VICP Registry Case Source Bundle Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_12-vv-00630 Package ID: USCOURTS-cofc-1_12-vv-00630 Petitioner: Bailey Day Filed: 2012-09-24 Decided: 2017-03-31 Vaccine: Gardasil and FluMist Vaccination date: 2011-09-28 Condition: neuromyelitis optica (NMO) or Devic’s Syndrome Outcome: compensated Award amount USD: 1361412 AI-assisted case summary: On September 24, 2012, Laura Day, as the parent and natural guardian of her daughter Bailey Day, filed a petition under the National Vaccine Injury Compensation Program. The petition alleged that the Gardasil and FluMist vaccinations administered on September 28, 2011, caused Bailey to develop multiple sclerosis (MS). It was later discovered that Bailey actually suffers from neuromyelitis optica (NMO), also known as Devic's Syndrome. The respondent, the Secretary of Health and Human Services, argued that the petitioner had not provided adequate evidence that the vaccinations caused B.K.D.'s NMO. An entitlement hearing was held on June 10-11, 2015, with testimony from the petitioner, B.K.D., and their respective experts. On November 13, 2015, Chief Special Master Nora Beth Dorsey issued a ruling on entitlement, finding that the petitioner was entitled to compensation. The public decision does not detail the specific symptoms, medical tests, or treatments B.K.D. experienced prior to the diagnosis of NMO, beyond what is described in the factual background. The decision does not name petitioner's counsel or respondent's counsel in the entitlement ruling, but later documents identify Anne Carrion Toale of Maglio, Christopher & Toale as petitioner's counsel and Gordon Elliot Shemin of the U.S. Department of Justice as respondent's counsel. Dr. Carlo Tornatore testified as petitioner's expert, and Dr. Thomas Leist testified as respondent's expert. Dr. Tornatore proposed three theories of causation: molecular mimicry, immune system imbalance, and a misdirected immune response. Dr. Leist disputed these theories, arguing that sequence homologies alone were insufficient to cause autoimmune disease and citing the Institute of Medicine's finding of insufficient evidence to assess an association between the HPV vaccine and NMO. Chief Special Master Dorsey found that the petitioner had provided preponderant evidence that the Gardasil and FluMist vaccinations could cause NMO via molecular mimicry, satisfying Althen Prong One. She also found that the petitioner had shown a logical sequence of cause and effect, satisfying Althen Prong Two, and that the timing of B.K.D.'s symptom onset (three days post-vaccination) was medically appropriate, satisfying Althen Prong Three. The ruling on entitlement was issued on November 13, 2015. On January 27, 2016, the parties filed a stipulation for interim attorneys' fees and costs, and Chief Special Master Dorsey awarded $112,500.00 to petitioner's attorney, Anne Toale. On May 31, 2016, Chief Special Master Dorsey awarded interim damages of $250,000.00 for past pain and suffering, noting the extreme financial hardship faced by B.K.D.'s family. This interim award was affirmed by Judge Victor J. Wolski on December 7, 2016, and judgment was entered on January 18, 2017. On March 6, 2017, Chief Special Master Dorsey issued a final decision awarding compensation based on a stipulation/proffer. The total award was $1,361,412.88, comprising a lump sum of $1,283,828.14 for life care expenses (first year), lost earnings, and past unreimbursable expenses; a lump sum of $7,584.74 to satisfy the Indiana Medicaid lien; and an amount sufficient to purchase an annuity for future life care expenses. The $250,000.00 for past pain and suffering had already been paid. The annuity was to include a 4% growth rate for non-medical items and a 5% growth rate for medical items. The final decision was issued on March 31, 2017. Theory of causation field: Laura Day, as guardian for Bailey Day (age 12), alleged Gardasil and FluMist vaccinations on September 28, 2011, caused neuromyelitis optica (NMO). Petitioner's expert, Dr. Carlo Tornatore, proposed that molecular mimicry, immune system imbalance, or a misdirected immune response could link the vaccines to NMO, citing studies on epitope homology between HPV antigens and aquaporin-4 (AQP4), the target of NMO-IgG antibodies, and post-vaccination ADEM/NMO cases. Respondent's expert, Dr. Thomas Leist, argued that sequence homology alone is insufficient and cited the Institute of Medicine's lack of evidence for an HPV vaccine-NMO association. Chief Special Master Nora Beth Dorsey found preponderant evidence for a causal link via molecular mimicry, a logical sequence of cause and effect, and a medically appropriate temporal relationship (3 days post-vaccination), satisfying the Althen prongs. The case resulted in an entitlement ruling on November 13, 2015, an interim damages award of $250,000 for past pain and suffering on May 31, 2016, and a final award of $1,361,412.88 on March 31, 2017, covering life care expenses, lost earnings, past unreimbursable expenses, and a Medicaid lien, with future life care expenses to be paid via annuity. Attorneys for petitioner were Maglio, Christopher & Toale; respondent was represented by the U.S. Department of Justice. Public staged source text: ================================================================================ DOCUMENT 1: USCOURTS-cofc-1_12-vv-00630-0 Date issued/filed: 2015-12-07 Pages: 31 Docket text: PUBLIC ORDER/RULING (Originally filed: 11/13/2015) regarding 82 Ruling on Entitlement Signed by Chief Special Master Nora Beth Dorsey. (tlf) Copy to parties. -------------------------------------------------------------------------------- Case 1:12-vv-00630-VJW Document 84 Filed 12/07/15 Page 1 of 31 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS Filed: November 13, 2015 * * * * * * * * * * * * * * * * PUBLISHED LAURA DAY, as parent and natural * guardian of B.K.D., * * No. 12-630V Petitioner, * * Chief Special Master Dorsey v. * * Entitlement; FluMist; Influenza SECRETARY OF HEALTH * Vaccine; Gardasil; Human Papilloma AND HUMAN SERVICES, * Virus; (“HPV”); Neuromyelitis * Optica (“NMO”) Respondent. * * * * * * * * * * * * * * * * * * Anne Carrion Toale, Maglio, Christopher & Toale, Sarasota, FL, for petitioner. Gordon Elliot Shemin, U.S. Department of Justice, Washington, D.C., for respondent. RULING ON ENTITLEMENT1 I. Introduction On September 24, 2012, Laura Day (“petitioner”) filed a petition for compensation under the National Vaccine Injury Compensation Program (“the Program”),2 as the legal representative of her daughter, B.K.D, in which she alleged that the Gardasil (“HPV”) and FluMist (“influenza”) vaccinations B.K.D. received on September 28, 2011, caused her to develop 1 Because this published ruling contains a reasoned explanation for the action this case, the undersigned intends to post this decision on the website of the United States Court of Federal Claims, in accordance with the E-Government Act of 2002 § 205, 44 U.S.C. § 3501 (2012). In accordance with the Vaccine Rules, each party has 14 days within which to request redaction “of any information furnished by that party: (1) that is a trade secret or commercial or financial in substance and is privileged or confidential; or (2) that includes medical files or similar files, the disclosure of which would constitute a clearly unwarranted invasion of privacy.” Vaccine Rule 18(b). Further, consistent with the rule requirement, a motion for redaction must include a proposed redacted ruling. If, upon review, the undersigned agrees that the identified material fits within the requirements of that provision, such material will be deleted from public access. 2 The Program comprises Part 2 of the National Childhood Vaccine Injury Act of 1986, 42 U.S.C. § 300aa. 1 Case 1:12-vv-00630-VJW Document 84 Filed 12/07/15 Page 2 of 31 multiple sclerosis (“MS”). Petition at 3, ¶11. Petitioner further alleged that the vaccinations “actually caused, or, alternatively, significantly aggravated” B.K.D.’s injuries. Id. After the filing of the petition, it was discovered that B.K.D. actually suffers from a rare autoimmune disorder known as neuromyelitis optica (“NMO”) or Devic’s Syndrome, rather than MS. See Petitioner’s (“Pet’r’s”) Exhibit (“Ex.”) 6 at 13. Respondent recommended against awarding compensation, stating that petitioner had not presented adequate evidence that B.K.D.’s Gardasil and FluMist vaccinations caused her to suffer from NMO. See Respondent’s Rule 4 Report (“Resp’t’s Report”) at 11. An entitlement hearing was held on June 10-11, 2015, in Washington, D.C., during which the petitioner, B.K.D., and the parties’ respective experts testified. The parties filed post-hearing briefs and the case is now ripe for adjudication. II. Factual Background a. Summary of Relevant Facts B.K.D. was born on August 25, 1998, in Mooresville, Indiana. Pet’r’s Ex. 1 at 1. As a young child, B.K.D. enjoyed relatively good health, although she suffered from occasional ear infections and colds. Pet’r’s Ex. 14 at 15. B.K.D.’s previous medical history includes symptoms of juvenile arthritis at the age of three and breaking her right wrist and the pinky finger on her right hand, for which she had surgery on September 17, 2011. Pet’r’s Ex. 3 at 4; Pet’r’s Ex. 4 at 5. B.K.D. was an otherwise active, healthy child who enjoyed playing competitive year-round softball. She received a physical examination at a CVS Minute Clinic in Mooresville, Indiana, on August 2, 2011, where she was cleared for participation in her school’s sports programs. Pet’r’s Ex. 16 at 1. The CVS nurse practitioner reported that B.K.D. “does not present apparent contraindications (including cardiovascular, musculoskeletal, and neurological) to practice and participate in [sports].” Id. On September 28, 2011, at the age of twelve, B.K.D. received a FluMist and a third Gardasil vaccination at the Morgan County Health Department.3 Pet’r’s Ex. 7 at 1. On October 4, 2011, she presented to the emergency room of St. Francis Mooresville Hospital (“St. Francis”) with complaints of abdominal pain, back pain, and generalized aches since October 1, 2011. Pet’r’s Ex. 2 at 176. B.K.D. also reported experiencing abdominal pain when urinating and said that she had not had a bowel movement in two days. Id. at 178. Dr. Godfrey, the treating physician, concluded that B.K.D. was constipated and sent her home with instructions to take Miralax. Id. On October 31, 2011, B.K.D. again presented in the emergency room at St. Francis complaining of constant diarrhea and a twelve pound weight loss over the course of the last two 3 BKD received the first two rounds of the Gardasil vaccine on January 5, 2011, and May 25, 2011, respectively. She reported no adverse symptoms after receiving either of them. Pet’r’s Ex. 7 at 1. 2 Case 1:12-vv-00630-VJW Document 84 Filed 12/07/15 Page 3 of 31 weeks. Pet’r’s Ex. 2 at 186. She also reported a sore neck, fever, and a rash that began on or around October 27, 2011, along with irregular pupils. Id. B.K.D. tested positive for strep throat, and an analysis of her cerebrospinal fluid showed elevated protein levels. Id. at 194-96. She received a shot of Rocephin for treatment of suspected bacterial meningitis and was sent to Riley Hospital for Children (“Riley Hospital”) for further evaluation. Id. at 190. Upon examination at Riley Hospital, the treating physicians suspected that B.K.D. could have viral or bacterial meningitis4 and also suspected possible Horner’s syndrome.5 Pet’r’s Ex. 4 at 14, 91-92. After B.K.D. began complaining of leg weakness and numbness that progressively worsened, she had an MRI of her brain and spine on November 2, 2011. Pet’r’s Ex. 4 at 93; Pet’r’s Ex. 4 at 347. The MRI of her spine revealed findings consistent with acute disseminated encephalomyelitis (“ADEM”).6 Pet’r’s Ex. 21 at 11. The MRI of her spine also revealed hyperintensity, and the MRI of her brain showed multiple T2 and FLAIR hyperintensities, all of which are consistent with ADEM. Pet’r’s Ex. 4 at 349-50. Dr. Meredith Golomb, one of B.K.D.’s physicians at Riley Hospital, noted that B.K.D. had recently received both the Gardasil and FluMist vaccinations and planned to investigate the incidence of HPV vaccine and ADEM. When discussing the possibility of one of the vaccines causing ADEM, Dr. Golomb noted, “Although I think [it] is unlikely, [I] would not be able to rule [it] out entirely.” Pet’r’s Ex. 4 at 114. After speaking with an ADEM expert, Dr. Golomb noted in the file that B.K.D. “[received] Gardasil and FluMist on a [Wednesday], [and] had onset of band-like back pain [Saturday;] [the] gap for vaccine response [is] generally [five to] 42 days.”7 Pet’r’s Ex. 4 at 123. B.K.D. continued to receive treatment for ADEM, including both intravenous and oral steroids and Neurontin, until she was discharged from Riley Hospital on November 9, 2011. She was immediately transferred to Inpatient Pediatric Rehabilitation Services. Pet’r’s Ex. 4 at 5. After spending a week in rehabilitation, B.K.D. regained much of her strength and was able to walk short distances when using a cane. Id. Her back, shoulder, and leg pain was controlled with Neurontin, and she continued taking oral steroids on a slow taper. B.K.D. was discharged from the rehabilitation facility on November 16, 2011. Id. at 6. 4 While the Riley Hospital physicians initially postulated that B.K.D. suffered from either viral or bacterial meningitis, this diagnosis was later revised to neuromyelitis optica (“NMO”). 5 Horner’s Syndrome is characterized by “homolateral miosis, mild ptosis, and apparent enophthalmos with slight elevation of the lower [eye]lid.” Robert Kliegman et al., Nelson Textbook of Pediatrics, 2155 (19th ed. 2011). 6 ADEM is “characterized by perivascular lymphocyte and mononuclear cell infiltration and demyelination . . . . It is believed to be a manifestation of an autoimmune attack on the myelin of the central nervous system.” Daniel Albert et al., Dorland’s Illustrated Medical Dictionary, 613 (32nd ed. 2012) (“Dorland’s”). 7 Although B.K.D.’s MRIs of the brain and spine initially revealed findings consistent with ADEM, the parties agree that B.K.D. did not suffer from ADEM and that her correct diagnosis is NMO. See Pet’r’s Ex. 6 at 4-5; Tr. 51. 3 Case 1:12-vv-00630-VJW Document 84 Filed 12/07/15 Page 4 of 31 When B.K.D. stopped taking oral steroids on December 16, 2011, her symptoms quickly worsened. On December 28, 2011, B.K.D. reported pupil irregularity, unsteady gait, right leg weakness, and back pain. She was admitted to Riley Hospital for overnight observation and was administered oral steroids. MRIs of her brain and spine were taken on December 29, 2011. The MRI of B.K.D.’s spine showed “areas of cervicothoracic cord expansion and … improving scattered thoracic meningeal enhancement.” Pet’r’s Ex. 11 at 36. However, B.K.D. continued to experience trouble walking. Pet’r’s Ex. 9 at 11. On January 5, 2011, B.K.D. again presented to the emergency room at Riley Hospital complaining of a severe headache and reporting that both of her legs felt numb, weak, and tingly. Pet’r’s Ex. 9 at 11-12. She also experienced back pain and urinary retention. Id. The next day, B.K.D. had an MRI of her brain which showed that the previous lesions in her brain had resolved. Pet’r’s Ex. 9 at 3. On a brain MRI limited by metallic artifact and motion, no intracranial abnormalities were seen. Pet’r’s Ex. 9 at 228. However, there was slight interval increase of the cervicothoracic spinal cord edema and expansion with new syrinx formation at T2 and T3. Id. at 229. The radiologist noted differential considerations, including ADEM and transverse myelitis. Id. B.K.D. was discharged from Riley Hospital on January 12, 2012, and was admitted to the pediatric rehabilitation facility, where she received treatment for persistent right lower limb weakness until she returned home on January 18, 2012. Id. at 4. B.K.D. continued to recover until June 12, 2012, when she was again admitted to the emergency room at Riley Hospital with complaints of left hand and arm tingling, left leg weakness, and trouble running. Pet’r’s Ex. 6 at 11. She also reported one episode of blurred vision in her left eye. An MRI of the brain showed no definite intracranial abnormalities, but an MRI of the spine showed extensive abnormalities from the C3 to the T6 level. Id. B.K.D. also tested positive for the aquaporin-4 antibody (“NMO IgG positive”), which is definitive of patients with NMO. Id. at 13. On July 10, 2012, B.K.D. followed up with Dr. David Mattson, a neurologist with expertise in the treatment of MS, at the MS Center of Indiana University. Dr. Mattson noted that B.K.D. had a long segment of spinal cord demyelination, which is another symptom consistent with a diagnosis of NMO. Dr. Mattson did not initially diagnose B.K.D. with NMO because she had not shown symptoms of optic neuritis, which is one of the disease’s most prominent symptoms. Ex. 6 at 5. He recommended that B.K.D. begin using Rebif, which is commonly used to treat patients with MS, in order to facilitate long-term management of the disease. Id. However, a Mayo clinic neurologist observed that an NMO-IgG positive test was “highly associated” with NMO, and B.K.D. was invited to participate in a study at the Mayo Clinic. Pet’r’s Ex. 20 at 298. When B.K.D. began having trouble walking and was admitted to Riley Hospital on October 9, 2012, the attending neurologist, Dr. Walsh, noted that B.K.D. suffered from NMO. Pet’r’s Ex. 12 at 5. B.K.D. has been receiving treatment at the MS Center of Indiana University. On November 12, 2012, Dr. Mattson reaffirmed a decision to continue treating B.K.D. long-term with Rebif. Pet’r’s Ex. 20 at 274. Rebif prevented B.K.D. from relapsing from the end of 2012 up until December 2013, when another relapse began. Tr. 18-19. On December 4, 2013, an MRI of her brain and spine showed new lesions, and B.K.D. began another round of steroids. 