VICP Registry Case Source Bundle Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_15-vv-00124 Package ID: USCOURTS-cofc-1_15-vv-00124 Petitioner: L.T. Filed: 2019-12-10 Decided: 2022-09-16 Vaccine: hepatitis B Vaccination date: 2012-11-06 Condition: alopecia areata Outcome: compensated Award amount USD: 259107 AI-assisted case summary: On February 9, 2015, Christine DeLozier, as parent and next friend of L.T., a minor, filed a petition seeking compensation under the National Vaccine Injury Compensation Program. Petitioner alleged that L.T. suffered from alopecia areata (AA) attributable to a hepatitis B vaccine (HBV vaccine) L.T. received on November 6, 2012. L.T. was three years old at the time of vaccination. Within days of receiving the vaccine, L.T. developed hair loss, joint pain, and a rash. A dermatologist diagnosed AA and noted a possible link to the vaccine. L.T. had a history of eczema and asthma, and a family history of autoimmune disease. An entitlement hearing was held, and on December 10, 2019, Chief Special Master Brian H. Corcoran issued a ruling finding that Petitioner had preponderantly established that the HBV vaccine could trigger an autoimmune response resulting in a single AA occurrence, and that this occurred in L.T.'s case. Petitioner was therefore entitled to damages associated with that first occurrence. However, the Chief Special Master did not find that the evidence supported the contention that all subsequent outbreaks of AA were attributable to the 2012 vaccination, and thus denied compensation for those recurrences. A damages decision followed on August 11, 2020, where the Chief Special Master awarded $50,000.00 for actual pain and suffering related to the first occurrence of AA. Petitioner then filed a motion for review, which was granted by Senior Judge Mary Ellen Coster Williams. The case was remanded to the Chief Special Master for a reassessment of damages to include subsequent and future recurrences of AA, recognizing it as a chronic, waxing-and-waning condition. On remand, Special Master Nora Beth Dorsey issued a decision on September 16, 2022. The final award included a lump sum payment of $257,153.97 for life care expenses and pain and suffering, a lump sum payment of $1,953.34 to satisfy a Medicaid lien, and an amount sufficient to purchase an annuity contract for future life care items. The total award, including the annuity, was $259,107.31. Petitioner was represented by Richard Gage, P.C., and Respondent was represented by the U.S. Department of Justice. Theory of causation field: Petitioner Christine DeLozier, on behalf of minor L.T., alleged that a hepatitis B vaccine administered on November 6, 2012, caused alopecia areata (AA). The Chief Special Master found that the HBV vaccine could cause AA and did cause L.T.'s first occurrence of AA, which began within days of vaccination. Petitioner's expert, Dr. David Norris, opined that vaccines can trigger autoimmune diseases like AA by altering the immune privilege of hair follicles, citing studies such as Wise et al. (1997) and Richardson et al. (2018). Respondent's expert, Dr. Megha Tollefson, acknowledged AA as a chronic autoimmune disease with a genetic basis, suggesting infections or stress as more likely triggers than vaccines, and noting L.T.'s family history and eczema as risk factors. The Chief Special Master initially ruled that while the vaccine caused the first AA episode, subsequent recurrences were more likely due to L.T.'s genetic predisposition. However, on remand following a court order, Special Master Dorsey determined that L.T. was entitled to compensation for subsequent and future recurrences of AA, recognizing its chronic nature. The final award included compensation for life care expenses, pain and suffering, and an annuity, totaling $259,107.31. Public staged source text: ================================================================================ DOCUMENT 1: USCOURTS-cofc-1_15-vv-00124-0 Date issued/filed: 2020-01-10 Pages: 25 Docket text: PUBLIC ORDER/RULING (Originally filed: 12/10/2019) regarding 66 Ruling on Entitlement, Signed by Chief Special Master Brian H. Corcoran. (sw) Service on parties made. -------------------------------------------------------------------------------- Case 1:15-vv-00124-MCW Document 68 Filed 01/10/20 Page 1 of 25 CORRECTED In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 15-124V (to be published) * * * * * * * * * * * * * * * * * * * * * * * * * Chief Special Master Corcoran CHRISTINE DELOZIER, * parent and next friend of L.T., a minor, * * Filed: December 10, 2019 Petitioner, * * Alopecia Areata; Autoimmune v. * Condition; Vaccine as Trigger; * Chronic Condition; Althen Prong SECRETARY OF HEALTH AND * One; Genetic Basis for Condition HUMAN SERVICES, * * Respondent. * * * * * * * * * * * * * * * * * * * * * * * * * * * Richard Gage, Richard Gage, P.C., Cheyenne, WY, for Petitioner. Jennifer L. Reynaud, U.S. Dep’t of Justice, Washington, DC, for Respondent. RULING ON ENTITLEMENT1 On February 9, 2015, Christine DeLozier,2 as parent and next of friend of L.T., a minor, filed a petition seeking compensation under the National Vaccine and Injury Compensation Program (the “Vaccine Program”).3 (ECF No. 1) (“Petition”). Petitioner alleged that L.T. suffered 1 This Ruling shall be posted on the Court of Federal Claims’ website in accordance with the E-Government Act of 2002, 44 U.S.C. § 3501 (2012)). This means that the Ruling will be available to anyone with access to the internet. As provided by 42 U.S.C. § 300aa-12(d)(4)(B), however, the parties may object to the Ruling’s inclusion of certain kinds of confidential information. Specifically, under Vaccine Rule 18(b), each party has fourteen days within which to request redaction “of any information furnished by that party: (1) that is a trade secret or commercial or financial in substance and is privileged or confidential; or (2) that includes medical files or similar files, the disclosure of which would constitute a clearly unwarranted invasion of privacy.” Vaccine Rule 18(b). Otherwise, the whole Ruling will be available to the public. Id. 2 Although the Petition was originally filed under the name “Christine Torres,” Petitioner has since changed her last name to DeLozier, and therefore the case caption has been amended. (ECF No. 58). 3 The Vaccine Program comprises Part 2 of the National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3758, codified as amended at 42 U.S.C. §§ 300aa-10 through 34 (2012) [hereinafter “Vaccine Act” or “the Act”]. Individual section references hereafter will be to § 300aa of the Act (but will omit that statutory prefix). 1 Case 1:15-vv-00124-MCW Document 68 Filed 01/10/20 Page 2 of 25 from alopecia areata (“AA”) attributable to a hepatitis B vaccine (“HBV vaccine”) L.T. received on November 6, 2012. An entitlement hearing was held in this matter on February 4, 2019, and with post-trial briefing concluded in June the case is now ripe for resolution. Based on the evidence submitted, I find that Petitioner has preponderantly established that the HBV vaccine could trigger an autoimmune response resulting in a single AA occurrence—and therefore since the medical record supports the contention that this occurred in L.T.’s case, Petitioner is entitled to an award of damages associated with that first occurrence. I do not find, however, that preponderant evidence supports Petitioner’s broader contention that all subsequent outbreaks of AA Petitioner has experienced (or may in the future) are also attributable to her 2012 receipt of the HBV vaccination—and therefore she is not entitled to damages associated with any such subsequent, unrelated AA occurrences. I. Factual Background L.T.’s family health history and pre-vaccination health L.T. was born on June 29, 2009, largely healthy after a 32-week pregnancy. Ex. 1 at 3; see also Ex. 4 at 11, 84, 89–90. Significantly for this case, L.T. appears to have a family history of autoimmune diseases. Ms. DeLozier in particular (who testified at trial) has previously experienced an unspecified autoimmune connective disorder. See Ex. 1 at 4; Tr. at 26–28. This condition carried symptoms of diffuse hair loss, a positive ANA,4 and occurred about seven to ten years before L.T.’s birth. Ex. 1 at 3; see also Ex. 4 at 11. Petitioner specifically reported that she developed this disorder after being out of the country—and recalled having received the HBV vaccine prior to travelling. Ex. 4 at 11. L.T. was growing and developing normally before her receipt of a third HBV dose, although she did suffer from asthma and eczema. Tr. 19–20 (stating that L.T. had eczema before her third HBV vaccine); Ex. 3 at 314 (noting diagnosis of asthma in November 2011). She had received her first and second HBV vaccine doses at two and four months old, respectively, with no reported reaction. Ex. 4 at 36–37; Tr. at 31; see generally Ex. 5 (vaccination record). Thereafter there is a gap in medical records—and a deviation from the normal HBV vaccination schedule— because of a lapse in insurance coverage. Tr. at 30–31. 4 An antinuclear antibody (“ANA”) test is typically used to assess the presence of systemic lupus erythematosus (“SLE”), as well as other autoimmune diseases (e.g., mixed connective tissue disease, scleroderma, rheumatoid arthritis, Sjögren’s syndrome, and polymyositis). However, because otherwise-healthy individuals often test positive for ANA, follow-up testing is necessary to corroborate the diagnosis, although a negative result generally excludes the diagnosis of some autoimmune diseases. See K. Pagana, et al., Mosby’s: Manual of Diagnostic and Laboratory Tests 80, 82 (6th ed. 2018). 2 Case 1:15-vv-00124-MCW Document 68 Filed 01/10/20 Page 3 of 25 L.T.’s vaccination and health history to the end of 2013 L.T. was three years old when she received her third dose of the HBV vaccine on November 6, 2012. Not long after, Ms. DeLozier noticed problems with L.T.’s health. Specifically, she observed that “a couple days after vaccine there was increased hair coming out [of L.T.’s head].” Tr. at 11. Then, four days after vaccination, she noticed “two prominent bald spots”—about the size of a quarter—on L.T.’s head. Id. at 11. At the same time, L.T. complained of joint pain in her hip and wrists, had developed a rash, and appeared to be walking with a limp. See id. at 11–12. Later that month, Ms. DeLozier took L.T. to a dermatologist, Dr. Elaine Gilmore.5 Ex. 4 at 8–10; see generally Ex. 7 (Records from Dr. Gilmore’s office). At that visit, Dr. Gilmore observed “widespread . . . alopecic patches on the scalp.” Ex. 4 at 9. In her assessment, Dr. Gilmore noted that L.T.’s recent hair loss was “possibly stimulated by [her] recent [HBV] vaccine,” although she expressed the need for further research to evaluate whether such a relationship had scientific support. Id. Dr. Gilmore also noted that L.T. had symptoms of eczema, and discussed the possible diagnosis of atopic dermatitis versus irritant contact dermatitis with Petitioner. Id. After examination, Dr. Gilmore prescribed L.T. a topical steroid to treat her alopecia and an ointment to treat her eczema. Ex. 4 at 9. Dr. Gilmore recorded L.T.’s family history of eczema, but noted (erroneously) that L.T. appeared to lack a family history of alopecia or similar conditions. Ex. 4 at 8, 11 (observing a family history of connective tissue disease in mother characterized by hair loss during doctor’s appointment a few months later); Tr. at 8–9 (describing family history in mother of autoimmune connective tissue disorder characterized by hair loss). In December 2012, L.T. had a series of lab tests done that revealed she had a positive ANA screen. Ex. 4 at 6. On January 7, 2013, L.T. visited Dr. Gilmore’s practice again and this time was treated by Kristen Ahern, M.D., a resident/fellow. Ex. 7 at 1. Petitioner reported that L.T.’s dermatitis was improving, although her bald spots were worsening. Id. Dr. Ahern (consistent with Dr. Gilmore) also noted that L.T.’s alopecia was “possibly stimulated by recent [HBV] vaccine,” and instructed Petitioner to continue on the treatment plan previously discussed. Id. at 2. A physical exam showed a negative hair pull test and small black dots in some of the bald spots indicating hairs that were present (and thus potentially returning) but had “not yet erupted.” Id. at 1. On January 22, 2013, L.T. visited Bethany Marston, M.D., a pediatric rheumatologist. See Ex. 4 at 11. Dr. Marston noted that L.T. was suffering from AA and transient joint pain that had developed about four days after her third HBV vaccination. Id. Dr. Marston recorded that L.T.’s 5 There is some discrepancy between when Petitioner alleges this visit occurred and what the records establish. Petitioner asserts that L.T. saw Dr. Gilmore on November 12, 2012. Pet’r’s Post-Hearing Brief at 2 (citing Ex. 4, at 1). But Exhibit 4 at 1 is actually a note from a subsequent March 2013 doctor’s visit at Sunrise Pediatrics, and thus references the November visit as part of L.T.’s medical history. See Ex. 4 at 1 (“date form completed 3/27/13”). The date “11/12” (on Ex. 4 at 1) seems to be a generic reference to November 2012. In any event, the evidence does establish that Petitioner sought some treatment for L.T. in November 2012, and the records reflect her contemporaneous assertion that L.T. experienced hair loss within a few days of vaccination. 3 Case 1:15-vv-00124-MCW Document 68 Filed 01/10/20 Page 4 of 25 joint pain was not associated with swelling, erythema, or functional disability and that L.T.’s symptoms were responding to the ointments and steroids she was earlier prescribed. See id. Other testing revealed negative inflammatory markers and rheumatoid factor, and, “despite a questionable family [history] of unspecified [mixed connective disease] in her mom and some other autoimmune-induced syndromes in her extended family,” L.T.’s positive ANA was deemed by Dr. Marston most likely the result of her then-resolving AA. Id. L.T. returned to Dr. Gilmore’s practice again in March 2013. Ex. 7 at 4. L.T. was seen at this time by Kimberly Brady, M.D., a resident. Ex. 7 at 4. Dr. Brady recorded that L.T.’s parents had not noticed any improvement in her condition since their last visit. Id. She also noted that L.T.’s HBV vaccine appeared temporally related to her AA, but “because this is not a widely seen association, and [AA] is a relatively common disorder, it is difficult to say that the hepatitis vaccine was responsible for the onset of [AA].” Id. at 4–5. Dr. Brady’s physical exam also revealed a negative hair pull test and small black dots in some bald areas. Id. at 4–5. To address the lack of improvement in L.T.’s AA symptoms, Dr. Brady changed L.T.’s steroid cream and ointment prescription. Id. Other than her AA, L.T. had a normal physical exam. Id. L.T. visited Dr. Gilmore’s practice three months later in June 2013 (now more than six months since the onset of her AA symptoms) and was seen by Rachel Garner, M.D., a resident. Ex. 7 at 7. Dr. Garner noted that L.T. still had some lingering AA symptoms, but there was evidence of recovery as well—some short hairs in the bald areas that appeared to be new. Id. at 7– 8. L.T.’s rash had also returned, but it was found to be negative for fungus, leading Dr. Garner to characterize it as atopic dermatitis (eczema), treatable with ointments and creams. Id. at 8. Dr. Garner also performed a hair pull test which was negative and observed short hairs that appeared new. Id. at 8. Later, in August 2013, Petitioner took L.T. to Rochester General Hospital. Ex. 11 at 1. There, L.T. was seen by Tracy Henderson, M.D. Id. at 4. Dr. Henderson observed that L.T. had patchy AA and had been diagnosed with AA in November 2012, four days after her third HBV vaccine. Id.at 4–5. Dr. Henderson also recorded a family history of an autoimmune disease in L.T.’s mother. Id. at 3. Notes from the visit also show that Petitioner brought several articles into the visit that mentioned an association between AA and the HBV vaccine. Id. at 4. L.T.’s health history from 2014 to 2016 There are several subsequent gaps in the medical record. L.T. appears to have had her next doctor’s visit in April 2014 for behavioral concerns at Rochester General Hospital. Ex. 11 at 12– 17. During this visit Dr. Henderson did not note any AA symptoms in the physical exam section of the visit records. Id. at 16 (“Well-appearing, alert, very active.”). No mention was made at this visit of L.T.’s AA, although it also appears the visit (besides behavioral concerns) was occasioned by Ms. DeLozier’s wish to inquire about L.T.’s dietary issues. 4 Case 1:15-vv-00124-MCW Document 68 Filed 01/10/20 Page 5 of 25 In August 2014, L.T. had a five-year well-child visit at Rochester General Hospital. Ex. 10. at 1-10. There, Andrew Sherman, M.D., observed that L.T. suffered from chronic eczema. Id. at 4. Dr. Sherman also logged that L.T. had previously experienced AA because of an adverse reaction to the HBV vaccine in November 2012. Id. Regarding L.T.’s initial hair loss, Dr. Sherman recorded that L.T. lost her hair for “about a year,” and also suffered from worsening eczema around the same time. Id. Dr. Sherman’s objective physical examination did not note any AA symptoms, but did note some eczema behind L.T.’s knees. See id. at 5–6. Only eczema was listed in the current concerns section. Id. at 6. Accordingly, this record does not suggest that L.T. was at this point still experiencing sequelae from her November 2012 onset of AA. L.T. returned to Rochester General Hospital nine months later, on May 22, 2015, because she developed chicken pox and a sore throat. Ex. 10 at 11–19. Dr. Sherman noted that she had run a fever for four days after likely exposure to the varicella virus from her brother and father. Id. at 17. At this visit, AA was recorded in the current problem list, but is not mentioned in her in her physical exam, assessment, and diagnoses (thus strongly suggesting she was not experiencing any active symptoms from it). Id. 11, 17–18. L.T. was treated for her sore throat and chicken pox and discharged. Id. at 18. A few months later, on July 1, 2015, L.T. had another visit at Rochester General Hospital because of possible insect bites and a swollen eye. Id. at 20. AA is mentioned nowhere but her medical history. See id. The next filed record is from August 2015, when L.T. returned to Rochester General Hospital for a sore throat. Ex. 11 at 18–24 (visit on August 10, 2015). L.T. was tested for a sore throat, treated for her sore throat, and discharged. Id. She was seen by Julia Stein, M.D., who noted a medical history of AA but did not record any other information about AA at that time. See generally id. Later that same month, L.T. visited Rochester General Hospital for a routine child exam. Ex. 10 at 28 (visit on August 19, 2015). L.T.’s weight was noted as being low and weight management was discussed. Id. at 35. Dr. Sherman did not list any current concerns, active issues, or chronic issues. Id. No notes of AA were made except in the health history section. See id. (noting that L.T. was visiting the dermatologist later that day). The same day, August 19, 2015, L.T. visited Universal Dermatology PLLC—Dr. Gilmore’s practice. Ex. 9 at 1. Petitioner’s reason for bringing L.T. in was for “hair loss that is multifocal and mild in severity,” that had manifested two weeks prior. Id. A physical exam revealed some hair loss patches on L.T.’s central forehead and right inferior occipital scalp, along with thin eyebrows and “coin-like eczematous patches” on her arms and left thigh. Id. Dr. Gilmore recommended that her AA could be treated using topical steroids, and that Petitioner should contact his office if symptoms plateaued or worsened despite treatment. Id. L.T. had a follow-up visit with Dr. Gilmore on September 25, 2015. Ex. 9 at 5. There, Dr. Gilmore noted that L.T.’s AA was improving with treatment and improved overall. Id. Dr. Gilmore observed “minimal alopecic patches on the anterior scalp and thin eyebrows throughout.” Id. Dr. Gilmore advised Petitioner to reduce the amount of steroid being taken and that L.T. could apply 5 Case 1:15-vv-00124-MCW Document 68 Filed 01/10/20 Page 6 of 25 ointment to her face to stimulate eyebrow growth. Id. L.T. was scheduled to follow-up in one- month for a “focused visit.” Id. L.T.’s health history from 2016 to present L.T. next returned to Dr. Gilmore more than six months later, in April 2016. Ex. 28 at 1. At this time, Dr. Gilmore observed discrete non-scarring patches of hair loss on the “right superior temple and left occipital scalp.” Id. Dr. Gilmore discussed with Petitioner the natural history of AA, which can be associated with flares and remissions. Id. Dr. Gilmore also noted that L.T.’s hair loss, at that time, was not severe enough to warrant systemic therapy. Id. In November 2016, L.T. presented to Dr. Gilmore again for further evaluation. Ex. 28 at 2. During the visit Dr. Gilmore observed AA on L.T.’s “right superior central forehead, left superior central forehead, and left lateral eyebrow.” Id. This distribution of AA was notably different than what had been reported in August 2015. Compare Ex. 9 at 3 (showing AA patches in August 2015 behind the right ear and on the left superior forehead), with Ex. 28 at 3 (showing AA patches in November 2016 on the left eyebrow and on two locations on the forehead). Dr. Gilmore discussed new possible therapies for L.T.’s condition, but explained that it would be difficult to predict her future hair growth. Id. The next month, L.T. went into Rochester Regional Health for a well-child visit. Ex. 29 at 6. Dr. Sherman observed that L.T. had AA symptoms, and was also complaining of knee, wrist, and elbow pain at times, consistent with complaints from the previous month. Id. L.T. went to the doctor again in December 16, 2016, for a well-child visit at Rochester Regional Health. Ex. 29 at 1. There, in the subjective notes section, Dr. Sherman recorded that L.T. “[s]till has [a] patch of alopecia behind right ear and near midline of mid occipital area.” Id. at 6. The AA patch behind her right ear was also noted in the objective section of the visit record. Id. at 6–7. L.T. was scheduled for another well-child visit next year and informed Dr. Sherman that she would follow-up on her AA with a dermatologist and rheumatologist. Id. at 6–8. L.T. presented to Rochester Regional again in late June 2017 for a cough and sore throat. Ex. 29 at 17. No notes on AA or eczema were made other than in the health history section. See id. Then, L.T. visited Rochester Regional again in August 2017 for her eight-year well-child visit. Ex. 29 at 27. In the subjective notes section of the visit Dr. Sherman recorded that L.T. had no current concerns and was “doing well.” Id. at 32. Dr. Sherman also did not mention any AA in his objective examination of L.T. Id. at 33. L.T. declined immunizations citing a prior medical history of AA after vaccination. Id. L.T. returned to Rochester Regional in October 2018 for her nine-year well-child visit. Ex. 29 at 42. In the subjective notes section Dr. Sherman recorded that there were no current concerns, L.T. was doing well, and there were “no current hair changes.” Id. at 47–48 (assessing no active or chronic issues and stating that L.T. was doing well). In the objective physical assessment Dr. Sherman did not note any AA. Id. at 48. No records were filed for the period after the end of 2018 setting forth any concerns about new AA flares. 6 Case 1:15-vv-00124-MCW Document 68 Filed 01/10/20 Page 7 of 25 II. Witness Testimony A. Petitioner’s expert: Dr. David Norris Dr. Norris filed a single report and testified at hearing. See Ex. 16, filed June 7, 2017 (ECF No. 40-1) (“Norris Report”). He opined largely that L.T.’s third HBV vaccine “was the trigger that caused [her] to develop [AA].” Norris Report at 2. Dr. Norris obtained a B.A. from Johns Hopkins University in 1969. Ex. 17, filed on June 7, 2017 (ECF No. 40-2) (“Norris CV”). He earned his M.D. from Duke University Medical School in 1972. Id. at 1. After completing his formal education, Dr. Norris held a sub-fellowship in Hematology and Oncology during 1973 at Duke University; an internship in Internal Medicine during 1973–1974 at Ohio State University; and a Dermatology Residency during 1974–1977 at the University of Colorado School of Medicine. Id. Additionally, Dr. Norris is board certified in Dermatology, Dermatologic Immunology and Diagnostic and Laboratory Immunology. Id. Dr. Norris is presently the chairman of the Department of Dermatology at the University of Colorado School of Medicine, where he has also been a professor. Norris CV at 1. Dr. Norris has received research funding for several topics relating to immunodermatology and the “Alopecia Areata Registry.” Id. at 3. Dr. Norris is also published and has conducted research related to AA, dermatology, and immunodermatology. See generally id. Dr. Norris provided an overall description of AA. Norris Report at 1. AA is a clinical hair loss disease that is “at its root an immunologic disease controlled by genes.” Tr. 41–42. In particular, AA is a polygenic autoimmune disease, with “other autoimmune components that go along with it.” Id. at 42. The most common of such comorbid conditions is hypothyroidism, “[b]ut another important immunologic disease that goes along with [AA] is atopy.” Tr. at 42–43 (noting that L.T. has atopic dermatitis). He also described the waxing and waning nature of the disease, and how a patient’s long-term prognosis is ultimately affected by her genetic profile. Id. at 51–52 (“the current thinking is that the patients that have the worst genetic profile will get the worst disease and early on and the . . . baldness on the scalp will remain”). From this, Dr. Norris proposed a theory of how vaccines generally (and more specifically, the HBV vaccine) could cause AA. Norris Report at 2. Dr. Norris submitted that because it is an autoimmune disease, AA’s onset may follow events such as “infections, periods of stress, and immunostimulation, including vaccination.” Id. (citing Y. Zafrir, et al., Vaccines, Infections, and Alopecia Areata, in Vaccines & Autoimmunity (Yehuda Shoenfeld et al. eds., 2015), filed as Ex. 27 on Jan. 30, 2019 (ECF No. 55-2) (“Zafrir”)); Tr. at 43–44. Dr. Norris, referring to Zafrir, explained that that these events can cause a change in the “immune privilege” of hair follicles (meaning the capacity to tolerate antigen presentation without an inflammatory, immune-driven response), which in turn causes the hair loss associated with AA. Tr. at 44–45. Dr. Norris added that in his understanding, the dermatologic medical community accepts the existence of triggers as significant in causing AA, with 25 percent of AA patients able to identify a likely trigger after 7 Case 1:15-vv-00124-MCW Document 68 Filed 01/10/20 Page 8 of 25 symptoms occur. Id. at 48. However, as Respondent has correctly observed, Zafrir considered mouse studies that “suggest[ed] that there was no association between vaccination and AA development.” Zafrir at 3 (emphasis added).6 Dr. Norris offered some other specific items of medical literature that he maintained supported the contention that the HBV vaccine could trigger AA. Tr. at 57; Norris Report at 2 (citing R. Wise, et al., Hair Loss After Routine Immunizations, 278 JAMA 1176 (1997), filed as Ex. 26 on Jan. 30, 2019 (ECF No. 55-1) (“Wise”) (concluding that “we believe that immunizations warrant consideration among potential causes of hair loss”); Tr. at 49–51. Wise analyzed reports from the Vaccine Adverse Event Reporting System (“VAERS”), plus reports made to the FDA that predated VAERS, of instances in which AA following vaccination was alleged. See Wise at 1. The study yielded 60 evaluable reports of hair loss following immunization since 1984 and coded for alopecia, with 46 of the instant cases involving the HBV vaccine. Id. In addition, 16 of the 60 cases involved a positive rechallenge7—meaning the individual had previously been vaccinated, but saw new symptoms in a shorter timeframe after receipt of a follow-up dose. Id. Although only four of the sixteen were confirmed as definite rechallenges, three of the four rechallenges involved the administration of the HBV vaccine. Id. at 1–2. Dr. Norris deemed such evidence to strongly support causation. Tr. at 51. But he did acknowledge some limitations with Wise. He conceded that Wise was published more than 20 years ago (and hence had not been followed up with any corroborative studies), and also that the study’s authors had only discussed hair loss in general terms. Id. at 50. However, he maintained his opinion that the cases discussed in Wise mostly involved AA. Id. Overall, Dr. Norris deemed Wise his best evidence for the proposition that the HBV vaccine could cause AA. See Tr. at 89. Petitioner also relied on a more recent article, although it was filed shortly after the hearing (and not otherwise mentioned by Dr. Norris in his testimony). See C. Richardson, et al., Evaluation of the Relationship Between Alopecia Areata and Viral Antigen Exposure, 9 Am. J. Clinical 6 Zafrir has other issues that limit the weight it should receive. It was co-authored by Dr. Yehuda Shoenfeld, a frequently-seen medical expert in Vaccine Program cases who takes an expansive (but frequently unpersuasive and/or unreliable) view of the capacity of vaccines generally to cause autoimmunity. See, e.g., Yalacki v. Sec’y of Health & Human Servs., No. 14-278V, 2019 WL 1061429, at *33 (Fed. Cl. Spec. Mstr. Jan. 31, 2019) (finding that Dr. Shoenfeld’s blanket assertions regarding vaccines and autoimmunity “harm his overall credibility”). Zafrir also relied on another article not filed in this case that—as Dr. Norris conceded—says nothing about AA triggers. Zafrir at 2, citing D. Bogdanos, et al., Tracing Environmental Markers if Autoimmunity: Introducing the Infectome, 56 Immunologic Research 220 (2013). Respondent’s Post-Hearing Brief at 6, filed on June 3, 2019, (ECF No. 65); Tr. at 97–98. 7 Other special masters have described “rechallenge” as follows: “[c]hallenge-rechallenge happens when a person (1) is exposed to one antigen, (2) reacts to that antigen in a particular way, (3) is given the same antigen again, and (4) reacts to that antigen similarly. Typically, the second reaction is faster and more severe.” Nussman v. Sec’y of Health & Human Servs., 83 Fed. Cl. 111, 119 (Fed. Cl. 2008) (internal citations omitted) (quoting Nussman v. Sec’y of Health & Human Servs., No. 99-500V, 2008 WL 449656, at *9 (Fed. Cl. Spec. Mstr. Jan. 31, 2008)). 8 Case 1:15-vv-00124-MCW Document 68 Filed 01/10/20 Page 9 of 25 Dermatology 119 (2018), filed on February 28, 2019, as Ex. 30 (ECF No. 60) (“Richardson”).8 Richardson’s findings are based on a larger sample of patients—nearly 250,000 cases of HBV vaccination and 656 cases of AA—derived from the electronic medical record database at the University of Rochester Medical Center. See Richardson at 1. The query sought “to identify patients with AA, coexisting viral infections, vaccinations, or interferon therapy [ ] to determine if the presence of AA and these conditions was higher than in AA patients without the associated conditions or therapy.” Id. Accounting for different types of alopecia and hair loss, Richardson’s authors observed an increased frequency of AA among those who had received the HBV surface antigen, whether from vaccination or wild virus infection. See Richardson at 4, 6 (finding support for the conclusion “that exposure to hepatitis B antigens, through either infection or vaccination, are associated with AA in a subset of patients”). Specifically, they observed AA to be two times more prevalent in individuals exposed to the HBV vaccine than the total population, and 2.73 times more likely to occur in a person exposed to the HBV vaccine. Id. at 4 (showing increased prevalence and odds ratio of AA after exposure to the HBV vaccine).9 Richardson discussed two possible mechanisms that could explain how HBV vaccination could trigger AA: (1) the induction of interferon (a cytokine whose upregulation could be instigated by the immune process stimulated by vaccination);10 or (2) molecular mimicry. Id. at 5. Richardson supports the plausibility of each of these causative theories, although it admits more research is needed to determine if either is the responsible biologic mechanism causing the increased prevalence and odds reported earlier. See id. at 5–7. 8 Richardson was not identified or discussed during the hearing, despite it being published almost a full year prior. It was also co-authored by one of L.T.’s treaters, Dr. Elaine Gilmore. Richardson at 1. In addition, it focuses on only two cases—one of which is likely L.T. herself. See Richardson at 2 (describing “patient 1” as a “3-year-old female with hair loss of several weeks’ duration []. [AA] began 4 days after receiving the third dose of the hepatitis B vaccine. The patient also developed transient joint pain of the wrists, arms, and right knee without associated swelling. She had a positive antinuclear antibody (ANA) (1:320 speckled/homogenous pattern) . . . . , and she had no significant medical history. Her family history included a mother with positive ANA and AA, and a sister with positive thyroid antibodies. Physical examination revealed widespread and well-demarcated alopecic patches on the scalp without scarring, erythema, or scale.”). Such references actually undercut Petitioner’s assertion that “nobody in [L.T.’s] family had ever been diagnosed with alopecia.” See Petitioner’s Post-hearing Brief at 1, filed on June 3, 2019, (ECF No. 64). 9 The authors also observed that the enhanced possibility of AA after vaccination was statistically reliable. See Richardson at 4 fig. 2 (reporting a p-value of <0.0005 for HBV and AA association). A low p-value helps establish “statistical significance,” because it shows “something other than chance must be involved.” Federal Judicial Center & National Research Council, Reference Manual on Scientific Evidence 250 (3d ed. 2011). By contrast, a large p- value “indicate[s] that disparity can easily be explained by the play of chance.” Id. Generally, a p-value of 5 percent or less (p<0.05) is considered the starting point—indicating that random error is not at work. Id. at 251–52; see also id. at 251 n.101 (citing Castaneda v. Partilda, 430 U.S. 482, 496 n.17 (1977); Hazelwood School District v. United States, 433 U.S. 299, 311 n.17 (1977)). 10 Interferons are “any family of glycoproteins that exert virus non-specific but host specific antiviral activity by inducing the transcription of cellular genes coding for antiviral proteins that selectively inhibit the synthesis of viral RNA and proteins.” Dorland’s Illustrated Medical Dictionary 948 (32 ed. 2012) (hereinafter “Dorland’s”). 9 Case 1:15-vv-00124-MCW Document 68 Filed 01/10/20 Page 10 of 25 In addition to proposing that the HBV vaccine could trigger AA, Dr. Norris testified about L.T.’s individual circumstances, opining that the vaccine had likely done so in this case (and in a reasonable timeframe as well). Norris Report at 2; Tr. at 55–56. In support, he identified four cases from Wise in which the studied individual reported hair loss as early as one day after vaccination. Norris Report at 2; Tr. at 55–56 (“[i]n the case here, though, it’s . . . . [onset is in] several days, and there are plenty of cases like that in the literature”); Wise at 1–2. He also emphasized that in the cases reported in Wise, onset of hair loss after vaccination was “usually more rapid after subsequent revaccination with HBV vaccine.” Norris Report at 2. Thus, he reasoned, because L.T. had previously received the HBV vaccine, her immune response in November 2012 (and its purported damaging impact, in the form of AA) was likely faster than it would have been. Tr. at 84 (disagreeing with Dr. Tollefson’s opinion). On cross examination Dr. Norris defended Wise and its applicability to this case. See Tr. at 108–32. Respondent’s counsel questioned Dr. Norris about several issues with Wise—e.g., the small sample size of clear rechallenge cases, the lack of specificity in Wise when describing the type of hair loss, and whether any of the clear rechallenge cases were similar enough to L.T.’s case to be helpful. Id. On each of these points Dr. Norris maintained that Wise was persuasive. Id. B. Respondent’s expert: Dr. Megha Tollefson Dr. Tollefson served as Respondent’s expert, and offered a single report as well as testimony at hearing. Ex. A, filed Sept. 15, 2017 (ECF No. 43-1) (“Tollefson Report”). Dr. Tollefson disputed Dr. Norris’s opinion that L.T.’s injuries were caused by her receipt of the HBV vaccine in February 2012, maintaining instead that her genetic risk factors played more of a role in causing her symptoms. See generally Tollefson Report. Dr. Tollefson graduated with a BA from Stanford University in 1999. Ex. B, filed on Jan. 28, 2019 (ECF No. 54-1) (“Tollefson CV”). She went on to earn her M.D. from Mayo Medical School in 2003. Tollefson CV at 1. She subsequently completed a pediatric residency at the Mayo Clinic College of Medicine from 2003–2006; a dermatology residency at the Mayo Clinic College of Medicine from 2007–2010; and a pediatric dermatology fellowship at Stanford University from 2010–2011. Id. Dr. Tollefson is board certified in dermatology and pediatric dermatology. Id. She has been an attending pediatric dermatologist at the Mayo Clinic since 2010. Id. at 2. She has also served as an assistant professor in pediatrics at the Mayo Clinic College of Medicine and Science. Id. Outside of her clinical practice Dr. Tollefson has a few publications and research projects on AA in children. Id. at 11, 19–20, 31. Like Dr. Norris, Dr. Tollefson took some time at hearing to review AA (which she agreed L.T. experienced). Tollefson Report at 4; Tr. at 150. She accepted Dr. Norris’s contention that AA is rightly understood to be an autoimmune disorder with a possible genetic basis. Tollefson Report at 2–3; Tr. at 150–51. However, in her view susceptibility to AA stems mostly from genetic 10 Case 1:15-vv-00124-MCW Document 68 Filed 01/10/20 Page 11 of 25 factors—particularly mutations in the filaggrin11 gene. See Tollefson Report at 3 (“[p]atients with [AA] have a strong underlying genetic susceptibility profile . . . more likely to be associated with more severe disease and strong risk among family members.”) (citing R. Betz, et al., Loss-of- function Mutations in the filaggrin gene and Alopecia Areata: Strong Risk Factor for a Severe Course of Disease in Patients Comorbid for Atopic Disease, 127(11) J. Investigative Dermatology 2539–43 (2007)); see also Tr. at 151. Dr. Tollefson also noted that certain gene mutations have been associated with a “more severe disease course, and also with atopic dermatitis (AD), or eczema.” Id. Dr. Tollefson allowed, however, that some environmental triggers (for example, stressful events) could also produce AA, but that no one trigger has been identified as a primary cause. Id. Based on review of the relevant medical records, Dr. Tollefson opined that L.T. possessed several of the risk factors necessary for the development of AA. Tollefson Report at 3. In particular, she identified L.T.’s family history, as well as her eczema and respiratory problems. Id. at 3–4. To support her assertion that L.T. had a strong family history of autoimmune disease, Dr. Tollefson referenced Ms. DeLozier’s unspecified autoimmune connective tissue disorder, with hair loss and a positive ANA; L.T.’s third cousin having vitiligo; and L.T.’s older sister having positive thyroid antibodies. Id. This, Dr. Tollefson maintained, opened the door to the possibility that L.T. would have a positive ANA if tested (and in fact L.T. did so on some occasions). Id. (noting that a positive ANA can develop even in the absence of other symptoms). At a minimum, such facts allowed for the conclusion that L.T. was at an increased risk of autoimmune disease and AA. Id. (citing N. Barahmani, et al., History of Atopy or Autoimmunity Increases Risk of Alopecia Areata, 61 J. Am. Acad. Dermatology 581–91 (2009), filed as Ex. C (ECF No. 54-2) (“Barahmani”)). Dr. Tollefson also discussed some other risk factors, like L.T.’s eczema and “episodes of wheezing responsive to albuterol and steroids.” Tollefson Report at 4. As she explained, eczema in many patients has been linked to mutations “in the filaggrin gene and other innate immune factors.” Id. (citing T. Miyagaki, et al., Lifetime Incidence Risk of Alopecia Areata Estimated at 2.1% by Rochester Epidemiology Project, 1990–2009, 134(4) J. Investigative Dermatology1141– 42 (2014), filed as Ex. G (ECF No. 54-6)) (noting also that “vaccines do not cause eczema). Respiratory problems are also common in patients who have a family history of eczema. Id. Based upon these factors, Dr. Tollefson proposed that L.T. might have “atopic diathesis,” with a genetic risk for atopic disorders “none of which are caused by any vaccines.” Id. The presence of such atopic diseases increased L.T.’s risk for AA. Id. (citing Barahmani). Besides offering her own reading of the record, Dr. Tollefson disputed the reliability of some of the primary literature relied upon by Dr. Norris to associate the HBV vaccine specifically 11 Filaggrin is “a protein that is synthesized in the granular level of the epidermis and aggregates intermediate filaments of keratin by promoting formation of disulfide bonds.” Dorland’s at 706. 11 Case 1:15-vv-00124-MCW Document 68 Filed 01/10/20 Page 12 of 25 with AA. See Tollefson Report at 3; Tr. 151–56. Wise, for example, did not appear to differentiate among the various types of alopecia. Tollefson Report at 3; Tr. at 155–56. This made it “impossible to say how many, if any of [those] cases, were associated with [AA].” Tollefson Report at 3. In addition, the four “clear examples” of hair loss from Wise offered to support proof of rechallenge after a subsequent HBV vaccination were either distinguishable from L.T.’s case or not probative of causation. Tr. at 153 (noting only a purely temporal relationship in patient 1 between vaccination and hair loss), 154–55 (stating that the facts given about patient 2 only show that patient was susceptible to hair loss and there was multiple triggers), 155 (stating that patient 3 likely suffered from telogen effluvium12 rather than from AA). As a result, Wise at best established a pure temporal association between vaccination and AA. Tollefson Report at 3. Dr. Tollefson similarly contested the degree to which the concept of challenge-rechallenge supported Petitioner’s causation arguments in light of L.T.’s own history. Many of the studied individuals referenced in Wise had experienced hair loss in the process of receiving multiple doses of HBV. Tr. at 151–55; Tollefson Report at 3; see also Wise at 1–2 (Patient 1 developing hair loss after second and third HPV vaccine; Patient 2 developing hair loss after first, second, and third HPV vaccine; Patient 3 developing hair loss after first and second HPV vaccine). By contrast, although L.T. received HPV twice prior to the vaccination at issue, she never previously experienced any adverse effects. Tollefson Report at 3. Dr. Tollefson also responded to questions on a number of related issues. See generally Tr. 166–72. Some of these questions were directed to the role of genetics in developing AA. Tr. at 168. She admitted that in some children, genetics played a more important role in the development of AA than a triggering event. Tr. at 168. Other questions were directed to a hypothetical: whether, in an individual who had AA, multiple relapses (separated by years) could be attributed to different triggers. Tr. at 171. To that, Dr. Tollefson answered yes. Id. Finally, Dr. Tollefson questioned whether onset of L.T.’s AA symptoms occurred in a medically acceptable timeframe. Tollefson Report at 3. In so maintaining, she noted that L.T.’s onset did not in fact closely match the cases reported in Wise, who received the same vaccine but experienced symptoms each time. Id. Dr. Tollefson proposed that onset of AA after a trigger could occur as much as a few weeks to a couple of months thereafter, although she was unable to identify a minimum time that it would take for symptoms to manifest, without more evidence of an autoimmune reaction. Tr. at 158. (stating that she would need to know “as Dr. Norris said, if there was any subclinical inflammation there”). C. Christine DeLozier 12 Telogen effluvium is “the early, excessive, temporary loss of club hairs from normal resting follicles in the scalp as a result of traumatization by some stimulus (e.g., after surgery or childbirth; with starvation, side effects of drugs, traction on hair, high fever, or certain diseases; or with psychogenic stress). The normal hair cycle is changed and the anagen phase ends prematurely, moving into the catagen and telogen phases.” Dorland’s at 595. 12 Case 1:15-vv-00124-MCW Document 68 Filed 01/10/20 Page 13 of 25 Ms. DeLozier testified at hearing about L.T.’s health history and family medical history. See Tr. at 5–31. She explained that she had a history of hair loss herself. Tr. at 8, 27. She had experienced such hair loss after a trip to Nicaragua, several years before L.T. was born, and recalled that she had received the HBV vaccine shortly before this trip. Tr. at 27–28. Ms. DeLozier’s hair loss was diagnosed as a mixed connective tissue disorder, and testing revealed a positive ANA. Tr. at 8–9. Petitioner also described L.T.’s experience with AA over time. Tr. at 12–22. As she admitted, L.T. had experienced a partial recovery from her AA about a year after onset. Tr. at 19– 20 (describing L.T.’s hairline as receded and thinner). Thereafter, L.T. would experience recurrences of hair loss if she had an illness or infection. Tr. 20–22. Petitioner did not testify to another post-vaccination AA recurrence. III. Procedural History After filing this action, Petitioner continued to file relevant medical records. Respondent then filed his Rule 4(c) Report on February 28, 2017 (ECF No. 36), contesting whether Petitioner had established an evidentiary basis for entitlement. Rule 4(c) Report at 4–5. Over the next few years, the parties continued to litigate this case, and even engaged in a period of settlement discussions that were ultimately unfruitful. (ECF No. 44). They filed expert reports, pre-hearing briefs, and then presented evidence at an entitlement hearing held in February of 2019. Post-trial briefs were filed in June 2019. (ECF Nos. 64, 65). IV. Applicable Law A. Standards for Vaccine Claims To receive compensation in the Vaccine Program, a petitioner must prove that: (1) they suffered an injury falling within the Vaccine Injury Table (i.e., a “Table Injury”); or (2) they suffered an injury actually caused by a vaccine (i.e., a “Non-Table Injury.) See Sections 13(a)(1)(A), 11(c)(1), and 14(a), as amended by 42 C.F.R. § 100.3; § 11(c)(1)(C)(ii)(I); see also Moberly v. Sec'y of Health & Human Servs., 592 F.3d 1315, 1321 (Fed. Cir. 2010); Capizzano v. Sec'y of Health & Human Servs., 440 F.3d 1317, 1320 (Fed. Cir. 2006). In this case, Petitioner does not assert a Table claim. For both Table and Non–Table claims, Vaccine Program petitioners bear a “preponderance of the evidence” burden of proof. Section 13(1)(a). That is, a petitioner must offer evidence that leads the “trier of fact to believe that the existence of a fact is more probable than its nonexistence before [he] may find in favor of the party who has the burden to persuade the judge of the fact's existence.” Moberly, 592 F.3d at 1322 n.2; see also Snowbank Enter. v. United States, 6 Cl. Ct. 476, 486 (1984) (explaining that mere conjecture or speculation is insufficient under a preponderance standard). On one hand, proof of medical certainty is not required. Bunting v. Sec'y of Health & Human Servs., 931 F.2d 867, 873 (Fed. Cir. 1991). But on the other hand, a petitioner 13 Case 1:15-vv-00124-MCW Document 68 Filed 01/10/20 Page 14 of 25 must demonstrate that the vaccine was “not only [the] but-for cause of the injury but also a substantial factor in bringing about the injury.” Moberly, 592 F.3d at 1321 (quoting Shyface v. Sec'y of Health & Human Servs., 165 F.3d 1344, 1352–53 (Fed. Cir. 1999)); Pafford v. Sec'y of Health & Human Servs., 451 F.3d 1352, 1355 (Fed. Cir. 2006). A petitioner may not receive a Vaccine Program award based solely on his assertions; rather, the petition must be supported by either medical records or by the opinion of a competent physician. Section 13(a)(1). In attempting to establish entitlement to a Vaccine Program award of compensation for a Non–Table claim, a petitioner must satisfy all three of the elements established by the Federal Circuit in Althen v. Sec'y of Health & Human Servs., 418 F.3d 1274 (Fed. Cir. 2005): “(1) a medical theory causally connecting the vaccination and the injury; (2) a logical sequence of cause and effect showing that the vaccination was the reason for the injury; and (3) a showing of proximate temporal relationship between vaccination and injury.” Althen, 418 F.3d at 1278. Each Althen prong requires a different showing and is discussed in turn along with the parties’ arguments and my findings. Under Althen prong one, petitioners must provide a “reputable medical theory,” demonstrating that the vaccine received can cause the type of injury alleged. Pafford, 451 F.3d at 1355–56 (citations omitted). To satisfy this prong, a petitioner's theory must be based on a “sound and reliable medical or scientific explanation.” Knudsen v. Sec'y of Health & Human Servs., 35 F.3d 543, 548 (Fed. Cir. 1994). Such a theory must only be “legally probable, not medically or scientifically certain.” Id. at 549. This standard was recently clarified by the Federal Circuit. See Boatmon v. Sec'y of Health & Human Servs., 941 F.3d 1351, 1359–60 (Fed. Cir. 2019) (stating that the correct standard for Althen prong one is “reputable,” and “sound and reliable” not a “lower reasonable standard” (internal quotations omitted)). Petitioners may satisfy the first Althen prong without resort to medical literature, epidemiological studies, demonstration of a specific mechanism, or a generally accepted medical theory. Andreu v. Sec'y of Health & Human Servs., 569 F.3d 1367, 1378–79 (Fed. Cir. 2009) (citing Capizzano, 440 F.3d at 1325–26). Special masters, despite their expertise, are not empowered by statute to conclusively resolve what are essentially thorny scientific and medical questions, and thus scientific evidence offered to establish Althen prong one is viewed “not through the lens of the laboratorian, but instead from the vantage point of the Vaccine Act's preponderant evidence standard.” Id. at 1380. This is consistent with the petitioner's ultimate burden to establish his overall entitlement to damages by preponderant evidence. W.C. v. Sec'y of Health & Human Servs., 704 F.3d 1352, 1356 (Fed. Cir. 2013) (citations omitted).13 13 Although there has been some confusion in the past as to whether the first Althen prong is itself subject to a preponderant standard, ample controlling authority stands for the more straightforward proposition that the first Althen prong is subject to a preponderance standard. Broekelschen v. Sec'y of Health & Human Servs., 618 F.3d 1339, 1350 (Fed. Cir. 2010). 14 Case 1:15-vv-00124-MCW Document 68 Filed 01/10/20 Page 15 of 25 The second Althen prong requires proof of a logical sequence of cause and effect, usually supported by facts derived from a petitioner's medical records. Althen, 418 F.3d at 1278; Andreu, 569 F.3d at 1375–77; Capizzano, 440 F.3d at 1326; Grant v. Sec'y of Health & Human Servs., 956 F.2d 1144, 1148 (Fed. Cir. 1992). In establishing that a vaccine “did cause” injury, the opinions and views of the injured party's treating physicians are entitled to some weight. Andreu, 569 F.3d at 1367; Capizzano, 440 F.3d at 1326 (“medical records and medical opinion testimony are favored in vaccine cases, as treating physicians are likely to be in the best position to determine whether a ‘logical sequence of cause and effect show[s] that the vaccination was the reason for the injury’”) (quoting Althen, 418 F.3d at 1280). Medical records are generally viewed as particularly trustworthy evidence, since they are created contemporaneously with the treatment of the patient. Cucuras v. Sec'y of Health & Human Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993). However, medical records and/or statements of a treating physician's views do not per se bind the special master to adopt the conclusions of such an individual, even if they must be considered and carefully evaluated. Section 13(b)(1) (providing that “[a]ny such diagnosis, conclusion, judgment, test result, report, or summary shall not be binding on the special master or court”); Snyder v. Sec'y of Health & Human Servs., 88 Fed. Cl. 706, 746 n.67 (2009) (“there is nothing . . . that mandates that the testimony of a treating physician is sacrosanct—that it must be accepted in its entirety and cannot be rebutted”). As with expert testimony offered to establish a theory of causation, the opinions or diagnoses of treating physicians are only as trustworthy as the reasonableness of their suppositions or bases. The views of treating physicians should also be weighed against other, contrary evidence also present in the record—including conflicting opinions among such individuals. Hibbard v. Sec'y of Health & Human Servs., 100 Fed. Cl. 742, 749 (2011) (not arbitrary or capricious for special master to weigh competing treating physicians' conclusions against each other), aff'd, 698 F.3d 1355 (Fed. Cir. 2012); Veryzer v. Sec'y of Dept. of Health & Human Servs., No. 06–522V, 2011 WL 1935813, at *17 (Fed. Cl. Spec. Mstr. Apr. 29, 2011), mot. for review den'd, 100 Fed. Cl. 344, 356–57 (2011), aff'd without opinion, 475 F. App’x. 765 (Fed. Cir. 2012). The third Althen prong requires establishing a “proximate temporal relationship” between the vaccination and the injury alleged. Althen, 418 F.3d at 1281. That term has been equated to the phrase “medically-acceptable temporal relationship.” Id. A petitioner must offer “preponderant proof that the onset of symptoms occurred within a timeframe which, given the medical understanding of the disorder's etiology, it is medically acceptable to infer causation.” de Bazan v. Sec'y of Health & Human Servs., 539 F.3d 1347, 1352 (Fed. Cir. 2008). The explanation for what is a medically acceptable timeframe must also coincide with the theory of how the relevant vaccine can cause an injury (Althen prong one's requirement). Id. at 1352; Shapiro v. Sec'y of Health & Human Servs., 101 Fed. Cl. 532, 542 (2011), recons. den'd after remand, 105 Fed. Cl. 353 (2012), aff'd mem., 2013 WL 1896173 (Fed. Cir. 2013); Koehn v. Sec'y of Health & Human Servs., No. 11–355V, 2013 WL 3214877 (Fed. Cl. Spec. Mstr. May 30, 2013), mot. for review den'd (Fed. Cl. Dec. 3, 2013), aff'd, 773 F.3d 1239 (Fed. Cir. 2014). 