See UNC School of Medicine, “TEACCH Autism Program,” available at https://www.teacch.com/ (last visited April 4, 2016). 8 Case 1:10-vv-00243-UNJ Document 88 Filed 04/28/16 Page 9 of 34 On December 6, 2007, a developmental evaluation was performed by Donna A. Merkwan, Ph.D., an Infant-Toddler-Family Specialist (“ITFS”). The report was issued on January 22, 2008. Pet’r’s Ex. 7 at 1-3. B.A.B. was referred for testing by his father due to concerns over his speech development and possible autism. Id. at 2. Entry level tests and results were as follows: gross and fine motor skills were within normal limits, cognitive skills were within normal limits, there was a 58 percent delay for chronological age for total language, self- help/adaptive behavior was within normal limits, and there was a 37 percent delay for chronological age for socio-emotional Early Learning Accomplishment Profile (“E-LAP”). Id. Dr. Merkwan questioned whether B.A.B.’s delay in social skills might be “related to his decreased interaction with other persons.” Id. at 3. Dr. Merkwan also noted that while some of his repetitive behaviors may seem “autistic-like,” they did not “constitute a definitive diagnosis for Autism Spectrum Disorder but may [] relate[] to [a] sensory processing disorder or to sensory integration issues.” Id. Dr. Merkwan recommended that B.A.B. undergo evaluation by the Early Intervention Service Coordinator (“EISC”) to determine his eligibility for services through the state’s Infant Toddler Program. Id. Dr. Merkwan did not note any association between B.A.B.’s vaccines and his delay in language or socio-emotional skills. Dr. Merkwan did not note any prior history consistent with encephalopathy or encephalitis, and she did not consider any such prior or current diagnosis. On January 17, 2008, Dana Miller, a speech therapist, evaluated B.A.B. Ms. Miller noted that a Receptive-Expressive Emergent Language Test, Third Edition (REEL-3) revealed that B.A.B. had a 38 percent language delay, and she recommended speech therapy twice weekly. Pet’r’s Ex. 10 at 3-4. Occupational testing was performed January 18, 2008, by Melanie Lee, M.S. She administered the Peabody Developmental Motor Scales, Second Edition (“PDMS-2”) test to measure B.A.B.’s developmental skills. Based on the test, B.A.B. was age appropriate in “visual-motor integration and grasping skills.” Id. at 6. However, based upon B.A.B.’s mother’s answers to the Infant/Toddler Sensory Profile Caregiver Questionnaire, B.A.B. experienced “differences in how he processes some types of sensory information.” Id. Ms. Lee recommended occupational therapy (“OT”) sessions once weekly. Id. at 8. Additional evaluations were conducted in January and February 2008. On February 4, 2008, B.A.B. underwent a psychological evaluation by John Wilson, MA, LPA, using the Bayley Scales of Infant Development, Third Edition (“BSID-III”), Cognitive Scale test. Pet’r’s Ex. 7 at 7. During the evaluation process, Mr. Wilson noted that B.A.B.’s family was concerned that his prior episode of elevated temperature of 107.5 may have impacted his development. B.A.B.’s score was 100, which “falls in the classification of average performance.” However, he was performing at approximately a 21 month age equivalence. Id. B.A.B. was also evaluated using the Childhood Autism Rating Scale (“CARS”) screening, a tool used to identify autism in children. B.A.B.’s score of 30 was “squarely on the line between non-autistic and the lowest bound of the mildly/moderately autistic range.” Id. B.A.B.’s scores were inconsistent with a diagnosis of autism but placed him “on the threshold of symptoms of a mild/moderate autism spectrum disorder.” Id. at 8.19 It was recommended that B.A.B. see a pediatric neurologist and that he be evaluated for the TEACCH program. Id. Mr. Wilson did not note any prior history 19 The International Statistical Classification of Diseases (“ICD”) billing code for this visit to Dr. Harum was 315.5, which represents Mixed Development Disorder. Pet’r’s Ex. 7 at 8. 9 Case 1:10-vv-00243-UNJ Document 88 Filed 04/28/16 Page 10 of 34 consistent with encephalopathy or encephalitis, nor did he note any such prior or current diagnosis. On September 26, 2008, B.A.B. underwent an evaluation by Dr. Karen Harum. Resp’s Ex. A at 115. Dr. Harum tested B.A.B. for metabolic and neurological disorders in 2009 and 2010. Pet’r’s Ex. 19 at 1. Genetic testing completed on October 16, 2008, for methylenetetrahydrofolate reductase (“MTHFR”) mutations C677T and A1298C, revealed that B.A.B. had a single copy of the C677 mutation. Resp’s Ex. A at 102-03. Genetic counseling was recommended. Id. at 103. Subsequent testing ordered by Dr. Harum reviewed that on March 4, 2009, B.A.B. had Rubeola AB (Antibodies), IgG, EIA, of 4.79H. Reference limits stated that greater than 1.09 was positive. Id. at 72. Lab results noted that “[p]resence of antibodies to Rubeola is presumptive evidence of immunity except when active infection is suspected.” Id. Additional tests for complete blood count with differential and comprehensive metabolic panel returned all normal results, except for elevated blood urea nitrogen (“BUN”)/Creatinine Ratio of 59 H, with a reference range of eight to 27. Id. at 71. Testing for interleukin-2 receptor alpha (“IL-2R”) performed in September 2008 and March 2009 showed that B.A.B.’s levels were elevated. Id. at 72, 103. B.A.B.’s Neuron-specific enolase was elevated in September 2008, but repeat testing showed that this was normal. Id. at 103, 72. Repeat testing of B.A.B.’s BUN/creatinine ratio remained elevated with a score of 52 in March 2010, and a repeat test of IL-2R alpha performed in March 2010 was normal. Id. at 70. Vitamin D and Ferritin testing completed in March 2010 revealed low results. Id. On October 8, 2009, B.A.B. had an EEG, which was normal. Id. at 94. On October 7, 2008, at B.A.B.’s two year old well-child visit to his pediatrician,20 he met all of his developmental milestones. Pet’r’s Ex. 6 at 19. He was using two words together, drawing/scribbling, running, climbing, throwing a ball and kicking. His parents reported that B.A.B. was making progress in PT, OT, and speech therapy and that he was undergoing an evaluation for ASD. Id. On April 14, 2009, when B.A.B. was almost three years old, he was seen by Dr. Vinod Doreswamy at UNC Hospital, located in Chapel Hill, North Carolina, due to his parents’ concerns regarding his elevated measles titer, his underlying developmental delay, and his recurrent fevers. Pet’r’s Ex. 12 at 6. With regard to B.A.B.’s positive measles titer, Dr. Doreswamy opined that this “does not seem to be reflective of anything else other than a good vaccine response.” Id. at 8. Dr. Doreswamy also noted that B.A.B. was “playing appropriately with toys, had short meaningful sentences in response to question[s], and made good eye contact.” Id. With regard to the recurrent fevers, Dr. Doreswamy recommended genetic testing and conservative measures, including antipyretics for fever. Id. Dr. Doreswamy did not diagnose B.A.B. with encephalopathy or encephalitis, nor did he note any prior history of either condition. Dr. Doreswamy did not implicate B.A.B.’s vaccinations as causally associated or related to any of his medical problems or his parents’ concerns. 20 The undersigned notes that B.A.B. was actually two and a half years old at this visit. See Pet’r’s Ex. 6 at 19. 10 Case 1:10-vv-00243-UNJ Document 88 Filed 04/28/16 Page 11 of 34 On July 6, 2009, B.A.B. was evaluated by Dr. Lynn M. Wegner of UNC to consult regarding further interventions for his developmental delay. B.A.B. was transitioned out of the North Carolina Infant Toddler Program when he reached three years of age. Pet’r’s Ex. 12 at 1. Dr. Wegner reviewed B.A.B.’s prior testing results and progress with speech and OT therapies. Id. at 1-2. Dr. Wegner opined that B.A.B. had “made incredible progress with the therapies offered” and expressed her concern about B.A.B. being withdrawn from school system support. Id. at 4. Dr. Wegner recommended that B.A.B. undergo updated language and fine motor integration assessments, that his school reinstate his Americans with Disabilities Act (“ADA”) therapy, and that he have an Individualized Education Program (“IEP”) to address language issues and fine and gross motor issues. Id. Dr. Wegner did not diagnose B.A.B. with encephalopathy or note any prior history of encephalopathy or encephalitis. Dr. Wegner did not document any issues associated with B.A.B.’s vaccinations, nor did she note any association between B.A.B.’s vaccinations and his developmental delay. On January 4, 2010, B.A.B. was given a diagnosis of autism (ICD 299.00).21 See Pet’r’s Ex. 20a at 19. On March 3, 2010, B.A.B. met the criteria to be placed on a waiting list for specialized services under the Community Alternative Program for Persons with Mental Retardation and/or Developmental Disabilities (“CAP-MR/DD”). Pet’r’s Ex. 11 at 1. On April 5, 2010, at approximately four years of age, B.A.B. had swollen tonsils and congestion, and he was diagnosed with strep pharyngitis. Pet’r’s Ex. 6 at 9. At that visit, the pediatrician noted that B.A.B. had features consistent with autism. Id. B.A.B. underwent a psychological evaluation by Christine Hook, Ph.D., on June 14, 2010, at the age of four years and two months. Pet’r’s Ex. 20a at 3. Dr. Hook administered a battery of tests, including the Wechsler Preschool and Primary Scale of Intelligence (“WPPSI- III”), Vineland Adaptive Behavior Scales (“Vineland-II”), Behavior Assessment System for Children (“BASC-2”), and Gillian Autism Rating Scale (“GARS-2”). In summarizing the test results, Dr. Hook noted that B.A.B. possessed good vocabulary skills and that his social skills had improved, but that he continued to struggle with following directions. Id. at 7. She also 21 At that time, ICD 299.00 was the diagnostic code for autism. Centers for Medicare & Medicaid Services, “ICD-9 Code Lookup,” available at https://www.cms.gov/medicare- coverage-database/staticpages/icd-9-code- lookup.aspx?KeyWord=299.00&bc=AAAAAAAAAAAEAA%3d%3d&# (last visited April 4, 2016). Autism is characterized by “[p]ersistent deficits in social communication and social interaction across multiple contexts,” as well as “restricted, repetitive patterns of behavior, interests, or activities.” The Diagnostic and Statistical Manual of Mental Disorders (American Psychiatric Association, 4th ed. text revision 2000) (“DSM-IV-TR”). A comprehensive discussion of the symptoms of autism can be found at White v. Sec’y of Health & Human Servs., No. 04-337V, 2011 WL 6176064, at *4-9 (Fed. Cl. Spec. Mstr. Nov. 22, 2011). The DSM-IV- TR has since been replaced by the Diagnostic and Statistical Manual of Mental Disorders, (American Psychiatric Association, 5th ed. 2013) (“DSM-V”), which uses the term “ASD”, but the discussion of the symptoms of autism found in White is still relevant. In the DSM-V, the symptoms recognized by the medical community at large as those of an ASD have not changed, but the criteria for diagnosis have been refined, and the distinctions drawn in the DSM-IV among the diagnoses of autistic disorder, PDD-NOS, and Asperger’s disorder have been eliminated. 