VICP Registry Case Source Bundle Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_19-vv-00070 Package ID: USCOURTS-cofc-1_19-vv-00070 Petitioner: Sally Herms Filed: 2019-01-15 Decided: 2024-08-15 Vaccine: DTaP Vaccination date: 2017-06-18 Condition: sensorineural hearing loss and tinnitus Outcome: denied Award amount USD: AI-assisted case summary: Sally Herms, a 58-year-old adult, received a DTaP vaccination on June 18, 2017. Two days later, she experienced fever, muscle aches, and a feeling of being in a tunnel. She awoke to find she was deaf in her left ear, and the following morning, she developed tinnitus in her left ear. These symptoms were diagnosed as sensorineural hearing loss (SNHL) and tinnitus. Ms. Herms filed a petition for compensation under the National Vaccine Injury Compensation Program, alleging the DTaP vaccine caused her hearing loss and tinnitus. The case proceeded as an off-Table claim, meaning Ms. Herms had to prove causation. She presented expert opinions from Dr. Arthur Brawer and Dr. Marcel Kinsbourne, who proposed theories of molecular mimicry and autoimmune attack, respectively, suggesting the DTaP vaccine triggered an immune response leading to her hearing loss. Respondent presented expert testimony from Dr. Ross Kedl, who argued that the proposed theories were not scientifically sound, that molecular mimicry was an outdated concept, and that Ms. Herms' condition was likely coincidental. The Special Master denied entitlement, finding that Ms. Herms failed to establish a sound and reliable medical theory connecting the DTaP vaccine to her hearing loss and tinnitus, and that the temporal proximity of her symptoms to the vaccination was insufficient on its own. The court affirmed the Special Master's decision, agreeing that Ms. Herms did not meet her burden of proof under the Althen framework for establishing causation. The petition was therefore denied. Theory of causation field: Off-Table Public staged source text: ================================================================================ DOCUMENT 1: USCOURTS-cofc-1_19-vv-00070-0 Date issued/filed: 2024-03-29 Pages: 35 Docket text: PUBLIC DECISION (Originally filed: 3/4/2024) regarding 142 DECISION of Special Master. Signed by Special Master Nora Beth Dorsey. (kis) Service on parties made. -------------------------------------------------------------------------------- Case 1:19-vv-00070-CFL Document 143 Filed 03/29/24 Page 1 of 35 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS Filed: March 4, 2024 * * * * * * * * * * * * * * * SALLY HERMS, * PUBLISHED * Petitioner, * No. 19-70V * v. * Special Master Nora Beth Dorsey * SECRETARY OF HEALTH * Dismissal; Diphtheria Tetanus Toxoid AND HUMAN SERVICES, * Acellular Pertussis (“DTaP”) Vaccine; * Sensorineural Hearing Loss (“SNHL”). Respondent. * * * * * * * * * * * * * * * * * John F. McHugh, Law Office of John McHugh, New York, NY, for Petitioner. Mitchell Jones, U.S. Department of Justice, Washington, DC, for Respondent. DECISION1 On January 15, 2019, Sally Herms (“Petitioner”) filed a petition for compensation under the National Vaccine Injury Compensation Program (“Vaccine Act” or “the Program”), 42 U.S.C. § 300aa-10 et seq. (2018),2 alleging that she sustained injuries “due to an adverse reaction to a [diphtheria tetanus toxoid acellular pertussis (“DTaP”)] vaccination given to her on June 18, 2017, which resulted in her loss of hearing on her left side and constant loud tinnitus.” Petition at Preamble (ECF No. 1). Respondent argued against compensation, stating “this case is not 1 Because this Decision contains a reasoned explanation for the action in this case, the undersigned is required to post it on the United States Court of Federal Claims’ website and/or at https://www.govinfo.gov/app/collection/uscourts/national/cofc in accordance with the E- Government Act of 2002. 44 U.S.C. § 3501 note (2018) (Federal Management and Promotion of Electronic Government Services). This means the Decision will be available to anyone with access to the Internet. In accordance with Vaccine Rule 18(b), Petitioner has 14 days to identify and move to redact medical or other information, the disclosure of which would constitute an unwarranted invasion of privacy. If, upon review, the undersigned agrees that the identified material fits within this definition, the undersigned will redact such material from public access. 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 (2018) (“Vaccine Act” or “the Act”). All citations in this Decision to individual sections of the Vaccine Act are to 42 U.S.C.A. § 300aa. 1 Case 1:19-vv-00070-CFL Document 143 Filed 03/29/24 Page 2 of 35 appropriate for compensation under the terms of the Act.” Respondent’s Report (“Resp. Rept.”) at 1 (ECF No. 38). After carefully analyzing and weighing the evidence presented in accordance with the applicable legal standards, the undersigned finds Petitioner has failed to provide preponderant evidence that the DTaP vaccine she received caused her hearing loss and tinnitus. Thus, Petitioner has failed to satisfy her burden of proof under Althen v. Secretary of Health & Human Services, 418 F.3d 1274, 1280 (Fed. Cir. 2005). Accordingly, the petition must be dismissed. I. ISSUES TO BE DECIDED The parties stipulate that Petitioner received the DTaP vaccine on June 18, 2017. Joint Submission, filed Mar. 24, 2023, at 1 (ECF No. 132). They also stipulate that “[t]wo days later, she experienced fever, muscle aches[,] and a feeling of being in a tunnel. She awoke and found she was deaf in her left ear. The following morning, she had tinnitus in her left ear.” Id. The parties do not dispute the diagnosis of hearing loss and tinnitus. However, they dispute causation and state that the following issues require resolution: “Can DTaP cause an autoimmune attack on nerves? Is onset of [Petitioner’s] condition within the time frame of an autoimmune reaction to the vaccination? Is [Petitioner’s] record consistent with an autoimmune or other adverse reaction to the DTaP vaccination? Is there any other explanation for the onset of her conditions?” Joint Submission at 2. Although the parties identify the issues above, the undersigned finds that the correct legal standards applicable here are those articulated in Althen. Althen, 418 F.3d at 1278 (indicating Petitioner must establish, 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”). II. BACKGROUND A. Procedural History Petitioner filed her petition on January 15, 2019. Petition. On April 29, 2019, Petitioner filed medical records,3 and on August 19, Petitioner filed a declaration.4 Petitioner’s Exhibits (“Pet. Exs.”) 1-8. On October 3, 2019, the case was reassigned to the undersigned. Notice of Reassignment dated Oct. 3, 2019 (ECF No. 22). On November 14, 2019, Petitioner filed an 3 Petitioner continued to file medical records throughout the course of litigation. 4 This exhibit is titled “Affidavit,” but it is not notarized, and therefore the undersigned references it as a declaration. The same is true of a second declaration filed by Petitioner on July 31, 2021. ECF No. 93-1. Some of Petitioner’s exhibits are not labeled. Therefore, the undersigned will refer to those exhibits by their ECF numbers. 2 Case 1:19-vv-00070-CFL Document 143 Filed 03/29/24 Page 3 of 35 expert report from Dr. Arthur E. Brawer. Pet. Ex. 10. Respondent filed his Rule 4(c) Report arguing against compensation on July 16, 2020. Resp. Rept. at 1. On August 17, 2020, Petitioner filed a supplemental expert report from Dr. Brawer. Pet. Ex. 50. On September 14, 2020, Respondent filed an expert report from Dr. Ross M. Kedl. Resp. Ex. A. On December 17, 2020, an order to show cause issued for Petitioner’s failure to file medical records. Order to Show Cause dated Dec. 17, 2020 (ECF No. 66). In response, Petitioner filed a status report and medical records. See ECF No. 67. At the request of the parties, the undersigned held a Rule 5 conference on July 27, 2021. Pet. Joint Status Rept., filed June 22, 2021 (ECF No. 90); Order dated July 27, 2021 (ECF No. 92). However, the undersigned was unable to give her preliminary findings and opinions due to an incomplete record. Order dated July 27, 2021, at 1. A second order to show cause issued on September 9, 2021. Order to Show Cause dated Sept. 9, 2021 (ECF No. 94). At a status conference on September 24, 2021, the undersigned indicated Petitioner did not need to respond to the order to show cause. Order dated Sept. 24, 2021, at 2 (ECF No. 97). Although Petitioner did not provide everything that was requested, the undersigned found the order to show cause satisfied. Id. On April 27, 2022, Petitioner filed an expert report from Dr. Marcel Kinsbourne. Pet. Ex. 163. On October 25, 2022, Respondent filed a supplemental report from Dr. Kedl, and Petitioner filed a supplemental report from Dr. Kinsbourne on November 28, 2022. Resp. Ex. C; Pet. Ex. 164. The parties agreed to resolve the issue of causation through a ruling on the record rather than an entitlement hearing. Pet. Status Rept., filed Jan. 3, 2023 (ECF No. 126); Resp. Joint Status Rept., filed Feb. 6, 2023 (ECF No. 129) (confirming the record is complete and indicating the parties previously discussed informal resolution but that Respondent intended to proceed on a litigation track). On March 22, 2023, Petitioner filed her motion for a ruling on the record. Pet. Motion for Ruling on the Record (“Pet. Mot.”), filed Mar. 22, 2023 (ECF No. 131). Respondent filed his response on June 21, 2023. Resp. Response to Pet. Mot. (“Resp. Response”), filed June 21, 2023 (ECF No. 138). On June 26, 2023, Petitioner filed a reply. Pet. Reply in Support of Pet. Mot. (“Pet. Reply”), filed June 26, 2023 (ECF No. 139). This matter is now ripe for adjudication. B. Factual History 1. Stipulated Facts The parties agreed to the following stipulated facts as set forth in their Joint Submission. See Joint Submission at 1. Petitioner received the DTaP vaccine on June 18, 2017. Id. “Two 3 Case 1:19-vv-00070-CFL Document 143 Filed 03/29/24 Page 4 of 35 days later, she experienced fever, muscle aches[,] and a feeling of being in a tunnel. She awoke and found she was deaf in her left ear. The following morning, she had tinnitus in her left ear.” Id. 2. Summary of Medical Records In addition to the facts stipulated to by the parties, the following summary of medical records provides additional relevant information. Petitioner’s prior medical history was significant for hypertension. Pet. Ex. 1 at 1-3 (ECF No. 8-1).5 Prior to receiving the vaccination at issue, Petitioner was seen at an urgent care facility on March 21, 2017, for complaints of “sinus infection, coughing, pressure, [and] eyes bright red and swollen for about three days.” Pet. Ex. 45 at 1. Physical examination revealed bilateral conjunctivitis with redness but no drainage. Id. at 1-2. Her ear examination did not reveal any redness or swelling, and her hearing was “grossly intact.” Id. at 1. She was diagnosed with bronchitis and conjunctivitis and given a prescription for Biaxin6 and TobraDex7 eye drops. Id. at 2. Petitioner was fifty-eight years old at the time she received a DTaP vaccination on June 18, 2017 at a Walgreens pharmacy. Pet. Ex. 4 at 1. 5 Some of Petitioner’s exhibits are mislabeled or duplicative. Therefore, to avoid confusion, the undersigned will refer cross-reference those exhibits with their ECF numbers. 6 Biaxin is trademark for clarithromycin which is a “macrolide antibiotic effective against a wide spectrum of gram-positive and gram-negative bacteria, used in the treatment of respiratory tract infections and skin and soft tissue infections, and in conjunction with omeprazole in the treatment of duodenal ulcer associated with Helicobacter pylori infections.” Clarithromycin, Dorland’s Med. Dictionary Online, https://www.dorlandsonline.com/dorland/definition?id=9992 (last visited Feb. 20, 2024); Biaxin, Dorland’s Med. Dictionary Online, https://www. dorlandsonline.com/dorland/definition?id=5990 (last visited Feb. 20, 2024). 7 TobraDex is trademark for combinations of preparations of tobramycin and dexamethasone. TobraDex, Dorland’s Med. Dictionary Online, https://www.dorlandsonline.com/dorland /definition?id=50179 (last visited Feb. 20, 2024). Tobramycin is “an aminoglycoside antibiotic . . . effective against a wide range of aerobic gram-negative bacilli and some gram-positive bacteria . . . used topically in the treatment of external infections of the eye and its adnexa.” Tobramycin, Dorland’s Med. Dictionary Online, https://www.dorlandsonline.com/dorland /definition?id=50180 (last visited Feb. 20, 2024). Dexamethasone is “a synthetic glucocorticoid, 25 times as potent as cortisol; used topically on the skin and conjunctiva as an antiinflammatory and administered orally in replacement therapy for adrenocortical insufficiency, as an antiinflammatory and immunosuppressant in a wide variety of disorders, and as an antiemetic in cancer chemotherapy.” Dexamethasone, Dorland’s Med. Dictionary Online, https://www.dorlandsonline.com/dorland/definition?id=13599 (last visited Feb. 20, 2024). 4 Case 1:19-vv-00070-CFL Document 143 Filed 03/29/24 Page 5 of 35 On June 20, 2017, Petitioner presented to her primary care physician (“PCP”), Dr. Nasseredin (“Nasser”) Shariati, with complaints of stiffness, chills, ear congestion, hearing loss, and “feeling that she [was] in a tunnel,” after receipt of the DTaP vaccine two days earlier. Pet. Ex. 1 at 1 (ECF No. 8-1). She also had body aches and a fever but was “somewhat better” at the time of the visit. Id. Dr. Shariati noted Petitioner was “obviously concerned about the possibility of side effect.” Id. Physical examination revealed minimal amount of wax in her left ear, and “[a]udiometry a[t] 25 dB revealed marked hearing loss on left side.” Id. Dr. Shariati’s impression was “[p]robable side effects from receiving DTaP” and “wax buildup on the left ear.” Id. He noted “one has to be concerned about the possibility of acoustic neuroma[8] as [Petitioner’s] younger daughter suffered from acoustic neuroma on her left ear and [as] result[] of that[,] she lost her hearing on that side permanently.” Id. Petitioner’s list of current medications included Bactrim,9 Cipro,10 Lisinopril,11 and Lo Loestrin Fe.12 Id. at 2. Diagnosis 8 An acoustic neuroma is “a progressively enlarging, benign tumor, usually within the internal auditory canal arising from Schwann cells of the vestibular division of the eighth cranial nerve.” Acoustic Neuroma, Dorland’s Med. Dictionary Online, https://www.dorlandsonline.com/dorland /definition?id=92588 (last visited Jan. 23, 2024). 9 Bactrim is trademark for combination preparations of trimethoprim and sulfamethoxazole. Bactrim, Dorland’s Med. Dictionary Online, https://www.dorlandsonline.com /dorland/definition?id=5402 (last visited Feb. 20, 2024). Trimethoprim is “an antibacterial closely related to the antimalarial pyrimethamine, acting by inhibiting a step in bacterial folate biosynthesis and effective against various gram-negative and gram-positive bacteria; administered orally in the prophylaxis and treatment of urinary tract infections and the treatment of pneumocystis pneumonia.” Trimethoprim, Dorland’s Med. Dictionary Online, https://www.dorlandsonline.com/dorland/definition?id=51090 (last visited Feb. 20, 2024). Sulfamethoxazole is “a sulfonamide used as an antibacterial active against various gram-negative and gram-positive organisms, especially for the treatment of acute urinary tract infections, and as an antiprotozoal.” Sulfamethoxazole, Dorland’s Med. Dictionary Online, https://www.dorlandsonline.com/dorland/definition?id=47958 (last visited Feb. 20, 2024). 10 Cirpro is trademark for preparations of ciprofloxacin hydrochloride which is “the monohydrated hydrochloride salt of ciprofloxacin, having the same actions as the parent compound and used to treat a wide variety of bacterial infections; administered orally, intravenously, and topically to the conjunctiva.” Ciprofloxacin Hydrochloride, Dorland’s Med. Dictionary Online, https://www.dorlandsonline.com/dorland/definition?id=65257 (last visited Feb. 20, 2024); Cipro, Dorland’s Med. Dictionary Online, https://www.dorlandsonline.com /dorland/definition?id=9880 (last visited Feb. 20, 2024). 11 Lisinopril is “the lysine derivative of the active form of enalapril; an angiotensin-converting enzyme inhibitor used in the treatment of hypertension (alone or in combination with a thiazide diuretic), congestive heart failure, and acute myocardial infarction; administered orally.” Lisinopril, Dorland’s Med. Dictionary Online, https://www.dorlandsonline.com /dorland/definition?id=28515 (last visited Feb. 20, 2024) 5 Case 1:19-vv-00070-CFL Document 143 Filed 03/29/24 Page 6 of 35 was “[u]nspecified sensorineural hearing loss [(“SNHL”)].”13 Id. Dr. Shariati’s plan of treatment included “application of Debrox into her left ear” to clear out the wax, consideration of computed tomography (“CT”) scan to rule out acoustic neuroma, and for Petitioner to resume taking her antihypertensive medication, which she had discontinued. Id. at 1. On June 29, 2017, Petitioner presented to otolaryngologist Dr. Gregory Fleming. Pet. Ex. 1 at 3 (ECF No. 8-1). History notes indicated Petitioner had “sudden [SNHL] in the left ear which began on June 19, 2017. It began 24 hours after having a [DTaP] vaccine. She did have some arm discomfort and some generalized rigors but no fever. She awoke the next day with diminished hearing in the left ear.” Id. at 4. Petitioner presented complaining of a “seashell type tinnitus[14] but no vertigo[15] or ear pain.” Id. Petitioner denied barotrauma, a history of Lyme disease, sinus complaints, sore throat, difficulty swallowing, or a preceding upper respiratory infection. Id. Dr. Fleming also noted Petitioner’s daughter had an acoustic neuroma but was “doing well following surgery.” Id. On examination, Dr. Fleming noted Petitioner’s cranial 12 Lo Loestrin Fe is trademark for combination preparations of norethindrone acetate, ethinyl estradiol, and iron. Lo Loestrin Fe, Dorland’s Med. Dictionary Online, https://www.dorlandsonline.com/dorland/definition?id=28707 (last visited Jan. 23, 2024). Norethindrone acetate is “used in the treatment of secondary amenorrhea, dysfunctional uterine bleeding, and endometriosis.” Norethindrone Acetate, Dorland’s Med. Dictionary Online, https://www.dorlandsonline.com/dorland/definition?id=93416 (last visited Jan. 23, 2024). Ethinyl estradiol “a semisynthetic derivative of estradiol, one of the most potent estrogens. It is used in combination with a progestational agent in oral contraceptives and contraceptive patches, and administered orally in hormone replacement therapy.” Ethinyl Estradiol, Dorland’s Med. Dictionary Online, https://www.dorlandsonline.com/dorland/definition?id=73904 (last visited Jan. 23, 2024). 13 Sensorineural hearing loss or SNHL is “hearing loss due to a lesion in either the cochlea (sensory mechanism of the ear), the vestibulocochlear nerve, the central neural pathways, or a combination of these structures.” Sensorineural Hearing Loss, Dorland’s Med. Dictionary Online, https://www.dorlandsonline.com/dorland/definition?id=80207 (last visited Jan. 23, 2024). It results from either damage to the cochlea or “disruption of the electrical conduction pathway from the inner ear to the brain. Thus, injury to hair cells, supporting cells, auditory neurons, or the central auditory pathway can cause [SNHL].” Anil K. Lalwani, Disorders of Hearing, in 1 Harrison’s Principles of Internal Medicine 238, 240 (Joseph Loscalzo et al. eds., 21st ed. 2022). Damage to the hair cells may be caused by intense noise, viral infections, or aging. Id. 14 Tinnitus is “a noise in the ears, such as ringing, buzzing, roaring, or clicking. It is usually subjective in type.” Tinnitus, Dorland’s Med. Dictionary Online, https://www.dorlandsonline.com/dorland/definition?id=50114 (last visited Jan. 23, 2024). 15 Vertigo is “an illusory sense that either the environment or one’s own body is revolving; it may result from diseases of the internal ear or may be due to disturbances of the vestibular centers or pathways in the central nervous system.” Vertigo, Dorland’s Med. Dictionary Online, https://www.dorlandsonline.com/dorland/definition?id=52968 (last visited Jan. 23, 2024). 6 Case 1:19-vv-00070-CFL Document 143 Filed 03/29/24 Page 7 of 35 nerves II-XII were intact. Id. Petitioner’s hearing test revealed a “moderate to severe [SNHL] in the left ear with no discernible speech discrimination. The tympanograms were normal. The right ear appeared normal.” Id.; see also Pet. Ex. 52 at 10-11. The plan was to begin a prednisone taper (steroids), obtain magnetic resonance imaging (“MRI”) to rule out an acoustic neuroma, and order a serology screening. Pet. Ex. 1 at 4 (ECF No. 8-1). “Antivirals were deferred in light of the 10 day[s] since onset of her hearing loss.” Id. Intratympanic steroids were discussed but Petitioner declined. Id. Dr. Fleming’s diagnosis was SNHL and tinnitus in the left ear. Id. A brain MRI performed on July 14, 2017 was normal. Pet. Ex. 1 at 12 (ECF No. 8-1). There was no evidence of an acute infarction, mass effect, pathologic enhancement, or cerebellopontine angle mass. Id. at 12-13. Serology results showed negative Lyme immunoblot and negative C-reactive protein.16 Id. at 9-11. Creatinine and blood urea nitrogen were normal. Id. at 10. On July 25, 2017, Petitioner returned to Dr. Fleming for a follow-up visit following prednisone treatment. Pet. Ex. 1 at 18, 20 (ECF No. 8-1). Dr. Fleming informed Petitioner of her normal lab work and normal brain MRI. Id. at 20. Petitioner denied ear pain but expressed interest in pursuing all treatment possible “prior to possible initiation of a lawsuit regarding a possible vaccine side effect as the cause of her hearing loss.” Id. Petitioner’s hearing test, performed July 18, 2017 showed “good improvement of her speech discrimination but persist[ent] moderate [SNHL] on pure tone testing.” Id. Petitioner requested a “neuro-otologic evaluation prior to initiating any invasive treatment,” and planned to contact otolaryngologist Dr. Samuel Selesnick who had previously performed her daughter’s acoustic neuroma surgery. Id. She was to follow-up with Dr. Fleming’s office for her SNHL and discuss the possibility of intratympanic steroids. Id. “She [was] aware that time [was] of the essence regarding this type of treatment.” Id. Petitioner refused a hearing aid in light of her improved speech discrimination. Id. Petitioner saw otolaryngologist Dr. Jed Kwartler on July 27, 2017. Pet. Ex. 1 at 22 (ECF No. 8-1). She presented for an evaluation for “left sudden hearing loss” that occurred on “June 18 after a [DTaP] vaccine.” Id. at 23. Petitioner also reported mild, low-level tinnitus. Id. No vertigo, head trauma, antecedent illnesses, prior hearing loss, or dizziness were noted. Id. Hypertension was documented as a significant comorbidity. Id. Dr. Kwartler reviewed Petitioner’s most recent hearing test which showed “moderately severe left [SNHL] with 80% discrimination.” Id. Because it had been approximately six weeks since onset, Dr. Kwartler explained that the likelihood of improvement with intratympanic steroid injections was decreased. Id. It was noted that they “spent time talking about the pathophysiology of idiopathic sudden [SNHL].” Id. Dr. Kwartler recommended a hearing aid as her next step, given “her reasonably good discrimination.” Id. 16 C-reactive protein is “a globulin that forms a precipitate with the somatic C-polysaccharide of the pneumococcus in vitro; it is the most predominant of the acute-phase proteins.” C-Reactive Protein, Dorland’s Med. Dictionary Online, https://www.dorlandsonline.com/dorland/ definition?id=100489 (last visited Feb. 20, 2024). 