15 Case 1:15-vv-00124-MCW Document 68 Filed 01/10/20 Page 16 of 25 B. Law Governing Analysis of Fact Evidence The process for making determinations in Vaccine Program cases regarding factual issues begins with consideration of the medical records. Section 11(c)(2). The special master is required to consider “all [ ] relevant medical and scientific evidence contained in the record,” including “any diagnosis, conclusion, medical judgment, or autopsy or coroner's report which is contained in the record regarding the nature, causation, and aggravation of the petitioner's illness, disability, injury, condition, or death,” as well as the “results of any diagnostic or evaluative test which are contained in the record and the summaries and conclusions.” Section 13(b)(1)(A). The special master is then required to weigh the evidence presented, including contemporaneous medical records and testimony. See Burns v. Sec'y of Health & Human Servs., 3 F.3d 415, 417 (Fed. Cir. 1993) (determining that it is within the special master's discretion to determine whether to afford greater weight to contemporaneous medical records than to other evidence, such as oral testimony surrounding the events in question that was given at a later date, provided that such determination is evidenced by a rational determination). Medical records that are created contemporaneously with the events they describe are presumed to be accurate and “complete” (i.e., presenting all relevant information on a patient's health problems). Cucuras, 993 F.2d at 1528; Doe/70 v. Sec'y of Health & Human Servs., 95 Fed. Cl. 598, 608 (2010) (“[g]iven the inconsistencies between petitioner's testimony and his contemporaneous medical records, the special master's decision to rely on petitioner's medical records was rational and consistent with applicable law”), aff'd, Rickett v. Sec'y of Health & Human Servs., 468 F. App’x 952 (Fed. Cir. 2011) (non-precedential opinion). This presumption is based on the linked propositions that (i) sick people visit medical professionals; (ii) sick people honestly report their health problems to those professionals; and (iii) medical professionals record what they are told or observe when examining their patients in as accurate a manner as possible, so that they are aware of enough relevant facts to make appropriate treatment decisions. Sanchez v. Sec'y of Health & Human Servs., No. 11–685V, 2013 WL 1880825, at *2 (Fed. Cl. Spec. Mstr. Apr. 10, 2013); Cucuras v. Sec'y of Health & Human Servs., 26 Cl. Ct. 537, 543 (1992), aff'd, 993 F.2d at 1525 (Fed. Cir. 1993) (“[i]t strains reason to conclude that petitioners would fail to accurately report the onset of their daughter's symptoms.”). Accordingly, if the medical records are clear, consistent, and complete, then they should be afforded substantial weight. Lowrie v. Sec'y of Health & Human Servs., No. 03–1585V, 2005 WL 6117475, at *20 (Fed. Cl. Spec. Mstr. Dec. 12, 2005). Indeed, contemporaneous medical records are generally found to be deserving of greater evidentiary weight than oral testimony— especially where such testimony conflicts with the record evidence. Cucuras, 993 F.2d at 1528; see also Murphy v. Sec'y of Health & Human Servs., 23 Cl. Ct. 726, 733 (1991), aff'd per curiam, 968 F.2d 1226 (Fed. Cir. 1992), cert. den'd, Murphy v. Sullivan, 506 U.S. 974 (1992) (citing United States v. United States Gypsum Co., 333 U.S. 364, 396 (1947) (“[i]t has generally been held that oral testimony which is in conflict with contemporaneous documents is entitled to little evidentiary weight.”)). 16 Case 1:15-vv-00124-MCW Document 68 Filed 01/10/20 Page 17 of 25 However, there are situations in which compelling oral testimony may be more persuasive than written records, such as where records are deemed to be incomplete or inaccurate. Campbell v. Sec'y of Health & Human Servs., 69 Fed. Cl. 775, 779 (2006) (“like any norm based upon common sense and experience, this rule should not be treated as an absolute and must yield where the factual predicates for its application are weak or lacking”); Lowrie, 2005 WL 6117475, at *19 (“[w]ritten records which are, themselves, inconsistent, should be accorded less deference than those which are internally consistent”) (quoting Murphy, 23 Cl. Ct. at 733)). Ultimately, a determination regarding a witness's credibility is needed when determining the weight that such testimony should be afforded. Andreu, 569 F.3d at 1379; Bradley v. Sec'y of Health & Human Servs., 991 F.2d 1570, 1575 (Fed. Cir. 1993). When witness testimony is offered to overcome the presumption of accuracy afforded to contemporaneous medical records, such testimony must be “consistent, clear, cogent, and compelling.” Sanchez, 2013 WL 1880825, at *3 (citing Blutstein v. Sec'y of Health & Human Servs., No. 90–2808V, 1998 WL 408611, at *5 (Fed. Cl. Spec. Mstr. June 30, 1998)). In determining the accuracy and completeness of medical records, the Court of Federal Claims has listed four possible explanations for inconsistencies between contemporaneously created medical records and later testimony: (1) a person's failure to recount to the medical professional everything that happened during the relevant time period; (2) the medical professional's failure to document everything reported to her or him; (3) a person's faulty recollection of the events when presenting testimony; or (4) a person's purposeful recounting of symptoms that did not exist. La Londe v. Sec'y of Health & Human Servs., 110 Fed. Cl. 184, 203–04 (2013), aff'd, 746 F.3d 1334 (Fed. Cir. 2014). In making a determination regarding whether to afford greater weight to contemporaneous medical records or other evidence, such as testimony at hearing, there must be evidence that this decision was the result of a rational determination. Burns, 3 F.3d at 417. C. Analysis of Expert Testimony Establishing a sound and reliable medical theory often requires a petitioner to present expert testimony in support of his claim. Lampe v. Sec'y of Health & Human Servs., 219 F.3d 1357, 1361 (Fed. Cir. 2000). Vaccine Program expert testimony is usually evaluated according to the factors for analyzing scientific reliability set forth in Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579, 594–96 (1993). See Cedillo v. Sec'y of Health & Human Servs., 617 F.3d 1328, 1339 (Fed. Cir. 2010) (citing Terran v. Sec'y of Health & Human Servs., 195 F.3d 1302, 1316 (Fed. Cir. 1999). Under Daubert, the factors for analyzing the reliability of testimony are: (1) whether a theory or technique can be (and has been) tested; (2) whether the theory or technique has been subjected to peer review and publication; (3) whether there is a known or potential rate of error and whether there are standards for controlling the error; and (4) whether the theory or technique enjoys general acceptance within a relevant scientific community. 17 Case 1:15-vv-00124-MCW Document 68 Filed 01/10/20 Page 18 of 25 Terran, 195 F.3d at 1316 n.2 (citing Daubert, 509 U.S. at 592–95). However, in the Vaccine Program the Daubert factors play a slightly different role than they do when applied in other federal judicial settings—e.g., the district courts. Typically, Daubert factors are employed by judges (in the performance of their evidentiary gatekeeper roles) to exclude evidence that is unreliable or could confuse a jury. By contrast, in Vaccine Program cases these factors are used in the weighing of the reliability of scientific evidence proffered. Davis v. Sec'y of Health & Human Servs., 94 Fed. Cl. 53, 66–67 (2010) (“uniquely in this Circuit, the Daubert factors have been employed also as an acceptable evidentiary-gauging tool with respect to persuasiveness of expert testimony already admitted”). The flexible use of the Daubert factors to evaluate the persuasiveness and reliability of expert testimony has routinely been upheld. See, e.g., Snyder, 88 Fed. Cl. at 742–45. In this matter (as in numerous other Vaccine Program cases), Daubert has not been employed at the threshold, to determine what evidence should be admitted, but instead to determine whether expert testimony offered is reliable and/or persuasive. Respondent frequently offers one or more experts of her own in order to rebut a petitioner's case. Where both sides offer expert testimony, a special master's decision may be “based on the credibility of the experts and the relative persuasiveness of their competing theories.” Broekelschen v. Sec'y of Health & Human Servs., 618 F.3d 1339, 1347 (Fed. Cir. 2010) (citing Lampe, 219 F.3d at 1362). However, nothing requires the acceptance of an expert's conclusion “connected to existing data only by the ipse dixit of the expert,” especially if “there is simply too great an analytical gap between the data and the opinion proffered.” Snyder, 88 Fed. Cl. at 743 (quoting Gen. Elec. Co. v. Joiner, 522 U.S. 146 91997)); see also Isaac v. Sec'y of Health & Human Servs., No. 08–601V, 2012 WL 3609993, at *17 (Fed. Cl. Spec. Mstr. July 30, 2012), mot. for review den'd, 108 Fed. Cl. 743 (2013), aff'd, 540 F. App’x. 999 (Fed. Cir. 2013) (citing Cedillo, 617 F.3d at 1339). Weighing the relative persuasiveness of competing expert testimony, based on a particular expert's credibility, is part of the overall reliability analysis to which special masters must subject expert testimony in Vaccine Program cases. Moberly, 592 F.3d at 1325–26 (“[a]ssessments as to the reliability of expert testimony often turn on credibility determinations”); see also Porter v. Sec'y of Health & Human Servs., 663 F.3d 1242, 1250 (Fed. Cir. 2011) (“this court has unambiguously explained that special masters are expected to consider the credibility of expert witnesses in evaluating petitions for compensation under the Vaccine Act”). D. Consideration of Medical Literature Both parties filed medical and scientific literature in this case, but not all such items factor into the outcome of this decision. While I have reviewed all the medical literature submitted in this case, I discuss only those articles that are most relevant to my determination and/or are central to Petitioner's case—just as I have not exhaustively discussed every individual medical record filed. Moriarty v. Sec'y of Health & Human Servs., No. 2015–5072, 2016 WL 1358616, at *5 (Fed. Cir. Apr. 6, 2016) (“[w]e generally presume that a special master considered the relevant record evidence even though he does not explicitly reference such evidence in his decision”) (citation 18 Case 1:15-vv-00124-MCW Document 68 Filed 01/10/20 Page 19 of 25 omitted); see also Paterek v. Sec'y of Health & Human Servs., 527 F. App’x 875, 884 (Fed. Cir. 2013) (“[f]inding certain information not relevant does not lead to—and likely undermines—the conclusion that it was not considered”). ANALYSIS I. Overview of Alopecia Areata As both testifying experts agreed, AA is widely understood to be an autoimmune disease characterized by hair loss. Norris Report at 1; Tollefson Report at 2–3. Such hair loss appears in patches, typically on the scalp. S. Birela, et al., Chapter 66: Non-bulbous Skin Diseases: Alopecia Areata, Vitiligo, Psoriasis, and Urticaria, in The Autoimmune Diseases 971, 971–74 (N. Rose & I. Mackay Eds., 2014) (co-authored by Dr. Norris) (“Autoimmune Diseases”).14 AA is relatively common, with around two percent of people experiencing it at some point in their lives. Id. at 971; Norris Report at 1. This translates to roughly 5.3–6.5 million people in the United States. See Autoimmune Diseases at 971; Norris Report at 1. AA is associated with a number of other diseases and conditions, such as vitiligo, atopic dermatitis (eczema), hyper and hypothryoidism, and, less commonly, other autoimmune diseases like connective tissue disease. Autoimmune Diseases at 972. Other conditions like nail loss or abnormalities may precede or follow AA. See Zafrir at 2. The disease also unquestionably has a genetic aspect. Norris Report at 1; Tollefson Report at 2–3. Indeed, literature suggests that “genetic control of innate and acquired immunity is the most powerful factor in determining the susceptibility to all variants of AA.” Autoimmune Diseases at 973 (emphasis added). AA occurs when a “mononuclear cell inflammatory infiltrate attacks the hair follicle (HF) bulb.” Autoimmune Diseases at 971. The HF is responsible for producing the hair shaft. See id. Thereafter, T cell cytokines and cytotoxic T cells produce cytotoxic damage. See id. This disrupts the normal function of the HF, resulting in thin, fragile hairs that easily detach or break off. See id. However, because immune damage is localized to the hair bulb, regrowth of the hair can occur after total hair loss, although the process can be slow. Id. at 972. The triggers for AA are not well understood. See Richardson at 2. “Potential triggers include emotional stress, metabolic or endocrine disorders, infections, drugs, and vaccines.” Id. Several potential pathogenic mechanisms by which AA might occur have been proposed, including molecular mimicry15, the induction of the cytokine interferon (type 1 IFN), or a “cytokine storm,” 14 AA is only one type of alopecia. Other types include alopecia totalis (loss of all hair on the scalp) and alopecia universialis (loss of all scalp and body hair). See Zafrir at 1–2. Additionally, there is another type of alopecia called telogen effluvium that is known to occur in response to stress on the body. Tollefson Report at 3. 15 Molecular mimicry is of course a commonly-invoked mechanism in the Vaccine Program for explaining how the immune system might aberrantly cause disease, and proposes that foreign antigens presenting to immune system cells might be confused with self-structures, causing the immune system to mistakenly attack both the antigens and self- 19 Case 1:15-vv-00124-MCW Document 68 Filed 01/10/20 Page 20 of 25 in which cytokines upregulated after some instigating event greatly increase in number for a period of time, causing harm simply through their proliferation. Richardson at 5–6; Tr. at 115; Pet’r’s Brief at 7. Once AA is triggered, its clinical course is variable and not monophasic in progression. Tr. at 51–52; Resp.’s Post-Hearing Brief at 7. As Dr. Norris elaborated in his testimony, some patients experience recurring loss and regrowth, other patients experience one episode, and some will experience “everything in between.” Tr. at 51–52. II. Petitioner Has Carried Her Althen Burden With Respect to Her First Instance of AA in November 2012 Petitioner has barely met her preponderant burden with respect to L.T.’s initial outbreak of AA. The evidence is close, and almost in equipoise, on most of the Althen prongs in this case. But well-reasoned and controlling precedent in the Vaccine Program requires me in such close cases to decide the matter for the petitioner. See Walther v. Sec’y of Health & Human Servs., 485 F.3d, 1146, 1150 (Fed. Cir. 2007) (“[u]nder our case law, ‘close calls regarding causation are resolved in favor of injured claimants.’”) (quoting Althen, 418 F.3d at 1280). I find that is appropriate here. First, there is just enough evidence to support Petitioner’s contention under the “can cause” prong that AA could be triggered by vaccination - and the HBV vaccine in particular. It was largely agreed-upon by the experts in this case that AA is likely an autoimmune process, thereby “opening the door” to a determination that something impacting the immune response could be implicated as causal. In addition, Petitioner offered some reasonable items of literature, like Wise, supporting the association between the HBV vaccine and hair loss generally, if not AA specifically. See Wise at 1–2. Wise also demonstrated some instances of challenge–rechallenge. While this aspect of Wise did not aid Petitioner specifically on the second Althen prong (since the record in this case does not establish that L.T. ever experienced AA or hair loss following her earlier HBV doses),16 it does lend some support for the contended HBV-AA association. Respondent is also correct about Wise’s limitations as strong proof of the association (indeed, its authors acknowledge the tentative scope of its determinations (Wise at 1)), and this item of literature has not been updated with corroborative research since its publication twenty years before (although it has not been rebutted either). Wise nevertheless is deserving of some weight, and does go directly to the issue in contention. structures (with the latter constituting the damaging autoimmune response). Lauren Sompayrac, How the Immune System Works 122 (5th ed. 2016). 16 Rechallenge is commonly understood to have this dichotomous effect when asserted by a Vaccine Act petitioner. Cases relying on rechallenge to prove Althen prong I have sometimes failed under Althen prong II. See Nussman v. Sec’y of Health & Human Servs., 83 Fed. Cl. 111, 119 (Fed. Cl. 2008) (“[t]here can only be rechallenge if there was an initial challenge and associated adverse reaction”). 20 Case 1:15-vv-00124-MCW Document 68 Filed 01/10/20 Page 21 of 25 Richardson also assists Petitioner’s theory to a degree. Richardson involved a significantly larger sample size than Wise, and statistical analysis of this sample showed a reliable correlation of increased rates of AA in individuals who also had the HBV vaccine. Richardson by its own admission is not definitive on the point (especially to the extent it did not account for the possibility of a mere temporal association of AA to HBV vaccination). See Richardson at 5. In addition, Richardson’s post-hearing filing (and the fact that it was not discussed by Dr. Norris) causes me to give it a little less weight than I might otherwise. See McClellan v. Sec’y of Health & Human Servs., No. 14-714V, 2019 WL 4072130, at *30 n.28 (Fed. Cl. Spec. Mstr. July 2019, 2019) (“I typically give late-filed items less weight where a party has not demonstrated a justification for their dilatoriness—for example, because the item in question was only published after hearing.”).17 It nevertheless was credible evidence favoring Petitioner’s claim—and was not refuted by Respondent, let alone addressed in his post-hearing briefing. Respondent’s failure to rebut Petitioner’s case went beyond not addressing the late-filed Richardson. Certainly he pointed out some deficiencies in Petitioner’s causation theory, such as the lack of a reliable mechanistic explanation for how a vaccine would induce the breaking of immune tolerance (although it is well recognized in the Program that petitioners can prevail even in the absence of proof of mechanism). Dr. Tollefson was also a credible and competent expert witness, and her points about the genetic basis for AA were effectively established. But in this case (unlike others) Respondent was unable to offer evidence casting doubt on Petitioner’s theory (e.g., an epidemiologic study that discounted the purported association between the HBV vaccine and AA).18 I also found Dr. Norris to be a qualified and persuasive expert witness, and his embrace of Petitioner’s theory gave it a little added heft. Second, the record does support (again, just barely) the conclusion that the HBV vaccine in this case likely triggered L.T.’s AA onset in November 2012. Petitioner has offered treater support for this contention, such as Dr. Gilmore’s notes from an appointment in January 2013. Ex. 7 at 1–2. While Respondent correctly observes that the record also includes some more ambiguous statements about an association (especially since not all treaters signed on to this reasoning), or may simply evidence overreliance on the temporal association (which is recognized as an insufficient basis to ascertain causation), I nevertheless discern sufficient, reliable treater support connecting L.T.’s AA to her HBV vaccination to deem it evidentiarily significant. Dr. Norris also 17 The fact that one of L.T.’s own treaters co-authored Richardson (and even appears to discuss L.T.) is also somewhat problematic—although in other cases articles written about an injured party have been deemed deserving of evidentiary weight (and in Respondent’s favor) if only for their discussion of a condition. See McClellan, 2019 WL 4072130, at *4 (discussing article addressing mutation in petitioner’s daughter, the allegedly injured party). 18 In many prior cases, I have found the existence of strong and reliable epidemiologic evidence to tip the scales in Respondent’s favor—even though it is unquestionably the case that this kind of proof need not be offered by a petitioner. See, e.g., Maciel v. Sec’y of Health & Human Servs., No. 15-362V, 2018 WL 6259230, at *27 (Fed. Cl. Spec. Mstr. Oct. 12, 2018). The converse must also be true: where Respondent does not offer such evidence, arguments a Petitioner may make on causation will stand a little more unscathed. 21 Case 1:15-vv-00124-MCW Document 68 Filed 01/10/20 Page 22 of 25 provided a persuasive interpretation of the record, and what factors specific to L.T. would implicate the vaccine as triggering her genetically-associated AA. See generally Tr. at 66–69.19 Finally, the timeframe in which L.T.’s AA began—two to four days post-vaccination— was established to be a medically acceptable temporal relationship for an autoimmune response. Petitioner claims this timeframe is supported by Wise and Dr. Norris’s expert opinion. Dr. Norris’s opinion as to timing, in his report and testimony, relied mostly on Wise. Tr. at 56; Norris Report at 2. Although Respondent’s criticisms of Wise are reasonable, I find overall that the concept that the autoimmune response to the HBV vaccine could begin in that timeframe is reasonable, especially given Dr. Norris’s acceptance of it. I again emphasize that Petitioner’s showing was not particularly robust. Other evidence could have rebutted it. But the record in this case establishes that, at least with respect to the first occasion of L.T.’s AA, Petitioner carried her preponderant burden. III. Petitioner Has Not Carried her Burden of Proof with Respect to Any Subsequent Occurrences of AA Although Petitioner has established entitlement to damages stemming from her first occurrence of AA after the November 2012 vaccination, I do not find that she persuasively established that any subsequent recurrences (the first of which appears to have happened around the time of her August 2015 return visit to Dr. Gilmore, reporting new-onset AA symptoms) can also be attributed to that same initial vaccine event. The thinness of Petitioner’s overall evidentiary showing may have been just enough to be preponderant in determining causation with respect to the first occurrence of AA, but that same slim showing shifts against Petitioner when the larger picture (including what the experts agreed about AA) is taken into account. Determination of this aspect of Petitioner’s claim turns almost wholly on the first Althen prong.20 Although I have found that Petitioner was successful in establishing that a vaccine might be a sufficient environmental trigger to produce an occurrence of AA, the context of that occurrence is significant. Both experts agreed that AA is known to have a significant genetic component that serves as a baseline “requirement” for AA to manifest. Tr. at 41–42, 150–51; see also A. Alkhalifah, et al., Alopecia Areata Update: Part I. Clinical Picture, Histopathology, and Pathogensis, 62 J. Am. Acad. Dermatology, no. 2, 177, 184–85 (2010) , filed on July 18, 2017, as 19 As already noted, however, this case does not support the conclusion that L.T.’s vaccine reaction was associated with her prior receipt of the HBV vaccine, under a challenge-rechallenge theory. The record does not establish she ever reacted to those prior vaccinations, nor did she experience AA after them. The general concept that a person who has received a vaccine before without incident will nevertheless inherently (or likely) have a faster response later, as reflected in the injury asserted in a Vaccine Act claim, is speculative and conclusory. 20 I note as well that Petitioner’s subsequent recurrences of AA (the first of which appears to have happened no earlier than August 2015) have not been shown to have happened post-vaccination. Accordingly, Petitioner would still in this case not be entitled to damages for those occurrences even if she had not maintained that the first vaccination explained all subsequent AA recurrences. 22 Case 1:15-vv-00124-MCW Document 68 Filed 01/10/20 Page 23 of 25 Ex. 18 (ECF No. 42) (family history of AA increases chances of developing the condition); A. Gilhar, et al., Alopecia Areata, 336:16 New Eng. J. Med. 1514, 1521–22 (2012), filed on July 18, 2017, as Ex. 19 (ECF No. 42-1) (patients with AA often have a family history of atopy and autoimmune disorders). Here, there was ample circumstantial evidence that L.T. was just such a person. Indeed, as Petitioner herself testified, she had experienced hair loss in association with a likely autoimmune event even before L.T. did. Tr. at 8–9. Given the above, can it be concluded that the same initial trigger—here, the November 2012 vaccination—could reliably be deemed responsible for all future AA recurrences? The evidence offered in this case does not support that assertion. AA is clearly viewed as non- monophasic and inherently subject to recurrence. Moreover, vaccines are not the sole possible trigger. Ms. DeLozier admitted as much, when she recounted the fact that L.T. had experienced recurrences under other circumstances, such as when L.T. had an infection or fever. Tr. at 20–22. The scientific and expert evidence filed in this case otherwise did not stand for the proposition that response to an initial vaccine trigger could explain every subsequent occurrence of AA in a susceptible individual. None of the literature offered by Petitioner so states, or establishes what a vaccine like HBV would do to alter a person’s subsequent immune privilege in future triggering events. At best, Dr. Norris attempted to outline how a vaccine could theoretically create a “smoldering immune response,” consistent with the condition’s relapsing nature, and thus even separate subsequent triggers would be linked to the initial event, but such assertions were (unlike most of his testimony) conclusory and unpersuasive. Tr. at 175–77. At bottom, nothing that is known about AA (at least as reflected in the filings in this case) suggests that the first instance of AA in a person (likely to occur in childhood) is the linchpin explanation for all subsequent recurrences. The capacity of a vaccine to trigger a pathologic response must be placed in the context of the overall disease’s expected course. In other cases in the Vaccine Program, petitioners have demonstrated that the “trigger effect” of vaccination can not only cause an initial reaction but lead to permanent progressive harm, with the initial injury beginning a progressive process of worsening symptoms. For example, vaccines have in some cases been shown to cause direct, catastrophic injury to the brain, such as an encephalopathy that has significant follow-on health impacts. See, e.g., Estep v. Sec’y of Health & Human Servs., 28 Fed. Cl. 664, 669 (Fed. Cl. 1993) (affirming special master’s finding that a “DPT vaccination can cause an acute encephalopathy, and that anything that can cause an acute encephalopathy can [subsequently] cause permanent neurologic damage”). A comparable theory that has found success involves circumstances where petitioners demonstrate that a seizure triggered by vaccination (sometimes merely due to the fever associated with the body’s innate immune response) will set up conditions for future, more harmful seizures in the future. Andreu v. Sec’y of Health & Human Servs., 569 F.3d 1367, 1375–76 (Fed. Cir. 2009) (reversing special master, and finding that petitioners had shown that the vaccine in question could trigger seizures). 