11 Case 1:10-vv-00243-UNJ Document 88 Filed 04/28/16 Page 12 of 34 noted that he had a “high level of over activity and impulsivity” as well as issues with sensory processing. Id. Dr. Hook concluded that B.A.B. met the criteria for Autistic Disorder and recommended a number of treatment strategies, including OT and continued programs in the school setting. Id. at 7-9. During this evaluation, Dr. Hook noted that B.A.B.’s “mother expressed concerns that [B.A.B.’s] regression was . . . possibly [related] to vaccines he received.” The physician records indicate that the improbability of this correlation was discussed with B.A.B.’s parents. Id. at 3. b. Statements from B.A.B.’s Parents The record includes statements given by B.A.B.’s father, Tre Benson, and his mother, petitioner Erica Benson (Fester). See Pet’r’s Ex. 14; Pet’r’s Ex. 15. Mr. Benson stated that shortly after B.A.B.’s first birthday and shortly after receiving the MMRV vaccine, his cousin, who was approximately B.A.B.’s same age, came over to stay at B.A.B.’s home for about one week. During this time, Mr. Benson stated that B.A.B.’s cousin was often fussy, which made B.A.B. very angry. He reported that “[B.A.B.] smacked his cousin every chance he got” and would have “frequent temper tantrums,” some of which would last for over an hour. Pet’r’s Ex. 14 at 1. Mr. Benson reported that shortly thereafter, B.A.B. bit petitioner and that his temper tantrums worsened to the point that B.A.B. would not look his parents in the eye. Id. at 2. Mr. Benson also reported events from the day that B.A.B. received the MMRV vaccination on April 18, 2007. He stated that B.A.B. had been crying and upset all day after receiving the vaccines and that afterwards he stopped talking altogether and did not say anything for almost a year. Pet’r’s Ex. 14 at 2-3. Mr. Benson stated, “[t]hings sort of started rolling downhill from there, little by [little, my] son started eroding into a different little boy.” Id. at 3. Mr. Benson detailed the progression of his son’s doctor’s appointments leading to his diagnosis of autism, highlighting the difficult impact of his son’s disease on the family. Id. at 6. Petitioner’s statements similarly highlighted the alleged changes in her son’s behavior that seemed to arise shortly after his vaccinations on April 18, 2007. She reported that B.A.B. “wouldn’t stop crying or being upset, had a fever[,] and wouldn’t take his normal nap” that afternoon. Pet’r’s Ex. 15 at 1. Petitioner stated that after April 2007, B.A.B. exhibited hostile behaviors, he became interested with repetitive actions, and his eye contact lessened. She further reported that “he was always sick with a cold or mild illness and always had a low fever.” Id. She described that as her son’s condition worsened, he “stopped responding to his name or looking at us, not noticing or caring if we were in the room.” Id. Given her growing concern, she eventually sought child development services to evaluate her son. Id. III. Standards for Adjudication The Vaccine Act established the Program to compensate vaccine-related injuries and deaths. § 10(a). “Congress designed the Vaccine Program to supplement the state law civil tort system as a simple, fair and expeditious means for compensating vaccine-related injured persons. The Program was established to award ‘vaccine-injured persons quickly, easily, and with certainty and generosity.’” Rooks v. Sec’y of Health & Human Servs. 35 Fed. Cl. 1, 7 (1996) (quoting H.R. REP. NO. 908 at 3, reprinted in 1986 U.S.C.C.A.N. at 6287, 6344). 12 Case 1:10-vv-00243-UNJ Document 88 Filed 04/28/16 Page 13 of 34 To receive compensation under the Program, petitioner must prove either: (1) that B.A.B. suffered a “Table Injury”—i.e., an injury listed on the Vaccine Injury Table—corresponding to a vaccine that he received, or (2) that B.A.B. suffered an injury that was actually caused by the vaccine (or vaccines) he received. See §§ 13(a)(1)(A) and 11(c)(1); Capizzano v. Sec’y of Health & Human Servs., 440 F.3d 1317, 1319-20 (Fed. Cir. 2006). Although the Vaccine Table includes an injury of encephalopathy (or encephalitis) suffered five to 15 days after administration of the MMRV vaccine or one of its components,22 petitioner is not alleging a Table Injury. See Petition at 1. Moreover, in order to qualify as a Table Injury, the encephalopathy petitioner claims B.A.B. suffered would have to satisfy the more narrow definition of encephalopathy contained in the Qualifications and Aids to Interpretation (“QAI”) section of the Vaccine Injury Table.23 The medical records and expert reports from Dr. Harum would not support an allegation of a Table encephalopathy, even if made. Because petitioner cannot show that B.A.B. suffered a Table injury, she must prove that a vaccine B.A.B. received caused his injury. To do so, she must establish, by preponderant evidence: (1) a medical theory causally connecting a vaccine and B.A.B.’s injury (“Althen Prong One”); (2) a logical sequence of cause and effect showing that a vaccine was the reason for his injury (“Althen Prong Two”); and (3) a showing of a proximate temporal relationship between a vaccine and his injury (“Althen Prong Three”). Althen v. Sec’y of Health & Human Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005); § 13(a)(1) (requiring proof by a preponderance of the evidence). IV. Expert Opinions In support of her claim, petitioner offers the expert reports of Dr. Harum. See Pet’r’s Exs. 19, 26, 29. Respondent provides the expert reports of Dr. Holmes. See Resp’t Exs. B, Q. Both experts disagree as to the nature and cause of B.A.B.’s condition. Furthermore, Dr. Holmes extensively criticizes the factual predicates upon which Dr. Harum bases her opinion. 22 42 C.F.R. § 100.3(a)(III)(B) (2015). 23 See 42 C.F.R. § 100.3(b)(2). As explained in Waddell, “[t]he scope of the medical term ‘encephalopathy’ is more expansive than the narrower, statutory definition set forth in the Table.” Waddell v. Sec’y of Health & Human Servs., No. 10-316V, 2012 WL 4829291, at *12 (Fed. Cl. Spec. Mstr. Sept. 19, 2012) (referencing Hazlehurst v. Sec’y of Health & Human Servs., No. 03-654V, 2009 WL 332306, at *26-29 (Fed. Cl. Spec. Mstr. Feb. 12, 2009)). Encephalopathy as generally used means “any degenerative disease of the brain.” DORLAND’S ILLUSTRATED MEDICAL DICTIONARY, 614 (32nd ed. 2012) (“DORLAND’S”). “The QAI definition of acute encephalopathy simply does not encompass every type of brain dysfunction to which the broader meaning of ‘encephalopathy’ applies.” Blake v. Sec’y of Health & Human Servs., No. 03-31V, 2014 WL 2769979, at *6 (Fed. Cl. Spec. Mstr. May 21, 2014). 13 Case 1:10-vv-00243-UNJ Document 88 Filed 04/28/16 Page 14 of 34 a. Petitioner’s Expert, Dr. Karen Horton Harum Dr. Harum is a board-certified pediatrician and specializes in the area of neurodevelopmental disabilities. Pet’r’s Ex. 19 at 6. She attended medical school at the University of Miami School of Medicine and completed her internship at the University of Florida School of Medicine, Shands Teaching Hospital. Dr. Harum completed her residency in pediatrics at the University of Miami School of Medicine. She then completed a fellowship in neurodevelopmental pediatrics at the Kennedy Krieger Institute, at the Johns Hopkins University School of Medicine. Thereafter, she served as a post-doctoral fellow at the Kennedy Krieger Research Institute and received a National Research Service Award in Neuroscience. Dr. Harum is currently in private practice in Wilmington, North Carolina, at the Clinic for Special Children. Id. at 4-8. i. B.A.B.’s Injury and Diagnosis The most comprehensive explanation of Dr. Harum’s opinions in this case is set forth in her third expert report (second supplemental report). As in all of her other reports, Dr. Harum describes B.A.B.’s injury as “subclinical encephalopathy, the manifestations of which are developmental regression, loss of language and sensory processing deficits.” Pet’r’s Ex. 29 at 4, filed June 3, 2015 (ECF No. 81). Dr. Harum defines “subclinical” encephalopathy as a subtle but not acute process that the parents could recognize, but “not obvious enough for the pediatrician to be concerned about.” Id. She defines “encephalopathy” as a “sub-acute neurologic dysfunction: language plateau, loss of language, loss of auditory awareness, loss of visual attention, and decreased level of activity.” Id. at 5. More specifically, Dr. Harum defines “regressive encephalopathy” as “neurological impairment of unknown cause that is associated with a period of past or on-going regression.” Id. She explains that “30 [percent] of children ultimately diagnosed with autism have experienced developmental regression and other neurological changes, including subtle EEG changes.” Id. In her initial expert report, Dr. Harum describes B.A.B. as suffering symptoms “indicative of encephalopathy,” and adding that “the symptoms of associated with Autism Spectrum Disorder are nearly identical.” Pet’r’s Ex. 19 at 3. She expands on this description in her second expert report (first supplemental report), opining that based on her “assessment at 29 months of age and the DSM-IV criteria, [B.A.B.] met [the]3 criteria for high functioning autism following encephalopathic regression.” Pet’r’s Ex. 26 at 4. Dr. Harum states that her diagnosis is consistent with John Wilson, Ph.D.’s diagnosis of autism when B.A.B. was 21 months of age, and Dr. Lynn Wegener’s diagnosis of autism at 39 months of age. ii. Medical Theory of Causation In her initial expert report, Dr. Harum opined that vaccines, including the measles vaccine, can cause infectious encephalitis, particularly in immune compromised children, and that encephalitis may thereafter result in developmental regression. Dr. Harum quotes the Institute of Medicine (“IOM”)’s Adverse Effects of Vaccines: Evidence and Causality,24 as follows: 24 Institute of Medicine (“IOM”), Adverse Effects of Vaccines: Evidence and Causality, 110 14 Case 1:10-vv-00243-UNJ Document 88 Filed 04/28/16 Page 15 of 34 There is mechanistic evidence of vaccine reactions that does account for acute onset of infections and deterioration, but also for delayed onset of infection, delayed up to [nine] months after vaccine administration. For example, the measles vaccine can cause measles inclusion body encephalitis due to the vaccine strain of measles, after administration of the measles vaccine, particularly in immune compromised individuals up to [nine] months after the vaccine administration. Pet’r’s Ex. 19 at 2 (quoting IOM at 110). Dr. Harum further posited that “there is a plausible body of evidence to associate MMRV and other vaccines and encephalitis resulting in mental retardation and speech impairment. Therefore, one can postulate that there is a plausible association between MMRV and other vaccines and subacute encephalopathy associated with developmental regression.” Pet’r’s Ex. 19 at 2. Subsequently, former Chief Special Master Vowell identified a number of problems with Dr. Harum’s medical theory as stated in her initial expert report. See Order dated Jan. 9, 2015 (ECF No. 68). First, “[t]he medical records and the parents’ early statements do not support the existence of encephalitis after the 12 month vaccinations.” Id. at 1-2. Additionally , “Dr. Harum mention[ed] “‘subclinical’ encephalitis [in her report] but fail[ed] to point to any evidence that one existed, or that subclinical encephalitis can result in an autism diagnosis.” Id. at 2. Moreover, “none of the articles or excerpts filed provide[] support for . . . Dr. Harum’s theory: that the 12 month vaccines caused encephalitis that manifested with autism-like symptoms.” Id. In conclusion, Chief Special Master Vowell stated, “[i]n essence, Dr. Harum strings together reported effects from MMR vaccines to conclude that MMR can cause autism or cause a condition resulting in ‘autism-like’ symptoms, in spite of a dearth of evidence that B.A.B. had symptoms of encephalitis or encephalopathy in the months after his Proquad vaccination.” Id. In her next supplemental report, Dr. Harum conceded that “there [was] no evidence of encephalitis following the 12 month vaccinations.” Pet’r’s Ex. 26 at 1. After this concession, however, Dr. Harum changed tack. Instead of arguing that the 12 month vaccines caused an acute or delayed infectious encephalitis or encephalopathy, manifested with autism-like symptoms, in her second and third expert reports, Dr. Harum posited a multi-faceted framework, built on a series of presumptions. Dr. Harum opined that B.A.B. “contracted roseola infantum[25] at [nine] months of age, coincident with granulocytopenia and symptoms of encephalopathy, including language plateau.” Pet’r’s Ex. 26 at 3; accord. Pet’r’s Ex. 29 at 8. Then, within “[three] months, while there was ongoing lymphocytosis and presumed brain inflammation, and in this immune dysregulated state, [B.A.B.] received a cluster of vaccines that contributed further to microglial activation, overactive Th2 immunity, and worsening encephalopathy.” Pet’r’s Ex. (Kathleen Stratton et al. eds., 2012) (internal citations removed). 25 Roseola Infantum is clinically defined as “a type of rose-colored rash seen most often in an infectious disease such as measles or other exanthematous diseases.” DORLAND’S at 1654. 15 Case 1:10-vv-00243-UNJ Document 88 Filed 04/28/16 Page 16 of 34 26 at 3. Dr. Harum argued that the vaccines further contributed to “this injury pathway through the load of aluminum, glutamate, formaldehyde and unidentified pathogens” found in the vaccines. Pet’r’s Ex. 26 at 3; accord Pet’r’s Ex. 29 at 8.26 Dr. Harum writes that these mechanisms contributed to B.A.B.’s “encephalopathic regression through pathophysiologic mechanisms described repeatedly in neuronal injury in the scientific literature.”27 Pet’r’s Ex. 29 at 9. In her third and final supplemental report, Dr. Harum elaborates upon several direct questions posed by former Chief Special Master Vowell in an earlier scheduling order. See Order dated January 9, 2015 (ECF No. 68). Dr. Harum posits that B.A.B. had a C667T mutation, the significance of which was “very limited, except under circumstances of folate deficiency.” Pet’r’s Ex. 29 at 1. Dr. Harum then states, “[I]f other undiagnosed problems within the methylation cycle . . . are also present, it weakens the individual’s ability to provide methyl groups to a wide variety of molecules. Under these circumstances, glutathione production can be limited by insufficient methylation cycle activity.” Id. Dr. Harum continues by stating that issues with the methylation cycle can inhibit methyl production, which thus limits production of glutathione, which helps protect the body from toxins. Id. These inhibitions of methylation pathways, according to Dr. Harum, can cause “adjuvants such as alum [to] pose a greater toxic effect.” Id. at 2. Dr. Harum summarizes her opinion of how B.A.B. suffered an encephalopathy by first stating that B.A.B. suffered from roseola infantum in January 2007 at the age of nine months. She then states, “[roseola infantum] may have caused a mild and temporary encephalitis that predisposed [B.A.B.] to further neurological inflammation and insult.” Pet’r’s Ex. 29 at 3. However, in the same paragraph, Dr. Harum admits that B.A.B. “did not have seizures,” that he “did not have [cerebro-spinal fluid] assays to document HHV-6 in the central nervous system,” and that “he did not meet the criteria for encephalitis.” Id. Surprisingly, however, Dr. Harum characterizes the alleged encephalopathy suffered by B.A.B. as “mild and temporary,” which “predisposed him to further neurological inflammation and insult.” Id. After he received his 12 month vaccines, Dr. Harum stated that B.A.B. then “suffered subclinical encephalopathy” between the age of 12 and 18 months, opining that his encephalopathy is “described as sub clinical because it was not acute and was subtle enough for parents to recognize, but not obvious enough for the pediatrician to be concerned about . . . .” Id. at 4. 26 Here, Dr. Harum cited to Campbell et al., “Chronic Exposure to Aluminum in Drinking Water Increases Inflammatory Parameters Selectively in the Brain,” 75 J. NEUROSCI. RES. 565-72 (2004) (complete article filed as Pet’r’s Ex. 28 at 40-47); and M. Giangaspero et al., “Genotypes of Pestivirus RNA Detected in Live Virus Vaccines for Human Use,” 63 J. VET. MED. SCI. 723- 33 (2001) (abstract only, filed as Pet’r’s Ex. 28 at 134). 27 In support of this assertion, Dr. Harum cited Atladottir, Thorsen, Schendel, et al., “Association of Hospitalization for Infection in Childhood with Diagnosis of Autism Spectrum Disorders: A Danish Cohort Study,” 164 ARCH PEDIATR. ADOLESC. MED., 470-77 (2010) (abstract only from the National Center for Biotechnology Information website, filed as Pet’r’s Ex. 28 at 135-36). 16 Case 1:10-vv-00243-UNJ Document 88 Filed 04/28/16 Page 17 of 34 Finally, Dr. Harum stated that several of B.A.B.’s laboratory test results indicate that he suffered some sort of subclinical encephalopathy. She points to abnormal folate insufficiency, oxidized DNA, reduced glutathione, irregular neuron specific enolase (“NSE”) levels, abnormal IgG total count, and Il-2 receptor alpha elevation, positing that all of these “abnormalities” suggest that B.A.B. “clearly has an encephalopathy.” Pet’r’s Ex. 29 at 6. To evaluate the viability of this theory, the undersigned will separately examine each of Dr. Harum’s presumptions. The undersigned will review both the foundation for each presumption and the supporting medical literature. While the undersigned has reviewed and considered all the evidence in this case and the entire record as a whole, the following is by no means a complete recitation of all the relevant facts and evidence considered. See § 300aa-13(a) (stating that the special master should consider the “record as a whole”). 1. Dr. Harum’s Theory Part 1 The first presumption made by Dr. Harum is that B.A.B. contracted roseola infantum at nine months of age. Pet’r’s Ex. 29 at 8. Dr. Harum initially saw B.A.B. when he was 29 months of age, so she necessarily relies on medical records for evidence of this part of her opinion. She writes that B.A.B. “contracted a febrile illness characterized by fever over 105 degrees at 9 months of age . . . later determined to be roseola infantum.” Pet’r’s Ex. 26 at 1. The medical records, however, do not show that B.A.B. was diagnosed with roseola infantum at nine months of age. On January 1, 2007, B.A.B. presented to CCH ED with a fever of 105.9, decreased activity, excessive crying, congestion and nasal discharge. Pet’r’s Ex. 5 at 7- 8. B.A.B’s oxygen saturation was excellent at 100 percent, he was otherwise well-appearing, he did not have a rash, and the treating physician did not observe any speech or neurological problems. Id. B.A.B. was diagnosed with a fever of likely viral origins. Pet’r’s Ex. 6 at 2. On January 3, 2007, B.A.B. was again seen by his pediatrician, who noted that B.A.B. had an ongoing fever for four days but that he was “well appearing.” Id. The pediatrician next saw B.A.B. on February 5, 2007, and at that time noted a rash but no fever. Id. at 3. B.A.B. was examined and evaluated by a pediatrician on three different dates during this febrile illness, but not once was he diagnosed with roseola infantum or noted to have any neurological abnormalities. B.A.B. was not diagnosed with roseola infantum until February 4, 2008, at 22 months of age, when he presented at his pediatrician’s office with a diffuse body rash, described as a “diffuse pink MP (maculopapular) rash which blanches on extremities and torso.” Pet’r’s Ex. 6 at 7. In addition to specifically describing the rash, the pediatrician documented that “this is a normal viral pattern specifically that of roseola.” Id. At that point, B.A.B. was 22 months of age, and nearly 10 months had passed since he received the vaccines at issue. Thus, the undersigned finds Dr. Harum’s opinion that B.A.B. suffered from roseola infantum at the age of nine months unpersuasive. 