4 Case 1:12-vv-00630-VJW Document 84 Filed 12/07/15 Page 5 of 31 Pet’r’s Ex. 35 at 5-6; Pet’r’s Ex. 36 at 6. B.K.D. continued her visits to the MS Clinic, where her lower extremity symptoms continued and she was slowly weaned off steroids. After B.K.D. was seen at the MS Clinic on February 4, 2014, Dr. Grimes decided to switch her medication from Rebif to azathioprine in hopes of decreasing the enhancing activity in her brain and spinal cord. Pet’r’s Ex. 36 at 4; Pet’r’s Ex. 35 at 19. b. Summary of Petitioner’s and B.K.D.’s Testimony Both petitioner, Laura Day, and her daughter, B.K.D., testified during the hearing on June 10, 2015. Ms. Day testified that although her daughter has never been diagnosed with rheumatoid arthritis, B.K.D. experienced aching in her legs when she was about two years old. Tr. 7. However, B.K.D. did not experience further problems after she visited a chiropractor, and she never visited a rheumatologist or had bloodwork done. Id. Ms. Day further stated that prior to receiving the Gardasil and FluMist vaccinations on September 28, 2011, her daughter was a happy, healthy seventh grader who enjoyed playing volleyball and softball. Tr. 9. B.K.D. received straight A’s, she was in the National Honor Society, and she was the recipient of her school’s prestigious presidential award. Id. Prior to September 2011, with the exception of getting a sports physical and receiving treatment for a sports injury, B.K.D. had not needed to go to the doctor in nearly four years. Tr. 7. Ms. Day also testified about the ways in which her daughter’s illness has impacted their family. She stated that since B.K.D.’s initial onset of NMO in September 2011, she has had to watch her daughter relearn to walk five times. Tr. 15. Ms. Day presented a clear timeline of her daughter’s illness, beginning with the onset of symptoms and including B.K.D.’s second relapse of NMO in March 2012 and her third relapse in June 2012. Tr. 17-18. Ms. Day reported that after B.K.D. was diagnosed with NMO and began taking Rebif in June 2012, she enjoyed 14 months of good health and started to return to a more normal life, until her daughter’s fourth relapse in December 2013. Tr. 20-21. Ms. Day described 2014 as a year of “one relapse after another,” during which B.K.D. was hospitalized over ten times. Tr. 21-22. Ms. Day stated that in October 2014, B.K.D. began seeing Dr. Weinshenker, an NMO specialist at the Mayo Clinic. While her health has improved with an increase in her steroid treatment and an experimental chemotherapy drug treatment, it is still unclear whether this course of treatment will prevent further relapses of NMO. Tr. 21, 33. Additionally, Ms. Day reported that the medications used to control B.K.D.’s NMO make it difficult for her to enjoy a normal life and have caused her to gain over 120 pounds. Tr. 26. Despite the uncertain future of her daughter’s health, Ms. Day testified that B.K.D. has tried to make the most of her situation and enjoy life. Ms. Day stated that she and B.K.D. attended a prom at Riley Hospital and that B.K.D. enjoyed her sixteenth birthday party in Riley Hospital’s lobby. Tr. 23, 25. B.K.D. also received a wish from the Make-A-Wish Foundation, where she, her family, and a friend traveled to California for a sightseeing trip. Tr. 28. And B.K.D.’s brother and his baseball team named one of their tournaments after B.K.D. and donated the money they raised to help pay for her treatment. Tr. 24. The family is hopeful that Dr. Weinshenker’s new therapies will help B.K.D. to resume a more normal life. 5 Case 1:12-vv-00630-VJW Document 84 Filed 12/07/15 Page 6 of 31 In addition to petitioner’s testimony, B.K.D. also testified. She described how the medications she takes for NMO make her feel tired, cause bruising in her arms, and occasionally make her sick. Tr. 41. B.K.D. testified about the difficulties of being in and out of the hospital and having to go to rehabilitation therapy to relearn how to walk. Tr. 43-44. She stated that she has had to teach herself how to walk many times, and that she has a cane, a walker, multiple leg braces, a gait belt, and two wheelchairs. Id. B.K.D. stated that her favorite color is orange because this is the awareness color for MS, which was one of her initial diagnoses. Tr. 46. B.K.D. concluded her testimony by stating, “I want to go to college to be a neurologist who specializes in MS and NMO.” Tr. 50. c. Procedural History Petitioner filed this case on September 24, 2012, alleging that B.K.D. suffered from MS as a result of receiving the Gardasil and FluMist vaccinations on September 28, 2011. Petition at 1, ¶¶ 8-9. Petitioner filed the first set of medical records on November 2, 2011. Respondent addressed petitioner’s claims in a report filed pursuant to Vaccine Rule 4(c), wherein respondent argued that petitioner was not entitled to compensation under the Program. Resp’t’s Report at 2. Respondent also asserted that petitioner had not filed a complete set of medical records or any affidavits in support of her position. Id. Additional time was granted for the filing of medical records, and petitioner filed an affidavit on July 24, 2013. The parties also filed expert reports in support of their respective positions. On January 24, 2014, petitioner filed an expert report from neurologist Dr. Carlo Tornatore, his curriculum vitae, and several articles referenced in his report. Pet’r’s Ex. 21. Dr. Tornatore concluded, “[B.K.D.] developed an HPV-induced ADEM/NMO mediated by an autoantibody to aquaporin- 4.” Id. at 11. Thereafter, respondent filed an expert report from neurologist Dr. Thomas Leist. Resp’t’s Ex. A. The parties also filed a joint pre-hearing submission outlining the facts and issues that were and were not in dispute. Joint Pre-Hearing Submission, filed May 15, 2015. As stipulated by the parties, there are no disputed facts in this case. 8 The parties agree that B.K.D. received the Gardasil and FluMist vaccinations on September 28, 2011. They also agree that B.K.D. previously received two Gardasil vaccinations on January 5, 2011, and May 25, 2011. Joint Pre-Hearing Submission at 1. The parties also agree that B.K.D. had a positive NMO-IgG antibody test. Id. The parties agree that B.K.D. currently suffers from NMO and that her symptoms in early October 2011 were the initial presentation of what would later be diagnosed as NMO. Id.; Tr. 51. 8 Petitioner’s expert, Dr. Carlo Tornatore, initially posited in his expert report that B.K.D.’s October 1 symptoms were the result of ADEM and that she later developed NMO. See Pet’r’s Ex. 21 at 11-12. However, the parties reached an agreement wherein petitioner and respondent stipulated that B.K.D.’s initial symptoms in early October 2011 were properly classified as symptoms of NMO and not of ADEM. See Joint Pre-Hearing Submission, filed May 15, 2015; Tr. 51. 6 Case 1:12-vv-00630-VJW Document 84 Filed 12/07/15 Page 7 of 31 The parties agree that B.K.D.’s alleged injury is not set forth on the Vaccine Injury Table,9 nor is there any dispute as to whether B.K.D. received these vaccines in the United States.10 Id. Additionally, the parties do not contest that B.K.D. has suffered from the residual complications of NMO for more than six months since the administration of the Gardasil and FluMist vaccinations.11 d. Issue to be Decided The sole issue to be decided is whether the Gardasil and FluMist vaccinations administered to B.K.D. on September 28, 2011, were the cause of her NMO. Joint Pre-Hearing Submission at 2. e. Neuromyelitis Optica (NMO) NMO is a demyelinating autoimmune disorder consisting of optic neuritis and transverse myelopathy.12 Optic neuritis is an inflammation of the optic nerve that is caused by antibodies that attack the myelin sheath13 surrounding the optic nerve. Optic neuritis can lead to partial or total loss of vision.14 Transverse myelitis is an abrupt onset of inflammation of the spinal cord that can cause permanent motor dysfunction.15 An astrocyte is a special kind of myelin- producing cell.16 In patients with NMO, the immune system becomes confused and begins to attack the body’s astrocytes rather than foreign pathogens. When the astrocytes are attacked, this causes swelling in the brain and spinal cord. Tr. 67. 9 See 42 U.S.C. § 300aa-11(c)(1)(A). 10 See 42 U.S.C. § 300aa-11(c)(1)(B). 11 See 42 U.S.C. § 300aa-11(c)(1)(D)(i). 12 Institute of Medicine (“IOM”), Adverse Effects of Vaccines: Evidence and Causality, 642 (Kathleen Stratton et al. eds., 2012) (internal citations removed). 13 Myelin is a substance that coils to form the myelin sheath and acts as an electrical insulator. Dorland’s at 1218. 14 Id. at 643. 15 Adverse Effects of Vaccines at 646. 16 Astrocytes are specialized neurological cells found in the central nervous system that “play a role in myelin formation, transport material to neurons and [aid in the] maintenance of the ionic environment of neurons.” Dorland’s at 169, 1265. 7 Case 1:12-vv-00630-VJW Document 84 Filed 12/07/15 Page 8 of 31 The study of NMO has been greatly advanced by the Mayo Clinic’s discovery of anti- immunoglobin G (“NMO-IgG”) antibodies in 2006. NMO-IgG antibodies target aquaporin-4 (“AQP4”), a protein that is present in astrocytes which helps conduct water through the cell membrane.17 AQP4 is mainly concentrated in the eyes, brain, and spinal cord. In NMO patients, instead of the immune system eliminating foreign pathogens, the immune cells become confused and NMO-IgG antibodies begin to target AQP4, which then causes destruction of myelin and subsequent brain and spinal cord inflammation. Tr. 67. Because the triggering event that causes the NMO-IgG antibodies to attack the self is unknown, NMO is currently classified as an idiopathic disorder. Tr. 189. III. Discussion The Vaccine Act established the Program to compensate vaccine-related injuries and deaths. 42 U.S.C. § 300aa-10(a). “Congress designed the Vaccine Program to supplement the state law civil tort system as a simple, fair and expeditious means for compensating vaccine- related injured persons. The program was established to award ‘vaccine-injured persons quickly, easily, and with certainty and generosity.’” Rooks v. Sec’y of Health & Human Servs., 35 Fed. Cl. 1, 7 (1996) (quoting H.R. Rep. No. 908 at 3, reprinted in 1986 U.S.C.C.A.N. at 6287, 6344). a. Standards for Adjudication Petitioner’s burden of proof is a preponderance of the evidence. 42 U.S.C. § 300aa- 13(a)(1). The preponderance of the evidence standard, in turn, has been interpreted to mean that a fact is more likely than not. Moberly v. Sec’y of Health & Human Servs., 592 F.3d 1315, 1322 n. 2 (Fed. Cir. 2010). Proof of medical certainty is not required. Bunting v. Sec’y of Health & Human Servs., 931 F.2d 867, 873 (Fed. Cir. 1991). A petitioner who satisfies this burden is entitled to compensation unless the government can prove by a preponderance of the evidence that the vaccinee’s injury is “due to factors unrelated to the administration of the vaccine.” 42 U.S.C. § 300aa-13(a)(1)(B). b. Elements of Petitioner’s Claim When a petitioner alleges that an injury listed on the Vaccine Injury Table (“the Table”) occurs within the time frame set forth in the Table, then petitioner’s vaccine claim is deemed a Table claim, and a presumption of vaccine causation attaches. See 42 U.S.C. § 300aa-14; see also 42 C.F.R. § 100.3. If, however, a petitioner alleges an injury that is not listed on the Table, (such as the injury alleged in this case) the vaccine claim is deemed a non-Table case, and there is no presumption of causation. Rather, petitioner must satisfy her burden of proof. See 42 17 Dorland’s at 122; see also Tr. 67 (referencing Pet’r’s Ex. 30 at 2). 8 Case 1:12-vv-00630-VJW Document 84 Filed 12/07/15 Page 9 of 31 U.S.C. § 300aa-13(a)(1)(A). In so doing, petitioner must show that the vaccine was “not only a but-for cause of the injury but also a substantial factor in bringing about the injury.” Moberly, 592 F.3d 1320, 1321 (Fed. Cir. 2010) (quoting Shyface v. Sec’y of Health & Human Servs., 165 F.3d 1344, 1352-53 (Fed. Cir. 1999)). Because petitioner does not allege that B.K.D. suffered a Table injury, she must prove that either the Gardasil or FluMist vaccines that B.K.D. received caused her injury. To do so, she must establish, by preponderant evidence: (1) a medical theory causally connecting the vaccine and B.K.D.’s injury (“Althen Prong One”); (2) a logical sequence of cause and effect showing that the vaccine was the reason for her injury (“Althen Prong Two”); and (3) a showing of a proximate temporal relationship between the vaccination and her injury (“Althen Prong Three”). Althen v. Sec’y of Health & Human Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005); 42 U.S.C. § 300aa-13(a)(1) (requiring proof by a preponderance of the evidence). In determining whether petitioner is entitled to compensation, the special master shall consider all material contained in the record, § 300aa-13(b)(1), including “any … conclusion, [or] medical judgment … which is contained in the record regarding … causation … of the petitioner’s illness.” § 300aa-13(b)(1)(A). Thus, the undersigned must weigh the submitted evidence and the testimony of the parties’ offered experts and rule in petitioner’s favor when the evidence weighs in her favor. Moberly, 592 F.3d at 1325-26 (“Finders of fact are entitled – indeed, expected – to make determinations as to the reliability of the evidence presented to them and, if appropriate, as to the credibility of the persons presenting that evidence”); Althen, 418 F.3d at 1280-81. i. Althen Prong One: Medical Theory of Causation Under Althen Prong One, petitioner must set forth a medical theory explaining how the received vaccine could have caused the sustained injury. Andreau v. Sec’y of Health & Human Servs., 569 F.3d 1367, 1375 (Fed. Cir. 2009). Under this prong, a petitioner must make a showing that the received vaccine “can” cause the alleged injury. Pafford v. Sec’y of Health & Human Servs., 451 F.3d 1352, 1355-56 (Fed. Cir. 2006). Petitioner’s theory of causation need not be medically or scientifically certain, Knudsen, 35 F.3d at 548-49, but it must be informed by “sound and reliable medical or scientific explanation.” Id. at 548; see also Veryzer v. Sec’y of Health & Human Servs., 98 Fed. Cl. 214, 223 (2011) (noting that special masters are bound by both § 300aa-13(b)(1) and Vaccine Rule 8(b)(1) to consider only evidence that is both “relevant” and “reliable”). If petitioner relies upon a medical opinion to support her theory, the basis for the opinion and the reliability of that basis must be considered in the determination of how much weight to afford the offered opinion. See Broekelschen v. Sec’y of Health & Human Servs., 618 F.3d 1339, 1347 (Fed. Cir. 2010) (“The special master’s decision often times is based on the credibility of the experts and the relative persuasiveness of their competing theories.”); Perreira v. Sec’y of Health & Human Servs., 33 F.3d 1375, 1377 n.6 (Fed. Cir. 1994) (“An expert opinion is no better than the soundness of the reasons supporting it.”) (citing Fehrs v. United States, 620 F.2d 255, 265 (Ct. Cl. 1980)). 9 Case 1:12-vv-00630-VJW Document 84 Filed 12/07/15 Page 10 of 31 As noted above, the sole issue to be decided in this case is whether the vaccinations that B.K.D. received caused the injuries she sustained. Petitioner must show by a preponderance of the evidence that the Gardasil and FluMist vaccinations caused B.K.D. to develop NMO. 1. Petitioner’s Expert, Dr. Tornatore Dr. Carlo Tornatore, a board certified neurologist at Georgetown University Medical Center, testified on behalf of petitioner. Dr. Tornatore received his M.D. from Georgetown University School of Medicine, and he completed his residency in the Department of Neurology at Georgetown University Hospital. Pet’r’s Ex. 55 at 2. Dr. Tornatore also completed a Fellowship in Molecular Virology at the National Institutes of Health. Id. He currently serves as the Vice Chairman of the Department of Neurology, the Director of the Georgetown Multiple Sclerosis Clinic, the Neurology Residency Program Director, and the Director of Neurology Clerkship for third year medical students at Georgetown University Hospital. Id. at 3; 7. He has been nominated for over 20 teaching awards and serves as an ad hoc reviewer for several neurology and virology journals. Id. at 4-6. Dr. Tornatore is a member of the American Neurologic Association and the American Academy of Neurology, and he has published articles, book chapters, and abstracts on a range of topics in neurology and virology in several reputable medical journals. Id. at 8-14. He sees patients with NMO at Georgetown Hospital’s MS Clinic, which he has run for nearly 20 years. Tr. 63. Of the clinic’s 3,000 patients, Dr. Tornatore assists in the treatment of patients with Multiple Sclerosis, Guillain-Barré Syndrome, transverse myelitis/ADEM, and NMO. Tr. 63-64. During the hearing, Dr. Tornatore opined that he believed to a reasonable degree of medical certainty that “B.K.D.’s NMO was caused by a combination of the Gardasil and influenza vaccinations she received on September 28, 2011.” Tr. 66. Dr. Tornatore proposed three possible theories, discussed in greater detail below, to explain how the vaccinations B.K.D. received could have caused her NMO. The first and petitioner’s primary theory of causation proposed by Dr. Tornatore was that of molecular mimicry. Tr. 96-97; see also Pet’r’s Ex. 21 at 11-12. Dr. Tornatore’s second theory was that the viral pathogens from the vaccines B.K.D. received upset the balance of her immune system, ultimately leading to a breakdown in her tolerance of self-antigens. Tr. 102-03. For his third theory, Dr. Tornatore posited that the co- administration of the Gardasil and FluMist vaccinations could have caused a misdirected immune response. Pet’r’s Ex. 21 at 13-14. a. Primary Theory of Causation: Molecular Mimicry Dr. Tornatore explained molecular mimicry as the immune system’s inability to distinguish between pathogen-derived antigens and self-antigens found in the tissue of the nervous system. Tr. 96-97. If both foreign antigens and self-antigens found within the body 10 Case 1:12-vv-00630-VJW Document 84 Filed 12/07/15 Page 11 of 31 share the same epitopes,18 the immune system is unable to identify differences in foreign pathogens and the self, so it begins to attack the self. Tr. 97; see also Pet’r’s Ex. 24 at 11-12. The immune system’s responsive attack can then lead to activation of self-reactive lymphocytes, which will be concentrated in the target organ – in B.K.D.’s case, the nervous system – and cause inflammation and swelling. Tr. 97 (explaining Pet’r’s Ex. 24 at 12). As previously mentioned above, NMO damages the astrocytes. Pet’r’s Ex. 30 at 2. AQP4 has been identified as the protein present in astrocytes which is the target for specific NMO antibodies. Tr. 65, 67. NMO is most often diagnosed by testing a person’s blood serum for the presence of AQP4 antibodies, known as NMO-IgG. Pet’r’s Ex. 30 at 3. Generally, when antigens are released into the body through a vaccine, a person’s immune system will direct antibodies to bind to those foreign antigens and destroy them. However, in patients with NMO, NMO-IgG antibodies are triggered to attack the AQP4 proteins, which in turn destroy the astrocytes and cause swelling in the nervous system.19 Molecular mimicry has been linked to the development of NMO due to the similarity in epitopes of AQP4 water channels and antigens found in the HPV vaccine. Pet’r’s Ex. 31 at 1.20 Dr. Tornatore explained that because the epitopes in NMO-IgG and HPV antigens are so similar, in some cases, the immune system does not correctly distinguish between the two and thus attacks the AQP4 channels on astrocytes as well as the viral antigens. Pet’r’s Ex. 21 at 12. Dr. Tornatore cited several studies in support of his opinion that the Gardasil and FluMist vaccinations led to B.K.D.’s development of NMO via the phenomenon of molecular mimicry. Dr. Tornatore relies on a study done by Noorbakhsh et al.,21 where researchers attempted to predict when molecular mimicry might occur by looking for similarity between epitopes of pathogens believed to cause ADEM. Pet’r’s Ex. 24; Tr. 98. Specifically, the researchers found homology between myelin basic protein and the hepatitis B vaccine, indicating the potential for molecular mimicry to occur. Pet’r’s Ex. 24 at 11-12. Dr. Tornatore noted that although the Noorbakhsh paper focuses primarily on the hepatitis B vaccine causing ADEM, rather than Gardasil and/or FluMist causing NMO, the paper can still be used as evidence that the mechanism of molecular mimicry is a “true phenomen[on].” Tr. 101. The authors further note that patients can develop ADEM/transverse myelitis, which is one of the clinical presentations of NMO, after a flu vaccination. See Pet’r’s Ex. 24 at 6; Tr. 103. According to Dr. Tornatore, the fact that the Noorbakhsh study found that post-vaccinal ADEM could be caused by a variety of vaccinations, including influenza, rabies, rubella, and hepatitis B vaccines, demonstrates that 18 An epitope is the specific piece of the antigen to which an antibody binds, known as an “antigenic determinant.” Dorland’s at 637. 19 Nelson Textbook of Pediatrics at 2077; see also Tr. 67. 20 “Homology” is a term used to describe the molecular similarity between self-antigens and foreign antigens. Two proteins that are made up of similar amino acids are said to be homologous. Tr. 99. 21 Farshid Noorbakhsh et al., Acute Disseminated Encephalomyelitis: Clinical and Pathogenesis Features, 26 NEUROL. CLIN. 759 (2008) [Pet’r’s Ex. 24]. 11 Case 1:12-vv-00630-VJW Document 84 Filed 12/07/15 Page 12 of 31 “multiple different antigenic stimuli lead to the same clinical phenomenology of inflammation in the spinal cord.” Tr. 105 (referencing Pet’r’s Ex. 24 at 6). In other words, NMO could be caused by many different antigens, including those found in both the Gardasil and FluMist vaccines. Dr. Tornatore also referenced an NMO-specific study done by Menge et al.22 In the Menge article, the authors reported four cases of NMO following HPV vaccination based upon a review of the VAERS database23 for the years 2006 to 2009. Given the fact that NMO is so rare (0.25 – 1/100,000), especially in adolescents, the authors concluded that the incidence of HPV vaccine associated NMO was “unexpected and may not simply reflect the natural disease prevalence.” Pet’r’s Ex. 31 at 1. Moreover, during the years studied, there were only eight total NMO cases reported. Two of these cases were associated with the hepatitis B vaccine, and the others followed the flu vaccine (1 case) and the DTP vaccines (1 case). Id. These findings suggested that the HPV vaccine “might be overrepresented” as it relates to this rare condition. Id. While the authors could not, however, confirm “humoral immunologic cross reactivity” to be the cause of NMO following HPV vaccination, they did note that theoretically, there were similar amino acid sequences between AQP4 and HPV types 6, 11, 16, and 18. Table 1 below sets forth the authors’ findings as to homology. Score Expec t AA begin AA end (bits) value Identities Positives Gaps HPV type 18 163 C A G V E I G R G 171 14.2 8.2 5/9 5/9 0/9 b b b b b AQP4 123 C L G A I I G A G 131 b c b c b b HPV type 16 128 C V G V E V G R G 136 14.6 6.9 4/9 6/9 0/9 AQP4 158 H G L L V E L I I T F Q L 170 b b c b b b b HPV type 16 392 H G E E Y D L Q F I F Q L 404 15.4 3.4 6/13 7/13 0/13 22 Til Menge et al., Neuromyelitis Optica Following Human Papillomavirus Vaccination, 79 NEUROLOGY 285 (2012) [Pet’r’s Ex. 31]. 23 The Vaccine Adverse Event Report System (VAERS) database is a self-reporting system that tracks adverse events and/or side effects resulting from vaccinations. The program is jointly managed by the Centers for Disease Control and Prevention and the Food and Drug Administration. Adverse Effects of Vaccines: Evidence and Causality, 646 (Kathleen Stratton et al. eds., 2012). 12 Case 1:12-vv-00630-VJW Document 84 Filed 12/07/15 Page 13 of 31 Pet’r’s Ex. 31 at 2. In summary, the Menge authors posit that the theory of humoral immunologic cross reactivity (molecular mimicry) may be the medical theory of causation of NMO following HPV vaccine. In the alternative, they suggest “induction of bystander lymphocyte activation by upregulating both the adaptive and innate immune system.” Pet’r’s Ex. 31 at 2. Moreover, since L1 capsid proteins24 of HPV and AQP4 share some similarities, Dr. Tornatore explained why everyone who is vaccinated for HPV does not develop NMO. Dr. Tornatore testified that the sequence homology between L1 and AQP4 is limited. He opined: [I]f someone were to be vaccinated with Gardasil and they happened to develop antibodies against these little stretches [of L1], those antibodies could then attach to aquaporin-4 and cause NMO. Is it possible that you could be vaccinated and have antibodies to L1, but that those antibodies are not directed against these little fragments? Of course. And then you’ll never develop NMO … [S]ome people … [only] develop immunity to different parts of the L1 molecule … that [will] never … cross-react with aquaporin-4. Tr. 112. Thus, as Dr. Tornatore explained, molecular mimicry can explain the development of NMO after a vaccine, but because the homology between the L1 protein and the AQP4 is limited, such an occurrence is extremely rare. Pet’r’s Ex. 31 at 1-2. Dr. Tornatore also cited several other studies which support his theory that the Gardasil and FluMist vaccinations can cause or contribute to the development of NMO. In a study by Karussis and Petrou,25 the authors reviewed medical literature from 1979 – 2013 and assessed the incidence of central nervous system (“CNS”) demyelinating diseases after vaccination. Pet’r’s Ex. 42 at 1. They found a rather high proportion of “NMO-like disease” associated with influenza and HPV vaccination. Pet’r’s Ex. 42 at 1. While the study found that the overall risk of contracting a demyelinating disorder such as NMO after a vaccination was “relatively low,” the authors noted that in “a very high proportion of the patients (and especially following influenza vaccination) the dominant localizations of demyelination were the optic nerves and the myelin, presenting as optic neuritis and myelitis. This predisposition to the spinal cord and the optic nerves is reminiscent to … the NMO-spectrum of diseases” that are highly associated with anti-aquaporin-4 antibodies. Id. at 2 (emphasis added). The authors further reported that seven patients developed NMO-like disorders subsequent to Gardasil vaccinations, raising the possibility of cross-reactivity between AQP4 and viral proteins. Id. 24 A capsid protein is the protein shell that typically encloses the genetic material of a virus. Dorland’s at 284. 25 Dimitrios Karussis & Panayiota Petrou, The Spectrum of Post-Vaccination Inflammatory CNS Demyelinating Syndromes, 13 AUTOIMMUN. REV. 215 (2014) [Pet’r’s Ex. 42]. 13 Case 1:12-vv-00630-VJW Document 84 Filed 12/07/15 Page 14 of 31 Dr. Tornatore also cited to a study by Fujinami and Oldstone26 which addressed whether the sequence similarity between the L1 protein in HPV and AQP4 is sufficient to induce cross- reactivity. After looking at several demyelinating disorders, the study concluded that homology with as few as six amino acids is sufficient to induce cross-reactivity. Pet’r’s Ex. 28 at 3-4. The authors stated, “Other investigators … have also shown that antibodies recognize as few as six amino acids.” Pet’r’s Ex. 28 at 4. Dr. Tornatore pointed out that the study shows that the immune system may be triggered based on homologies from very small amino acid residues, in rare cases, to cause NMO. Tr. 124. In a study by Souyah et al.,27 Dr. Tornatore opined that the HPV vaccine causes a “forty- fold increase in HPV antibodies” as compared to the antibodies created due to a “natural HPV infection.” Pet’r’s Ex. 48 at 3; Tr. 120. This fact, combined with a “genetic predisposition … to develop vaccine-induced autoimmunity,” could explain why the HPV vaccine may play a role in causing injury via the mechanism of molecular mimicry or “other immune system stimulation mechanisms.” Pet’r’s Ex 48 at 3. At the conclusion of his testimony during the hearing, Dr. Tornatore also referenced a study by Gautam et al.28 The authors injected mice with a viral peptide with homology to myelin basic protein 1-11, which caused the development of experimental autoimmune encephalomyelitis (EAE). Pet’r’s Ex. 40 at 2. The researchers showed that a sequence of only five peptide residues was sufficient to induce an autoimmune response leading to the development of EAE. The authors note, “Since only five native residues in a peptide are sufficient to induce EAE, it is conceivable that a pathogen with homology to self proteins at only a few residues may trigger autoimmune disease.” Pet’r’s Ex. 40 at 3. Dr. Tornatore urged, “This is very, very important and shows that [] very limited homology with very few amino acids can … cause an autoimmune response, [or] molecular mimicry.” Tr. 125. b. Dr. Tornatore’s Other Theories i. Immune System Imbalance Although Dr. Tornatore’s primary theory for how B.K.D. developed NMO from the Gardasil and FluMist vaccines is molecular mimicry, Dr. Tornatore also proposed two other 26 Robert Fujinami & Michael Oldstone, Amino Acid Homology Between the Encephalitogenic Site of Myelin Basic Protein and Virus: Mechanism for Autoimmunity, 230 SCIENCE 1043 (1985) [Pet’r’s Ex. 28] 27 Nizar Souyah et al., Guillain-Barre Syndrome After Gardasil Vaccination: Data from Vaccine Adverse Event Reporting System 2006-2009, 29 VACCINE 886 (2011) [Pet’r’s Ex. 48]. 28 Gautam et al., A Viral Peptide with Limited Homology to a Self Peptide Can Induce Clinical Signs of Experimental Autoimmune Encephalomyelitis, 161 J. IMMUNOL. 60 (1998) [Pet’r’s Ex. 40]. 14 Case 1:12-vv-00630-VJW Document 84 Filed 12/07/15 Page 15 of 31 theories of causation. The first alternative theory proposed by Dr. Tornatore is that of immune system imbalance. Dr. Tornatore referenced the Noorbakhsh report for the principle that viral pathogens can disturb the balance of the immune system causing an autoimmune disorder such as NMO. The Noorbakhsh researchers note: Even in the absence of epitopes common with self-antigens [i.e. homology leading to molecular mimicry], pathogens can cause autoimmunity by perturbing the intrinsic balance of the immune system, the so-called ‘immunoregulatory mechanisms.’ This could take place in the peripheral immune system, leading to a breakdown in the so-called ‘self-tolerance’ to self-antigens. Pet’r’s Ex. 24 at 12. The Menge paper’s authors also posit a mechanism whereby a disturbance of the balance of the immune system could lead to the development of a disorder such as NMO. The authors reported, “An alternative pathogenic concept [in the development of NMO] may be induction of bystander lymphocyte activation by upregulating both the adaptive and innate immune systems as was shown for HPV vaccines.” Pet’r’s Ex. 31 at 2. The authors suggest that a protein found in a vaccine could disrupt the immune system, causing it to lose its inhibitory properties and ultimately result in the development of an autoimmune disorder. Id. ii. Misdirected Immune Response With respect to the second alternative theory of causation, Dr. Tornatore briefly explained that concurrent administration of the Gardasil and FluMist vaccinations could have caused a misdirected immune system response. In reference to such an immune response, Dr. Tornatore stated: There is precedent for this in the animal model experimental [autoimmune] encephalomyelitis. In that model, animals are vaccinated with myelin basic protein mixed in an adjuvant … made to augment the immune response. Four days following dual vaccination, one would reasonably expect that there would be circulating activated lymphocytes that could then cross the blood-brain barrier and result in autoimmune inflammation. Indeed, a routine test for tuberculosis … is a common example of this type of phenomen[on]. Pet’r’s Ex. 21 at 14. 2. Respondent’s Expert, Dr. Leist Dr. Leist is a professor of Neurology at Thomas Jefferson University and serves as the Chief of the Clinical Neuroimmunology Division and the Director of the Comprehensive Multiple Sclerosis Center at Thomas Jefferson University Hospital. Resp’t’s Ex. B at 1. Dr. 15 Case 1:12-vv-00630-VJW Document 84 Filed 12/07/15 Page 16 of 31 Leist also works as a neurology consultant at the Inglis Foundation and is the Director of the Hospital-based Neurology Infusion Service. Id. He graduated with a Ph.D. in biochemistry from the University of Zurich in Zurich, Switzerland, and he completed an M.D. at the University of Miami in Miami, Florida. Id. Dr. Leist is certified by the American Board of Psychiatry and Neurology, and he is a member of the American Medical Association, the American Academy of Neurology, the Society for Neuroimmunology, and the Society for Neurovirology. Id. at 1-2. Additionally, he has served as an advisor to the Vaccine Injury and Compensation Program for over ten years. Dr. Leist has written numerous peer-reviewed articles, book chapters, and abstracts on different facets of MS, and he has been invited to give lectures about the development of MS research around the world. Id. at 2-10. Dr. Leist has participated in a number of clinical trials on MS and optic neuritis. Id. at 10-11. Dr. Leist opined that petitioner had not met her burden of presenting a preponderant medical theory causally connecting the Gardasil and FluMist vaccinations that B.K.D. received with her onset of NMO. Resp’t’s Ex. A at 1. Dr. Leist first testified that while molecular mimicry is a real phenomenon, it could not have led to B.K.D.’s development of NMO. Dr. Leist also testified that the co-administration of the third round of Gardasil and the FluMist vaccine could not have had any impact on the development of NMO. a. Arguments Against Molecular Mimicry Dr. Leist agreed that sequence homologies as described by Dr. Tornatore can be frequently found. Resp’t’s Ex. A at 10; Tr. 185. Dr. Leist introduced a paper by Albert and Inman29 to demonstrate the frequency of sequence homologies. Resp’t’s Ex. C at 2-3; Tr. 179. The authors explain: The development of peptide-sequence data bases has resulted in the identification of many linear sequences of amino acids shared by organisms and humans, but many of these sequences lack any clinical correlation. Furthermore, it has been calculated that, on the basis of chance alone, up to 10 perfect matches can be found in protein-sequence data bases for a sequence of [five] amino acids. Resp’t’s Ex. C at 2-3. However, Dr. Leist disagreed as to the significance of sequence homologies. Citing the Kohm30 and Albert and Inman articles, Dr. Leist argued that if the “short-sequence homologies alone [were] sufficient to cause autoimmune disease, then [the] diseases [would] be very [] frequent.” Tr. 180. Specifically with respect to petitioner’s theory of causation, Dr. Leist testified that “showing a sequence homology or 29 Lori Albert & Robert Inman, Molecular Mimicry and Autoimmunity, 341 NEW ENG. J. MED. 2068 (1999) [Resp’t’s Ex. C]. 