23 Case 1:15-vv-00124-MCW Document 68 Filed 01/10/20 Page 24 of 25 The “trigger” effect of the vaccine in this case, by contrast, is different – more isolated and discrete in scope. Both sides’ experts agreed that AA has a significant genetic underpinning, and thus a person who likely possesses that predisposition (a conclusion that can be made about L.T. based on preponderant evidence) is more susceptible to experiencing AA on a lifelong basis. While it may have been established in this case that the HBV vaccine could trigger one instance of AA, it has not been similarly shown that any trigger (vaccine or not) would so alter a person’s immune response that all AA recurrences would invariably be associated with the first, made worse due to the first, etc. None of the medical literature filed in this case stands for this proposition, and in fact (in stressing the importance of the genetic susceptibility to AA) actually undermines it. It is more likely that an individual’s subsequent recurrences are attributable to the genetic susceptibility underlying AA. See McClellan, 2019 WL 4072130, at *35–36 (finding that petitioner “did not establish that a vaccine could, under the circumstances, trigger a non-febrile seizure sufficient to significantly worsen a preexisting seizure disorder with an unmistakable genetic origin”); Sharpe v. Sec’y of Health & Human Servs., No. 14-65V, 2018 WL 7625360 (Fed. Cl. Spec. Mstr. Nov. 5, 2018) (finding that neither the record supported “[p]etitioner’s contention that the vaccines [] received could, or did, injure [their daughter] as alleged,” nor did petitioners establish a significant aggravation claim given their daughter’s existing “DYNC [gene] mutation”), aff’d, 142 Fed. Cl. 630 (2019), appeal docketed, No. 19-1951 (Fed. Cir. May 31, 2019). And Dr. Norris did not otherwise credibly establish with reliable evidence that AA can be thought of as a “smoldering” condition, in which the instigating trigger for an outbreak is a spark that is never extinguished. The implication of my ruling is that Petitioner’s recoverable damages in this case are circumscribed in several respects. Clearly she is entitled to costs associated with L.T.’s treatment from November 2012 until any initial AA symptoms associated with the triggering abated (and a preliminary review of the record suggests that had occurred by no later than August 2014). She can also seek an award of pain and suffering associated with her initial November 2012 symptoms. But she cannot recover damages associated with any new, discrete AA recurrences that L.T. experienced post-vaccination, beginning no later than August 2015. CONCLUSION Ms. DeLozier has carried her burden in establishing that the HBV vaccine could trigger AA, and did so in L.T.’s case in November 2012. She should therefore receive a damages award reflecting the costs of treatment of that first occurrence, plus any other damages flowing therefrom. However, she has not established an entitlement to damages associated with any subsequent AA recurrences, which have not preponderantly been shown to be attributable to the earlier HBV vaccine. 24 Case 1:15-vv-00124-MCW Document 68 Filed 01/10/20 Page 25 of 25 In order to guide the parties through the damages phase of the action, a separate damages order will issue. IT IS SO ORDERED. /s/ Brian H. Corcoran Brian H. Corcoran Chief Special Master 25 ================================================================================ DOCUMENT 2: USCOURTS-cofc-1_15-vv-00124-1 Date issued/filed: 2020-09-25 Pages: 9 Docket text: PUBLIC DECISION (Originally filed: 08/11/2020) regarding 75 DECISION of Special Master Signed by Chief Special Master Brian H. Corcoran. (ey) Service on parties made. -------------------------------------------------------------------------------- Case 1:15-vv-00124-MCW Document 80 Filed 09/25/20 Page 1 of 9 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 15-124V (to be published) * * * * * * * * * * * * * * * * * * * * * * * * * Chief Special Master Corcoran CHRISTINE DELOZIER, * parent and next friend of L.T., a minor, * * Filed: August 11, 2020 Petitioner, * * Alopecia Areata; Autoimmune v. * Condition; Pain and Suffering; * Damages SECRETARY OF HEALTH AND * HUMAN SERVICES, * * Respondent. * * * * * * * * * * * * * * * * * * * * * * * * * * * Richard Gage, Richard Gage, P.C., Cheyenne, WY, for Petitioner. Jennifer L. Reynaud, U.S. Dep’t of Justice, Washington, DC, for Respondent. DAMAGES DECISION1 On February 9, 2015, Christine DeLozier,2 as parent and next friend of L.T., a minor, filed a petition seeking compensation under the National Vaccine and Injury Compensation Program (the “Vaccine Program”).3 (ECF No. 1) (“Petition”). Petitioner alleged that L.T. suffered from alopecia areata (“AA”) attributable to a hepatitis B vaccine (“HBV”) L.T. received on November 6, 2012. A hearing was held in this matter on February 4, 2019, and I determined that Petitioner 1 This Decision shall be posted on the Court of Federal Claims’ website in accordance with the E-Government Act of 2002, 44 U.S.C. § 3501 (2012)). This means that the Decision will be available to anyone with access to the internet. As provided by 42 U.S.C. § 300aa-12(d)(4)(B), however, the parties may object to the Ruling’s inclusion of certain kinds of confidential information. Specifically, under Vaccine Rule 18(b), each party has fourteen days within which to request redaction “of any information furnished by that party: (1) that is a trade secret or commercial or financial in substance and is privileged or confidential; or (2) that includes medical files or similar files, the disclosure of which would constitute a clearly unwarranted invasion of privacy.” Vaccine Rule 18(b). Otherwise, the whole Ruling will be available to the public. Id. 2 Although the Petition was originally filed under the name “Christine Torres,” Petitioner has since changed her last name to DeLozier, and therefore the case caption has been amended. (ECF No. 58). 3 The Vaccine Program comprises Part 2 of the National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3758, codified as amended at 42 U.S.C. §§ 300aa-10 through 34 (2012) [hereinafter “Vaccine Act” or “the Act”]. Individual section references hereafter will be to § 300aa of the Act (but will omit that statutory prefix). 1 Case 1:15-vv-00124-MCW Document 80 Filed 09/25/20 Page 2 of 9 had established an entitlement to a damages award based on her success in preponderantly demonstrating that the HBV vaccine triggered a single instance of AA. Ruling on Entitlement, dated December 10, 2019 (ECF No. 66) (the “Ruling”). I subsequently ordered the parties to attempt to resolve damages in this matter, and although they agree that the sole item of damages to be awarded is pain and suffering, they dispute the quantum of that component. Now, based on review of the filed materials and briefs, and for the reasons set forth below, I award $50,000.00 in actual pain and suffering in this case. Procedural History As noted, this case was filed over five years ago, and went to hearing only after the parties were unable to settle. At hearing, it was established that L.T. was three years old (and thus a toddler) when she received the HBV vaccine in November 2012, and that she began experiencing hair loss within a week of vaccination. Ruling at 3. Although the process of treating the hair loss extended into the next year, by August 2014 (almost two years after L.T. received HBV) the medical records ceased to indicate that it was still a concern. Id. at 5. L.T. then experienced a recurrence of AA about a year later, in August 2015 (when she was six) that required follow-up treatment. Id. at 5–6. However, subsequent records fail to show the problem persisted in later years—and although at one point in the efforts to resolve damages Petitioner maintained that one component of damages would include the cost of ongoing treatment, that need was never substantiated. Id. at 6. My December 2019 Ruling was favorable to Petitioner—but only with respect to the initial occurrence of AA in November 2012 that appears to have thereafter required approximately two years to treat before resolving. Ruling at 2, 20–24. Petitioner had only preponderantly established that the HBV vaccine could cause (and in L.T.’s case, had caused) a single episode of AA—not initiated a chronic process that would likely recur. Id. at 23–24. The evidence and expert testimony (which acknowledged that AA was believed to have a genetic origin) did not support the conclusion that a one-time triggering of AA, due to vaccine or otherwise, meant that the same initial trigger was also responsible in part for all subsequent occurrences. As a result, the HBV vaccine L.T. received in 2012 could not be blamed for any subsequent occurrences L.T. experienced (or may yet experience). Id. Because of my finding, Petitioner could only recover damages associated with the first documented instance of AA that had occurred within a week of receipt of the vaccine—the cost of treatment relating to this single instance, plus pain and suffering attributable to it. I issued an Order requiring the parties to attempt to reach agreement on damages (and specifically tasking Petitioner with calculating the sum to be requested). Damages Order, dated Dec. 11, 2019 (ECF No. 67). 2 Case 1:15-vv-00124-MCW Document 80 Filed 09/25/20 Page 3 of 9 Thereafter, the parties attempted to resolve the issue of damages, but were unsuccessful in so doing. It does appear, however, that their discussions somewhat succeeded in narrowing the relevant categories of damages. Thus, in an initial status report responding to my Damages Order, Petitioner represented that the damages components to be requested would include future treatment costs associated with the first instance of AA,4 plus pain and suffering and “minor out-of-pocket costs.” Joint Status Report, dated Feb. 10, 2020 (ECF No. 69) at 1. However, Petitioner’s subsequently-filed Brief on Damages reported that “the only award to L.T. will be for pain and suffering.” Petitioner’s Brief, dated May 22, 2020 (ECF No. 72) (“Brief”) at 1.5 Petitioner’s Brief offers no other substantiation for the claimed damages categories (and in fact did not even request a specific amount to be awarded for pain and suffering). It also does not cite to findings from the Ruling, or other record evidence that would support any particular damages calculation. At most, it refers to an earlier-filed declaration from Ms. DeLozier. Declaration, dated Mar. 3, 2020 (ECF No. 71-1). In that declaration, Petitioner recounts the aftermath of L.T.’s vaccination and associated hair loss, maintaining that L.T.’s head had to be shaved, and that her appearance caused other children to make fun of her. Declaration at ¶4. Ms. DeLozier stresses the psychologic impact of the hair loss on her daughter, adding that regrowth was subsequently thinner. Id. at ¶6. Ms. DeLozier’s declaration also mentions itchy eczema patches that caused L.T. discomfort—although (as my Ruling indicates) L.T. had experienced eczema before vaccination (Ruling at 2), and independent of her vaccine-triggered AA (although it is an associated condition). Respondent filed a brief setting forth his position on damages on June 22, 2020. ECF No. 73 (“Opp.”). Respondent argues therein that the damages to be awarded should be limited to $15,000.00 in compensation for past pain and suffering. Opp. at 1. Because L.T.’s hair loss experience was generally limited, resolving “with minimal treatment over a year or two” before she was in kindergarten, Respondent contends that a nominal pain and suffering award is all that is justified under the facts of the case. Id. at 4. Respondent otherwise highlights the fact that Petitioner requested no other damages components of the kind often sought in Program cases (e.g., lost past or future wages, unreimbursable expenses, etc.) 4 In reaction, I reminded Petitioner of my Ruling’s determination—that HBV had not been shown to be responsible for any “chronic” subsequent hair loss/AA incidents—meaning that future care costs were only recoverable if associated with the first instance of hair loss that I had found was vaccine-caused. See Scheduling Order, dated Feb. 11, 2020 (ECF No. 70) at 1–2. I also note that Petitioner’s first status report made no effort to calculate the damages she expected to demand, and only identified categories of damages to be requested. 5 Incongruously, the Brief also again claims that Petitioner incurred “some out of pocket expenses,” and maintains they were still in the process of being compiled (Brief at 2)—despite the fact that I had asked Petitioner to perform this task almost six months before. To date, Petitioner has never substantiated them, despite a full and fair opportunity to do so, and her most recently-filed Reply drops any request whatsoever for this category of damages. 3 Case 1:15-vv-00124-MCW Document 80 Filed 09/25/20 Page 4 of 9 On July 17, 2020, Petitioner filed a reply in support of her damages request. ECF No. 74 (“Reply”). Now (and for the first time since the Entitlement Ruling), Petitioner made clear that she seeks a pain and suffering award of $250,000.00—the maximum available under the Act—for all emotional distress/pain and suffering experienced by L.T. Reply at 3. In support, Petitioner referred again to her March 2020 declaration, but referenced no other evidence or case law that would substantiate this demand. Id. The matter is now ripe for resolution. ANALYSIS I. Relevant Law on Calculation of Pain and Suffering Awards The sole damages issue before me is the amount of pain and suffering to be awarded in this case—as both sides agree some amount is appropriate. There is no mathematic formula for assigning a monetary value to a person’s pain and suffering and emotional distress. I.D. v. Sec'y of Health & Hum. Servs., No. 04-1593V, 2013 WL 2448125, at *9 (Fed. Cl. Spec. Mstr. May 14, 2013) (“[a]wards for emotional distress are inherently subjective and cannot be determined by using a mathematical formula”); Stansfield v. Sec'y of Health & Hum. Servs., No. 93-0172V, 1996 WL 300594, at *3 (Fed. Cl. Spec. Mstr. May 22, 1996) (“the assessment of pain and suffering is inherently a subjective evaluation”). Many Vaccine Program cases discuss calculation of two subcategories of pain and suffering awards—past (or “actual”) and projected—and then add them together, to come up with the total sum (with the future component discounted to net present value). See, e.g., Collado v. Secretary of Health & Hum. Services, No. 17-0225V, 2018 WL 3433352, at *6–8 (Fed. Cl. Spec. Mstr. June 6, 2018). Here, I do not find the total sum to be awarded needs to be so separately calculated. Petitioner has not requested a bifurcated award, based on prior suffering plus anticipated future experience—and more importantly, Petitioner has not established entitlement to a future award, given that her single, vaccine-caused AA occurrence has not been shown to have resulted in life-long sequelae or likely future emotional harm. Thus, an award for actual past pain and suffering is all that is warranted in this case. The Vaccine Act caps the awardable amount of total pain and suffering damages at $250,000.00. Section 15(a)(4). One question raised by the parties’ briefs is how to calculate a pain and suffering award in light of this cap. A persuasive Court of Federal Claims decision issued within the last seven years suggests that special masters should calculate the total pain and suffering award appropriate (whatever it is) before applying the cap, rather than treating the $250,000.00 amount as the top of a “range” of potential awards, with cases falling within a spectrum based on comparable severity. Graves v. Sec’y of Health & Hum. Servs., 109 Fed. Cl. 579, 589–90 (2013). Respondent has argued (in this case6 as well as others) that the latter approach 6 See Opp. at 3–4. 4 Case 1:15-vv-00124-MCW Document 80 Filed 09/25/20 Page 5 of 9 was regularly applied before Graves was decided and is preferable, and otherwise maintains that the cap should not be treated as a default (based on the assumption that many petitioners could demonstrate a greater degree of pain and suffering). However, special masters have accepted Graves’s methodology since the case’s issuance. See, e.g., Bruegging v. Sec’y of Health & Hum. Servs., No. 17-0261V, 2019 WL 2620957 (Fed. Cl. Spec. Mstr. May 13, 2019); Reed v. Sec’y of Health & Hum. Servs., No. 16-1670V, 2019 WL 1222925 (Fed. Cl. Spec. Mstr. Feb. 1, 2019). Graves is not controlling precedent in this case, no matter how well-reasoned. In addition, the Vaccine Act itself only states that pain and suffering awards cannot “exceed” the cap and does not provide a specific means of its application. Section 15(a)(4). Certainly, it logically cannot be the case (and cannot have been the intent of Congress in creating the Program) that all Program cases in which a pain and suffering award is merited should receive $250,000.00. Although a persuasive argument can be made that the passage of time has rendered the cap an artificial limitation on total recoverable pain and suffering, it still reflects Congress’s judgment that there should be an outer bound for pain and suffering awards—and implicit to that is the reasonable likelihood that many cases will warrant some lower figure. Nevertheless, I have in prior cases followed Graves, and I will apply it herein as well—although I do so mindful of the need to consider the overall strength of Petitioner’s showing herein. What total amount has in this case been demonstrated to be appropriate? In calculating pain and suffering awards, Court of Federal Claims judges and special masters have frequently considered three primary factors: (a) severity of the injury, (b) awareness of the injury, and (c) duration of the suffering. Collado, 2018 WL 343352, at *6. Awareness is often deemed a function of whether the injured party was mentally competent (see, e.g., Meyers v. Sec’y of Health & Hum. Servs., No. 18-0909V, 2020 WL 3755335, at *3 (Fed. Cl. Spec. Mstr. June 5, 2020))—suggesting that injuries experienced by an infant or very young child, whose mental cognition was not yet fully developed, might not meet these criteria.7 Duration and severity, by contrast, relate to the amount of pain or loss of normal function imposed by the injury, and the length and invasiveness of treatments required for it. As a number of decisions on the subject reached in cases involving shoulder injuries related to vaccine administration (“SIRVA”) reveal, the amount to be awarded should take into account not only how painful (both in terms of immediacy and duration) the injury has proven, but the degree of treatment it required—measured in terms of things like whether surgical intervention was needed (and if so, how invasive it was), and how many treater visits were necessary. See, e.g., Smallwood 7 This is not to say that awareness in young children can never be established, thus putting out of reach a larger award in such cases. See generally McAllister v. Sec’y of Health & Hum. Servs., 91-1037V, 1993 WL 777030 (Fed. Cl. Spec. Mstr. Mar. 26, 1993) (awarding statutory cap of $250,000.00 to a child who was injured at the age of three months old), vacated and remanded on other grounds, 70 F.3d 1240 (Fed. Cir. 1995). 5 Case 1:15-vv-00124-MCW Document 80 Filed 09/25/20 Page 6 of 9 v. Sec’y of Health & Hum. Servs., No. 18-029V, 2020 WL 2954958 (Fed. Cl. Spec. Mstr. Apr. 29, 2020). II. Calculation of Petitioner’s Actual Pain and Suffering Award Although the parties agree that a pain and suffering award is merited in this case, I also find that the record amply supports one as well. The only question is the magnitude of that award. Consideration of the three criteria set forth in Collado and many other decisions helps to define what these circumstances suggest would be a just and fair award. Unquestionably, L.T. was old enough to perceive her hair loss and how it made her appear. I also find that Petitioner’s declaration substantiates the kinds of anguish and concern that would accompany loss of hair that could be observed publicly—especially by other children.8 At the same time, however, I find that the duration of L.T.’s hair loss and subsequent treatment was not unusually long, nor has the severity of the injury and associated treatment been shown to be especially high. L.T.’s overall hair loss attributable to a single instance of AA was not permanent, her treatment mostly appears to have involved topical creams, and Petitioner did not establish that this initial loss has persisted. Ruling at 3–6. Petitioner argues that her total pain and suffering exceeds the statutory cap, and therefore requests $250,000.00 in total, without differentiating between past and present suffering. But a sum of this magnitude (let alone one exceeding it) has hardly been established by Petitioner’s limited showing. Indeed—Petitioner did not even request a $250,000.00 award until her Reply, and she offers no comparable cases or other evidence beyond her own declaration to support the figure. Respondent proposes no more than the far more modest sum of $15,000.00. Like Petitioner, however, Respondent has not identified any basis, such as in past decisions, to justify this amount. While few, if any, cases alleging alopecia have been resolved through reasoned decision, a number of settled cases give some insight into what might be the fair contours of an award in this case.9 Cases in which the injured party suffered a more severe form of alopecia, such as alopecia totalis and alopecia universalis, resulting in complete and persistent hair loss, have resulted in higher total awards. See, e.g., Angell v. Sec’y of Health & Hum. Servs., No. 14-914V, 8 Respondent argues that Petitioner’s contention that L.T.’s head had to be shaved is not substantiated by the Record. Opp. at 4 n.2. Petitioner did submit photographs of L.T. in which several bald patches are noticeable, and her remaining hair had been shaved. Ex. 8, filed May 21, 2015 (ECF No. 13). These photos, however, appear to have been taken in May 2015 during a separate flare of AA unrelated to the vaccination she received in 2012. Thus, I find Petitioner was unable to substantiate the claim that L.T.’s head had to be shaved during the initial flare for which I have found entitlement, but this point does not substantially undercut the reasoning behind the calculation of the award in this case. 9 While decisions awarding damages via stipulation or settlement serve as useful comparisons under the circumstances, they do not provide a reasoned analysis as to how much of the total award amount is specific to past and future pain and suffering, or how such an amount was deemed appropriate. Under the circumstances, however, they are the next- best-available evidence for consideration. 6 Case 1:15-vv-00124-MCW Document 80 Filed 09/25/20 Page 7 of 9 2016 WL 5819224 (Fed. Cl. Spec. Mstr. Sept. 6, 2016) (awarding a lump sum award of $225,000 to a minor petitioner who suffered from persistent alopecia totalis); Desiderio v. Sec’y of Health & Hum. Servs., No. 11-444V, 2012 WL 1392316 (Fed. Cl. Spec. Mstr. Mar. 19, 2012) (awarding a lump sum of $95,000 to an adult petitioner who suffered alopecia universalis after receiving several vaccines). By contrast, cases alleging other subtypes of alopecia, including AA, have resulted in smaller total sums. See Trezza v. Sec’y of Health & Hum. Servs., No. 13-231V, 2014 WL 6845794 (Fed. Cl. Spec. Mstr. Nov. 5, 2014) (awarding a lump sum of $50,000 for an unspecified subtype of alopecia experienced by a minor); Andrews-Turner v. Sec’y of Health & Hum. Servs., No. 11-506V, 2012 WL 6788395 (Fed. Cl. Spec. Mstr. Dec. 10, 2012) (awarding a lump sum of $115,000 for AA experienced by a minor and alleged to have lasted for more than four years following receipt of the MMR vaccine). Yet high or low, in none of these cases can it be discerned from the settlement what component of the total award reflected pain and suffering— and it is likely that cases involving more severe kinds of alopecia included larger future and past treatment components. L.T. suffered from the less severe, AA-subtype of alopecia, and her symptoms persisted for approximately two years. Although she required minimal treatment of a non-invasive nature, she still suffered from the stigma and embarrassment of hair loss, at an age where she would likely comprehend the experience. I thus find that an award of $50,000 is fair, in light of the circumstances of this case and best comparables available. This sum fairly captures the temporally- limited severity of L.T.’s suffering, and generously compensates her for the experience of her AA, which thankfully happened when she was quite young (thus limiting somewhat the trauma that a teenager (subject to peer pressure) or older adult might experience. The award I make is more than three times what Respondent offers, underscoring my view that a somewhat more substantial award is warranted, even if Petitioner’s cap-hitting request has not been persuasively established. I note that this award exceeds what has been agreed to or ordered in cases involving somewhat-comparable one-time, non-catastrophic vaccine injuries that have resolved favorably, with mild-to-moderate sequelae and limited to no pain, but some evidence of stigma or embarrassment due to the outward/visual nature of the injury. See, e.g., Olschansky v. Sec'y of Health & Hum. Servs., No. 17-1096V, 2019 WL 7560417 (Fed. Cl. Spec. Mstr. Oct. 21, 2019) (joint stipulation was reasonable for $38,696.72 representing all damages available for compensation under 42. U.S.C. § 300aa-15(a) for an adult petitioner suffering from vitiligo); Williams v. Sec'y of Health & Hum. Servs., No. 15-1224V, 2019 WL 994570 (Fed. Cl. Spec. Mstr. Jan. 29, 2019) (parties settled for $12,500.00 in case where child was suffering from eczema). In addition, cases involving more obviously severe, if durationally-limited, injuries to young children, such as intussusception (an acute intestinal blockage typically requiring surgical intervention), have also resulted in somewhat lower pain and suffering awards. See, e.g., Reed on behalf of M.C. v. Sec'y of Health & Hum. Servs., No. 14-653V, 2015 WL 779137 (Fed. Cl. Spec. Mstr. Jan. 9, 2015) (stipulating to $35,000.00 in pain and suffering in intussusception case); E.J.N. by Noon v. Sec'y of Health & Hum. Servs., No. 13-1029V, 2014 WL 1614526 (Fed. Cl. Spec. Mstr. 7 Case 1:15-vv-00124-MCW Document 80 Filed 09/25/20 Page 8 of 9 Apr. 1, 2014) (same amount proffered in intussusception case). Only where the intussusception was unusually severe, requiring more invasive treatment and likely to produce uncommon future sequelae, has a higher amount been awarded. Neiman v. Sec’y of Health & Hum. Servs., No. 15- 631V, 2016 WL 6459618, at *7 (Fed. Cl. Spec. Mstr. Aug. 22, 2016) (awarding $144,000.00 for past pain and suffering, plus future pain and suffering in the amount of $1,000.00 per year for life, where surgical intervention required removal of portion of child’s bowel that would result in lifetime of GI problems). All of the above underscores the justness of a $50,000.00 actual pain and suffering award in this case. L.T.’s pain and suffering is mostly a function of the distress she likely experienced from her temporary hair loss—some of which (and in particular her subsequent AA bouts that did not occur after vaccination) is attributable to a genetic predisposition unrelated to vaccination, and not shown to have been exacerbated or exposed by vaccination. As distressing as her injury may have been, it was not life-threatening or physically painful. The amount to be awarded makes L.T. whole for the loss she experienced, and requires no other compensatory elements (for example, for past or future treatment costs)10—another indirect factor that might have counseled for a higher award.11 10 Although I did not find that any of L.T.’s subsequent AA occurrences were vaccine-caused—and thus do not include any costs associated with them in my award—I invited Petitioner to substantiate future costs associated with her one- time AA occurrence. Scheduling Order, dated Feb. 11, 2020 (ECF No. 70) at 3 n.3. But Petitioner has offered no evidence to this effect, nor did she attempt to substantiate these future treatment costs, despite repeated opportunities to do so. 11 I am opting to resolve damages in this case without hearing additional testimony. The Vaccine Act and Rules not only contemplate but encourage special masters to decide issues raised by petitions on the papers where (in the exercise of their discretion) they conclude that doing so will properly and fairly resolve the case. Section 12(d)(2)(D); Vaccine Rule 8(d). The decision to rule on the record in lieu of hearing has been affirmed on appeal. See Kreizenbeck v. Sec’y of Health & Hum. Servs., No. 08-209V, slip op. at 8 (Fed. Cir. Jan. 6, 2020); Hooker v. Sec’y of Health & Hum. Servs., No. 02-472V, 2016 WL 3456435, at *21 n.19 (Fed. Cl. Spec. Mstr. May 19, 2016) (citing numerous cases where special masters decided the matter on the papers in lieu of hearing, and the decision to do so was upheld on appeal). I am simply not required to hold a hearing in every matter, no matter the preferences of the parties. Hovey v. Sec’y of Health & Hum. Servs., 38 Fed. Cl. 397, 402–03 (1997) (special master acted within his discretion in denying evidentiary hearing); Burns, 3 F.3d at 417; Murphy 23 Cl. Ct. at 730–31. Here, there was no need to allow further witness testimony to decide the amount of pain and suffering to be awarded. At the February 2019 entitlement hearing, I had the opportunity to listen to Petitioner—and I have taken into account her testimony about the scope of L.T.’s injury and the suffering it caused in reaching the current calculation. In addition, Petitioner’s submissions on damages establish no grounds to hear again from her, or from any other witness. Indeed, beyond her recent two-page declaration, she has provided little to no additional evidence bearing on damages, and certainly nothing else that would justify the requested $250,000.00 award. 8 Case 1:15-vv-00124-MCW Document 80 Filed 09/25/20 Page 9 of 9 CONCLUSION In light of the above, I award $50,000.00 in damages for actual pain and suffering, in the form of a check payable to Petitioner. This amount represents compensation for all items of damages that would be available under Section 15(a). In the absence of a timely-filed motion for review (see Appendix B to the Rules of the Court), the Clerk SHALL ENTER JUDGMENT in accordance with this decision.12 IT IS SO ORDERED. /s/ Brian H. Corcoran Brian H. Corcoran Chief Special Master 12 Pursuant to Vaccine Rule 11(a), the parties may expedite entry of judgment by filing a joint notice renouncing their right to seek review. 9 ================================================================================ DOCUMENT 3: USCOURTS-cofc-1_15-vv-00124-2 Date issued/filed: 2021-02-19 Pages: 14 Docket text: PUBLIC OPINION and REMAND ORDER (re-issuance of 86 Order on Motion for Review for publication). Signed by Senior Judge Mary Ellen Coster Williams. (anh) Service on parties made. Docket text modified on 2/19/2021 for clarity. (dls). -------------------------------------------------------------------------------- Case 1:15-vv-00124-MCW Document 92 Filed 02/19/21 Page 1 of 14 In the United States Court of Federal Claims No. 15-124V (Filed: February 19, 2021)1 * * * * * * * * * * * * * * * * * * * * * * * * * CHRISTINE DeLOZIER, parent and * next friend of L.T., a minor, * National Childhood Vaccine Injury * Act, 42 U.S.C. §§ 300aa-1 et seq.; Petitioner, * Causation-in-fact; Burden of Proof; * Chronic Condition; Recurrence; v. * Remand. * SECRETARY OF HEALTH AND * HUMAN SERVICES, * * Respondent. * * * * * * * * * * * * * * * * * * * * * * * * * * Richard Gage, Richard Gage, P.C., 1815 Pebrican Avenue, P.O. Box 1223, Cheyenne, WY 82003, for Petitioner. Jeffrey B. Clark, C. Salvatore D’Alessio, Catharine E. Reeves, Alexis B. Babcock, Julia M. Collison, United States Department of Justice, Civil Division, Torts Branch, P.O. Box 146, Benjamin Franklin Station, Washington, D.C. 20044, for Respondent. _________________________________________________________ OPINION AND REMAND ORDER _________________________________________________________ WILLIAMS, Senior Judge. In the underlying action, Petitioner, on behalf of her minor daughter L.T., claimed that L.T. developed alopecia areata (“AA”) as a result of receiving a hepatitis B vaccine (“HBV vaccine”) and sought compensation under the National Vaccine Injury Compensation Program. The Chief Special Master ruled that Petitioner established that the HBV vaccine caused the onset of a single AA occurrence, but that Petitioner did not prove that the HBV vaccine could cause subsequent or future outbreaks of AA. The Chief Special Master awarded Petitioner $50,000 for pain and suffering limited to the first occurrence of AA. 1 Pursuant to Vaccine Rule 18 of the Rules of the United States Court of Federal Claims, the Court issued its Opinion under seal to provide the parties an opportunity to submit redactions. The parties did not propose any redactions. Accordingly, the Court publishes this Opinion. Case 1:15-vv-00124-MCW Document 92 Filed 02/19/21 Page 2 of 14 Petitioner timely filed a motion for review requesting that this Court remand the case to the Chief Special Master for a new damages calculation that takes into account L.T.’s recurrences of AA. This Court grants the motion. After finding that the HBV vaccine caused the onset of L.T.’s AA, a chronically recurring autoimmune condition, the Chief Special Master applied a heightened burden of proof in requiring Petitioner to again demonstrate causation for each subsequent outbreak of AA. As such, this Court remands this matter for a reassessment of damages that takes into account L.T.’s recurring episodes of AA. Background2 Relevant Medical History On November 6, 2012, L.T. received a third dose of an HBV vaccine. ECF No. 68 at 3. At the time of the vaccination, L.T. was three years old and had a history of eczema and asthma, as well as a family history of autoimmune disease. Id. at 2, 9 n.8, 11. L.T. had previously received her first and second HBV doses without any reported reaction. Id. at 2. Within a few days of her third HBV dose, L.T. began experiencing hair loss, complained of joint pain in her hip and wrists, developed a rash, and appeared to walk with a limp. Id. at 3. Later that month, Dr. Elaine Gilmore, a dermatologist, diagnosed L.T. with AA, noting “widespread . . . alopecic patches on the scalp” and prescribing a topical steroid for treatment. Id. (quoting Ex. 4 at 9). L.T.’s hair loss continued to worsen and did not show evidence of improvement until more than six months after the onset of her symptoms, when a June 2013 visit with a dermatologist revealed that new hairs had appeared in L.T.’s bald patches. Id. at 3-4. L.T. continued to “gradually recover[] some of her hair,” though her hair did not return to baseline. See Entitlement Hr’g Tr. 17-18. In a 2017 letter, L.T.’s treating dermatologist reported that L.T. “has areas of the scalp and eyebrows in which hair has not regrown, despite best efforts.” ECF No. 37, Ex. 13. L.T.’s mother testified that L.T. “has a permanently receded hairline all the way around her scalp.” Entitlement Hr’g Tr. 18. In years following L.T.’s 2012 onset of AA, she experienced recurrences of AA resulting in additional patches of hair loss -- in August 2015, and April, November, and December 2016. ECF No. 68 at 5-6. Overview of Alopecia Areata As the Chief Special Master found, AA is an autoimmune disease characterized by hair loss, typically appearing in patches on the scalp. ECF No. 68 at 19 (citing Stanca A. Birlea et al., Chapter 66: Non-bulbous Skin Diseases: Alopecia Areata, Vitiligo, Psoriasis, and Urticaria, in The Autoimmune Diseases 971-74 (N. Rose & I. Mackay eds., 2014) (“Autoimmune Diseases”). “AA is associated with a number of other diseases and conditions, such as vitiligo, atopic dermatitis (eczema), hyper and hypothyroidism, and, less commonly, other autoimmune diseases like connective tissue disease,” and “unquestionably has a genetic aspect” that determines susceptibility. Id. (citing Autoimmune Diseases at 972-73; Norris Report at 1; Tollefson Report at 2-3). 2 This background is derived from the record before the Chief Special Master and this Court. 2 Case 1:15-vv-00124-MCW Document 92 Filed 02/19/21 Page 3 of 14 “AA occurs when ‘a mononuclear cell inflammatory infiltrate attacks the hair follicle (HF) bulb.’” Id. (quoting Autoimmune Diseases at 971). “Thereafter, T cell cytokines and cytotoxic T cells produce cytotoxic damage,” which disrupts the functioning of the hair follicle and results in “thin, fragile hairs that easily detach or break off.” Id. (citing Autoimmune Diseases at 971-72). Although it is not well understood what causes the onset of AA, “[p]otential triggers include emotional stress, metabolic or endocrine disorders, infections, drugs, and vaccines.” Id. (quoting Autoimmune Diseases at 972). As the Chief Special Master determined, “[o]nce AA is triggered, its clinical course is variable and not monophasic in progression.” Id. at 20. “[S]ome patients will experience ‘recurring loss and regrowth,’ while others may experience only one episode of AA and some will experience ‘everything in between.’” Id. (quoting Entitlement Hr’g Tr. 51-52). Petitioner’s Expert Dr. David Norris, M.D., board certified in Dermatology, Dermatologic Immunology and Diagnostic and Laboratory Immunology, testified for Petitioner. ECF No. 68 at 7. Dr. Norris is the chairman of the Department of Dermatology at the University of Colorado School of Medicine, and he has conducted and published research relating to AA, dermatology, and immunodermatology. Id.; Entitlement Hr’g Tr. 34-35. The Chief Special Master found Dr. Norris to be a “qualified and persuasive expert witness.” ECF No. 68 at 21. Dr. Norris described AA as a clinical hair loss disease that “at its root is an immunologic disease controlled by genes.” Entitlement Hr’g Tr. 42. Specifically, AA is a polygenic disease -- “meaning that [it] may be determined not by one gene but by 30 genes or 40 genes,” and “that disease is expressed when you have the gene, or 30 genes, and then you get some kind of an environmental trigger that makes the person have an autoimmune response against the target.” Id. “In the case of [AA], it’s the hair follicle that’s the target.” Id. Dr. Norris explained the waxing and waning nature of AA, stating: There’s no one pattern that you can say, well, this is typical of [AA]. So these patients often develop hair loss and then get regrowth, and at a later time, they’ll also have more hair loss and regrowth. And that may progress to the loss of all of the hair on the head and no regrowth. Or, the most common patient that you see is someone who comes in and . . . they’ve had one or two or three patches of hair loss, it regrows, and that’s the end of it. And we see everything in between. Id. at 51-52. Dr. Norris proposed a theory of how the HBV vaccine could cause AA, opining that because it is an autoimmune disease, “the onset of AA may follow infections, periods of stress, and immunostimulation, including vaccination.” ECF No. 40, Ex. 16 (Norris Report) at 2 (citing Yaron Zafrir et al., Vaccines, Infections, and Alopecia Areata, in Vaccines & Autoimmunity (Yehuda Shoenfeld et al. eds., 2015) (“Zafrir”). Dr. Norris explained: “The way that the immune response works in autoimmune diseases, it’s dependent on a broad immunologic genetic network, [and] really makes it quite ideal for the idea of a trigger being necessary to make the disease appear, even if the genetic susceptibility is there.” Entitlement Hr’g Tr. 57. Dr. Norris further explained that the trigger can destroy a person’s “immune privilege”: 3 Case 1:15-vv-00124-MCW Document 92 Filed 02/19/21 Page 4 of 14 [Immune privilege] is a unique characteristic of some organs in the body that . . . are protected from the induction of autoimmunity in that target so that you don’t end up destroying important parts of the body, like the eyes or sometimes reproductive organs. Hair is also believed to be a structure that is protected by immune privilege and that in [AA] this immune privilege is destroyed by changing . . . the immune makeup of the hair follicle so that it is more susceptible to the induction of autoimmunity that attacks that hair follicle. Id. at 44-45 (citing Zafrir). In further support of the proposition that the HBV vaccine could cause AA, Dr. Norris cited a study, R. Wise et al., Hair Loss After Routine Immunizations, 278 JAMA 1176 (1997) (“Wise”), which concluded that “immunizations warrant consideration among potential causes of hair loss.” See id. at 49-51, 57; ECF No. 68 at 8. In Dr. Norris’ opinion, when AA patients “get a really strong immune response, and especially early in their life if they get a very extensive hair loss, like we see in L.T., then she’s more likely to have an immune response that after that trigger, will continue through her life.” Entitlement Hr’g Tr. 175. He elaborated: When we see a patient who has early onset and also has extensive hair loss, even total hair loss of the scalp, and if they have atopy, which is another health factor . . . then those patients may go on for their whole lives to have [AA] significantly. They may along the way also be stimulated, so that . . . they have a little kerosene thrown on [the fire that’s already burning] if they get infection, or if they take certain kinds of medications, or if they have stress. But it’s that initial presentation of disease that determines that they’ve got the population of specifically activated T cells that will carry them through with that disease for a long time. Id. at 175-76. Dr. Norris further explained that when AA is in a period of waxing, or increasing, it is not a new disease process, but rather is “the same immunologic process, attacking the same targets and making the same destruction of hair follicles.” Id. at 176. In Dr. Norris’ opinion, although patients may have a “smoldering specific immune response that can be reactivated by some other trigger, . . . it’s not a new disease and it’s not a new target that it’s going after. It’s the same target, the same disease as before, only reactivated.”3 Id. at 177. Respondent’s Expert Dr. Megha Tollefson, M.D., board certified in general pediatrics, dermatology, and pediatric dermatology, served as Respondent’s expert in the field of pediatric dermatology. Entitlement Hr’g Tr. 146-47, 149. Presently, Dr. Tollefson is a pediatric dermatologist at the Mayo 3 The Chief Special Master disagreed with this aspect of Dr. Norris’ opinion, stating “[a]t best, Dr. Norris attempted to outline how a vaccine could theoretically create a ‘smoldering immune response,’ consistent with the condition’s relapsing nature, and thus even separate subsequent triggers would be linked to the initial event, but such assertions were (unlike most of his testimony) conclusory and unpersuasive.” ECF No. 68 at 23. 4 Case 1:15-vv-00124-MCW Document 92 Filed 02/19/21 Page 5 of 14 Clinic in Rochester, Minnesota. Id. at 146; ECF No. 43, Ex. A at 1. As part of her clinical practice, Dr. Tollefson treats pediatric patients with AA, and she has published approximately 70 articles relating to pediatric dermatology. Entitlement Hr’g Tr. at 147-48. Dr. Tollefson agreed with Petitioner’s expert, Dr. Norris, that AA is an autoimmune disease, and she acknowledged its chronic nature, noting that L.T. “has [AA] that is at high risk for remaining a chronic disease.” ECF No. 43, Ex. A (Tollefson Expert Report) at 4; Entitlement Hr’g Tr. 150. Dr. Tollefson agreed with Petitioner’s expert, Dr. Norris, that “most, if not all, patients with [AA] likely have a genetic predisposition, but then there is also a trigger or a variety of triggers that are necessary or part of the process to develop [AA].” Entitlement Hr’g Tr. 151. Dr. Tollefson opined that “[i]n pediatric dermatology, the two main triggers are infections, and that’s probably number one, two, and three, but also stress.” Id. Dr. Tollefson disagreed that the HBV vaccine received by L.T. in November 2012 was a “substantial contributing factor in her developing [AA].” Id. at 150. Although she acknowledged that “a temporal association has been reported in . . . medical literature,” Dr. Tollefson emphasized that L.T. did not have a reaction to the first two HBV vaccines she received, opining that if a person is “going to have an autoimmune response to all three exposures, then [the vaccine] would be more likely to be the trigger.” Id. at 159, 162-64. When asked what triggered L.T.’s AA, Dr. Tollefson responded: Well, you know the thing about children is that their bodies and immune systems are constantly being exposed to viruses. That might be a subclinical infection. You might not actually see the [symptoms] -- like a fever or cold symptoms at the time, but everybody, and especially children, are much more -- they’re a lot more exposed. And so in pediatrics in general, we believe that an actual symptoms infection doesn’t mean that your body’s not fighting something off. And so that potentially could be also considered as a possible trigger. Id. at 166. Dr. Tollefson opined that when considering “numerically the number of doses of vaccines that are given, the number of children that develop [AA] as well as the number of viruses children continually are exposed to, I think it’s much more likely for a viral infection to be the trigger” of a child’s AA. Id. at 169. However, Dr. Tollefson acknowledged that there is no record of L.T. having an infection at the time she received the vaccination. Id. at 165-66. Based on L.T.’s family history of autoimmune disease, Dr. Tollefson opined that L.T. had an increased risk of autoimmune disease and development of AA. ECF No. 43, Ex. A at 3-4. Dr. Tollefson also noted the presence of other risk factors in L.T., such as a history of eczema and respiratory problems, which indicate that L.T. has “a genetic make-up at risk for atopic disorders such as eczema, asthma, and allergies, none of which are caused by any vaccine” -- but the presence of such disorders “actually increases the risk for [AA].” Id. at 4 (citing Nazila Barahmani et al., History of Atopy or Autoimmunity Increases Risk of Alopecia Areata, 61 J. Am. Acad. Dermatol. (2009)). When asked by the Chief Special Master about the “breaking [of] immune privilege” that Dr. Norris discussed, Dr. Tollefson indicated that she was familiar with the concept of immune privilege but had not studied it in detail. Entitlement Hr’g Tr. 167-68. The Chief Special Master 5 Case 1:15-vv-00124-MCW Document 92 Filed 02/19/21 Page 6 of 14 then asked whether “the genetic basis for someone developing alopecia areata [would] be a better indication of why they get it or more central than the thing that triggers it manifests it?” Id. at 168. Dr. Tollefson responded: I believe so. I mean, I think from seeing children with [AA], I think that there is a genetic basis that a certain percentage of these kids that have that genetic basis will develop [AA], but whatever trigger . . . that leads to that is not necessarily consistent, even in the same person, as Dr. Norris also said. Id. Additionally, the Chief Special Master initiated the following exchange: CHIEF SPECIAL MASTER: [W]ith respect to triggers, let’s pose a hypothetical. So let’s talk about a trigger you’d agree on, so an infectious trigger. And let’s say you had a case where an individual was -- it was understood and agreed by treaters that that was the trigger of their [AA]. If they subsequently down the road, a year or two later, had recurrences, could they be triggered by different things? DR. TOLLEFSON: Yes. CHIEF SPECIAL MASTER: And those recurrences would not pertain to the initial manifestation of the condition? DR. TOLLEFSON: Not necessarily. I mean, I think similar to what is seen in L.T., you know, recurrent infectious triggers are probably what we know most commonly, but it’s not necessarily the same exact virus every time. You know, there are multiple viruses kids get, so it could be that, it could be stress. You know, a lot of times what we’ll see in the pediatric population is that initially the triggers are viruses and infections. Later on in life, when they became teenagers, that’s more stress. CHIEF SPECIAL MASTER: So what would bring it -- cause the recurrence of symptoms would again be the underlying genetic susceptibility to the condition. DR. TOLLEFSON: Right. Id. at 171-72. However, as Dr. Tollefson acknowledged, “most, if not all, patients with [AA] likely have a genetic predisposition, but then there is also a trigger or a variety of triggers that are necessary or part of the process to develop [AA].” Id. at 151. The Chief Special Master’s Entitlement Ruling In his December 10, 2019 Entitlement Ruling, the Chief Special Master determined that Petitioner established that “the HBV vaccine could trigger AA, and did so in L.T.’s case in November 2012.” ECF No. 68 at 24. With regard to the first Althen4 prong, the Chief Special Master concluded that “there is just enough evidence to support Petitioner’s contention under the 4 Althen v. Sec’y of Health & Human Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005). 6 Case 1:15-vv-00124-MCW Document 92 Filed 02/19/21 Page 7 of 14 ‘can cause’ prong that AA could be triggered by the vaccination - and the HBV vaccination in particular.” Id. at 20. He explained: It was largely agreed-upon by the experts in this case that AA is likely an autoimmune process, thereby ‘opening the door’ to a determination that something impacting the immune response could be implicated as causal. In addition, Petitioner offered some reasonable items of literature, like Wise, supporting the association between the HBV vaccine and hair loss generally, if not AA specifically. Id. With regard to the second Althen prong -- “did cause” -- the Chief Special Master concluded that “the HBV vaccine in this case likely triggered L.T.’s AA onset in November 2012.” Id. at 21. With regard to the third Althen prong -- “a proximate temporal relationship” -- the Chief Special Master concluded that “the timeframe in which L.T.’s AA began—two to four days post- vaccination—was established to be a medically acceptable temporal relationship for an autoimmune response.” Id. at 22. Accordingly, he ruled that “the record in this case establishes that, at least with respect to the first occasion of L.T.’s AA, Petitioner carried her preponderant burden.” Id. However, regarding L.T.’s subsequent recurrences of AA, the Chief Special Master ruled: I do not find that [Petitioner] persuasively established that any subsequent recurrences (the first of which appears to have happened around the time of her August 2015 return visit to Dr. Gilmore, reporting new-onset AA symptoms) can also be attributed to that same initial vaccine event. The thinness of Petitioner’s overall evidentiary showing may have been just enough to be preponderant in determining causation with respect to the first occurrence of AA, but that same slim showing shifts against Petitioner when the larger picture (including what the experts agreed about AA) is taken into account. Id. In making this determination, the Chief Special Master separately required Petitioner to establish vaccine-related causation for each subsequent recurrence of AA, and found that Petitioner was unable to meet the first Althen prong -- that the vaccine could cause L.T.’s AA recurrences in August 2015 and later. Id. at 22-23. He noted that “[b]oth experts agreed that AA is known to have a significant genetic component that serves as a baseline ‘requirement’ for AA to manifest” and that “L.T. was just such a person.” Id. The Chief Special Master concluded that the evidence did not support the assertion that “the same initial trigger -- here, the November 2012 vaccination -- could reliably be deemed responsible for all future AA recurrences.” Id. at 23. “At bottom, nothing that is known about AA (at least as reflected in the filings in this case) suggests that the first instance of AA in a person (likely to occur in childhood) is the linchpin explanation for all subsequent recurrences.” Id. The Chief Special Master distinguished this case from others where a “trigger effect” has been found, such as encephalopathy which causes both injury to the brain and significant ensuing 7 Case 1:15-vv-00124-MCW Document 92 Filed 02/19/21 Page 8 of 14 impacts, or a seizure triggered by a vaccination which “will set up conditions for . . . more harmful seizures in the future.” Id. He reasoned: The “trigger” effect of the vaccine in this case, by contrast, is different – more isolated and discrete in scope. Both sides’ experts agreed that AA has a significant genetic underpinning, and thus a person who likely possesses that predisposition (a conclusion that can be made about L.T. based on preponderant evidence) is more susceptible to experiencing AA on a lifelong basis. While it may have been established in this case that the HBV vaccine could trigger one instance of AA, it has not been similarly shown that any trigger (vaccine or not) would so alter a person’s immune response that all AA recurrences would invariably be associated with the first, made worse due to the first, etc. None of the medical literature filed in this case stands for this proposition, and in fact (in stressing the importance of the genetic susceptibility to AA) actually undermines it. It is more likely that an individual’s subsequent recurrences are attributable to the genetic susceptibility underlying AA. See McClellan, 2019 WL 4072130, at *35- 36 (finding that petitioner “did not establish that a vaccine could, under the circumstances, trigger a non-febrile seizure sufficient to significantly worsen a preexisting seizure disorder with an unmistakable genetic origin”); Sharpe v. Sec’y of Health & Human Servs., No. 14-65V, 2018 WL 7625360 (Fed. Cl. Spec. Mstr. Nov. 5, 2018) (finding that neither the record supported “[p]etitioner’s contention that the vaccines [] received could, or did, injure [their daughter] as alleged,” nor did petitioners establish a significant aggravation claim given their daughter’s existing “DYNC [gene] mutation”), aff’d, 142 Fed. Cl. 630 (2019), appeal docketed, No. 19-1951 (Fed. Cir. May 31, 2019). And Dr. Norris did not otherwise credibly establish with reliable evidence that AA can be thought of as a “smoldering” condition, in which the instigating trigger for an outbreak is a spark that is never extinguished. Id. at 24 (alterations in original). The Chief Special Master denied compensation for “any new, discrete AA recurrences that L.T. experienced post-vaccination, beginning no later than August 2015,” because these recurrences “have not preponderantly been shown to be attributable to the earlier HBV vaccine.” Id. The Chief Special Master’s Damages Decision The Chief Special Master awarded Petitioner $50,000 for pain and suffering associated with L.T.’s first AA episode and explained: My December 2019 Ruling was favorable to Petitioner—but only with respect to the initial occurrence of AA in November 2012 that appears to have thereafter required approximately two years to treat before resolving. Petitioner had only preponderantly established that the HBV vaccine could cause (and in L.T.’s case, had caused) a single episode of AA—not initiated a chronic process that would likely recur. The evidence and expert testimony (which acknowledged that AA was 8 Case 1:15-vv-00124-MCW Document 92 Filed 02/19/21 Page 9 of 14 believed to have a genetic origin) did not support the conclusion that a one-time triggering of AA, due to vaccine or otherwise, meant that the same initial trigger was also responsible in part for all subsequent occurrences. As a result, the HBV vaccine L.T. received in 2012 could not be blamed for any subsequent occurrences L.T. experienced (or may yet experience). ECF No. 75 at 2 (internal citations omitted). In calculating damages for pain and suffering, the Chief Special Master ruled: L.T. suffered from the less severe, AA-subtype of alopecia, and her symptoms persisted for approximately two years. Although she required minimal treatment of a non-invasive nature, she still suffered from the stigma and embarrassment of hair loss, at an age where she would likely comprehend the experience. I thus find that an award of $50,000 is fair, in light of the circumstances of this case and best comparables available. This sum fairly captures the temporally-limited severity of L.T.’s suffering, and generously compensates her for the experience of her AA, which thankfully happened when she was quite young (thus limiting somewhat the trauma that a teenager (subject to peer pressure) or older adult might experience. Id. at 7. The Chief Special Master added: Although I did not find that any of L.T.’s subsequent AA occurrences were vaccine- caused—and thus [did] not include any costs associated with them in my award— I invited Petitioner to substantiate future costs associated with her one-time AA occurrence. But Petitioner has offered no evidence to this effect, nor did she attempt to substantiate these future treatment costs, despite repeated opportunities to do so. Id. at 8 n.10 (internal citations omitted). When Petitioner requested a life care planner to substantiate future treatment needs, the Chief Special Master denied the request, stating: [A]larmingly, certain representations contained in the [Joint Status Report filed by Petitioner (ECF No. 69)] suggest that the Petitioner is seeking to relitigate issues already decided by my Ruling (or worse, is not even aware of how I ruled in the first place). Thus, Petitioner attempts to justify the lack of progress on damages by noting that she requires the assistance of a life care planner to “assess treatment options and costs for her chronic hair loss” attributable to her first AA, adding that “L.T.’s hair never grew back fully from her initial episode of [AA].” These rationales directly contradict the existing fact findings in this case. In effect, Petitioner wants time to obtain a life care planner who will substantiate treatment needs associated with ongoing hair loss—even though my Ruling (by its very terms) largely precludes such damages as inconsistent with the nature of the injury supported by the preponderant record. 9 Case 1:15-vv-00124-MCW Document 92 Filed 02/19/21 Page 10 of 14 ECF No. 70 at 2 (internal citations omitted). Discussion Jurisdiction and Standard of Review This Court has jurisdiction under the Vaccine Act to review the decision of a special master to: (A) uphold the findings of fact and conclusions of law of the special master and sustain the special master’s decision, (B) set aside any of the findings of fact or conclusions of law of the special master found to be arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law and issue its own findings of fact and conclusions of law, or (C) remand the petition to the special master for further action in accordance with the court’s direction. 42 U.S.C. § 300aa-12(e)(2)(A)-(C); Doe 93 v. Sec’y of Health & Human Servs., 98 Fed. Cl. 553, 564-65 (2011). “Findings of fact of the special master are reviewed under the arbitrary and capricious standard, conclusions of law are reviewed under the not in accordance with law standard, and discretionary rulings are reviewed under the abuse of discretion standard.” Broekelschen v. Sec’y of Health & Human Servs., 89 Fed. Cl. 336, 343 (2009), aff’d, 618 F.3d 1339 (Fed. Cir. 2010) (internal citations and quotation marks omitted). An abuse of discretion occurs when a special master’s decision is: “(1) … clearly unreasonable, arbitrary, or fanciful; (2) … based on an erroneous conclusion of the law; (3) … clearly erroneous; or (4) the record contains no evidence on which the … [special master] rationally could have based his decision.” Murphy v. Sec’y of Health & Human Servs., 30 Fed. Cl. 60, 61 (1993) (quoting Hendler v. United States, 952 F.2d 1364, 1380 (Fed. Cir. 1991)) (alteration in original). The Court’s role is not to “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.” Lampe v. Sec’y of Health & Human Servs., 219 F.3d 1357, 1360 (Fed. Cir. 2000) (internal citation and quotation marks omitted). However, the Court has “a duty to ensure that the special master has properly applied Vaccine Act evidentiary standards, ‘considered the relevant evidence of record, drawn plausible inferences and articulated a rational basis for [his] decision.’” Paluck v. Sec’y of Health & Human Servs., 786 F.3d 1373, 1380 (Fed. Cir. 2015) (quoting Hines ex rel. Sevier v. Sec’y of Health & Human Servs., 940 F.2d 1518, 1528 (Fed. Cir. 1991)) (alteration in original). Conclusions of law are reviewed de novo by this Court. See 42 U.S.C. § 300aa–12(e)(2)(B); Althen v. Sec’y of Health & Human Servs., 418 F.3d 1274, 1278-79, 1281 (Fed. Cir. 2005). Burden of Proof under the Vaccine Act In the seminal case of Althen v. Secretary of Health & Human Services, the Federal Circuit articulated the petitioner’s burden to demonstrate causation-in-fact as follows: 10 Case 1:15-vv-00124-MCW Document 92 Filed 02/19/21 Page 11 of 14 [Petitioner’s] burden is to show by preponderant evidence that the vaccination brought about her 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 1274, 1278 (Fed. Cir. 2005). Petitioner must prove causation-in-fact “by a preponderance of the evidence.” 42 U.S.C. § 300aa–13(a)(1)(A). The Federal Circuit “has interpreted the preponderance of the evidence standard referred to in the Vaccine Act as one of proof by a simple preponderance, of more probable than not causation.” Althen, 418 F.3d at 1279 (internal citation and quotation marks omitted). Petitioner’s claim must be “substantiated by medical records or medical opinion.” Id. The Federal Circuit “adopt[ed] the Restatement rule for purposes of determining vaccine injury, that an action is the ‘legal cause’ of harm if that action is a ‘substantial factor’ in bringing about the harm, and that the harm would not have occurred but for the action.” Shyface v. Sec’y of Health & Human Servs., 165 F.3d 1344, 1352 (Fed. Cir. 1999) (citing Restatement (Second) of Torts § 431)). To effectuate Congress’s intent and advance the objectives of the Vaccine Act, causation is determined on a case-by-case basis, as follows: Causation in fact under the Vaccine Act is thus based on the circumstances of the particular case, having no hard and fast per se scientific or medical rules. The determination of 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. Thus, for example, causation can be found in vaccine cases based on epidemiological evidence and the clinical picture regarding the particular child without detailed medical and scientific exposition on the biological mechanisms. Knudsen v. Sec’y of Health & Human Servs., 35 F.3d 543, 548-49 (Fed. Cir. 1994) (internal citations omitted). The Vaccine Act permits proof of causation through “the use of circumstantial evidence envisioned by the preponderance standard.” Capizzano v. Sec’y of Health & Human Servs., 440 F.3d 1317, 1325 (Fed. Cir. 2006) (internal citation and quotation marks omitted). As the Federal Circuit has consistently reiterated, under the Vaccine Act, “close calls regarding causation are resolved in favor of injured claimants.” Althen, 418 F.3d at 1280; Capizzano, 440 F.3d at 1324- 26; Andreu v. Sec’y of Health & Human Servs., 569 F.3d 1367, 1378 (Fed. Cir. 2009). If the petitioner proves by a preponderance of the evidence that the vaccine caused petitioner’s injury under the Althen test, the burden then shifts to the Government to prove, by a preponderance of the evidence, that a factor unrelated to the vaccination actually caused the injury. de Bazan v. Sec’y of Health & Human Servs., 539 F.3d 1347, 1352 (Fed. Cir. 2008); 42 U.S.C. § 300aa–13(a)(1)(B). If the Government fails to meet this burden, the petitioner is entitled to compensation. de Bazan, 539 F.3d at 1352. “So long as the petitioner has satisfied all three prongs 11 Case 1:15-vv-00124-MCW Document 92 Filed 02/19/21 Page 12 of 14 of the Althen test, she bears no burden to rule out possible alternative causes.” Id. (footnote and citation omitted). After Finding the HBV Vaccine Caused L.T.’s AA, the Chief Special Master Erroneously Required Petitioner to Separately Prove that the Vaccine Caused Each Recurrence of Her AA The Chief Special Master found that the HBV vaccine could cause and did cause L.T.’s autoimmune disease, a condition that “waxes and wanes” and entails recurring episodes. In his entitlement ruling, the Chief Special Master found “that the HBV vaccine in this case likely triggered L.T.’s AA onset in November 2012.” ECF No. 68 at 21. Rather than compensate Petitioner for subsequent and future recurrences of this condition, the Chief Special Master stopped at the first episode and required Petitioner to prove that each recurrence of her AA was also caused by that vaccine. Specifically, the Chief Special Master ruled that L.T. could not “recover damages associated with any new, discrete AA recurrences that [she] experienced post-vaccination, beginning no later than August 2015,” because these recurrences “have not preponderantly been shown to be attributable to the earlier HBV vaccine.” ECF No. 68 at 24. The requirement that petitioners separately prove each ensuing episode of an autoimmune condition found to be caused by a vaccine imposes a heightened burden of proof inconsistent with the Vaccine Act and precedent. In articulating this onerous causation standard in the instant case, the Chief Special Master acknowledged the chronic aspect of AA: the Chief Special Master stated that “[o]nce AA is triggered, its clinical course is variable and not monophasic in progression.” ECF No. 68 at 20. He continued: “some [AA] patients experience recurring loss and regrowth, other patients experience only one episode, and some will experience ‘everything in between.’” Id. (quoting Entitlement Hr’g Tr. at 51-52).5 The parties’ experts both acknowledged, and the medical literature of record substantiates, that AA is a chronic disease. As Respondent’s expert, Dr. Tollefson, opined in her expert report: “[L.T.] has [AA] that is at high risk for remaining a chronic disease.” ECF No. 43, Ex. A at 4 (emphasis added). Literature cited by Dr. Tollefson in her expert report states: “[a]ny mode of treatment may need to be used for long periods because of the chronic nature of [AA].” ECF No. 54, Ex. J (Yong-Kwang Tay, Pediatric Dermatology, ch.11 (4th ed. 2010)) at 6 (emphasis added). Literature cited in Dr. Norris’ expert report provides: “AA is a chronic disease, typically presenting as patches of hair loss involving the scalp that can progress to alopecia totalis (loss of all scalp hair) or alopecia universalis (loss of all body hair).” ECF No. 42, Ex. 20 (Lucy Y. Liu et al., Health-related Quality of Life (HRQoL) Among Patients with Alopecia Areata (AA): A Systemic Review, 75 J. Am. Acad. Dermatol. 806 (2016)) at 1 (emphasis added); ECF No. 40, Ex. 16 at 3. Another publication cited in Dr. Norris’ expert report states: 5 This Court recognizes that the Chief Special Master did not accept Dr. Norris’ opinion that AA is “a ‘smoldering’ condition, in which the instigating trigger for an outbreak is a spark that is never extinguished.” ECF No. 68 at 24. But the Chief Special Master described AA as a condition that, once triggered, is “inherently subject to recurrence,” and both experts characterized the condition as chronic. Id. at 23. 12 Case 1:15-vv-00124-MCW Document 92 Filed 02/19/21 Page 13 of 14 Alopecia areata (AA) is an autoimmune disease characterized by one or more well demarcated oval and round noncicatricial patches of hair loss. The disease usually involves the scalp but may affect any hair-bearing parts of the body, including the eyebrows, beard, and body hair. It may include the entire scalp (alopecia totalis, AT) or the entire body (alopecia universalis, AU). Furthermore, due to its chronic relapsing nature and its profound effect on physical appearance, patients may experience a devastating loss of quality of life and self-esteem. ECF No. 55, Ex. 27 (Zafrir) at 1 (emphasis added); ECF No. 40, Ex. 16 at 3. Further, the Chief Special Master acknowledged that L.T. is not among the AA patients fortunate enough to only experience one episode. ECF No. 68 at 22. He recognized that a person who is genetically predisposed to AA, “(a conclusion that can be made about L.T. based on preponderant evidence) is more susceptible to experiencing AA on a lifelong basis.” Id. at 24. In 2015 and in 2016, while the record in this case was being developed, L.T. experienced two recurrences of AA.6 To this Court’s knowledge, no other Vaccine Act case holds that a petitioner must demonstrate causation for each recurring outbreak of a chronic condition triggered by a vaccine and that each recurrence must be separately analyzed under Althen. On the contrary, in other Vaccine Program cases, special masters have only required petitioners to prove causation for the onset of waxing and waning conditions in awarding compensation. See Bryan v. Sec’y of Health & Human Services, No. 14-898V, 2020 WL 7089841, at *1, 28, 30 (Fed. Cl. Spec. Mstr. Oct. 9, 2020) (granting compensation for chronic fatigue syndrome (CFS) caused by a flu vaccine and noting “a unique feature of CFS is the waxing and waning course of the disease”) and Bryan, ECF 1:14-vv-898 136 (granting the petitioner’s request for a life-care planner); G.C. v. Sec’y of Health & Human Servs., No. 15-773V, 2019 WL 4941087, at *10, 19-20 (Fed. Cl. Spec. Mstr. Sept. 5, 2019) (awarding compensation for the petitioner’s vaccine-caused urticarial vasculitis, a chronic autoimmune disease which caused the petitioner “continue[d] . . . leg and joint pain, along with rash flare-ups and mouth ulcers”).7 6 As of the time of oral argument on this motion for review, on December 9, 2020, counsel for Petitioner indicated that L.T. has experienced “more than two [recurrences] at this point, . . . and I don’t have an exact number, but I believe she’s probably up to four by now, maybe five.” Oral Arg. Tr. 4. 7 The Chief Special Master also appears to have concluded that there was an alternative cause for L.T.’s subsequent episodes -- finding her genetic pre-disposition more likely caused recurrences. See ECF No. 68 at 24 (“It is more likely that an individual’s subsequent recurrences are attributable to the genetic susceptibility underlying AA.”). In the Vaccine Program, once a petitioner has established causation, she is “entitled to recover unless the [government] shows, also by a preponderance of the evidence, that the injury was in fact caused by factors unrelated to the vaccine.” Althen, 418 F.3d at 1278 (alteration in original) (citation omitted). Here, the Government never argued a theory of alternative causation for L.T.’s AA recurrences, and the Chief Special Master never shifted the burden of proof to Respondent because he found that Petitioner failed to demonstrate Althen prong one -- that the HBV vaccine “could cause” recurrences of L.T.’s AA. But this finding contradicts the Chief Special Master’s original 13 Case 1:15-vv-00124-MCW Document 92 Filed 02/19/21 Page 14 of 14 Forcing petitioners to sue over each recurrence of an episode of a vaccine-caused condition would spawn adverse ramifications for future Vaccine Act litigation. Aside from creating statute- of-limitations issues, this path would invite multiple litigations and increase the cost and complexity of pursuing these claims -- contrary to the purpose of the Vaccine Compensation Program. As the Federal Circuit explained in Knudsen v. Secretary of the Department of Health & Human Services: The Vaccine Act does not contemplate full blown tort litigation in the Court of Federal Claims. The Vaccine Act established a federal “compensation program” under which awards are to be “made to vaccine-injured persons quickly, easily, and with certainty and generosity.” The program is supposed to be “fair, simple, and easy to administer.” 35 F.3d 543, 549 (Fed. Cir. 1994) (citations omitted); see also Koston v. Sec’y of Health & Human Servs., 974 F.2d 157, 161 (Fed. Cir. 1992) (“[The Vaccine Program] envisons that awards be made ‘quickly, easily, and with certainty and generosity,’ . . . even if this results in ‘compensation to some children whose illness is not, in fact, vaccine-related.’” (quoting H.R. Rep. No. 908, 99th Cong., 2d Sess. 3, 18 (1986))). Conclusion Petitioner’s motion for review is GRANTED, and this matter is REMANDED to the Chief Special Master for further proceedings consistent with this opinion. The Chief Special Master is directed to reopen the evidentiary record on remand and determine appropriate compensation for subsequent and future recurrences of L.T.’s AA. s/Mary Ellen Coster Williams MARY ELLEN COSTER WILLIAMS Senior Judge conclusion that the HBV vaccine could cause AA. Moreover, the Chief Special Master’s introduction of genetic susceptibility alone as an alternative cause for L.T.’s recurrences is at odds with both expert opinions that a trigger, such as a vaccine or virus, in addition to genetic susceptibility must be at play in causing AA. See Entitlement Hr’g Tr. 42, 151. 14 ================================================================================ DOCUMENT 4: USCOURTS-cofc-1_15-vv-00124-5 Date issued/filed: 2022-08-26 Pages: 14 Docket text: PUBLIC RULING (Originally filed: 8/1/2022) regarding 170 Findings of Fact & Conclusions of Law. Signed by Special Master Nora Beth Dorsey. (mjf) Service on parties made. -------------------------------------------------------------------------------- Case 1:15-vv-00124-MCW Document 174 Filed 08/26/22 Page 1 of 14 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS Filed: August 1, 2022 * * * * * * * * * * * * * * * * * * * * * * * * * CHRISTINE DeLOZIER, * parent and next friend of L.T., a minor, * PUBLISHED * Petitioner, * No. 15-124V * v. * Special Master Nora Beth Dorsey * SECRETARY OF HEALTH * Ruling Awarding Pain and Suffering AND HUMAN SERVICES, * Damages; Hepatitis B Vaccine; Alopecia * Areata. Respondent. * * * * * * * * * * * * * * * * * * * * * * * * * * * Richard Gage, Richard Gage, P.C., Cheyenne, WY, for petitioner. Julia Marter Collison, U.S. Department of Justice, Washington, DC, for respondent. RULING AWARDING PAIN AND SUFFERING DAMAGES1 On February 9, 2015, Christine DeLozier2 (“petitioner”), as parent and next friend of L.T., a minor, filed a petition for compensation under the National Vaccine Injury Compensation 1 Because this Ruling 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 in accordance with the E-Government Act of 2002. 44 U.S.C. § 3501 note (2012) (Federal Management and Promotion of Electronic Government Services). This means the Ruling 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 During pendency of this case, petitioner changed her last name from Torres to DeLozier, and therefore the case caption was amended. Order dated Feb. 1, 2019 (ECF No. 58). Case 1:15-vv-00124-MCW Document 174 Filed 08/26/22 Page 2 of 14 Program (“Vaccine Act” or “the Program”), 42 U.S.C. § 300aa-10 et seq. (2012).3 Petitioner alleged that L.T. suffered from alopecia areata as the result of a hepatitis B vaccination administered on November 6, 2012. Petition at 1 (ECF No. 1). On December 10, 2019, a ruling on entitlement issued, finding petitioner entitled to compensation. Ruling on Entitlement dated Dec. 10, 2019 (ECF No. 66). The Chief Special Master found L.T. was entitled to compensation associated with the first occurrence of alopecia areata, but not for any subsequent occurrence of alopecia areata after August 2015. Id. at 2, 24. A damages decision issued on August 11, 2020, awarding petitioner $50,000.00 in actual pain and suffering. Damages Decision dated Aug. 11, 2020 (ECF No. 75). Thereafter, petitioner filed a motion for review, which was granted by Senior Judge Mary Ellen Coster Williams, and remanded to the Chief Special Master to determine appropriate compensation for subsequent and future recurrences of L.T.’s alopecia areata. Opinion and Remand Order (“Remand Order”) dated Feb. 19, 2021 (ECF No. 92). Specifically, “[t]he Chief Special Master [was] directed to reopen the evidentiary record on remand and permit the parties to submit additional evidence on damages and retain relevant damages experts, such as life care planners, to render opinions on appropriate compensation for subsequent and future recurrences of L.T.’s [alopecia areata].” Order Clarifying Remand Instructions (“Order Clarifying Remand”) dated June 24, 2021 (ECF No. 110). Because the parties have been unsuccessful in resolving damages, a damages hearing was held on June 23, 2022. The only issue that remains in dispute is petitioner’s actual and future pain and suffering award. After consideration of all of the evidence, and for the reasons described below, the undersigned finds that in addition to the award of $50,000.00, petitioner is entitled to receive an additional award in the amount of $70,000.00 (to reflect 2015 to present) for actual pain and suffering for a total of $120,000.00, and an award for future pain and suffering in the amount of $10,000.00 per year, reduced to net present value, for petitioner’s remaining life expectancy or until the statutory cap is met. The total award for actual and future pain and suffering is capped at the statutory maximum of $250,000.00.4 3 The National Vaccine Injury Compensation Program is set forth in Part 2 of the National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755, codified as amended, 42 U.S.C. §§ 300aa-10 to -34 (2012). All citations in this Ruling to individual sections of the Vaccine Act are to 42 U.S.C. § 300aa. 4 Based on L.T.’s birth date of June 29, 2009, L.T. is expected to live for approximately 69 additional years based on the data for all females. See Elizabeth Arias & Jiaquan Xu, Nat’l Ctr. for Health Statistics, Ctrs. for Disease Control & Prevention, United States Life Tables, 2019, 70 Nat’l Vital Stat. Reps. 1, 3 tbl.A (2022). Thus, the statutory cap will be reached before the full payments reflecting her remaining life expectancy are reached. 2 Case 1:15-vv-00124-MCW Document 174 Filed 08/26/22 Page 3 of 14 I. RELEVANT PROCEDURAL HISTORY After this case was remanded to the Chief Special Master in February 2021, an order clarifying the remand was issued in June 2021. Remand Order; Order Clarifying Remand. Thereafter, the case was reassigned to the undersigned on June 9, 2021. Notice of Reassignment dated June 9, 2021 (ECF No. 109). The undersigned held status conferences in June 2021, August 2021, October 2021, and December 2021, and during this time, petitioner filed updated medical records, photographs, a sworn declaration, and medical literature, and the parties filed life care plans. Petitioner’s Exhibits (“Pet. Exs.”) 32-40; Respondent’s (“Resp.”) Ex. L. In January 2022, respondent filed a consolidated life care plan and petitioner filed an expert report from Dr. David Norris. Resp. Ex. M; Pet. Ex. 42. On February 14, 2022, petitioner filed a damages memorandum. Pet. Memorandum on Damages (“Pet. Mem.”), filed Feb. 14, 2022 (ECF No. 144). Respondent filed his damages brief on March 1, 2022, along with an expert report from Dr. Megha Tollefson. Resp. Damages Brief (“Resp. Br.”), filed Mar. 11, 2022 (ECF No. 146); Resp. Ex. N. A damages hearing was held on June 23, 2022. Thereafter, the parties filed updated life care plans, consistent with the undersigned’s bench rulings issued during the June 23, 2022 hearing. Pet. Ex. 47; Resp. Ex. P. In a joint status report, respondent stated that he agrees to reimburse the New York State Medicaid Lien in the amount of $1,953.34. Joint Status Rept., filed July 18, 2022, at 1 (ECF No. 169) (citing Pet. Ex. 46). The parties also agreed that the only remaining item of damages was pain and suffering. Id. The issue of pain and suffering is now ripe for adjudication. II. BACKGROUND A. Medical Records The Ruling on Entitlement set forth a summary of petitioner’s medical records until the end of 2018. See Ruling on Entitlement at 2-6. Only those relevant portions since August 2015 will be repeated here. On August 10, 2015, L.T. returned to Rochester General Hospital for a sore throat. Pet. Ex. 11 at 18-24. L.T. was tested for a sore throat, treated for her sore throat, and discharged. Id. She was seen by Dr. Julia Stein, who noted a medical history of alopecia areata but did not record any other information about alopecia areata at that time. Id. L.T. visited Rochester General Hospital for a routine child exam on August 19, 2015. Pet. Ex. 10 at 28. L.T.’s weight was noted as being low and weight management was discussed. Id. at 35. Dr. Andrew Sherman did not list any current concerns, active issues, or chronic issues. Id. No notes of alopecia areata were made except in the health history section. Id. 3 Case 1:15-vv-00124-MCW Document 174 Filed 08/26/22 Page 4 of 14 The same day, August 19, 2015, L.T. visited Universal Dermatology PLLC, Dr. Elaine Gilmore’s practice. Pet. Ex. 9 at 1. Petitioner’s reason for bringing L.T. in was for “hair loss that is multifocal and mild in severity,” that had manifested two weeks prior. Id. A physical exam revealed some hair loss patches on L.T.’s central forehead and right inferior occipital scalp, along with thin eyebrows and “coin-like eczematous patches” on her arms and left thigh. Id. Dr. Gilmore recommended that her alopecia areata could be treated using topical steroids, and that petitioner should contact the office if symptoms plateaued or worsened despite treatment. Id. L.T. returned to see Dr. Gilmore on September 25, 2015. Pet. Ex. 9 at 5. Dr. Gilmore noted that L.T.’s alopecia areata was improving with treatment and had improved overall. Id. Dr. Gilmore observed “minimal alopecic patches on the anterior scalp and thin eyebrows throughout.” Id. She advised petitioner to reduce the amount of steroid being taken and that L.T. could apply ointment to her face to stimulate eyebrow growth. Id. L.T. next saw Dr. Gilmore in April 2016. Pet. Ex. 28 at 1. At this time, Dr. Gilmore observed discrete non-scarring patches of hair loss on the “right superior temple and left occipital scalp.” Id. Dr. Gilmore discussed with petitioner the natural history of alopecia areata, which was associated with flares and remissions. Id. Dr. Gilmore also noted that L.T.’s hair loss, at that time, was not severe enough to warrant systemic therapy. Id. In November 2016, L.T. presented to Dr. Gilmore for further evaluation. Pet. Ex. 28 at 2. During the visit, Dr. Gilmore observed alopecia areata on L.T.’s “right superior central forehead, left superior central forehead, and left lateral eyebrow.” Id. This distribution of alopecia areata was notably different than what had been reported in August 2015. Compare Pet. Ex. 9 at 3 (showing alopecia areata patches in August 2015 behind the right ear and on the left superior forehead), with Pet. Ex. 28 at 3 (showing alopecia areata patches in November 2016 on the left eyebrow and on two locations on the forehead). Dr. Gilmore discussed new possible therapies for L.T.’s condition, but explained that it would be difficult to predict her future hair growth. Id. The next month, L.T. went to Rochester Regional Health for a well-child visit. Pet. Ex. 29 at 6. Dr. Sherman observed that L.T. had alopecia areata symptoms, and was also complaining of knee, wrist, and elbow pain at times, consistent with complaints from the previous month. Id. L.T. went to the doctor again on December 16, 2016 for a well-child visit at Rochester Regional Health. Pet. Ex. 29 at 1. Dr. Sherman recorded that L.T. “[s]till has [a] patch of alopecia behind right ear and near midline of mid occipital area.” Id. at 6-7. L.T. was scheduled for another well-child visit the following year and informed Dr. Sherman that she would follow- up on her alopecia areata with a dermatologist and rheumatologist. Id. at 6-8. Moving forward to 2017, L.T. presented to Rochester Regional in late June 2017 for a cough and sore throat. Pet. Ex. 29 at 17. No notes on alopecia areata or eczema were made other than in the health history section. See id. 4 Case 1:15-vv-00124-MCW Document 174 Filed 08/26/22 Page 5 of 14 In August 2017, L.T. visited Rochester Regional for her eight-year well-child visit. Pet. Ex. 29 at 27. L.T. had no current concerns and was “doing well.” Id. at 32. Dr. Sherman did not note any alopecia areata in his objective examination of L.T. Id. at 33. L.T. declined immunizations citing her prior medical history of alopecia areata after vaccination. Id. L.T. returned to Rochester Regional in October 2018 for her nine-year well-child visit. Pet. Ex. 29 at 42. L.T. had no current concerns, was doing well, and had “no current hair changes.” Id. at 47-48. Dr. Sherman did not note any alopecia areata flares. Id. at 48. On July 10, 2019, L.T. saw Dr. Sherman at Rochester Regional seeking advice regarding vaccines and “her patchy hair loss.” Pet. Ex. 32 at 17. Dr. Sherman provided guidance for the vaccine and hair concerns and referred L.T. to an allergist. Id. at 18. On January 20, 2021, L.T. had a follow up telemedicine appointment with Dr. Gilmore to discuss her alopecia areata. Pet. Ex. 33 at 1. Petitioner reported that “for the most part they haven’t seen any large flare ups in [L.T.’s] hair loss.” Id. Petitioner inquired about different treatments. Id. Dr. Gilmore noted “alopecia areata on [L.T.’s] right superior central forehead, left superior central forehead, and left lateral eyebrow.” Id. Under impression, Dr. Gilmore noted “[d]iscrete non-scarring patches of hair loss,” and noted L.T.’s alopecia areata was “worsening.” Id. L.T. was prescribed a topical ointment. Id. No additional medical records were filed. B. Hearing Testimony, Affidavits, and Expert Reports 1. Petitioner In a sworn declaration executed on November 5, 2021, petitioner “estimate[d] that L.T. has had seven relapses since the original onset of [alopecia areata] in 2012.” Pet. Ex. 36 at ¶ 5. Petitioner explained that when L.T. experienced her first relapse, “she developed [] two large, half-dollar sized bald spots on her head,” which “eventually filled in.” Id. at ¶ 3. Since then, L.T. “periodically gets bald spots and has trended toward a thinner and more receded hairline.” Id. at ¶ 4. L.T. also suffers from eczema and joint pain. Id. At the damages hearing, petitioner testified in further detail about L.T.’s relapses. She explained that during one relapse, L.T. had bald spots in the front of her head, which were very visible and hard to cover up. Transcript (“Tr.”) 7. Other times, L.T. would have bald spots on the side of her head that petitioner could cover if L.T. wore her hair a certain way. Id. With each relapse, L.T.’s “entire hairline has receded.” Tr. 11. These relapses “lasted quite a long time,” at least a few months up to four months before L.T.’s hair started to grow back. Tr. 9-10. L.T.’s treatment began with “alternating clobetasol, which is a topical steroid, with Protopic, which is an anti-inflammatory cream.” Tr. 11. Recently, “Dr. Gilmore[] recommended a topical Retin-A type cream . . . to be used in place of the steroids.” Tr. 12. This cream is administered outside of a relapse on the areas of hair loss to stimulate hair growth. Tr. 14-15. However, petitioner stated they have not seen a lot of improvement with this cream. Tr. 5 Case 1:15-vv-00124-MCW Document 174 Filed 08/26/22 Page 6 of 14 12-13, 15. When L.T. has a relapse, petitioner still administers a topical steroid to the areas of hair loss. Tr. 13. L.T. is very self-conscious about her hair and her condition has affected her self-esteem. Tr. 8, 16. Petitioner explained that L.T. thinks “bald is ugly,” and lives in fear that she will lose her hair again. Tr. 8. Some people at school have made fun of L.T., calling her “bald” and “ugly.” Id. L.T. has tried to completely avoid talking about her condition and finds it very stressful. Id. During periods of baldness, people thought L.T. had cancer and have stared at her, which has made L.T. feel uncomfortable. Tr. 17. Additionally, L.T. is visibly nervous and worried about people noticing her bald spots. Id. Additionally, L.T. “continues to have a rash on [] the back of her legs” and as a result, L.T. does not like wearing bathing suits or shorts because she does not want people to see her rash. Tr. 18. The hair loss and rashes typically get worse at the same time. Id. 2. Dr. David Norris5 Dr. Norris is an expert on behalf of petitioner. He is a board-certified dermatologist who works as a dermatologist at the Denver Department of Veteran Affairs Hospital. Pet. Ex. 17 at 1; Tr. 84. He is a member of the National Alopecia Areata Foundation, where he has participated in numerous activities over the past 25 years. Tr. 85. Additionally, he has conducted research on alopecia areata throughout his career. Tr. 86. Dr. Norris opined that L.T. is “likely to have issues long term with [a]lopecia [a]reata and will likely need some type of treatment throughout her life.” Pet. Ex. 42 at 1. He explained that alopecia areata is a chronic disease, and once it is triggered, it “will likely continue lifelong.” Id.; Tr. 134. “Given her past history, complete hair loss is a concern for [L.T.] in the future.” Pet. Ex. 42 at 2. Citing Madani and Shapiro,6 Dr. Norris noted risk factors that clinicians use to determine the severity of a patient’s outcome. Tr. 89 (citing Pet. Ex. 21). The authors noted prognosis of alopecia areata “is unpredictable.” Pet. Ex. 21 at 9-10. They stated “[i]ndicators of a poor prognosis are atopy,[7] the presence of other immune diseases, family history of [alopecia areata], 5 Petitioner filed two expert reports from Dr. Norris, one on causation (Pet. Ex. 16) and one on damages (Pet. Ex. 42). Damages is the issue most relevant here. A significant portion of Dr. Norris’ expert report on damages dealt with appropriate medical treatment. That aspect of his opinion is not discussed in this Ruling. 6 Shabnam Madani & Jerry Shapiro, Alopecia Areata Update, 42 J. Am. Acad. Dermatology 549 (2000). 7 Atopy is “a genetic predisposition toward the development of immediate (type I) hypersensitivity reactions against common environmental antigens (atopic allergy).” Atopy, Dorland’s Med. Dictionary Online, https://www.dorlandsonline.com/dorland/definition?id=4738 (last visited July 26, 2022). A clinical manifestation of atopy is atopic dermatitis. Id. 6 Case 1:15-vv-00124-MCW Document 174 Filed 08/26/22 Page 7 of 14 young age at onset, nail dystrophy, extensive hair loss, and ophiasis.”8 Id. at 10; see also Pet. Ex. 16 at 2. These criteria are also risk factors for the propensity of the disease to recur. Tr. 132. Dr. Norris opined that L.T. “fits into the phenotype of patients who are going to have severe risk” because L.T. has “most of the criteria predicting severe outcome.” Tr. 89-90. L.T. has atopy, was young at onset, has extensive hair loss, and has ophiasis. Tr. 89-90, 132; Pet. Ex. 16 at 2. Dr. Norris also opined “that the diagnosis of [a]lopecia [a]reata usually has a large psychological impact on children, teenagers, and young adults with this condition.” Pet. Ex. 42 at 1. He discussed Liu et al.,9 who provided a systematic review of studies assessing the impact of alopecia areata on health-related quality of life. Tr. 132-33 (citing Pet. Ex. 20 at 1). Liu et al. noted that those affected with alopecia areata “often experience marked emotional and psychological distress. Children and adults often report being harassed, ostracized, stared at, or assumed to be undergoing chemotherapy because of their hair loss.” Pet. Ex. 20 at 1. “Multiple studies have shown the presence of psychological comorbidities among patients with [alopecia areata], including depression and anxiety.” Id. Loss of hair has also been associated with loss of self-esteem and lack of confidence. Id. at 1, 4. Additionally, pediatric patients have been reported to have lower health-related quality of life. Id. at 4. Liu et al. noted “the negative impact of [alopecia areata] on [health-related quality of life] is comparable with that of other common, chronic dermatologic conditions . . . and therefore warrants a similar level of attention.” Id. at 6. Dr. Norris testified that based on his experience, Lui et al. correctly described issues that occur in alopecia areata patients. Tr. 133. Dr. Norris also testified that steroid use, including topical steroids that L.T. uses, cause side effects over time. Tr. 135. Some side effects that can result from continuous steroid use over time include “weak bones, peptic ulcer, weight gain, high blood pressure, psychological effects and mood swings[,] and infection.” Id. Topical steroids “usually . . . limit the spread of that medication to the local area.” Tr. 136. As of the time of the hearing, L.T. had not used oral steroids. Id. Dr. Norris testified that “side effects would be worse with the systemic drug than the topical.” Tr. 147. 3. Dr. Elaine Gilmore10 Dr. Gilmore is a board-certified dermatologist and L.T.’s treating physician. Tr. 102-03. She is currently the owner and medical director of Universal Dermatology, a private dermatology practice in New York. Tr. 103. Prior to that position, she was a full-time tenure-track faculty 8 Ophiasis is “a form of alopecia areata of long duration, involving the temporal and occipital margins of the scalp in a continuous band.” Ophiasis, Dorland’s Med. Dictionary Online, https://www.dorlandsonline.com/dorland/definition?id=35215 (last visited July 26, 2022). 9 Lucy Y. Liu et al., Health-Related Quality of Life (HRQoL) Among Patients with Alopecia Areata (AA): A Systematic Review, 75 J. Am. Acad. Dermatology 806 (2016). 10 Dr. Gilmore submitted a letter in this case. See Pet. Ex. 13. Dr. Gilmore also testified at the damages hearing. 7 Case 1:15-vv-00124-MCW Document 174 Filed 08/26/22 Page 8 of 14 member in the dermatology department at the University of Rochester, School of Medicine and Dentistry. Tr. 103-04. At the hearing, Dr. Gilmore briefly discussed her visits with L.T. over the years. Dr. Gilmore first treated L.T. in November or December of 2012. Tr. 105. According to records from a follow up visit in January 2013, L.T. was “started on topical steroid therapy, clobetasol solution, alternating on a weekly basis with Protopic ointment.” Id. At the January 2013 visit, Dr. Gilmore noted “widespread, scattered, well demarcated circular, nonscarring patches of alopecia.” Id. L.T.’s hair pull test was negative. Id. L.T. was starting to see new hairs on her right temporal scalp. Id. Dermatitis on L.T.’s posterior legs was also noted. Tr. 106. Dr. Gilmore next saw L.T. in March 2013, and noted there was not a lot of significant improvement since January. Tr. 106. L.T. “continu[ed] to have widespread scattered hair loss, and at that time, it was starting to coalesce into what we call an ophiasis distribution, which is essentially like a band of hair loss along the lower scalp. And she was still having multiple patches of hair loss at the crown.” Tr. 107. Dr. Gilmore altered L.T.’s treatment regimen to see if L.T.’s hair regrowth would improve. Id. On physical examination in June 2013, L.T. “had some patchy nonscarring alopecia” that “was partially ophiasis, so perhaps it was a little bit of improvement.” Tr. 107-08. Some new hairs were also noted. Tr. 108. L.T.’s treatment regimen increased in frequency of application. Id. In August 2015, L.T. experienced another flare and visited Dr. Gilmore complaining of hair loss. Tr. 109. Physical examination revealed “well circumscribed alopecic patches.” Id. Topical steroids were prescribed. Id. One month later, in September 2015, L.T. had improvement on the scalp. Tr. 110. “At that time, her alopecia patches were rated as minimal on the anterior scalp” and “her eyebrows were thin throughout.” Id. Dr. Gilmore decreased L.T.’s topical steroid use by supplementing with Protopic ointment. Id. Dr. Gilmore next saw L.T. in April 2016. Tr. 110-11. Dr. Gilmore “noticed several discrete patches of alopecia on the right scalp as well as on the parietal scalp, measuring multiple centimeters in diameter.” Tr. 111. L.T.’s “hair loss . . . was pretty confined to these discrete patches.” Id. Dr. Gilmore discussed the chronic nature of L.T.’s condition and treatment options with L.T. and petitioner. Id. In November 2016, at a follow up visit, Dr. Gilmore noted L.T. “[c]ontinued to have flares and areas of involvement,” including “discrete nonscarring patches of hair loss.” Tr. 112. In January 2021, L.T. returned to see Dr. Gilmore via telemedicine. Tr. 113. “There were some small flares that had occurred during the interim period, but for the most part, [there] [were not] any large significant flares that would have required an office visit.” Id. Dr. Gilmore opined that L.T. “undoubtedly” suffers from a chronic case of alopecia areata and L.T. is likely to have periodic flares throughout her life. Tr. 114-15. She testified that “over the past decade, [L.T.] has had significant periods of time with flares of her alopecia areata,” which is “very unpredictable.” Tr. 115. Examining the number and extent of flares that 8 Case 1:15-vv-00124-MCW Document 174 Filed 08/26/22 Page 9 of 14 L.T. has displayed over the past decade, Dr. Gilmore found it “highly unlikely that [L.T.] is going to go decades without having involvement.” Id. She noted “published studies have shown that younger age of onset may be associated with a poorer prognosis.” Pet. Ex. 13 at 1. Further, Dr. Gilmore opined that there is a psychological component to alopecia areata, especially in females and children. Tr. 115-17. Additionally, Dr. Gilmore, examining photographs of L.T., opined L.T. has had significant hair loss. Tr. 114. Dr. Gilmore testified that a severe case of alopecia areata does not necessarily mean at least 50% hair loss. Tr. 125-26. “[E]very patient is different. . . . Forty percent hair loss is pretty bad, and certainly if a patient is having significant psychological effects, if they’re not able to function because of what they’re experiencing . . . .” Tr. 126. 4. Dr. Megha Tollefson11 Dr. Tollefson is an expert retained on behalf of respondent. She is a board-certified pediatric dermatologist at the Mayo Clinic in Rochester, Minnesota. Resp. Ex. N at 1. She did not testify at the damages hearing but submitted expert reports. Dr. Tollefson opined L.T. “has alopecia areata that is at high risk for remaining a chronic disease.” Resp. Ex. A at 4. Based on L.T.’s medical records, Dr. Tollefson found L.T. “has experienced intermittent flares of her alopecia areata, with good results and improvement with topical medications.” Resp. Ex. N at 1. She agreed that L.T. “may experience intermittent flares of her [alopecia areata] for years.” Id. at 2. “As indicated by Dr. Gilmore, if [L.T.] continues to have flares, she is much more likely to experience flares with circular patches of hair loss as has been the case for her previously, rather than more generalized complete hair loss.” Id. Dr. Tollefson opined “it is far more likely that [L.T.’s] [alopecia areata] will continue to respond to the treatments already prescribed by Dr. Gilmore and other more standard medications such as intralesional steroid injections, than it is that she would ever develop the severe refractory disease.” Id. Additionally, Dr. Tollefson noted there is a potential impact on L.T.’s quality of life and/or mental health due to her alopecia areata. Id. at 3. III. PARTIES’ CONTENTIONS A. Petitioner’s Contentions Petitioner requests an actual pain and suffering award of $100,000.00 for year three (2015) to the present, which is a span of approximately seven years. Pet. Mem. at 10. Petitioner also requests an award of $10,000.00 per year in future pain and suffering, reduced to net present value. Id. The statutory cap of $250,000.00 would thus be reached in 2032. Id. 11 Dr. Tollefson submitted two expert reports, one on causation (Resp. Ex. A) and one on damages (Resp. Ex. N). Damages is the issue most relevant here. A portion of Dr. Tollefson’s expert report on damages rebutted some of Dr. Norris’ opinions regarding appropriate medical treatment. That portion of her opinion is not included in this Ruling. 9 Case 1:15-vv-00124-MCW Document 174 Filed 08/26/22 Page 10 of 14 Petitioner argues this award “would provide L.T. with an emotional distress award through her schooling years, including college and her entry into the work force.” Pet. Mem. at 10. L.T. has continued to suffer relapses of her alopecia areata. Id. Additionally, her treating physician, Dr. Gilmore, has described L.T.’s alopecia areata as “worsening.” Id. Petitioner also notes L.T. has become more aware of her injury over the years. Id. B. Respondent’s Contentions Respondent acknowledges that several alopecia cases have been settled, nearly all involving total and permanent hair loss, and none by proffer. Resp. Br. at 21. Additionally, “[t]here are no reasoned decisions awarding damages in an alopecia case.” Id. Using the same three-factor assessment used by the Chief Special Master in the first damages decision, which looks at (1) severity of the injury, (2) awareness of the injury, and (3) duration of the suffering, respondent argues petitioner should be awarded an additional $50,000.00 in pain and suffering, totaling $100,000.00 in actual and future pain and suffering. Resp. Br. at 21-23 (citing Collado v. Sec’y of Health & Hum. Servs., No. 17-0225V, 2018 WL 3433352, at *6-8 (Fed. Cl. Spec. Mstr. June 6, 2018)). With regard to the element of awareness, respondent agrees that L.T. “is certainly able to understand her [alopecia areata].” Id. Regarding severity, respondent contends that L.T. has experienced one additional flare since 2015, lasting from August 2015 to November 2016.12 Resp. Br. at 23. “Since then, the medical records show that [L.T.’s] condition has been stable and limited. Indeed, at the January 2021 visit, Dr. Gilmore noted that [L.T.] had not been seen for more than four years, and [L.T.’s] mother confirmed that there had not been any large flare-ups during that time.” Id. Lastly, with regard to duration, respondent agrees L.T. “may experience intermittent flares of her [alopecia areata] for years.” Resp. Br. at 23. Respondent’s expert, Dr. Tollefson, opined L.T. is “much more likely to experience flares with circular patches of hair loss as has been the case for her previously, rather than more generalized complete hair loss.” Id. (quoting Resp. Ex. N at 2). Based on this opinion, respondent contends L.T.’s alopecia areata “will remain stable, as it has since 2016.” Id. IV. LEGAL FRAMEWORK Compensation awarded pursuant to the Vaccine Act shall include “[f]or actual and projected pain and suffering and emotional distress from the vaccine-related injury, an award not to exceed $250,000.” § 15(a)(4). Petitioner bears the burden of proof with respect to each element of compensation requested. Brewer v. Sec’y of Health & Hum. Servs., No. 93-0092V, 1996 WL 147722, at *22-23 (Fed. Cl. Spec. Mstr. Mar. 18, 1996). 12 Respondent’s brief was submitted before the damages hearing, and thus, may not reflect some of the testimony. 10 Case 1:15-vv-00124-MCW Document 174 Filed 08/26/22 Page 11 of 14 There is no formula for assigning a monetary value to a person’s pain and suffering and emotional distress. I.D. v. Sec’y of Health & Hum. Servs., No. 04-1593V, 2013 WL 2448125, at *9 (Fed. Cl. Spec. Mstr. May 14, 2013) (“Awards for emotional distress are inherently subjective and cannot be determined by using a mathematical formula.”); Stansfield v. Sec’y of Health & Hum. Servs., No. 93-0172V, 1996 WL 300594, at *3 (Fed. Cl. Spec. Mstr. May 22, 1996) (“[T]he assessment of pain and suffering is inherently a subjective evaluation.”). Factors to be considered when determining an award for pain and suffering include: (i) awareness of the injury; (ii) severity of the injury; and (iii) duration of the suffering. I.D., 2013 WL 2448125, at *9 (quoting McAllister v. Sec’y of Health & Hum. Servs., No. 91-1037V, 1993 WL 777030, at *3 (Fed. Cl. Spec. Mstr. Mar. 26, 1993), vacated & remanded on other grounds, 70 F.3d 1240 (Fed. Cir. 1995)). The undersigned may look to prior pain and suffering awards to aid in the resolution of the appropriate amount of compensation for pain and suffering in this case. See, e.g., Doe 34 v. Sec’y of Health & Hum. Servs., 87 Fed. Cl. 758, 768 (2009) (finding that “there is nothing improper in the chief special master’s decision to refer to damages for pain and suffering awarded in other cases as an aid in determining the proper amount of damages in this case”). The undersigned may also rely on her experience adjudicating similar claims. Hodges v. Sec’y of Health & Hum. Servs., 9 F.3d 958, 961 (Fed. Cir. 1993) (noting that Congress contemplated the special masters would use their accumulated expertise in the field of vaccine injuries to judge the merits of individual claims). Importantly, however, it must also be stressed that pain and suffering is not determined based on a continuum. See Graves v. Sec’y of Health & Hum. Servs., 109 Fed. Cl. 579 (2013). In Graves, Judge Merrow rejected the special master’s approach of awarding compensation for pain and suffering based on a spectrum from $0.00 to the statutory $250,000.00 cap. Judge Merrow noted that this constituted “the forcing of all suffering awards into a global comparative scale in which the individual petitioner’s suffering is compared to the most extreme cases and reduced accordingly.” Graves, 109 Fed. Cl. at 589-90. Instead, Judge Merrow assessed pain and suffering by looking to the record evidence, prior pain and suffering awards within the Vaccine Program, and a survey of similar injury claims outside of the Vaccine Program. Id. at 595. V. DISCUSSION A. Actual Pain and Suffering When performing this analysis, the undersigned reviews the record as a whole, including the medical records, affidavits, testimony, and expert opinions. The undersigned bases her decision as to the appropriate amount of damages on the particular facts and circumstances of this specific case. In this case, awareness of injury is not in dispute. Even though L.T. was young when her injury occurred, the testimony by her mother, petitioner, established that L.T. was and continues to be aware of her condition. 11 Case 1:15-vv-00124-MCW Document 174 Filed 08/26/22 Page 12 of 14 With regard to severity, petitioner testified that L.T. developed bald spots, thinner hair, and a receded hairline with each relapse. According to Dr. Norris, indicators of a poor prognosis include atopy, young onset, extensive hair loss, and ophiasis, all of which L.T. has experienced. Dr. Gilmore agreed with Dr. Norris that a “younger age of onset may be associated with a poorer prognosis.” Pet. Ex. 13 at 1. Examining photographs of L.T., Dr. Gilmore opined L.T. has had significant hair loss. On the other hand, Dr. Tollefson, respondent’s expert, opined that it is less likely “that [L.T.] would ever develop the severe refractory disease” or a “more generalized complete hair loss.” Resp. Ex. N at 2. However, alopecia areata is unpredictable and chronic. Dr. Gilmore testified that a severe case of alopecia areata does not necessarily mean at least 50% hair loss. Tr. 125-26. Dr. Gilmore noted that to determine a severe case, one must also look at psychological effects of the hair loss. The experts, Dr. Norris and Dr. Tollefson, and petitioner’s treating dermatologist, Dr. Gilmore, agree that there are psychological issues patients with alopecia areata are at risk of developing that may affect their quality of life. Lui et al. noted “[c]hildren and adults often report being harassed, ostracized, stared at, or assumed to be undergoing chemotherapy because of their hair loss.” Pet. Ex. 20 at 1. Lui et al. also reported depression, anxiety, loss of self- esteem, and lack of confidence in those suffering from alopecia areata, and Dr. Norris agreed. Additionally, Lui et al. and Dr. Gilmore noted this psychological component has been found to especially affect females and children. Petitioner testified that L.T.’s alopecia areata has already resulted in psychological issues in L.T., affecting her self-esteem and confidence. L.T. has been bullied in school and people have stared at her and thought she had cancer. Petitioner also explained that L.T. fears and worries about relapses and people noticing her bald spots. As for duration, L.T. has experienced multiple flares since her initial onset. Petitioner testified that based on her review of photographs, L.T. has had approximately seven flares. The experts, Dr. Norris and Dr. Tollefson, and petitioner’s treating dermatologist, Dr. Gilmore, agree L.T. will continue to experience flares throughout her life. Dr. Norris explained that alopecia areata “will likely continue lifelong” after being triggered. Pet. Ex. 42 at 1. Dr. Tollefson agreed that L.T. “may experience intermittent flares of her [alopecia areata] for years.” Resp. Ex. N at 2. Dr. Gilmore testified that she “would expect unfortunately [L.T.] to have flares periodically going forward.” Tr. 115. Given the number and extent of flares that L.T. has displayed over the past decade, Dr. Gilmore found it “highly unlikely that [L.T.] is going to go decades without having involvement.” Id. Based on a review of the entire record and consideration of the facts and circumstances presented here, the undersigned finds an award of $10,000.00 per year, from 2015 to present, totaling seven years, to be an appropriate and reasonable award for actual pain and suffering. Thus, the undersigned awards $70,000.00 in compensation for L.T.’s actual pain and suffering. 12 Case 1:15-vv-00124-MCW Document 174 Filed 08/26/22 Page 13 of 14 B. Future Pain and Suffering The undersigned finds an award of future pain and suffering reasonable and appropriate. As respondent noted, “[e]veryone agrees that [L.T.] may experience intermittent flares of her [alopecia areata] for years.” Resp. Br. at 23. The experts agree, and the medical literature substantiates, that alopecia areata is an unpredictable, chronic disease that can result in intermittent flares for years. Dr. Gilmore, for example, opined that L.T. “undoubtedly” suffers from a chronic case of alopecia areata. Tr. 115. She also opined that L.T. is likely to have periodic flares throughout her life. As L.T.’s treating dermatologist, Dr. Gilmore discussed with petitioner the natural history of alopecia areata, which is “very unpredictable” and can be associated with flares and remissions. Pet. Ex. 28 at 1; Tr. 115. In November 2016, Dr. Gilmore noted L.T. “[c]ontinued to have flares and areas of involvement,” including “discrete nonscarring patches of hair loss.” Tr. 112. At L.T.’s most recent visit to Dr. Gilmore in January 2021, Dr. Gilmore noted L.T.’s alopecia areata was “worsening.” Pet. Ex. 33 at 1. At the hearing, Dr. Gilmore opined that L.T. has had significant hair loss. She found it “highly unlikely that [L.T.] is going to go decades without having involvement.” Tr. 114-15. She also noted “published studies have shown that younger age of onset may be associated with a poorer prognosis.” Pet. Ex. 13 at 1. Petitioner’s expert, Dr. Norris, agreed that alopecia areata is a chronic disease that continues through life. He opined L.T. is “likely to have issues long term with [a]lopecia [a]reata and will likely need some type of treatment throughout her life.” Pet. Ex. 42 at 1. “Given L.T.’s history, Dr. Norris opined that complete hair loss is a concern for [L.T.] in the future.” Id. at 2. Dr. Norris listed risk factors for a poor prognosis and propensity of the disease to recur, and noted L.T. has most of the criteria, including atopy, young onset, extensive hair loss, and ophiasis. Although Dr. Tollefson, respondent’s expert, did not agree that L.T. “would ever develop the severe refractory disease” or complete hair loss, she agreed that L.T. “has alopecia areata that is at high risk for remaining a chronic disease” and L.T. “may experience intermittent flares of her [alopecia areata] for years.” Resp. Ex. A at 4; Resp. Ex. N at 2. Based on the L.T.’s medical records, and the evaluation and opinions of Drs. Gilmore, Norris, and Tollefson, the undersigned finds an award of future pain and suffering is appropriate and reasonable given the chronic nature of alopecia areata and its known psychological sequela. The undersigned finds an award of $10,000.00 per year for her life expectancy, reduced to net present value, is appropriate. This amount shall be capped so that L.T.’s total award for pain and suffering does not exceed the statutory cap of $250,000.00.13 13 Compensation awarded pursuant to the Vaccine Act shall include “[f]or actual and projected pain and suffering and emotional distress from the vaccine-related injury, an award not to exceed $250,000.” § 15(a)(4). 13 Case 1:15-vv-00124-MCW Document 174 Filed 08/26/22 Page 14 of 14 VI. CONCLUSION In determining an award in this case, the undersigned does not rely on a single decision or case. Rather, the undersigned has reviewed the particular facts and circumstances in this case, giving due consideration to her knowledge and experience adjudicating vaccine injury cases. In light of the above analysis, and in consideration of the record as a whole, the undersigned finds that petitioner should be awarded (1) $50,000.00, as reflected in the prior damages decision for actual (or past) pain and suffering for L.T.’s initial occurrence of alopecia areata up to August 2015; (2) $70,000.00 in compensation for actual (or past) pain and suffering for August 2015 to present; and (3) $10,000.00 per year reduced to net present value, for the rest of L.T.’s life expectancy or until the statutory cap is met, for future pain and suffering. Therefore, petitioner is awarded $120,000.00 for actual pain and suffering and $10,000.00 per year, reduced to net present value, for future pain and suffering, for the rest of her life or until the statutory cap of $250,000.00 is met. The parties are to file a joint status report by Wednesday, August 31, 2022, (1) converting the undersigned’s award of future pain and suffering to its net present value, and (2) providing a statement of all damages in the manner that the parties agree as the parties proposed in their July 18, 2022 joint status report. If the parties are unable to agree on the amount of the net present value of the future award, the undersigned will use a one percent net discount rate for future payments.14 Thereafter, a damages decision will issue. IT IS SO ORDERED. s/Nora Beth Dorsey Nora Beth Dorsey Special Master 14 See Dillenbeck v. Sec’y Health & Hum. Servs., No. 17-428V, 2019 WL 4072069, at *15 (Fed. Cl. Spec. Mstr. July 29, 2019) (applying a one percent net discount rate for the first fifteen years, followed by a two percent net discount rate for the remaining years), aff’d in part, 147 Fed. Cl. 131 (2020); Curri v. Sec’y of Health & Hum. Servs., No. 17-432V, 2018 WL 6273562, at *5 (Fed. Cl. Spec. Mstr. Oct. 31, 2018) (same); Petronelli v. Sec’y Health & Hum. Servs., No. 12- 285V, 2016 WL 3252082, at *5-6 (Fed. Cl. Spec. Mstr. May 12, 2016) (analyzing the appropriateness of a one percent discount for future damages). 14 ================================================================================ DOCUMENT 5: USCOURTS-cofc-1_15-vv-00124-6 Date issued/filed: 2022-09-16 Pages: 11 Docket text: PUBLIC DECISION (Originally filed: 8/22/2022) regarding 173 DECISION of Special Master. Signed by Special Master Nora Beth Dorsey. (mjf) Service on parties made. -------------------------------------------------------------------------------- Case 1:15-vv-00124-MCW Document 175 Filed 09/16/22 Page 1 of 11 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS Filed: August 22, 2022 * * * * * * * * * * * * * * * * * * * * * * * * CHRISTINE DeLOZIER, * parent and next friend of L.T., a minor, * UNPUBLISHED * Petitioner, * No. 15-124V * v. * Special Master Dorsey * SECRETARY OF HEALTH * Damages Award; Hepatitis B Vaccine; AND HUMAN SERVICES, * Alopecia Areata. * Respondent. * * * * * * * * * * * * * * * * * * * * * * * * ** Richard Gage, Richard Gage, P.C., Cheyenne, WY, for Petitioner. Julia Marter Collison, U.S. Department of Justice, Washington, DC, for Respondent. DECISION AWARDING DAMAGES1 On February 9, 2015, Christine DeLozier2 (“Petitioner”), as parent and next friend of L.T., a minor, 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. (2012).3 Petitioner alleged that L.T. suffered from alopecia areata as the result of a hepatitis B vaccination 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 in accordance with the E-Government Act of 2002. 44 U.S.C. § 3501 note (2012) (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 During pendency of this case, Petitioner changed her last name from Torres to DeLozier, and therefore the case caption was amended. Order dated Feb. 1, 2019 (ECF No. 58). 3 The National Vaccine Injury Compensation Program is set forth in Part 2 of the National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755, codified as amended, 42 U.S.C. §§ 300aa-10 to -34 (2012). All citations in this Decision to individual sections of the Vaccine Act are to 42 U.S.C. § 300aa. 1 Case 1:15-vv-00124-MCW Document 175 Filed 09/16/22 Page 2 of 11 administered on November 6, 2012. Petition at 1 (ECF No. 1). On December 10, 2019, a ruling on entitlement issued, finding Petitioner entitled to compensation. Ruling on Entitlement dated Dec. 10, 2019 (ECF No. 66). The Chief Special Master found L.T. was entitled to compensation associated with the first occurrence of alopecia areata, but not for any subsequent occurrence of alopecia areata after August 2015. Id. at 2, 24. A damages decision issued on August 11, 2020, awarding Petitioner $50,000.00 in actual pain and suffering. Damages Decision dated Aug. 11, 2020 (ECF No. 75). Thereafter, Petitioner filed a motion for review, which was granted by Senior Judge Mary Ellen Coster Williams, and remanded to the Chief Special Master to determine appropriate compensation for subsequent and future recurrences of L.T.’s alopecia areata. Opinion and Remand Order (“Remand Order”) dated Feb. 19, 2021 (ECF No. 92). Specifically, “[t]he Chief Special Master [was] directed to reopen the evidentiary record on remand and permit the parties to submit additional evidence on damages and retain relevant damages experts, such as life care planners, to render opinions on appropriate compensation for subsequent and future recurrences of L.T.’s [alopecia areata].” Order Clarifying Remand Instructions (“Order Clarifying Remand”) dated June 24, 2021 (ECF No. 110). A damages hearing was held on June 23, 2022. After the undersigned’s Bench Rulings during the hearing, the only item that remained in dispute was Petitioner’s actual and future pain and suffering award. Ruling Awarding Pain & Suffering dated Aug. 1, 2022, at 2 (ECF No. 170). On August 1, 2022, the undersigned issued a ruling awarding pain and suffering, finding that in addition to the award of $50,000.00, Petitioner is entitled to receive an additional award in the amount of $70,000.00 (to reflect 2015 to present) for actual pain and suffering for a total of $120,000.00, and an award for future pain and suffering in the amount of $10,000.00 per year, reduced to net present value, for L.T.’s remaining life expectancy or until the statutory cap of $250,000.00 is met. Id. On August 22, 2022, Respondent filed a joint status report in response to the undersigned’s ruling awarding pain and suffering (“Joint Status Rept.”), attached hereto as Appendix A. Respondent submitted the Joint Status Report providing a statement of all damages, including those that the parties have agreed upon as well as those decided by the undersigned, in the manner that the parties agree upon. Joint Status Rept. at 1. In the joint status report, Respondent represented that Petitioner does not object to the representations made. Id. Based on the record as a whole, the undersigned finds that Petitioner is entitled to an award as stated in the Joint Status Report. Pursuant to the terms stated in the attached Joint Status Report, the undersigned awards Petitioner: (1) A lump sum payment of $257,153.97, representing compensation for life care expenses (including health insurance premiums and maximum out of pocket, topical Tofacitinib ointment, National Alopecia Areata Annual Meeting, Alopecia Areata Support Group/Group Therapy, and mileage expenses awarded by the Special Master) expected to be incurred during the first year after judgment ($14,603.20), and pain and suffering ($242,550.77), in the 2 Case 1:15-vv-00124-MCW Document 175 Filed 09/16/22 Page 3 of 11 form of a check payable to Petitioner, as guardian(s)/ conservator(s) of the estate of L.T., for the benefit of L.T. (2) A lump sum payment of $1,953.34, representing compensation for satisfaction of the Monroe County Department of Social Services Medicaid lien, payable jointly to Petitioner and: Monroe County Department of Social Services ATTN: Susan G. Fittos Resource Recovery Technician 39 West Main Street, Room 307 Rochester, New York 14614 Member ID: ES90155M (3) An amount sufficient to purchase an annuity contract described in Section II.C. of the Joint Status Report. Joint Status Rept. at 3-6. In the absence of a motion for review filed pursuant to RCFC Appendix B, the Clerk of the Court SHALL ENTER JUDGMENT herewith.4 IT IS SO ORDERED. s/Nora Beth Dorsey Nora Beth Dorsey Special Master 4 Pursuant to Vaccine Rule 11(a), entry of judgment is expedited by the parties’ joint filing of notice renouncing the right to seek review. 3 Case 1:15-vv-00124-MCW Document 175 Filed 09/16/22 Page 4 of 11 IN THE UNITED STATES COURT OF FEDERAL CLAIMS OFFICE OF SPECIAL MASTERS ____________________________________ ) CHRISTINE DeLOZIER, parent and ) next friend of L.T., a minor, ) ) Petitioner, ) No. 15-124V ) Special Master Dorsey v. ) ECF ) SECRETARY OF HEALTH AND ) HUMAN SERVICES, ) ) Respondent. ) ) RESPONDENT’S JOINT STATUS REPORT IN RESPONSE TO RULING AWARDING PAIN AND SUFFERING DAMAGES (ECF NO. 170) In the Special Master’s August 1, 2022 Ruling Awarding Pain and Suffering Damages (“Ruling”), the Special Master noted that “the parties are to file a joint status report by Wednesday, August 31, 2022, (1) converting the undersigned’s award of future pain and suffering to its net present value, and (2) providing a statement of all damages in the manner that the parties agree as the parties proposed in their July 18, 2022 joint status report.” Respondent submits this Joint Status Report providing the Special Master with a statement of all damages, including those that the parties have agreed upon as well as those decided by the Special Master, in the manner that the parties agree contains the information needed for the Special Master’s damages decision. While preserving his right, pursuant to 42 U.S.C. § 300aa-12(3), to seek review of the Special Master’s June 23, 2022 Bench Ruling and August 1, 2022 Ruling (ECF No. 170), respondent submits the following joint status report regarding damages. Petitioner’s counsel has reviewed this joint status report and does not object to the representations made herein. Case 1:15-vv-00124-MCW Document 175 Filed 09/16/22 Page 5 of 11 I. Items of Compensation A. Life Care Items Respondent engaged life care planner Linda Curtis, RN, MS, CNLCP, CCM, CNLCP, and petitioner engaged Elizabeth Kattman, MS, Rehabilitation Counselor and Laura Woodard, M.A., Rehabilitation Counselor, to provide an estimation of L.T.’s future vaccine-injury-related needs. Life care plans were filed in this case. Agreed-upon life care items, as well as life care items delineated as awarded by the Special Master, are illustrated by the chart entitled “Appendix A: Items of Compensation for L.T.,” attached to this Joint Status Report as Tab A.1 B. Lost Future Earnings No loss of earnings was requested or awarded. C. Pain and Suffering The parties agreed that based upon the evidence of record, L.T. is entitled to an award for pain and suffering under the Vaccine Act, 42 U.S.C. § 300aa-15(a)(4). However, the parties did not agree on an overall award or the allocation to actual versus projected pain and suffering. On August 1, 2022, the Special Master awarded L.T. $120,000.00 for actual pain and suffering and “$10,000.00 per year reduced to net present value, for the rest of her life or until the statutory cap 1 The chart at Tab A illustrates the parties’ agreed-upon annual amounts for life care items and, pursuant to the Special Master’s June 23, 2022 Bench Ruling and August 1, 2022 Ruling, includes the Special Master’s award of the following life care items: health insurance premiums and maximum out of pocket expenses from the date of judgment through compensation year 2034; topical Tofacitinib ointment expenses from the date of judgment through the remainder of L.T.’s life; National Alopecia Areata Annual Meeting expenses from the date of judgment through the remainder of L.T.’s life; Alopecia Areata Support Group/Group Therapy expenses from the date of judgment through compensation year 2028; individual therapy expenses from compensation year 2029 through the remainder of L.T.’s life; mileage expenses from the date of judgment through the remainder of L.T.’s life. Annual benefit years run from the date of judgment up to the first anniversary of the date of judgment, and every year thereafter up to the anniversary of the date of judgment. 2 Case 1:15-vv-00124-MCW Document 175 Filed 09/16/22 Page 6 of 11 of $250,000.00 is met.” Ruling dated August 1, 2022, at 14 (ECF No. 170). Applying the Court’s guidance on the award for projected pain and suffering, the parties agree that the amount to be awarded for L.T.’s projected pain and suffering is $122,550.77. This results in a total award for pain and suffering of $242,550.77. See 42 U.S.C. § 300aa-15(a)(4). D. Medicaid Lien The parties agree that L.T. should be awarded funds to satisfy a Monroe County, New York Department of Social Services Medicaid lien in the amount of $1,953.34, which represents full satisfaction of any right of subrogation, assignment, claim, lien, or cause of action the Monroe County Department of Social Services may have against any individual as a result of any Medicaid payments Monroe County Department of Social Services has made to or on behalf of L.T., from the date of her eligibility for benefits through the date of judgment in this case as a result of her vaccine-related injury suffered on or about November 6, 2012, under Title XIX of the Social Security Act. II. Form of the Award The parties request that the compensation provided to petitioner be made through a combination of a lump sum payment and future annuity payments as described below, and request that the Special Master’s Decision on Damages and the Court’s judgment award the following2: A. A lump sum payment of $257,153.97, representing compensation for life care 2 Should L.T. die prior to entry of judgment, the parties reserve the right to move the Court for appropriate relief. In particular, respondent would oppose any award for future medical expenses and future pain and suffering. 3 Case 1:15-vv-00124-MCW Document 175 Filed 09/16/22 Page 7 of 11 expenses (including health insurance premiums and maximum out of pocket, topical Tofacitinib ointment, National Alopecia Areata Annual Meeting, Alopecia Areata Support Group/Group Therapy, and mileage expenses awarded by the Special Master) expected to be incurred during the first year after judgment ($14,603.20), and pain and suffering ($242,550.77), in the form of a check payable to petitioner as guardian(s)/ conservator(s) of the estate of L.T., for the benefit of L.T. If petitioner is not authorized by a court of competent jurisdiction to serve as guardian(s)/ conservator(s) of the estate of L.T., any such payment shall be made to the party or parties appointed by a court of competent jurisdiction to serve as guardian(s)/conservator(s) of the estate of L.T. upon submission of written documentation of such appointment to the Secretary. B. A lump sum payment of $1,953.34, representing compensation for satisfaction of the Monroe County Department of Social Services Medicaid lien, payable jointly to petitioner and: Monroe County Department of Social Services ATTN: Susan G. Fittos Resource Recovery Technician 39 West Main Street, Room 307 Rochester, New York 14614 Member ID: ES90155M Petitioner agrees to endorse this payment to the Monroe County Department of Social Services. C. An amount sufficient to purchase an annuity contract,3 subject to the conditions described below, that will provide payments for the life care items contained in the life care plan, as illustrated by the chart at Tab A, attached hereto, paid to the life insurance company4 from 3 In respondent’s discretion, respondent may purchase one or more annuity contracts from one or more life insurance companies. 4 The Life Insurance Company must have a minimum of $250,000,000 capital and surplus, exclusive of any mandatory security valuation reserve. The Life Insurance Company must have one of the following ratings from two of the following rating organizations: a. A.M. Best Company: A++, A+, A+g, A+p, A+r, or A+s; 4 Case 1:15-vv-00124-MCW Document 175 Filed 09/16/22 Page 8 of 11 which the annuity will be purchased.5 Compensation for Year Two (beginning on the first anniversary of the date of judgment) and all subsequent years shall be provided through respondent’s purchase of an annuity, which annuity shall make payments directly to petitioner,6 as guardian(s)/conservator(s) of L.T., only so long as L.T. is alive at the time a particular payment is due. At the Secretary’s sole discretion, the periodic payments may be provided to petitioner in monthly, quarterly, annual, or other installments. The “annual amounts” set forth in the chart at Tab A describe only the total yearly sum to be paid to petitioner and do not require that the payment be made in one annual installment. 1. Growth Rate The parties agree that a four percent (4%) growth rate should be applied to all non- medical life care items, and a five percent (5%) growth rate should be applied to all medical life care items. Thus, the benefits illustrated in the chart at Tab A that are to be paid through annuity payments should grow as follows: four percent (4%) compounded annually from the date of judgment for non-medical items, and five percent (5%) compounded annually from the date of judgment for medical items. b. Moody’s Investor Service Claims Paying Rating: Aa3, Aa2, Aa1, or Aaa; c. Standard and Poor's Corporation Insurer Claims-Paying Ability Rating: AA-, AA, AA+, or AAA; d. Fitch Credit Rating Company, Insurance Company Claims Paying Ability Rating: AA-, AA, AA+, or AAA. 5 Petitioner authorizes the disclosure of certain documents filed by the petitioner in this case consistent with the Privacy Act and the routine uses described in the National Vaccine Injury Compensation Program System of Records, No. 09-15-0056. 6 Once L.T. reaches the age of majority, future payments will be made directly to her. 5 Case 1:15-vv-00124-MCW Document 175 Filed 09/16/22 Page 9 of 11 2. Life-contingent annuity Petitioner will continue to receive the annuity payments from the Life Insurance Company only so long as L.T. is alive at the time that a particular payment is due. Written notice shall be provided to the Secretary of Health and Human Services and the Life Insurance Company within twenty (20) days of L.T.’s death. 3. Guardianship No payments shall be made until petitioner provides respondent with documentation establishing that she has been appointed as the guardian(s)/conservator(s) of L.T.’s estate. If petitioner is not authorized by a court of competent jurisdiction to serve as guardian(s)/ conservator(s) of the estate of L.T., any such payment shall be made to the party or parties appointed by a court of competent jurisdiction to serve as guardian(s)/conservator(s) of the estate of L.T. upon submission of written documentation of such appointment to the Secretary. III. Summary of Recommended Payments Following Judgment A. Lump Sum paid to the court-appointed guardian(s)/ conservator(s) of the estate of L.T. for the benefit of L.T.: $257,153.97 B. Medicaid lien: $ 1,953.34 C. An amount sufficient to purchase the annuity contract described above in section II. C. 6 Case 1:15-vv-00124-MCW Document 175 Filed 09/16/22 Page 10 of 11 Respectfullysubmitted, BRIAN M. BOYNTON Principal Deputy Assistant Attorney General C.SALVATORE D’ALESSIO Acting Director Torts Branch, Civil Division HEATHER L. PEARLMAN Deputy Director Torts Branch, Civil Division ALEXIS B. BABCOCK Assistant Director Torts Branch, Civil Division s/Julia M. Collison JULIA M. COLLISON, ESQ. Trial Attorney Torts Branch, Civil Division U.S. Department of Justice P.O. Box 146 Benjamin Franklin Station Washington, D.C. 20044-0146 Tel: (202) 305-0102 DATED: August 22, 2022 7 Case 1:15-vv-00124-MCW Document 175 Filed 09/16/22 Page 11 of 11 Appendix A: Items of Compensation for Delozier (I.T.) Page 1 of 1 Lump Sum ITEMS OF Compensation Compensation Compensation Compensation Compensation Compensation Compensation Compensation COMPENSATION G.R. * M Year 1 Years 2-7 Year 8 Years 9-13 Year 14 Years 15-52 Year 53 Years 54-Life 2022 2023-2028 2029 2030-2034 2035 2036-2073 2074 2075-Life Insurance 5% M 9 ,092.76 9,092.76 9,092.76 9,092.76 Medicare Part B Deductible 5% 233.00 233.00 Dermatology 5% * 7 0.00 70.00 70.00 70.00 300.00 300.00 60.00 60.00 Tofacitinib 5% 3 20.00 320.00 320.00 320.00 320.00 320.00 320.00 320.00 Clobetasol Solution 5% 2 0.00 20.00 20.00 20.00 676.00 676.00 676.00 676.00 Lab Testing 5% * 3 5.00 14.00 14.00 14.00 330.00 132.00 Alopecia Areata Conference Travel Expenses 4% 3 ,090.00 1,545.00 1,545.00 1,545.00 1,545.00 1,545.00 1,545.00 1,545.00 Alopecia Areata Support Group 4% M 1 ,920.00 1,920.00 Indiv Therapy 4% * 165.00 60.00 1,400.00 560.00 280.00 112.00 Mileage: Group Therapy 4% 5 2.80 52.80 Mileage: Indiv Therapy 4% 11.00 4.40 4.40 4.40 4.40 4.40 Mileage: Dermatology 4% 2 .64 2.64 2.64 2.64 2.64 2.64 2.64 2.64 Pain and Suffering 2 42,550.77 Medicaid Lien 1 ,953.34 Annual Totals 2 59,107.31 13,037.20 11,240.40 11,128.80 4,578.04 3,540.04 3,121.04 2,953.04 Note: Compensation Year 1 consists of the 12 month period following the date of judgment. Compensation Year 2 consists of the 12 month period commencing on the first anniversary of the date of judgment. As soon as practicable after entry of judgment, respondent shall make the following payment to the court-appointed guardian(s)/ conservators(s) of the estate of L.T. for the benefit of L.T. for pain and suffering ($242,550.77), and Year 1 life care expenses ($14,603.20): $257,153.97. As soon as practicable after entry of judgment, respondent shall make the following payment jointly to petitioner and the Monroe County Department of Social Services, as reimbursement of the county's Medicaid lien: $1,953.34. Annual amounts payable through an annuity for future Compensation Years follow the anniversary of the date of judgment. Annual amounts shall increase at the rates indicated in column "G.R." above, compounded annually from the date of judgment. Items denoted with an asterisk (*) covered by health insurance and/or Medicare. Items denoted with an "M" payable in 12 monthly installments at the discretion of respondent.