2. Dr. Harum’s Theory Part 2 In order to continue the evaluation of Dr. Harum’s theory, the undersigned next assumes, for the sake of argument, that B.A.B. did have roseola infantum at nine months of age, or that his 17 Case 1:10-vv-00243-UNJ Document 88 Filed 04/28/16 Page 18 of 34 viral illness was the equivalent of that condition. Dr. Harum’s next presumption is that the illness (i.e. the alleged roseola infantum) was “coincident with granulocytopenia and symptoms of encephalopathy including language plateau.” Pet’r’s Ex. 26 at 3. Granulocytopenia is defined as a “reduction in the number of granular leukocytes in the blood.”28 Dr. Harum opined, “Lab evidence demonstrated a . . . low granulocyte count.” Id. at 1. B.A.B.’s blood work from January 3, 2007, does show decreased granular leukocytes. Id. at 25. B.A.B.’s pediatrician at the time documented that a CBC had been performed and that the results were “reassuringly viral.” Id. at 2. Thus, while Dr. Harum is correct that B.A.B. had granulocytopenia, in that he had decreased granular leukocytes, this was a product of a reassuring immune response to his viral illness, as evidenced by his pediatrician’s contemporaneous record. Moreover, Dr. Harum failed to provide support for her position that roseola infantum or any other viral illness causes or contributes to encephalopathy or language plateau. And in fact, in her third supplemental report, Dr. Harum concedes that on April 18, 2007, “prior to [B.A.B.’s] cluster of vaccines, [his] granulocytopenia . . . resolved and he appeared quite healthy with normal developmental milestones.” Pet’r’s Ex. 29 at 3. Despite her acknowledgment that B.A.B.’s roseola infantum resolved prior to receiving his 12 month vaccinations, Dr. Harum opined that roseola infantum is associated with HHV-6, “an encephalitic virus, with a predilection for brain infection and latent colonization of neuronal tissue.” Pet’r’s Ex. 26 at 1. However, she concedes that B.A.B. did not have seizures, that there was no testing of his cerebrospinal fluid, and thus that there is no evidence of HHV-6 in his brain. Nevertheless, she argues that this HHV-6 infection, of which there is no evidence, caused encephalopathy, “based on the history of regression.” Id. B.A.B. did not show regression at nine months, and according to his pediatrician’s records and his parents’ early statements, he did not experience any developmental delays until he was 15 months old. There are no facts to support Dr. Harum’s underlying premise that B.A.B. had any abnormal process in play prior to receiving his 12 month vaccinations. Thus, there is no basis for the first tenet of Dr. Harum’s theory, that B.A.B. “contracted roseola infantum at 9 months of age, coincident with granulocytopenia and symptoms of encephalopathy including language plateau.” Id. at 3. Similarly, Dr. Harum argues that the vaccines were given in proximity to a “significant encephalitic virus infection.” Pet’r’s Ex. 26 at 3. In her later report, the “significant encephalitic virus infection” is downgraded to a “mild and temporary encephalitis.” Pet’r’s Ex. 29 at 3. Dr. Harum conceded, however, that B.A.B. “did not meet the criteria for encephalitis.” Id. She specifically stated, “I concede that there is no evidence of encephalitis following the 12 month vaccinations.” Id. at 4. Moreover, the medical literature Dr. Harum cites to support this part of her proposed medical theory is insufficient to show roseola, or any other viral illness, coincident with one transient episode of granulocytopenia, causes or is diagnostic of encephalitis or encephalopathy, manifest by language plateau, which “predisposed [B.A.B.] to further neurological inflammation and insult.” Id. Dr. Harum claims the “mechanisms of injury” she describes are “described repeatedly” in 28 DORLAND’S at 803. 18 Case 1:10-vv-00243-UNJ Document 88 Filed 04/28/16 Page 19 of 34 scientific literature and cites Atladottir, et al.29 to support her claim. Pet’r’s Ex. 29 at 9. However, petitioner has filed only the abstract of this article, and it does not provide the support Dr. Harum claims. See Pet’r’s Ex. 28 at 135-36. The abstract describes a Danish population- based cohort study that examines whether there is an association between infections requiring hospitalization and ASDs. Id. at 135. The study found that there was an increase in ASD diagnoses and mental retardation in these hospitalized children, but the authors observed that this association was found for children suffering from noninfectious diseases and infectious diseases that were both bacterial and viral in origin. The authors specifically concluded that the association found did not suggest causality because the association was observed throughout these different groups. Id. To support her claim that “mechanisms [of injury] converge onto the more recently described neuronal pathways and signaling systems identified as impaired in autism,” Dr. Harum cites the Pinto article.30 This article examines the genetic variations involved in ASDs. Pet’r’s Ex. 27 at 35. The authors concluded that the studies performed “highlighted a striking degree of genetic heterogeneity, implicating both de novo germline mutation and rare inherited ASD variation distributed across numerous genes.” Id. 36. It did not, however, provide support for Dr. Harum’ claims. The article does not mention vaccines. Repeatedly throughout her expert report, Dr. Harum makes conclusory statements that language plateau, developmental regression, and sensory processing deficits are symptoms or manifestations of encephalopathy. Pet’r’s Exs. 26 at 1; 29 at 4. But she does not offer any support for these conclusory statements, especially in light of the facts and circumstances of this case. Moreover, these are some of the most common symptoms of ASD. See White, 2011 WL 6176064, at *4-9. B.A.B.’s first symptom, speech delay, is generally the first symptom observed by parents of autistic children. Id. at *8. Dr. Harum does not provide any evidence to support a conclusion that B.A.B.’s symptoms should be categorized as encephalopathy rather than autism. Dr. Harum stated that because B.A.B. had an elevated neuron specific enolase (“NSE”) level of 17.4 on September 29, 2008, approximately one and one-half years after his vaccinations, this is evidence of neuronal death and encephalopathy. Pet’r’s Ex. 29 at 6; see Pet’r’s Ex. 9 at 10 (reporting B.A.B.’s test results). She does not explain, however, why B.A.B. would have normal NSE results six months later, on March 4, 2009, if he were experiencing “ongoing neuronal injury.” See Pet’r’s Ex. 29 at 6. In support of her opinion that B.A.B.’s elevated NSE levels are consistent with an “ongoing neuronal injury,” Dr. Harum cited a study by Berger, et al.31 regarding infants and 29 See supra note 27. 30 Pinto et al., “Convergence of Genes and Cellular Pathways Dysregulated in Autism Spectrum Disorders,” 94 AM. J. HUMAN GENETICS, 677-94 (2014) (filed twice at Pet’r’s Ex. 27 at 35-52 and Pet’r’s Ex. 28 at 86-103). The undersigned will cite to the article filed as part of Pet’r’s Ex. 27. 31 Berger et al., “Neuron-Specific Enolase and S100B in Cerebrospinal Fluid After Severe Traumatic Brain Injury in Infants and Children,” 109 PEDIATRICS E31 (2002) (filed as Pet’r’s Ex 19 Case 1:10-vv-00243-UNJ Document 88 Filed 04/28/16 Page 20 of 34 children who have experienced traumatic brain injuries (“TBI”). See Pet’r’s Ex. 27 at 2. The Berger researchers surveyed 10 pediatric patients ranging in ages from two months to nine years who were admitted to the Children’s Hospital of Pittsburgh with both inflicted and non- inflicted32 TBI. Id. at 3. The researchers tested the children’s cerebrospinal fluid (“CSF”) for the presence of NSE, hypothesizing that the concentration of NSE in children is higher after a TBI. Indeed, the study found that patients with inflicted TBI experienced “an initial peak in NSE concentration on day 1 after injury followed by a second, higher peak that was sustained for up to 8 days.” Id. at 4. In patients with non-inflicted TBI, “the initial concentration [of NSE] was the peak concentration,” meaning that the patients experienced their peak NSE levels shortly after the initial injury that lead to the TBI. Id. Dr. Harum’s citation to the Berger study in support of her contention that B.A.B. experienced an “ongoing neuronal injury” is erroneous for several reasons. First, petitioner does not contend, and the record does not reflect, that B.A.B. ever suffered from an inflicted TBI. However, even if B.A.B. had suffered an inflicted TBI, the NSE levels from the patients in the Berger study peaked one day after injury and were only sustained for up to eight days after injury. Pet’r’s Ex. 27 at 4. B.A.B.’s elevated NSE levels were not measured until one and a half years after he received the MMRV vaccination at issue here. Thus, the results of the study are inapplicable to B.A.B. The Berger study actually disproves Dr. Harum’s theory that B.A.B.’s elevated NSE levels point to an “ongoing neuronal injury” that resulted from the vaccinations he received on April 18, 2007. Assuming the Berger study is applicable to B.A.B.’s case, the results of the study suggest that his elevated NSE levels on September 29, 2008, were actually the result of a much more recent injury than the vaccines he received more than five months earlier. 3. Dr. Harum’s Theory Part 3 The next part of Dr. Harum’s medical theory is that within “3 months [of having roseola – at age nine months], while there was ongoing lymphocytosis33 and presumed brain inflammation, and in this immune dysregulated state, [B.A.B.] received a cluster of vaccines that contributed further to microglial activation, overactive Th2 immunity, and worsening encephalopathy.” Pet’r’s Ex. 26 at 3. With respect to Dr. Harum’s contention that B.A.B. experienced an “ongoing lymphocytosis,” a CBC with differential was performed on January 3, 2007, when B.A.B. had a fever and was diagnosed with a viral illness. See Pet’r’s Ex. 6 at 25. B.A.B.’s lymphocyte levels 27 at 1-8). 32 The Berger researchers note that there are two sub-groups of TBI: inflicted and non-inflicted. Pet’r’s Ex. 27 at 2. “The mechanism of [inflicted] TBI – violent shaking often followed by impact with a hard surface – is unlike any of the mechanism of [non-inflicted] TBI and is particularly deleterious to the brain.” Id. at 3. 33 Lymphocytosis is defined as an “excess of normal lymphocytes in the blood.” DORLAND’S at 1085. 20 Case 1:10-vv-00243-UNJ Document 88 Filed 04/28/16 Page 21 of 34 were normal at that time. Id. The CBC was repeated on April 18, 2007, at the time of his 12 month checkup when he received the vaccinations at issue in this case, and again his lymphocyte levels were in the normal range. Id. at 24. Dr. Harum writes that on April 18, 2007, B.A.B. had a “low normal granulocyte count and high lymphocyte count . . . reflecting ongoing activation following a viral infection.” Id. at 2. But the laboratory results identify the white blood cell count, the granulocyte count, and the lymphocyte count as being within normal limits. Id. at 24. Furthermore, there is no indication in the pediatrician’s records that B.A.B. experienced any “ongoing activation” or other abnormal immune response. See Pet’r’s Ex. 6 at 15. In fact, at his 12 month visit, B.A.B.’s physical exam, including his neurological exam, was completely normal. Id. No parental concerns are noted and no follow up was needed. Id. B.A.B.’s parents did not call or visit his pediatrician after the 12 month visit until July 13, 2007, when B.A.B. lacerated his lip. There is no indication of illness whatsoever during this time frame. Moreover, on October 7, 2008, at approximately 18 months of age, a repeat CBC again showed normal granulocyte and lymphocyte levels. Id. at 21. Dr. Harum’s conclusions that B.A.B. had ongoing lymphocytosis or that he had “ongoing activation following viral infection” are erroneous. Pet’r’s Ex. 26 at 2. There is simply no evidence that B.A.B. had any “immune dysregulation” following his viral illness that occurred in January 2007. Next, Dr. Harum stated that B.A.B. had “presumed brain inflammation.” Pet’r’s Ex. 26 at 3. There is, however, no evidence of brain inflammation. The CBCs were reassuringly normal. See Pet’r’s Exs. 6 at 21, 24, 25; 13 at 3.34 Physical and neurological examinations were normal. Id. at 15. There is no foundation upon which Dr. Harum could base the presence of brain inflammation at any time leading up to B.A.B.’s 12 month vacations, or even after them. Similarly, Dr. Harum used the phrases “neuronal inflammation,” “neuronal irritation,” and “neuronal injury” to describe B.A.B.’s health prior to receipt of his 12 month vaccinations. Pet’r’s Exs. 26 at 3; 29 at 6. She stated that the vaccines were “delivered at a vulnerable period of immune dysregulation (discussed above) and neuronal35 inflammation.” Pet’r’s Ex. 26 at 3. She also stated that the vaccines “independently elicit neuronal irritation, even doubling the risk of seizures.” Id. Dr. Harum does not cite to any evidence in B.A.B.’s medical records, or provide any supporting literature to provide a basis for her statements that B.A.B. had either neuronal inflammation, seizures, or other injury. And as discussed above, the record lacks evidence of either symptom manifestation or diagnosis of such an injury either before or after B.A.B.’s 12 month vaccinations. 