30 Adam Kohm et al., Mimicking the Way to Autoimmunity: An Evolving Theory of Sequence and Structural Homology, 11 TRENDS IN MICROBIOLOGY 101 (2003) [Pet’r’s Ex. 43]. 16 Case 1:12-vv-00630-VJW Document 84 Filed 12/07/15 Page 17 of 31 … conformational homology between one protein and another protein alone is not sufficient to … prove that this is now causing an autoimmune disease.” Tr. 180-81. Turning to petitioner’s medical literature in support of molecular mimicry, Dr. Leist pointed out that the Menge study did not confirm cross reactivity on the basis of serologic testing in patients with NMO. See Tr. 182; Pet’r’s Ex. 31 at 1. Dr. Leist explained that the authors tested the capsid protein of HPV-1 to see whether it cross-reacted with AQP4 in patients with NMO, but the majority of patients did not have antibodies against the capsid proteins on HPV-1, meaning that the disorder was likely not the result of molecular mimicry in those patients. See Pet’r’s Ex. 31 at 1-2; Tr. 182-83. Moreover, Dr. Leist opined that the Menge study was not based on reliable data, as it was merely a collection of cases from the VAERS database. He argued, “[T]he Menge article is nothing but the collection of case reports” and thus its findings are not based on epidemiologic data.” Tr. 214-15. In summary, Dr. Leist urged: [I]f we look at the sequence homology as discussed by Menge [] and view this in the context of the NMO situation … in my way of looking at this article, the sequence homology has been described, NMO has been observed, but the two events have not been linked beyond a temporal association. Tr. 185. Dr. Leist admitted, however, that the theory that NMO could be caused by molecular mimicry is not totally implausible. He testified, “[Molecular mimicry] could be a potential theory by which one could think … that [NMO] … could be caused. [But] sequence homology, in itself, is only one of the building blocks by which ultimately the molecular mimicry would … generate the disease.” Tr. 204. Although Dr. Leist disagreed with Dr. Tornatore that molecular mimicry was the causal mechanism of B.K.D.’s development of NMO, he nonetheless acknowledged that molecular mimicry and sequence homology are real medical phenomena. Tr. 177. Dr. Leist also referenced findings from the Institute of Medicine’s Committee to Review Adverse Effects of Vaccines31 (“IOM”) to support his position that B.K.D.’s NMO was not caused by either the Gardasil or the FluMist vaccine. The IOM reported, “No studies were identified in the literature for the Committee to evaluate the risk of neuromyelitis optica (NMO) after the administration of HPV vaccine . . . . The epidemiological evidence is insufficient or absent to assess an association between HPV vaccine and NMO.” Resp’t’s Ex. I at 6. Dr. Leist opined that NMO is not caused by the HPV vaccine, as the IOM was unable to find an association between the two. Resp’t’s Ex. I at 6. 31 Kathleen Stratton, “Evaluating Biological Mechanisms of Adverse Events,” in Institute of Medicine, Adverse Effects of Vaccines: Evidence and Causality 51 (Stratton et al., eds. 2011) [Resp’t’s Ex. I]. 17 Case 1:12-vv-00630-VJW Document 84 Filed 12/07/15 Page 18 of 31 Furthermore, Dr. Leist disputed the relevance of the medical literature on which Dr. Tornatore relied to support his opinions. See Resp’t’s Ex. A at 10 (referencing Pet’r’s Exs. 21, 23, 25 and 32). Dr. Leist’s expert report references studies by Tenembaum et al.32 and Johnson,33 which petitioner offered to show that the development of ADEM can follow a vaccination. See Pet’r’s Ex. 21 at 11-12; Pet’r’s Ex. 25 at 1; Pet’r’s Ex. 23 at 1. Dr. Leist stated that B.K.D. never suffered from ADEM and thus, the Tenembaum and Johnson studies were irrelevant in B.K.D.’s case.34 He stated, “I think that the Tenembaum report does not really provide evidence of association with a particular infection or infections and ADEM beyond temporality.” Tr. 189-90. Dr. Leist also opined that Dr. Tornatore’s reference to the Schonberger et al. study35 showing that GBS is often preceded by an influenza vaccination was also irrelevant, as B.K.D. was never diagnosed with GBS. Resp’t’s Ex. A at 10; (referencing Pet’r’s Ex. 32 at 1). However, Dr. Tornatore’s references to the Tenembaum, Johnson, and Schonberger studies were not determinative of the outcome in this case, nor were they central to the petitioner’s causal theory, and thus the undersigned does not find Dr. Leist’s argument persuasive on this point. b. Arguments Against Petitioner’s Alternative Theories With respect to Dr. Tornatore’s theory that the Gardasil and FluMist vaccinations caused an imbalance of B.K.D.’s immune system, Dr. Leist stated that the Noorbakhsh study which Dr. Tornatore referenced in support of this second theory was not applicable to B.K.D.’s situation because it focused on ADEM, rather than NMO. Resp’t’s Ex. A at 10. Specifically with respect to the Noorbakhsh study, Dr. Leist opined, “It is my opinion that [B.K.D.] did not suffer from ADEM … [This article] is therefore not related to this case.” Id. Dr. Leist’s also addressed Dr. Tornatore’s third causative theory regarding the co- administration of the Gardasil and FluMist vaccinations causing B.K.D. to experience a 32 Silvia Tenembaum et al., Acute Disseminated Encephalomyelitis: A Long-Term Follow-Up Study of 84 Pediatric Patients, 59 NEUROLOGY 1224 (2002) [Pet’r’s Ex. 25]. 33 Richard Johnson, The Pathogenesis of Acute Viral Encephalitis and Postinfectious Encephalomyelitis, 155 J. INFECTIOUS DISEASES 359 (1987) [Pet’r’s Ex. 23]. 34 As B.K.D. was initially diagnosed with ADEM, the parties initially disputed whether B.K.D. suffered from ADEM prior to her onset of NMO. See Pet’r’s Ex. 4 at 7. However, the parties later agreed that B.K.D.’s correct initial diagnosis was NMO or an NMO spectrum disorder and that she never suffered from ADEM. Tr. 51. 35 Lawrence Schonberger et al., Guillain-Barre Syndrome Following Vaccination in the National Influenza Immunization Program, United States, 1976-1977 110 AM. J. EPIDEMIOLOGY 105 (1979) [Pet’r’s Ex. 32]. 18 Case 1:12-vv-00630-VJW Document 84 Filed 12/07/15 Page 19 of 31 misdirected immune response. See Resp’t’s Ex. A at 11. Dr. Leist referenced a study by Martinón-Torres et al.,36 which analyzed various safety concerns associated with the co- administration of pediatric vaccinations and found a “favorable safety profile in both infants and toddlers.” Resp’t’s Ex. F at 7. However, the study did not provide any information on the Gardasil or FluMist vaccines. Dr. Leist stated, “While HPV was not included in the [Martinón- Torres] study, the authors did not report occurrence of unexpected side effects resulting from multiple vaccine administrations at a time.” Resp’t’s Ex. A at 11. 3. Evaluation of the Evidence The undersigned evaluates the parties’ respective experts’ opinions based on the record as a whole. Snyder v. Sec’y of Health & Human Servs., 88 Fed. Cl. 706, 742-43 (Fed. Cl. 2009) (citing General Electric Co. v. Joiner, 522 U.S. 136, 146 (1997)). The undersigned finds that there is preponderant evidence in the record to demonstrate that the Gardasil and FluMist vaccinations led to B.K.D.’s development of NMO through the mechanism of molecular mimicry. In support of his theory, Dr. Tornatore used the Menge study to show that there is sequence homology between HPV types 16 and 18 and AQP4. Pet’r’s Ex. 31 at 2 (referencing Table 1); Tr. 111. This sequence homology demonstrates the potential for cross-reactivity to occur. Pet’r’s Ex. 31 at 2. Dr. Leist testified that if frequently occurring short sequence homologies were sufficient to induce an autoimmune reaction, then there would be a high incidence of autoimmune disorders in the general population. Tr. 180. However, Dr. Leist did not address Dr. Tornatore’s explanation of why people only rarely develop autoimmune disorders due to sequence homology that then results in molecular mimicry. According to Dr. Tornatore, “[It is] possible that [a person] could be vaccinated and have antibodies to L1 but [that] those antibodies are not directed against these little fragments [on the HPV antigen] … Some people are going to develop immunity to different parts of the L1 molecule … that [will] never … cross-react with aquaporin-4.” Tr. 112. In addition to his opinion that the sequence similarity between L1 and AQP4 was sufficient to induce cross-reactivity and cause B.K.D. to develop NMO, Dr. Tornatore cited studies by Karussis and Petrou, Gautam, and Fujinami & Oldstone demonstrating that the sequence similarity between L1 and AQP4 is sufficient to induce cross reactivity. Pet’r’s Ex. 42 at 2 (assessing the incidence of NMO after HPV vaccination and concluding that there was a possibility of cross-reactivity between L1 and AQP4); Pet’r’s Ex. 40 at 3 (finding that “it is conceivable that a pathogen with homology to self proteins at only a few residues may trigger autoimmune disease”); Pet’r’s Ex. 28 at 3-4 (addressing whether the sequence similarity is sufficient to induce cross-reactivity between L1 and AQP4); Tr. 116. 36 Federico Martinón-Torres et al., 13-Valent Pneumococcal Conjugate Vaccine Given with Meningococcal C-Tetanus Toxoid Conjugate and Other Routine Pediatric Vaccinations: Immunogenicity and Safety, 31 PEDIATRIC INFECTIOUS DISEASE J. 392 (2012) [Resp’t’s Ex. F]. 19 Case 1:12-vv-00630-VJW Document 84 Filed 12/07/15 Page 20 of 31 Therefore, the undersigned finds that petitioner has provided preponderant evidence that the Gardasil and FluMist vaccinations can cause NMO via molecular mimicry. Accordingly, petitioner has satisfied Althen Prong One. ii. Althen Prong Two: Logical Sequence of Cause and Effect Under Althen Prong Two, petitioner must prove “a logical sequence of cause and effect showing that the vaccination was the reason for [B.K.D.’s] injury.” Althen, 418 F.3d at 1278. This requires petitioner to show by preponderant evidence that the vaccines B.K.D. received actually caused the alleged injury. Pafford, 451 F.3d at 1354. Petitioner need not make a specific type of evidentiary showing. That is, petitioner is not required to offer “epidemiologic studies, re-challenge, the presence of pathological markers or genetic disposition, or general acceptance in the scientific or medical communities to establish a logical sequence of cause and effect.” Capizzano v. Sec’y of Health & Human Servs., 440 F.3d 1317, 1325 (Fed. Cir. 2006). Instead, petitioner may satisfy her burden by presenting circumstantial evidence and reliable medical opinions. See id. at 1325-26. 1. Petitioner’s Expert, Dr. Tornatore a. Logical Sequence of Cause and Effect Dr. Tornatore opines that there is a logical sequence of cause and effect between the Gardasil and FluMist vaccinations B.K.D. received and her subsequent development of NMO. Pet’r’s Ex. 21 at 10-11; Tr. 127-30. Dr. Tornatore discussed the onset of B.K.D.’s NMO in three phases. In phase one, B.K.D. received two previous Gardasil vaccinations in January and May 2011. Dr. Tornatore explained that B.K.D.’s immune system would have responded to the antigens found in these first two Gardasil vaccinations. Pet’r’s Ex. 21 at 11. However, Dr. Tornatore clarified that these first two Gardasil vaccinations did not lead to the development of NMO because the antibody titers that developed as a result of the vaccine were too low and thus the immune response was not sufficient to lead to the onset of NMO symptoms. Tr. 128. After B.K.D. received the third Gardasil vaccination on September 28, 2011, Dr. Tornatore explained that her immune system developed an immediate response to the HPV antigens. During this immune response, autoimmune antibodies were directed to the L1 protein found in the HPV vaccine, and those antibodies “very quickly [found] the homology in aquaporin-4 in the nervous system, and so those antibodies hone[d] in on that area, and then they start[ed] to cause inflammation … initially in the lower thoracic [area].” Tr. 128. The immune system’s timely response to the HPV antigens thus resulted in B.K.D.’s initial symptom onset of abdominal pain on October 1, 2011. Tr. 128; Pet’r’s Ex. 21 at 11. In phase two of his causation theory, Dr. Tornatore detailed the progression of B.K.D.’s symptoms. Pet’r’s Ex. 2 at 176. He explained that B.K.D.’s abdominal pain was caused by inflammation of her spinal cord. Pet’r’s Ex. 21 at 11. Dr. Tornatore stated: 20 Case 1:12-vv-00630-VJW Document 84 Filed 12/07/15 Page 21 of 31 The spinal cord inflammation was due to an immune response directed at antigens in the spinal cord with homology to the antigens found on the HPV vaccine (molecular mimicry). Indeed, [B.K.D.] had antibodies to aquaporin-4 antigens (NMO antibodies), [] which have homology with human papilloma virus … It is highly probable that the inflammatory lesions seen on the MRI of the brain may have occurred during this time frame as well, however, they were in non-eloquent areas of the brain and [did not cause symptoms]. Pet’r’s Ex. 21 at 11. Dr. Tornatore’s testimony connected B.K.D.’s NMO symptom onset approximately three days after receiving the Gardasil and FluMist vaccinations with the clinical symptoms of abdominal pain and generalized aches that she reported experiencing at that time. In the third phase of his theory, Dr. Tornatore reported that three and a half weeks after receiving the vaccinations, B.K.D. developed inflammation in her spinal cord, which resulted in weakness in her lower extremities. Pet’r’s Ex. 21 at 11. Dr. Tornatore opined that this acute inflammation is reflected in B.K.D.’s November 2, 2011 spinal MRI. See Pet’r’s Ex. 4 at 93. Dr. Tornatore stated that the MRI of the spine shows that B.K.D.’s NMO could not have been caused by her strep infection37 in late October 2011. He reported, “The previous areas of inflammation in the lower thoracic spine and brain did not enhance with gadolinium, consistent with inflammatory areas that were several weeks old, clearly preceding the strep infection that [B.K.D.] was diagnosed with on [October 31, 2011].” Pet’r’s Ex. 21 at 11. According to Dr. Tornatore, the approximate onset of NMO can be deduced by reviewing B.K.D.’s MRIs of the brain and spine concurrently with her progression of symptoms. The MRI findings on November 2, 2011, conclusively demonstrate that the onset of NMO occurred around the first week of October, shortly after B.K.D. received the Gardasil and FluMist vaccinations. Tr. 128- 29. Although Dr. Tornatore spent a great deal of time during the hearing discussing how the Gardasil vaccination caused B.K.D.’s NMO, he also discussed how the FluMist vaccination could have created the immune response. Dr. Tornatore testified, “And the same thing … [goes for] the FluMist [vaccination] … the antigens on that virus may trigger the immune system, and that then causes the inflammation in the spinal cord, and then … [you] release antigens, you have epitope spreading,38 [] you develop antibodies against aquaporin-4, and you may get the full- blown NMO developing.” Tr. 132. 37 Respondent’s expert agrees that B.K.D.’s strep infection was not the cause of her NMO. Tr. 176-78. 38 With regard to the phenomena of “epitope spreading”, Dr. Tornatore analogized, “[I]f you have a cabinet and it catches fire, if you put it out very quickly, you’ll only get a little char on the outside of the cabinet. If, on the other hand, the inflammation continues, the top of the cabinet may get burnt [sic] away, and now you can look inside, and you can see the utensils inside the drawer. So, those antigens that were hidden are now exposed, and then you could develop an immune response against that. And so that’s what we call epitope spreading. The more the 21 Case 1:12-vv-00630-VJW Document 84 Filed 12/07/15 Page 22 of 31 b. B.K.D.’s Genetic Predisposition to Autoimmune Disorders Dr. Tornatore also discussed how B.K.D.’s family history of autoimmunity may have predisposed her to develop an autoimmune disease from a vaccination. Tr. 131. The medical record documents that several of B.K.D.’s family members have suffered from autoimmune disorders. B.K.D.’s paternal grandmother suffered from rheumatoid arthritis and Graves’ disease,39 her father had Crohn’s disease,40 her brother currently suffers from a seizure disorder, and a paternal cousin has MS. Pet’r’s Ex. 57 at 19; Pet’r’s Ex. 3 at 4. Dr. Tornatore stated that a family history of autoimmunity suggests a genetic predisposition to the development of other autoimmune disorders. He testified, “Clearly, there are genes that are predisposing her family to autoimmunity, [so] that their immune system is more likely to attack self-antigens” than someone else’s immune system. Tr. 130. He stated that the exact genetic process is unknown but that there are a few theories of how a person’s genetic makeup can affect her autoimmunity. According to Dr. Tornatore: [S]omehow [a person’s genes] either release[] the inhibition of … white blood cells so that they [are] not kept down or they may in some way play a role in activating one’s immune system in the right type of antigen presentation. So, a family history of autoimmunity would suggest that [B.K.D.] was at risk for developing an autoimmune disease in the right setting. Tr. 131. Thus, Dr. Tornatore explained that because several other people in B.K.D.’s immediate family have experienced issues with autoimmune disorders, it is likely that B.K.D. would be more likely to develop an autoimmune disorder than the average person. In conclusion, Dr. Tornatore summarized, “[T]he … FluMist, in combination with the Gardasil, in the right timing, with the third dose of Gardasil, in the right person, with the right genetic background, [it] may have been [a] perfect storm that … then caused the NMO to develop.” Tr. 130-31. inflammation goes on, the more immunity you develop against many different things, because now they’re exposed where they previously weren’t.” Tr. 132-33. 39 Graves’ disease is an autoimmune disorder that affects the thyroid. Although the exact cause of the disease is still unknown, disease onset is believed to be genetic. The disease occurs when antibodies cause the thyroid gland to produce excess hormones, causing hyperthyroidism. Robert Kliegman et al., Nelson Textbook of Pediatrics 1909-11 (19th ed. 2011). 40 Crohn’s disease is a chronic inflammation of the bowel caused by a combination of environmental, bacterial, and immune factors. Although Crohn’s has not been classified as an autoimmune disorder, it is believed that the immune system directs itself against microbial antigens found in the gastrointestinal tract, thus resulting in inflammation. Nelson at 1300-03. 22 Case 1:12-vv-00630-VJW Document 84 Filed 12/07/15 Page 23 of 31 2. Respondent’s Expert, Dr. Leist While Dr. Leist agreed with Dr. Tornatore that B.K.D. suffers from NMO, he argued that NMO is an idiopathic disorder. See Tr. 187. He then turned to a discussion of B.K.D.’s potential genetic predisposition to autoimmune disorders, arguing that her genetic predisposition, rather than the Gardasil or FluMist vaccinations, led to her onset of NMO. Dr. Leist also stated that B.K.D.’s family history of autoimmune disorders and her juvenile arthritis,41 which could have potentially been an early manifestation of an autoimmune disease, show that B.K.D. could have developed NMO due to a genetic predisposition toward autoimmune diseases and not because she received the Gardasil and FluMist vaccinations. Tr. 200. Dr. Leist referenced a paper by McKeon et al.,42 which studied serologic evidence from individuals with multiple autoimmune disorders. Resp’t’s Ex. G at 2. The study tested children whose sera were positive for the NMO-IgG antibody to determine whether coexisting auto- antibodies were also present. Out of 75 total children with NMO-IgG antibodies, 57 showed additional auto-antibodies and 16 out of 38 children had an additional, co-existing autoimmune disease, including juvenile rheumatoid arthritis and Grave’s disease. Id. Dr. Leist pointed out that as a child, B.K.D. may have had symptoms consistent with juvenile rheumatoid arthritis, which is classified as an autoimmune condition. See Pet’r’s Ex. 3 at 4; Tr. 200. Dr. Leist conceded, however, that his opinion in the case “is not dependent on the presence of another autoimmune disease.” Tr. 200. 3. Evaluation of the Evidence Dr. Tornatore’s opinion regarding a logical sequence of cause and effect is pursuasive and is supported by B.K.D.’s medical records. Dr. Tornatore opined that the Gardasil and FluMist vaccinations B.K.D. received on September 28, 2011, initiated a brisk immune response to specific antigens found in the Gardasil vaccine through the process of molecular mimicry. Petr’s Ex. 21 at 11. Dr. Tornatore noted, “[O]ne of the most interesting pieces of information regarding the timing of [B.K.D.’s] symptom onset is her MRIs of the brain and spine done November 2, 2011, which correlate precisely with her symptoms.” Pet’r’s Ex. 21 at 14. Dr. Tornatore opined that B.K.D.’s spinal MRI on November 2, 2011, showed an area of inflammation in the spinal cord from T9 to T12, consistent with B.K.D.’s complaints of “band- like” abdominal pain in early October. Pet’r’s Ex. 21 at 14; Tr. 89. The inflammation of the thoracic spinal cord caused B.K.D.’s abdominal discomfort and the back pain. Tr. 94. 41 Petitioner testified during the hearing that B.K.D. never suffered from juvenile rheumatoid arthritis. Tr. 7. Petitioner stated that when B.K.D. was two years old, she once complained of leg pain, but after she was evaluated by a chiropractor, B.K.D. never experienced further episodes. Id. 42 A. McKeon et al., CNS Aquaporin-4 Autoimmunity in Children, 71 NEUROLOGY 94 (2008) [Resp’t’s Ex. G]. 23 Case 1:12-vv-00630-VJW Document 84 Filed 12/07/15 Page 24 of 31 B.K.D.’s MRI of her spine on November 2, 2011, showed a relatively new inflammation of her upper cervical spine, which would explain why she began experiencing head and neck pain as well as leg weakness on October 31, 2011. Tr. 89-90; Pet’r’s Ex. 2 at 190; Pet’r’s Ex. 4 at 11, 13. Dr. Tornatore summarized, “[B.K.D.’s] MRI[s] [are] a beautiful, beautiful ability for us to look back in time” and see a clinical picture of the onset and progression of [B.K.D.’s] NMO after she received the Gardasil and FluMist vaccinations. Tr. 91. Dr. Leist agreed with B.K.D.’s diagnosis of NMO, but he opined that the vaccinations she received on September 28, 2011, could not have caused the initial symptoms of NMO that she developed three days later. Resp’t’s Ex. A at 7-8. In refutation of Dr. Tornatore’s theory of causation, Dr. Leist stated that the precise cause of NMO is unknown. Tr. 187. Dr. Leist suggested that BKD’s NMO was an “underlying condition [that] was already ongoing …” and could have been due to a genetic predisposition to autoimmune disorders. Tr. 225; Resp’t’s Ex. A at 9-10. Dr. Leist did not refute the interpretation of B.K.D.’s MRIs by Dr. Tornatore. Instead, he focused on the fact that NMO is currently classified as an idiopathic disorder. Tr. 188-89. Dr. Leist also emphasized, “[B.K.D.] may carry a diagnosis of juvenile rheumatoid arthritis, an autoimmune condition.” Resp’t’s Ex. A at 9. Both experts agree that BKD may have been predisposed to developing autoimmune disease. Dr. Tornatore stated: [E]ssentially, if you have bad genes, then you[r] [body] [is] not going to be able to adequately control [an autoimmune] response, or if your genes are such that … there is an inherent genetic problem in your family, given the … right antigen in the right circumstance, you could then develop an autoimmune process. And … that’s what we feel happened with B.K.D. Tr. 230. For all of the reasons stated above, the undersigned finds that petitioner has shown by preponderant evidence a logical sequence of cause and effect that B.K.D.’s HPV and flu vaccinations caused her to develop NMO. Thus petitioner has satisfied her burden under Althen Prong II. iii. Althen Prong Three: Timing Under Althen Prong Three, petitioner must establish that B.K.D.’s injury occurred within a time frame that is medically appropriate for the alleged mechanism of harm. See Pafford, 451 F.3d at 1358 (“Evidence demonstrating petitioner’s injury occurred within a medically acceptable time frame bolsters a link between the injury alleged and the vaccination at issue under the ‘but-for’ prong of the causation analysis.”). Petitioner may meet her burden by showing: (1) when the condition for which she seeks compensation first appeared after vaccination, and (2) that the period of symptom onset is “medically acceptable to infer causation.” Shapiro v. Sec’y of Health & Human Servs., No. 99-552V, 2011 WL 1897650, at *13 (Fed. Cl. Spec. Mstr. Apr. 27, 2011), granting in part, vacating in part, 101 Fed. Cl. 532 24 Case 1:12-vv-00630-VJW Document 84 Filed 12/07/15 Page 25 of 31 (2011); aff’d, 503 F. App’x 952 (2013) (per curiam). The appropriate temporal association will vary according to the particular medical theory advanced in the case. See Pafford, 451 F.3d at 1358. 1. Petitioner’s Expert, Dr. Tornatore a. Sufficient Period of Time Between Vaccination and Onset of NMO The medical records demonstrate that three days after B.K.D. received the Gardasil and FluMist vaccinations, she began experiencing symptoms consistent with the initial onset of NMO, including abdominal pain, lack of bowel movement, and generalized aches. Pet’r’s Ex. 2 at 178.43 Dr. Tornatore testified that the timing of B.K.D.’s third round of Gardasil and FluMist vaccinations on September 28, 2011, and B.K.D.’s initial symptoms on October 1, 2011, sufficiently demonstrates a proximate temporal relationship between the vaccinations and B.K.D.’s subsequent development of NMO. Dr. Tornatore cited medical literature to support his opinion that the time period between a vaccination and NMO symptom onset can be anywhere from two to 42 days. Tr. 138. He first referenced a report published by the IOM44 discussing the latency period between antigen exposure and immune response. The report describes the latency period between vaccination and initial symptom presentation as the “lag phase.” Pet’r’s Ex. 47 at 1. The IOM report explains: The lag phase is characterized by the initial activation of B and T cells upon encounter with the antigen for which they are specific, and this triggers the cells’ differentiation into effector and memory cells.45 The lag phase between primary exposure to an antigen and the logarithmic phase is classically thought to be four to seven days, but it varies depending on route of exposure and the antigen itself. Id. at 1. Although the IOM study shows a lag phase beginning at four to 10 days, Dr. Tornatore stated that because B.K.D. had received two prior Gardasil vaccinations, her immune system’s 43 The parties do not dispute that B.K.D. first showed symptoms of an illness on October 1, 2011, three days after she received the HPV and FluMist vaccinations. Joint Pre-hearing Submission, filed May 15, 2015, at 1. 44 Adverse Effects of Vaccines at 51 (Stratton et al., eds. 2012). 45 The author previously explained, “Antigen exposure initiates an array of reactions involving the immune system, including the activation of white blood cells called lymphocytes that fight infection. After antigen exposure, two types of lymphocytes, B cells and T cells, differentiate into effector (e.g. antibody-producing B cells and cytotoxic and helper T cells) and memory cells.” Pet’r’s Ex. 47 at 1 (emphasis in original). 25 Case 1:12-vv-00630-VJW Document 84 Filed 12/07/15 Page 26 of 31 primary response to the HPV antigens was much faster. Tr. 134. In fact, the IOM study reports, “Due to the development of memory B and T cells during the primary immune response, the latency between subsequent exposure to the antigen and development of the immune response will usually be shorter. The lag phase is generally one to three days.” Pet’r’s Ex. 47 at 2. Dr. Tornatore opined that because B.K.D. had twice been exposed to the HPV antigens, her immune response to the third vaccination was more immediate, making the latency phase much shorter and causing her to develop symptoms of NMO after three days. Tr. 135. Dr. Tornatore also cited a study by Tenembaum et al.46 discussing events preceding ADEM in pediatric patients. See Pet’r’s Ex. 25 at 1. The authors of the study reported that the mean latency period between a vaccination and the subsequent development of ADEM was 12.1 days, with a range of two to 30 days. Id. at 2. Additionally, Dr. Tornatore pointed to the Noorbakhsh study’s findings that the first symptoms of vaccine-induced ADEM can appear “within days to weeks” after vaccination. Pet’r’s Ex. 24 at 1. Similarly, a study of ADEM and MS in children completed by Dale et al.47 found the average latency period between a demyelinating illness and ADEM symptom onset to be between two to 31 days with a mean latency of 13 days. Pet’r’s Ex. 26 at 4. Although the Tenembaum, Noorbakhsh, and Dale articles all referenced ADEM rather than NMO, Dr. Tornatore opined, “the basic concepts in immunology [of ADEM and NMO] are the same, and so I think these [studies] are very applicable to this case.” Tr. 136.48 Dr. Tornatore demonstrated through these articles that B.K.D.’s post-vaccine NMO symptom onset of three days is medically appropriate. Dr. Tornatore also referenced a study published by the Risk Interval Working Group of the Clinical Immunization Safety Assessment Network (“the Risk Interval Working Group”)49 to support his opinion that B.K.D. could have developed NMO three days after receiving the Gardasil and FluMist vaccinations.50 The goal of the Risk Interval Working Group’s project was to calculate “biologically plausible and evidence-based risk intervals” that could be used by other specialists to perform immunization safety research on ADEM and febrile seizures. Pet’r’s Ex. 46 Silvia Tenembaum et al., 59 NEUROLOGY 1224. 47 R.C. Dale et al., Acute Disseminated Encephalomyelitis, Multiphasic Disseminated Encephalomyelitis and Multiple Sclerosis in Children, 123 BRAIN 2407 (2000) [Pet’r’s Ex. 26]. 48 Dr. Tornatore also referenced a second study by Dale et al. regarding the latency period between a vaccination and the symptom onset for NMO. See Pet’r’s Ex. 26. 49 Ali Rowhani-Rahbar et al., Biologically Plausible and Evidence-Based Risk Intervals in Immunization Safety Research, 31 VACCINE 271 (2012) [Pet’r’s Ex. 46]. 50 The undersigned notes that the first page of the Risk Interval Working Group’s study states the following disclaimer, “The findings and conclusions in this report are those of the authors and do not necessarily represent the official position or views of the CDC.” However, as was clarified during the cross-examination of Dr. Leist, one of the Group’s individual participants worked in the CDC’s immunization office, and each of the Group’s members is a well-qualified pediatric and public health specialist. See Tr. 208. 26 Case 1:12-vv-00630-VJW Document 84 Filed 12/07/15 Page 27 of 31 46 at 1-2; Tr. 137-38. The Risk Interval Working Group established primary and secondary risk intervals as follows: [T]wo sets of risk intervals to examine the association between vaccines and ADEM would be appropriate. For determining the likelihood of a role of a vaccine in development of neurologic illness in an individual, an interval of [two to] 42 days that remains biologically plausible but is associated with greater uncertainty, was proposed. For epidemiologic assessments of causality between a particular vaccine and ADEM, a primary short interval of [five to] 28 days was proposed. This interval incorporates the time periods best substantiated by available biological and epidemiologic data. A long period of [two to] 42 days could be used as a secondary risk interval. Pet’r’s Ex. 46 at 4; see also Tr. 138. In summary, Dr. Tornatore testified that NMO could occur three days after vaccination, and he provided medical literature to support his position. b. Treating Physicians Dr. Mattson and Dr. Golomb, two of B.K.D.’s treating physicians, also noted a temporal association between B.K.D.’s receipt of the Gardasil and FluMist vaccinations and her onset of NMO. After reviewing B.K.D.’s November 2, 2011 MRI results, Dr. Golomb noted that B.K.D.’s symptoms began shortly after her receipt of the Gardasil and FluMist vaccinations. Pet’r’s Ex. 4 at 123. Additionally, after Dr. Mattson confirmed that B.K.D. tested positive for the NMO-IgG antibody, he noted, “[B.K.D.] has had an October 2011 episode, [about] a week after vaccinations, involving numbness and tingling with right leg weakness [] [and] gait deterioration …” Pet’r’s Ex. 6 at 13. 2. Respondent’s Expert, Dr. Leist a. Insufficient Period of Time Between Vaccination and NMO Dr. Leist disagreed with Dr. Tornatore that B.K.D. could have developed NMO three days after receiving the Gardasil and FluMist vaccinations. Dr. Leist described the immune response that invades the central nervous system as a “multistep process” which could not be accomplished in such a short time interval.51 Tr. 193. He stated, “The time interval of about three days between vaccinations and onset of a cross-reactive cognate immune response is too brief to cause induction or reactivation of a T and plasma cell as well as antibody dependent 51 Dr. Leist further explained, “[I]n order to have a process within the spinal cord, the immune response needs to be upregulated, there needs to be invasion into the central nervous system, and there needs to be a generation of a … local damage within the central nervous system.” Tr. 193. 27 Case 1:12-vv-00630-VJW Document 84 Filed 12/07/15 Page 28 of 31 immune response leading to involvement of the central nervous system.” Resp’t’s Ex. A at 10- 11. Furthermore, Dr. Leist disputed the relevance of some of the medical literature referenced by Dr. Tornatore regarding an appropriate onset, including the Tenembaum article regarding the onset of post-vaccine ADEM. Dr. Leist commented, “Tenembaum et al. reported in the series of 84 children with ADEM that symptoms arose two to 30 (mean 12.1) days after a preceding event in 74 % of the cases. However, their evaluation of the potential causes did not go beyond temporality.” Resp’t’s Ex. A at 11 (referencing Pet’r’s Ex. 25 at 1). Also, as mentioned above, Dr. Leist also stated that because B.K.D. did not suffer from ADEM, the Tenembaum study was not applicable to her case. Resp’t’s Ex. A. at 12. Additionally, Dr. Leist opined that the study done by the Risk Interval Working Group measuring risk intervals for immunization safety research was insufficient proof of the two to 42 day risk interval. Dr. Leist stated that although the researchers calculated a plausible secondary risk interval of two to 42 days, there was insufficient data to support this position. The Risk Interval Working Group reported: Of 250 publications of ADEM reviewed, nine studies met the inclusion criteria, were deemed to be potentially informative, and were assessed in their entirety for any report of ADEM onset following immunization … Only two studies had explicitly indicated the timing of ADEM onset following immunization … The mean onset of ADEM following immunization was 17 days (range [nine to] 30 days). Pet’r’s Ex. 46 at 3. Accordingly, Dr. Leist stated that the results of the Risk Interval Working Group’s study actually showed that the potential risk interval of three days was highly implausible, given that there were only two studies that explicitly indicated symptom onset. Finally, Dr. Leist pointed out that the Risk Interval Working Group’s study does not reflect the CDC’s official position on vaccine risk intervals, despite the fact that an individual CDC employee was part of the research team. Tr. 192-93. Dr. Leist referenced medical literature by Mannara et al.52 to support his position that three days is an insufficient time interval within which B.K.D. could have developed NMO after receiving the Gardasil and FluMist vaccinations. In the Mannara study, researchers induced experimental autoimmune encephalomyelitis (EAE) in mice by giving them a vaccine with activated EAE; they then measured the latency period between the vaccination and the onset of EAE symptoms. Resp’t’s Ex. H at 1. The mice were injected with T cells in order to speed up their immune systems’ response. Dr. Leist explained, “Instead of inducing an immune response, you actually give the components of an immune response … to [the] mouse.” Tr. 195-96; see also Resp’t’s Ex. H at 3. The study found that even though the mice had already been exposed to EAE activated T cells, they developed the first neurological symptoms of EAE eight days after injection. Resp’t’s Ex. H at 3. 52 Francesco Mannara et al., Passive Experimental Autoimmune Encephalomyelitis in C57BL/6 with MOG: Evidence of Involvement of B Cells, 7 PLOS ONE 1 (2012) [Resp’t’s Ex. H]. 28 Case 1:12-vv-00630-VJW Document 84 Filed 12/07/15 Page 29 of 31 Dr. Leist stated, “This work shows that even when a preformed immune response is present there is a delay in the occurrence of neurologic symptoms.” Resp’t’s Ex. A at 11. Dr. Leist compared B.K.D.’s three day symptom onset with the results from the Mannara study to conclude that the symptoms B.K.D. developed on October 1, 2011, could not have been caused by her Gardasil and FluMist vaccinations. Resp’t’s Ex. A at 11; Tr. 196. 3. Evaluation of the Evidence The undersigned finds that the onset of B.K.D.’s NMO occurred on October 1, 2011, when she began complaining of back and abdominal pain. Prior to that date, B.K.D. had no history of NMO or an NMO spectrum disorder, nor had she ever experienced any serious neurological problems. Petitioner has presented preponderant evidence showing that in rare cases, a person’s immune response after receiving a vaccination can be as short as three days, especially if the body is already primed with the specific viral antigens. Dr. Tornatore opined that a three day time frame from vaccination to the onset of NMO symptoms is medically acceptable given the process of molecular mimicry. The medical literature supports Dr. Tornatore’s opinion that a person can quickly develop an immune response after a vaccination, especially if there have been previous exposures to the same viral antigens. Tr. 135; see also Pet’r’s Ex. 47 at 1; Pet’r’s Ex. 25 at 1; Pet’r’s Ex. 46 at 1-2. Although the lag phase as discussed in the IOM report was most often reported as between four to seven days or between seven to ten days, Dr. Torantore explained that due to B.K.D.’s previous exposure to the HPV antigens, the immune response after the third round of Gardasil and the FluMist vaccination led to a more brisk autoimmune response. Tr. 135; Pet’r’s Ex. 47 at 2. The IOM study reported, “Due to the development of memory B and T cells during the primary immune response, the latency between subsequent exposure to the antigen and development of the immune response will usually be shorter. The lag phase is generally one to three days.” Pet’r’s Ex. 47 at 2. This brisk immune response was also noted in the development of post-vaccinal ADEM, which can occur anywhere from two to 30 days. Pet’r’s Ex. 25 at 2. Dr. Tornatore’s theory that molecular mimicry resulted in B.K.D.’s development of NMO after three days also fits within the second risk interval time frame as established by the Risk Interval Working Group. The Risk Interval Working Group observed that while the primary risk interval for studying adverse reactions to vaccines is approximately five to 28 days, two to 42 days was “biologically plausible” as a secondary risk interval. Pet’r’s Ex. 46 at 4. Moreover, while Dr. Leist opined that such intervals are merely suggested for the study of post- vaccinal neurological disorders, the undersigned finds these suggested intervals persuasive. See Tr. 191-92. Dr. Liest stated that three days was an insufficient time period between vaccination and NMO symptom onset to preponderantly prove a temporal relationship between vaccination and injury in B.K.D.’s case. However, the undersigned notes that Dr. Leist did not sufficiently address Dr. Tornatore’s point that B.K.D.’s immune response had been primed by two earlier doses of the Gardasil vaccination. Dr. Liest simply stated that “even in a situation where there 29 Case 1:12-vv-00630-VJW Document 84 Filed 12/07/15 Page 30 of 31 has been a priming occurring by prior exposure, a representation of the same antigen, if we purport that this causes the disease, will still take time … [and] 72 hours … is too short.” Tr. 196. Respondent did not adequately address petitioner’s argument that the previous receipt of multiple doses of the same viral antigen could speed up the body’s immune response. Moreover, while Dr. Leist cited medical literature in support of his opinion that three days is an insufficient time period by which a person might normally develop NMO in response to a vaccine, the undersigned finds petitioner’s evidence more persuasive. Dr. Leist stated that the Mannara study regarding the development of post-viral encephalomyelitis in mice demonstrates that three days is an insufficient time period for a person to develop visible symptoms of NMO after receiving a vaccine. Tr. 195; Resp’t’s Ex. H at 2. Dr. Leist highlighted the Mannara researchers’ findings that mice injected with activated EAE T cells first exhibited motor symptoms of EAE seven days after vaccination to support his opinion that B.K.D. could not have developed NMO from a vaccine after three days. Resp’t’s Ex. H at 2; Tr. 195-96. However, Dr. Tornatore pointed out how the Mannara article could be construed to support petitioner’s position, because the mice showed non-motor signs of EAE after two days. Resp’t’s Ex. H at 2. Similarly, B.K.D. showed non-motoric signs of NMO three days after her vaccinations. Tr. 234. Dr. Tornatore argued, “[T]his paper … demonstrates that within two days, you can have evidence of an adverse response from a vaccination.” Tr. 234. Two of B.K.D.’s treating physicians documented a temporal association between the vaccines and the onset of illness. Dr. Golomb, one of B.K.D.’s treating physicians at Riley Hospital, reviewed B.K.D.’s November 2, 2012 MRI results with an ADEM expert and noted in B.K.D.’s file that she received the Gardasil and FluMist vaccinations on Thursday53 and then experienced “band-like back pain” on Monday. Pet’r’s Ex. 4 at 123. Dr. Golomb then mentioned that the vaccine response is typically five to 42 days. Id. In June 2012, after B.K.D. experienced several recurring episodes of what was thought to be ADEM, she followed up with Dr. Mattson at the MS Center of Indiana University, where it was first postulated that she suffered from NMO.54 Pet’r’s Ex. 6 at 4-5; Pet’r’s Ex. 21 at 9-10. On June 12, 2012, B.K.D. tested positive for the NMO-IgG antibody, which her physicians noted as consistent with a diagnosis of NMO. Pet’r’s Ex. 6 at 13. Dr. Mattson also reported, “[B.K.D.] has had an October 2011 episode, a week after vaccinations, involving numbness and tingling with right leg weakness [] [and] gait deterioration…” Id. at 4. The undersigned is persuaded by Dr. Tornatore’s argument that B.K.D. could have developed symptoms of NMO three days after receiving the Gardasil and FluMist vaccinations, 53 The undersigned notes that Dr. Golomb’s dates here are incorrect. B.K.D. received the Gardasil and FluMist vaccinations on Wednesday, September 28, 2011, and her symptoms first began on Saturday, October 1, 2011. 54 B.K.D.’s diagnoses progress from viral/bacterial meningitis to ADEM and then from ADEM to NMO. Both Dr. Tornatore and Dr. Leist agree that B.K.D.’s correct diagnosis from the onset of symptoms on October 1, 2011, is NMO. 30 Case 1:12-vv-00630-VJW Document 84 Filed 12/07/15 Page 31 of 31 and petitioner has demonstrated that this three day time frame is medically appropriate. Therefore, petitioner has satisfied her burden of presenting preponderant evidence of Althen Prong Three. IV. Conclusion For the reasons discussed above, the undersigned finds that the petitioner is entitled to compensation because she has provided sufficient evidence that preponderates in her favor. A separate damages order will issue. IT IS SO ORDERED. /s/ Nora Beth Dorsey Nora Beth Dorsey Chief Special Master 31 ================================================================================ DOCUMENT 2: USCOURTS-cofc-1_12-vv-00630-1 Date issued/filed: 2016-02-17 Pages: 2 Docket text: PUBLIC DECISION (Originally filed: 01/27/2016) regarding 91 DECISION Interim Fees Stipulation/Proffer Signed by Chief Special Master Nora Beth Dorsey. (tlf) Copy to parties. -------------------------------------------------------------------------------- Case 1:12-vv-00630-VJW Document 96 Filed 02/17/16 Page 1 of 2 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 12-630V Filed: January 27, 2016 * * * * * * * * * * * * * * * * * * * * * * * * * UNPUBLISHED LAURA DAY as parent and natural * guardian of B.K.D., * * Petitioner, * Chief Special Master Dorsey v. * * * SECRETARY OF HEALTH * Interim Attorneys’ Fees & Costs; AND HUMAN SERVICES, * Reasonable Amount Requested to * which Respondent Does Not Object. Respondent. * * * * * * * * * * * * * * * * * * * * * * * * * * Anne Carrion Toale, Maglio, Christopher & Toale, Sarasota, FL, for petitioner. Gordon Elliot Shemin, U.S. Department of Justice, Washington, D.C., for respondent. INTERIM ATTORNEYS’ FEES AND COSTS DECISION1 On September 24, 2012, Laura Day (“petitioner”) filed a petition for compensation under the National Vaccine Injury Compensation Program (“the Program”),2 as the legal representative of her daughter, B.K.D, in which she alleged that the Gardasil (“HPV”) and FluMist (“influenza”) vaccinations B.K.D. received on September 28, 2011, caused her to develop multiple sclerosis (“MS”). Petition at 3, ¶11. Petitioner further alleged that the vaccinations “actually caused, or, alternatively, significantly aggravated” B.K.D.’s injuries. Id. After the filing of the petition, it was discovered that B.K.D. actually suffers from a rare autoimmune disorder known as neuromyelitis optica (“NMO”) or Devic’s Syndrome, rather than MS. See Petitioner’s (“Pet’r’s”) 1 Because this decision contains a reasoned explanation for the undersigned’s action in this case, the undersigned intends to post this decision on the website of the United States Court of Federal Claims, in accordance with the E-Government Act of 2002, Pub. L. No. 107-347, 116 Stat. 2899, 2913 (Dec. 17, 2002). As provided by Vaccine Rule 18(b), each party has 14 days within which to request redaction “of any information furnished by that party: (1) that is a trade secret or commercial or financial in substance and is privileged or confidential; or (2) that includes medical files or similar files, the disclosure of which would constitute a clearly unwarranted invasion of privacy.” Vaccine Rule 18(b). Otherwise, the entire decision will be available to the public. Id. 2 The Program comprises Part 2 of the National Childhood Vaccine Injury Act of 1986, 42 U.S.C. § 300aa. Case 1:12-vv-00630-VJW Document 96 Filed 02/17/16 Page 2 of 2 Exhibit (“Ex.”) 6 at 13. On November 13, 2015, the undersigned issued a decision finding that petitioner was entitled to compensation. On January 22, 2016, the parties filed a stipulation concerning interim attorneys’ fees and costs. Petitioner requests a total award of interim attorneys’ fees and costs in the amount of $112,500.00. Stipulation at ¶ 4. Respondent does not object to an award in this amount. Id. at ¶ 4. The undersigned finds that petitioner is entitled to an award of interim attorneys’ fees and costs under the unique facts and circumstances of this case. See Butler v. Sec’y of Health & Human Servs., No. 02-1051, 2012 WL 4458203 (Fed. Cl. Spec. Mstr. June 25, 2012) (awarding interim attorneys’ fees and costs over respondent’s objection); Shaw v. Sec’y of Health & Human Servs., 609 F.3d 1372, 1375 (Fed. Cr. 2010) (holding that “[w]here the claimant establishes that the cost of litigation has imposed an undue hardship and that there exists a good faith basis for the claim, it is proper for the special master to award interim attorneys’ fees”); Avera v. Sec’y of Health & Human Servs., 515 F.3d 1343, 1352 (Fed. Cir. 2008). The undersigned finds that paragraphs 4-6 of the stipulation are reasonable and adopts them as the decision of the Court in awarding interim attorneys’ fees and costs, on the terms set forth therein. Accordingly, the undersigned hereby awards a total of $112,500.00 issued in the form of a check payable jointly to petitioner and petitioner’s attorney, Anne Toale of Maglio, Christopher & Toale, for interim attorneys’ fees and costs. In the absence of a motion for review filed pursuant to RCFC Appendix B, the clerk of the court SHALL ENTER JUDGMENT in accordance with the terms of the parties’ stipulation.3 IT IS SO ORDERED. s/Nora Beth Dorsey Nora Beth Dorsey Chief Special Master 3 Pursuant to Vaccine Rule 11(a), entry of judgment is expedited by the parties’ joint filing of notice renouncing the right to seek review. 2 ================================================================================ DOCUMENT 3: USCOURTS-cofc-1_12-vv-00630-2 Date issued/filed: 2016-06-21 Pages: 9 Docket text: PUBLIC DECISION (Originally filed: 05/31/2016) regarding 111 DECISION of Special Master Signed by Chief Special Master Nora Beth Dorsey. (tlf) Copy to parties. -------------------------------------------------------------------------------- Case 1:12-vv-00630-VJW Document 114 Filed 06/21/16 Page 1 of 9 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 12-630V Filed: May 31, 2016 * * * * * * * * * * * * * * * * * * * * * * * * * PUBLISHED LAURA DAY and TODD DAY, as * Guardians of the person and estate of * Case No. 12-630 V B.K.D., * * Petitioners, * Chief Special Master Dorsey * v. * Gardasil (“HPV”); FluMist * (“influenza”); Interim Damages; SECRETARY OF HEALTH * Past Pain and Suffering. AND HUMAN SERVICES, * * Respondent. * * * * * * * * * * * * * * * * * * * * * * * * * * Anne Carrion Toale, Maglio, Christopher & Toale, Sarasota, FL, for petitioner. Gordon Elliot Shemin, U.S. Department of Justice, Washington, DC, for respondent. DECISION AWARDING INTERIM DAMAGES1 On September 24, 2012, Laura Day and Todd Day (“petitioners”) filed a petition for compensation under the National Vaccine Injury Compensation Program2 (“the Program”), as the legal representatives of their daughter, B.K.D., in which they alleged that the Gardasil (“HPV”) and FluMist (“influenza”) vaccinations B.K.D. received on September 28, 2011, caused her to develop multiple sclerosis (“MS”). Petition at ¶¶ 8-9. Petitioners further alleged that the vaccinations “actually caused, or alternatively, significantly aggravated” B.K.D.’s injuries.” Id. 1 Because this decision contains a reasoned explanation for the undersigned’s action in this case, the undersigned intends to post this ruling on the website of the United States Court of Federal Claims, in accordance with the E-Government Act of 2002, 44 U.S.C. § 3501 note (2012)(Federal Management and Promotion of Electronic Government Services). As provided by Vaccine Rule 18(b), each party has 14 days within which to request redaction “of any information furnished by that party: (1) that is a trade secret or commercial or financial in substance and is privileged or confidential; or (2) that includes medical files or similar files, the disclosure of which would constitute a clearly unwarranted invasion of privacy.” Vaccine Rule 18(b). 2 The 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 order to individual sections of the Vaccine Act are to 42 U.S.C. § 300aa. 1 Case 1:12-vv-00630-VJW Document 114 Filed 06/21/16 Page 2 of 9 at ¶ 11. After the filing of the petition, it was discovered that B.K.D. actually suffers from a rare autoimmune disorder known as neuromyelitis optica (“NMO”), or Devic’s Syndrome, rather than MS. See Petitioners’ (“Pet’rs’”) Exhibit (“Ex.”) 6 at 13. On November 13, 2015, the undersigned issued a ruling on entitlement finding that petitioners were entitled to compensation. Ruling on Entitlement dated November 13, 2015 (ECF No. 82). A damages order was entered on the same day. I. Procedural History of Petitioners’ Motion On January 7, 2016, petitioners filed a Motion for Ruling on Entitlement to Interim Damages, outlining the extreme financial hardships that B.K.D.’s family currently faces. Motion for Ruling on Entitlement to Interim Damages (“Pet’rs’ Motion”) dated January 7, 2016 (ECF No. 88). Petitioners stated that B.K.D. has an urgent need for a wheelchair van and ADA- compliant housing. Id. at 1-2. Petitioners further stated that the life care planning process has just begun and could take more than one year to resolve. Id. at 1. Petitioners urged that the parties were likely to agree on the appropriate amounts of pain and suffering and lost earning capacity. Id. at 2. Petitioners also disclaimed any intention to reject any future awards of damages. Id. Respondent filed her response on January 22, 2016, opposing an award of interim damages and arguing that the Vaccine Act does not authorize special masters to issue more than one decision on damages. Respondent’s Response (“Resp’s Resp.”) dated January 22, 2016 (ECF No. 89). A status conference was held on January 28, 2016, during which the parties discussed petitioners’ motion for interim damages. The undersigned noted respondent’s continued objection to an award of interim damages and stated that respondent was not waiving her objection by conferring with petitioners’ counsel to reach an agreement on an appropriate amount of damages. See Scheduling Order dated January 28, 2016 (ECF No. 93). On February 29, 2016, the parties filed status reports in which they agreed that the amount of lost wages is $931,359.63. See Status Reports dated February 29, 2016 (ECF Nos. 98-99). Petitioners also argued that the Court should award $250,000.00 for pain and suffering, as B.K.D. suffers from a debilitating autoimmune disorder, but respondent declined to take a position on the appropriate amount of pain and suffering at that time. See id.3 3 On April 13, 2016, the undersigned issued a scheduling order asking the parties to provide information on whether they could agree to an amount of past unreimbursed expenses. Scheduling order dated April 13, 2016 (ECF No. 104). Petitioners reported that the parties had not yet begun discussing the appropriate amounts to be paid for past unreimbursed expenses. Pet’rs’ Status Report dated April 14, 2016 (ECF No. 105). In a status report filed on April 21, 2016, petitioners stated that they provided their attorney with some receipts for past medical expenses as well as travel and mileage expenses, but the amount of unreimbursed expenses has not been finalized. Pet’rs’ Status Report dated April 21, 2016 (ECF No. 106). 2 Case 1:12-vv-00630-VJW Document 114 Filed 06/21/16 Page 3 of 9 II. Statement of the Issues The first issue presented in petitioners’ motion is whether the statute permits an award of interim damages. Assuming that the statute allows a special master to award interim damages, the second issue is whether this case presents an appropriate circumstance for such an award. The third issue is what type(s) of damages petitioners may receive on an interim basis. The undersigned discusses each of these issues in turn. III. Summary of Petitioners’ Arguments Petitioners assert three main arguments in support of their motion for interim damages. First, petitioners argue that the plain meaning of the Vaccine Act supports multiple awards of damages. Petitioners next argue that multiple damages awards comport with the overall purpose of the Vaccine Act. Finally, petitioners argue that the Federal Circuit has previously allowed awards of interim damages in extreme circumstances. a. Plain Meaning of the Vaccine Act Supports Awarding Interim Damages The Vaccine Act authorizes special masters to determine whether petitioners are entitled to compensation and the amount of such compensation. The Act reads, in relevant part, “A special master to whom a petition has been assigned shall issue a decision on such petition with respect to whether compensation is to be provided under the Program and the amount of such compensation.” § 300aa-12(d)(3). Petitioners argue that where the Vaccine Act refers to “a” decision, the Congressional rules of statutory construction allow the word “a” to be interpreted as “several.” Pet’rs’ Proposed Order at 4. The Congressional rules provide that “in determining the meaning of any Act of Congress, unless the context indicates otherwise – words importing the singular include and apply to several persons, parties, or things.” See id. at 4 (quoting 1 U.S.C. § 1). Petitioners thus argue that the language of the Vaccine Act does not prohibit special masters from issuing multiple awards of damages. b. Overall Purpose of the Vaccine Act Supports Awarding Interim Damages Petitioners next argue that an award of interim damages comports with the overall purpose of the Vaccine Act. Petitioners urge that a statute should be construed consistent with its Congressional intent. Pet’rs’ Proposed Order at 5 (citing Saunders v. Sec’y of Health & Human Servs., 25 F.3d 1031, 1036 (Fed Cir. 1994); Doyon, Ltd. v. United States, 214 F.3d 1309, 1314 (Fed. Cir. 2010); see also Cloer v. Sec’y of Health & Human Servs., 675 F.3d 1358, 1362 (Fed. Cir. 2012) (noting the Vaccine Act should be constructed in a manner that effectuates its underlying spirit and purpose)). Petitioners emphasize that Congress’ intent in passing the Vaccine Act was to compensate vaccine-injured individuals “quickly, easily, and with certainty and generosity.” Id. (citing H.R. Rep. 99-908 (1986)). Petitioners argue that interpreting the Act so as to permit multiple awards of interim damages gives effect to this Congressional intent. Id. 3 Case 1:12-vv-00630-VJW Document 114 Filed 06/21/16 Page 4 of 9 c. Previous Federal Circuit Rulings Support Awarding Interim Damages Petitioners next highlight several Federal Circuit rulings which have permitted multiple damages awards in Program cases, arguing that these cases support an award of interim damages in B.K.D.’s case. Petitioners argue that Avera, which allowed multiple awards of attorneys’ fees and costs, supports multiple damages awards, because awarding fees and costs is procedurally similar to awarding damages. Pet’rs’ Proposed Order at 6 (discussing Avera v. Sec’y of Health & Human Servs., 515 F.3d 1343 (Fed. Cir. 2008). Petitioners further argue that the Federal Circuit authorized multiple elections to accept damages in both Heinzelman and Tembenis. Id. (citing Heinzelman v. Sec’y of Health and Human Servs., 681 F.3d 1374 (Fed. Cir. 2012) (granting petitioner’s motion for interim damages)); Tembenis v. Sec’y of Health and Human Servs., 733 F.3d 1190 (Fed. Cir. 2013) (awarding an uncontested amount of interim damages)). IV. Summary of Respondent’s Arguments Respondent argues that an award of interim damages is improper for three main reasons. First, respondent contends that the language of the Vaccine Act does not permit special masters to award interim damages. Resp’s Resp. at 1. Respondent next argues that interim fee awards, though permitted by the Federal Circuit in Avera, are procedurally different from interim damages awards, because petitioners are not required to file an election to accept judgment for awards of interim fees. Id. at 2. Finally, respondent argues that Heinzelman and Tembenis are non-precedential and procedurally different, and thus they do not constitute the Federal Circuit’s “approval” of interim damages. Id. at 3-4. a. Language of the Vaccine Act Does Not Permit Interim Awards Respondent first argues that the language of the Vaccine Act only contemplates a single judgment and does not allow flexibility for multiple damages decisions. Resp’s Resp. at 2. The Secretary argues, “Indeed, a single damages decision leads to a single judgment, and a single election, a proposition that makes perfect sense given that the Act requires a special master to informally adjudicate the petition within 240 days … and [the Program] is designed to work faster … than the civil tort system.” Id. (citing 42 U.S.C. §300aa-12(d)(3); Shalala v. Whitecotton, 514 U.S. 268, 269 (1995) (citing H.R. Rep. No.99-908, at 3-7)). Respondent also observes that the Office of Special Masters is a “creature of statute” and is thus required to interpret the Vaccine Act according to the will of Congress and at the direction of the Federal Circuit. Resp’s Resp. at 2 (quoting Patton v. Sec’y of Health & Human Servs., 25 F.3d 1021, 1027 (Fed Cir. 1994). b. Procedural Differences Between Interim Fee and Interim Damages Awards Make Interim Damages Inappropriate Respondent contends that contrary to the special master’s reasoning in Lerwick v. Sec’y of Health & Human Servs., No. 06-847V, 2014 WL 1897656 (Fed. Cl. Spec. Mstr. April 16, 2014) (awarding interim damages), interim fee awards are procedurally distinguished from interim damages awards because petitioners are not required to file an election to accept the judgment of an award of interim attorneys’ fees. Resp’s Resp. at 2, 4. The Secretary points to 4 Case 1:12-vv-00630-VJW Document 114 Filed 06/21/16 Page 5 of 9 an earlier order from the Federal Circuit for the proposition that “[a]ttorneys’ fees, and the judgments allowing them, are wholly separate matters from the compensation payable to vaccine-injured individuals for their vaccine-related injury.” Resp.’s Resp. at 2-3; (citing Saunders v. Sec’y of Health & Human Servs., 25 F.3d 1031, 1034-35 (Fed. Cir. 1994) (internal quotations omitted)). c. Procedural Differences in Federal Circuit Decisions Make Awarding Interim Damages Inappropriate Finally, respondent argues that neither Heinzelman nor Tembenis constitutes the Federal Circuit’s approval of interim damages awards, as they were non-precedential orders decided under different procedural circumstances. Resp’s Resp. at 3. The Secretary urges that neither order states that special masters have the power to issue interim damages awards and that both cases in which the Federal Circuit allowed petitioners to receive interim damages were on appeal after all damages proceedings had been concluded. Id. Respondent further argues that “the underlying premise … in Tembenis and Heinzelman – that an election as to one judgment binds the petitioner to accept all subsequent judgments – is subject to question.” Id. at 4. The Secretary contends that the Federal Circuit has not provided persuasive case law to support this holding. She states, “[T]here is nothing in the Vaccine Act itself that requires a petitioner who elects to accept a judgment awarding interim damages to accept any subsequent judgment.” Id. at 5. The Secretary thus reasons that “a petitioner who accepts one judgment is not clearly bound to accept a separate judgment.” Id. V. Analysis a. The Statute Permits an Award of Interim Damages In Lerwick, the special master awarded interim damages to petitioner for past pain and suffering and past unreimbursed medical expenses. 2014 WL 1897656, at *11. Despite the Secretary’s argument that “a” decision should be interpreted to mean “one” decision, the special master found that the rules of statutory construction permit interpretive flexibility. Id. at *3.4 The undersigned agrees with this analysis and finds that the plain language of the Vaccine Act does not prohibit special masters from issuing multiple decisions on compensation. The undersigned further notes that this interpretation of the statute comports with the overall intent of Congress,5 who instructed that the purpose of the Vaccine Act is to compensate vaccine-injured individuals “quickly, easily, and with certainty and generosity.” H.R. Rep. 99-908, at 3 (1986). 4 The special master explained, “In a statute, the use of an indefinite article (“a” or “an”) can mean “one or more.” In contrast, the use of the definite article (“the”) usually suggests a single item . . . . The Federal Circuit has used the same guidelines in construing patents.” Lerwick, 2014 WL 1897656, at 3 (citing Colorado v. Sunoco, Inc., 337 F.3d 1233, 1241 (10th Cir. 2003) (interpreting the Comprehensive Environmental Response, Compensation and Liability Act)); Boeing Co. v. United States, 75 Fed. Cl. 34, 43 (2007) (“If more than one such official were contemplated, the indefinite articles ‘an’ or ‘a’ should have been used.”)). 5 It is well established that principles of statutory construction require a statute to be interpreted in a way consistent with Congress’ intent. See Saunders, 25 F.3d at 1036; Doyon, 214 F.3d 1309 5 Case 1:12-vv-00630-VJW Document 114 Filed 06/21/16 Page 6 of 9 The question of whether the Vaccine Act authorizes multiple decisions on compensation has also been addressed by the Federal Circuit. In Avera, the Federal Circuit stated that special masters have the authority to issue multiple decisions awarding attorneys’ fees and costs. 515 F.3d at 1352. Moreover, the Federal Circuit rejected the Secretary’s arguments against interim damages in both Heinzelman and Tembenis. In Heinzelman, the Federal Circuit granted petitioner’s motion for interim damages and ordered the Court of Federal Claims to issue an interim damages award to petitioner. Heinzelman, Order dated August 6, 2012 at 2. In Tembenis, the Federal Circuit rejected respondent’s concerns that interim damages would compromise the structure of the Program by causing inconsistent elections and thus result in claims outside of the Program. Tembenis, Order dated May 16, 2013 at 5-6. With regard to the Secretary’s arguments about the potential for inconsistent elections of judgments, the Federal Circuit found that a judicial officer could hold that the election to accept a judgment awarding interim compensation implied the acceptance of a later judgment awarding final compensation, thus preventing the problem of inconsistent elections. Id. at 5-6; accord Lerwick, 2014 WL 1897656, at *7. While the undersigned is not bound by these non-precedential Federal Circuit rulings, she finds their reasoning to be sound, in accordance with the Act, and therefore highly persuasive. For these reasons, the undersigned finds that special masters possess the legal authority to award compensation on an interim basis. b. An Award of Interim Damages is Appropriate in This Case Now that the undersigned has determined that special masters possess the discretionary authority to award interim damages, she must determine whether interim damages are appropriate under the facts and circumstances of this case. Petitioners suggest four factors to consider in determining whether interim damages are appropriate, including: “(1) the length of time since the vaccine injury; (2) the length of time … since the ruling on entitlement; (3) the general nature and extent of expenses related to the vaccine injury …., and (4) the agreement of the parties as to undisputed damages.” Pet’rs’ Proposed Order at 9. The basis for an award of interim damages is the November 13, 2015 Ruling, which found that petitioners had established that the Gardasil and FluMist vaccinations that B.K.D. received on September 28, 2011, caused her to develop NMO. Ruling on Entitlement at 31. As a result of these vaccinations, she suffers from a rare and debilitating autoimmune disorder known as NMO. It has been almost five years since the onset of B.K.D.’s injury. The parties are in the process of developing a life care plan for B.K.D., which will provide guidance as to the appropriate amount of damages. Petitioners’ life care planner recently advised that B.K.D. will need to be evaluated by at least three new specialists, in addition to her (“The objective when interpreting statutes is to give effect to the intent of Congress . . . . To fully understand the meaning of a statute, we look not only to the particular statutory language, but to the design of the statute as a whole and to its object and policy.”). 6 Case 1:12-vv-00630-VJW Document 114 Filed 06/21/16 Page 7 of 9 current team of doctors, in order to create an accurate life care plan.6 See Pet’rs’ Reply dated March 22, 2016 (ECF No. 101). In addition, because B.K.D. now receives Medicaid, there is a Medicaid lien, which will require additional time to process. See Pet’rs’ Status Report dated April 14, 2016 (ECF No. 105).7 The final resolution of B.K.D.’s damages could take several more months. While her damages award remains pending, B.K.D. has an immediate need for wheelchair-accessible transportation. 8 Pet’rs’ Motion at 2. Due to extreme family and financial hardships,9 petitioners are unable to make this purchase. Id. at 1-2. An interim damages award will assist her in making this purchase. This decision does not contemplate that interim damages would be routinely or even frequently awarded, but in this case, petitioners have made a persuasive case that there is extreme hardship and that accordingly, the purpose of the Vaccine Act is better fulfilled by making the interim award. For all of the reasons above, the undersigned finds that an award of interim damages is appropriate in this case. c. Petitioners May Receive Interim Damages for Past Pain and Suffering Petitioners have proposed an award of $931,359.63 for lost earnings and $250,000.00 for past pain and suffering. Pet’rs’ Reply at 2-3. While the parties agree that the present value of B.K.D.’s earning capacity is $931,359.63, respondent has declined to take a position on the appropriate amount to be awarded for pain and suffering. Pet’rs’ Status Report dated February 29, 2016 (ECF No. 98); Resp.’s Status Report dated February 29, 2016 (ECF No. 99). The 6 Petitioners’ most recent status report stated that B.K.D. has appointments with a urologist on June 14, 2016, a plastic surgeon on May 25, 2016, and a physical medicine and rehabilitation physician on November 14, 2016. She is on a waiting list to see the physical medicine specialist should an appointment become available sooner. Pet’rs’ Status Report dated May 23, 2016 (ECF No. 110). 7 In a status report dated April 21, 2016, petitioners reported that their attorney had received the Medicaid lien but was awaiting further information. Pet’rs’ Status Report dated April 21, 2016. In their most recent status report, petitioners stated that the Medicaid lien amount is $7,584.74, but that this amount only encompasses one date of service. Petitioner stated that billing records reflecting other Medicaid payments were being discussed with the Medicaid agency but will take time to collect. 8 Petitioners report that “[B.K.D.] is [almost 18] years old and is quite heavy due to the steroid- induced weight gain, and [she] has outgrown her mother’s ability to help lift her into the family car. A wheelchair van is urgently needed.” Pet’rs’ Motion at 2. 9 Unfortunate family and financial circumstances have prompted petitioners to request an award of interim damages. Petitioners report that they are currently going through a divorce and will likely be declaring bankruptcy and surrendering the family home. Pet’rs’ Motion at 1. Moreover, the home flooded and the family is currently living in a hotel. Id. And while Ms. Day is currently employed as a waitress, she will soon bear the primary residential responsibility for her four children, including B.K.D. Id. 7 Case 1:12-vv-00630-VJW Document 114 Filed 06/21/16 Page 8 of 9 undersigned declines to award interim damages for B.K.D.’s future lost earnings but finds that B.K.D is entitled to receive $250,000.00 for past pain and suffering.10 B.K.D.’s injury is devastating and has been associated with multiple relapses. Hearing Transcript (“Tr”) at 17-18. In late 2011, when she first became ill, B.K.D. presented to the emergency room on numerous occasions with weight loss, fever, irregular pupils, and leg weakness and numbness. Pet’rs’ Ex. 2 at 186; Pet’rs’ Ex. 4 at 14, 91-92. She began taking both intravenous and oral steroids, which caused her to gain weight. When she stopped taking oral steroids in December 2011, her NMO symptoms returned, and she again experienced unsteady gait, right leg weakness, back pain, and pupil irregularity. Pet’rs’ Ex. 11 at 36. B.K.D. has had a number of relapses of NMO since late 2011, each associated with weakness, numbness, and tingling in her legs, back pain, and blurred vision. See, e.g., Pet’rs’ Ex. 9 at 11-12; Pet’rs’ Ex. 6 at 11; Pet’rs’ Ex. 35 at 5-6; Pet’rs’ Ex. 36 at 6. At the hearing on entitlement, there was testimony that she was hospitalized ten times in 2014 alone. Tr. 21-22. B.K.D. takes a variety of medications and has ongoing and extensive rehabilitation. During the hearing, B.K.D. testified that the medications leave her tired, weak, and sometimes sick. Tr. 41. The steroids alone have caused her to gain over one hundred pounds. While the NMO is better managed with medications, B.K.D. can relapse at any time. Due to the relapsing nature of her injury, B.K.D. has had to relearn to walk five times and has relied on medical equipment for walking, including a cane, a walker, leg braces, and a gait belt. When unable to walk, she relies on a wheelchair for transportation. Tr. 15; 43-44. Her illness has made it difficult for her to have a normal life. B.K.D. takes classes online rather than attending school, and she had her sixteenth birthday party at Riley Hospital. Tr. 42, 45. B.K.D. is also unable to play softball, her favorite sport and one of her life long passions. Tr. 9. Her mother testified during the hearing that despite the uncertain future of her daughter’s health, B.K.D. has tried to make the most of her situation and enjoy life. Tr. 23, 25. After reviewing B.K.D.’s testimony, the medical records, and all of the medical treatment and therapy she has undergone since 2011, the undersigned finds that B.K.D. is entitled to receive $250,000.00 to compensate her for past pain and suffering. VI. Conclusion The undersigned finds that petitioners are entitled to an award of interim damages under the unique facts and circumstances of this case. An award of B.K.D.’s past pain and suffering is appropriate in this case, and there is no reason to delay the entry of judgment on this item of damages, especially given petitioners’ particularly difficult financial circumstances. The undersigned reserves ruling on the remaining statutory elements of damages for a future date. 10 The undersigned declines to award interim damages for B.K.D.’s lost earning capacity. The death of a vaccinee prior to the issuance of a final judgment could affect the amount of compensation to which one is entitled. See Tembenis, 733 F.3d at 1195; Lerwick, 2014 WL 1897656, at *11. Therefore, the undersigned will not grant her an award of interim damages for lost earning capacity. 8 Case 1:12-vv-00630-VJW Document 114 Filed 06/21/16 Page 9 of 9 Accordingly, the undersigned awards a total of $250,000.00, issued in the form of a check made payable to petitioner, Laura Day, as Guardian of the Person and Estate of B.K.D. In the absence of a motion for review filed pursuant to RCFC Appendix B, the clerk of court SHALL ENTER JUDGMENT in accordance herewith.11 IT IS SO ORDERED. /s/ Nora Beth Dorsey Nora Beth Dorsey Chief Special Master 11 Pursuant to Vaccine Rule 11(a), entry of judgment is expedited by the parties’ joint filing of notice renouncing the right to seek review. 9 ================================================================================ DOCUMENT 4: USCOURTS-cofc-1_12-vv-00630-3 Date issued/filed: 2016-12-21 Pages: 6 Docket text: PUBLIC DECISION (Originally filed: 12/07/2016) regarding 133 Order on Motion for Review, Judge Vaccine Order/Opinion Signed by Judge Victor J. Wolski. (ar1) Copy to parties. -------------------------------------------------------------------------------- Case 1:12-vv-00630-VJW Document 137 Filed 12/21/16 Page 1 of 6 In the United States Court of Federal Claims No. 12-630V (Filed under seal December 7, 2016) (Reissued December 21, 2016) * * * * * * * * * * * * * * * * * * * * LAURA DAY and TODD DAY, as * Vaccine Act, 42 U.S.C. §§ 300aa-12, guardians of the person and * 300aa-15, 300aa-21; interim damages estate of B.K.D., * award upheld; cap on actual pain and * suffering; election to accept damages; Petitioners, * extreme financial hardship; * Dictionary Act, 1 U.S.C. § 1. v. * * SECRETARY OF HEALTH & * HUMAN SERVICES, * * Respondent, * * * * * * * * * * * * * * * * * * * * Jennifer Anne Gore Maglio, Maglio Christopher & Toale, PA, with whom was Anne Carrión Toale, both of Sarasota, Fla., for petitioners. Gordon Shemin, Trial Attorney, Torts Branch, Civil Division, Department of Justice, with whom were Benjamin C. Mizer, Principal Deputy Assistant Attorney General, Rupa Bhattacharyya, Director, Catharine E. Reeves, Acting Deputy Director, and Voris E. Johnson, Jr., Assistant Director, all of Washington, D.C., for respondent. ORDER WOLSKI, Judge. In this matter, it is not disputed that the petitioners are entitled to compensation due to the vaccine injury suffered by their daughter, B.K.D. Nor does the Secretary of Health and Human Services challenge the amount of compensation awarded by the Chief Special Master in the decision under review, the $250,000 maximum for the pain and suffering already inflicted upon B.K.D. The question presented in the Secretary’s motion for review is one solely of procedure, not substance --- namely, whether the National Childhood Vaccine Injury Act of 1986 (Vaccine Act), 42 U.S.C. §§ 300aa-1–300aa-34, allows for an interim award of Case 1:12-vv-00630-VJW Document 137 Filed 12/21/16 Page 2 of 6 compensation to be paid before a special master has determined the full extent of compensation owed to petitioners. On November 13, 2015, the Chief Special Master issued a ruling on entitlement in this vaccine case, finding that human papillomavirus and influenza vaccinations caused B.K.D. to develop the autoimmune disorder neuromyelitis optica. Day ex rel. B.K.D. v. Sec’y of Health & Human Servs., No. 12-630V, 2015 WL 8028393, at *14, *17–18, *21–23 (Fed. Cl. Sp. Mstr. Nov. 13, 2015). On January 7, 2016, petitioners filed a motion seeking interim damages in light of their extreme financial hardship and B.K.D.’s urgent need for a wheelchair accessible van and housing modifications. On May 31, 2016, determining that special masters possess the discretionary authority to award interim damages, the Chief Special Master awarded petitioners $250,000.00 in interim damages for B.K.D.’s past pain and suffering.1 Decision Awarding Interim Damages at 2, 6–9 (Fed. Cl. Spec. Mstr. May 31, 2016) (Decision). The Chief Special Master based her decision on the plain language of the Vaccine Act and analysis from a decision of another special master, as well as on one binding and two nonprecedential Federal Circuit opinions.2 She explained that she did “not contemplate that interim damages would be routinely or even frequently awarded, but in this case, petitioners have made a persuasive case that there is extreme hardship and that accordingly, the purpose of the Vaccine Act is better fulfilled by making the interim award.” Id. at 7. Respondent filed a motion for our court to review the decision awarding interim damages, arguing that interim damages awards are not authorized by the Vaccine Act. Resp’t’s Mot. for Review at 2 (Resp’t’s Mot.). The Secretary contends that the Vaccine Act does not contain language expressly providing for an interim damages award, and that the act is best understood as authorizing a single damages decision. Id. at 4–8. Respondent further argued that the rationale supporting interim attorneys’ fees does not apply to interim damages, id. at 10–11; that the nonprecedential orders allowing partial judgments have no bearing on 1 Although the parties filed status reports agreeing that B.K.D.’s lost wages totaled $931,359.63, the Chief Special Master declined to include this amount in the interim award, since a change in circumstances prior to final judgment would affect such an award. Decision at 8 n.10 (citing, inter alia, Tembenis v. Sec’y of Health & Human Servs., 733 F.3d 1190, 1195 (Fed. Cir. 2013)). The remainder of damages could not be calculated at the time the interim damages decision issued. 2 Decision at 5–6 (citing Avera v. Sec’y of Health & Human Servs., 515 F.3d 1343, 1352 (Fed. Cir. 2008); Tembenis v. Sec’y of Health & Human Servs., No. 2103-5029, Order at 5–6 (Fed. Cir. May 16, 2013); Heinzelman v. Sec’y of Health & Human Servs., No. 2011-5127, Order at 2 (Fed. Cir. June 13, 2012); Lerwick v. Sec’y of Health & Human Servs., No. 06-847V, 2014 WL 1897656, at *3, 7 (Fed. Cl. Sp. Mstr. Apr. 16, 2014)). – 2 – Case 1:12-vv-00630-VJW Document 137 Filed 12/21/16 Page 3 of 6 whether special masters may award interim damages, id. at 11–13; and that interim damages present procedural difficulties, id. at 14–17. The plain language of the Vaccine Act states that “[a] special master to whom a petition has been assigned shall issue a decision on such petition with respect to whether compensation is to be provided under the Program and the amount of such compensation.” 42 U.S.C. § 300aa-12(d)(3)(A) (2012). The decision under review is without question such a decision, as compensation under the Vaccine Act includes, “[f]or actual and projected pain and suffering and emotional distress from the vaccine-related injury, an award not to exceed $250,000.” Id. § 300aa-15(a)(4) (2012). But the Vaccine Act itself is silent as to whether special masters are limited to issuing just one such decision.3 The use of the indefinite, singular article “a,” in the formulation “a decision,” hardly settles the matter. The Dictionary Act, which courts “must consult” when construing federal statutes, Burwell v. Hobby Lobby Stores, Inc., 134 S. Ct. 2751, 2768 (2014), provides that, “[i]n determining the meaning of any Act of Congress, unless the context indicates otherwise—words importing the singular include and apply to several persons, parties, or things . . . .” 1 U.S.C § 1 (2012). Respondent argues that, considering the Vaccine Act’s overall context and structure, other language suggests that a single damages decision was intended by Congress. Resp’t’s Mot. at 5–7. For instance, the sentence authorizing the issuance of “a decision” refers to “the amount of such compensation” in the singular, and the same paragraph twice mentions “[t]he decision of the special master.” 42 U.S.C. § 300aa- 12(d)(3)(A). A subsequent subsection describes the procedures for our court’s review of “the special master’s decision.” Id. § 300aa-12(e)(1). The mere use of terms in the singular, of course, hardly provides the context for escaping the ambit of the Dictionary Act rule regarding the use of the singular. And the initial description of “a decision” to be issued shows that the Vaccine Act is not a statute in which “[t]he consistent use of the definite article in reference to [something] indicates that there is generally only one . . . .” Rumsfeld v. Padilla, 542 U.S. 426, 434 (2004). But the biggest problem with the Secretary’s reading of the Vaccine Act is that it rests on the interpretation of certain words in the singular that cannot be squared with Federal Circuit precedent. For purposes of our Court’s jurisdiction to review rulings of a special master, the Federal Circuit has held that a special master’s decision on a request for interim attorneys’ fees “is a decision on compensation” under subsections 12(d)(3)(A) and 12(e) of the Vaccine Act. Shaw v. Sec’y of Health & Human Servs., 609 F.3d 1372, 1375–76 (Fed. Cir. 2010) (citing 42 U.S.C. § 300aa-12(d)(3)(A), (e)). In Shaw, the 3 Congress has, in at least one statute, expressly authorized payment of interim damages. See 33 U.S.C. § 2705(a). – 3 – Case 1:12-vv-00630-VJW Document 137 Filed 12/21/16 Page 4 of 6 Federal Circuit recognized that decisions on attorneys’ fees were reviewable “independent from a decision on the merits,” and specifically allowed review of an interim fee denial prior to the issuance of a ruling on a petitioner’s entitlement to compensatory damages. Id. at 1375–78. In such cases, no one questions the authority of our Court to review the subsequent decision regarding compensatory damages, and thus “the decision” reviewable by our Court under subsections 12(d)(3)(A) and 12(e) cannot be limited to just one. The Secretary argues that the decisions concerning attorneys’ fees are distinguishable, as the purpose of fees awards “is to ensure that vaccine-injury claimants will have a readily available competent bar to prosecute their claims under the Act,” Saunders v. Sec’y of Dep’t of Health & Human Servs., 25 F.3d 1031, 1035–36 (Fed. Cir. 1994), rather than to compensate for injuries, and the Federal Circuit has found that the requirement that a petitioner elect to accept judgment, see 42 U.S.C. §§ 300aa-15(f)(1), 300aa-21(a), did not apply to such an award. Resp’t’s Mot. at 10–11 (citing Saunders, 25 F.3d at 1034–36).4 But while this may explain how the Federal Circuit came to allow multiple decisions to be reviewed under the Vaccine Act, see Shaw, 609 F.3d at 1375, the important point is that it does --- which is fatal to the Secretary’s argument that only one decision on compensation may be reviewed. Moreover, the Court notes that when compensatory damages are awarded a petitioner, the Vaccine Act mandates that attorneys’ fees and costs “shall also [be] award[ed] as part of such compensation.” 42 U.S.C. § 300aa-15(e)(1) (emphasis added). In those circumstances, an interim fee award allows one element of the total amount of compensation awarded a petitioner to be received in advance of the rest. The Vaccine Act does not contain any language that would prohibit the same treatment from being extended to actual pain and suffering damages under 42 U.S.C. § 300aa-15(a)(4). That the subsection 21(a) election to receive compensation would apply to any interim damages award is no reason to avoid such awards. The Secretary raises the prospect that a petitioner could elect to accept an interim damages award, but then elect to file a civil action for damages instead of accepting the remainder of the award, causing procedural difficulties. Resp’t’s Mot. at 14–16. But no such concern is present in this case, as petitioners have “disclaimed any intention to reject any future awards of damages.” Decision at 2; see also Resp’t’s Mot. at 14 n.4; