VICP Registry Case Source Bundle Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_21-vv-01369 Package ID: USCOURTS-cofc-1_21-vv-01369 Petitioner: Richard Munoz Filed: 2021-05-18 Decided: 2024-12-20 Vaccine: Tdap Vaccination date: 2019-07-02 Condition: polymyalgia rheumatica Outcome: denied Award amount USD: AI-assisted case summary: On May 18, 2021, Richard Munoz filed a petition seeking compensation under the National Vaccine Injury Compensation Program, alleging that he developed polymyalgia rheumatica (PMR) after receiving a Tdap vaccine on July 2, 2019. Mr. Munoz was 65 years old at the time of vaccination. Prior to vaccination, he had received treatment for hip pain, experienced arm paresthesias and syncope, and had an x-ray showing cervical spondylosis with radiculopathy. He also had knee pain attributed to osteoarthritis. Approximately three weeks after his Tdap vaccination, Mr. Munoz reported joint pain and fatigue, which he believed began about three days post-vaccination. Initial medical evaluations were unrevealing, but he was diagnosed with synovitis, arthralgia, morning joint stiffness, myalgia, and fatigue. By August 2019, he reported hand swelling, fatigue, aches, and joint pain, with lab work showing elevated inflammation markers. By September 2019, treaters suspected PMR, and a rheumatologist confirmed the possibility. A neurologist considered vaccine-induced brachial neuritis, and Mr. Munoz underwent physical therapy. Electromyographic testing in October 2019 did not confirm polyneuropathy or other nerve issues. PMR remained the prevailing diagnosis. The case proceeded as an off-Table claim, as PMR is not listed on the Vaccine Injury Table. Petitioner's expert, rheumatologist Dr. Petros Efthimiou, testified that PMR could be caused by the Tdap vaccine through complex immune responses, potentially involving autoimmune and autoinflammatory processes, genetic susceptibility (specifically HLA subtypes), and immune system senescence due to aging. He cited studies, including the Falsetti study, which suggested a temporal association between vaccination and PMR, and a case report referenced in the Soriano article involving a tetanus vaccine and PMR relapse. Respondent presented expert testimony from rheumatologist Dr. Roland Staud and immunologist Dr. William Hawse. Dr. Staud stated that PMR's causes remain unknown, with only speculative associations to infections or environmental agents not congruent with Tdap components, and denied any vaccine could cause PMR. Dr. Hawse disputed Dr. Efthimiou's proposed immunologic mechanisms, stating vaccines are designed for specific antigens and do not initiate autoimmune disease tolerance. He also rejected the senescence theory, noting aging typically leads to weaker immune responses to vaccines, not aberrant ones. On August 12, 2024, Chief Special Master Brian H. Corcoran denied entitlement, finding that Mr. Munoz failed to establish a credible medical theory causally connecting the Tdap vaccine to his PMR by a preponderance of the evidence. The Chief Special Master found Dr. Efthimiou's arguments repetitive of those previously rejected and lacking specific evidence of a PMR-Tdap link, genetic susceptibility, or a well-substantiated senescence theory. He found Respondent's experts effectively rebutted Petitioner's contentions. Mr. Munoz sought review of this decision, arguing the Chief Special Master applied an impermissibly high evidentiary standard. On December 20, 2024, Judge Carolyn N. Lerner issued an opinion affirming the Chief Special Master's decision, finding that the Chief Special Master correctly applied the preponderance of the evidence standard and did not err in weighing the evidence or assessing the persuasiveness of the expert testimony. The court found no legal error and denied the motion for review. No compensation was awarded. Theory of causation field: Richard Munoz, a 65-year-old male, received a Tdap vaccine on July 2, 2019, and subsequently developed polymyalgia rheumatica (PMR). The claim was an off-Table, causation-in-fact claim. Petitioner's expert, Dr. Petros Efthimiou (rheumatologist), proposed that the Tdap vaccine could cause PMR through a complex immune response involving innate and adaptive immunity, potentially triggered by vaccine antigens, leading to a break in immune tolerance. His theory incorporated genetic susceptibility (HLA subtypes) and immune system senescence as contributing factors, suggesting that aging increases the likelihood of autoimmune disease following vaccination. Dr. Efthimiou cited case reports and studies (Falsetti, Soriano) suggesting a temporal association between vaccination and PMR. Respondent's experts, Dr. Roland Staud (rheumatologist) and Dr. William Hawse (immunologist), disputed this theory. Dr. Staud stated PMR causes are unknown and not linked to Tdap components, and Dr. Hawse argued vaccines do not initiate autoimmune disease and that senescence leads to weaker, not aberrant, immune responses. Chief Special Master Brian H. Corcoran denied entitlement, finding Petitioner failed to establish a credible medical theory by a preponderance of the evidence, citing a lack of specific evidence linking Tdap to PMR, insufficient support for genetic susceptibility and senescence theories, and speculative assumptions. Judge Carolyn N. Lerner affirmed, holding the Chief Special Master correctly applied the preponderance standard and did not err in weighing the evidence or assessing persuasiveness. No award was made. Public staged source text: ================================================================================ DOCUMENT 1: USCOURTS-cofc-1_21-vv-01369-cl-extra-10735193 Date issued/filed: 2024-05-28 Pages: 1 Docket text: Supplementary opinion from CourtListener cluster 10268603 -------------------------------------------------------------------------------- In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 21-1369V ************************* RICHARD MUNOZ, * Chief Special Master Corcoran * Petitioner, * Filed: May 1, 2024 * v. * * SECRETARY OF HEALTH AND * HUMAN SERVICES, * * Respondent. * * ************************* Amber Diane Wilson, Wilson Science Law, Washington, DC, for Petitioner. Jennifer A. Shah, U.S. Department of Justice, Washington, DC, for Respondent. DECISION GRANTING IN PART MOTION FOR INTERIM AWARD OF ATTORNEY’S FEES AND COSTS 1 On May 18, 2021, Richard Munoz filed a petition seeking compensation under the National Vaccine Injury Compensation Program (the “Vaccine Program”). 2 Petitioner alleges that he developed polymyalgia rheumatica and other unspecified injuries after receipt of the tetanus, diphtheria, and pertussis vaccine on July 2, 2019. Petition (ECF No. 1). A one-day Entitlement Hearing was held on January 25, 2024, and resolution of the matter is still pending. Petitioner has made a second request for an interim award of attorney’s fees and costs, relating to the work performed by present counsel (Amber Wilson, Esq.) since her appearance in the matter. (Petitioner previously obtained an interim fees award in March 2023, after prior 1 Under Vaccine Rule 18(b), each party has fourteen (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). Otherwise, the whole Decision will be available to the public in its present form. Id. 2 The Vaccine Program comprises Part 2 of the National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3758, codified as amended at 42 U.S.C. §§ 300aa-10 through 34 (2012) (“Vaccine Act” or “the Act”). Individual section references hereafter will be to § 300aa of the Act (but will omit that statutory prefix). counsel’s withdrawal from the matter, and was granted $56,491.00). Decision—Interim Attorney’s Fees and Costs, dated May 2, 2023 (ECF No. 37). Petitioner now requests $155,699.59 (representing $128,736.30 in attorney’s fees, plus $26,963.29 in costs), based on work performed by Ms. Wilson through the recent trial date. See Motion, dated Jan. 31, 2024 (ECF No. 53) (“Mot.”) at 1–2; Supplemental Fees and Costs Invoice, dated Mar. 14, 2024 (ECF No. 58). Petitioner also requests reimbursement for $27,502.34 in costs incurred by his previous attorneys at the “mctlaw” firm. See Reply, dated Feb. 15, 2024 (ECF No. 55). Respondent reacted to the fees request on February 14, 2024. See Response, dated Feb. 14, 2024 (ECF No. 54) (“Resp.”). Respondent defers to my discretion as to whether the statutory requirements for an award of attorney’s fees and costs are met in this case, and if so, the calculation of the amount to be awarded. Id. at 2–3. For the reasons set forth below, I hereby GRANT IN PART Petitioner’s motion, awarding fees and costs in the total amount of $177,289.43. ANALYSIS I. Petitioner’s Claim has Reasonable Basis Although the Vaccine Act only guarantees a reasonable award of attorney’s fees and costs to successful petitioners, a special master may also award fees and costs in an unsuccessful case if: (1) the “petition was brought in good faith”; and (2) “there was a reasonable basis for the claim for which the petition was brought.” Section 15(e)(1). I have in prior decisions set forth at length the criteria to be applied when determining if a claim possessed “reasonable basis” sufficient for a fees award. See, e.g., Sterling v. Sec’y of Health & Hum. Servs., No. 16-551V, 2020 WL 549443, at *4 (Fed. Cl. Spec. Mstr. Jan. 3, 2020). Importantly, establishing reasonable basis does not automatically entitle an unsuccessful claimant to fees, but is instead a threshold obligation; fees can still thereafter be limited, if unreasonable, or denied entirely. Cases that are unresolved and/or pending, like this one, must also be evaluated for reasonable basis, because the claim’s success remains to be determined. A claim’s reasonable basis 3 is demonstrated through some objective evidentiary showing. Cottingham v. Sec’y of Health & Hum. Servs., 971 F.3d 1337, 1344 (Fed. Cir. 2020) (citing Simmons v. Sec’y of Health & Hum. Servs., 875 F.3d 632, 635 (Fed. Cir. 2017)). This objective inquiry is focused on the claim—counsel’s conduct is irrelevant (although it may bulwark good faith). Simmons, 875 F.3d at 635. Reasonable basis inquiries are not static—they evaluate not only what was known at the time the petition was filed, but also take into account what is learned about the evidentiary support for the claim as the matter progresses. Perreira v. Sec’y of Health & Hum. 3 Because this claim’s good faith is not in dispute, I do not include a discussion of the standards applicable to that fees prong. 2 Servs., 33 F.3d 1375, 1377 (Fed. Cir. 1994) (upholding the finding that a reasonable basis for petitioners’ claims ceased to exist once they had reviewed their expert's opinion, which consisted entirely of unsupported speculation). The standard for reasonable basis is lesser (and thus inherently easier to satisfy) than the preponderant standard applied when assessing entitlement, as cases that fail can still have sufficient objective grounding for a fees award. Braun v. Sec’y of Health & Hum. Servs., 144 Fed. Cl. 72, 77 (2019). The Court of Federal Claims has affirmed that “[r]easonable basis is a standard that petitioners, at least generally, meet by submitting evidence.” Chuisano v. Sec’y of Health & Hum. Servs., 116 Fed. Cl. 276, 287 (Fed. Cl. 2014) (internal quotations omitted) (affirming special master). The factual basis and medical support for the claim is among the evidence that should be considered. Carter v. Sec’y of Health & Hum. Servs., 132 Fed. Cl. 372, 378 (Fed. Cl. 2017). Under the Vaccine Act, special masters have “maximum discretion” in applying the reasonable basis standard. See, e.g., Silva v. Sec’y of Health & Hum. Servs., 108 Fed. Cl. 401, 401–02 (Fed. Cl. 2012). 4 Also, relevant herein are the standards governing interim awards—meaning fees awards issued while a case is still pending. See generally Auch v. Sec'y of Health & Human Servs., No. 12-673V, 2016 WL 3944701, at *6–9 (Fed. Cl. Spec. Mstr. May 20, 2016); Al-Uffi v. Sec'y of Health & Human Servs., No. 13-956V, 2015 WL 6181669, at *5–9 (Fed. Cl. Spec. Mstr. Sept. 30, 2015). It is well-established that a decision on entitlement is not required before fees or costs may be awarded. Fester v. Sec’y of Health & Human Servs., No. 10-243V, 2013 WL 5367670, at *8 (Fed. Cl. Spec. Mstr. Aug. 27, 2013); see also Cloer v. Sec’y of Health and Human Servs., 675 F.3d 1358, 1362 (Fed. Cir. 2012); Avera v. Sec’y of Health & Human Servs., 515 F.3d 1343, 1352 (Fed. Cir. 2008). There is no presumption of entitlement to interim awards, but special masters may in their discretion permit such awards, and often do so. Perreira v. Sec’y of Health & Human Servs., 27 Fed. Cl. 29, 34 (1992), aff’d, 33 F.3d 1375 (Fed. Cir. 1994). Requests for interim costs are subject to the same standards governing fees. Perreira, 27 Fed. Cl. at 34; Presault v. United States, 52 Fed. Cl. 667, 670 (2002); Fester, 2013 WL 5367670, at *16. However, there must be some showing that a petitioner’s circumstances render an interim award just. Criteria that I have found to be important in determining whether an interim award should be permitted include: 1) whether the amount of fees requested exceeds $30,000; 2) where expert costs are requested, if the aggregate amount is more than $15,000; and/or 3) whether the case has been pending for more than 18 months. See Knorr v. Sec’y of Health & Human Servs., No. 15-1169V, 2017 WL 2461375 (Fed. Cl. Spec. Mstr. Apr. 17, 2017). 4 See also Chuisano, 116 Fed. Cl. at 285 (cautioning against rigid rules or criteria for reasonable basis because they would subvert the discretion of special masters and stating that an amorphous definition of reasonable basis is consistent with the Vaccine Act as a whole). 3 I find that Petitioner has made a sufficient showing of reasonable basis to justify an interim fees award. While the ultimate resolution of causation remains to be determined, Petitioner has put forward more than enough objective support for the claim. In addition, the other indicia I consider significant in resolving interim award requests have been met. This matter has been pending for three years, many expert reports have been filed, the requested fees are substantial, and I generally find it appropriate to request an interim award after a hearing is held. And no other circumstances exist that make an interim award inappropriate. (I note, however, that no additional interim fees and costs requests will be entertained. It is not my practice to permit successive interim awards to the same counsel; there are two interim awards in this matter only because the earlier award compensated withdrawing counsel). II. Calculation of Fees Determining the appropriate amount of the fees award is a two-part process. The first part involves application of the lodestar method—“multiplying the number of hours reasonably expended on the litigation times a reasonable hourly rate.” Avera v. Sec’y of Health & Hum. Servs., 515 F.3d 1343, 1347–48 (Fed. Cir. 2008) (quoting Blum v. Stenson, 465 U.S. 886, 888 (1984)). The second part involves adjusting the lodestar calculation up or down to take relevant factors into consideration. Id. at 1348. This standard for calculating a fee award is considered applicable in most cases where a fee award is authorized by federal statute. Hensley v. Eckerhart, 461 U.S. 424, 429–37 (1983). An attorney’s reasonable hourly rate is determined by the “forum rule,” which bases the proper hourly rate to be awarded on the forum in which the relevant court sits (Washington, D.C., for Vaccine Act cases), except where an attorney’s work was not performed in the forum and there is a substantial difference in rates (the so-called “Davis exception”). Avera, 515 F.3d at 1348 (citing Davis Cty. Solid Waste Mgmt. & Energy Recovery Special Serv. Dist. v. U.S. Envtl. Prot. Agency, 169 F.3d 755, 758 (D.C. Cir. 1999)). A 2015 decision established the hourly rate ranges for attorneys with different levels of experience who are entitled to the forum rate in the Vaccine Program. See McCulloch v. Sec’y of Health & Hum. Servs., No. 09-293V, 2015 WL 5634323, at *19 (Fed. Cl. Spec. Mstr. Sept. 1, 2015). Petitioner requests the following rates for Ms. Wilson’s time, based on the years work was performed: 2022 2023 2024 Amber Wilson (Wilson $427.00 $454.00 $479.00 Science Law) ECF No. 53-1 at 1–5, 11–14; ECF No. 58-1 at 1–6. 4 Ms. Wilson practices in Washington, DC—a jurisdiction that has been deemed “in forum.” Accordingly, she is entitled to the rates established in McCulloch. See Stuart v. Sec’y of Health & Hum. Servs., No. 16-940V, 2022 WL 176145, at *4 (Fed. Cl. Spec. Mstr. Jan. 5, 2022). Rates requested for time billed in 2022-23 have been allowed in other cases, and although the 2024 rate request ($479.00 per hour) is slightly on the higher end of the scale, it is consistent with what has previously been awarded for Ms. Wilson, reflecting her work and experience in the Program, and is otherwise in accordance with the Office of Special Masters’ fee schedule. 5 See Rivera v. Sec’y of Health & Hum. Servs., No. 22-1310V, 2023 WL 4312968, at *2 (Fed. Cl. Spec. Mstr. June 6, 2023). I thus find no cause to reduce it. And I award all attorney time devoted to the matter as requested. III. Calculation of Attorney’s Costs for Wilson Science Law Just as they are required to establish the reasonableness of requested fees, petitioners must also demonstrate that requested litigation costs are reasonable. Presault v. United States, 52 Fed. Cl. 667, 670 (2002): Perreira v. Sec’y of Dep’t of Health & Hum. Servs., 27 Fed. Cl. 29, 34 (1992). Reasonable costs include the costs of obtaining medical records and expert time incurred while working on a case. Fester v. Sec’y of Health & Hum. Servs., No. 10-243V, 2013 WL 5367670, at *16 (Fed. Cl. Spec. Mstr. Aug. 27, 2013). When petitioners fail to substantiate a cost item, such as by not providing appropriate documentation to explain the basis for a particular cost, special masters have refrained from paying the cost at issue. See, e.g., Gardner-Cook v. Sec’y of Health & Hum. Servs., No. 99-480V, 2005 WL 6122520, at *4 (Fed. Cl. Spec. Mstr. June 30, 2005). Petitioner seeks $26,963.29 in outstanding costs, including mailing costs, costs associated with the work of a single expert—Petros Efthimiou, M.D., and costs associated with travel. ECF No. 53-1 at 5, 7–8; ECF No. 58-1 at 7. Dr. Efthimiou prepared two written reports and testified at hearing on behalf of Petitioner. Initially, he submitted an invoice reflecting a total amount of $10,950.00 charged to the matter (18.25 hours of work billed at $600.00 per hour). Id. Dr. Efthimiou later submitted a second invoice for additional work, requesting $14,462.50 charged to the matter (22.25 hours of work billed at $650.00 per hour) on top of what he billed before. ECF No. 58-1 at 11. Adjustment of the sums to be awarded for his time are merited. In his second invoice, Dr. Efthimiou provides a 2024 Fee Schedule which includes "Court Appearance" rates per half day ($4,000.00), as well as per full day ($8,000.00). ECF No. 58-1 at 11, 12. The Vaccine Program does not pay experts for their time in this manner (and doing so would amount to greatly overpaying them). See e.g., Zumwalt v. Sec’y of Health & Hum. Servs., No. 16-994V, 2018 WL 6975184, at *5 (Fed. Cl. Spec. Mstr. Nov. 27, 2018) (declining to award expert’s requested “day rate” for hearing and travel days). I note, however, that it does not appear 5 OSM Attorneys’ Forum Hourly Rate Fee Schedules, https://www.uscfc.uscourts.gov/node/2914 (last visited May 1, 2024). 5 Dr. Efthimiou is relying on the proposed full day rate for his court appearance, but instead is requesting his hourly rate of $650.00 for a total of sixteen hours based on two days for hearing (although the trial concluded after one day), totaling $10,400.00. Secondly, Dr. Efthimiou’s requested expert costs as requested in his second invoice reflects a rate increase of $50.00—for an hourly rate of $650.00 for time billed in 2024. However, I will only award Dr. Efthimiou $600.00 for all time billed in this matter. I will consider larger rate increases for work performed in future cases. Petitioner will therefore receive a total of $19,500.00 for costs associated with Dr. Efthimiou’s work on the matter, based on a reduction of $5,912.50. 6 All other requested litigation-related costs are commonly incurred in the Vaccine Program, are reasonable herein, and shall be awarded in full without reduction. IV. Calculation of Deferred Attorney’s Costs for mctlaw In addition to the sums previously awarded for existing trial counsel, Petitioner herein seeks reimbursement for $27, 502.34 in costs incurred by the attorneys who represented him before Ms. Wilson’s appearance at the “mctlaw” firm. They include the filing fee, medical record and medical literature retrieval costs, mailing costs, and costs associated with the work of two experts—Dr. Efthimiou and Thomas Wright, M.D. ECF No. 31-3 at 2, 50, 51, 62–65. 7 Dr. Wright reviewed Petitioner’s medical records and case chronology. He submitted an invoice for a total of $1,625.00 (at an hourly rate of $650.00 for 2.5 hours of work). Id. at 51. I find this sum was reasonable for the work performed, and thus, I do not find any reason to make any reductions. Again, Dr. Efthimiou prepared two written reports and testified at hearing on behalf of Petitioner. He received a retainer fee of $3,000.00 and submitted two invoices to mctlaw, reflecting a total of $18,660.00 (at an hourly rate of $600.00 for 31.1 hours of work). This is in addition to the $19,500.00 I previously authorized he be reimbursed—meaning his total compensation for work on this case to date is nearly $40,000.00. Facially, this seems excessive for this case, and gives me some pause. However, the hearing is completed, and this expert’s contribution will aid 6 Dr. Efthimiou has requested a total of $25,412.50 in expert costs (reflecting (18.25 hours x $600.00 per hour = $10,950.00) + (22.25 hours x $650.00 per hour = $14,462.50)). However, and based on my reasoning set forth above, I will only award Dr. Efthimiou at a rate of $600.00 per hour for all time billed in the matter, but not including time billed for January 26, 2024, given the hearing concluded in one day. Thus, the adjusted total for expert costs associated with Dr. Efthimiou’s work on the matter is calculated as follows: (18.25 hours x $600.00 per hour = $10,950.00) + (14.25 hours x $600.00 per hour = $8,550.00) = $19,500.00. 7 After an initial review of the materials relevant to previous counsel’s incurred costs, Chambers noted a missing invoice corresponding to one of the payments made to Dr. Efthimiou. Chambers contacted the parties via email and asked Petitioner to provide the necessary documentation. Thereafter, Petitioner’s counsel emailed Chambers and Respondent with the missing invoice. 6 my determination, and so I will award this sum without adjustment (although I will give greater scrutiny to Dr. Efthimiou’s billed time in future cases). CONCLUSION Based on the foregoing, and in the exercise of the discretion afforded to me in determining the propriety of an interim fees award, I GRANT IN PART Petitioner’s Motion for an Interim Award of Attorney’s Fees and Costs, and award a total of $177,289.43, reflecting (a) $149,787.09—$128,736.30 in attorney’s fees and $21,050.79 in costs—in the form of a check made jointly payable to Petitioner and Petitioner’s counsel of record, Amber Wilson of Wilson Science Law, and (b) $27,502.34 in attorney’s costs, in the form of a check made jointly payable to Petitioner and Petitioner’s previous counsel, mctlaw. The first check shall be forwarded to Wilson Science Law, 1629 K Street NW, Ste 300, Washington, D.C., 20006, and the second to Maglio Christopher and Toale, PA, 1605 Main Street, Ste 710, Sarasota, FL 43236. In the absence of a motion for review filed pursuant to RCFC Appendix B, the Clerk of the Court SHALL ENTER JUDGMENT in accordance with the terms of this Decision. 8 IT IS SO ORDERED. s/ Brian H. Corcoran Brian H. Corcoran Chief Special Master 8 Pursuant to Vaccine Rule 11(a), the parties may expedite entry of judgment if (jointly or separately) they file notices renouncing their right to seek review. 7 ================================================================================ DOCUMENT 2: USCOURTS-cofc-1_21-vv-01369-2 Date issued/filed: 2024-09-06 Pages: 19 Docket text: PUBLIC DECISION (Originally filed: 08/12/2024) regarding 70 DECISION of Special Master. Signed by Chief Special Master Brian H. Corcoran. (mva) Service on parties made. -------------------------------------------------------------------------------- Case 1:21-vv-01369-CNL Document 72 Filed 09/06/24 Page 1 of 19 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 21-1369V * * * * * * * * * * * * * * * * * * * * * * * * * Chief Special Master Corcoran RICHARD MUNOZ, * * Petitioner, * Filed: August 12, 2024 * v. * * SECRETARY OF HEALTH AND * HUMAN SERVICES, * * Respondent. * * * * * * * * * * * * * * * * * * * * * * * * * * * Amber Diane Wilson, Wilson Science Law, Washington, DC, for Petitioner. Alexis Babcock, U.S. Department of Justice, Washington, DC, for Respondent. ENTITLEMENT DECISION1 On May 18, 2021, Richard Munoz filed a petition seeking compensation under the National Vaccine Injury Compensation Program (the “Vaccine Program”).2 Petitioner alleges that he suffered polymyalgia rheumatica (“PMR”) after receipt of the tetanus, diphtheria, and pertussis vaccine (“Tdap”) on July 2, 2019. Petition (ECF No. 1). A hearing was held in this matter on January 25, 2024. For the reasons discussed in more detail below, I hereby deny entitlement. PMR has not generally been viewed in prior reasoned Program decisions as an injury likely caused by most 1 Because this Decision contains a reasoned explanation for my actions in this case, it must be posted on the United States Court of Federal Claims website, in accordance with the E-Government Act of 2002, 44 U.S.C. § 3501 (2012). As provided by 42 U.S.C. § 300aa-12(d)(4)(B), however, the parties may object to the Decision’s inclusion of certain kinds of confidential information. Specifically, under Vaccine Rule 18(b), each party has fourteen 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). Otherwise, the whole Decision will be available to the public. Id. 2 The Vaccine Program comprises Part 2 of the National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3758, codified as amended at 42 U.S.C. §§ 300aa-10 through 34 (2012) (“Vaccine Act” or “the Act”). Individual section references hereafter will be to § 300aa of the Act (but will omit that statutory prefix). Case 1:21-vv-01369-CNL Document 72 Filed 09/06/24 Page 2 of 19 covered vaccines, including Tdap—and nothing offered in this case suggests a basis for departing from these prior determinations. I. Factual Background Petitioner was 65 when he received the vaccination at issue. He had previously obtained orthopedic treatment in 2016 for left hip pain that was deemed likely related to lower back dysfunction. Ex. 3 at 123, 139–40. Then, in the winter of 2019, he reported some arm parasthesias and syncope when sitting up. Ex. 5 at 36. An x-ray of his cervical spine showed moderate cervical spondylosis3 with radiculopathy. Id. at 34. That spring, Petitioner complained of right knee joint pain and paresthesias traveling down to his right foot for the last two months, and an x-ray of the knee revealed evidence of osteoarthritis. Id. at 26. And he sought additional orthopedic treatment in July 2019. Ex. 3 at 11. Vaccination and Subsequent Medical Records On July 2, 2019, Mr. Munoz received a Tdap vaccine during his annual primary care physician (“PCP”) visit. Ex. 1 at 6–7. He complained of no symptoms or concerns relevant to the claim at this time. Ex. 5 at 23. Three weeks later, however, Petitioner returned to his PCP, now reporting aching joint pain and constant fatigue that he asserted had begun approximately three days after his July 2nd visit, and which he speculated could be vaccine-related. Id. at 18. An exam revealed no special findings, and lab testing was also unrevealing. Petitioner’s PCP diagnosed him with synovitis of the wrist, arthralgia, morning joint stiffness, myalgia, and fatigue. Id. at 19–20; Ex. 2 at 13–16. Petitioner thereafter continued in August 2019 to complain of fatigue and joint pain, specifically in the larger joints (although exams revealed little more than range of motion issues). Ex. 5 at 15. By mid-August, he began to report hand swelling plus fatigue, aches, and joint pain. Ex. 13 at 15. Lab work conducted that month was now positive for an elevated biomarker for inflammation. Ex. 6 at 22–24; Ex. 7 at 1–5. By September 2019, Mr. Munoz was still experiencing some joint swelling, and treaters began to note their suspicion of PMR. Ex. 5 at 11, 12–13. He saw a rheumatologist that month, who confirmed the possibility of PMR. Ex. 8 at 6–8. However, a neurologist Petitioner saw in September proposed instead (based on a physical exam) the possibility that vaccine-induced brachial neuritis was the issue—and to that end had Petitioner begin a course of physical therapy 3 “Cervical Spondylosis” is defined as “degenerative joint disease affecting the cervical vertebrae, intervertebral disks, and surrounding ligaments and connective tissue, sometimes with pain or paresthesia radiating along the upper limbs as a result of pressure on the nerve roots.” Cervical Spondylosis, Dorland’s Medical Dictionary Online, https://www.dorlandsonline.com/dorland/definition?id=107846&searchterm=cervical+spondylosis (last visited Jan. 25, 2024). 2 Case 1:21-vv-01369-CNL Document 72 Filed 09/06/24 Page 3 of 19 (“PT”). Ex. 3 at 16, 19–20, 23. Petitioner attended PT sessions through November 2023, reporting some improvement. Id. at 24, 62. And electromyographic testing performed in October 2019 did not confirm the presence of polyneuropathy, radiculopathy, plexopathy, or myopathy affecting his extremities. Id. at 39. PMR thereafter continued to be the prevailing assessment for Petitioner’s condition, although other treaters argued for brachial neuritis. Ex. 3 at 39, 69. Petitioner received additional treatment for his symptoms into 2020 and beyond, and the PMR diagnosis was maintained. Although some subsequent records memorialize Petitioner’s belief (as stated to treaters) that vaccination was the cause of his condition, overall these latter records are not particularly probative of causation, and therefore I do not include a lengthy summary of their contents. II. Trial Testimony A. Petitioner’s Expert – Petros Efthimiou, M.D., F.A.C.R. Dr. Efthimiou, a rheumatologist, prepared two written reports and testified at hearing. See Efthimiou Report, dated June 27, 2022, filed as Ex. 24 (ECF No. 24-1); Efthimiou Supplemental Report, dated March 16, 2023, filed as Ex. 39 (ECF No. 30-1). Dr. Efthimiou earned his medical degree from the University of Ioannina Medical School in Greece. Efthimiou CV at 1, filed on June 28, 2022 as Ex. 25 (ECF No. 24-2). He completed residency at Brown University’s Rhode Island Hospital, and a rheumatology fellowship at New York Presbyterian. Efthimiou CV at 1–2. He maintains an active clinical practice, and teaches at NYU School of Medicine. Id. He has also led research on rheumatic conditions for over 20 years, and has published several journal articles. Efthimiou Report at 2. He is board-certified in rheumatology. Id. Dr. Efthimiou acknowledged that he does not have specific expertise in immunology, however (although much of the opinion he offered relevant to the disposition of this case involves immunologic issues). Tr. at 105–06. Much of Dr. Efthimiou’s testimony was devoted to explaining why the diagnosis of PMR was accurate for Petitioner. Tr. at 8–37. However, the case does not turn on the nature of Petitioner’s injury, and I accordingly do not summarize herein Dr. Efthimiou’s comments on Petitioner’s medical history in association with the propriety of the diagnosis.4 PMR, Dr. Efthimiou maintained, could be caused by a Tdap vaccine. Tr. at 45. To explain the basis for his opinion, he made several points about PMR’s nature, and possible etiology/pathogenesis. He deemed PMR to be a fairly common, immune-mediated inflammatory condition, contending that Respondent’s characterization of it as an “inflammatory rheumatic disease” was essentially describing the same thing. Tr. at 38, 108. Although Dr. Efthimiou acknowledged that PMR’s etiology was not fully understood, he proposed that it was likely 4 I similarly do not reference Dr. Efthimiou’s testimony regarding potential alternative causes (such as a possible interceding upper respiratory infection), or his discussion of the timing of onset. 3 Case 1:21-vv-01369-CNL Document 72 Filed 09/06/24 Page 4 of 19 autoimmune (and more specifically an autoinflammatory condition). Id. at 39–40, 110. And he maintained that the disease process would involve both the initial, innate response to a foreign antigen (the nonspecific, “powerful inflammatory response,”) and the subsequent adaptive leg of the immune response, in which antibodies and T cells specific to the presenting foreign antigen would attack it. Id. at 40, 41. It would also occur due to a break in “immune tolerance”—the body’s way to control damaging autoimmune self-attack, through regulatory immune cells. Id. at 44, 45. In support, Dr. Efthimiou referenced evidence establishing that PMR occurs in a context of elevated cytokines (proinflammatory immune cells stimulated during the innate immune response) as well as “T helper cells,” which encourage the production by B cells of antibodies specific to a foreign antigen. Tr. at 43. An article filed by Respondent, he contended, confirmed that PMR was understood to involve evidence of heightened macrophages and helper T-cells, as well as to occur in an inflammatory milieu. Id. at 49–51; C. Salvarani et al., Polymyalgia Rheumatica and Giant-Cell Arteritis, 347 N. Engl. J. Med. 261 (2002), filed on October 4, 2022 as Ex. A Tab 1 (ECF No. 26-1). He stressed that PMR was known to involve dysregulation of a large number of kinds of T cells. Tr. at 137. Dr. Efthimiou maintained that some kind of environmental trigger could reasonably explain PMR in many cases. Tr. at 63, 69–70. For example, certain viruses had been identified as possible triggers. Savarani at 3. In Dr. Efthimiou’s view, vaccinations could provoke the same kind of immune response. Tr. at 80. In particular, Dr. Efthimiou maintained, vaccines could instigate a pathogenic process leading to PMR—first through the “classic immune response” leading to an inflammatory environment. Tr. at 42, 43. In addition, a vaccine could impact certain helper T-cells relevant to the adaptive response (since T-helper cells work to stimulate B-cell production of antibodies).5 Id. at 64, 93. Exposure to vaccine antigens could also prompt a response from preexisting “autoreactive” T cells, or T memory cells, that had previously had been exposed to a particular antigen (here, the tetanus toxoid vaccine component) and would thus recognize it. Id. at 92–93. And vaccines might later impede immune cell regulatory processes, with the inflammation the vaccine initially instigated overwhelming those regulatory cells and encouraging disease. Id. at 45–46, 94. This final aspect of pathogenesis would, Dr. Efthimiou maintained, occur even if the disease process was otherwise “autoimmune” (meaning involving a direct, if mistaken, attack by antibodies or specific T cells on self tissue instigated by a foreign antigen—here, a vaccine component). Tr. at 46–47. But in so arguing, Dr. Efthimiou denied that his theory involved the vaccine impacting “three seemingly separate immunological mechanisms,” maintaining that it was the response to the vaccine-caused initial immune stimulation that was the essence of his theory. Tr. at 55. He also posited that any immune reaction would involve both arms of the response 5 Cleveland Clinic, Helper T Cells, https://my.clevelandclinic.org/health/body/23193-helper-t-cells (last accessed August 9, 2024). 4 Case 1:21-vv-01369-CNL Document 72 Filed 09/06/24 Page 5 of 19 (innate and adaptive), and hence stimuli experienced at the outset (such as cytokines produced in reaction to a vaccine) would inherently impact the subsequent, adaptive process. Id. at 67–69. Also critical to Dr. Efthimiou’s theory was his argument that the disease process resulting in PMR would unfold in the context of a person’s individual susceptibility to a damaging autoimmune process—and he devoted a substantial part of his testimony to explaining this. Tr. at 55-63. He proposed that PMR was likely “polygenic,” meaning that several genetic mutations contributed to disease pathogenesis. Id. at 56. PMR, he argued, was likely associated with certain subtypes of human leukocyte antigens (“HLA”)—a genetic complex that codes proteins that regulate immune system function. Id. at 57–58. Someone possessing a mutated HLA gene was more likely to experience an autoimmune disease, under the right circumstances (which here are posited to flow from the initial impact of vaccination). Id. at 59, 62–63. Merely possessing a specific form of HLA mutation did not guarantee an individual would experience PMR, Dr. Efthimiou admitted, and an environmental trigger would still be required—but he still deemed it a risk factor (although PMR could occur even in the absence of a mutated HLA gene). Id. at 59–60, 62, 124. Dr. Efthimiou offered testimony about how his theory “worked” in the context of a late middle-aged individual like Mr. Munoz. He consistently proposed that immune system “senescence,” which would occur as a person ages, would increase the likelihood of a break in tolerance, and therefore more autoimmune disease potentiality, due to the immune system’s greater likelihood of an ineffective response to foreign pathogens. Tr. at 44. He suggested that Petitioner’s age at the time of vaccination likely made him even more prone to not simply PMR (which usually afflicts older individuals), but to a vaccine-caused form of it. Id. at 85. On cross, however, Dr. Efthimiou acknowledged (as evidenced by the Tdap vaccine’s package insert) that clinical studies pertaining to the vaccine’s effect on older patient cohorts had generally found the immune response to be lower (and hence less effective), as opposed to aberrant in the manner proposed in this case. Id. at 131–33. As additional support for a vaccine-PMR association, Dr. Efthimiou referenced some case reports or studies. Tr. at 71–72. One study, for example, considered data regarding 58 PMR patients, determining that six had received a vaccine prior to their onset of symptoms. Tr. at 78– 81; P. Falsetti et al., Polymyalgia Rheumatica Following Infective Triggers or Vaccinations: A Different Subset of Disease? 58 Rheumatologia 2:76-80 (2020), filed as Ex. 58 (ECF No. 43-1) (“Falsetti”). Dr. Efthimiou also read Falsetti to establish that individuals reporting possible environmental triggers for their PMR had experienced “more of a chronic course” of disease, and displayed higher inflammation biomarker levels – consistent with Petitioner’s medical history. Tr. at 81–82. And the chronicity of disease course underscored Dr. Efthimiou’s prior arguments about senescence. Id. at 84. On cross, however, Dr. Efthimiou acknowledged that Falsetti’s authors had relied on self- reporting by existing PMR patients—not only to determine they had in fact been vaccinated before 5 Case 1:21-vv-01369-CNL Document 72 Filed 09/06/24 Page 6 of 19 onset, but that (in the subjective view of the surveyed patients) there might have been a relationship between the two. Tr. at 117–18. Thus, Falsetti in no way established more than a possible temporal association between receipt of a vaccine and PMR—and its authors did not reach a scientifically- reliable conclusion to the end, as Dr. Efthimiou admitted (although he claimed it would be “impossible” for such a small sample). Id. at 118. Dr. Efthimiou highlighted other items of literature that also purportedly connected the Tdap vaccine specifically to PMR. See, e.g., A. Soriano et al., Giant Cell Arteritis and Polymyalgia Rheumatica After Influenza Vaccination: Report of 10 Cases and Review of the Literature, 21 Lupus 153-57 (2012), filed as Ex. 34 (ECF No. 24-11) (“Soriano”).6 Although Soriano’s focus was on the flu vaccine, it referenced one other case report (never filed in this case) involving an observed temporal association between a tetanus vaccine (which would contain antigens comparable to what is found in Tdap) and PMR in a woman in her late 60s. Soriano at 155, Table 2. Although that individual (as described in Soriano) had experienced a relapse of PMR (not new onset as in the case of Mr. Munoz) after vaccination, Dr. Efthimiou deemed the case report relevant, in terms of potentially confirming the proposed immunologic mechanism. Tr. at 86–88.7 But he admitted nothing was known about this individual relevant to the case (such as whether she had previously received a Tdap vaccine, what had possibly caused her PMR the first time, or anything about her treatment or disease severity) beyond what was briefly summarized in Soriano. Id. at 119–21. Also connecting the Tdap vaccine to PMR, Dr. Efthimiou argued, was the capacity of the tetanus toxoid antigenic component8 to prompt a “cellular response” from different T cells 6 Several items of literature offered in this case discuss giant cell arteritis (“GCA”), a vascular condition, and PMR together, since PMR often develops comorbidly with GCA. Soriano at 153. However, as Dr. Efthimiou admitted, Petitioner was never diagnosed with GCA, and it is not contended in this case he might have suffered from it (Tr. at 12–13)—greatly diminishing the probative value of articles involving GCA in any regard. 7 In referencing this case report referred to in Soriano, Dr. Efthimiou also spoke of “rechallenge” (Tr. at 88). But this usage is wholly distinguishable from circumstances of “challenge-rechallenge” as normally discussed in the Vaccine Program. That concept refers to instances where an individual (a) previously was exposed to a particular vaccine, (b) displayed some adverse reaction, then (c) experiences a second, often more acute, reaction when exposed again. Capizzano v. Sec'y of Health & Hum. Servs., 440 F.3d 1317, 1322 (Fed. Cir. 2006). Here (and as noted on cross- examination), there is no evidence that the case study patient mentioned in Soriano had previously received a tetanus- containing vaccine, or experienced an adverse reaction to it—and in any event that set of circumstances is inapplicable to this case as well, since it is not known that Mr. Munoz did previously receive a Tdap vaccine, or experience a reaction to it. Tr. at 127–30. 8 In addition, Dr. Efthimiou made some references to the possibility that the other vaccine Petitioner received at the relevant time—the pneumococcal vaccine—could have contributed to his injury, but he acknowledged in his testimony that he had found more evidence supporting a Tdap association, and ultimately seemed to posit only that it was “highly possible” a combination of vaccines played a contributory causal role (although he did try to outline a hypothesis for how this might have occurred). Tr. at 98, 99–101. He certainly admitted he had offered nothing specific to an association between PMR and co-administration of these two vaccines. Id. at 134. I ultimately find most of Petitioner’s evidence goes to the Tdap vaccine’s role, whereas Dr. Efthimiou admitted in passing he could offer less evidence on this topic, such as in the form of a relevant case report. See, e.g., Tr. at 116. Most evidence offered in this case involved the Tdap vaccine—and since that showing alone was insufficient to meet the preponderant standard, 6 Case 1:21-vv-01369-CNL Document 72 Filed 09/06/24 Page 7 of 19 (autoreactive or helper T cells). Tr. at 95–96; Efthimiou Supplemental Report at 16. He deemed it likely Mr. Munoz had been exposed to the vaccine before (although he admitted he had no evidence of this, and was therefore engaging in some speculation). Id. at 96. But the autoreactive T cells could, he maintained, still mount a response even if they had no prior exposure to tetanus. Id. at 97. Despite the foregoing, Dr. Efthimiou repeatedly acknowledged the existence of a number of evidentiary holes in his theory. For example, he agreed that no autoantibody had been identified as associated with PMR. Tr. at 42, 110. He admitted that there was no evidence Petitioner possessed a genetic susceptibility that could be associated with PMR. Id. at 60–61, 124. He allowed that his contentions about immunologic senescence did not have scientific or medical support specific to the impacyt of vaccines in encouraging the development of PMR. Id. at 124–26. More broadly, Dr. Efthimiou admitted he could offer no literature generally evaluating a purported PMR- Tdap connection (other than the case reports previously mentioned). Id. at 110. Nor could he reference items of literature showing how the vaccine would impact helper T cells, T regulatory cells, or cytokine production. Id. at 111. B. Respondent’s Experts 1. Roland Staud, M.D. – Dr. Staud has expertise in rheumatology as well as clinical immunology, and he offered testimony at the hearing as well as one written report. Staud Report, dated September 15, 2022, filed as Ex. A (ECF No. 25-1). Dr. Staud is a clinical rheumatologist and professor at the University of Florida. Staud CV at 1, filed on September 15, 2022, as Ex. B (ECF No. 25-2). He earned his medical degree from Freie Universitat Berlin, and completed residencies in internal medicine and a fellowship in rheumatology. Id. He is the director of the Center for Chronic Musculoskeletal Pain and Fatigue Research at UF, and has conducted NIH-funded research there for over 20 years. Staud Report at 1. He has authored or co-authored over 230 journal articles, as well as textbooks. Id. He regularly sees patients with a variety of rheumatological conditions, including PMR. Id. Dr. Staud provided insights into the nature of PMR and its characteristics. See generally Tr. at 144–48. Most of this testimony does not bear on the claim’s resolution, although he did deny that the nature or length of a patient’s treatment said anything about the cause of the individual’s PMR. Id. at 147–48, 155–56. He admitted Petitioner had been appropriately diagnosed with PMR. Id. at 148–49. But he maintained PMR’s causes remain unknown. At most, it is speculated that PMR may have some association with “infection and environmental agents,” although the infections that have been identified as possibly associated have no congruence with the Tdap vaccine’s components. Id. at 150, 163. Dr. Staud at most allowed that there were case reports then the facially less-supported contentions about the concurrent causality of the two vaccines at once have even less persuasive value. 7 Case 1:21-vv-01369-CNL Document 72 Filed 09/06/24 Page 8 of 19 possibly linking the flu vaccine to PMR—but far less, if anything, relevant to the Tdap vaccine. Id. at 165–66. Dr. Staud flatly denied the Tdap vaccine—or any vaccine for that matter (including the pneumococcal vaccine)—could be causal of PMR. Staud Report at 9; Tr. at 151. He offered some literature in support of his opinion. See, e.g., K.L. Nichol et al., Side Effects Associated With Pneumococcal Vaccination, 25 Am. J. Infect. Control 223 (1997), filed on October 4, 2022 as Ex. A, Tab 6 (ECF No. 26-6) (“[i]n this study we have demonstrated that pneumococcal vaccination was not associated with an increase in systemic symptoms among patients at high risk for pneumococcal disease when compared with a control period”). In fact, worldwide professional rheumatology organizations recommended vaccination to individuals experiencing likely autoimmune inflammatory conditions, like PMR. Tr. at 159–60; see V. Furer et al., 2019 Update of EULAR Recommendations for Vaccination in Adult Patients With Autoimmune Inflammatory Rheumatic Diseases, 79 Ann. Rheum. Dis. 39 (2020) (“Tetanus toxoid and human papilloma virus vaccination should be provided to AIIRD patients as recommended for the general population”), filed on December 14, 2023 as Ex. E (ECF No. 46-1). By contrast, Dr. Staud noted that articles Dr. Efthimiou relied upon, such as Falsetti, based their findings on self-reporting as well as mere temporal associations between vaccination and PMR. Tr. at 153–55. 2. William Hawse, Ph.D. – Dr. Hawse is an immunologist, and he prepared a report in this case and also testified. See Hawse Report, dated September 22, 2022, filed as Ex. C (ECF No. 25-3). Dr. Hawse is an Assistant Professor in the Department of Immunology at the University of Pittsburgh School of Medicine. Hawse CV at 1, filed on September 15, 2022, as Ex. D (ECF No. 25-4). He earned his Ph.D. in biophysical chemistry at Johns Hopkins. Id. He runs a laboratory studying CD4+ T-cell generation and immune tolerance, to inform therapeutic strategies for autoimmune diseases. Hawse Report at 1. He has published 14 peer-reviewed journal articles. Id. Dr. Hawse is not a medical doctor or experimental clinician, however, and thus did not offer commentary on the nature of PMR or whether Petitioner’ presentation fit the diagnostic classification. Tr. at 174, 190. Dr. Hawse overall disputed the immunologic mechanism proposed by Dr. Efthimiou to explain the etiology and pathogenesis of Petitioner’s PMR—whether through an autoimmune cross-reaction or otherwise. Tr. at 174, 192–93. Vaccines, he noted, are intended to provoke an immune response to the specific antigens they contain. Id. at 174–75, 192. But that response is not precisely identical from one vaccine to another. Id. at 175. Although an autoimmune disease might reasonably be understood to involve some break in immune tolerance (such that the body would mistakenly attack self-structures), Dr. Hawse did not accept that vaccines could initiate that break. Id. And other evidence of a vaccine-disease relationship mostly relied on proof that vaccines are associated with increase in some immune cells found in autoimmune diseases—not that vaccination’s impact on production of them leads to autoimmunity. Id. at 183–84. 8 Case 1:21-vv-01369-CNL Document 72 Filed 09/06/24 Page 9 of 19 Dr. Hawse further commented on Dr. Efthimiou’s contentions about genetic susceptibility (and particularly the role of HLA genes might play in encouraging PMR under certain circumstances). He saw nothing in Dr. Efthimiou’s reports reliably linking such genetic variants to PMR, acknowledging at most that the issue had been inconclusively explored in some studies as a hypothetical possibility. Tr. at 176–77. He denied there was any independent scientific support associating vaccination with PMR when an individual was thought to possess this genetic variant. Id. at 177. Dr. Hawse similarly rejected the notion that immunologic senescence might also be a risk factor for individuals developing PMR after vaccination. Tr. at 177–82. Immune system senescence, he maintained, was characterized by the body generating “weaker responses to vaccination”—not experiencing greater aberrant reactions with aging. Id. at 186. Pre-market testing of the Tdap vaccine had actually observed this. Id. at 187, Package Insert: Adacel, filed on March 20, 2023, as Ex. 45 (ECF No. 30-7). In addressing the issue of immune system senescence, Dr. Hawse specifically discussed an aspect of one of Dr. Efthimiou’s written reports, in which he had proposed that a particular kind of immunosenescent T cell lymphocyte could be stimulated into a cascade, resulting in (or at least encouraging) PMR. Id. at 178; Efthimiou Report at 13. Dr. Hawse disputed the reliability of the view that the identified T cell was associated with autoimmunity based on existing literature—and regardless, he was aware of no evidence that the Tdap vaccine could promote the production of this T cell (or the others alleged to be involved with PMR). Id. at 178–79, 182. In addition, Dr. Hawse argued, literature that suggested that certain immune cells proliferated due to the presence of immunosenescent cells relied on artificial lab conditions (in vitro stimulation of certain immune cells) that could not be compared to the body’s likely reaction to a vaccination, Tr. at 180; C. Dejaco et al., NKG D Stimulated T-Cell Autoreactivity in Giant Cell Arteritis and Polymyalgia 2 Rheumatica, 72 Ann. Rheum. Dis. 1852 (2013), filed on June 28, 2022 as Ex. 27 (ECF No. 24-4). III. Procedural History A year after the case’s initiation, Respondent filed his Rule 4(c) Report contesting Petitioner’s right to compensation. ECF No. 20. The parties thereafter began obtaining and offering the aforementioned expert reports. The matter was set for hearing in January 2024, and after post- hearing briefs were filed this past spring, the case became ripe for full resolution. IV. Applicable Law A. Petitioner’s Overall Burden in Vaccine Program Cases To receive compensation in the Vaccine Program, a petitioner must prove either: (1) that he suffered a “Table Injury”—i.e., an injury falling within the Vaccine Injury Table— corresponding to one of the vaccinations in question within a statutorily prescribed period of time or, in the alternative, (2) that his illnesses were actually caused by a vaccine (a “Non-Table 9 Case 1:21-vv-01369-CNL Document 72 Filed 09/06/24 Page 10 of 19 Injury”). See Sections 13(a)(1)(A), 11(c)(1), and 14(a), as amended by 42 C.F.R. § 100.3; § 11(c)(1)(C)(ii)(I); see also Moberly, 592 F.3d at 1321; Capizzano v. Sec’y of Health & Hum. Servs., 440 F.3d 1317, 1320 (Fed. Cir. 2006).9 There is no Table claim for PMR as an injury associated with any covered vaccine, so Petitioner can only advance a causation-in-fact claim. For both Table and Non-Table claims, Vaccine Program petitioners bear a “preponderance of the evidence” burden of proof. Section 13(1)(a). That is, a petitioner must offer evidence that leads the “trier of fact to believe that the existence of a fact is more probable than its nonexistence before [he] may find in favor of the party who has the burden to persuade the judge of the fact’s existence.” Moberly, 592 F.3d at 1322 n.2; see also Snowbank Enter. v. United States, 6 Cl. Ct. 476, 486 (1984) (mere conjecture or speculation is insufficient under a preponderance standard). Proof of medical certainty is not required. Bunting v. Sec’y of Health & Hum. Servs., 931 F.2d 867, 873 (Fed. Cir. 1991). In particular, a petitioner must demonstrate that the vaccine was “not only [the] but-for cause of the injury but also a substantial factor in bringing about the injury.” Moberly, 592 F.3d at 1321 (quoting Shyface, 165 F.3d at 1352–53); Pafford v. Sec’y of Health & Hum. Servs., 451 F.3d 1352, 1355 (Fed. Cir. 2006). A petitioner may not receive a Vaccine Program award based solely on his assertions; rather, the petition must be supported by either medical records or by the opinion of a competent physician. Section 13(a)(1). In attempting to establish entitlement to a Vaccine Program award of compensation for a Non-Table claim, a petitioner must satisfy all three of the elements established by the Federal Circuit in Althen v. Sec'y of Health & Hum. Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005): “(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 proximate temporal relationship between vaccination and injury.” Each of the Althen prongs requires a different showing. Under Althen prong one, petitioners must provide a “reputable medical theory,” demonstrating that the vaccine received can cause the type of injury alleged. Pafford, 451 F.3d at 1355–56 (citations omitted). To satisfy this prong, a petitioner’s theory must be based on a “sound and reliable medical or scientific explanation.” Knudsen v. Sec’y of Health & Hum. Servs., 35 F.3d 543, 548 (Fed. Cir. 1994). Such a theory must only be “legally probable, not medically or scientifically certain.” Id. at 549. Petitioners may satisfy the first Althen prong without resort to medical literature, epidemiological studies, demonstration of a specific mechanism, or a generally accepted medical theory. Andreu, 569 F.3d at 1378–79 (citing Capizzano, 440 F.3d at 1325–26). Special masters, 9 Decisions of special masters (some of which I reference in this ruling) constitute persuasive but not binding authority. Hanlon v. Sec’y of Health & Hum. Servs., 40 Fed. Cl. 625, 630 (1998). By contrast, Federal Circuit rulings concerning legal issues are binding on special masters. Guillory v. Sec’y of Health & Hum. Servs., 59 Fed. Cl. 121, 124 (2003), aff’d 104 F. Appx. 712 (Fed. Cir. 2004); see also Spooner v. Sec’y of Health & Hum. Servs., No. 13-159V, 2014 WL 504728, at *7 n.12 (Fed. Cl. Spec. Mstr. Jan. 16, 2014). 10 Case 1:21-vv-01369-CNL Document 72 Filed 09/06/24 Page 11 of 19 despite their expertise, are not empowered by statute to conclusively resolve what are essentially thorny scientific and medical questions, and thus scientific evidence offered to establish Althen prong one is viewed “not through the lens of the laboratorian, but instead from the vantage point of the Vaccine Act’s preponderant evidence standard.” Id. at 1380. Accordingly, special masters must take care not to increase the burden placed on petitioners in offering a scientific theory linking vaccine to injury. Contreras, 121 Fed. Cl. at 245. In discussing the evidentiary standard applicable to the first Althen prong, the Federal Circuit has consistently rejected the contention that it can be satisfied merely by establishing the proposed causal theory’s scientific or medical plausibility. See Kalajdzic v. Sec’y of Health & Hum. Servs., No. 2023-1321, 2024 WL 3064398, at *2 (Fed. Cir. June 20, 2024) (arguments “for a less than preponderance standard” deemed “plainly inconsistent with our precedent” (citing Moberly, 592 F.3d at 1322)); Boatmon v. Sec’y of Health & Hum. Servs., 941 F.3d 1351, 1359 (Fed. Cir. 2019); see also Howard v. Sec'y of Health & Hum. Servs., 2023 WL 4117370, at *4 (Fed. Cl. May 18, 2023) (“[t]he standard has been preponderance for nearly four decades”), aff’d, 2024 WL 2873301 (Fed. Cir. June 7, 2024) (unpublished). And petitioners always have the ultimate burden of establishing their overall Vaccine Act claim with preponderant evidence. W.C. v. Sec’y of Health & Hum. Servs., 704 F.3d 1352, 1356 (Fed. Cir. 2013) (citations omitted); Tarsell v. United States, 133 Fed. Cl. 782, 793 (2017) (noting that Moberly “addresses the petitioner’s overall burden of proving causation-in-fact under the Vaccine Act” by a preponderance standard). The second Althen prong requires proof of a logical sequence of cause and effect, usually supported by facts derived from a petitioner’s medical records. Althen, 418 F.3d at 1278; Andreu, 569 F.3d at 1375–77; Capizzano, 440 F.3d at 1326; Grant v. Sec’y of Health & Hum. Servs., 956 F.2d 1144, 1148 (Fed. Cir. 1992). In establishing that a vaccine “did cause” injury, the opinions and views of the injured party’s treating physicians are entitled to some weight. Andreu, 569 F.3d at 1367; Capizzano, 440 F.3d at 1326 (“medical records and medical opinion testimony are favored in vaccine cases, as treating physicians are likely to be in the best position to determine whether a ‘logical sequence of cause and effect show[s] that the vaccination was the reason for the injury’”) (quoting Althen, 418 F.3d at 1280). Medical records are generally viewed as particularly trustworthy evidence, since they are created contemporaneously with the treatment of the patient. Cucuras v. Sec’y of Health & Hum. Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993). Medical records and statements of a treating physician, however, do not per se bind the special master to adopt the conclusions of such an individual, even if they must be considered and carefully evaluated. Section 13(b)(1) (providing that “[a]ny such diagnosis, conclusion, judgment, test result, report, or summary shall not be binding on the special master or court”); Snyder v. Sec’y of Health & Hum. Servs., 88 Fed. Cl. 706, 746 n.67 (2009) (“there is nothing . . . that mandates that the testimony of a treating physician is sacrosanct—that it must be accepted in its entirety and cannot be rebutted”). As with expert testimony offered to establish a theory of causation, the 11 Case 1:21-vv-01369-CNL Document 72 Filed 09/06/24 Page 12 of 19 opinions or diagnoses of treating physicians are only as trustworthy as the reasonableness of their suppositions or bases. The views of treating physicians should be weighed against other, contrary evidence also present in the record—including conflicting opinions among such individuals. Hibbard v. Sec’y of Health & Hum. Servs., 100 Fed. Cl. 742, 749 (2011) (not arbitrary or capricious for special master to weigh competing treating physicians’ conclusions against each other), aff’d, 698 F.3d 1355 (Fed. Cir. 2012); Veryzer v. Sec’y of Dept. of Health & Hum. Servs., No. 06-522V, 2011 WL 1935813, at *17 (Fed. Cl. Spec. Mstr. Apr. 29, 2011), mot. for review den’d, 100 Fed. Cl. 344, 356 (2011), aff’d without opinion, 475 F. Appx. 765 (Fed. Cir. 2012). The third Althen prong requires establishing a “proximate temporal relationship” between the vaccination and the injury alleged. Althen, 418 F.3d at 1281. That term has been equated to the phrase “medically-acceptable temporal relationship.” Id. A petitioner must offer “preponderant proof that the onset of symptoms occurred within a timeframe which, given the medical understanding of the disorder’s etiology, it is medically acceptable to infer causation.” de Bazan v. Sec’y of Health & Hum. Servs., 539 F.3d 1347, 1352 (Fed. Cir. 2008). The explanation for what is a medically acceptable timeframe must align with the theory of how the relevant vaccine can cause an injury (Althen prong one’s requirement). Id. at 1352; Shapiro v. Sec’y of Health & Hum. Servs., 101 Fed. Cl. 532, 542 (2011), recons. den’d after remand, 105 Fed. Cl. 353 (2012), aff’d mem., 503 F. Appx. 952 (Fed. Cir. 2013); Koehn v. Sec’y of Health & Hum. Servs., No. 11-355V, 2013 WL 3214877 (Fed. Cl. Spec. Mstr. May 30, 2013), mot. for rev. den’d (Fed. Cl. Dec. 3, 2013), aff’d, 773 F.3d 1239 (Fed. Cir. 2014). B. Legal Standards Governing Factual Determinations The process for making determinations in Vaccine Program cases regarding factual issues begins with consideration of the medical records. Section 11(c)(2). The special master is required to consider “all [ ] relevant medical and scientific evidence contained in the record,” including “any diagnosis, conclusion, medical judgment, or autopsy or coroner's report which is contained in the record regarding the nature, causation, and aggravation of the petitioner's illness, disability, injury, condition, or death,” as well as the “results of any diagnostic or evaluative test which are contained in the record and the summaries and conclusions.” Section 13(b)(1)(A). The special master is then required to weigh the evidence presented, including contemporaneous medical records and testimony. See Burns v. Sec'y of Health & Hum. Servs., 3 F.3d 415, 417 (Fed. Cir. 1993) (determining that it is within the special master's discretion to determine whether to afford greater weight to contemporaneous medical records than to other evidence, such as oral testimony surrounding the events in question that was given at a later date, provided that such determination is evidenced by a rational determination). As noted by the Federal Circuit, “[m]edical records, in general, warrant consideration as trustworthy evidence.” Cucuras, 993 F.2d at 1528; Doe/70 v. Sec'y of Health & Hum. Servs., 95 12 Case 1:21-vv-01369-CNL Document 72 Filed 09/06/24 Page 13 of 19 Fed. Cl. 598, 608 (2010) (“[g]iven the inconsistencies between petitioner's testimony and his contemporaneous medical records, the special master's decision to rely on petitioner's medical records was rational and consistent with applicable law”), aff'd, Rickett v. Sec'y of Health & Hum. Servs., 468 F. App’x 952 (Fed. Cir. 2011) (non-precedential opinion). A series of linked propositions explains why such records deserve some weight: (i) sick people visit medical professionals; (ii) sick people attempt to honestly report their health problems to those professionals; and (iii) medical professionals record what they are told or observe when examining their patients in as accurate a manner as possible, so that they are aware of enough relevant facts to make appropriate treatment decisions. Sanchez v. Sec'y of Health & Hum. Servs., No. 11–685V, 2013 WL 1880825, at *2 (Fed. Cl. Spec. Mstr. Apr. 10, 2013); Cucuras v. Sec'y of Health & Hum. Servs., 26 Cl. Ct. 537, 543 (1992), aff'd, 993 F.2d at 1525 (Fed. Cir. 1993) (“[i]t strains reason to conclude that petitioners would fail to accurately report the onset of their daughter's symptoms”). Accordingly, if the medical records are clear, consistent, and complete, then they should be afforded substantial weight. Lowrie v. Sec'y of Health & Hum. Servs., No. 03–1585V, 2005 WL 6117475, at *20 (Fed. Cl. Spec. Mstr. Dec. 12, 2005). Indeed, contemporaneous medical records are often found to be deserving of greater evidentiary weight than oral testimony—especially where such testimony conflicts with the record evidence. Cucuras, 993 F.2d at 1528; see also Murphy v. Sec'y of Health & Hum. Servs., 23 Cl. Ct. 726, 733 (1991), aff'd per curiam, 968 F.2d 1226 (Fed. Cir. 1992), cert. den'd, Murphy v. Sullivan, 506 U.S. 974 (1992) (citing United States v. United States Gypsum Co., 333 U.S. 364, 396 (1947) (“[i]t has generally been held that oral testimony which is in conflict with contemporaneous documents is entitled to little evidentiary weight.”)). However, the Federal Circuit has also noted that there is no formal “presumption” that records are accurate or superior on their face to other forms of evidence. Kirby v. Sec’y of Health & Hum. Servs., 997 F.3d 1378, 1383 (Fed. Cir. 2021). There are certainly situations in which compelling oral or written testimony (provided in the form of an affidavit or declaration) may be more persuasive than written records, such as where records are deemed to be incomplete or inaccurate. Campbell v. Sec'y of Health & Hum. Servs., 69 Fed. Cl. 775, 779 (2006) (“like any norm based upon common sense and experience, this rule should not be treated as an absolute and must yield where the factual predicates for its application are weak or lacking”); Lowrie, 2005 WL 6117475, at *19 (“[w]ritten records which are, themselves, inconsistent, should be accorded less deference than those which are internally consistent”) (quoting Murphy, 23 Cl. Ct. at 733)). Ultimately, a determination regarding a witness's credibility is needed when determining the weight that such testimony should be afforded. Andreu, 569 F.3d at 1379; Bradley v. Sec'y of Health & Hum. Servs., 991 F.2d 1570, 1575 (Fed. Cir. 1993). When witness testimony is offered to overcome the presumption of accuracy afforded to contemporaneous medical records, such testimony must be “consistent, clear, cogent, and 13 Case 1:21-vv-01369-CNL Document 72 Filed 09/06/24 Page 14 of 19 compelling.” Sanchez, 2013 WL 1880825, at *3 (citing Blutstein v. Sec'y of Health & Hum. Servs., No. 90–2808V, 1998 WL 408611, at *5 (Fed. Cl. Spec. Mstr. June 30, 1998)). In determining the accuracy and completeness of medical records, the Court of Federal Claims has listed four possible explanations for inconsistencies between contemporaneously created medical records and later testimony: (1) a person's failure to recount to the medical professional everything that happened during the relevant time period; (2) the medical professional's failure to document everything reported to her or him; (3) a person's faulty recollection of the events when presenting testimony; or (4) a person's purposeful recounting of symptoms that did not exist. La Londe v. Sec'y of Health & Hum. Servs., 110 Fed. Cl. 184, 203–04 (2013), aff'd, 746 F.3d 1334 (Fed. Cir. 2014). In making a determination regarding whether to afford greater weight to contemporaneous medical records or other evidence, such as testimony at hearing, there must be evidence that this decision was the result of a rational determination. Burns, 3 F.3d at 417. C. Analysis of Expert Testimony Establishing a sound and reliable medical theory often requires a petitioner to present expert testimony in support of his claim. Lampe v. Sec’y of Health & Hum. Servs., 219 F.3d 1357, 1361 (Fed. Cir. 2000). Vaccine Program expert testimony is usually evaluated according to the factors for analyzing scientific reliability set forth in Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579, 594–96 (1993). See Cedillo v. Sec’y of Health & Hum. Servs., 617 F.3d 1328, 1339 (Fed. Cir. 2010) (citing Terran v. Sec’y of Health & Hum. Servs., 195 F.3d 1302, 1316 (Fed. Cir. 1999). Under Daubert, the factors for analyzing the reliability of testimony are: (1) whether a theory or technique can be (and has been) tested; (2) whether the theory or technique has been subjected to peer review and publication; (3) whether there is a known or potential rate of error and whether there are standards for controlling the error; and (4) whether the theory or technique enjoys general acceptance within a relevant scientific community. Terran, 195 F.3d at 1316 n.2 (citing Daubert, 509 U.S. at 592–95). In the Vaccine Program the Daubert factors play a slightly different role than they do when applied in other federal judicial settings, like the district courts. Typically, Daubert factors are employed by judges (in the performance of their evidentiary gatekeeper roles) to exclude evidence that is unreliable or could confuse a jury. By contrast, in Vaccine Program cases these factors are used in the weighing of the reliability of scientific evidence proffered. Davis v. Sec'y of Health & Hum. Servs., 94 Fed. Cl. 53, 66–67 (2010) (“uniquely in this Circuit, the Daubert factors have been employed also as an acceptable evidentiary-gauging tool with respect to persuasiveness of expert testimony already admitted”). The flexible use of the Daubert factors to evaluate the persuasiveness and reliability of expert testimony has routinely been upheld. See, e.g., Snyder, 88 14 Case 1:21-vv-01369-CNL Document 72 Filed 09/06/24 Page 15 of 19 Fed. Cl. at 742–45. In this matter (as in numerous other Vaccine Program cases), Daubert has not been employed at the threshold, to determine what evidence should be admitted, but instead to determine whether expert testimony offered is reliable and/or persuasive. Respondent frequently offers one or more experts in order to rebut a petitioner’s case. Where both sides offer expert testimony, a special master's decision may be “based on the credibility of the experts and the relative persuasiveness of their competing theories.” Broekelschen v. Sec'y of Health & Hum. Servs., 618 F.3d 1339, 1347 (Fed. Cir. 2010) (citing Lampe, 219 F.3d at 1362). However, nothing requires the acceptance of an expert's conclusion “connected to existing data only by the ipse dixit of the expert,” especially if “there is simply too great an analytical gap between the data and the opinion proffered.” Snyder, 88 Fed. Cl. at 743 (quoting Gen. Elec. Co. v. Joiner, 522 U.S. 146 (1997)); see also Isaac v. Sec'y of Health & Hum. Servs., No. 08–601V, 2012 WL 3609993, at *17 (Fed. Cl. Spec. Mstr. July 30, 2012), mot. for review den'd, 108 Fed. Cl. 743 (2013), aff'd, 540 F. App’x. 999 (Fed. Cir. 2013) (citing Cedillo, 617 F.3d at 1339). Weighing the relative persuasiveness of competing expert testimony, based on a particular expert's credibility, is part of the overall reliability analysis to which special masters must subject expert testimony in Vaccine Program cases. Moberly, 592 F.3d at 1325–26 (“[a]ssessments as to the reliability of expert testimony often turn on credibility determinations”); see also Porter v. Sec'y of Health & Hum. Servs., 663 F.3d 1242, 1250 (Fed. Cir. 2011) (“this court has unambiguously explained that special masters are expected to consider the credibility of expert witnesses in evaluating petitions for compensation under the Vaccine Act”). D. Consideration of Medical Literature Both parties filed numerous items of medical and scientific literature in this case, but not all such items factor into the outcome of this decision. While I have reviewed all the medical literature submitted in this case, I discuss only those articles that are most relevant to my determination and/or are central to Petitioner’s case—just as I have not exhaustively discussed every individual medical record filed. Moriarty v. Sec’y of Health & Hum. Servs., No. 2015–5072, 2016 WL 1358616, at *5 (Fed. Cir. Apr. 6, 2016) (“[w]e generally presume that a special master considered the relevant record evidence even though he does not explicitly reference such evidence in his decision”) (citation omitted); see also Paterek v. Sec’y of Health & Hum. Servs., 527 F. App’x 875, 884 (Fed. Cir. 2013) (“[f]inding certain information not relevant does not lead to—and likely undermines—the conclusion that it was not considered”). 15 Case 1:21-vv-01369-CNL Document 72 Filed 09/06/24 Page 16 of 19 ANALYSIS I. Program Treatment of PMR as Vaccine Injury Petitioner’s proposed PMR diagnosis is not contested. Tr. at 90, 144, 148. But PMR has not generally been deemed in the Program to be a likely vaccine-caused injury. See generally Thompson v. Sec’y of Health & Hum. Servs., No. 18-1217V, 2023 WL 9053982 (Fed. Cl. Spec. Mstr. Dec. 5, 2023) (SM Oler) (pneumococcal vaccine not found causal of claimant’s PMR); Van Dycke v. Sec’y of Health & Hum. Servs., No. 18-106V, 2023 WL 4310701 (Fed. Cl. Spec. Mstr. June 7, 2023) (SM Dorsey) (Tdap vaccine not found causal of claimant’s PMR); Giesbrecht v. Sec’y of Health & Hum. Servs., No. 16-1338V, 2023 WL 2721578 (Fed. Cl. Spec. Mstr. March 30, 2023) (SM Moran) (flu vaccine not found causal of claimant’s PMR); Kelly v. Sec’y of Health & Hum. Servs., No. 17-1475V, 2022 WL 1781957 (Fed. Cl. Spec. Mstr. Oct. 12, 2022) (SM Horner) (flu vaccine not found causal of claimant’s PMR); Suliman v. Sec’y of Health & Hum. Servs., No. 13-993V, 2018 WL 6803697 (Fed. Cl. Spec. Mstr. Nov. 27, 2023) (SM Roth) (Tdap vaccine not found causal of claimant’s PMR). All of these decisions provide persuasive, useful guidance for resolving this matter, and none were appealed. The two most on-point determinations are Van Dycke and Suliman, since both involve the Tdap vaccine. In Suliman, a petitioner alleged onset of PMR within two weeks of receipt of the Tdap vaccine. Suliman, 2018 WL 6803697, at *5, *20. Suliman admittedly turned in part on the special master’s rejection of a theory that the vaccine’s adjuvant triggered PMR (something not contended in this case). Id. at *25–26. However, the special master also found fault in the proposed causation theory, since (a) nothing was established showing how any antigenic component of the Tdap vaccine could spark PMR, (b) nothing was offered to link the vaccine to PMR more generally, (c) no known causes of PMR were established that could be deemed analogous to the Tdap vaccine, and (d) no secondary kinds of proof, such as case reports, had been offered. Id. at *26–28. Although Suliman is over five years old, it highlights the baseline issues with the theory that the Tdap vaccine could cause PMR. Van Dycke, by contrast, was decided a year ago, and its analysis of the persuasiveness of the theory more closely tracks what has been advanced here. In that matter, the relevant expert failed to identify a specific causal antigen—and even assumed a vaccine-instigated process without proposing molecular mimicry as the mechanism. Van Dycke, 2023 WL 43120701, at *22. As here, that expert also proposed a T cell-driven pathogenic process, but failed to link the vaccine to the initiation of that process. Id. The expert similarly maintained that an immunosenescent context (involving an aged petitioner) played a role, but had not shown that an aberrant immune process sufficient to trigger pathogenesis due to immune system senescence was likely. Id. at *23. Articles offered in this case, like Falsetti, were also cited by the Van Dycke petitioner’s expert. Id. at *24. And the Van Dycke expert relied on a theory that involved both 16 Case 1:21-vv-01369-CNL Document 72 Filed 09/06/24 Page 17 of 19 the innate and immune responses—“casting a broad net,” but without ultimately providing sufficient preponderant proof that the Tdap vaccine could likely initiate such a complex, interconnected disease process. Id. These cases do not control the outcome of this matter. But they all provide reasoned grounds to be skeptical of claims that many covered vaccines—including the Tdap vaccine—can cause PMR. II. Petitioner Has Not Carried His Burden of Proof As is well understood in the Program, the failure to establish even one of the three Althen prongs in the context of a causation-in-fact claim is sufficient basis for a claim’s dismissal. Dobrydnev v. Sec’y of Health & Hum. Servs., 566 Fed. Appx. 976, 980 (Fed. Cir. 2014). This case wholly turns on the first, “can cause” prong—and because I find it has not been preponderantly established, no discussion of Petitioner’s success with respect to the other prongs is necessary. Dr. Efthimiou’s causation opinion largely repeats the kinds of arguments that other special masters have routinely rejected as unpersuasive. Like experts in past cases, he fails to identify a specific antigen associated with the development of PMR, or demonstrate that Petitioner himself possessed the proposed genetic susceptibility. Further, Petitioner has not otherwise offered any more recent scientific or medical studies or articles that would suggest a PMR-vaccine association is now thought to be more likely—and even admitted during testimony that there were not even case reports documenting PMR after receipt of the Tdap vaccine (other than the unfiled report involving a tetanus vaccine that was referenced in Soriano). Tr. at 116. By contrast, Respondent’s experts (especially Dr. Hawse) effectively and persuasively rebutted Petitioner’s causation contentions. Dr. Hawse not only highlighted an absence of direct evidence associating the vaccine with PMR, but also the degree to which the proposed theory relied on the vaccine doing multiple things as the disease process progressed—but without ever showing how the impact of the initial receipt of either vaccine would be significant enough to affect the immune process at so many different inflection points. This is, in the end, another matter in which a claimant wants to transmute the intended effect of vaccination, and/or a vaccine’s understood capacity to provoke some immune response, into something pathogenic, but without sufficient probative evidence to connect all the dots. Palattao v. Sec'y of Health & Hum. Servs., No. 13-591V, 2019 WL 989380, at *36 (Fed. Cl. Spec. Mstr. Feb. 4, 2019) (“claimants cannot transmute scientific evidence exploring how vaccines normally function in the immune system into a reliable and persuasive causation theory that any vaccine can be pathogenic without a more specific showing that applies to the circumstances at hand”). And to reverse-engineer a causation theory, Petitioner assumes different susceptibilities— 17 Case 1:21-vv-01369-CNL Document 72 Filed 09/06/24 Page 18 of 19 due to age, or some individual genetic propensity to autoimmunity—that are not bulwarked with enough evidence to show that vaccination likely poses risks in these contexts. This is not a matter in which no probative evidence was offered. Petitioner has identified a handful of case reports, and although case reports stand as weak evidence to support causation (especially when they involve a different vaccine), they should not be disregarded categorically. Campbell v. Sec'y of Health & Hum. Servs., 97 Fed. Cl. 650, 668 (2011) (“‘[c]ase reports do not purport to establish causation definitively, and this deficiency does indeed reduce their evidentiary value,’ even if they should receive some weight”). Dr. Efthimiou has also provided insights into the pathogenic mechanisms of PMR, showing how the immune response’s different stages might play a role in disease progression—somewhat allowing for a faint possibility that a vaccine could impact that process (although at what point, and where most importantly, remains unknown). And he has offered some evidence explaining how individual susceptibility might also encourage PMR (although the aspects of Dr. Efthimiou’s theory relying on immune system senescence were ultimately not well constructed or substantiated—especially since the very concept of immune response senescence involves reduced immune system effectiveness, rather than greater aberrance due to age). But what is ultimately missing is sufficient probative evidence allowing for the conclusion that it is more likely than not that a Tdap vaccine’s components can trigger PMR. Instead, there are too many speculative assumptions about the roles prior exposure to the vaccine, or the Petitioner’s unspecified genetic susceptibilities (assumed, in circular fashion, to have existed merely because Petitioner developed PMR), would play in setting up a disease process. And large leaps are made from evidence that PMR involves the presence of certain immune cells (T helper cells, or cytokines) to the conclusion that vaccines not only provoke the production of these cells— but that they would drive pathogenesis. The Program has now repeatedly observed the lack of persuasive scientific/medical evidence linking most covered vaccines to PMR. Until a claimant is able to muster some newly- published research on the topic more specific to PMR and/or its studied association with a vaccine, petitioners (and their counsel) would be advised not to continue to pursue this causation theory. 18 Case 1:21-vv-01369-CNL Document 72 Filed 09/06/24 Page 19 of 19 CONCLUSION Preponderant evidence does not support Petitioner’s causation theory. He is therefore not entitled to compensation. In the absence of a motion for review filed pursuant to RCFC Appendix B, the Clerk of the Court SHALL ENTER JUDGMENT in accordance with the terms of this Decision.10 IT IS SO ORDERED. s/ Brian H. Corcoran Brian H. Corcoran Chief Special Master 10 Pursuant to Vaccine Rule 11(a), the parties may expedite entry of judgment if (jointly or separately) they file notices renouncing their right to seek review. 19 ================================================================================ DOCUMENT 3: USCOURTS-cofc-1_21-vv-01369-3 Date issued/filed: 2024-12-20 Pages: 14 Docket text: JUDGE VACCINE REPORTED OPINION (PUBLIC VERSION) reissuing 78 Opinion/Order Denying Motion for Review (originally filed under seal on 12/5/2024) for publication. Signed by Judge Carolyn N. Lerner. (tsr) Service on parties made. -------------------------------------------------------------------------------- Case 1:21-vv-01369-CNL Document 80 Filed 12/20/24 Page 1 of 14 In the United States Court of Federal Claims RICHARD MUNOZ, Petitioner, v. No. 21-1369V (Filed: December 20, 2024) 1 SECRETARY OF HEALTH AND HUMAN SERVICES, Respondent. Amber Diane Wilson, Wilson Science Law, Washington, DC, for Petitioner. Naseem Kourosh, Civil Division, United States Department of Justice, Washington, DC, for Respondent. OPINION AND ORDER LERNER, Judge. Petitioner Richard Munoz seeks review of Chief Special Master Brian H. Corcoran’s Decision denying compensation for his claim under the National Vaccine Injury Compensation Program (“Vaccine Act”), 42 U.S.C. § 300aa et seq. Pet’r’s Mot. for Review (“Mot.”) at 1, ECF No. 73. Petitioner brought this action alleging that the tetanus, diphtheria, and pertussis (“Tdap”) and pneumococcal vaccines caused him to develop polymyalgia rheumatica (“PMR”). Id. at 2. Chief Special Master Corcoran found that Petitioner failed to meet his burden to prove a medical theory causally connecting the vaccine to his injury as set out in the first prong of the Althen test. Entitlement Decision (“Dec.”) at 17, ECF No. 70. See also Althen v. Sec’y of Health & Hum. Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005). Petitioner alleges the Chief Special Master made legal errors and applied an impermissibly high evidentiary burden. Mot. at 1, 5. For the reasons below, this Court DENIES Petitioner’s Motion for Review. I. Background A. Factual Background2 Petitioner Richard Munoz was sixty-five years old when he received the Tdap and pneumococcal vaccines on July 2, 2019, during his annual primary care physician (“PCP”) 1 This Opinion was initially filed on December 5, 2024. The parties were afforded fourteen days to propose redactions. The parties did not. Accordingly, the Court reissues this Opinion in its original form, with an update to the Vaccine Program’s title in the first paragraph. 2 To resolve the pending Motion for Review, the Court summarizes the facts as presented in the Chief Special Master’s Decision. 1 Case 1:21-vv-01369-CNL Document 80 Filed 12/20/24 Page 2 of 14 visit. Dec. at 2. He was previously treated in 2016 for hip pain that was deemed “likely related to lower back dysfunction.” Id. at 2 (citing Ex. 3 at 123, 139–40, ECF No. 6). In the months prior to his vaccination, Petitioner reported paresthesias3 in his arm and right leg, joint pain in his right knee, and syncope.4 Id. (citing Ex. 5 at 26, 36, ECF No. 6). An x-ray of his cervical spine from February 2019 showed “moderate cervical spondylosis”—a “degenerative joint disease affecting the cervical vertebrae . . . sometimes with pain or paresthesia radiating along the upper limbs as a result of pressure on the nerve roots.” Id. at 2 (citing Ex. 5 at 34), 2 n.3. The same x- ray revealed radiculopathy5 in the cervical spine. A May 2019 x-ray also identified evidence of osteoarthritis in his knee. Id. at 2; Ex. 5 at 62. Three weeks after receiving the vaccines, Mr. Munoz returned to his PCP reporting “aching joint pain and constant fatigue.” Id. (citing Ex. 5 at 18). He reported that these symptoms began approximately three days after his vaccination. Id. Petitioner continued to experience fatigue and joint pain in August 2019 and, by mid-August, additional hand swelling. Id. In September 2019, a rheumatologist indicated Mr. Munoz might have PMR.6 Id. A neurologist proposed the possibility of vaccine-induced brachial neuritis, which was supported by some other physicians. Id. However, as Petitioner continued to seek treatment, “PMR continued to be the prevailing assessment for his condition” through 2020. Id. at 3. Petitioner’s PMR diagnosis was not contested by the parties. Id. at 16; Mot. at 2; Resp’t.’s Mem. in Resp. to Pet’r’s Mot. for Review (“Resp.”) at 1, ECF 77. B. Procedural Background On May 18, 2021, Mr. Munoz filed a petition in this Court alleging that the 2019 vaccinations caused his PMR. Pet., ECF No. 1. The parties submitted expert reports and 3 “Paresthesia refers to a burning, itching, tingling, or prickling sensation that is usually felt in the hands, arms, legs, or feet.” Glossary of Neurological Terms, Nat’l. Inst. of Neurological Disorders & Stroke, https://www.ninds.nih.gov/health-information/disorders/glossary- neurological-terms (last visited Dec. 4, 2024). 4 “Syncope is used to describe a loss of consciousness for a short period of time.” Syncope, Nat’l Inst. of Neurological Disorders & Stroke, https://www.ninds.nih.gov/health- information/disorders/syncope (last visited Dec. 4, 2024). 5 “Cervical radiculopathy occurs when a nerve in the neck is compressed or irritated at the point where it leaves the spinal cord. This can result in pain in shoulders, and muscle weakness and numbness that travels down the arm into the hand.” Radiculopathy (Nerve Root Disorder), Penn Medicine, https://www.pennmedicine.org/for-patients-and-visitors/patient- information/conditions-treated-a-to-z/radiculopathy (last visited Dec. 4, 2024). 6 “Polymyalgia rheumatica (PMR) is the most common inflammatory rheumatic disease affecting people older than 50 years . . . . Common symptoms include pain and morning stiffness in the shoulder and pelvic girdle . . . . Fatigue, fever, and weight loss may also be present . . . . Diagnosis is made based on clinical history and the presence of elevated inflammatory markers.” Wilkinson v. Sec’y of Health & Hum. Servs., No. 18-1829V, 2024 WL 3857696, at *1 (Fed. Cl. Spec. Mstr. July 22, 2024) (citing Ingrid E. Lundberg, An Update on Polymyalgia Rheumatica, 292 J. Internal Med. 717 (2022)) (cleaned up). 2 Case 1:21-vv-01369-CNL Document 80 Filed 12/20/24 Page 3 of 14 medical literature, and on January 25, 2024, the Chief Special Master held a hearing where the parties’ experts testified. Dec. at 1, 3, 7–8. 1. Petitioner’s Evidence and Expert’s Testimony Petitioner’s expert, rheumatologist Dr. Petros Efthimiou, M.D., provided two reports and testified at the hearing. Id. at 3–7. He “acknowledged that he does not have specific expertise in immunology” even though “much of the opinion he offered . . . involves immunologic issues.” Id. at 3. Dr. Efthimiou proposed that PMR “could be caused by a Tdap vaccine.” Id. Although “[he] acknowledged that PMR’s etiology was not fully understood,” Dr. Efthimiou testified that PMR “was likely autoimmune (and more specifically an autoinflammatory condition).” Id. at 3–4. He explained a theory of how PMR disease develops: an initial innate response to a foreign antigen—described as a nonspecific, powerful inflammatory response—is followed by an adaptive immune response that leads antibodies and T cells to attack the foreign antigen. Id. at 4. Dr. Efthimiou referenced scientific articles filed by Respondent that he claimed show that PMR occurs in a context of elevated cytokines (immune cells stimulated during the innate response) and T helper cells that encourage the production of antibodies specific to a foreign antigen. Id. To link this theory to vaccination, Dr. Efthimiou proposed that “some kind of environmental trigger,” including certain viruses, “could reasonably explain PMR in many cases.” Id. He then reasoned that vaccinations could provoke the same kind of immune response in three specific ways. First, a vaccine could impact helper T cells that influence antibody production. Id. Second, a vaccine antigen could prompt a response from autoreactive T memory cells that had “previously been exposed to a particular antigen.” Id. In the context of Petitioner’s case, he hypothesized that if an individual had been exposed before to the “tetanus toxoid vaccine component,” T memory cells with prior exposure could recognize the antigen and prompt a response. Id. Finally, Dr. Efthimiou averred that the inflammation at first instigated by the vaccine might later overwhelm immune regulatory cells and encourage disease development. Id. Dr. Efthimiou denied that this theory involved “three seemingly separate immunological mechanisms” and emphasized that the theory stemmed from the initial stimuli experienced at the outset of vaccination. Id. at 4–5. Dr. Efthimiou’s theory relied on additional assumptions. First, he “devoted a substantial part of his testimony” to explaining that disease progression depended on “a person’s individual susceptibility to a damaging autoimmune process.” Id. at 5. He proposed that several genetic mutations contributed to disease and argued that PMR was “likely associated with certain subtypes of human leukocyte antigens (‘HLA’).” Id. He claimed that “someone possessing a mutated HLA gene was more likely to experience an autoimmune disease, under the right circumstances.” Id. Petitioner’s expert admitted that “[m]erely possessing a specific HLA mutation did not guarantee” PMR, and “an environmental trigger was still required.” Id. And Dr. Efthimiou ultimately “admitted that there was no evidence Petitioner possessed a genetic susceptibility that could be associated with PMR.” Id. at 7. Dr. Efthimiou also relied on a theory of immune system “senescence.” Id. at 5. He asserted that a break in immune tolerance occurs as one ages, leading to the possibility of 3 Case 1:21-vv-01369-CNL Document 80 Filed 12/20/24 Page 4 of 14 increased autoimmune disease because the body is less effective at fighting foreign pathogens. Id. at 4. He thus reasoned that Mr. Munoz’s age “likely made him even more prone” to a vaccine-caused form of PMR. Id. at 5. Yet Dr. Efthimiou acknowledged on cross-examination that clinical studies on the Tdap vaccine’s impact on older patients have found the opposite was true: “immune response [was] lower (and hence less effective).” Id. Finally, Dr. Efthimiou “allowed that his contentions about immunologic senescence did not have scientific or medical support specific to the impayct [sic] of vaccines in encouraging the development of PMR.” Id. at 7. Dr. Efthimiou also relied on studies filed in this case, including a study authored by Paolo Falsetti and others (the “Falsetti study”). Id. at 5 (citing Ex. 58, ECF No. 43-1). This study determined six out of fifty-eight patients had received a vaccine prior to PMR symptoms. Id. However, Dr. Efthimiou “acknowledged that [the study’s] authors had relied on self-reporting by existing PMR patients . . . to determine . . . that (in the subjective view of the surveyed patients) there might have been a relationship between the two.” Id. at 5–6. And he admitted that its authors “did not reach a scientifically-reliable conclusion,” as it would have been “‘impossible’ for such a small sample.” Id. at 6 (citing Tr. at 118). Petitioner’s expert also highlighted an article published by Alessandra Soriano (“Soriano article”). Id. (citing Ex. 34, ECF No. 24-11). This article reviewed case reports involving the flu vaccine. Id. The article referenced a case report, the underlying details of which were not filed in this case. Id. This lone report involved an observed temporal association between a tetanus vaccine—which would contain comparable antigens to a Tdap vaccine—and PMR in a woman in her sixties. Id. However, the Soriano article described that this woman suffered a relapse of PMR—not a new onset as Mr. Munoz had. Id. See also Ex. 34 at 3. And Dr. Efthimiou “admitted nothing [else] was known about this individual relevant to the case (such as whether she had previously received a Tdap vaccine, what had possibly caused her PMR the first time, or anything about her treatment or disease severity).” Dec. at 6 (citing Tr. at 119–21). Further, the expert “admitted he could offer no literature generally evaluating a purported PMR-Tdap connection” other than these case reports. Id. at 7. As for the autoreactive or helper T cell component of the theory, Petitioner’s expert “deemed it likely Mr. Munoz had been exposed to the vaccine before.” Id. at 6–7. But he “admitted he had no evidence of this, and was therefore engaging in some speculation.” Id. at 7. Dr. Efthimiou also speculated that co-administration of the pneumococcal vaccine with the Tdap could have contributed to the injury, but “admitted he had offered nothing specific to” a co- administration theory. Id. at 6 n.8 (citing Tr. at 98, 99–101, 134). 2. Respondent’s Experts a. Dr. Roland Staud, M.D. Dr. Staud, a rheumatologist, testified and filed a report. Id. at 7. He admitted Petitioner’s PMR diagnosis was correct but “maintained its causes remain unknown.” Id. PMR “may have some association with infection and environmental agents,” he admitted. Id. (emphasis in original). That said, he asserted that the infections identified as possibilities “have no congruence with the Tdap vaccine’s components.” Id. (citation omitted). Dr. Staud 4 Case 1:21-vv-01369-CNL Document 80 Filed 12/20/24 Page 5 of 14 acknowledged case reports linking the flu vaccine to PMR but pointed to a dearth of reports on Tdap. Id. at 7–8. He denied any link between the Tdap or pneumococcal vaccines—or any vaccine, for that matter—and PMR. Id. at 8. He pointed to studies to support this assertion, including one finding no link for the pneumococcal vaccine. Id. To contest a tetanus or Tdap link to PMR, Dr. Staud noted that rheumatology organizations specifically recommend tetanus vaccination to individuals experiencing autoimmune inflammatory conditions like PMR. Id. And he asserted the Falsetti study’s reliance on self-reporting and mere temporal associations undermined its conclusions. Id. b. William Hawse, Ph.D. Immunologist Dr. Hawse also submitted a report and testified. Id. He disputed Dr. Efthimiou’s theory of an immunologic mechanism. While vaccines are intended to generate an immune response to specific antigens, Dr. Hawse stressed that response is not identical across different vaccines. Id. He disputed the proposition that vaccines could initiate an autoimmune disease tolerance. Id. Dr. Hawse also rejected Petitioner’s senescence theory, reasoning that senescence involved the body generating “weaker responses to vaccination—not experiencing greater aberrant reactions with aging.” Id. at 9 (citing to pre-market testing of the Tdap vaccine). He also challenged Dr. Efthimiou’s proposal that a certain T cell lymphocyte could be “stimulated into a cascade, resulting in (or at least encouraging) PMR.” Id. Dr. Hawse disputed the reliability of this proposition, and stated he did not know of any evidence showing the Tdap vaccine could promote production of this T cell or any others allegedly involved with PMR. Id. He also argued that literature supporting this conclusion “relied on artificial lab conditions . . . that could not be compared to the body’s likely reaction to a vaccination.” Id. C. The Chief Special Master’s Decision On August 12, 2024, Chief Special Master Corcoran issued a Decision denying entitlement. Dec. at 1. He explained that “PMR has not generally been viewed in prior reasoned Program decisions as an injury likely caused by . . . Tdap—and nothing offered in this case suggests a basis for departing from these prior determinations.” Id. at 1–2 (emphasis in original). He considered the medical literature, prior special masters’ decisions regarding PMR, and the parties’ experts’ reports and testimony. Id. at 3–9, 15–17. The Chief Special Master determined Petitioner failed to carry his burden of proof to preponderantly establish the first of the Althen prongs to demonstrate causation. Id. at 17. There was not “sufficient probative evidence allowing for the conclusion that it is more likely than not that a Tdap vaccine’s components can trigger PMR.” Id. at 18. He found that Petitioner’s expert repeated arguments “that other special masters have routinely rejected as unpersuasive”; “fail[ed] to identify a specific antigen associated with the development of PMR”; did “not otherwise offer[] any more recent scientific or medical studies”; and made “too many speculative assumptions” and “large leaps” of logic. Id. at 17–18. And Respondent’s experts “effectively and persuasively” highlighted both a lack of direct evidence and logical issues with Petitioner’s theory. Id. at 17. Since Petitioner failed on the first Althen prong, the Chief Special Master did not proceed to the second and third prongs. Id. (“[T]he failure to establish even one of the three Althen 5 Case 1:21-vv-01369-CNL Document 80 Filed 12/20/24 Page 6 of 14 prongs in the context of a causation-in-fact claim is sufficient basis for a claim’s dismissal.”) (citing Dobrydnev v. Sec’y of Health & Hum. Servs., 566 Fed. App’x 976, 980 (Fed. Cir. 2014)). D. Motion for Review On September 11, 2024, Petitioner filed a motion for review of Chief Special Master Corcoran’s Decision denying entitlement. Mot. at 1. Mr. Munoz asserts “legal error,” claiming that the Chief Special Master “applied an incorrect evidentiary standard of review” under Althen’s first prong. Id. at 5. He asks that the Court set aside the Chief Special Master’s conclusions as “clear legal error” and grant entitlement. Id. at 18. In the alternative, he requests the Court remand to the Chief Special Master with instructions on the proper legal standard. Id. Respondent filed its opposition to the motion on October 11, 2024. The case is ripe for resolution. II. Standard of Review Under the Vaccine Act, parties may request the United States Court of Federal Claims to review a special master’s decision. 42 U.S.C. § 300aa–12(e)(1). Upon such review, the Court may: (A) uphold the findings of fact and conclusions of law of the special master and sustain the special master’s decision, (B) set aside any findings of fact or conclusion of law of the special master found to be arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law and issue its own findings of fact and conclusions of law, or (C) remand the petition to the special master for further action in accordance with the court’s direction. 42 U.S.C. § 300aa-12(e)(2). Accord Vaccine Rule 27. The standards in section 12(e)(2)(B) “vary in application as well as degree of deference” as each “standard applies to a different aspect of the judgment.” Munn v. Sec’y of Health & Hum. Servs., 970 F.2d 863, 870 n.10 (Fed. Cir. 1992). “Fact findings are reviewed . . . under the arbitrary and capricious standard; legal questions under the ‘not in accordance with law’ standard; and discretionary rulings under the abuse of discretion standard.” Id. “Thus, the [Court of Federal Claims] judge reviews the special master’s decision essentially for legal error or factual arbitrariness.” Bradley v. Sec’y of Health & Hum. Servs., 991 F.2d 1570, 1574 (Fed. Cir. 1993). The standard of review is “the most deferential possible.” Munn, 970 F.2d at 870. When reviewing a special master’s factual findings, the Court does “not reweigh the factual evidence, assess whether the special master correctly evaluated the evidence, or examine the probative value of the evidence or the credibility of the witnesses—these are all matters within the purview of the fact finder.” Porter v. Sec’y of Health & Hum. Servs., 663 F.3d 1242, 1249 (Fed. Cir. 2011); see also Hodges v. Sec’y of Health & Hum. Servs., 9 F.3d 958, 961 (Fed. Cir. 1993) (stating that the Vaccine Act “makes clear that, on review, the Court of Federal Claims is not to second guess the Special Masters[’] fact-intensive conclusions”); Snyder ex rel. Snyder v. Sec’y of Health & Hum. Servs., 88 Fed. Cl. 706, 718 (2009) (“[T]he law is settled that 6 Case 1:21-vv-01369-CNL Document 80 Filed 12/20/24 Page 7 of 14 neither the Court of Federal Claims nor the Federal Circuit can substitute its judgment for that of the special master merely because it might have reached a different conclusion.”). “[S]pecial masters have broad discretion to weigh evidence and make factual determinations.” Dougherty v. Sec’y of Health & Hum. Servs., 141 Fed. Cl. 223, 229 (2018). The special master does not need to “discuss every item of evidence in the record” when making a factual finding “so long as the decision makes clear that the special master fully considered a party’s position and arguments on point.” Snyder v. Sec’y of Health & Hum. Servs., 36 Fed. Cl. 461, 466 (1996), aff’d, 117 F.3d 545 (Fed. Cir. 1997) (citation omitted); see, e.g., Hazlehurst v. Sec’y of Health & Hum. Servs., 604 F.3d 1343, 1352 (Fed. Cir. 2010) (noting that a reviewing court presumes that the fact finder has considered all the material in the record, whether or not it is mentioned in his or her decision). Furthermore, the “special master’s decision often times is based on the credibility of the experts and the relative persuasiveness of their competing theories.” Broekelschen v. Sec’y of Health & Hum. Servs., 618 F.3d 1339, 1347 (Fed. Cir. 2010). The Federal Circuit has made clear that the special master’s credibility findings “are virtually unchallengeable on appeal.” Lampe v. Sec’y of Health & Hum. Servs., 219 F.3d 1357, 1362 (Fed. Cir. 2000). III. Discussion To receive compensation under the National Vaccine Injury Compensation Program, a petitioner must prove by a preponderance of the evidence that a vaccine caused the injury at issue. 42 U.S.C. §§ 300aa–11(c)(1), 13(a)(1). If the claimed injury is not listed in the Vaccine Injury Table (i.e., an “off-Table injury”), the petitioner may seek compensation by proving causation in fact. Moberly v. Sec’y of Health & Hum. Servs., 592 F.3d 1315, 1321 (Fed. Cir. 2010); 42 U.S.C. § 300aa–11(c)(1)(C)(ii). Here, it is undisputed that Petitioner suffered an off-Table injury, PMR, following his July 2, 2019 vaccination. Therefore, Mr. Munoz needs to prove “causation in fact” under the Althen test. Althen, 418 F.3d at 1278. To succeed under the test, a Petitioner must demonstrate by a preponderance of the evidence: “(1) a medical theory causally connecting the vaccination and the injury; (2) a logical sequence of cause and effect showing that the vaccination was the reason for the injury; and (3) a showing of a proximate temporal relationship between vaccination and injury.” Id. Petitioner argues the Chief Special Master applied an incorrect legal standard for prong one. Mot. at 2–5. First, Mr. Munoz claims that the Chief Special Master erred in “reject[ing] the contention that [prong one] can be satisfied merely by establishing the proposed causal theory’s scientific or medical plausibility.” Mot. at 3. See also Dec. at 11. Second, the Chief Special Master imposed an elevated “requirement . . . [to] present a persuasive medical theory.” Mot. at 4. Third, the Chief Special Master’s application of this allegedly incorrect standard led him to conclude that Petitioner’s evidence was insufficiently probative, which impermissibly raised the burden of proof. Mot. at 5. In response, the Government argues Petitioner misreads the controlling legal standard and asserts the Chief Special Master properly applied the Vaccine Act’s preponderance standard to the evidence. Resp. at 5, 9, 15–18. For the reasons explained below, the Government is correct. 7 Case 1:21-vv-01369-CNL Document 80 Filed 12/20/24 Page 8 of 14 A. The Chief Special Master Articulated the Correct Evidentiary Standard for Althen Prong One. Petitioner claims that he should have been able to “satisfy prong one by setting forth a biologically plausible theory” of causation. Mot. at 16–17 (cleaned up) (citing Andreu v. Sec’y of Health & Hum. Servs., 569 F.3d 1367, 1375 (Fed. Cir. 2009)). Mr. Munoz incorrectly asserts that “‘biological plausibility’ remains the evidentiary standard for Althen’s first element.” Mot. at 2–3 (citation omitted). 1. Althen Prong One Must be Proven by a Preponderance of the Evidence. The standard of evidentiary proof under Althen prong one is preponderance of the evidence, not plausibility. The statute is clear on this point. See 42 U.S.C. § 300aa-13(a)(1)(A) (“Compensation shall be awarded . . . if . . . the petitioner has demonstrated by a preponderance of the evidence the matters required in the petition.”). The Federal Circuit has “consistently rejected theories that the vaccine only ‘likely caused’ the injury and reiterated that a ‘plausible’ or ‘possible’ causal theory does not satisfy the standard.” Boatmon v. Sec’y of Health and Hum. Servs., 941 F.3d 1351, 1360 (Fed. 2019) (citing Moberly, 592 at 1322). “Proof of a ‘plausible’ or ‘possible’ causal link between the vaccine and the injury . . . is not the statutory standard” and is too “relaxed.” Moberly, 592 at 1322. “[S]imply identifying a ‘plausible’ theory of causation is insufficient for a petitioner to meet [his] burden of proof.” LaLonde v. Sec’y of Health & Hum. Servs., 746 F.3d 1334, 1339 (Fed. Cir. 2014). The Federal Circuit continues to affirm this proposition. See, e.g., Orloski v. Sec’y of Health & Hum. Servs., 839 F. App’x 538, 541 (Fed. Cir. 2021); Kalajdzic v. Sec’y of Health & Hum. Servs., No. 23-1321, 2024 WL 3064398, at *2 (Fed. Cir. June 20, 2024) (“[W]e have repeatedly explained that a petitioner must prove a medical theory by a preponderance of the evidence that a vaccination can cause a particular injury.”). This is consistent with the frequent instruction that “[t]he petitioner’s ‘burden . . . to show [causation] by preponderant evidence’” applies equally to “each of the requirements set forth in” the Althen prongs. Oliver v. Sec’y of Health & Hum. Servs., 900 F.3d 1357, 1361 (Fed. Cir. 2018). See also Olson v. Sec’y of Health & Hum. Servs., 758 F. App’x 919, 922 (Fed. Cir. 2018). Petitioner claims the Chief Special Master misread Boatmon. Mr. Munoz asserts that the Federal Circuit’s rejection of plausibility does not apply to Althen prong one. Mot. at 3–4 (asserting “[t]he Boatmon court reserved a separate section to discuss Althen element one” that did not discuss plausibility and only used the terms “sound and reliable”) (citing J. v. Sec’y of Health & Hum. Servs., 155 Fed. Cl. 20, 43 (2021)). He is mistaken. In Boatmon, the Federal Circuit reviewed the Special Master’s finding that an expert’s theory satisfied the first Althen prong despite being “only ‘plausible.’” Boatmon, 941 F.3d at 1360 (“By the Special Master’s and Dr. Miller’s own assessment, Dr. Miller’s theory is only ‘plausible’ . . . .”). The Federal Circuit reversed this finding. Id. “The [Boatmon] Special Master erred in allowing a theory that was at best ‘plausible’ to satisfy the Petitioners’ burden of proof.” Id. The Federal Circuit further rejected the plausible mechanism theory as “insufficient” under the first Althen prong. Boatmon, 941 F.3d at 1359–60. Further, the paragraph after Boatmon’s rejection of plausibility also reviewed and rejected the Special Master’s finding explicitly under Althen prong one. Id. at 1360 (citing Boatmon v. Sec’y of Health & Hum. Servs., 8 Case 1:21-vv-01369-CNL Document 80 Filed 12/20/24 Page 9 of 14 No. 13-611V, 2017 WL 3432329, at *21 (Fed. Cl. Spec. Mstr. July 10, 2017) (analyzing Petitioner’s expert’s evidence under “Althen Prong One”)). Boatmon is clear that plausibility does not satisfy the first Althen prong. 2. Petitioner’s Attempt to Refashion Plausibility as Preponderance is Unsupported by Precedent. Petitioner admits that Althen prong one’s standard is preponderance. See Mot. at 12. But he argues that “preponderant evidence of a biologically plausible scientific explanation” may satisfy the burden. Id. (emphasis added). See also, e.g., id. at 10 (stating that Mr. Munoz must provide preponderant proof “to propound a biologically plausible theory”). But as Respondent points out, “grafting plausibility onto preponderance” would “make little, if any, sense” in light of the Federal Circuit’s repeated rejection of plausibility as distinct from and impermissibly lower than preponderance. Resp. at 15, 15 n.8. See also Kaladjzic, 2024 WL 3064398, at *2 (“[A] less than preponderance standard . . . is plainly inconsistent with our precedent.”) (citing Moberly, 592 F.3d at 1322); K.A. v. Sec’y of Health & Hum. Servs., 164 Fed. Cl. 98, 125 (2022) (rejecting petitioner’s “attempts to refashion the first Althen prong standard” as a plausibility test). Petitioner relies on Andreu, which found “[t]he first [Althen] prong was satisfied because . . . the Andreus’ expert[] presented a ‘biologically plausible’ theory.” Andreu, 569 F.3d at 1376. But the Federal Circuit has directly rejected this interpretation. It stated that “in Andreu, although we noted at one point that the petitioner’s expert presented a ‘biologically plausible theory,’ Althen prong one was not disputed, and we thus could not have endorsed a lower standard of proof than the preponderance standard.” Kalajdzic, 2024 WL 3064398, at *2. Similarly, other cases dealing with plausibility were ones where causation was conceded by the Government, or the Court merely used the term “plausible” to explain a petitioner did not have to meet a standard of scientific certainty. See, e.g., Paluck v. Sec’y of Health & Hum. Servs., 786 F.3d 1373, 1377, 1380 (2015) (“[T]he government does not meaningfully dispute that [petitioner’s] theory of causation is medically plausible. Indeed, the government conceded that vaccination could have, in theory, exacerbated [petitioner’s injury].”); Sharpe v. Sec’y of Health & Hum. Servs., 964 F.3d 1072, 1085 (2020) (using term “plausible” to explain that a petitioner need not present “medical literature, epidemiological studies, demonstration of a specific mechanism, or a generally accepted medical theory” to prove a causation theory preponderantly). Thus, cases referencing plausibility at most stand for the unobjectionable proposition that Althen prong one “does not require medical certainty” but also “does not absolve Petitioner from his burden to present a ‘persuasive’ theory supported by ‘reputable’ scientific or medical evidence.” Trollinger v. Sec’y of Health & Hum. Servs., 167 Fed. Cl. 127, 138 (2023). Similarly, Petitioner misreads Kottenstette. As this Court stated—and the Federal Circuit affirmed: “a special master need not require proof of a specific biological mechanism for Althen prong one.” Howard v. United States, No. 16-1592V, 2023 WL 4117370, at *5 (Fed. Cl. May 18, 2023) (citing Kottenstette v. Sec’y of Health & Hum. Servs., 861 F. App’x 433, 437 (Fed. Cir. 2021)). “Kottenstette did not dilute the preponderance standard . . . . The only references to plausibility throughout the decision are direct quotes from the decisions below. Its ruling made no mention of plausibility and, instead, hinged on whether ‘sufficient evidence’ weighed in favor of preponderance.” Id. And the Federal Circuit in Kaladjzic affirmed that “Kottenstette . . . 9 Case 1:21-vv-01369-CNL Document 80 Filed 12/20/24 Page 10 of 14 [does not] undercut[] the requirement that a petitioner’s medical theory must be proven by preponderant evidence.” 2024 WL 3064398, at *2. 3. The Chief Special Master Identified the Correct Standard. The Chief Special Master correctly explained Petitioner’s burden to prove the first Althen prong by a preponderance of the evidence. Dec. at 10 (“[P]etitioners bear a ‘preponderance of the evidence’ burden of proof.”), 11 (citing caselaw rejecting plausibility as to first Althen prong). He explained that the theory need “only be ‘legally probable, not medically or scientifically certain.’” Id. at 10 (quoting Knudsen v. Sec’y of Health & Hum. Servs., 35 F.3d 543, 548–49 (Fed. Cir. 1994)). And he correctly stated that “[p]roof of medical certainty is not required” and “epidemiological studies, demonstration of a specific mechanism, or a generally accepted medical theory” are not mandatory. Id. at 10 (citations omitted). Cf. Kottenstette, 861 F. App’x at 441. To the extent that he determined that Petitioner’s evidence “somewhat allow[ed] for a faint possibility that a vaccine could impact” disease development, the Chief Special Master properly found this insufficient. Dec. at 18 (emphasis in original). Cf. Moberly, 592 F.3d at 1322. And as discussed further in III.C, the Chief Special Master applied the preponderance standard to determine Petitioner failed to provide “sufficient probative evidence allowing for the conclusion that it is more likely than not that a Tdap vaccine’s components can trigger PMR.” Dec. at 18. B. The Chief Special Master Did Not Incorrectly Require an Impermissibly High “Persuasive Theory” Under Althen Prong One. Next, Petitioner argues the Chief Special Master required him to present “a persuasive theory” under Althen prong one that impermissibly raised the evidentiary burden. Mot. at 5–6 (“The Chief’s bottom line was that Mr. Munoz’s medical theory was not bulwarked by sufficient probative scientific/medical evidence to allow him to conclude that Althen’s prong one was persuasively proven.”) (emphasis in original). But the Chief Special Master did not err. A special master’s obligation to examine the evidence under the preponderance standard requires her to “inquir[e] into the soundness of scientific evidence” presented. Cedillo v. Sec’y of Health & Hum. Servs., 617 F.3d 1328, 1339 (Fed. Cir. 2010) (citing Vaccine Rules of the Court of Federal Claims Rule 8(b)(1)). Special masters are responsible for “[w]eighing the persuasiveness of particular evidence” by “assessing the reliability of testimony.” Moberly, 592 F.3d at 1325. “The special master’s decision often times is based on the credibility of the experts and the relative persuasiveness of their competing theories,” and “[a]s such, the special master’s credibility findings ‘are virtually unchallengeable on appeal.’” Broekelschen, 618 F.3d at 1347 (citing Lampe, 219 F.3d at 1361). First, Petitioner appears to misconstrue the Decision below. The Chief Special Master properly articulated Petitioner’s burden to prove a “reputable medical theory” that is “based on a sound and reliable medical or scientific explanation” but need only be “legally probable, not medically or scientifically certain.” Dec. at 10 (citation omitted). Second, contrary to the Petitioner’s claims, the Decision’s references to “persuasiveness” are almost entirely related to describing the quality of the evidence. See, e.g., id. at 13 (explaining that oral or written testimony “may be more persuasive than written records”), 14 (explaining role of Daubert factors “with respect to [evaluating] persuasiveness of expert testimony”), 15 (stating a decision 10 Case 1:21-vv-01369-CNL Document 80 Filed 12/20/24 Page 11 of 14 “may be ‘based on the credibility of the experts and the relative persuasiveness of their competing theories’”), 16 (describing past special masters’ decisions as persuasive guidance), 17 (rejecting a specific causation opinion as “unpersuasive” and describing Respondent’s experts as “effectively and persuasively rebutt[ing] Petitioner’s causation contentions”). The Chief Special Master noted that a prior special master’s decision analyzed the persuasiveness of a petitioner’s causation theory. Id. at 16. He also parenthetically cited a case which used the term “reliable and persuasive causation theory.” Id. at 17 (citing Palattao v. Sec’y of Health & Hum. Servs., No. 13-591V, 2019 WL 989380, at *36 (Fed. Cl. Spec. Mstr. Feb. 4, 2019)). But the Chief Special Master cited that case for the principle that a petitioner must provide probative evidence of a causal theory that “applies to the circumstances at hand.” Id. at 17. This is merely consistent with the edict that a petitioner “must provide a reputable medical or scientific explanation that pertains specifically to the petitioner’s case.” Broekelschen, 618 F.3d at 1345. Third, and most importantly, the Chief Special Master would not have erred in evaluating the persuasiveness of the evidence or the theory because the Vaccine Act places a “statutory burden of persuasion . . . upon the petitioner [by] 42 U.S.C. §300aa-13(a)(1)” to prove causation in off-table injuries. Hodges, 9 F.3d at 961. Thus, the Federal Circuit has made clear that the preponderance standard is one of persuasion: The petitioner is not required to prove the case to a level of scientific certainty. Rather, the burden of showing something by a preponderance of the evidence, the most common standard in the civil law, simply requires the trier of fact to believe that the existence of a fact is more probable than its nonexistence before [he] may find in favor of the party who has the burden to persuade the [judge] of the fact’s existence. LaLonde, 746 F.3d at 1338. See also Moberly, 592 F.3d at 1322 (citing Concrete Pipe & Prods. of Cal., Inc. v. Constr. Laborers Pension Tr. for S. Cal., 508 U.S. 602, 622 (1993)). Accordingly, Althen held petitioners must “prove by a preponderance of the evidence that the . . . vaccination caused” the injury with a “persuasive medical theory.” Althen, 418 F.3d at 1278. See also Oliver, 900 F.3d at 1361 (“The Chief Special Master thoroughly evaluated both parties’ evidence as to each Althen prong and found the Government’s more persuasive.”); Cedillo, 617 F.3d at 1349 (affirming special master’s finding that the “fatal deficiency in the petitioner’s causation theories [is] the lack of any persuasive evidence that the . . . vaccine can contribute to the causation”). This is why a special master’s decision may be “based on the credibility of experts and the relative persuasiveness of their competing theories.” Broekelschen, 618 F.3d at 1347. As discussed in part III.C below, “[t]he Chief Special Master . . . took issue with the quality and quantity of [evidence], finding the overall support for [Mr. Munoz’s] general causation theory unpersuasive and insufficient to carry [his] burden.” Bechel v. Sec’y of Health & Hum. Servs., 168 Fed. Cl. 602, 622 (2023). In using the term “persuasive,” it is clear the Chief Special Master did not articulate a heightened standard. He merely “evaluated the evidence presented and found it lacking.” Howard, 2023 WL 4117370, at *5. His use of the term “persuasive” is consistent with the Vaccine Act’s preponderance standard, not a deviation from it. 11 Case 1:21-vv-01369-CNL Document 80 Filed 12/20/24 Page 12 of 14 C. The Chief Special Master Correctly Applied the Preponderance Standard to Find Petitioner Did Not Prove a Sound and Reliable Theory by Preponderant Evidence. To meet the burden of preponderantly proving that the vaccine “can cause” the injury under Althen prong one, a petitioner must provide evidence of a “reputable medical or scientific explanation.” Boatmon, 941 F.3d at 1359. The theory must be “sound and reliable,” but need not prove causation to medical or scientific certainty. Knudsen, 35 F.3d at 548. Petitioners may use “circumstantial evidence” to meet their burden of proof. Capizzano v. Sec’y of Health & Hum. Servs., 440 F.3d 1317, 1325 (Fed. Cir. 2006). “Proof of causation does not require identification and proof of specific biological mechanisms.” Kottenstette, 861 F. App’x at 441 (internal quotations omitted). Nor is “[p]roof in the form of epidemiological studies or well- established medical evidence . . . mandatory.” Moberly, 592 F.3d at 1325. The Chief Special Master applied this standard faithfully to the evidence. “The Chief Special Master did not treat the presence or absence of specific kinds of evidence—such as medical and scientific literature—in Petitioner’s filings as dispositive.” Trollinger, 167 Fed. Cl. at 138. He acknowledged that Petitioner had provided some probative evidence. Dec. at 17. He credited Dr. Efthimiou’s “insights” on PMR’s pathogenesis, recognized a “faint possibility” that vaccines could impact immune response in relation to PMR, and lent some weight to Petitioner’s theories on senescence and individual susceptibility. Id. at 18 (emphasis removed). However, he ultimately determined Petitioner’s theory contained analytical gaps, assumptions, and logical leaps that undermined its persuasive value. See, e.g., id. at 17 (finding Petitioner did not “provid[e] sufficient preponderant proof that the Tdap vaccine could likely initiate such a complex, interconnected disease process”), (“[Dr. Efthimiou] fails to identify a specific antigen associated with the development of PMR.”), 17–18 (“Petitioner assumes different susceptibilities . . . that are not bulwarked with enough evidence to show that vaccination likely poses risks in these contexts.”), 18 (“[T]he aspects of Dr. Efthimiou’s theory relying on immune system senescence were ultimately not well constructed or substantiated.”), (“[T]here are too many speculative assumptions [in Petitioner’s case].”). And Petitioner’s expert admitted many “evidentiary holes in his theory” that required him to “engag[e] in some speculation” as to nearly every portion of his theory. Id. at 7. See also id. at 6, 7. These admissions, for the Chief Special Master, further undercut the reliability of Petitioner’s evidence. See e.g., id. at 17 (noting Dr. Efthimiou “even admitted during testimony that there were not even case reports . . . other than the unfiled [Soriano] report). Given these evidentiary gaps, the Chief Special Master was within his discretion to conclude there was “too great an analytical gap between the data and the opinion proffered.” Cedillo, 617 F.3d at 1339 (quoting Gen. Elec. Co. v. Joiner, 522 U.S. 136, 146 (1997)). Given his determination that Petitioner’s complex theory “relied on the vaccine doing multiple things” and “affect[ing] the immune process at so many different inflection points,” the Chief Special Master reasonably found the evidence Petitioner put forward insufficient “to connect all the dots.” Dec. at 17. Petitioner also claims the Chief Special Master “require[d] [him] to provide specific pathologic mechanisms” or “objective proof.” Mot. at 10 (emphasis removed). But the Chief 12 Case 1:21-vv-01369-CNL Document 80 Filed 12/20/24 Page 13 of 14 Special Master did not require Petitioner to propose a specific mechanism: he merely discounted the persuasiveness of the one proposed. Mr. Munoz protests that the information in the Falsetti study and Soriano article, which purportedly identified an association between the tetanus toxoid and PMR, should have been given more weight. See, e.g., Mot. at 8, 12–15. Petitioner also objects to the Chief Special Master’s statement that case reports generally “stand as weak evidence to support causation.” Dec. at 18. While case reports have “reduce[d] . . . evidentiary value” compared to formal epidemiological studies, the Chief Special Master did not dismiss the Falsetti study or Soriano article out of hand. Echols v. Sec’y of Health & Hum. Servs., 165 Fed. Cl. 9, 17 (2023) (cleaned up) (quoting Campbell v. Sec’y of Health & Hum. Servs., 97 Fed. Cl. 650, 668 (2011), aff’d, 786 F.3d 1373 (Fed. Cir. 2015)). The Chief Special Master fully considered and analyzed the Falsetti study. He acknowledged that it “underscored Dr. Efthimiou’s prior arguments about senescence” and that some of its data were “consistent with Petitioner’s medical history.” Dec. at 5. But the Chief Special Master found the study lacked reliability because of its reliance on patients’ self-reporting of causation, its absence of a scientifically-reliable conclusion, and its finding of at most only a “possible” temporal relationship. Id. at 6, 8. The Chief Special Master also cited a prior special master’s decision that considered the Falsetti material and found it unpersuasive. Dec. at 16 (citing Dycke v. Sec’y of Health & Hum. Servs., No. 18-106V, 2023 WL 4310701, at *24 (Fed. Cl. Spec. Mstr. June 7, 2023)). The decision similarly evaluated the Soriano article and its second-hand case summary regarding an observed tetanus-PMR association. Dec. at 6, 17. However, the Chief Special Master identified multiple reasons to discount Petitioner’s reliance on this case report. These included the article’s lack of analogous circumstances and applicable details. The subject in question had “experienced a relapse of PMR.” Id. at 6 (emphasis in original). In contrast, Mr. Munoz experienced a new onset. Id. And the Chief Special Master noted Dr. Efthimiou’s admission of the lack of any other relevant information about this individual. Id. at 6. He observed that the case report was “inapplicable to this case as well, since it is not known that Mr. Munoz did previously receive a Tdap vaccine or experience a reaction to it.” Id. at 6 n.7. And he found the fact that there were no other case reports connecting PMR and tetanus outside this sole “unfiled report” further reduced the Soriano article’s persuasiveness. Id. at 17. The Chief Special Master also reasonably found Petitioner’s theory on genetic susceptibility—a critical element of his immunologic theory—lacking because it required similar logical leaps. Id. at 5. Although Petitioner “offered some evidence explaining how individual susceptibility might also encourage PMR,” the Chief Special Master determined there was a dearth of evidence to support its application to Petitioner’s specific case. Id. at 18. Petitioner’s expert also acknowledged this weakness. Id. at 7 (“Dr. Efthimiou admitted that there was no evidence Petitioner possessed a genetic susceptibility that could be associated with PMR.”). Mr. Munoz had the burden to provide a “reputable medical or scientific explanation that pertains specifically to [his] case.” Broekelschen, 618 F.3d at 1345. The Chief Special Master found Mr. Munoz did not meet his burden. The theory relied on “speculative assumptions about . . . [his] unspecified genetic susceptibilities,” and “assumed, in circular fashion” that Petitioner possessed a mutated HLA gene “merely because Petitioner developed PMR.” Id. at 18. Thus, the Chief Special Master did not require “proof of causation to the level of scientific certainty.” Boatmon, 941 F.3d at 1360 (quoting Moberly, 592 F.3d at 1324). Instead, he assessed the evidence for “indicia of reliability to support the assertion of the expert witness” and found it lacking. Id. 13 Case 1:21-vv-01369-CNL Document 80 Filed 12/20/24 Page 14 of 14 The Decision’s assessment of Dr. Efthimiou’s senescence theory was similar. Dr. Efthimiou testified that aging would generate “more autoimmune disease potentiality.” Dec. at 5. However, he also acknowledged that clinical studies generally found immune responses to be lower with age because the body “generat[es] weaker responses to vaccination,” a point emphasized by Dr. Hawse. Dec. at 5, 9 (internal quotes omitted). The Chief Special Master found Dr. Efthimiou’s senescence theory illogical “since the very concept of immune response senescence involves reduced immune system effectiveness, rather than greater aberrance due to age.” Id. at 18 (emphasis in original). As a result, he found this theory “ultimately not well constructed or substantiated.” Id. Petitioner also claims in a footnote that “the Chief’s decision . . . fails to accurately note the factual receipt of two covered vaccinations concomitantly.” Mot. at 2 n.1. This is inaccurate. He addressed this fact. See, e.g., Dec. at 6–7 n.8 (“Dr. Efthimiou made some references to the possibility that the other vaccine Petitioner received at the relevant time—the pneumococcal vaccine—could have contributed to his injury.”). The Chief Special Master found Dr. Efthimiou’s testimony inconclusive. Id. (“[Dr. Efthimiou] ultimately seemed to posit only that it was ‘highly possible’ a combination of vaccines played a contributory causal role.”). Further, Petitioner’s expert “admitted he had offered nothing specific to an association between PMR and co-administration of these two vaccines.” Id. (citing Tr. at 134). The Chief Special Master also found “most of Petitioner’s evidence goes to the Tdap vaccine’s role” rather than a co-administration theory. Id. He also noted that Dr. Efthimiou “admitted in passing he could offer less evidence on this topic” than the Tdap theory. Id. Thus, the Chief Special Master found the co-administration theory “facially less-supported” than the Tdap theory, and Dr. Efthimiou’s testimony on co-administration of “even less persuasive value.” Id. There is no basis for the Court to reverse this finding. In summary, Petitioner’s Motion requests this Court “review the evidence anew to conclude that [Mr. Munoz] has presented preponderant evidence linking the tetanus containing vaccines specifically to PMR illness.” Mot. at 17. But the Court may “not reweigh the factual evidence,” Porter, 663 F.3d at 1249, or “second guess the [Chief] Special Master’s fact-intensive conclusions.” Hodges, 9 F.3d at 961. The Chief Special Master’s Decision “grappled with the quality and quantity of the evidence . . . and found both metrics lacking.” Howard, 2023 WL 4117370, at *6. His findings were not in error. IV. Conclusion The Chief Special Master applied the correct legal standard and weighed the evidence properly within his discretion. Accordingly, the Court DENIES Petitioner’s Motion for Review and SUSTAINS the Special Master’s Decision. The Clerk of the Court shall enter judgment for Respondent accordingly. IT IS SO ORDERED. s/ Carolyn N. Lerner CAROLYN N. LERNER Judge 14