34 Blood tests (CBCs) were performed on October 7, 2008, April 18, 2007, January 3, 2007, and March 4, 2009, respectively. The results were mostly normal. The records do indicate decreased levels of WBCs and granulocytes on January 3, 2007, but these levels returned to normal and were normal on April 18, 2007, October 7, 2008, and March 4, 2009. Id. 35 Neurons are classified as “any of the conducting cells of the nervous system. A typical neuron consists of a cell body, containing the nucleus and the surrounding cytoplasm; several short radiating processes; and one long process, which terminates in twiglike branches and may have branches projecting along its course. The axon together with its covering or sheath forms the nerve fiber.” DORLAND’S at 1267. 21 Case 1:10-vv-00243-UNJ Document 88 Filed 04/28/16 Page 22 of 34 The article cited by Dr. Harum to support her assertions regarding inflammation, Vargas, et al.36, was discussed extensively in the OAP. The authors of that article “demonstrated a marked increase in neuroglial responses, characterized by activation of the microglial and astroglia in the brains of autistic patients.” Pet’r’s Ex. 27 at 24. They concluded that these increases were “likely part of neuroinflammatory reactions.” Id.; see also Snyder, 2009 WL 332044 at, *87-88 (discussing Vargas). However, as the special masters in the OAP test case indicated, the authors did not discuss whether they believed the neuroinflammation found was a cause or effect of autism. See e.g., King, 2010 WL 892296 at, *40-41; Snyder, 2009 WL 332044, at *88. Moreover, there is no connection to or even the mention of a vaccine in the article. The entire notion that BAB had some “identifiable predisposing conditions, such as metabolic abnormalities or immune deficiencies” which would cause him to be susceptible to increased microglial and astroglial activation from vaccines is wholly unsupported by the medical records. Pet’r’s Ex. 29 at 5. Dr. Harum also concedes there is no evidence that B.A.B. had any relevant genetic abnormality that would have affected his development. Id. at 5-6. 4. Dr. Harum’s Theory Part 4 The next part of Dr. Harum’s medical theory is that B.A.B. “received a cluster of vaccines that contributed further to microglial activation, overactive Th2 immunity, and worsening encephalopathy.” Pet’r’s Ex. 26 at 3. She assumes that B.A.B. already had microglial activation, overactive Th2 immunity, and encephalopathy. Dr. Harum does not define microglial activation in her expert report, but she again references the article by Vargas, et al. to support her broad assertions.37 However, in Vargas, the authors do not suggest that vaccines cause or contribute to any microglial activation they found. Moreover, it is unclear what Dr. Harum means by referencing B.A.B.’s “overactive Th2 immunity,” as a component of her theory. Presumably, it ties into the aspect of her theory related to the notion that B.A.B. had an abnormal immune response following his viral illness which was worsened by the vaccines and played a role in causing or contributing to encephalopathy. Throughout her reports, Dr. Harum suggests that B.A.B. may have an immune dysregulation, immune incompetence, or that he may have suffered an “untoward immunologic reaction.” Pet’r’s Ex. 26 at 3. She believes that B.A.B.’s abnormal granulocyte and lymphocyte counts are evidence of his immune incompetence. Id. She also writes that B.A.B.’s “IgG total count was also high, suggesting excessive immunoglobulin mediated inflammation (Th2 predominance).” Pet’r’s Exs. 26 at 2; 29 at 6. The IgG test to which Dr. Harum references, however, was performed on September 29, 2008, a year and a half after the vaccines were given. Dr. Harum provides no explanation for how that 36 Vargas et al., “Neuroglial Activation and Neuroinflammation in the Brain of Patients with Autism,” 57 ANN. NEUROL. 67-81 (2004) (filed as Pet’r’s Exs. 27 at 16-30; 28 at 111-25). 37 See Vargas et al., supra note 34. 22 Case 1:10-vv-00243-UNJ Document 88 Filed 04/28/16 Page 23 of 34 result, 18 months later, provides evidence of immune mediated inflammation that contributed to autism or encephalopathy temporally associated with the vaccinations. She also cites an article by Asherman, et al.,38 which examined the pro-inflammatory and anti-inflammatory characteristics of IgG. See Pet’r’s Ex. 28 at 104-10. The authors devoted much of the discussion to the anti-inflammatory aspects of IgG, theorizing that a better understanding of this aspect “might enable us to replace this primary blood product [(IVIG)39] in the future with a recombinant therapeutic.” Id. at 105. One other test relied upon by Dr. Harum is the IL-2 receptor Alpha, which was found to be elevated on September 29, 2008, and March 4, 2009. Pet’r’s Ex. 9 at 10; Pet’r’s Ex. 13 at 1. Dr. Harum states that these results suggest “immune system activation.” Pet’r’s Ex. 26 at 2. Again, she does not explain how this fact supports her theory or provides evidence that B.A.B. suffered a vaccine-related injury. Dr. Harum further cited an article by Triger, et al.40 for the proposition that “highly elevated measles antibodies have been seen in a variety of clinical and autoimmune disorders, characterized by excessive antibody production and inadequate innate immunity.” Pet’r’s Ex. 26 at 3. Examining groups of 21 to 6541 patients (depending on the disease involved), the authors sought to determine if the elevated measles antibody titers reported in patients with chronic active hepatitis could also be observed in patients with other diseases. Pet’r’s Ex. 28 at 126. The authors found the same result in patients with other diseases, such as DLE,42 but not diseases such as rheumatoid arthritis. Id. at 126, 131.43 This article, however, offers no support for Dr. Harum’s assertions in this case. As stated earlier, B.A.B.’s elevated measles antibody titer following the MMRV vaccination was characterized by Dr. Doreswamy as nothing more than “a good vaccine response.” Pet’r’s Ex. 12 at 8. And even Dr. Harum seems to doubt her commitment to the point that B.A.B.’s response to the measles vaccine was somehow evidence of immune 38 Ascherman et al., “The Other Side of Immunoglobulin G: Suppressor of Inflammation,” 160 CLINIC. EXP. IMMUN. 161-67 (2010) (filed as Pet’r’s Ex. 28 at 104-10). 39 “IVIG” stands for intravenous immunoglobulin. Neil M. Davis, MEDICAL ABBREVIATIONS, 15th Edition, at 178 (2011). 40 Triger et al., “Measles Antibodies and Autoantibodies in Autoimmune Disorders,” 24 CLIN. EXP. IMMUNOL. 407-14 (1976) (filed as Pet’r’s Ex. 28 at 126-33). 41 The total for the group of patients with rheumatoid arthritis is listed as 55 at one point and 65 at another. Compare Pet’r’s Ex. 28 at 126 with id. at 128 (total listed in table). 42 The authors of this article do not provide the disease labeled as DLE but it appears to stand for discoid lupus erythematosus, “a chronic form of cutaneous lupus erythematosus.” DORLAND’S at 1079. 43 The authors acknowledged their result with regard to rheumatoid arthritis differed from other studies but argued those studies were not comparable. Pet’r’s Ex. 28 at 131. 23 Case 1:10-vv-00243-UNJ Document 88 Filed 04/28/16 Page 24 of 34 incompetence when she says, “[w]hile . . . robust antibody production against the vaccine strain of measles is good, it may also contribute to ongoing inflammation of the brain . . . .” Pet’r’s Ex. 26 at 3. The word “may” in this context is weak when compared with the balance of Dr. Harum’s opinions. In her third report, Dr. Harum finally conceded that B.A.B.’s “antibody response to measles was normal.” Pet’r’s Ex. 29 at 7. The last phase of this part of Dr. Harum’s theory is that B.A.B. “received a cluster of vaccines that contributed further to . . . worsening encephalopathy.” Pet’r’s Ex. 26 at 3. The lack of evidence to support any conclusion that B.A.B. had encephalopathy has been previously discussed. Here, however, Dr. Harum implies that B.A.B.’s condition is worsening, and again, she fails to cite to any medical records to provide a basis for this characterization. 5. Dr. Harum’s Theory Part 5 The last aspect of Dr. Harum’s medical theory is that the vaccines further contributed to “this injury pathway through the load of aluminum, glutamate, formaldehyde and unidentified pathogens.” 44 Pet’r’s Exs. 26 at 3; 29 at 8. Dr. Harum stated that B.A.B. received “225 mcg in the PedVax and 125 mcg in [the] Proquad” vaccines, for “a total of 350 mcg aluminum.” Pet’r’s Ex. 29 at 8. Dr. Harum further stated that the “FDA recommends no more than 25 mcg of aluminum per day, when parenterally delivered.” Id. However, Dr. Harum provided no citation for her assertion, nor did she discuss the potential effect that the alleged larger dose of aluminum in B.A.B.’s vaccinations could have had on his development. Furthermore, Dr. Harum opined that in the context of the C677T MTHFR mutation, “the aluminum may have presented an additional aggravating factor.” Pet’r’s Ex. 29 at 8. She states generally that “vaccines can contribute further to this pathway of injury through the load of aluminum, glutamate, formaldehyde and unidentified pathogens.” Id. She does not, however, explain how the aluminum may have been an aggravating factor, nor does she provide any evidence that the vaccinations B.A.B. received contained aluminum, glutamate, formaldehyde, or other unidentified pathogens. And even if B.A.B.’s vaccinations contained all of these alleged ingredients, Dr. Harum failed to show how they could have caused B.A.B. to develop encephalopathy. She cites two articles, one by Campbell et al. 45 and another by Giangaspero et al.46 to support her generalizations, neither of which is relevant to B.A.B.’s case. The Campbell researchers discuss the links between exposure to aluminum and the development of age-related neurological disorders, mainly focusing on Alzheimer’s disease (“AD”). Pet’r’s Ex. 28 at 40. Acknowledging that “epidemiological studies show that long-term 44 To support her assertion, Dr. Harum cited Campbell et al., “Chronic Exposure to Aluminum in Drinking Water Increases Inflammatory Parameters Selectively in the Brain,” 75 J. NEUROSCI. RES. 565-72 (2004) (filed as Pet’r’s Ex. 28 at 40-47). 45 Campbell et al., supra note 42 at 565-72. 46 Giangaspero et al., “Genotypes of Pestivirus RNA Detected in Live Virus Vaccines for Human Use,” 63 J. VET. MED. SCI. 723-33 (2001) (abstract only filed as Pet’r’s Ex. 28 at 134). 24 Case 1:10-vv-00243-UNJ Document 88 Filed 04/28/16 Page 25 of 34 exposure to [aluminum] is necessary for adverse health effects,” they exposed mice to levels of aluminum in drinking water for ten weeks, a period comparable to eight years for humans. Id. at 42. Although the activation of transcription factors (one of the initial steps of an inflammatory response) was found at the lowest levels of aluminum (comparable to levels found in certain areas of Canada), values associated with inflammation “reached significance only at the higher [levels of aluminum] exposures).” Id. at 43. The researchers cautioned that “it is possible that a threshold concentration of the metal has to be accumulated in the brain before an inflammatory response is even initiated.” Id. at 43-44. Furthermore, they theorized that the “[i]nflammatory processes . . . within the aging brain . . . may provide the substrate upon which aluminum can act and thus accelerate the progression of age-related neurodegenerative disease.” Id. at 44 (emphasis added). They concluded only that aluminum “could contribute to progressions of neurodegeneration.” Id. at 40. The authors of the Campbell study state, “Abnormal neurological symptoms have been observed in several patients receiving intramuscular injections of [aluminum]-containing vaccines,” and “the [World Health Organization] Vaccine Safety Advisory Committee has recognized that there may be a subset of predisposed individuals who are sensitive to [aluminum]-containing adjuvant.” Pet’r’s Ex. 28 at 40 (internal citations omitted) (emphasis added). However, the authors do not reach any other conclusions. Vaccines are mentioned only briefly to provide support for the proposition that aluminum potassium sulfate is an adjuvant that “enhance[s] the systematic immune response.” Id. at 44. Dr. Harum does not suggest, and the record does not indicate, that B.A.B. was exposed to aluminum over a period of weeks or years. Moreover, B.A.B. is not elderly and Dr. Harum does not explain or suggest that B.A.B. is a “predisposed individual [] who [is] sensitive to [aluminum]-containing adjuvant.” Pet’r’s Ex. 28 at 40. While Dr. Harum postulates that the alleged high levels of aluminum found in the Proquad vaccines could have led B.A.B. to experience an “inflammatory event” such as an encephalopathy, the Campbell study and its findings are focused on long-term aluminum exposure through drinking water. Thus, the undersigned finds the Campbell article inapplicable to B.A.B.’s case. Dr. Harum’s cite to the Giangaspero study47 is also not persuasive evidence that B.A.B. suffered an encephalopathy, and the undersigned struggles to see how it is relevant to B.A.B.’s case at all. The researchers tested 33 different live virus vaccines for human use48 for the presence of pestivirus49 and found that “[f]ive (13.1%) out of 38 tested samples were positive for 47 The undersigned notes that petitioner did not file the full Giangaspero article but rather only a one page abstract. See Pet’r’s Ex. 28 at 134. 48 The vaccines tested included “29 monovalent vaccines against measles, mumps, rubella or polio, eight polyvalent vaccines against measles-mumps-rubella and one bacterial polyvalent vaccine against Streptococcus pneumoniae.” Pet’r’s Ex. 28 at 134. 49 Pestivirus is “a genus of viruses of the family Flaviviridae comprising bovine diarrhea virus, hog cholera virus, and border disease virus of sheep. DORLAND’S at 1421-22. 25 Case 1:10-vv-00243-UNJ Document 88 Filed 04/28/16 Page 26 of 34 pestivirus RNA.” Pet’r’s Ex. 28 at 134. According to the researchers, “[t]hese findings indicate that contamination by animal pestivirus may occur in biological products for human use.” Id. Presumably, petitioner introduced the Giangaspero article to show the potential for human vaccines to be contaminated. Assuming, arguendo, that contaminants were present in the vaccinations that B.A.B. received, Dr. Harum offers no explanation as to how these potential contaminants, including pestivirus, could have caused B.A.B. to develop encephalopathy. The abstract of the Giangaspero article that petitioner filed, without further explanation from Dr. Harum or petitioner, seems to be irrelevant to B.A.B.’s alleged development of encephalopathy. Considering Dr. Harum’s theory on the whole reveals a fundamental flaw: in her second report, she notes that there is evidence of loss of skills, language plateau, auditory awareness and visual attention after B.A.B.’s 12-month vaccinations. Pet’r’s Ex. 26 at 1. However, the medical records demonstrate that B.A.B. did not begin to lose any skills until approximately 18 months of age, when petitioner first expressed concern to the pediatrician during an office visit on October 19, 2007. Pet’r’s Ex. 6 at 4, 16. Moreover, at B.A.B.’s nine, 12, and 18-month well-child visits, he was noted to be a well-child and to have met all developmental milestones. Pet’r’s Ex. 6 at 14-16. As for the abnormalities seen by Dr. Harum on September 26, 2008, when B.A.B. was 29 months old, including “reduced eye contact, limited cooperation with balance maneuvers, frequent tripping, [] intermittent toe walking … [and] oral aversion,” Dr. Harum concedes that these physical findings “do not specifically relate to vaccination at 12 months of age, nor do they confirm regression of any sort.” Pet’r’s Ex. 29 at 7. In addition to the issues with Dr. Harum’s expert reports noted above, the undersigned notes several other problems. Dr. Harum fails to explain how subclinical encephalopathy would more likely result from the MMRV vaccine than from the viral illnesses accompanied by fever and other symptoms that B.A.B. experienced two to three months before the MMRV vaccine or four months after it. She makes vague references to vitamin, iron and folate deficiencies, “if present at the time of vaccine complications,” as possible contributors to B.A.B.’s poor immune response. Pet’r’s Ex. 19 at 1. However, the record reflects that B.A.B. did not experience such deficiencies, nor did he have a poor immune response to the MMRV vaccine. In fact, his pediatrician noted that he had a robust response to the measles portion. Dr. Harum refers to vaccine-caused seizures, but B.A.B. has never been diagnosed with a seizure disorder,50 much less one temporally related to a vaccination. Likewise, Dr. Harum makes vague references to markers of “oxidized DNA and reduced glutathione stores” and data which “suggest oxidized molecules are elevated” when B.A.B. was 29 months of age, but she does not explain how vaccines given at 12 months of age relate to these findings, or that these findings prove a vaccine related injury. See Pet’r’s Ex. 29 at 6. 50 While B.A.B.’s parents expressed concerns about seizures, no doctor ever diagnosed him as having had one. Dr. Harum also admits that B.A.B. never experienced even one seizure. Pet’r’s Ex. 26 at 3. In her third report, Dr. Harum does clarify her position on several important issues. B.A.B.’s parents describe “spells,” which were temporally associated with his 12 month vaccines. Pet’r’s Ex. 29 at 7. Dr. Harum concedes, however, that these spells did not constitute seizures and that B.A.B. “clearly does not have a seizure disorder.” Id. 26 Case 1:10-vv-00243-UNJ Document 88 Filed 04/28/16 Page 27 of 34 b. Respondent’s Expert, Dr. Gregory L. Holmes Dr. Gregory Holmes testified on behalf of respondent. Dr. Holmes received his medical degree from Washington and Lee University, and he holds an honorary degree from Harvard. Resp’s Ex. C at 1. He did an internship in pediatrics and completed his residency in pediatrics at the Yale University School of Medicine, after which he completed another residency in Neurology at the University of Virginia School of Medicine. Id. He is certified by the American Board of Pediatrics, the American Board of Psychiatry and Neurology with Special Competence in Child Neurology, and the American Board of Clinical Neurophysiology. Id. Dr. Holmes has also held various academic appointments, including his current positions as a professor of pediatrics at the University of Vermont College of Medicine and the professor and chair of the neurology and pediatrics department at Dartmouth Medical School. Id. at 2. He has received numerous academic and fellowship awards, and he has served as an editor for over a dozen pediatric and neurology medical journals. Id. at 5-7. In addition, he has published numerous medical articles on topics ranging from pediatric seizures to brain development and behavior. Id. at 39-65. Dr. Holmes set forth a lengthy overview of B.A.B.’s medical history and clinical course, concluding that B.A.B. is an “eight year old boy with the diagnosis of autistic spectrum disorder (ASD) and language delay. His clinical history and neurological examination are quite consistent with this diagnosis.” Resp’s Ex. B at 7.51 As for Dr. Harum’s conclusion that B.A.B. sustained encephalopathy, Dr. Holmes disagreed. Dr. Holmes defined encephalopathy as a “general term used to describe brain dysfunction.” Resp’s Ex. B at 7. He explains that the “clinical features” of encephalopathy include “a change in mental status, ranging from confusion to stupor or coma, alterations in muscle tone, abnormal movements or severe seizures.” Id. Examples of encephalopathy set forth in the IOM include “encephalitis, meningitis, seizures and head trauma, none of which were suffered by [B.A.B.].” Id. Moreover, B.A.B.’s pediatrician saw him three times following the vaccinations at issue (July 14, August 15, and September 17), and in the records of those visits, “there is no mention of any behavior consistent with an encephalopathy.” Id. at 7. Dr. Holmes summarized, “The report of Dr. Harum does not dissuade me from my original opinion. There is no evidence in the medical record to indicate that [B.A.B.] suffered from an acute or subacute encephalopathy.” Resp’s Ex. Q at 4. He further stated, “[B.A.B.] has autistic spectrum disorder and the MMR vaccine has no bearing on his current clinical condition. Dr. Harum has provided no reliable evidence linking the MMR vaccine to autism.” Id. As explained in further detail below, the undersigned finds Dr. Holmes’ opinions to be more persuasive than those of Dr. Harum. V. Encephalitis vs. Encephalopathy vs. Subacute/Subclinical Encephalopathy To provide further clarity to the discussion of the Althen prongs, the undersigned first notes the differences between encephalitis and encephalopathy. Encephalitis is defined as 51 It should be noted that respondent’s Exhibit B was filed twice, once on December 17, 2014 (ECF No. 65) and again on January 7, 2015 (ECF No. 66). 27 Case 1:10-vv-00243-UNJ Document 88 Filed 04/28/16 Page 28 of 34 “inflammation of the brain.”52 In contrast, encephalopathy is defined as “any degenerative disease of the brain.”53 Dr. Harum conflates these terms throughout her expert reports, despite the fact that they represent two distinct diagnoses. For example, in her first expert report, Dr. Harum states, “. . . there is a plausible body of evidence to associate MMR and other vaccines and encephalitis resulting in mental retardation and speech impairment.” Pet’r’s Ex. 19 at 2. From this assertion, she concludes that “one can postulate that there is a plausible association between MMR and other vaccines and subacute encephalopathy associated with developmental regression.” Id. (emphasis added). While Dr. Harum is correct that the MMR vaccination has been known to cause acute encephalopathy in children five to 15 days post vaccination,54 it is incorrect to assume that therefore there is a relationship between MMRV and “subtle” or subacute encephalopathy, as described by. Dr. Harum.55 While Dr. Harum eventually concludes that B.A.B. did not suffer from encephalitis and only from encephalopathy, the central component of her theory is that B.A.B. suffered from a “subacute” or “subclinical” encephalopathy. Dr. Harum describes B.A.B.’s condition as subacute or subclinical “because it was not acute and was subtle enough for parents to recognize, but not obvious enough for the pediatrician to be concerned about or to inhibit ridicule of Mom’s internet research.” Pet’r’s Ex. 29 at 4. She believes that B.A.B.’s “developmental plateau . . . . suggests a subacute encephalopathy.” Pet’r’s Ex. 26 at 4. Despite the fact that none of B.A.B.’s treating physicians ever suggested a diagnosis of encephalopathy, Dr. Harum presumes that B.A.B. suffered “subclinical encephalopathy,” which went unnoticed by his physicians during numerous doctor’s appointments over a period of several months. 52 DORLAND’S at 612. 53 DORLAND’S at 614. 54 While petitioner has not alleged that B.A.B. suffered a Table encephalopathy, it is important to note that “encephalopathy” does exist as a Table injury for several vaccinations, including pertussis or measles containing vaccines. However, the Table specifies a lengthy and precise definition of an “encephalopathy.” See 42 C.F.R. § 100.3(b)(2). To summarize, the regulation requires a “significantly decreased level of consciousness” that lasts at least 24 hours, which was not seen in B.A.B.’s case. As former Chief Special Master Campbell-Smith noted in Waddell v. Sec’y of Health & Human Servs., No. 10-316V, 2012 WL 4829291, at *6 (Fed. Cl. Spec. Mstr. Sept. 19, 2012), the symptoms of a Table Injury encephalopathy are not “subtle.” 55 It should also be noted that Dr. Harum does not give a citation to a definition of subacute or subclinical encephalopathy. Furthermore, Dr. Holmes noted: The pathophysiological mechanisms by which such a “subtle encephalopathy” could result in autism spectrum disorder is not discussed by Dr. Harum. The term “subtle encephalopathy” is not a medically recognized entity and it is difficult to understand how such a subtle process could result in harm. It is highly unlikely that a vaccine-induced encephalopathy could be so subtle that it was not noted by the pediatrician. Resp’s Ex. Q at 3. 28 Case 1:10-vv-00243-UNJ Document 88 Filed 04/28/16 Page 29 of 34 VI. Petitioner has Failed the Althen Test In Althen, the United States Court of Appeals for the Federal Circuit discussed the issue of “causation-in-fact” in Vaccine Act cases. The court stated: [Petitioner’s] burden is to show by preponderant evidence that the vaccination brought about [the child’s] 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 the vaccination and injury. If [petitioner] satisfies this burden, she is entitled to recover unless the [government] shows, also by a preponderance of the evidence, that the injury was in fact caused by factors unrelated to the vaccine. Althen v. Sec’y of Health & Human Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005) (internal citations and quotations omitted). In the pages above, the undersigned has provided a detailed explanation of how petitioner has failed to demonstrate preponderant evidence of “causation-in- fact.” The next section shows how that analysis fits within the three prongs of the Althen test. For the reasons set forth below, the undersigned finds that petitioner has failed to satisfy the Althen test and is therefore not entitled to compensation. A. Althen Prong One: Lack of a Reliable Medical Theory As discussed below, petitioner has failed Prong One of Althen for three reasons. First, the record lacks evidence to show that Proquad can cause encephalopathy or sub-clinical encephalopathy, as described by Dr. Harum. Second, Dr. Harum mischaracterizes B.A.B.’s diagnosis as an encephalopathy despite the fact that he was clearly diagnosed with ASD. Finally, Dr. Harum’s medical theory bears a striking resemblance to the theory proposed by Dr. Marcel Kinsbourne during the OAP, which was found unpersuasive in all three test cases. a. Lack of Evidence Demonstrating that Proquad can Cause Encephalopathy or “SubClinical” Encephalopathy Prong One of Althen requires petitioner to show by preponderant evidence a medical theory of how the MMRV vaccination B.A.B. received on April 18, 2007, can cause encephalopathy. As discussed above, however, Dr. Harum has not demonstrated that the Proquad vaccine can cause encephalopathy. Instead, Dr. Harum has conflated the definitions of encephalitis and encephalopathy and has presented a number of claims and statements in her expert reports which lack foundation. b. Mischaracterization of B.A.B.’s ASD Diagnosis as a “Subclinical” Encephalopathy In denying petitioner’s earlier motion for interim fees and costs, former Chief Special Master Vowell noted that after the OAP proceedings, some petitioners chose, in spite of an ASD diagnosis, to pursue their cases by characterizing their children’s injuries as “encephalopathy” or seizure disorders accompanied by developmental delay, among others. Former Chief Special Master Vowell observed that petitioners often chose to amend their theories “based on a belief 29 Case 1:10-vv-00243-UNJ Document 88 Filed 04/28/16 Page 30 of 34 that claims alleging autism [would] not be compensated, but that claims alleging these other conditions may be compensated.” Fester v. Sec’y of Health & Human Servs., No. 10-243V, 2013 WL 5367670, at 1 n.5 (Fed. Cl. Spec. Mstr. Aug. 27, 2013). She further stated, “[R]e- characterizing a condition as an “encephalopathy”—a term that can encompass conditions ranging from intoxication to a coma—when another diagnosis is more specific and appropriate does little to advance a vaccine injury claim.” Id.56 Not only does Dr. Harum conflate encephalopathy and encephalitis, but she has offered no support for her proposed theories of causation. Although not required to provide medical literature to support her theory, the medical literature Dr. Harum has cited provides no support. See Andreu ex rel. Andreu v. Sec’y of Health & Human Servs., 569 F.3d. 1367, 1378-79 (Fed. Cir. 2009) (explaining that “requiring ‘objective confirmation’ in the medical literature prevents the use of circumstantial evidence … and negates the system created by Congress through the Vaccine Act” (internal citations omitted)). However, Dr. Harum is still required to prove her theory by preponderant evidence, which she has failed to do. 56 Though the issue of causation was not adjudicated, former Chief Special Master Campbell- Smith explained in Poling v. Sec’y of Health & Human Servs., No. 02-1466V, 2011 WL 678559 (Fed. Cl. Spec. Mstr. Jan. 28, 2011), that petitioners received compensation because the child suffered a Table Injury, specifically a Table encephalopathy, and not because respondent conceded or the special master found that the child’s ASD was either caused or significantly aggravated by a vaccination. Similarly, in Wright v. Sec’y of Health & Human Servs., No.12- 423V, 2015 WL 6665600, at *30 (Fed. Cl. Spec. Mstr. Sept. 21, 2015), former Chief Special Master Vowell found that a child who was later found to have ASD suffered a Table Injury (encephalopathy) after receiving a vaccination. In finding that petitioner was entitled to compensation, however, Special Master Vowell emphasized that she was not finding that the child’s ASD was “caused-in-fact” by the vaccination, even remarking that petitioner’s medical theory of causation was “absurd.” See Sturdivant, 2016 WL 552529, at *5, note 4. As Special Master Hastings has noted, the compensation of the petitioners in Poling and Wright “does not afford any support to the notion that vaccinations can contribute to the causation of autism …. Congress forthrightly acknowledged that the Table Injury presumptions would result in compensation for some injuries that were not, in fact, truly vaccine caused.” Sturdivant v. Sec’y of Health & Human Servs., No. 07-788V, http://www.help.senate.gov/hearings/s-2700-s185-s2713-s_-nih-strategic-plan-and-inclusion-in- clinical-research-and-s_-promoting-biomedical-research-and-public-health-for-patients-act, 2016 WL 552529, at *5 n.4 (Fed. Cl. Spec. Mstr. Jan 21, 2016)(emphasis in original). In this case, petitioner has made clear that although B.A.B. suffers from ASD, her medical theory is that B.A.B developed encephalopathy from the Proquad vaccination, which subsequently caused him to develop a serious brain injury and developmental delay. Whether characterized as autism or encephalopathy, petitioner still has to prove that B.A.B.’s injury was “caused-in-fact” by the Proquad vaccination, and this she has not done. 30 Case 1:10-vv-00243-UNJ Document 88 Filed 04/28/16 Page 31 of 34 c. Dr. Harum’s Medical Theory of Causation is Similar to the Earlier Proposed Theory of Dr. Marcel Kinsbourne In addition to being unable to articulate a reliable medical theory tending to show that MMRV can cause encephalopathy, the undersigned further notes that certain parts of Dr. Harum’s theory are remarkably similar to the theory and testimony of Dr. Kinsbourne, as given in Snyder, 2009 WL 332044, which was part of the OAP. Dr. Kinsbourne was the leading expert witness for petitioners in the Theory 1 test cases.57 “Dr. Kinsbourne’s role was to provide the theory or theories to explain how measles virus could, directly or indirectly, cause at least some cases of ASD.” Snyder, 2009 WL 332044, at *87. Dr. Kinsbourne offered two overarching theories to explain how the measles virus could lead to the development of ASD. Id. Special Master Vowell explained, “The first theory was that the virus caused an inflammatory process in the brain leading to an encephalopathy. The second theory, built in some measure on the first, relied on persistent measles virus causing inflammatory damage to cells, leading to an imbalance in the excitation-inhibition chemicals in the brain.” Id. Dr. Kinsbourne’s theory was divided into three core stages. Stage One occurred as the brain’s innate immune system caused neuroinflammation, mediated by microglial activation, which in turn caused the release of cytokines and damaged astrocytes. As a result of damage to the astrocytes, brain glutamate levels rose. Snyder, 2009 WL 332044, at *87. In Stage Two, the excess glutamate in the brain caused over-arousal or over-activation of the brain, which then caused the potential for seizures and neuronal death as the result of excitotoxicity. Id. In Stage Three, Dr. Kinsbourne hypothesized that “[n]eural activation and over-arousal could account for autistic behavior.” Id. Dr. Harum’s theory bears a striking resemblance to Dr. Kinsbourne’s three tiered theory, which was found to contain no persuasive evidence that the MMR vaccine contributed in any way to cause ASD. For example, Dr. Harum opines: These mechanisms of injury contribute to [B.A.B.’s] autism spectrum condition through an increase in brain inflammation, a pathophysiologic mechanism well described in spectrum disorders. This mechanism converges onto the more recently described neuronal pathways and signaling systems identified as 57 The Petitioners’ Steering Committee (“PSC”), formed in 2002 by petitioners’ attorneys in the Vaccine Program, presented two separate theories in the OAP regarding how vaccines cause ASD. “The first theory alleged that the measles 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.” Sturdivant, 2016 WL 552529, at *3 (emphasis in original). In all those cases, the special masters rejected petitioners’ theory of causation. See Cedillo, 2009 WL 331968; Hazlehurst v. Sec’y of Health & Human Servs., 03-645V, 2009 WL 332306 (Fed. Cl. Spec. Mstr. Feb. 12, 2009), aff’d, 88 Fed. Cl. 473 (2009), aff’d, 604 F.3d 1343 (Fed. Cir. 2010); Snyder, 2009 WL 332044. 31 Case 1:10-vv-00243-UNJ Document 88 Filed 04/28/16 Page 32 of 34 impaired in autism by virtue of over activity of the glutamate receptors and excitetoxicity [sic] to developing synapses. Pet’r’s Ex. 26 at 3 (emphasis added). Dr. Harum also states, “The evidence that immune deregulation is associated with an autism diagnosis lies in the landmark data that points toward chronic inflammation in autism. The [Vargas] authors demonstrated long-term microglial activation and abnormally high cytokine levels.” Id. at 2 (emphasis added). It appears from these and other similar statements that Dr. Harum simply borrows and enhances certain aspects of Dr. Kinsbourne’s earlier theory in an effort to opine that the Proquad vaccine could cause encephalopathy and eventually lead to neuronal damage. However, Dr. Harum, like Dr. Kinsbourne, has failed to demonstrate a reliable theory demonstrating that MMR can cause subacute encephalopathy. Dr. Kinsbourne’s theory was ultimately rejected in the three tests cases. See Cedillo, 2009 WL 331968; Hazlehurst, 2009 WL 332306; Snyder, 2009 WL 332044. So too, the undersigned rejects Dr. Harum’s similar reasoning in this case. For all of the reasons stated above, petitioner has failed to provide evidence of causation sufficient to meet Prong One of Althen. B. Althen Prong Two: Lack of a Logical Sequence of Cause and Effect Althen Prong Two requires petitioner to show by preponderant evidence a logical sequence of cause and effect to explain how the MMRV vaccination caused B.A.B. to develop encephalopathy. As explained above, the medical records are devoid of any evidence that B.A.B. ever developed or was diagnosed with encephalopathy. Moreover, Dr. Harum’s three medical expert reports do not clearly or logically delineate facts to show that B.A.B. developed encephalopathy, much less that the MMRV vaccine actually caused this alleged encephalopathy. Dr. Harum also relies upon factual inaccuracies and medical presumptions which are not supported by B.A.B.’s medical records. For example, the first step of Dr. Harum’s theory of causation is that B.A.B. suffered from roseola infantum at the age of nine months. See Pet’r’s Ex. 29 at 8; Pet’r’s Ex. 26 at 3. However, it is clear from the record that B.A.B. was not diagnosed with roseola infantum until the age of 22 months, which was 10 months after he received the Proquad vaccine. Dr. Harum did not become B.A.B.’s treating physician until he was 29 months old, and thus her medical opinion is based on B.A.B.’s pediatric records. These records do not indicate that B.A.B. suffered from roseola infantum prior to the age of 22 months, and B.A.B.’s treating physicians did not ever consider the diagnosis until that time. Additionally, despite Dr. Harum’s contention that the vaccines were given in proximity to a “significant encephalitic virus infection” or a “mild and temporary encephalitis,” there are no records or notes from any of B.A.B.’s doctors regarding a condition or diagnosis, despite the fact that B.A.B. visited his pediatrician a number of times while he ostensibly suffered from the condition. Pet’r’s Ex. 26 at 3; Pet’r’s Ex. 29 at 3. The assertion that B.A.B. suffered from a subacute encephalopathy that went undetected and untreated by pediatricians for several months is unfounded. The undersigned further notes that no previous Program cases have awarded compensation to petitioners based on a diagnosis of subacute or subclinical encephalopathy. 32 Case 1:10-vv-00243-UNJ Document 88 Filed 04/28/16 Page 33 of 34 Dr. Harum suggests that B.A.B.’s lab results are evidence of an apparent, undetected encephalopathy. She points to B.A.B.’s granular leukocyte count, elevated NSE levels, abnormal IgG count, and Il-2 Receptor Alpha elevation to support these assertions. She follows her discussion of these lab results with citations to a number of medical articles that supposedly support her contention that B.A.B. suffered from encephalopathy. However, Dr. Harum does not actually explain how their findings are applicable to B.A.B.’s case and/or discuss how they provide evidence that he suffered an encephalopathy. Upon further examination of the medical articles cited by Dr. Harum, most are irrelevant to B.A.B.’s diagnosis of ASD and a few actually contradict her opinions altogether. For example, as discussed above, Dr. Harum’s citation to the Berger58 study actually disproves her theory that B.A.B.’s elevated NSE levels point to “ongoing neuronal injury” and encephalopathy. According to the Berger study, if B.A.B. had suffered from an inflicted TBI, one would expect his NSE levels to peak up to eight days after the injury. The study’s findings suggest that B.A.B.’s elevated NSE levels on September 29, 2008, were the result of a much more recent injury than his April 18, 2007 Proquad vaccination. Dr. Harum’s second and third medical expert reports adapt a “kitchen sink approach” of including all potential medical theories, such as the theory that “the load of aluminum, glutamate, formaldehyde and unidentified pathogens” presumably contributed to B.A.B.’s development of encephalopathy. See Pet’r’s Ex. 26 at 3; Pet’r’s Ex. 29 at 8. Dr. Harum seems to suggest that the amount of aluminum found in the PedVax and the Proquad vaccines contributed to the alleged development of encephalopathy. However, petitioner contends that the Proquad vaccine, not PedVax, caused B.A.B.’s encephalopathy. Petition at Preamble. Moreover, the articles cited by Dr. Harum do not support her assertion that foreign contaminants found in vaccines contribute to neurological injuries. Dr. Harum merely cites these studies and does not provide any explanation as to how or why they are applicable to B.A.B.’s case. Thus, petitioner has failed to provide preponderant evidence of actual causation under Althen Prong Two. C. Althen Prong Three: Lack of a Temporal Relationship Under Prong Three of Althen, petitioner must show by preponderant evidence B.A.B.’s encephalopathy occurred within a time frame that is medically appropriate for the alleged mechanism of harm. See Pafford, 451 F.3d 1352, 1358 (Fed. Cir. 2006) (“Evidence demonstrating petitioner’s injury occurred within a medically acceptable time frame bolsters a link between the injury alleged and the vaccination at issue under the ‘but-for’ prong of the causation analysis.”). As the undersigned has already explained, Dr. Harum did not offer sufficient evidence tending to show that the Proquad vaccination causes encephalopathy, much less that B.A.B. developed an encephalopathy from the Proquad vaccination. It follows, then, that petitioner cannot prove Prong Three of Althen. 58 Berger et al., 109 PEDIATRICS E31 (2002) (filed as Pet’r’s Ex 27 at 1-8). 33 Case 1:10-vv-00243-UNJ Document 88 Filed 04/28/16 Page 34 of 34 Even if Dr. Harum had shown that B.A.B. developed encephalopathy after receiving the MMRV vaccination, Dr. Harum does not provide preponderant evidence of a temporal relationship between the vaccine and B.A.B.’s alleged encephalopathy. Dr. Harum does not address the issue of a proximate temporal relationship between Proquad and encephalopathy other than to note the IOM’s conclusion that the measles vaccine “can cause measles inclusion body encephalitis [not encephalopathy] due to the vaccine strain of measles, after administration of the measles vaccine, particularly in immune compromised individuals up to nine months after the vaccine administration.” IOM at 110 (emphasis added); see also Pet’r’s Ex. 26 at 1. Apart from this assertion, Dr. Harum does not offer any medical theory showing a proximate temporal relationship between B.A.B.’s vaccination and his alleged encephalopathy. Therefore, petitioner has failed to prove Prong Three of Althen. VII. Conclusion For the reasons discussed above, the undersigned finds that petitioner has not established entitlement to compensation and her petition must be dismissed. Therefore, this case is dismissed for insufficient proof. The Clerk shall enter judgment accordingly. IT IS SO ORDERED. s/ Nora Beth Dorsey Nora Beth Dorsey Chief Special Master 34