VICP Registry Case Source Bundle Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_19-vv-00985 Package ID: USCOURTS-cofc-1_19-vv-00985 Petitioner: Lauren Miller Filed: 2019-07-10 Decided: 2025-09-23 Vaccine: HPV; influenza Vaccination date: 2016-11-22 Condition: severe headaches, fatigue, memory problems, and intermittent low-grade fevers Outcome: dismissed Award amount USD: AI-assisted case summary: On July 10, 2019, Lauren Miller filed a petition alleging that HPV and influenza vaccinations administered on November 22, 2016 caused severe headaches, fatigue, memory problems, and intermittent low-grade fevers. The public dismissal decision does not state her exact age, but the case was filed in her own name. The case did not move forward on a supported causal record. Petitioner's expert, Dr. Omid Akbari, offered a vaccine-causation theory, while respondent relied on experts Dr. Shawn Aylward and Dr. S. Mark Tompkins. In a Rule 5 order, Chief Special Master Brian H. Corcoran identified several causation problems, especially timing. The medical records included histories of headaches beginning before the vaccinations, including notations of headaches one year earlier and two to three years earlier. The Chief Special Master also found the proposed theory non-specific and the claimed injury presentation shifting. After being directed to provide better temporal evidence, Ms. Miller did not supply evidence sufficient to cure those problems. On September 22, 2025, she moved to dismiss, stating that she intended to reject judgment and pursue a civil action. Chief Special Master Corcoran dismissed the petition with prejudice on September 23, 2025. No compensation was awarded. Ms. Miller was represented by Mark T. Sadaka of the Law Offices of Sadaka Associates, LLC. Theory of causation field: HPV and influenza vaccines, November 22, 2016, adult inferred, alleged severe headaches, fatigue, memory problems, and intermittent low-grade fevers. DISMISSED with prejudice after petitioner could not establish causation. Petitioner expert Dr. Omid Akbari offered a non-specific immune theory; respondent experts Dr. Shawn Aylward and Dr. S. Mark Tompkins opposed. Rule 5 assessment found significant temporal problems, including records indicating headaches one year and 2-3 years before vaccination and onset too remote for petitioner's theory. Petitioner did not produce additional temporal evidence and moved to dismiss, intending to reject judgment and pursue civil action. Chief Special Master Corcoran September 23, 2025. No award. Attorney Mark T. Sadaka; respondent Katherine C. Esposito. Public staged source text: ================================================================================ DOCUMENT 1: USCOURTS-cofc-1_19-vv-00985-0 Date issued/filed: 2025-10-24 Pages: 3 Docket text: PUBLIC DECISION (Originally filed: 09/23/2025) regarding 56 DECISION of Special Master Signed by Special Master Thomas L. Gowen. (hs) Service on parties made. -------------------------------------------------------------------------------- Case 1:19-vv-00985-UNJ Document 60 Filed 10/24/25 Page 1 of 3 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS Filed: September 23, 2025 * * * * * * * * * * * * * LAUREN MILLER, * * Petitioner, * No. 19-985V * v. * Special Master Gowen * SECRETARY OF HEALTH * AND HUMAN SERVICES, * * Respondent. * * * * * * * * * * * * * * Mark T. Sadaka, Law Offices of Sadaka Associates, LLC, Englewood, NJ, for petitioner. Katherine C. Esposito, U.S. Depart. of Justice, Washington, D.C., for respondent. DISMISSAL DECISION1 On July 10, 2019, Lauren Miller (“petitioner”), filed her claim in the National Vaccine Injury Compensation Program.2 Petition (ECF No. 1). Petitioner alleges that as a result of receiving the human papilloma virus (“HPV”) and influenza vaccines on November 22, 20216, she developed severe headaches, fatigue, memory problems, and intermittent low-grade fevers. Id. at ¶¶ 2-3. Petitioner filed medical records to accompany her petition and an expert report from Dr. Omid Akbari. See Pet’r Exhibits (“Exs.”) 1-11. Respondent filed a Rule 4(c) report, recommending against compensation on July 8, 2020. Respondent (“Resp’t”) Report (“Rept.”) (ECF No. 19). Respondent also filed an expert report by Drs. Shawn Aylward and Dr. S. Mark Tompkins. Resp’t Exs. A & C. 1 Pursuant to the E-Government Act of 2002, see 44 U.S.C. § 3501 note (2012), because this opinion contains a reasoned explanation for the action in this case, I intend to post it on the website of the United States Court of Federal Claims. The Court’s website is at http://www.uscfc.uscourts.gov/aggregator/sources/7. Before the opinion is posted on the Court’s website, each party has 14 days to file a motion requesting 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). An objecting party must provide the Court with a proposed redacted version of the opinion. Id. If neither party files a motion for redaction within 14 days, the opinion will be posted on the Court’s website without any changes. Id. 2 The National Vaccine Injury Compensation Program is set forth in Part 2 of the National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755, codified as amended, 42 U.S.C. §§ 300aa-10 to 34 (2012) (hereinafter “Vaccine Act” or “the Act”). Hereinafter, individual section references will be to 42 U.S.C. § 300aa of the Act. Case 1:19-vv-00985-UNJ Document 60 Filed 10/24/25 Page 2 of 3 The undersigned held a Rule 5 Status Conference on May 30, 2024, and explained that petitioner’s case presented numerous problems, including that onset of petitioner’s alleged injury was too remote based on the theory presented by petitioner’s expert, Dr. Akbari. Rule 5 Order (ECF No. 36). Additionally, the medical records provided inconsistent evidence as it related to the onset of petitioner’s headaches. See Pet’r Ex. 1 at 4 (noting onset of headaches a year prior to vaccination); Pet’r Ex. 3 at 33 (noting onset of headaches beginning two to three years prior to vaccination). Petitioner was ordered to file additional evidence to demonstrate a temporal association between the vaccination and her alleged injuries. Rule 5 Order at 2. On May 15, 2025, the undersigned held another status conference, after petitioner had failed to file additional evidence to support a temporal association between the vaccines and her alleged injury. Scheduling Order (ECF No. 51). During this status conference, the undersigned explained that petitioner’s expert’s theory was non-specific as to how the vaccines petitioner received could cause the injury she was alleging, and that petitioner’s alleged injury appeared to be shifting. Scheduling Order at 2. Accordingly, I recommended that petitioner voluntarily dismiss her claim, as she was unlikely to demonstrate by preponderant evidence that the vaccines she received caused her alleged injuries. On September 22, 2025, petitioner filed a motion for a decision dismissing her petition. Petitioner’s Motion (“Pet’r Mot.”) (ECF No. 55). In her motion, petitioner stated that she understands that the decision dismissing her petition will result in a judgment against her and that such a judgment will end all of her rights in the Vaccine Program. Pet’r Mot. at 1. Petitioner also understands that her attorney may be made once a decision dismissing her petition is entered and that respondent reserves the right, pursuant to 42 U.S.C. § 300aa-15(e), to question the good faith and reasonable basis of petitioner’s claim and oppose, if appropriate, petitioner’s application for attorneys’ fees and costs. Id. Petitioner stated that she intends to reject the Vaccine Program judgment against her and protect her rights to file a civil action in the future. Id. at 1-2. To receive compensation in the Vaccine Program, petitioners have the burden of proving either: (1) that the vaccinee suffered a “Table Injury,” i.e., an injury beginning within a specified period of time following receipt of a corresponding vaccine listed on the Vaccine Injury Table (a “Table injury”) or (2) that the vaccinee suffered an injury that was caused-in-fact by a covered vaccine. §§ 13(a)(1)(A); 11(c)(1). In this case, petitioner is not alleging a Table Injury and therefore, must demonstrate the vaccine was the cause-in-fact of her alleged injuries. To satisfy her burden of proving causation in fact, petitioner must show by preponderant 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.” Althen v. Sec’y of Health & Human Servs., 418 F. 3d 1274, 1278 (Fed. Cir. 2005). Petitioner’s burden of proof is by a preponderance of the evidence. § 13(a)(1). The preponderance standard requires a petitioner to demonstrate that it is more likely than not that the vaccine at issue caused the injury. Moberly v. Sec’y of Health & Hum. Servs., 592 F.3d 1315, 1322 n.2 (Fed. Cir. 2010). 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, petitioner must prove that the 2 Case 1:19-vv-00985-UNJ Document 60 Filed 10/24/25 Page 3 of 3 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 v. Sec’y of Health & Hum. Servs., 165 F.3d 1344, 1352-53 (Fed. Cir. 1999)); see also Pafford v. Sec’y of Health & Hum. Servs., 451 F.3d 1352, 1355 (Fed. Cir. 2006). Under the Vaccine Act, the Vaccine Program may not award compensation based on the petitioner’s claims alone. §13(a)(1). In this case, petitioner has not presented preponderant evidence of a proximate temporal association between the vaccines she received and the alleged injury. As discussed above, petitioner’s medical records are inconsistent as to the onset of her alleged injury and suggest that her condition began prior to the vaccination on November 22, 2016. Further, petitioner is requesting that her claim be voluntarily dismissed and in accordance with Vaccine Rule 21(b), the special master or the court may dismiss a petition at the petitioner’s request on terms that the special master or the court considers a proper issuance of a decision pursuant to 42 U.S.C. § 300aa-12(d)(3). A dismissal under Vaccine Rule 21(b) will be with prejudice and result in judgment pursuant to Vaccine Rule 11 for purposes of 42 U.S.C. § 300aa- 21(a). Vaccine Rule 21(b)(2). Accordingly, the evidence submitted is insufficient to establish entitlement and petitioner has not presented preponderant evidence to support a finding of vaccine causation under Althen. Thus, petitioner’s motion is GRANTED. This matter is DISMISSED for insufficient proof. The Clerk of the Court shall enter judgment accordingly.3 IT IS SO ORDERED. s/Thomas L. Gowen Thomas L. Gowen Special Master 3 Entry of judgment is expedited by each party’s filing notice renouncing the right to seek review. Vaccine Rule 11(a). 3