7 Case 1:19-vv-00070-CFL Document 143 Filed 03/29/24 Page 8 of 35 Petitioner presented for an updated hearing test on April 11, 2018. Pet. Ex. 52 at 4-7. Petitioner was going to a specialist in New York City the following day and the doctor requested an updated audiogram. Id. at 5. The notes stated “[history] of sudden hearing loss [] which [Petitioner] attribute[d] to [DTaP] vaccine, hearing loss happened [one and one half] days post vaccine.” Id.; see also Pet. Ex. 1 at 24 (ECF No. 8-1). The following day, on April 12, Petitioner saw Dr. Selesnick at Weill Cornell Otolaryngology Head and Neck Surgery. Pet. Ex. 1 at 26 (ECF No. 8-1). Notes indicated Petitioner received the DTaP vaccine in June 2017 and “[w]ithin 36 hours, [Petitioner] had a [three] hour episode of tremors and then awoke with sudden left-sided hearing loss and tinnitus.” Id. Dr. Slesnick documented that Petitioner “was treated with oral steroids without benefit. [Petitioner] was offered intratympanic steroid in the past but was told that it would not likely be of help, since it was being suggested at an extended time after the event.” Id. Petitioner denied “other inciting events such as loud noises, head trauma[,] or upper respiratory infections.” Id. Dr. Selesnick noted a family history of ear disease in that Petitioner’s daughter had an acoustic neuroma but that all other otologic history was negative. Id. at 27. Dr. Selesnick noted Petitioner’s history of hypertension, and antihypertensive medication. Id. Cranial nerves II through VII were “grossly intact with the exception of the left VIII[] cranial nerve.” Id. On examination, Petitioner’s “ability to communicate [was] limited by her hearing loss.” Pet. Ex. 1 at 27 (ECF No. 8-1). There was no evidence of gaze nystagmus,17 ataxia,18 dysdiadochokinesia,19 or tremor. Id. Dr. Selesnick noted Petitioner’s brain MRI was normal. Id. A review of audiograms from June 29, 2017, July 18, 2017, and April 11, 2018, showed “stable low and mid frequency severe left sided [SNHL].” Id. Dr. Selesnick found the laboratory testing from July 2017 “noncontributory.” Id. The impression was that Petitioner suffered “sudden left-sided [SNHL].” Id. Dr. Selesnick wrote that “[d]ue to the close time proximity of the administration of the vaccine, it is likely that the vaccine is at least in some way 17 Gaze nystagmus is “nystagmus made apparent by looking to the right or to the left.” Gaze Nystagmus, Dorland’s Med. Dictionary Online, https://www.dorlandsonline.com/dorland/ definition?id=94215 (last visited Feb. 20, 2024). Nystagmus is “an involuntary, rapid, rhythmic movement of the eyeball, which may be horizontal, vertical, rotatory, or mixed, i.e., of two varieties.” Nystagmus, Dorland’s Med. Dictionary Online, https://www.dorlandsonline.com /dorland/definition?id=34565 (last visited Feb. 20, 2024). 18 Ataxia is “failure of muscular coordination; irregularity of muscular action.” Ataxia, Dorland’s Med. Dictionary Online, https://www.dorlandsonline.com/dorland/definition?id=4630 (last visited Feb. 20, 2024). 19 Dysdiadochokinesia is “a dyskinesia consisting of impaired ability to perform the rapid alternating movements of diadochokinesia.” Dysdiadochokinesia, Dorland’s Med. Dictionary Online, https://www.dorlandsonline.com/dorland/definition?id=15173 (last visited Feb. 20, 2024). Diadochokinesia is “the function of arresting one motor impulse and substituting for it one that is diametrically opposite, to permit sequential alternating movements, as pronation and supination of the arm.” Diadochokinesia, Dorland’s Med. Dictionary Online, https://www.dorlandsonline.com/dorland/definition?id=13720 (last visited Feb. 20, 2024). 8 Case 1:19-vv-00070-CFL Document 143 Filed 03/29/24 Page 9 of 35 responsible for [Petitioner’s] [SNHL].” Id. Dr. Selesnick concluded that Petitioner was a candidate for a hearing aid. Id. Petitioner returned to her PCP, Dr. Shariati, on September 20, 2018 for a routine physical examination. Pet. Ex. 3 at 1. Dr. Shariati noted that “unfortunately, [Petitioner] stopped taking her blood pressure medication.” Id. Review of symptoms noted Petitioner had no hearing on the left side and constant tinnitus. Id. Audiometry at 25 dB was normal on Petitioner’s right ear but there was “no hearing on the left side.” Id. at 2. The impression was “[s]ignificant hearing loss on the left side associated with tinnitus probably secondary to administration of vaccine [DTaP].” Id. On April 16, 2019, Petitioner returned to Dr. Selesnick for a follow-up visit. Pet. Ex. 2 at 1. Petitioner reported ongoing complaints of tinnitus, which was having a significant effect on her ability to communicate and sleep. Id. at 2. Various treatment options were discussed. Id. Instead of medications and surgeries, which would unlikely suppress the tinnitus, Dr. Selesnick advised Petitioner that she was a candidate for a hearing aid that could suppress the tinnitus. Id. Tinnitus retraining therapy and cognitive behavioral therapy by an audiologist were also suggested. Id. On May 20, 2019, Petitioner presented to Dr. Shariati complaining of “pounding headache, significant hearing loss, and significant ringing in her left ear.” Pet. Ex. 1, ECF No. 67-5 at 2. Dr. Shariati documented that Petitioner “ha[d] major hearing loss in her left ear and ringing that was contributed from the [DTaP] vaccination that she received on [June 18, 2017]. . . . She was seen for a second opinion in New York City and nothing was identified.” Id. No other relevant medical records were filed. 3. Letters from Dr. Shariati On April 13, 2018, Dr. Shariati authored a letter on behalf of Petitioner, stating that Petitioner presented to his office on June 20, 2017 and received the DTaP vaccination two days earlier. Pet. Ex. 1 at 29 (ECF No. 8-1). He stated Petitioner complained of “stiffness in her muscles, along with chills and congestion in her ears.” Id. Petitioner indicated “that her fever and chills were somewhat better but she was concerned about the possibility of reaction to the vaccine.” Id. “At the time of the examination, [Petitioner] was complaining of significant hearing loss and feeling as though she was in a tunnel.” Id. Dr. Shariati concluded that “based on these observations, it is reasonable to assume that she in fact did have a reaction to the DTaP vaccination.” Id. On July 29, 2021, Dr. Shariati authored a second letter addressing the entry in his medical records stating that Petitioner’s current medication included Bactrim and Cipro. See Pet. Ex. 62 at 2; Pet. Ex. 1 at 2 (ECF No. 8-1). In the letter, Dr. Shariati wrote that Petitioner “was not on antibiotics at the time she received the DTaP vaccine.” Pet. Ex. 62 at 1. 9 Case 1:19-vv-00070-CFL Document 143 Filed 03/29/24 Page 10 of 35 4. Petitioner’s Declarations Petitioner filed two declarations dated January 7, 2018 and July 30, 2021. Pet. Ex. 6; ECF No. 93-1. Prior to June 18, 2017, Petitioner had no medical conditions besides hypertension. Pet. Ex. 6 at ¶ 1. On Sunday, June 18, 2017, Petitioner received a DTaP vaccination because she wanted to visit her newborn grandchild. ECF No. 93-1 at ¶ 3. At the time of vaccination, she was well; she did not have a cold, she did not have any signs of illness, and she was not on any antibiotics. Id. at ¶¶ 2-3. “That evening, [Petitioner] noticed soreness at the injection site. The following night, about 1 A.M on June 19, 2017, [Petitioner] began to experience full body tremors, chills, aches[,] and stiffness which lasted approximately two and a half hours.” Pet. Ex. 6 at ¶ 3. The next morning, Petitioner experienced “the loss of hearing in [her] left ear.” Id. at ¶ 4. By the next day, June 20, “the loss of hearing in [her] left ear was nearly total and [she] began to experience tinnitus.” Id. at ¶ 5. On June 20, 2017, Petitioner presented to Dr. Shariati and explained “on the evening of the 19th/early morning hours of the 20th [she] experienced approximately [three] hours of full body tremors and awoke with noticeable loss of hearing on [her] left side.” ECF No. 93-1 at ¶ 4. She recalled it initially sounded like she was “listening to a sea shell or wind tunnel but soon after, the noise became the loud roaring Tinnitus which continue[d].” Id. At this visit, Petitioner was advised that these conditions “were a reaction to the DTaP vaccination [she] had received, i.e. an adverse reaction to that DTaP vaccination.” Pet. Ex. 6 at ¶ 6. Petitioner wrote that she went to two additional specialists who confirmed her hearing loss “and one stated that the cause of [her] condition was a reaction to the vaccine. The other stated he could not determine any cause.” Pet. Ex. 6 at ¶ 7. Petitioner concluded that she was advised by Dr. Shariati and Dr. Selsenick that her condition “is more likely than not the result of an adverse effect of the DTaP vaccination [she] received on June 18, 2017.” Id. at ¶ 9. On July 29, 2021, Petitioner spoke with Dr. Shariati about the notes from her visit with him on June 20, 2017. ECF No. 93-1 at ¶ 1. She asked about the antibiotics listed as her current medications at that visit. Id. Dr. Shariati informed Petitioner “that the ‘current’ list [was] of all the drugs [she] had been prescribed in the entire time [she] had been seeing him which was approximately 25 years. That particular note was not indicative of the medication [she] was taking at the time of the visit.” Id. Petitioner further declared that “there is no doubt in [her] mind that when [she] got the DTaP vaccination [she] had not had a cold or any other condition which would have called for the use of antibiotics.” ECF No. 93-1 at ¶ 2. In late March of 2017, she was prescribed a ten- day course of an antibiotics from an urgent care for cold-like symptoms, which she took and finished by April 1 or April 2, 2017. Id. She “was not prescribed Bactrim, or Cipro, at any time within years of the vaccination.” Id. at ¶ 5. Petitioner had “been on and off” her hypertension medication (lisinopril) “for some time,” and the Lo Loestrin was prescribed for menopause symptoms but she “took it only for a few weeks apparently in 2012.” Id. 10 Case 1:19-vv-00070-CFL Document 143 Filed 03/29/24 Page 11 of 35 C. Expert Reports 1. Petitioner’s Expert, Dr. Arthur E. Brawer20 a. Background and Qualifications Dr. Brawer is a rheumatologist, or “arthritis specialist,” who received his M.D. from Boston University School of Medicine. Pet. Ex. 55 at 1. He is board-certified in internal medicine and rheumatology. Id. at 3. Since 1976, Dr. Brawer has maintained a rheumatology private practice and served as the Director of Rheumatology and Director of the Arthritis Clinic at Monmouth Medical Center, Long Branch, New Jersey. Id. at 1, 3. As of 2018, he was also an attending physician at Monmouth Medical Center. Id. at 3. Previously, he was also an Assistant Clinical Professor of Medicine at Robert Wood Johnson Medical School, New Brunswick, New Jersey, and an Associate Clinical Professor of Medicine at Drexel College of Medicine, Philadelphia, Pennsylvania. Id. at 1, 4. Dr. Brawer has authored or co-authored numerous publications. Id. at 4-7. His “research interests and peer reviewed publications encompass new arthritis conditions, new arthritis treatments, alternative medicine, . . . fibromyalgia, physical trauma and arthritis, [and] vaccine-induced autoimmunity.” Id. at 1. A review of his curriculum vitae does not indicate that Dr. Brawer has any training, education, or experience in the diagnosis or treatment of hearing loss or hearing disorders. Pet. Ex. 55. Additionally, there is no indication he has training, education, or experience in immunology. See id. b. Opinion Dr. Brawer opined Petitioner has “permanent [SNHL] in her left ear as a direct consequence of the [DTaP] vaccination she received on June 18, 2017.” Pet. Ex. 10 at 2. He also opined the “unremitting, intractable tinnitus” Petitioner suffers is a direct result of the DTaP vaccination. Id. i. Althen Prong One Dr. Brawer did not offer a specific opinion about the mechanism or mechanisms by which the DTaP vaccination can cause SNHL. Instead, he provided a list of mechanisms generally associated with autoimmune disorders, focusing on the theory of molecular mimicry. Pet. Ex. 10 at 3-4. In his first expert report, Dr. Brawer provided a paragraph with an overview of different mechanisms that have been described in the literature for how vaccinations generally can cause autoimmune disorders. Pet. Ex. 10 at 3-4. In part, these included molecular mimicry, polyclonal B cell activation, bystander activation, adjuvants (such as aluminum), “modification of surface antigens, induction of novel antigens, and exposure of sequestered antigens.” Id. at 4-5. He suggested that research will continue to reveal the “relative contributions of each of these 20 Petitioner filed two expert reports from Dr. Brawer. Pet. Exs. 10, 50. 11 Case 1:19-vv-00070-CFL Document 143 Filed 03/29/24 Page 12 of 35 mechanisms.” Id. at 5. Other than molecular mimicry, Dr. Brawer did not describe the enumerated theories. And he did not appear to commit to any of the theories he identified as the mechanism whereby the DTaP vaccination can cause SNHL, although he spent more time discussing molecular mimicry than the others. See id. at 3-4. Regarding molecular mimicry, he briefly summarized its history and stated “[i]t has been known for well over 20 years that there exists a cross reactivity between routinely used vaccine materials and self-antigens in the body.” Pet. Ex. 10 at 3. He cited two examples of molecular mimicry from Kanduc and Shoenfeld,21 related to hepatitis B virus antigens and human papilloma virus antigens that share amino acid sequences with human proteins. Id. (citing Pet. Ex. 21). However, the Kanduc and Shoenfeld study did not examine amino acids sequences in the DTaP vaccine or offer theories relative to SNHL caused by vaccines. Thus, while the paper generally supports the theory of molecular mimicry, it does not provide evidence that molecular mimicry plays a role in causing hearing loss after a DTaP vaccination. Another paper cited by Dr. Brawer, Sutjita et al.,22 showed cross-reactivity between epitopes in tetanus and diphtheria toxoid vaccines and self-antigens. Pet. Ex. 22 at 1, 7. Notably, the authors urged caution “in assessing the significance of the reactivities of monoclonal antibodies derived from humans” because this finding “do[es] not necessarily reflect on the propensity of an individual to develop autoimmune disease.” Id. at 5-6. Further, they explained that antibodies from patients with autoimmune disease “may not be necessarily related to the pathogenic autoantibodies found [in] their serum.” Id. at 5-6. Further, the study did not identify a mechanism by which the DTaP vaccine can cause an autoimmune disorder and SNHL was not discussed. After generally identifying mechanisms implicated in autoimmune disorders, Dr. Brawer purported to cite publications “attesting to vaccination induced [SNHL]” caused by “damage . . . to the cochlear hair cells in the inner ear and/or damage to the hearing nerves themselves.” Pet. Ex. 10 at 2-3. The first of these articles was by De Marco et al.,23 who reported a case of a 33- year-old male who had sudden hearing loss after receiving tetanus and diphtheria and meningococcal vaccinations. Pet. Ex. 11 at 1. The patient improved following treatment with Bentelan (a steroid) and hearing testing at six months showed functional recovery on low and medium frequencies. Id. at 2. While the authors proposed that the temporal association to vaccination suggested an adverse reaction, they concluded that the “cause of [their] patient’s [] hearing loss remain[ed] unknown” despite investigations by different specialties. Id. While they described possible explanations for how nerve damage could occur, they surmised that the hearing loss was possible due to “toxic-autoimmune damage of nerve cells” caused by “central 21 Darja Kanduc & Yehuda Shoenfeld, From HBV to HPV: Designing Vaccines for Extensive and Intensive Vaccination Campaigns Worldwide, 15 Autoimmunity Revs. 1054 (2016). 22 M. Sutjita et al., Polyspecific Human and Murine Antibodies to Diphtheria and Tetanus Toxoids and Phospholipids, 73 Clinical & Experimental Immunology 191 (1988). 23 Federica De Marco et al., Post Vaccinal Temporary Sensorineural Hearing Loss, 15 Int’l J. Env’t Rsch. & Pub. Health 1780 (2018). 12 Case 1:19-vv-00070-CFL Document 143 Filed 03/29/24 Page 13 of 35 nervous system sensitization, probably established during previous vaccinations.” Id. at 3. Dr. Brawer did not offer the mechanism of prior sensitization here, and there are no facts presented to support such a mechanism. The other case reports cited by Dr. Brawer do not involve the DTaP vaccine.24 See, e.g., Pet. Ex. 14 (describing a 79-year-old woman who developed bilateral deafness two days after a flu vaccine and hearing loss did not improve with steroids);25 Pet. Ex. 15 (describing a 42-year- old man who developed unilateral SNHL and tinnitus after a series of hepatitis B vaccinations, and who had no improvement with steroids, but had gradual improvement over time);26 Pet. Ex. 16 (describing a 27-year-old woman who developed bilateral hearing loss 22 days after a measles-rubella vaccine, and a trial of steroids did not improve hearing);27 Pet. Ex. 17 (describing a 17-year-old girl who developed bilateral hearing loss 14 hours after H1N1 vaccination, where hearing improved after steroid therapy).28 Although causal mechanisms were discussed in several of these case reports, none of them identified molecular mimicry as an accepted theory. And steroid therapy was only successful in one case, suggesting that autoinflammatory or immune-mediated mechanisms may not have been at play in the other cases. See Pet. Ex. 17 at 1. Further, Dr. Brawer did not explain why case reports involving other vaccines would be relevant or persuasive evidence of vaccine causation as it relates to any of his proffered mechanisms, including molecular mimicry. Other articles cited by Dr. Brawer do not support vaccine causation. For example, he cited a paper by Karussis and Petrou29 about post-vaccination central nervous system demyelinating syndromes such as optic neuritis30 and acute demyelinating encephalomyelitis 24 Petitioner’s other expert, Dr. Kinsbourne, also discussed some of these reports, and if so, the cases are discussed below in Dr. Kinsbourne’s section. 25 Claudia Kolarov et al., Bilateral Deafness Two Days Following Influenza Vaccination: A Case Report, 15 Hum. Vaccines & Immunotherapeutics 107 (2018). 26 B. Biacabe et al., A Case Report of Fluctuant Sensorineural Hearing Loss After Hepatitis B Vaccination, 24 Auris Nasus Larynx 357 (1997). 27 Tim. V. Hulbert et al., Bilateral Hearing Loss After Measles and Rubella Vaccination in an Adult, 325 New Eng. J. Med. 134 (1991). 28 Hsueh-Hsin Huang et al., Bilateral Sudden Deafness Following H1N1 Vaccination, 143 Otolaryngology Head & Neck Surgery 849 (2010). 29 Dimitrios Karussis & Panayiota Petrou, The Spectrum of Post-Vaccination Inflammatory CNS Demyelinating Syndromes, 13 Autoimmunity Revs. 215 (2014). 30 Optic neuritis is “inflammation of the optic nerve; it is classified as either [] affecting the part of the nerve within the eyeball . . . or [] affecting the portion behind the eyeball.” Optic Neuritis, Dorland’s Med. Dictionary Online, https://www.dorlandsonline.com/dorland/definition? id=92519 (last visited Jan. 23, 2024). 13 Case 1:19-vv-00070-CFL Document 143 Filed 03/29/24 Page 14 of 35 (“ADEM”). Pet. Ex. 35 at 1. However, Dr. Brawer offered no evidence that SNHL is a demyelinating disorder of the central nervous system following the DTaP vaccination. Dr. Brawer also cited Cabrera-Maqueda et al.,31 which discussed two case reports of pregnant women who developed unilateral optic neuritis three weeks after tetanus-diphtheria-acellular pertussis (“Tdap”) vaccination. Pet. Ex. 20 at 1. Both women had a complete recovery. Id. However, the authors assessed the causal association as “indeterminate” because there was no laboratory test that implicated vaccine causation.32 Id. at 2. Moreover, the article did not discuss hearing loss or tinnitus and Dr. Brawer did not explain its relevance. Dr. Brawer also cited articles about optic neuritis, Guillain-Barré syndrome (“GBS”), acute hemolytic anemia, rheumatoid arthritis, systemic lupus erythematosus, connective tissue disease, fatigue syndromes, channelopathies, breast implants, and rheumatologic disorders. Pet. Ex. 10 at 4. But these disorders are not at issue and Dr. Brawer did not explain why papers about other disorders, many of which have been proven to be autoimmune in nature, provide persuasive evidence of causation here. See, e.g., Pet. Ex. 32 (describing a seven-month-old who developed acute transverse myelitis (“TM”) after diphtheria-tetanus-pertussis immunization);33 Pet. Ex. 33 (describing three patients who developed systemic lupus erythematosus (“SLE”), polymyalgia rheumatica (“PMR”), and rheumatoid arthritis following flu vaccinations);34 Pet. Ex. 34a (describing two women who developed optic neuritis after varicella zoster vaccinations and both completely recovered after treatment with steroids);35 Pet. Ex. 37 (describing a patient who developed GBS after vaccination with tetanus toxoid);36 Pet. Ex. 41 at 1 (describing two females who developed rheumatoid arthritis and one female who developed SLE “in close proximity” to flu vaccinations);37 Pet. Ex. 42 (finding that vaccinations are associated with an 31 Jose M. Cabrera-Maqueda et al., Optic Neuritis in Pregnancy After Tdap Vaccination: Report of Two Cases, 160 Clinical Neurology & Neurosurgery 116 (2017). 32 In Cabrera-Maqueda et al., the authors used the Halsey et al. algorithm to assess causation. Pet. Ex. 20 at 2 (citing Neal A. Halsey et al., Algorithm to Assess Causality After Individual Adverse Events Following Immunizations, 30 Vaccine 5791 (2016)). This article was not filed. 33 RMS Riel-Romero, Acute Transverse Myelitis in a 7-Month-Old Boy After Diphtheria- Tetanus-Pertussis Immunization, 44 Spinal Cord 688 (2006). 34 M.A. Brown & J.V. Bertouch, Rheumatic Complications of Influenza Vaccination, 24 Austl. N.Z. J. Med. 572 (1994). 35 Sang Beom Han et al., Optic Neuritis Following Varicella Zoster Vaccination: Report of Two Cases, 32 Vaccine 4881 (2014). 36 Norris Newton, Jr. & Abdorassol Janati, Guillain-Barré Syndrome After Vaccination with Purified Tetanus Toxoid, 80 S. Med. J. 1053 (1987). 37 Arthur E. Brawer & Sai Koyoda, The Onset of Rheumatoid Arthritis and Systemic Lupus Erythematosus Following Influenza Vaccination: Reports of Three Cases, 4 Clinical Microbiology & Infectious Diseases (2019). This is also cited as Pet. Ex. 54. 14 Case 1:19-vv-00070-CFL Document 143 Filed 03/29/24 Page 15 of 35 increased risk of SLE and rheumatoid arthritis);38 Pet. Ex. 43 (finding a temporal association between the hepatitis B vaccine and 10 cases of SLE);39 Pet. Ex. 44 at 1 (reviewing five patients who developed SLE after immunization and finding it “immunologically plausible” that vaccination can trigger autoimmunity in rare cases);40 Pet. Ex. 51 (discussing novel mechanisms for vaccine-induced diseases);41 Pet. Ex. 52a (discussing the diversity of rheumatologic diseases that may arise following vaccination);42 Pet. Ex. 53 (describing a 21-year-old female who developed a “multisystem illness” or “[human papillomavirus (“HPV”)] vaccine-induced illness” after receiving the HPV vaccines and discussing the components of the vaccine).43 He also cited research papers and papers about specific theories, tetanus toxoid, or other matters, but the subject matter results of the studies discussed are either collateral to the issues here or irrelevant, and again, Dr. Brawer did not explain their relevance.44 See, e.g., Pet. Ex. 24 (describing the induced immune response from tetanus toxoid and cross-reactivity with self- 38 Bin Wang et al., Vaccinations and Risk of Systemic Lupus Erythematosus and Rheumatoid Arthritis: A Systematic Review and Meta-Analysis, 16 Autoimmunity Revs. 756 (2017). 39 N. Agmon-Levin et al., Ten Cases of Systemic Lupus Erythematosus Related to Hepatitis B Vaccine, 18 Lupus 1192 (2009). 40 Steven A. Older et al., Can Immunization Precipitate Connective Tissue Disease? Report of Five Cases of Systemic Lupus Erythematosus and Review of the Literature, 29 Seminars Arthritis & Rheumatism 131 (1999). 41 Arthur E. Brawer, Vaccination Induced Disease and Their Relationship to Neurologic Fatiguing Syndromes, Channelopathies, Breast Implant Illness, and Autoimmunity via Molecular Mimicry, 4 Int’l J. Vaccines & Immunization (2020). 42 Arthur E. Brawer, Why Are Vaccination Induced Rheumatologic Disorders So Diverse?, 4 J. Med. Clinical Rsch. & Revs. (2020). 43 Arthur E. Brawer, Hidden Toxicity of Human Papillomavirus Vaccine Ingredients, 5 J. Rheumatic Diseases & Treatment (2019). 44 Dr. Brewer also referenced case numbers for two other Vaccine Program hearing loss cases: Case Number 14-916V, involving the flu vaccine where Petitioner also sustained ADEM, and Case Number 13-916V, involving the MMR vaccine. Pet. Ex. 10 at 2; see Haworth v. Sec’y of Health & Hum. Servs., No. 14-916V, 2015 WL 10436103 (Fed. Cl. Spec. Mstr. Oct. 15, 2015); Bosco v. Sec’y of Health & Hum. Servs., No. 13-916V, 2014 WL 6606561 (Fed. Cl. Spec. Mstr. Oct. 22, 2014). Neither case involved the DTaP vaccination, and Dr. Brawer did not explain their relevance. Further, there is no reasoned decision in either case as both of these matters resolved by stipulation and there was no finding as to whether those Petitioners proved vaccine causation by preponderant evidence. 15 Case 1:19-vv-00070-CFL Document 143 Filed 03/29/24 Page 16 of 35 antigens);45 Pet. Ex. 25 (testing bystander activation of non-vaccine specific CD4+T cells);46 Pet. Ex. 28 (arguing to teach physicians to use a mix of methodologic and biologic reasoning in medicine );47 Pet. Ex. 29 (editorial discussing problems with the application of evidence based medicine in rheumatology).48 ii. Althen Prongs Two and Three Dr. Brawer opined “based on a reasonable degree of medical certainty, that the [DTaP] vaccination received by [Petitioner] on June 18, 2017 was the direct cause of her [SNHL] and chronic tinnitus.” Pet. Ex. 10 at 3. He offered three reasons for his opinion. First, Dr. Brawer opined Petitioner did not “manifest any chronic nor recurrent hearing impairment,” nor “suffer from any systemic neurological, rheumatological, or otolaryngological condition prior to the administration of the [DTaP] vaccination on June 18, 2017.” Pet. Ex. 10 at 3, 5. He stated Petitioner was in “her usual state of good health” until the date of vaccination and there were “no prior ear problems of any kind.” Id. at 1-2. Second, he explained that based on the medical records, Petitioner’s condition began within 36 to 48 hours following the DTaP vaccination on June 18, 2017. Pet. Ex. 10 at 5. On that date, Petitioner received the DTaP vaccine and within 36 hours, Petitioner “developed transient self-limited myalgias and chills, followed nearly immediately (within hours) by sudden hearing loss in her left ear, accompanied by tinnitus.” Id. at 1. Accordingly, Dr. Brawer opined there is a temporal relationship connecting Petitioner’s DTaP vaccination to her development of SNHL and tinnitus. Id. And third, Dr. Brawer asserted that Petitioner’s SNHL and tinnitus “cannot be attributed to any other well-defined and well-known causes that can trigger such phenomena.” Pet. Ex. 10 at 5; see also Pet. Ex. 50 at 1 (opining the DTaP vaccine “is the only substantial factor that brought about [Petitioner’s] injury” and “there is no other ‘agent’ that was the actual cause of her injury”). Petitioner underwent “comprehensive evaluations” and was examined by Dr. Brawer on October 23, 2019. Pet. Ex. 10 at 1. Dr. Brawer opined the assessments “clearly excluded a multiple of other potential causes for [Petitioner’s] hearing loss.” Id. at 1-2. Dr. Brawer listed some of the potential causes that were excluded including autoimmune disease, physical trauma 45 Marijana Stojanovic et al., Role of Molecular Mimicry and Polyclonal Cell Activation in the Induction of Pathogenic β2-Glycoprotein I-Directed Immune Response in Balb/c Mice upon Hyperimmunization with Tetanus Toxoid, 56 Immunologic Rsch. 20 (2013). 46 Susan van Aalst et al., Bystander Activation of Irrelevant CD4+T Cells Following Antigen- Specific Vaccination Occurs in the Presence and Absence of Adjuvant, 12 PLoS ONE e0177365 (2017). 47 Jan P. Vandenbroucke, Observational Research and Evidence-Based Medicine: What Should We Teach Young Physicians?, 51 J. Clinical Epidemiology 467 (1998). 48 Paul Dieppe & Béla Szebenyi, Evidence Based Rheumatology, 27 J. Rheumatology 4 (2000). 16 Case 1:19-vv-00070-CFL Document 143 Filed 03/29/24 Page 17 of 35 or rupture to the ear, vascular disease, aging, excessive noise, medications, and upper or lower respiratory infections. Id. at 2. Although Dr. Brewer opined generally that medications were not an alternative cause of Petitioner’s hearing loss, he did not address the fact that the medical records documented that Petitioner was taking antibiotics on the date of vaccination. Pet. Ex. 10 at 1-2, 5; see also Pet. Ex. 50 at 1. In conclusion, Dr. Brawer opined “were it not for the [DTaP] vaccination of June 18, 2017, [Petitioner] would not now be suffering from [SNHL] and tinnitus.” Pet. Ex. 10 at 5. 2. Petitioner’s Expert, Dr. Marcel Kinsbourne49 a. Background and Qualifications Dr. Kinsbourne’s prior career focused on pediatric neurology. See Pet. Ex. 170. There is no indication that Dr. Kinsbourne specializes in otolaryngology. And he agreed that he is not an immunologist and he specifically deferred to Dr. Brawer “on technical issues in immunology.” Pet. Ex. 163 at 1. In 1955, Dr. Kinsbourne obtained his B.M., B.Ch. from Oxford University Medical School, and he completed postdoctoral training through 1964 in the United Kingdom. Pet. Ex. 170 at 1. Thereafter, he obtained board certification and licensing in the United States and Canada and worked as a professor at various teaching institutions. Id. at 2-3. Dr. Kinsbourne has served and is currently serving on a number of editorial boards. Id. at 4-5. He has authored or co-authored more than 400 publications. Id. at 6-39. Dr. Kinsbourne is no longer a practicing physician. Pet. Ex. 170 at 2-3. He has not treated patients in a clinical setting since the 1990s. Id. at 3. b. Opinion i. Althen Prong One At the outset, Dr. Kinsbourne explained that there are many causes of SNHL. Pet. Ex. 163 at 2. “[V]iral infections, genetic mutations, trauma, toxic agents, neoplastic diseases, vascular damage, and immune mechanisms” can cause damage to the inner ear and can be “responsible for sudden [SNHL].” Pet. Ex. 163 at 2. But he also noted that sudden SNHL is sometimes considered to be autoimmune. Id. at 3, 5 (citing Pet. Ex. 163-7).50 49 Petitioner filed two expert reports from Dr. Kinsbourne. Pet. Exs. 163-64. 50 Bruno Almeida Antunes Rossini et al., Sudden Sensorineural Hearing Loss and Autoimmune Systemic Diseases, 21 Int’l Archives Otorhinolaryngology 213 (2017). 17 Case 1:19-vv-00070-CFL Document 143 Filed 03/29/24 Page 18 of 35 Dr. Kinsbourne stated he was not an immunologist and he deferred to Dr. Brawer “on technical issues of immunology.” Pet. Ex. 164 at 1. He did not offer an opinion as to a mechanism whereby the DTaP vaccine could cause SNHL. However, he cited several articles about autoimmunity and hearing loss. Li et al.51 explained that the “inner ear and brain” were “traditionally viewed as being immune privileged” due to the “blood-labyrinthine barrier,” which like the “blood-brain barrier,” is generally thought to be protective against autoimmune disorders. Pet. Ex. 163-4 at 1. According to the authors, the idea of autoimmune hearing loss emerged in 1979 when research by McCabe showed that some patients with hearing loss responded well to steroids. Id. The inner ear immune response described in Li et al. is quite complex and well beyond the scope of this Decision. As explained by Li et al., “the exact mechanism of pathogenesis” of SNHL “is not yet fully understood”52 and the pathogenesis of “the injury process remains unclear.” Id. at 3-4. An additional challenge is that the diagnosis of autoimmune hearing loss is difficult to make but immunosuppressive therapy generally results in a positive response, and thus, glucocorticoids are the first line of treatment for autoimmune disorders of the inner ear. Id. at 6. Notably, Li et al. did not discuss vaccinations as a possible cause for autoimmune hearing loss or identify any mechanism by which vaccinations could cause SNHL. Greco et al.53 also acknowledged that the “[]etiology and pathogenesis” of SNHL “remain unknown.” Pet. Ex. 163 at 2 (citing Pet. Ex. 163-3). The authors described several theories of causation, including “viral infections, vascular occlusion[,] and immune system- mediated mechanisms.” Pet. Ex. 163-3 at 1. They discussed the idea that systemic or distant viral infections may play a causal role, but concluded that further studies are necessary to “clarify the immunologic role of antibodies found in SNHL patients.” Id. at 4. The authors did not identify vaccines as a cause of immune mediated hearing loss or hypothesize that vaccines could serve as agents that trigger such an immune response. Regarding the mechanisms of systemic or distant infections discussed by Greco et al. according to Dr. Kinsbourne, it is rare to find evidence of such infection. Pet. Ex. 163 at 2. Thus, Dr. Kinsbourne appears to suggest that autoimmune reactions to these types of infections may be more likely. Id. (citing Pet. Ex. 163-3 at 2-4). He argued that vaccines are like infections in that they can invoke an immune response. Id. (citing Pet. Ex. 163-2 (describing 51 Guangfei Li et al., The Role of Autoimmunity in the Pathogenesis of Sudden Sensorineural Hearing Loss, 2018 Neural Plasticity 7691473. 52 For a more complete discussion of the various mechanisms of autoimmune SNHL that have been identified, see Pet. Ex. 163-4. 53 A. Greco et al., Sudden Sensorineural Hearing Loss: An Autoimmune Disease?, 10 Autoimmunity Revs. 756 (2011). 18 Case 1:19-vv-00070-CFL Document 143 Filed 03/29/24 Page 19 of 35 proinflammatory cytokine response after flu vaccination));54 see also Pet. Ex. 36 (describing how peripheral cytokines expressed after vaccination can cause neuroinflammation).55 Specific to vaccine-induced injury, Dr. Kinsbourne first noted that it is “well known that the [DTaP] vaccination can trigger immune overreactions, resulting in autoimmune syndromes, notably [GBS].” Pet. Ex. 163 at 5. But he did not explain how SNHL is like GBS. And he failed to show that SNHL is a demyelinating disease of the peripheral nerves like GBS. Next, Dr. Kinsbourne cited several case reports of vaccinations triggering SNHL. Okhovat et al.56 reported the case of a 33-year-old man who developed “profound sudden onset right-sided hearing loss with tinnitus and vertigo” within 24 hours of a rabies vaccination. Pet. Ex. 13 at 1. After two months, the tinnitus resolved and the patient’s hearing slightly improved. Id. at 2. The authors postulated a hypersensitivity reaction as the mechanism, not molecular mimicry. Id. at 1. They concluded that the mechanism for sudden SNHL after immunization remained unclear. Id. Stewart and Prabhu57 reported six children with SNHL after measles, mumps, and rubella (“MMR”) vaccinations in which the cause was unknown, but MMR remained a “possible” etiology. Pet. Ex. 12 at 1. Four of the six children had unilateral hearing loss. Id. at 1 tbl.1. The authors concluded that the risk of hearing loss after MMR vaccination was low and that the risk should be weighed against the risks of natural infection. Id. at 2. Like Dr. Brawer, Dr. Kinsbourne also cited De Marco et al. See Pet. Ex. 163 at 3; Pet. Ex. 11. The DTaP vaccine was not at issue in these case reports. Finally, Dr. Kinsbourne cited the Baxter et al.58 study, a large case-centered analysis using Kaiser Permanente North California databases of over 3.5 million patients to research the association between vaccinations and sudden SNHL. Pet. Ex. 163 at 3 (citing Pet. Ex. 163-1); 54 Lisa M. Christian, Proinflammatory Cytokine Responses Correspond with Subjective Side Effects after Influenza Virus Vaccination, 33 Vaccine 3360 (2015). 55 G. Giannotta & N. Giannotta, Vaccines and Neuroinflammation, 3 Int. J Public Health & Safety 163 (2018). 56 Saleh Okhovat et al., Sudden Onset Unilateral Sensorineural Hearing Loss After Rabies Vaccination, 2015 BMJ Case Reps. 1. 57 Barbara J.A. Stewart & P. Umesh Prabhu, Reports of Sensorineural Deafness After Measles, Mumps, and Rubella Immunisation, 69 Archives Disease Childhood 153 (1993). 58 Roger Baxter et al., Sudden-Onset Sensorineural Hearing Loss After Immunization: A Case- Centered Analysis, 155 Otolaryngology Head & Neck Surgery 81 (2016). 19 Case 1:19-vv-00070-CFL Document 143 Filed 03/29/24 Page 20 of 35 see also Pet. Ex. 163-5 at 7 (discussing the Baxter et al. study).59 The study found no “statistically significant” association between the DTaP vaccine, or any vaccine, and the onset of sudden SNHL. Pet. Ex. 163 at 4 (citing Pet. Ex. 163-1 at 1, 5). Dr. Kinsbourne acknowledged the results of the Baxter et al. study but asserted that epidemiological studies “are rarely powerful [enough] to detect rare events.” Pet. Ex. 164 at 3-4. ii. Althen Prongs Two and Three Dr. Kinsbourne opined that “the [DTaP] vaccination triggered an immune attack on [Petitioner’s] left inner ear, resulting in . . . abrupt onset of unilateral sudden hearing loss two days after [] [DTaP] vaccination.” Pet. Ex. 163 at 5. Dr. Kinsbourne assumed that Petitioner’s hearing loss was due to autoimmunity because he asserted there was no evidence of another cause to explain her hearing loss, “other than the close temporal relationship to the [DTaP] vaccination, which suggests an immune mechanism.” Pet. Ex. 163 at 2. Dr. Kinsbourne opined “[w]hich of the several known mechanisms of autoimmunity is operative in an individual case is of no clinical significance because the same treatments apply to them all. . . . The key clinical issue for treatment is whether the injury was immune or not.” Pet. Ex. 164 at 2. Specifically, Dr. Kinsbourne reasoned that “[i]n the absence of associated syndromes . . . or evidence of structural damage, it is very likely [Petitioner] was a victim of an isolated autoimmune attack.” Pet. Ex. 163 at 2. He stated Petitioner was “in good health” on June 18, 2017, when she received the DTaP vaccination. Id. at 1. “Thirty-six hours after the [DTaP] vaccination[,] [Petitioner] began to have muscle pains, chills, and a feeling of congestion in her left ear.” Id. Dr. Kinsbourne attributed these symptoms to “a robust flow of proinflammatory cytokines post vaccination.” Id. at 4. He did not offer any explanation or discuss any causal role related to the post vaccination “proinflammatory cytokines.” Dr. Kinsbourne noted Petitioner’s laboratory testing was unrevealing and there was no evidence of infection. Pet. Ex. 163 at 1-2. However, he conceded that the “presence of antibodies was not investigated” which might support one of the mechanisms of causation discussed in the literature cited. Id. at 2. Next, Dr. Kinsbourne relied on Petitioner’s treatment with steroids to further support his position. He stated that “the treating physician attempted the use of an oral steroid at the onset, implying that he regarded [Petitioner’s] hearing loss as autoimmune-mediated.” Pet. Ex. 163 at 2. According to Dr. Kinsbourne, “[t]he clinician would not have ventured to use a steroid if there was any chance that the left inner ear had been invaded by an infectious organism, in which case the use of steroids is contraindicated.” Id. at 4. In contrast, Dr. Kinsbourne offered that “treatment with steroids would be appropriate if the mechanism of injury were autoimmune.” Id. 59 Yi-Chun Carol Liu et al., Sensorineural Hearing Loss (SNHL) as an Adverse Event Following Immunization (AEFI): Case Definition & Guidelines for Data Collection, Analysis, and Presentation of Immunization Safety Data, 38 Vaccine 4717 (2020). 20 Case 1:19-vv-00070-CFL Document 143 Filed 03/29/24 Page 21 of 35 at 5. However, Dr. Kinsbourne acknowledged “[o]ral steroids conveyed no benefit” to Petitioner here. Id. at 1-2. Lastly, Dr. Kinsbourne opined there were no known risk factors of SNHL or other potential alternate causes for Petitioner’s hearing loss in the evidence. Pet. Ex. 163 at 5. Dr. Kinsbourne disagreed that the antibiotics, specifically Cipro and Bactrim, caused Petitioner’s hearing loss, because he argued that the effect would have been gradual and not sudden. Id. at 4. Moreover, he noted that Petitioner’s PCP explained that Petitioner was not taking these medications at the time of vaccination. Id. In summary, Dr. Kinsbourne opined Petitioner’s sudden onset of unilateral hearing loss was “more likely than not” caused by the DTaP vaccination because (1) she had no known risk factors, (2) SNHL is “sometimes . . . autoimmune,” (3) “[a]utoimmune [sudden SNHL] is indistinguishable from [sudden SNHL] that occurs in isolation,” and (4) it “occurred within two days of a [DTaP] vaccination.” Pet. Ex. 163 at 5. 3. Respondent’s Expert, Dr. Ross M. Kedl, Ph.D.60 a. Background and Qualifications Dr. Kedl is a Professor of Immunology in the Department of Immunology and Microbiology at the University of Colorado Denver. Resp. Ex. A at 1; Resp. Ex. B at 1. He received his Ph.D. in Pathobiology from the University of Minnesota. Resp. Ex. B at 1. Thereafter, he completed a postdoctoral fellowship at the National Jewish Medical and Research Center in Denver, Colorado, then spent three years as a senior immunologist at 3M Pharmaceuticals in their Immune Response Modifier Program. Resp. Ex. A at 1; Resp. Ex. B at 2. Since joining the University of Colorado in 2004, Dr. Kedl has maintained a National Institutes of Health (“NIH”) funded research program “centered on the biology of vaccine adjuvants and their capacity to induce robust and enduring cellular immunity.” Resp. Ex. A at 1. Dr. Kedl has authored or co-authored numerous publications in areas “focused on vaccine adjuvants and the mechanisms by which they induce adaptive (T and B cell) immunity.” Id.; see Resp. Ex. B at 12-20. Dr. Kedl is not a medical doctor and there is no indication he has specialized experience in otolaryngology. b. Opinion i. Althen Prong One Dr. Kedl opined that neither Dr. Brawer nor Dr. Kinsbourne provided evidence to support “a valid theory of causation.” Resp. Ex. C at 2. He referenced a paper by Mascola and Haynes61 that illustrates the complexity of immune pathways in disease development. Resp. Ex. A-5. 60 Respondent filed two expert reports from Dr. Kedl. Resp. Exs. A, C. 21 Case 1:19-vv-00070-CFL Document 143 Filed 03/29/24 Page 22 of 35 Regarding the focus on molecular mimicry, Dr. Kedl offered several observations62 to illustrate his point that a simple assertion of molecular mimicry as a causal theory, without consideration of the complexities involved, is insufficient to establish causation. See Resp. Ex. A at 4-5; Resp. Ex. C at 4-6. First, he explained that short sequence similarity between proteins is very common. Resp. Ex. A at 5. The finding of short sequences that are similar without more does not provide support for the mechanism. Id. He cited a study by Silvanovich et al.63 which showed that “short amino acid sequence matches of eight amino acids or fewer to identify proteins as potential cross-reactive allergens is a product of chance and adds little value to [] assessments for newly expressed proteins.” Resp. Ex. A-7 at 1. Even if short sequence similarity alone was proof of a causal theory, Dr. Kedl opined that Petitioner has not provided evidence of a “putative ear specific antigen” with “similarity to any of the antigens contained within the [DTaP] vaccine formulation.” Resp. Ex. C at 4; see also Resp. Ex. A at 4-5. Moreover, Petitioner has not gone the next step to show a “plausible path from a vaccine-specific antigen to its self-antigen ‘mimic.’” Resp. Ex. A at 5; Resp. Ex. C at 4. Further, Dr. Kedl opined that “detection of autoantigen cross reactivity” does not prove “autoimmune pathology.” Resp. Ex. A at 7. In support of this aspect of his opinion, Dr. Kedl cited several papers. Hurez et al.64 found “natural autoantibodies directed against a wide range of self-antigens [including tetanus toxoid] present in the serum of healthy individuals.” Resp. Ex. A-2 at 1. The authors suggested that autoantibodies are not necessarily indicators of disease, but instead may be a factor of the aging process. Id. at 1, 6; see also Resp. Ex. A-3 at 1 (finding autoreactive antibodies and B cells, as well as autoreactive T cells, “present in healthy individuals”).65 Moreover, “the stability of self-reactive antibody repertoires” were found in a study of five adult males over a period of 25 years. Resp. Ex. A-4 at 1.66 And a recent study cited by Dr. Kedl suggested that “cross reactivity with self-antigens may have more to do with intrinsic biochemical features of the [B cell receptors] [] rather than 61 John R. Mascola & Barton F. Haynes, HIV-1 Neutralizing Antibodies: Understanding Nature’s Pathways, 254 Immunological Revs. 225 (2013). 62 For Dr. Kedl’s full discussion of the reasons that Petitioner’s theory based on molecular mimicry fails, see Resp. Ex. A at 4-8. 63 Andre Silvanovich et al., The Value of Short Amino Acid Sequence Matches for Prediction of Protein Allergenicity, 90 Toxicological Scis. 252 (2006). 64 Vincent Hurez et al., Expression and Control of the Natural Autoreactive IgG Repertoire in Normal Human Serum, 23 Eur. J. Immunology 783 (1993). 65 Sébastien Lacroix-Desmazes et al., Self-Reactive Antibodies (Natural Autoantibodies) in Healthy Individuals, 216 J. Immunological Methods 117 (2016). 66 Sébastien Lacroix-Desmazes et al., Stability of Natural Self-Reactive Antibody Repertoires During Aging, 19 J. Clinical Immunology 26 (1999). 22 Case 1:19-vv-00070-CFL Document 143 Filed 03/29/24 Page 23 of 35 similarity between the self and foreign [antigens].” Resp. Ex. A-9 at 9.67 Overall, according to Dr. Kedl, the current knowledge about molecular mimicry establishes that “the simple detection of autoantigen cross reactivity is not an indication of autoimmune pathology.” Resp. Ex. A at 7. Next, Dr. Kedl explained the problems with using case studies over “research designed to investigate the actual causality of vaccine-related adverse events.” Resp. Ex. A at 3-4; see also Resp. Ex. C at 1-2. He opined that case studies are “not [] designed to investigate [] causality of vaccine-related adverse events,” and thus, they are less reliable than epidemiology studies designed to study the side effects of the DTaP vaccination. Resp. Ex. A at 3-4. Dr. Kedl observed that Petitioner did not provide “any scientifically reliable literature supporting a linkage between the [DTaP] vaccine and [] hearing loss.” Id. at 4. In summary, Dr. Kedl opined that Petitioner failed to offer evidence of a valid theory of causation, and regarding the focus on molecular mimicry, Petitioner “failed to lay out any logical course of events connecting [DTaP] antigens to ear-related antigens.” Resp. Ex. A at 8. ii. Althen Prongs Two and Three Dr. Kedl opined that Petitioner failed to provide evidence that her hearing loss was consistent with “an inflammatory or immune-related” event. Resp. Ex. C at 4. In support of his position that Petitioner’s hearing loss was not immune-mediated, Dr. Kedl noted that the Petitioner did not have a positive response to steroids. Resp. Ex. C at 4. According to Dr. Kedl, the “presupposition of an immune based mechanism is actively contradicted by [Petitioner’s] failure to respond to a treatment specifically used as a tool for the differential diagnosis of immune-mediated mechanisms of disease.” Id. More simply put, Petitioner’s failure to respond to steroids is evidence against an immune-mediated form of hearing loss. Next, Dr. Kedl opined that the records show that Petitioner was taking antibiotics, Cipro and Bactrim, when she received her vaccination, and one of those, Cipro, is in the Quinolone class of medicines known to cause ototoxicity and hearing loss. Resp. Ex. A at 3. Further, he noted that the combination of antibiotics reflected in Petitioner’s medical records, Cipro and Bactrim, are often given for otitis media, or ear infection, which could also be relevant. Id. Dr. Kedl criticized Petitioner’s experts’ approach of arguing that there was no evidence of any other cause, other than vaccination, for her hearing loss. Resp. Ex. C at 2. And he disagreed that this position fails to advance a valid theory to explain causation, particularly a standard of “more likely than not.” Id. Dr. Kedl explained that a scientifically valid theory is important to eliminate claims based on coincidence due to a temporal association with vaccination. Id. 67 Holly R. Steach et al., Cross-Reactivity with Self-Antigen Tunes the Functional Potential of Naïve B Cells Specific for Foreign Antigens, 204 J. Immunology 498 (2020). 23 Case 1:19-vv-00070-CFL Document 143 Filed 03/29/24 Page 24 of 35 Lastly, Dr. Kedl opined that Petitioner’s hearing loss after vaccination was “coincidental and not related to her vaccination.” Resp. Ex. C at 6. He explained that an onset of complete hearing loss in two days after vaccination does not support an immune response to vaccination, particularly in “the absence of any clinical signs of a local destructive inflammatory response.” Id. at 4. In summary, while Dr. Kedl agreed that Petitioner suffered hearing loss in her left ear, he opined that “the preponderance of evidence does not support a vaccine-related cause for [her] hearing loss.” Resp. Ex. C at 6; Resp. Ex. A at 8. III. DISCUSSION A. Standards for Adjudication The Vaccine Act was established to compensate vaccine-related injuries and deaths. § 10(a). “Congress designed the Vaccine Program to supplement the state law civil tort system as a simple, fair and expeditious means for compensating vaccine-related injured persons. The Program was established to award ‘vaccine-injured persons quickly, easily, and with certainty and generosity.’” Rooks v. Sec’y of Health & Hum. Servs., 35 Fed. Cl. 1, 7 (1996) (quoting H.R. Rep. No. 908 at 3, reprinted in 1986 U.S.C.C.A.N. at 6287, 6344). 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). Petitioner need not make a specific type of evidentiary showing, i.e., “epidemiologic studies, rechallenge, the presence of pathological markers or genetic predisposition, or general acceptance in the scientific or medical communities to establish a logical sequence of cause and effect.” Capizzano v. Sec’y of Health & Hum. Servs., 440 F.3d 1317, 1325 (Fed. Cir. 2006). Instead, Petitioner may satisfy her burden by presenting circumstantial evidence and reliable medical opinions. Id. at 1325-26. In particular, a petitioner must prove 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 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). The received vaccine, however, need not be the predominant cause of the injury. Shyface, 165 F.3d at 1351. A petitioner who satisfies this burden is entitled to compensation unless Respondent can prove, by a preponderance of the evidence, that the vaccinee’s injury is “due to factors unrelated to the administration of the vaccine.” § 13(a)(1)(B). However, if a petitioner fails to establish a prima facie case, the burden does not shift. Bradley v. Sec’y of Health & Hum. Servs., 991 F.2d 1570, 1575 (Fed. Cir. 1993). “Regardless of whether the burden ever shifts to the [R]espondent, the special master may consider the evidence presented by the [R]espondent in determining whether the [P]etitioner has established a prima facie case.” Flores v. Sec’y of Health & Hum. Servs., 115 Fed. Cl. 157, 24 Case 1:19-vv-00070-CFL Document 143 Filed 03/29/24 Page 25 of 35 162-63 (2014); see also Stone v. Sec’y of Health & Hum. Servs., 676 F.3d 1373, 1379 (Fed. Cir. 2012) (“[E]vidence of other possible sources of injury can be relevant not only to the ‘factors unrelated’ defense, but also to whether a prima facie showing has been made that the vaccine was a substantial factor in causing the injury in question.”); de Bazan v. Sec’y of Health & Hum. Servs., 539 F.3d 1347, 1353 (Fed. Cir. 2008) (“The government, like any defendant, is permitted to offer evidence to demonstrate the inadequacy of the [P]etitioner’s evidence on a requisite element of the [P]etitioner’s case-in-chief.”); Pafford, 451 F.3d at 1358-59 (“[T]he presence of multiple potential causative agents makes it difficult to attribute ‘but for’ causation to the vaccination. . . . [T]he Special Master properly introduced the presence of the other unrelated contemporaneous events as just as likely to have been the triggering event as the vaccinations.”). B. Causation To receive compensation through the Program, Petitioner must prove either (1) that she suffered a “Table Injury”—i.e., an injury listed on the Vaccine Injury Table—corresponding to a vaccine that she received, or (2) that she suffered an injury that was actually caused by a vaccination. See §§ 11(c)(1), 13(a)(1)(A); Capizzano, 440 F.3d at 1319-20. Petitioner must show that the vaccine was “not only a 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). Because Petitioner does not allege she suffered a Table Injury, she must prove a vaccine she received actually caused her injury. To do so, Petitioner must establish, 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, 418 F.3d at 1278. The causation theory must relate to the injury alleged. Petitioner must provide a sound and reliable medical or scientific explanation that pertains specifically to this case, although the explanation need only be “legally probable, not medically or scientifically certain.” Knudsen v. Sec’y of Health & Hum. Servs., 35 F.3d 543, 548-49 (Fed. Cir. 1994). Petitioner cannot establish entitlement to compensation based solely on her assertions; rather, a vaccine claim must be supported either by medical records or by the opinion of a medical doctor. § 13(a)(1). In determining whether Petitioner is entitled to compensation, the special master shall consider all material in the record, including “any . . . conclusion, [or] medical judgment . . . which is contained in the record regarding . . . causation.” § 13(b)(1)(A). The special master must weigh the submitted evidence and the testimony of the parties’ proffered experts and rule in Petitioner’s favor when the evidence weighs in her favor. See Moberly, 592 F.3d at 1325-26 (“Finders of fact are entitled—indeed, expected—to make determinations as to the reliability of the evidence presented to them and, if appropriate, as to the credibility of the persons presenting that evidence.”); Althen, 418 F.3d at 1280 (noting that “close calls” are resolved in petitioners’ favor). Testimony that merely expresses the possibility—not the probability—is insufficient, by itself, to substantiate a claim that such an injury occurred. See Waterman v. Sec’y of Health & Hum. Servs., 123 Fed. Cl. 564, 573-74 (2015) (denying Petitioner’s motion for review and 25 Case 1:19-vv-00070-CFL Document 143 Filed 03/29/24 Page 26 of 35 noting that a possible causal link was not sufficient to meet the preponderance standard). The Federal Circuit has made clear that the mere possibility of a link between a vaccination and a petitioner’s injury is not sufficient to satisfy the preponderance standard. Moberly, 592 F.3d at 1322 (emphasizing that “proof of a ‘plausible’ or ‘possible’ causal link between the vaccine and the injury” does not equate to proof of causation by a preponderance of the evidence); Boatmon v. Sec’y of Health & Hum. Servs., 941 F.3d 1351, 1359-60 (Fed. Cir. 2019). While certainty is by no means required, a possible mechanism does not rise to the level of preponderance. Moberly, 592 F.3d at 1322; see also de Bazan, 539 F.3d at 1351. IV. ANALYSIS A. Althen Prong One Under Althen prong one, Petitioner must set forth a medical theory explaining how the received vaccine could have caused the sustained injury. Andreu v. Sec’y of Health & Hum. Servs., 569 F.3d 1367, 1375 (Fed. Cir. 2009); Pafford, 451 F.3d at 1355-56. Petitioner’s theory of causation need not be medically or scientifically certain, but it must be informed by a “sound and reliable” medical or scientific explanation. Boatmon, 941 F.3d at 1359; see also Knudsen, 35 F.3d at 548; Veryzer v. Sec’y of Health & Hum. Servs., 98 Fed. Cl. 214, 257 (2011) (noting that special masters are bound by both § 13(b)(1) and Vaccine Rule 8(b)(1) to consider only evidence that is both “relevant” and “reliable”). If Petitioner relies upon a medical opinion to support her theory, the basis for the opinion and the reliability of that basis must be considered in the determination of how much weight to afford the offered opinion. See Broekelschen v. Sec’y of Health & Hum. Servs., 618 F.3d 1339, 1347 (Fed. Cir. 2010) (“The special master’s decision often times is based on the credibility of the experts and the relative persuasiveness of their competing theories.”); Perreira v. Sec’y of Health & Hum. Servs., 33 F.3d 1375, 1377 n.6 (Fed. Cir. 1994) (stating that an “expert opinion is no better than the soundness of the reasons supporting it” (citing Fehrs v. United States, 620 F.2d 255, 265 (Ct. Cl. 1980))). The undersigned finds Petitioner failed to provide preponderant evidence of a sound and reliable theory to explain how the DTaP vaccine can cause SNHL and tinnitus. There are several reasons for this finding. First, the undersigned finds that Dr. Brawer’s opinions as to Althen prong one are not developed and are conclusory in nature.68 When evaluating whether petitioners have carried their burden of proof, special masters consistently reject “conclusory expert statements that are not themselves backed up with reliable scientific support.” Kreizenbeck v. Sec’y of Health & Hum. Servs., No. 08-209V, 2018 WL 3679843, at *31 (Fed. Cl. Spec. Mstr. June 22, 2018), mot. 68 Dr. Brawer’s opinions in other cases have also been criticized as underdeveloped and/or conclusory. See, e.g., McDonald v. Sec’y of Health & Hum. Servs., No. 15-612V, 2023 WL 2387844, at *5-8, *23 (Fed. Cl. Spec. Mstr. Mar. 7, 2023); Hughes v. Sec’y of Health & Hum. Servs., No. 20-1548V, 2023 WL 8432849, at *3-4, *12-13 (Fed. Cl. Spec. Mstr. Nov. 7, 2023); Whelan v. Sec’y of Health & Hum. Servs., No. 16-1174V, 2019 WL 1061473, at *3-4, *13-15 (Fed. Cl. Spec. Mstr. Jan. 28, 2019); Clark v. Sec’y of Health & Hum. Servs., No. 17-1553V, 2023 WL 4897284, *27, *29 (Fed. Cl. Spec. Mstr. June 16, 2023). 26 Case 1:19-vv-00070-CFL Document 143 Filed 03/29/24 Page 27 of 35 for rev. den’d, decision aff’d, 141 Fed. Cl. 138, aff’d, 945 F.3d 1362 (Fed. Cir. 2020). The undersigned will not rely on “opinion evidence that is connected to existing data only by the ipse dixit of the expert.” Moberly, 592 F.3d at 1315. Instead, special masters are expected to carefully scrutinize the reliability of each expert report submitted. See id. In his initial report, Dr. Brawer provides a paragraph listing potential causes of hearing loss and then, without analysis, concludes that Petitioner has SNHL due to vaccination. He does not explain SNHL, the pathogenesis of the illness, or provide evidence for his conclusions that it can be caused by vaccination. Regarding Dr. Brawer’s focus on molecular mimicry, he provides a brief history and overview of the theory. But he does not explain how molecular mimicry explains hearing loss due to the DTaP vaccination. He does not explain how antigens from the DTaP vaccination activate the immune system of the inner ear. He does not offer insight into what antigens are involved. He does not describe any target of the antigens in the inner ear. He does not cite any literature that explains how the DTaP vaccine, or any component of the vaccine, could trigger the immune system of the inner ear so as to cause hearing loss. Then Dr. Brawer provides another long list of other mechanisms for autoimmune conditions. But he does not explain why this list is relevant or describe how any of the mechanisms can cause hearing loss after vaccination. And he cites articles without explaining why they are relevant, or how they provide evidence that the DTaP vaccine can cause SNHL. Regarding the case reports cited, many relate to other vaccines, and Dr. Brawer does not explain if or why they are relevant. Dr. Kinsbourne takes a broader approach as to the mechanism and discusses an immune- mediated theory with an emphasis on autoimmunity. Dr. Kinsbourne does not disagree with Dr. Brawer on the legitimacy of molecular mimicry, but states that there are several mechanisms of autoimmunity, including molecular mimicry, and does not opine as to one in particular for this case. Dr. Kinsbourne cites literature discussing viral infection as a trigger for immune- mediated hearing loss, but this literature does not contemplate vaccination as a trigger via the same process. Further, neither Greco et al. nor Li et al. discuss vaccination. Dr. Kinsbourne explains that “[v]accines are designed to elicit an immune reaction against the relevant antigen, like the immune reaction to the corresponding infection.” Pet. Ex. 163 at 2. But he does not discuss the corresponding infection here. Respondent’s expert, Dr. Kedl, rejects molecular mimicry as a viable theory here. In addition to opining that molecular mimicry is “highly questionable as a relevant mechanism of pathology,” Dr. Kedl states that Dr. Brawer fails to provide “evidence that any putative ear specific antigen has any similarity to any of the antigens contained within the [DTaP] vaccine formulation.” Resp. Ex. A at 4; Resp. Ex. C at 4. The undersigned agrees with Dr. Kedl’s interpretation of Dr. Brawer’s opinions. Based on the current understanding of immune-mediated hearing loss as described in the literature filed 27 Case 1:19-vv-00070-CFL Document 143 Filed 03/29/24 Page 28 of 35 herein, Petitioner’s proposed mechanisms fall short of sound and reliable, are conclusory in nature, and vague. Petitioner need not make a specific type of evidentiary showing or require identification of a specific antigenic trigger for an immune-mediated pathology to prove that a theory is sound and reliable by preponderant evidence. Given the state of current scientific knowledge, there is no way that a petitioner could satisfy such a requirement. Requiring proof of the identify of a specific antigen to prove causation would require scientific certainty, which is a bar too high. See Knudsen, 35 F.3d at 549 (explaining that “to require identification and proof of specific biological mechanisms would be inconsistent with the purpose and nature of the vaccine compensation program”). As the medical literature filed herein shows, the causal mechanism of immune-mediated SNHL is unknown. See, e.g., Pet. Ex. 163-3 at 1-2 (explaining the etiology and pathogenesis of SNHL remains unknown, making SNHL “one of the most controversial and challenging issues in otology”); Pet. Ex. 163-4 at 4 (stating the “exact mechanism behind the injury process remains unclear”); Pet. Ex. 13 (noting 90% of sudden SNHL cases are idiopathic and the mechanism responsible for cases of sudden SNHL after immunization remains unclear); Pet. Ex. 163-7 at 2 (noting that the “pathophysiology of immune-mediated SNHL remains unknown”); Pet. Ex. 11 at 2 (noting that sudden SNHL is usually idiopathic). Further, although molecular mimicry is an accepted scientific mechanism, generally opining that molecular mimicry is a causal theory, without more, is insufficient. See, e.g., Loyd ex rel. v. Sec’y of Health & Hum. Servs., No. 16-811V, 2021 WL 2708941, at *31 (Fed. Cl. Spec. Mstr. May 20, 2021) (“[T]hough molecular mimicry is a generally accepted scientific concept, and is frequently invoked in Program cases, the mere mention of it does not constitute satisfaction of the preponderant evidentiary standard. Rather, it must be shown that the mechanism likely does link the vaccine in question to the relevant injury.” (internal citations omitted)); McKown v. Sec’y of Health & Hum. Servs., No. 15-1451V, 2019 WL 4072113, at *50 (Fed. Cl. Spec. Mstr. July 15, 2019) (explaining that “merely chanting the magic words ‘molecular mimicry’ in a Vaccine Act case does not render a causation theory scientifically reliable, absent additional evidence specifically tying the mechanism to the injury and/or vaccine in question” (emphasis omitted)); Sheets v. Sec’y of Health & Hum. Servs., No. 16-1173V, 2019 WL 2296212, at *17 (Fed. Cl. Spec. Mstr. Apr. 30, 2019) (determining Petitioner had not satisfied Althen prong one when he did not relate molecular mimicry “to either the vaccines in question or Petitioner’s own specific condition”). Moreover, only one of Petitioner’s case reports of hearing loss associated with vaccination involved Tdap. Therefore, the relevance of the remaining case reports is unclear as case reports about one vaccine cannot automatically be imputed to a different vaccine, particularly when the mechanisms offered have not been suggested as to the vaccine at issue. “An expert may ‘extrapolate from existing data,’ and use ‘circumstantial evidence,’ [b]ut the reasons for the extrapolation should be transparent and persuasive.” K.O. v. Sec’y of Health & Hum. Servs., No. 13-472V, 2016 WL 7634491, at *12 (Fed. Cl. Spec. Mstr. July 7, 2016) (internal citations omitted) (first quoting Snyder v. Sec’y of Health & Human Servs., 88 Fed. Cl. 706, 743 (2009); and then quoting Althen, 418 F.3d at 1280). 28 Case 1:19-vv-00070-CFL Document 143 Filed 03/29/24 Page 29 of 35 Here, Petitioner does not explain how data from other unrelated vaccines could be extrapolated to the vaccines at issue here and accordingly, the data is not persuasive. See K.O., 2016 WL 7634491, at *12 (finding the case reports offered by Petitioner as having even less value than case reports do generally because they reported a sequence in which a vaccine, but not the vaccine at issue, preceded the onset of the injury at issue (citing Campbell v. Sec’y of Health & Hum. Servs., 97 Fed. Cl. 650, 668 (2011))); Crosby v. Sec’y of Health & Hum. Servs., No. 18-1478V, 2021 WL 3464125, at *9 (Fed. Cl. Spec. Mstr. July 22, 2021) (declining to give substantial weight to an article because it was on a different vaccine than the one at issue making reasoning difficult); see also Deshler v. Sec’y of Health & Hum. Servs., No. 16-1070V, 2020 WL 4593162, at *19-21 (Fed. Cl. Spec. Mstr. July 1, 2020) (declining to attribute case reports on the flu vaccine to pneumococcal vaccines); McDonald v. Sec’y of Health & Hum. Servs., No. 15-612V, 2023 WL 2387844, at *23 (Fed. Cl. Spec. Mstr. Mar. 7, 2023). And the one epidemiological study of vaccination as a cause/trigger of sudden SNHL cited by Dr. Kinsbourne does not support Petitioner’s position. Baxter et al. found no increased risk or association between SNHL and the DTaP vaccine or any other vaccine. While Dr. Kinsbourne explains that DTaP-related SNHL has “little to no chance of generating a signal in this study” because it is a rare event difficult to detect with epidemiological studies, that observation will not carry the day. Pet. Ex. 163 at 4. As De Marco et al. noted two years after the Baxter et al. study, “to date, there is not sufficient scientific evidence indicating sudden [hearing loss] [is] an adverse event to vaccination.” Pet. Ex. 11 at 3. Although a petitioner need not make a specific type of evidential showing (i.e., epidemiologic studies) to satisfy his burden, special masters shall still consider and weigh the evidence in the record, including the epidemiological studies filed. See § 13(b)(1) (indicating the special master shall consider all materials in the record); Capizzano, 440 F.3d at 1325-26; Grant v. Sec’y of Health & Hum. Servs., 956 F.2d 1144, 1149 (Fed. Cir. 1992) (finding “epidemiological studies are probative medical evidence relevant to causation” and “considerable weight [is] due to epidemiological studies in the absence of direct evidence of actual causation”). And after weighing the submitted evidence, the undersigned finds the evidence does not weigh in Petitioner’s favor. See Moberly, 592 F.3d at 1325-26 (“Finders of fact are entitled—indeed, expected—to make determinations as to the reliability of the evidence presented to them and, if appropriate, as to the credibility of the persons presenting that evidence.”). The undersigned finds the totality of the evidence presented fails to demonstrate by preponderance evidence that the DTaP vaccine can cause SNHL. Lastly, there are several other Vaccine Program cases with reasoned decisions regarding numerous causation theories for hearing loss, and the special masters in those cases often denied entitlement. None of these cases involved the DTaP vaccination; instead, they relate to the flu vaccine. Regardless, SNHL has been rejected as a vaccine-related injury due to insufficient evidence to support causation. Although decisions of other special masters are not binding, the undersigned generally agrees with the reasoning of her colleagues in these cases. See Boatmon, 941 F.3d at 1358; Hanlon v. Sec’y of Health & Hum. Servs., 40 Fed. Cl. 625, 630 (1998), aff’d, 191 F.3d 1344 (Fed. Cir. 1999). 29 Case 1:19-vv-00070-CFL Document 143 Filed 03/29/24 Page 30 of 35 The Petitioner in Inamdar alleged the flu vaccine caused his bilateral SNHL. Inamdar v. Sec’y of Health & Hum. Servs., No. 15-1173V, 2019 WL 1160341, at *1 (Fed. Cl. Spec. Mstr. Feb. 8, 2019). Petitioner proposed the flu vaccine “could cause the production of proinflammatory cytokines immediately upon vaccine administration,” and alternatively, that specific components of the vaccine “were structurally homologous with ganglioside receptors on the neuronal myelin contained in the inner ear tissue, and that antibodies generated in response to the vaccine could also cross-react with the self-myelin, resulting in tissue damage.” Id. at *5-6. The special master found the first theory relied too heavily on what was known about the wild virus rather than the vaccine, and further found that both theories were unsupported by the literature. Id. at *17-18. Additionally, the Inamdar Petitioner “did not adequately substantiate the how (i.e. the mechanistic process) portion of his theory—the manner in which the rapid upregulation of cytokines would cause tissue damage in the ear resulting in hearing loss.” Id. at *18. Similarly, in Doe/16, Petitioner’s expert proposed an autoimmune hypersensitivity reaction theory for how the flu vaccine can cause unilateral sudden SNHL. Doe/16 v. Sec’y of Health & Hum. Servs., No. 06-670V, 2008 WL 2390064, at *5 (Fed. Cl. Spec. Mstr. June 2, 2008). Petitioner’s expert “did not believe the killed virus in the vaccine could directly provoke an illness,” rather that the flu vaccine “triggered an antigen reaction, which caused inflammation” in the endolymphatic sac. Id. The special master found the medical literature lacked support for the autoimmune hypersensitivity reaction. Id. at *12-14. In Kelly, the Petitioner alleged the flu vaccine caused his unilateral SNHL. Kelly v. Sec’y of Health & Hum. Servs., No. 16-878V, 2021 WL 5276373, at *1 (Fed. Cl. Spec. Mstr. Oct. 18, 2021), mot. for rev. den’d, 160 Fed. Cl. 316 (2022). Petitioner proposed a Type I sensitivity reaction and alternatively, an autoimmune response. Id. at *25-26. The Chief Special Master found limited support for the primary theory and found the autoimmune theory inconsistent with the facts presented, including the fact that Petitioner’s hearing loss was unilateral, and the onset was two hours. Id. at *24-26. Recently, the undersigned denied entitlement where Petitioner alleged the flu and Prevnar 13 vaccines caused his hearing loss. Alsaadeh v. Sec’y of Health & Hum. Servs., No. 19-1097V, 2024 WL 694072 (Fed. Cl. Spec. Mstr. Jan. 23, 2024). The undersigned found Petitioner’s immune-mediated theory was not sound or reliable in part because the causal mechanism of immune-mediated hearing loss is unknown. Id. at *31-34. While there is one reasoned decision where entitlement was granted to a petitioner who alleged the flu vaccine caused sudden SNHL, the undersigned notes that the facts and theory here are different. Madigan v. Sec’y of Health & Hum. Servs., No. 14-1187V, 2021 WL 3046614, at *1 (Fed. Cl. Spec. Mstr. June 25, 2021). In Madigan, the Petitioner proposed a stress response theory which “suggests that stress leaves people susceptible to immune disruption both by reducing natural killer (‘NK’) cells, which help resist viral and bacterial infection, and by promoting production of proinflammatory cytokines IL-1 and IL-6.” Id. at *12. The special master distinguished Madigan from Doe/16 and Inamdar because those cases relied on “the presence of post-vaccination inflammation seemingly without an explanation (such as the stress response theory) for how they could affect the inner ear and/or be injurious.” Id. at *17. 30 Case 1:19-vv-00070-CFL Document 143 Filed 03/29/24 Page 31 of 35 In summary, Petitioner has failed to offer a sound and reliable medical theory in support of her claim. Thus, the undersigned finds Petitioner has failed to provide preponderant evidence with respect to the first Althen prong. B. Althen Prong Two Under Althen prong two, Petitioner must prove by a preponderance of the evidence that there is a “logical sequence of cause and effect showing that the vaccination was the reason for the injury.” Capizzano, 440 F.3d at 1324 (quoting Althen, 418 F.3d at 1278). “Petitioner must show that the vaccine was the ‘but for’ cause of the harm . . . or in other words, that the vaccine was the ‘reason for the injury.’” Pafford, 451 F.3d at 1356 (internal citations omitted). In evaluating whether this prong is satisfied, the opinions and views of the vaccinee’s treating physicians are entitled to some weight. Andreu, 569 F.3d at 1367; Capizzano, 440 F.3d at 1326 (“[M]edical 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 trustworthy evidence since they are created contemporaneously with the treatment of the vaccinee. Cucuras v. Sec’y of Health & Hum. Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993). While the medical records and opinions of treating physicians must be considered, they are not binding on the special master. § 13(b)(1)(B) (specifically stating that the “diagnosis, conclusion, judgment, test result, report, or summary shall not be binding on the special master or court”). Since Petitioner failed to prove Althen prong one, it follows that she cannot prove Althen prong two. In addition, Petitioner has failed to show by preponderant evidence that there is a logical sequence of cause and effect showing Petitioner’s DTaP vaccine caused her hearing loss because she has failed to establish that her hearing loss was autoimmune in nature. Although no antibody testing69 was done which would have been helpful to prove or disprove an autoimmune etiology, here Petitioner failed to have a significant response to steroid therapy. If her condition had been autoimmune in origin, an improvement would be expected. The medical literature cited by the parties establishes that SNHL thought to be autoimmune is treated with corticosteroids. See, e.g., Pet. Ex. 163-7 at 2 (stating that recovery of hearing after immunosuppressive therapy helps reinforce the existence of an immune-mediated mechanism of hearing loss); Pet. Ex. 163-4 at 1 (same); Pet. Ex. 163-3 at 4 (recommending patients with SNHL treating with steroids or immunosuppressants). But see Pet. Ex. 163-7 at 12 (the Brighton Collaboration SNHL Working Group deciding against using “treatment or treatment response towards the fulfilment of the SNHL case definition” because a “standard treatment is not established, and a treatment response or its failure is not in itself diagnostic of SNHL”). 69 Petitioner’s C-reactive protein, an indicator of inflammation, was not elevated. Pet. Ex. 1 at 10 (ECF No. 8-1). 31 Case 1:19-vv-00070-CFL Document 143 Filed 03/29/24 Page 32 of 35 However, the experts agree that Petitioner did not have any significant response to the steroids. Pet. Ex. 163 at 1 (Dr. Kinsbourne acknowledging “[o]ral steroids conveyed no benefit” to Petitioner); Resp. Ex. C at 4 (Dr. Kedl opining “oral steroids had absolutely no benefit to [Petitioner’s] condition”); Pet. Ex. 10 at 1 (Dr. Brawer indicating that Petitioner’s hearing loss is “fixed and permanent”). Dr. Kedl opines that Petitioner’s failure to respond to steroid treatment is evidence that she did not have an autoimmune disorder. Thus, Petitioner’s clinical course is not consistent with an autoimmune reaction. Next, although some of Petitioner’s treating physicians documented her reports of symptoms and/or their temporal association with vaccination, the undersigned does not find their statements provide persuasive evidence of causation. Generally, treating physician statements are typically “favored” 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.’” Capizzano, 440 F.3d at 1326 (quoting Althen, 418 F.3d at 1280). However, no treating physician’s views bind the special master, per se; rather, their views are carefully considered and evaluated. § 13(b)(1); Snyder, 88 Fed. Cl. at 746 n.67. “As with expert testimony offered to establish a theory of causation, the opinions or diagnoses of treating physicians are only as trustworthy as the reasonableness of their suppositions or bases.” Welch v. Sec’y of Health & Hum. Servs., No. 18-494V, 2019 WL 3494360, at *8 (Fed. Cl. Spec. Mstr. July 2, 2019). Dr. Shariati was Petitioner’s primary care provider. His records show that he is an internist, not an otolaryngologist or immunologist. He documented several statements attributing Petitioner’s hearing loss to vaccination. See, e.g., Pet. Ex. 1 at 1 (ECF No. 8-1) (assessing Petitioner’s hearing loss as “[p]robable side effect[] from receiving DTaP”); Pet. Ex. 3 at 2 (assessing Petitioner’s hearing loss with tinnitus as “probably secondary to administration of vaccine”); Pet. Ex. 1, ECF No. 67-5 at 2 (noting Petitioner’s hearing loss and ringing in her left ear “was contributed from the [DTaP] vaccination”). Although Dr. Shariati consistently documented his opinion that Petitioner’s hearing loss was caused by vaccination, he did not provide any explanation for his opinion. “As with expert testimony offered to establish a theory of causation, the opinions or diagnoses of treating physicians are only as trustworthy as the reasonableness of their suppositions or bases.” Welch v. Sec’y of Health & Hum. Servs., No. 18-494V, 2019 WL 3494360, at *8 (Fed. Cl. Spec. Mstr. July 2, 2019). An opinion by a treating physician that is not supported by a factual basis or other evidence is conclusory in nature. See Robertson v. Sec’y of Health & Hum. Servs., No. 18- 554V, 2022 WL 17484980, at *17 (Fed. Cl. Spec. Mstr. Dec. 7, 2022) (finding treating physicians’ statements of mere suspicion fall short of an opinion supporting vaccine causation); Cedillo v. Sec’y of Health & Hum. Servs., 617 F.3d 1328, 1347 (Fed. Cir. 2010) (concluding the special master did not err in affording little weight to the opinions of Petitioner’s treating physicians where “none of the treating physicians concluded that the [] vaccine caused [Petitioner’s] [condition]”). 32 Case 1:19-vv-00070-CFL Document 143 Filed 03/29/24 Page 33 of 35 The balance of the records by Petitioner’s treating physicians appear to be based on the temporal association between vaccination and hearing loss. For example, otolaryngologist Dr. Selesnick wrote that “[d]ue to the close time proximity of the administration of the vaccine, it is likely that the vaccine is at least in some way responsible for [Petitioner’s] [SNHL].” Pet. Ex. 1 at 27 (ECF No. 8-1); see also Pet. Ex. 1 at 4 (ECF No. 8-1) (Dr. Flemming indicating Petitioner had sudden SNHL in the left ear and that it “began 24 hours after having a [DTaP] vaccine”); 22 (Dr. Kwartler noting Petitioner’s hearing loss occurred after DTaP vaccine). A “treating physician’s recognition of a temporal relationship does not advance the analysis of causation.” Isaac v. Sec’y of Health & Hum. Servs., No. 08-601V, 2012 WL 3609993, at *26 (Fed. Cl. Spec. Mstr. July 30, 2012). And a temporal relationship between a vaccine and an injury, standing alone, does not constitute preponderant evidence of vaccine causation. See, e.g., Veryzer, 100 Fed. Cl. at 356 (explaining that “a temporal relationship alone will not demonstrate the requisite causal link and that [P]etitioner must posit a medical theory causally connecting the vaccine and injury”). Lastly, Respondent’s expert offers an opinion as to alternate cause for Petitioner’s hearing loss, namely the antibiotic Cipro documented in her medical records. Dr. Kedl opines the medical records show that Petitioner was taking antibiotics when she received her vaccination, and that one of the antibiotics is known to cause ototoxicity and hearing loss. Dr. Kinsbourne disagrees that the antibiotics caused Petitioner’s hearing loss, because he argues that the effect would have been gradual and not sudden. Moreover, he notes that Petitioner’s PCP explained that Petitioner was not taking these medications at the time of vaccination. When Petitioner first presented to her PCP, Dr. Shariati, with complaints of hearing loss on June 20, 2017, antibiotics (Bactrim and Cipro) were listed as current medications. Petitioner later asked Dr. Shariati about the antibiotics listed as her current medications from that visit and Dr. Shariati informed her “that the ‘current’ list [was] of all the drugs [she] had been prescribed in the entire time [she] had been seeing him” and “[t]hat particular note was not indicative of the medication [she] was taking at the time of the visit.” ECF No. 93-1 at ¶ 1. Petitioner further declared she was not on antibiotics at that time. Dr. Shariati also submitted a letter addressing this entry writing that Petitioner “was not on antibiotics at the time she received the DTaP vaccine.” Pet. Ex. 62 at 1. The undersigned acknowledges that Petitioner is not required to eliminate other potential causes in order to be entitled to compensation. See Walther v. Sec’y of Health & Hum. Servs., 485 F.3d 1146, 1149-52 (Fed. Cir. 2007) (finding a petitioner does not bear the burden of eliminating alternative independent potential causes). However, it is reasonable to consider “evidence of other possible sources of injury” to determine “whether a prima facie showing has been made that the vaccine was a substantial factor in causing the injury in question.” Stone, 676 F.3d at 1379; see also Winkler v. Sec’y of Health & Hum. Servs., 88 F.4th 958, 963 (Fed. Cir. 2023) (finding the special master’s “contemplation of a potential causative agent when evaluating whether or not a petitioner has established a prima facie case is in accordance with the law”). 33 Case 1:19-vv-00070-CFL Document 143 Filed 03/29/24 Page 34 of 35 However, after consideration of all of the evidence, the undersigned finds that while the records document that Petitioner was on antibiotics at the time that she received her vaccination, she has filed evidence to show that the record was incorrect. The undersigned finds that Petitioner provided preponderant evidence to show that she was not taking antibiotics at the time of vaccination. Therefore, the antibiotics do not constitute an alternative cause for her hearing loss and there is no evidence of an alternative cause. Regardless of this finding, the undersigned finds that Petitioner has failed to show that her condition was autoimmune. Moreover, in essence, Dr. Brawer opines that because Petitioner did not have any hearing impairment or systemic neurological or otolaryngological condition prior to her DTaP vaccine, Petitioner’s condition began within 36 to 48 hours following the DTaP vaccination, and Petitioner’s SNHL and tinnitus “cannot be attributed to any other well-defined and well-known causes that can trigger such phenomena,” that the DTaP vaccine did cause Petitioner’s SNHL and tinnitus. Pet. Ex. 10 at 5. The Federal Circuit in Capizzano noted that “[t]he second prong of the Althen . . . test is not without meaning.” Capizzano, 440 F.3d at 1327. Indeed, in Althen, the Court stated: “Although probative, neither a mere showing of a proximate temporal relationship between vaccination and injury, nor a simplistic elimination of other potential causes of the injury suffices, without more, to meet the burden of showing actual causation.” Althen, 418 F.3d at 1278. Therefore, Petitioner has failed to provide preponderant evidence of a logical sequence of cause and effect. C. Althen Prong Three Althen prong three requires Petitioner to establish a “proximate temporal relationship” between the vaccination and the injury alleged. Althen, 418 F.3d at 1281. That phrase has been defined as a “medically acceptable temporal relationship.” Id. A petitioner must offer “preponderant proof that the onset of symptoms occurred within a timeframe for which, given the medical understanding of the disorder’s etiology, it is medically acceptable to infer causation-in-fact.” de Bazan, 539 F.3d at 1352. The explanation for what is a medically acceptable time frame must also coincide with the theory of how the relevant vaccine can cause the injury alleged (under Althen prong one). de Bazan, 539 F.3d at 1352; see also Koehn v. Sec’y of Health & Hum. Servs., 773 F.3d 1239, 1243-44 (Fed. Cir. 2014); Shapiro, 101 Fed. Cl. at 542. Thus, prong three contains two parts. First, Petitioner must establish the “timeframe for which it is medically acceptable to infer causation” and second, she must demonstrate that the onset of the disease occurred in this period. Shapiro, 101 Fed. Cl. at 542-43. A temporal relationship between a vaccine and an injury, standing alone, does not constitute preponderant evidence of vaccine causation. See, e.g., Veryzer, 100 Fed. Cl. at 356 (explaining that “a temporal relationship alone will not demonstrate the requisite causal link and that [P]etitioner must posit a medical theory causally connecting the vaccine and injury”). Because Althen prong three coincides with Althen prong one, Petitioner’s inability to meet his burden demonstrating how the DTaP vaccine can cause hearing loss effectively 34 Case 1:19-vv-00070-CFL Document 143 Filed 03/29/24 Page 35 of 35 precludes him from being able to meet his burden under the third Althen prong. Thus, because the undersigned found that Petitioner did not offer a sound and reliable theory of causation, he cannot demonstrate that his condition arose in a medically acceptable timeframe pursuant to that theory. Even assuming that Petitioner satisfied Althen prong three, that alone would not satisfy Petitioner’s overall burden of proof. Veryzer, 100 Fed. Cl. at 356 (explaining that a “temporal relationship alone will not demonstrate the requisite causal link and that petitioner must posit a medical theory causally connecting the vaccine and injury.”). However, Petitioner’s showing with respect to the third Althen prong is deficient. The parties stipulated that Petitioner’s hearing loss began approximately two days after receiving the DTaP vaccine. Joint Submission at 1. Dr. Brawer opines there is a temporal relationship because Petitioner’s development of SNHL and tinnitus began within 36 to 48 hours of her DTaP vaccination. But he does not explain how this is a medically acceptable timeframe pursuant to the mechanisms discussed. Similarly, Dr. Kinsbourne opines Petitioner developed sudden hearing loss two days after the DTaP vaccination but does not provide any explanation of how this is consistent with autoimmunity induced hearing loss. Dr. Kedl explains that an onset of hearing loss two days after vaccination is not supportive of an immune response to vaccination but does not explain why. As explained above, there is insufficient evidence of a mechanistic theory and while there are opinions stated as to onset, the opinions are not developed within the context of a supportive theory of causation. Accordingly, the undersigned finds Petitioner failed to provide preponderant evidence of Althen prong three. V. CONCLUSION The undersigned extends her sympathy to Petitioner for her hearing loss and tinnitus. The undersigned’s Decision, however, cannot be decided based upon sympathy, but rather on the evidence and law. For the reasons discussed above, the undersigned finds that Petitioner has failed to establish by preponderant evidence that DTaP vaccination she received caused her hearing loss and tinnitus. Therefore, Petitioner is not entitled to compensation and the petition must be dismissed. In the absence of a timely filed motion for review pursuant to Vaccine Rule 23, the Clerk of Court SHALL ENTER JUDGMENT in accordance with this Decision. IT IS SO ORDERED. s/Nora Beth Dorsey Nora Beth Dorsey Special Master 35 ================================================================================ DOCUMENT 2: USCOURTS-cofc-1_19-vv-00070-1 Date issued/filed: 2024-08-15 Pages: 19 Docket text: JUDGE VACCINE REPORTED OPINION (PUBLIC VERSION) re: 150 Order on Motion for Review, Judge Vaccine Order/Opinion. Signed by Senior Judge Charles F. Lettow. (vas) -------------------------------------------------------------------------------- Case 1:19-vv-00070-CFL Document 152 Filed 08/15/24 Page 1 of 19 In the United States Court of Federal Claims No. 19-70V (Filed under seal: July 29, 2024) (Reissued for Publication: August 15, 2024) ___________________________________ ) SALLY HERMS, ) ) Petitioner, ) ) v. ) ) SECRETARY OF HEALTH AND ) HUMAN SERVICES, ) ) Respondent. ) ___________________________________ ) John F. McHugh, Law Office of John McHugh, New York, NY, for Petitioner. Mitchell H. Jones, Trial Attorney, Torts Branch, Civil Division, United States Department of Justice, Washington, D.C., for Respondent. With him on the briefs were Brian M. Boynton, Principal Deputy Assistant Attorney General, Civil Division, as well as C. Salvatore D’Alessio, Director, Heather L. Pearlman, Deputy Director, and Colleen C. Hartley, Assistant Director, Torts Branch, Civil Division, United States Department of Justice, Washington, D.C. OPINION AND ORDER1 LETTOW, Senior Judge. Pending before the court is petitioner’s motion for review of Special Master Dorsey’s decision issued on March 4, 2024, denying petitioner compensation under the National Vaccine Injury Compensation Program (“Vaccine Act” or “the Program”), 42 U.S.C. §§ 300aa-10 to aa-34. Petitioner, Ms. Sally Herms, claims that the diphtheria tetanus toxoid acellular pertussis (“DTaP” or “TDaP”) vaccination2 that she received on June 18, 2017, caused sensorineural 1 In accord with the Rules of the Court of Federal Claims (“RCFC”), App. B (“Vaccine Rules”), Vaccine Rule 18(b), this opinion and order was initially filed under seal. By rule, the parties had fourteen days within which to propose redactions. 2 The DTaP vaccine is meant “to prevent diphtheria, tetanus, and pertussis.” Pet’r’s Ex. 4, ECF No. 12-3. Case 1:19-vv-00070-CFL Document 152 Filed 08/15/24 Page 2 of 19 hearing loss (“SNHL” or “hearing loss”) and tinnitus in her left ear. Pet’r’s Mot. for Review of the Special Master’s March 4, 2024 Decision (“Pet’r’s Mot.”), ECF No. 144. Because petitioner does not allege that she sustained an injury included in the Vaccine Injury Table, she must establish causation. 42 U.S.C. § 300aa-11(c)(1)(B), (C)(ii)(I). In her decision, the Special Master applied the causation prongs set forth in Althen v. Sec’y of Health & Hum. Servs., 418 F.3d 1274 (Fed. Cir. 2005), and concluded that petitioner had not shown by a preponderance of the evidence that the DTaP vaccine caused her tinnitus and hearing loss. See generally Herms v. Sec’y of Health & Hum. Servs. (“Entitlement Decision”), No. 19-70V, 2024 WL 1340669 (Fed. Cl. Spec. Mstr. Mar. 4, 2024). Petitioner’s motion for review is fully briefed and a hearing was held on May 29, 2024. Resp’t’s Resp. to Pet’r’s Mot. for Review (“Resp’t’s Resp.”), ECF No. 146; Hr’g Tr. (May 29, 2024), ECF No. 149. Accordingly, the court reviews the Special Master’s finding of no causation. BACKGROUND3 A. Sensorineural Hearing Loss and Tinnitus Ms. Herms seeks compensation for two conditions: SNHL and tinnitus. SNHL is defined as “hearing loss of at least 30 [decibels] in three sequential frequencies in the standard pure tone audiogram. SNHL results from dysfunction of the inner ear, the vestibulocochlear nerve, or the central processing centers of the brain.” Pet’r’s Ex. 163-5 at 12, ECF No. 141. Establishing a diagnosis of SNHL requires both “[a] physical examination to exclude conductive hearing loss” and “[a]n audiometric evaluation consistent with SNHL.” Id. at 11-12. The medical community has not yet definitively identified a known etiology or pathogenesis of SNHL. Pet’r’s Ex. 163-3 at 1-2, ECF No. 141. SNHL is commonly unilateral. Id. at 1. SNHL is also frequently associated with tinnitus. Id. (reporting that “[t]innitus occurs in about 80% of patients” with SNHL); see also Pet’r’s Ex. 163-7 at 7, ECF No. 141 (reporting that “all (100%) patients in [SNHL] study had tinnitus”). Tinnitus is the “[p]erception of a sound,” e.g., “a pure tone or noise including (ringing, whistling, hissing, roaring, or booming),” “in the absence of an environmental acoustic stimulus.” Tinnitus, Stedmans Med. Dictionary 921820, Westlaw (database updated November 2014). B. Ms. Herms’ Medical History The parties stipulate that on June 18, 2017, petitioner was administered the DTaP vaccination. Joint Submission of Mar. 24, 2023 at 1, ECF No. 132. The parties also stipulate that “[t]wo days later, [Ms. Herms] experienced fever, muscle aches[,] and a feeling of being in a tunnel. She awoke and found she was deaf in her left ear” and the next morning “she had tinnitus in her left ear.” Id. 3 The following recitations are drawn from the factual and procedural history detailed in the Special Master’s decision and the attendant referenced sources. 2 Case 1:19-vv-00070-CFL Document 152 Filed 08/15/24 Page 3 of 19 Petitioner visited her primary care provider, Dr. Nasseredin Shariati on June 20, 2017, two days after receiving the DTaP vaccination, with symptoms including chills, ear congestion, hearing loss, stiffness, body aches, and a fever. Pet’r’s Ex. 1 at 1, ECF No. 8-1. Dr. Shariati indicated Ms. Herms was “obviously concerned about the possibility of [a] side effect” from the vaccination, and he concluded that Ms. Herms’ symptoms were “[p]robable side effects from receiving [the] DTaP” vaccination, coupled with “wax buildup on the left ear.” Id. He also expressed concern that Ms. Herms could have a possible acoustic neuroma, given that Ms. Herms’ daughter “suffered from acoustic neuroma on her left ear and [as a] result[] of that[,] she lost hearing on that side permanently.” Id. Nine days later, on June 29, 2017, Ms. Herms visited Dr. Gregory Fleming, an otolaryngologist, and expressed symptoms of “seashell type tinnitus but no vertigo or ear pain.” Pet’r’s Ex. 1 at 3-4. Audiological testing revealed “moderate to severe [SNHL] in [Ms. Herms’] left ear with no discernible speech discrimination,” and Dr. Fleming prescribed a steroidal taper of prednisone, a magnetic resonance imaging (“MRI”) test to ensure Ms. Herms did not have an acoustic neuroma, and a serology screening. Id. at 4. Following her prednisone steroidal taper, Ms. Herms returned to Dr. Fleming to review the results of a second audiological test conducted on July 18, 2017. Id. at 16, 20. Dr. Fleming identified “good improvement of [Ms. Herms’] speech discrimination but persisting moderate [SNHL] on pure tone testing.” Id. at 20. Then, on July 27, 2017, petitioner visited otolaryngologist Dr. Jed Kwartler with similar symptoms to those she experienced a month prior. Id. at 22-23. Dr. Kwartler noted that intratympanic steroid injections would not likely help Ms. Herms given the time that had passed since her symptoms began and discussed “the pathophysiology of idiopathic sudden [SNHL].” Id. at 23. On April 12, 2018, Ms. Herms visited Dr. Samuel Selesnick, an otolaryngologist at Weill Cornell Otolaryngology Head and Neck Surgery, following an updated hearing test administered the prior day. Pet’r’s Ex. 1 at 24-27. Dr. Selesnick noted Ms. Herms’ familial history of ear disease (her daughter’s acoustic neuroma) and that Ms. Herms had no other otologic history. Id. at 27. Finally, Dr. Selesnick noted that Ms. Herms’ third through seventh cranial nerves were “grossly intact with the exception of the left VIII[] cranial nerve.” Id. Following examination and review of testing, Dr. Selesnick noted that “[d]ue to the close time proximity of the administration of the vaccine, it is likely that the vaccine is at least in some way responsible for [petitioner’s] [SNHL].” Id. On September 20, 2018, Petitioner had a routine visit with her primary care provider, Dr. Shariati, where she reported deafness on her left side and constant tinnitus. Pet’r’s Ex. 3 at 1, ECF No. 12-1. Following an audiometry, Dr. Shariati confirmed that Ms. Herms had “[s]ignificant hearing loss on the left side associated with tinnitus,” which he believed was “probably secondary to [the] administration of” the DTaP vaccination. Id. at 2. Several months later, on April 16, 2019, Dr. Herms had a follow-up appointment with Dr. Selesnick, during which Ms. Herms reiterated her complaints of tinnitus and Dr. Selesnick discussed possible treatment and therapeutic options. Pet’r’s Ex. 2 at 1-2, ECF No. 8-2. Finally, petitioner returned to Dr. Shariati on May 20, 2019, complaining of a “pounding headache, significant hearing loss, and significant ringing in her left ear.” Pet’r’s Ex. 1-2 at 2, ECF No. 67-5. Dr. Shariati reiterated his prior impression that Ms. Herms’ “[s]ignificant hearing loss on 3 Case 1:19-vv-00070-CFL Document 152 Filed 08/15/24 Page 4 of 19 the left side” was “associated with tinnitus” and was “probably secondary to” her DTaP vaccination. Id. at 2-3. Petitioner also recounts her medical experiences in two declarations, dated January 7, 2018, and July 30, 2021. See Pet’r’s Ex. 6, ECF No. 13-1; Aff. of Sally Herms, July 30, 2021, ECF No. 93-1. In her 2021 declaration, Ms. Herms states she received a DTaP vaccine at a pharmacy on June 18, 2017, in preparation to visit her newborn grandchild. See Aff. of Sally Herms ¶ 3, July 30, 2021. At that time, Ms. Herms was 58 years of age. See Pet’r’s Ex. 4 at 1. She attests that she did not have any conditions that would have necessitated her taking antibiotics at that time, and that she had completed a prior course of antibiotics “by April 1 or 2” Aff. of Sally Herms ¶ 2, July 30, 2021. Ms. Herms’ primary care provider, Dr. Shariati, further confirmed that she “was not on antibiotics at the time she received the DTaP vaccine.” ECF No. 93-2 at 2. Petitioner attests that later in the evening on June 18, 2017, she “noticed soreness at the injection site” of the vaccination and that at around 1:00 am the next day, she “began to experience full body tremors, chills, aches[,] and stiffness which lasted approximately two and a half hours.” Pet’r’s Ex. 6 ¶ 3. Petitioner recalls that she then experienced “loss of hearing in [her] left ear,” the next morning, which had become “nearly total,” with the addition of tinnitus, by the following day, June 20, 2017. Id. ¶¶ 4-5. She also reports experiencing “approximately 3 hours of full body tremors,” as well as the sensation that she was “listening to a sea shell or wind tunnel, but soon after, the noise became [a] loud roaring [t]innitus which continues.” Aff. of Sally Herms ¶ 4, July 30, 2021. Petitioner recounts that she visited Dr. Shariati, on June 20, 2017, due to the symptoms she had been experiencing the prior evening and early that morning. Aff. of Sally Herms ¶ 4, July 30, 2021. Ms. Herms attests that Dr. Shariati advised her that her symptoms “were a reaction to the DTaP vaccination [she] had received, i.e. an adverse reaction to that DTaP vaccination.” Pet’r’s Ex. 6 ¶ 6. Petitioner also explains that she visited two additional specialists who “both confirmed [her] hearing loss”—one of whom “stated that the cause of [her] condition was a reaction to the vaccine,” while the other “stated that he could not determine any cause.” Id. ¶ 7. C. The Expert Reports Petitioner advanced the reports of two experts, Dr. Arthur E. Brawer and Dr. Marcel Kinsbourne, in support of her claim, while the government advanced those of one expert, Dr. Ross Kedl. 1. Petitioner’s experts Dr. Arthur Brawer is board-certified in internal medicine and rheumatology and operates a rheumatology private practice. Pet’r’s Ex. 55 at 1, 3, ECF No. 40-5. Dr. Brawer provided two expert reports detailing his opinion as to Ms. Herms’ condition. Pet’r’s Ex. 10, ECF No. 25; Pet’r’s Ex. 50, ECF No. 41-1. In his first report, Dr. Brawer opines that “[b]ased on a reasonable degree of medical certainty, [he] [is] in complete agreement” with petitioner’s diagnosis of 4 Case 1:19-vv-00070-CFL Document 152 Filed 08/15/24 Page 5 of 19 “permanent sensorineural hearing loss in her left ear as a direct consequence of the TDaP vaccination she received on June 18, 2017.” Pet’r’s Ex. 10 at 2. Dr. Brawer relies on the theory of molecular mimicry and explains that “[i]t has been known for well over 20 years that there exists a cross reactivity between routinely used vaccine materials and self-antigens in the body.” Id. at 3-4. He further notes that Ms. Herms began experiencing SNHL and tinnitus “within 36 to 48 hours following the TDaP vaccination on June 18 of 2017.” Id. at 5. Dr. Brawer also explains that Ms. Herms underwent “comprehensive evaluations” that “clearly excluded a multitude of other potential causes for Ms. Herms’ hearing loss.” Id. at 1-2. Moreover, she did not suffer any “systemic . . . condition[s]” before receiving the vaccination, and her SNHL and tinnitus “cannot be attributed to any other well-defined and well-known causes.” Id. at 5. Ultimately, Dr. Brawer concludes that “[b]ased on a reasonable degree of medical certainty, were it not for the TdaP vaccination of June 18, 2017, Ms. Herms would not now be suffering from [SNHL] and tinnitus.” Id. Dr. Brawer’s first report includes citations to several publications in support of his theory. See Pet’r’s Ex. 10 at 2-5. One such publication, entitled “Post Vaccinal Temporary Sensorineural Hearing Loss” and authored by De Marco et al., involves both the DTaP vaccination and SNHL. Pet’r’s Ex. 11, ECF No. 25-1. The De Marco article details the case of a 33-year-old man who experienced sudden hearing loss after receiving intramuscular tetanus and diphtheria vaccines and a subcutaneous meningococcal polysaccharide vaccine. Id. at 1. The article opines that “[s]udden neurosensory hearing loss (SHL) is usually idiopathic but in some cases it may be associated with infections, vasculitis, tumors, some genetic diseases and cardiovascular diseases.” Id. at 2. Although the authors posit that “[t]he close association between the vaccinations and the onset of hearing loss suggests . . . that it may be the result of an adverse reaction to vaccines,” they conclude that “[t]he cause of [their] patient’s neurosensory hearing loss remain[ed] unknown.” Id. at 4. Moreover, the authors admit that “the data on possible neurological collateral effects following vaccination in the literature are few and inconsistent.” Id. at 3. Ultimately, the authors conclude that “the sudden onset of transient sensorineural hearing loss is more likely to have been triggered by a post-vaccinal damage rather than onset of a new pathology,” but that the cause in this particular case remained “unknown.” Id. at 4. The other publication Dr. Brawer cites which involves the DTaP vaccination is that of Cabrera-Maqueda et al., entitled “Optic neuritis in pregnancy after Tdap vaccination: Report of two cases.” Pet’r’s Ex. 20, ECF No. 25-10. This publication involved case reports of two pregnant women who “developed one-eye blurring vision within three weeks after Tdap vaccination.” Id. at 1. This case study did not discuss SNHL, and ultimately concluded that “[w]hile [the authors] have no definitive link for the relationship between vaccination and [optic neuritis][,] causation is suggested” due to a variety of factors such as temporal relationship and lack of alternative etiology. Id. at 2-3. In his second report, Dr. Brawer supplements and confirms the opinion he provided in his first report. Pet’r’s Ex. 50. Overall, Dr. Brawer notes that he reviewed Dr. Kedl’s report and its summary of the relevant medical records of Ms. Herms, and that nothing refutes the fact that the vaccination “is solely the cause of her injury.” Id. at 1. In support of his theory of causation, Dr. Brawer cites four self-authored, peer-reviewed publications and “the persuasive medical theories” and “the sum total of the medical literature submitted as exhibits.” Id. at 1-2. On these 5 Case 1:19-vv-00070-CFL Document 152 Filed 08/15/24 Page 6 of 19 bases, Dr. Brawer reiterates his opinion that “there is a preponderance of evidence clearly demonstrating that petitioner’s vaccination was the reason for her injury.” Id. at 2. Dr. Marcel Kinsbourne, petitioner’s second expert, is a former licensed and board-certified pediatric neurologist, who has served as a professor at several institutions. See Pet’r’s Ex. 170, ECF No. 137-1. Dr. Kinsbourne provided two reports, the first establishing his theory of causation with respect to petitioner’s diagnosis, Pet’r’s Ex. 163, ECF No. 111-1, and the second addressing respondent’s expert report. Pet’r’s Ex. 164, ECF No. 123-1. In his first report, Dr. Kinsbourne provides an overview of SNHL and the various possible causes of inner ear damage, which he notes “can be caused by viral infections, genetic mutations, trauma, toxic agents, neoplastic diseases, vascular damage, and immune mechanisms.” Pet’r’s Ex. 163 at 2. He opines that “Ms. Herms had no evidence of any of the” pathologies he described as generally resulting in SNHL, “other than the close temporal relationship to the Tdap vaccination, which suggests an immune mechanism.” Id. Accordingly, he concludes “it is very likely that she was a victim of an isolated autoimmune attack.” Id. That Ms. Herms’ symptoms were treated with an oral corticosteroid, Dr. Kinsbourne explains, “implies an assumption of autoimmunity.” Id. at 2-3. Dr. Kinsbourne further summarizes various case reports of other instances where vaccinations were found to have triggered SNHL, although most of the case reports did not deal with the specific vaccination Ms. Herms received. Id. at 2-4. The case-centered study that did deal in part with both the DTaP vaccination and SNHL, authored by Baxter et. al, ultimately concluded that there was no “statistically significant” association between this vaccine (or any, for that matter), and SNHL. Id. at 4 (citing Pet’r’s Ex. 163-1 at 1, 5). The authors of that study further caution against assuming “that if an event follows immunization, it is due to immunization.” Pet’r’s Ex. 163-1 at 5. Ultimately, Dr. Kinsbourne’s report concluded that “[b]ased on the circumstantial evidence presented [in his report], it is [his] opinion, to a reasonable degree of medical probability, that the Tdap vaccination triggered an immune attack on Ms. Herms’ left inner ear, resulting in her permanent left-sided hearing loss.” Pet’r’s Ex. 163 at 5. Dr. Kinsbourne’s second report rebuts the report advanced by Dr. Kedl, respondent’s expert. Pet’r’s Ex. 164 at 1. Specifically, Dr. Kinsbourne contends that “Dr. Kedl did not confine himself to his field of specialization,” immunology, improperly opined on “the standard to which evidence in Vaccine Court proceedings should be held,” and failed to provide an alternative theory to molecular mimicry. Id. at 1-2. Dr. Kinsbourne also critiqued Dr. Kedl’s “reliance on epidemiological studies” because they often fail “to detect rare events, such as serious adverse effects of vaccinations,” and are “therefore a plentiful source of false negatives.” Id. at 3. Dr. Kinsbourne further insists the case reports he relies upon are not coincidental. Id. at 4. Finally, Dr. Kinsbourne argues that, as a researcher, Dr. Kedl lacks relevant experience with “the compromises that clinicians make when dealing with rare events involving individual patients.” Id. at 5. Dr. Kinsbourne states that “Dr. Kedl’s objections do not change [his] opinion that a Tdap vaccination caused/triggered Ms. Sally Herms’ acute unilateral hearing loss.” Id. 2. Respondent’s expert The government’s expert was Dr. Ross Kedl, an immunology professor and researcher with a PhD in pathobiology. Resp’t’s Ex. A at 1, ECF No. 44-1. In his first report, Dr. Kedl 6 Case 1:19-vv-00070-CFL Document 152 Filed 08/15/24 Page 7 of 19 responds to Dr. Brawer’s molecular mimicry theory, and opines that it “is an outdated theory that fails to accommodate known parameters of immunology, is fundamentally flawed in its assumptions[,] and as such is one of the most unlikely causes of Ms. Herms’ clinical manifestations.” Id. at 3-8. Relatedly, Dr. Kedl indicates that Dr. Brawer improperly ruled out alternative possible causes of Ms. Herms’ condition, namely the antibiotics she had taken, Ciprofloxacin and Bactrim. Id. at 3. He notes that Ciprofloxacin has “a well-established side effect [of] ototoxicity and hearing loss,” and that these antibiotics are often prescribed to treat ear infections. Id. Moreover, Dr. Kedl challenges the case studies cited by Dr. Brawer, because “medical case studies presuppose that a preceding event is a precipitating event. . . . In other words, the case is essentially built around coincidence.” Id. at 3-4. Dr. Kedl also debunks the theory of molecular mimicry, asserting that “a growing majority of immunologists question[ ]” the “usefulness” of the theory “in explaining autoimmune phenomenon,” and noting that “there are no human conditions in which molecular mimicry is a confirmed causal mechanism” because “antibodies or T cells cross reactive between infectious/vaccine antigens and self-antigens can never be convincingly shown to be the cause of autoimmunity and not the effect of tissue damage elicited by other means.” Id. Dr. Kedl then goes on to set out various reasons why he considers molecular mimicry to be “highly questionable as a relevant mechanism of pathology.” Id. at 4-8. Moreover, Dr. Kedl critiques that “Dr. Brawer has completely failed to lay out any logical course of events connecting Tdap antigens to ear-related antigens” in support of his proffered theory. Id. at 8. Ultimately, Dr. Kedl “conclude[s] that the preponderance of evidence does not support a vaccine-related cause for Ms. Herms’ hearing loss.” Id. In his second report, Dr. Kedl responds to petitioner’s supplemental materials. Resp’t’s Ex. C, ECF No. 121-1. With respect to Dr. Brawer’s supplemental report, Dr. Kedl asserts that “reliable scientific literature” has yet to confirm an association “between vaccines and hearing loss.” Id. at 1-2. He further notes that the articles Dr. Brawer cites “are authored by Dr. Brawer himself, and as such do not constitute robust evidence for anything other than Dr. Brawer’s already offered opinions.” Id. Dr. Kedl similarly critiques Dr. Kinsbourne’s report on the basis that it merely reiterates the lack of alternative possible causes for Ms. Herms’ condition “without being guided by a scientifically valid theory of causation.” Id. at 2. Relatedly, Dr. Kedl critiques the two additional sources supporting Dr. Kinsbourne’s report, noting that the first, a 1994 Institute of Medicine report, “has been superseded numerous times by more recent data” and that the cited portions “concern Guillain-Barre syndrome,” not SNHL or tinnitus. Id. at 2-3. And the remaining case studies “are all coincidence-based” and “do nothing to support a reliable theory of causation.” Id. As in his first report, Dr. Kedl then goes on to further his critique of molecular mimicry theory and contends that his opinions were not adequately addressed in the supplemental reports of petitioner’s experts. Id. at 3-6. Moreover, Dr. Kedl emphasizes that, even if molecular mimicry were a “reliable theory of causation,” the notion that Ms. Herms suffered an “inflammatory or immune-related medical incident” in this case is “preposterous,” given what he perceived as “the complete absence of any clinical signs of a local destructive inflammatory response” and the fact that “oral steroids had absolutely no benefit to Ms. Herms’ condition.” Id. at 4. As such, Dr. Kedl ultimately opines that Ms. Herms’ “condition appears nothing more than coincidental to her vaccination, and is, in [his] opinion, wholly insufficient to assign causation.” Id. 7 Case 1:19-vv-00070-CFL Document 152 Filed 08/15/24 Page 8 of 19 D. The Special Master’s Decision Ms. Herms filed her petition seeking compensation for her alleged vaccine injury on January 15, 2019. Pet., ECF No. 1. Per the parties’ agreement, the Special Master resolved petitioner’s case by ruling on the record rather than after an entitlement hearing. Joint Status Report of Feb. 6, 2023, ECF No. 129. Following briefing by the parties, the parties also stipulated to the following facts: petitioner received the DTaP vaccination at issue on June 18, 2017; “[t]wo days later, she experienced fever, muscle aches[,] and a feeling of being in a tunnel. She awoke and found she was deaf in her left ear. The following morning, she had tinnitus in her left ear.” See Joint Submission of Mar. 24, 2023, at 1. The parties did, however, dispute the issue of causation. The Special Master issued her decision finding petitioner was not entitled to compensation on March 4, 2024. See Entitlement Decision, 2024 WL 1340669. Petitioner timely sought review of that decision on April 3, 2024. Pet’r’s Mot.; see also Vaccine Rule 23(a) (providing that a motion for review must be filed “within 30 days after the date the [Special Master’s] decision is filed”). The Special Master applied the well-established Althen framework. Entitlement Decision, 2024 WL 1340669, at *1. The Althen framework requires that the petitioner establish by “preponderant evidence that the vaccination brought about [the] injury by providing: (1) a medical theory causally connecting the vaccination and the injury; (2) a logical sequence of cause and effect showing that the vaccination was the reason for the injury; and (3) a showing of a proximate temporal relationship between vaccination and injury.” 418 F.3d at 1278. The Special Master concluded that petitioner had “failed to establish by preponderant evidence that [the] DTaP vaccination she received caused her hearing loss and tinnitus.” Entitlement Decision, 2024 WL 1340669, at *27. Specifically, the Special Master concluded that petitioner had failed to establish by preponderant evidence any of the three Althen prongs. Id. at *23, 26. With respect to Althen prong one, the Special Master concluded petitioner “failed to provide preponderant evidence of a sound and reliable theory to explain how the DTaP vaccine can cause SNHL and tinnitus.” Entitlement Decision, 2024 WL 1340669, at *19. First, the Special Master concluded that Dr. Brawer provided opinions which were “not developed” and “conclusory in nature.” Id. Specifically, the Special Master pointed to the fact that Dr. Brawer’s initial expert report “does not explain SNHL, the pathogenesis of the illness, or provide evidence for his conclusions that it can be caused by vaccination.” Id. Similarly, the Special Master noted that Dr. Brawer “does not explain how molecular mimicry explains hearing loss due to the DTaP vaccination.” Id. In the same vein, the Special Master commented that although Dr. Brawer “provide[d] another long list of other mechanisms for autoimmune conditions,” he did not “explain why this list is relevant or describe how any of the mechanisms can cause hearing loss after vaccination.” Id. The Special Master also found Dr. Kinsbourne’s report unpersuasive, noting that the literature he cites considers viral infection but not vaccination, “as a trigger for immune- mediated hearing loss.” Entitlement Decision, 2024 WL 1340669, at *19-20. Moreover, the Special Master indicated that, although Dr. Kinsbourne explained that vaccines are meant to “elicit an immune reaction against the relevant antigen, like the immune reaction to the 8 Case 1:19-vv-00070-CFL Document 152 Filed 08/15/24 Page 9 of 19 corresponding infection,” id. at *20 (quoting Pet’r’s Ex. 163 at 2), he did not “discuss the corresponding infection here” and thus failed to fully connect the causal theory. Id. Conversely, the Special Master was persuaded by Dr. Kedl’s opinion that molecular mimicry was a “‘highly questionable’” theory, and that “[b]ased on the current understanding of immune-mediated hearing loss as described in the literature filed herein, [p]etitioner’s proposed mechanisms fall short of sound and reliable, are conclusory in nature, and vague.” Entitlement Decision, 2024 WL 1340669, at *20 (citing Resp’t’s Ex. A at 4). Although the Special Master did not require that petitioner identify any “specific antigenic trigger for an immune-mediated pathology,” she did conclude that “generally opining that molecular mimicry is a causal theory, without more, is insufficient,” and petitioner’s citations to case reports were largely irrelevant in establishing her claimed theory. Id. at *20-21. With respect to the second Althen prong, the Special Master concluded Ms. Herms failed to establish a logical connection between her vaccine and her ensuing condition. Entitlement Decision, 2024 WL 1340669, at *23. As a threshold matter, although the Special Master noted that because Ms. Herms “failed to prove Althen prong one, it follows that she cannot prove Althen prong two,” the Special Master nevertheless assessed prong two. Id. The Special Master identified that Ms. Herms “did not have any significant response to the steroids” prescribed to her, even though “[t]he medical literature cited by the parties establishes that SNHL thought to be autoimmune is treated with corticosteroids.” Id. Moreover, the Special Master explained that Ms. Herms’ treating physicians seemed to provide either unreasoned explanations for their opinion regarding the cause of Ms. Herms’ condition, or explanations based on temporal association or the elimination of alternative causes. Id. at *24-26. As such, the Special Master concluded that Ms. Herms did not establish “a logical sequence of cause and effect” connecting the vaccine to her condition. Id. at *26. Finally, the Special Master concluded that the temporal proximity between when Ms. Herms was vaccinated and when her symptoms began alone is insufficient to establish her burden under Althen prong three. Entitlement Decision, 2024 WL 1340669, at *26. Specifically, the Special Master reasoned that Ms. Herms’ experts fail to explain how the onset of her symptoms falls within “a medically acceptable timeframe pursuant to the mechanisms discussed,” nor do they “provide any explanation of how [the timing of her symptom onset] is consistent with autoimmunity induced hearing loss.” Id. Accordingly, because Ms. Herms’ arguments regarding temporal proximity were “not developed within the context of a supportive theory of causation,” the Special Master concluded the third Althen prong had not been satisfied. Id. at *26-27. STANDARDS FOR REVIEW The Vaccine Act gives this court jurisdiction to review a Special Master’s decision regarding whether a petitioner who alleges they suffered a vaccine-related injury is entitled to compensation. 42 U.S.C. § 300aa-12(e)(1)-(2). Pursuant to the Vaccine Act, the court may: (1) “uphold the findings of fact and conclusions of law of the special master and sustain the special master's decision”; (2) “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 9 Case 1:19-vv-00070-CFL Document 152 Filed 08/15/24 Page 10 of 19 and issue its own findings of fact and conclusions of law”; or (3) “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). Ultimately, the court’s review of a Special Master’s decision is “uniquely deferential” and “on review, [this court] is not to second guess the Special Masters[’] fact-intensive conclusions.” Hodges v. Sec’y of Health & Hum. Servs., 9 F.3d 958, 961 (Fed. Cir. 1993). Put differently, this 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” as “these are all matters within the purview of the fact finder.” Paluck ex rel. Paluck v. Sec’y of Health & Hum. Servs., 104 Fed. Cl. 457, 467 (2012) (quoting Porter v. Sec’y of Health & Hum. Servs., 663 F.3d 1242, 1249 (Fed. Cir. 2011)). Rather, the court will uphold the Special Master’s determination as long as the findings are “based on evidence in the record that [is] not wholly implausible.” Id. (quoting Lampe v. Sec’y of Health & Hum. Servs., 219 F.3d 1357, 1363 (Fed. Cir. 2000)). Moreover, the court’s deference in reviewing the decision of a Special Master “is especially apt in a case in which the medical evidence of causation is in dispute.” Id. (quoting Hodges v. Sec’y of Health & Hum. Servs., 9 F.3d 958, 961 (Fed. Cir. 1993)). Ultimately, although the court’s review of a Special Master’s decision “is not a rubber stamp,” Porter, 663 F.3d at 1256 (O’Malley, J., concurring in part and dissenting in part), it is indeed a highly deferential one, as “reversible error will be extremely difficult to demonstrate” as long as “the special master has considered the relevant evidence of record, drawn plausible inferences and articulated a rational basis for the decision.” Hines ex rel. Sevier v. Sec’y of Dep’t of Health & Hum. Servs., 940 F.2d 1518, 1528 (Fed. Cir. 1991). ANALYSIS At issue is the Special Master’s finding that petitioner failed to establish causation. In Althen, the United States Court of Appeals for the Federal Circuit held that a petitioner seeking to prove causation in an off-table vaccine case must establish 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. 418 F.3d at 1278. The Federal Circuit has further articulated, with respect to this causation framework, that “[a] persuasive medical theory is demonstrated by proof of a logical sequence of cause and effect showing that the vaccination was the reason for the injury[,] the logical sequence being supported by reputable medical or scientific explanation, i.e., evidence in the form of scientific studies or expert medical testimony.” Althen, 418 F.3d at 1278 (internal citation and quotation marks omitted). With respect to the petitioner’s burden of proof, the Federal Circuit has clarified that preponderant evidence is analogous to a showing of “more probable than not causation.” Id. at 1279 (internal citation and quotation marks omitted). The preponderant-evidence standard, 10 Case 1:19-vv-00070-CFL Document 152 Filed 08/15/24 Page 11 of 19 however, does not require a showing of “scientific certainty,” Bunting v. Sec’y of Health & Hum. Servs., 931 F.2d 867, 873 (Fed. Cir. 1991), as establishing “causation in fact under the Vaccine Act involves ascertaining whether a sequence of cause and effect is logical and legally probable, not medically or scientifically certain.” Knudsen ex rel. Knudsen v. Sec’y of Health & Hum. Servs., 35 F.3d 543, 548-49 (Fed. Cir. 1994) (internal quotation marks omitted). To establish causation by a preponderance of the evidence, the petitioner’s theory must be supported by either medical records or an opinion advanced by a medical doctor. See 42 U.S.C. § 300aa-13(a)(1). In assessing a theory of causation based on an expert witness’ medical opinion, “the special master is entitled to require some indicia of reliability to support the assertion of the expert witness.” Moberly v. Sec’y of Health & Hum. Servs., 592 F.3d 1315, 1324 (Fed. Cir. 2010). As the Federal Circuit has stated, “one factor in assessing the reliability of expert testimony is whether the theory espoused enjoys general acceptance within a relevant scientific community.” Andreu ex rel. Andreu v. Sec’y of Health & Hum. Servs., 569 F.3d 1367, 1379 (Fed. Cir. 2009) (citing Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579, 593-97 (1993)). In her motion for review, Ms. Herms lodges two main objections to the Special Master’s entitlement decision. Pet’r’s Mot. at 1-2. First, petitioner asserts “it is error to ignore the opinions of treating physicians that the DTaP was causative” because her injury is “consistent with an autoimmune attack,” “occur[red] within two days of a DTaP vaccination, a vaccine known to cause autoimmune injur[i]es,” and “no explanation for that injury exists except for the DTaP vaccination.” Id. Put differently, this would amount to “finding that the injury is idiopathic” in violation of 42 U.S.C. § 300aa-13(a)(2)(A). Id.4 Second, petitioner asserts it is 4 This assertion takes the cited statutory sub-section out of context. Indeed, this sub- section refers to the fact that compensation shall be awarded if the Special Master determines “(A) that the petitioner has demonstrated by a preponderance of the evidence the matters required in the petition by section 300aa-11(c)(1) of this title, and (B) that there is not a preponderance of the evidence that the illness, disability, injury, condition, or death described in the petition is due to factors unrelated to the administration of the vaccine described in the petition,” and where “the term ‘factors unrelated to the administration of the vaccine’” “does not include any idiopathic, unexplained, unknown, hypothetical, or undocumentable cause, factor, injury, illness, or condition.” 42 U.S.C. § 300aa-13(a)(1)-(2). This means that in instances where the petitioner successfully establishes a prima facie case, “the burden shifts to respondent to demonstrate by a preponderance of the evidence that a ‘factor unrelated’ to the vaccine ‘was the sole substantial factor in bringing about the injury.’” Hammitt ex rel. Hammitt v. Sec’y of Health & Hum. Servs., 98 Fed. Cl. 719, 726 (2011), aff’d sub nom. Stone v. Sec’y of Health & Hum. Servs., 676 F.3d 1373 (Fed. Cir. 2012) (quoting de Bazan v. Sec’y of Health & Hum. Servs., 539 F.3d 1347, 1354 (Fed. Cir. 2008)) (citing 42 U.S.C. § 300aa-13(a)). Here, the Special Master never found that petitioner had established a prima facie case, and thus such burden-shifting is inapposite. And regardless, the Special Master made no such finding regarding idiopathy. While the Special Master did reference medical literature concluding that “the causal mechanism of 11 Case 1:19-vv-00070-CFL Document 152 Filed 08/15/24 Page 12 of 19 error to ignore an opinion offered by a treating physician who “is one of the top experts in his/her field,” where the opinion is “based upon his/her review of the case including all relevant tests, and after a full examination of the [p]etitioner,” and “no contrary evidence exists.” Id. at 2, 10-11. In support of her objections, Ms. Herms largely recapitulates the facts she presented in support of her original claim, including her symptoms, physician visits and corresponding impressions, and expert opinions and corresponding publications. See generally id. at 2-11 (detailing “[f]acts [a]pplicable to both [o]bjections”). Overall, Ms. Herms’ motion for review revolves around the notion that the Special Master should have afforded more weight to the opinions of her treating physicians who, as petitioner pronounces, “have agreed that the vaccine caused this loss.” Pet’r’s Mot. at 7-8. Specifically, Ms. Herms avers that she has, contrary to the Special Master’s conclusion, established Althen prong one, as she “has provided a sound and reliable medical or scientific explanation that pertains specifically to this case.” Id. at 8. Specifically, Ms. Herms contends that she “can establish entitlement to compensation based upon the opinions of her treating physicians,” id. at 9 (citing 42 U.S.C. § 300aa-13(a)(1)),5 as summarized in her motion for review, and “[t]he fact that these physicians’ diagnoses relied largely on the temporal proximity of Ms. Herm[s’] injuries to the administration of the vaccine is not disqualifying.” Id. (citing Capizzano v. Sec’y of Dep’t of Health & Hum. Servs., No. 00-759V, 2004 WL 1399178, at *25 (Fed. Cl. June 8, 2004)). To this effect, petitioner contends that her experts’ medical opinions are “quite probative” because the “close temporal proximity, combined with the finding that a vaccine can cause an autoimmune reaction which is a vaccine injury, demonstrates that it is logical to conclude that the vaccine was the cause of Ms. Herms[’] injury.” Id. Relatedly, petitioner suggests that the Special Master improperly elevated her burden of proof “beyond possibility,” by refusing to accept the conclusions of her treating physicians as evidence of causation and requiring her to identify a “perfect” causal theory in support of her condition. See Hr’g Tr. 20:10 to 21:9. Ms. Herms also challenges the Special Master’s decisions to disregard “literature related to autoimmune studies that did not mention DTaP vaccine or similar events” as well as petitioner’s causal theory for “a lack of specific references to Ms. Herm[s’] situation.” Pet’r’s Mot. at 11. In support of her objection, Ms. Herms re-emphasizes that “[t]he record provides no explanation other than the presence of DTaP [of why] this damage occurred,” and that immune-mediated SNHL is unknown,” Entitlement Decision, 2024 WL 1340669, at *20, this was by no means foundational to the Special Master’s causation analysis. Rather, the Special Master’s decision went on to reasonably critique the fact that petitioner failed to articulate a plausible causal theory or adequately support her claim that the DTaP vaccination caused her injuries. Id. at *20-21; see also Hr’g Tr. 21:20 to 22:23. That the Special Master concluded petitioner did not sufficiently establish causation does not mean the Special Master ultimately determined petitioner’s condition was idiopathic. 5 Petitioner cites 42 U.S.C. § 2000aa-13(a)(1), but as this provision is unrelated to the vaccine case at hand, the court reads this as a typographical error with respect to the sub-section cited. 12 Case 1:19-vv-00070-CFL Document 152 Filed 08/15/24 Page 13 of 19 “[i]gnoring the opinions of treating physicians” to this effect, and instead classifying Ms. Herms’ injuries as idiopathic, was erroneous. Id.6 Finally, petitioner disputes the conclusion that the steroidal taper of prednisone prescribed on June 29, 2017, was ineffective. See Hr’g Tr. 5:13 to 6:24, 10:1-17, 25:19 to 26:24; see also Pet’r’s Ex. 1 at 4. Specifically, petitioner indicated that both the experts and the Special Master seemed to ignore the fact that, weeks after the steroidal taper was prescribed, Ms. Herms experienced “good improvement of her speech discrimination.” Pet’r’s Ex. 1 at 20, as well as “improvement [of] 3 [kilohertz] [to] 8 [kilohertz] compared to” her hearing test on June 29, 2017. Id. at 16; see also Pet’r’s Ex. 163 at 1; Resp’t’s Ex. C at 4. Petitioner’s argument to this effect seems to be premised on the assumption that improvement following a steroidal taper treatment indicates an autoimmune reaction, and that the Special Master failed to identify that such improvement took place. See, e.g., Entitlement Decision, 2024 WL 1340669, at *14 (noting that “Dr. Kinsbourne acknowledged ‘[o]ral steroids conveyed no benefit’ to [p]etitioner here”); see also Pet’r’s Ex. 163 at 5 (Dr. Kinsbourne’s explanation that “treatment with steroids would be appropriate if the mechanism of injury were autoimmune.”). In response, the government contends that, contrary to petitioner’s assertions, “the Special Master applied the correct legal standards, considered all the relevant evidence, and articulated a rational basis for her [d]ecision.” Resp’t’s Resp. at 6. Accordingly, the Special Master “properly concluded that vaccine causation had not been proven, and there are no grounds upon which to disturb her [d]ecision.” Id. Ultimately, respondent asserts that “[p]etitioner’s arguments amount to a request that this [c]ourt reweigh the evidence and substitute its own judgment in order to reach a different conclusion than the Special Master reached,” but that petitioner makes this request without “showing that the Special Master erred.” Id. at 5-6. Regarding Althen prong one, respondent asserts that “the Special Master applied the correct legal standard” regarding whether petitioner established a sound and reliable medical theory, and that her factual findings “were based on the evidence as a whole, were rationally explained, and were supported by the record.” Resp’t’s Resp. at 6-9. Specifically, respondent avers the Special Master correctly identified that the theory petitioner advanced—and the corresponding expert opinions provided in support—were overly general and failed to explain the particular pathogenesis of SNHL or how molecular mimicry could have triggered this condition in petitioner’s case. Id. at 7-9. Ultimately, respondent argues that the Special Master appropriately assessed the medical theory advanced by petitioner under Althen prong one, and rendered rational and supported factual findings to that effect. Id. at 9. 6 Ms. Herms, at several points in her motion, asserts that the Special Master erred by “ignoring the opinions of [her] treating physicians.” Pet’r’s Mot. at 2, 11. The court finds that, far from ignoring such opinions, the Special Master undertook a “meticulous review,” Moberly ex rel. Moberly v. Sec’y of Health & Hum. Servs., 592 F.3d 1315, 1323 (Fed. Cir. 2010), of petitioner’s medical records, expert testimony, and record as a whole, in rendering her ultimate assessments. 13 Case 1:19-vv-00070-CFL Document 152 Filed 08/15/24 Page 14 of 19 Second, respondent asserts that the Special Master properly analyzed whether petitioner established a logical sequence of cause and effect connecting her claimed injury to the vaccine under Althen prong two, even though she “was under no obligation” to do so. Resp’t’s Resp. at 9-12. According to respondent, that petitioner disagrees with the Special Master’s findings is insufficient to disturb them under this court’s deferential review. Id. at 9-10. Relatedly, respondent contends petitioner’s argument that the Special Master “minimized the opinions of her treating physicians and erroneously elevated her burden of proof” represents “another inappropriate attempt to have this [c]ourt reweigh the evidence” on review. Id. at 10. Ultimately, respondent emphasizes that the Special Master’s assessment of the record was entirely reasonable, and the court should deny petitioner’s request to “reweigh evidence or substitute its judgment for that of the Special Master.” Id. at 10-12. The court finds that the Special Master’s decision has a rational basis in the record and properly applied the relevant law. First, the Special Master properly concluded that, without more, a medical theory predicated predominantly on temporal proximity is insufficient to establish causation under Althen prong one. As this court has stated, “a temporal relationship alone will not demonstrate the requisite causal link.” Veryzer v. Sec’y of Health & Hum. Servs., 100 Fed. Cl. 344, 356 (2011), aff’d sub nom. Veryzer v. United States, 475 F. App’x 765 (Fed. Cir. 2012). Instead, “the proximate temporal relationship prong” also “requires preponderant proof that the onset of symptoms occurred within a timeframe for which, given the medical understanding of the disorder’s etiology, it is medically acceptable to infer causation-in-fact.” de Bazan, 539 F.3d at 1352. In this case, petitioner relies on the temporal proximity of her symptom onset without proffering a sufficiently particularized causal theory that is sound and reliable considering the specific etiology of her condition. As such, although it is the case that Ms. Herms’ treating physicians highlighted the close temporal proximity between her vaccination and the onset of her symptoms, it was reasonable for the Special Master to conclude that such proximity was insufficient to infer causation here, when petitioner did not advance an appropriately sound and reliable medical theory connecting her condition to the vaccine in this particular case. Accordingly, the Special Master gave due consideration to the timing of Ms. Herms’ injury in relation to her vaccination. The Special Master also gave adequate consideration to the publications Ms. Herms cites for the proposition that the DTaP vaccine is “known to cause autoimmune injur[i]es.” Pet’r’s Mot. at 1. The Special Master noted many of the articles petitioner put forth to support her claim involved vaccinations other than the DTaP vaccination. See, e.g., Pet’r’s Exs. 14-17; see also Entitlement Decision, 2024 WL 1340669, at *19. Those that did involve the DTaP vaccination afforded at most weak support for petitioner’s claim. For instance, the De Marco publication concluded that the cause of the patient’s sudden hearing loss was, ultimately, “unknown.” Pet’r’s Ex. 11 at 2-3. Moreover, the Cabrera-Maqueda study covered the cases of two pregnant women who developed a different condition—optic neuritis—following a DTaP vaccination, and the authors concluded that there was “no definitive link” between the condition and the vaccination. Pet’r’s Ex. 20 at 2-3. And finally, the Baxter et al. case-centered study of the possible association between vaccination and sudden SNHL found no “statistically significant” association or increased risk between the DTaP vaccine and sudden SNHL. Indeed, it even cautioned against the “fallacy” “that if an event follows immunization, it is due to immunization,” because “some adverse events are bound to happen shortly after immunization, 14 Case 1:19-vv-00070-CFL Document 152 Filed 08/15/24 Page 15 of 19 due to random chance alone.” Pet’r’s Ex. 163-1 at 1, 5 (emphasis added); see also Pet’r’s Ex. 163-5 at 12 (identifying that although “[c]ases of SNHL have been reported in the literature after receipt of certain immunizations . . . a causal association has not been established”). As such, although Ms. Herms points to a multitude of publications involving vaccinations and resulting injuries generally, these articles mostly deal with different vaccinations, different conditions, or both. Those that do deal with the vaccination or conditions at issue in this case are inconclusive at best regarding causation. Therefore, the Special Master gave proper consideration to petitioner’s cited publications. Moreover, the Special Master reasonably concluded that petitioner failed to demonstrate a sound and reliable medical theory in this case. “[T]he mere mention of [molecular mimicry] does not constitute satisfaction of the preponderant evidentiary standard,” as petitioner must actually demonstrate “that the mechanism likely does link the vaccine in question to the relevant injury.” Loyd v. Sec’y of Health & Hum. Servs., 2021 WL 2708941, at *31 (Fed. Cl. Spec. Mstr. May 20, 2021), aff’d, 2023 WL 1878572 (Fed. Cir. Feb. 10, 2023). Here, the Special Master found that petitioner’s contentions and expert reports described molecular mimicry at only a high level and failed to apply the theory with particularity to connect petitioner’s hearing loss to the DTaP vaccination specifically. See Entitlement Decision, 2024 WL 1340669, at *19-20; see also Pet’r’s Ex. 10 at 3 (opining generally that “[i]t has been known for well over 20 years that there exists a cross reactivity between routinely used vaccine materials and self-antigens in the body”); Pet’r’s Ex. 164 at 2 (asserting broadly that “[l]ists of alternative mechanisms of autoimmunity continue to feature molecular mimicry”). The Special Master’s conclusion that petitioner’s medical theory was not sound and reliable is also supported by contrary evidence in the record. See, e.g., Resp’t’s Ex. A at 3 (opining that “molecular mimicry is an outdated theory that fails to accommodate known parameters of immunology [and] is fundamentally flawed in its assumptions”); Resp’t’s Ex. C at 6 (identifying that “[t]he scientific community has rejected molecular mimicry as a basis for a reliable theory of vaccine causation”). Ultimately, the court concludes the Special Master’s analysis of petitioner’s molecular mimicry theory is adequately supported by the record. The Special Master also properly concluded that there was insufficient circumstantial evidence to support petitioner’s medical theory. Although extrapolation from indirect or circumstantial evidence may be warranted in certain cases, see K.O. v. Sec’y of Health & Hum. Servs., No. 13-472V, 2016 WL 7634491, at *12 (Fed. Cl. Spec. Mstr. July 7, 2016), the Special Master rationally concluded that petitioner did not put forth sufficiently “transparent” or “persuasive” reasons to draw such extrapolations in this case. Indeed, petitioner did nothing to explain how such circumstantial evidence “could be extrapolated to the vaccines at issue here.” Entitlement Decision, 2024 WL 1340669, at *21; see also Resp’t’s Resp. at 7-8. The court also rejects Ms. Herms’ assertion that the Special Master erred by not finding causation considering alternative possible causes of Ms. Herms’ symptoms had been eliminated. Pet’r’s Mot. at 1-2. While Dr. Brawer opined that Ms. Herms’ condition was not attributable to another known cause, see, e.g., Pet’r’s Ex. 10 at 5, eliminating alternative causes is insufficient on its own to establish causation. Althen, 418 F.3d at 1278; see also Welch v. Sec’y of Health & Hum. Servs., No. 18-494V, 2019 WL 3494360, at *13 (Fed. Cl. July 2, 2019) (“[M]erely eliminating possible alternative causes does not establish causation.”). As such, the Special 15 Case 1:19-vv-00070-CFL Document 152 Filed 08/15/24 Page 16 of 19 Master did not err in declining to find causation based on the elimination of alternate causes of Ms. Herms’ condition. In the circumstances, the court finds it was rational for the Special Master to find that petitioner failed to establish a sound and reliable medical theory under Althen prong one. Although the Special Master was not obligated to do so, she proceeded to assess whether petitioner had satisfied Althen prong two. Entitlement Decision, 2024 WL 1340669, at *23-26. Petitioner’s argument under prong two focuses again on the Special Master’s consideration of petitioner’s treating physicians’ diagnoses. Petitioner also contends the Special Master ignored evidence that her condition improved following treatment. Pet’r’s Mot. at 2.7 While the opinions of treating physicians are generally given preferential weight, Capizzano v. Sec’y of Health & Hum. Servs., 440 F.3d 1317, 1326 (Fed. Cir. 2006), such opinions are not “sacrosanct,” Snyder ex rel. Snyder v. Sec’y of Health & Hum. Servs., 88 Fed. Cl. 706, 746 n.67 (2009). They are still assessed for their underlying reasonableness. Welch v. Sec’y of Health & Hum. Servs., No. 18-494V, 2019 WL 3494360, at *8 (Fed. Cl. Spec. Mstr. July 2, 2019). Here, the Special Master concluded that the treating physicians’ conclusions were not sufficiently persuasive in light of the record as a whole, and in the absence of an underlying sound and reliable medical theory explaining petitioner’s condition. Entitlement Decision, 2024 WL 1340669, at *23-25. The Special Master’s assessment is rational and this court may not re- engage in that assessment or reweigh the strength of those opinions on review. The Special Master found evidence from petitioner’s treating physicians unpersuasive because the treating physicians’ opinions were relatively generic or seemed to be based primarily on temporal proximity. Although petitioner’s treating physicians do attribute her condition to her vaccination, they do so in a conclusory manner. For instance, Dr. Shariati, Ms. Herms’ primary care physician, posited that Ms. Herms’ symptoms were “[p]robable side effects” and that her condition “was contributed from” the vaccine, but did not identify particular features of petitioner’s condition supporting this statement. See Pet Ex. 1 at 1; Pet’r’s Ex. 1-2 at 2; see also Pet’r’s Ex. 1-2 at 6 (noting petitioner’s condition was “presumably secondary” to her vaccination). The Special Master’s decision to afford little weight to “statements of mere suspicion”—which “fall short of an opinion supporting a vaccine-causation of petitioner’s condition”—was reasonable and within the discretion afforded to special masters in weighing the 7 Ms. Herms provides an excerpt of the credentials of one of her treating physicians, Dr. Selesnick, as well as a citation to a portion of Richardson v. Perales, 402 U.S. 389, 402 (1971), in which the Supreme Court discussed the evidentiary nature of a licensed physician’s written report. Pet’r’s Mot. at 6-7. As the Federal Circuit has previously stated, however, this court’s deferential standard of review does not permit the court to “examine the probative value of the evidence or the credibility of the witnesses.” Porter v. Sec’y of Health & Hum. Servs., 663 F.3d 1242, 1249 (Fed. Cir. 2011). And given that the citation to Dr. Selesnick’s credentials would, if anything, go to his credibility, it is not pertinent to the court’s analysis at this time. Likewise, petitioner’s citation to the Supreme Court’s decision in Richardson, 402 U.S. at 402, is inapposite as it deals primarily with admissibility considerations surrounding a physician’s report that are not at issue here. 16 Case 1:19-vv-00070-CFL Document 152 Filed 08/15/24 Page 17 of 19 evidence in the record before them. See Robertson v. Sec’y of Health & Hum. Servs., No. 18- 554V, 2022 WL 17484980, at *17 (Fed. Cl. Spec. Mstr. Dec. 7, 2022); see also Whitecotton v. Sec’y of Health & Hum. Servs., 81 F.3d 1099, 1108 (Fed. Cir. 1996) (“Congress desired the special masters to have very wide discretion with respect to the evidence they would consider and the weight to be assigned that evidence.”). Moreover, the explanations provided by petitioner’s treating physicians seem to primarily revolve around the temporal proximity between vaccination and symptom onset, without offering much by way of causal explanation. See, e.g., Pet’r’s Ex. 1 at 27 (opining “it is likely that the vaccine is at least in some way responsible” for Ms. Herms’ condition “[d]ue to the close time proximity” between vaccination and symptom onset). Such statements, without more, are insufficient to establish causation. Veryzer, 100 Fed. Cl. at 356. As such, it was reasonable for the Special Master to determine that these statements by petitioner’s treating physicians failed to establish causation. Further, the court disagrees with petitioner’s suggestion that the Special Master erroneously elevated her burden of proof “beyond possibility” by requiring her to establish a “perfect” medical theory in support of causation. Hr’g Tr. 20:10 to 21:9. Indeed, the Special Master herself stated that “[p]etitioner need not make a specific type of evidentiary showing or require identification of a specific antigenic trigger for an immune-mediated pathology” because such proof “would require scientific certainty, which is a bar too high” “[g]iven the state of current scientific knowledge.” Entitlement Decision, 2024 WL 1340669, at *20. As such, the Special Master did not require a scientifically certain, or “perfect” causal theory in support of petitioner’s condition. Rather, as evidenced by the foregoing, the Special Master rationally concluded that petitioner failed to provide preponderant evidence in support of her causal theory. Id. at *22-23. Finally, petitioner has suggested—for the first time during oral argument in this court’s motion hearing—that the Special Master overlooked the improvement in petitioner’s audiological test results between her first hearing test on June 29, 2017, and her second on July 18, 2018. See Hr’g Tr. 5:13 to 6:24, 10:1-17, 25:19 to 26:24. Specifically, in analyzing the second Althen prong, the Special Master articulated that “[t]he medical literature cited by the parties establishes that SNHL thought to be autoimmune is treated with corticosteroids” and “the experts agree that [p]etitioner did not have any significant response to the steroids” she was prescribed. Entitlement Decision, 2024 WL 1340669, at *23 (citing Pet’r’s Ex. 163 at 1; Pet’r’s Ex. 10 at 1; Resp’t’s Ex. C at 4). Contrary to petitioner’s argument, however, the Special Master specifically identified that “[p]etitioner’s hearing test, performed July 18, 2017,” following petitioner’s steroidal taper, “showed ‘good improvement of her speech discrimination[’].” Id. at *4 (emphasis added).8 In her assessment of Althen prong two, the Special Master concluded not that Ms. Herms had no response at all to the steroids, but that she did not have “any significant 8 Moreover, the Federal Circuit has indicated that there is a presumption that a Special Master has considered all evidence in the record, unless there is an indication to the contrary. Hazlehurst v. Sec’y of Health & Hum. Servs., 604 F.3d 1343, 1352 (Fed. Cir. 2010). Here, far from being selective in her review, the Special Master was quite thorough in assessing the record before her, as outlined in her thirty-five-page decision. 17 Case 1:19-vv-00070-CFL Document 152 Filed 08/15/24 Page 18 of 19 response.” Id. at *23 (emphasis added) (quoting Pet’r’s Ex. 1 at 18-20). This indicates the Special Master was aware of some improvement to Ms. Herms’ condition. Moreover, notwithstanding the ambiguity surrounding the possible improvement to petitioner’s condition following steroids, the Special Master also included a citation to the record which explains that “a treatment response or its failure is not in itself diagnostic of SNHL” and therefore that “treatment or treatment response” had not been utilized “towards the fulfillment of the SNHL case definition.” See Pet’r’s Ex. 163-5 at 12; see also Entitlement Decision, 2024 WL 1340669, at *23. So, even if the Special Master overlooked evidence that Ms. Herms’ condition did improve following her steroidal treatment, she still could have rationally concluded, based on the record, that causation had not been established. As such, the court finds no error in the Special Master’s consideration of evidence that petitioner’s steroidal treatment improved some of her symptoms. Relatedly, the court identifies a possible inconsistency in the factual record regarding whether Ms. Herms suffered a “local destructive inflammatory response” that could indicate an “inflammatory or immune-related medical incident.” Resp’t’s Ex. C at 4. According to Dr. Kedl, Ms. Herms’ symptoms arose too quickly after vaccination to be attributable to an immune response. Id. at 4. Dr. Kedl found the immune-response mechanism even less plausible based on “the complete absence of any clinical signs of a local destructive inflammatory response.” Id. But, Ms. Herms’ medical records indicate her III through XII cranial nerves “were grossly intact with the exception of the left VIII[] cranial nerve.” Pet’r’s Ex. 1 at 27 (emphasis added). In his first expert report, Dr. Kedl confirmed that he reviewed petitioner’s medical records. See Resp’t’s Ex. A at 2. It is possible that Dr. Kedl identified the aberration to Ms. Herms’ left, eighth cranial nerve, and simply concluded it did not amount to a “clinical sign[] of a local destructive inflammatory response.” Resp’t’s Ex. C at 4. Alternatively, Dr. Kedl may have overlooked this fact. Regardless, the Special Master did not. She expressly identified that petitioner’s medical records indicated that her left, eighth cranial nerve had been damaged. Entitlement Decision, 2024 WL 1340669, at *5 (citing Pet’r’s Ex. 1 at 27). With this fact in mind, the Special Master found Dr. Kedl’s reasoning persuasive. Id. at *16 (citing Resp’t’s Ex. C at 3-4). This was reasonable because Dr. Kedl explained other features of Ms. Herms’ condition that undermined the immune response theory, namely that she suffered “complete hearing loss, in only one ear.” Resp’t’s Ex. C at 4. Accordingly, even if respondent’s expert and the Special Master had both identified a local destructive inflammatory response in petitioner’s left ear, the Special Master nonetheless could have reasonably ruled out petitioner’s medical theory based on all the evidence taken together. As such, neither evidence that the steroidal taper administered to Ms. Herms caused some improvement nor evidence of a local destructive inflammatory response provides sufficient grounds for this court to disturb the Special Master’s rational decision. CONCLUSION Based on the foregoing, petitioner’s motion for review of the Special Master’s March 4, 2024, entitlement ruling is DENIED and the Special Master’s entitlement ruling is AFFIRMED. The Clerk is DIRECTED to enter judgment in accordance with this opinion. 18 Case 1:19-vv-00070-CFL Document 152 Filed 08/15/24 Page 19 of 19 It is so ORDERED. s/ Charles F. Lettow Charles F. Lettow Senior Judge 19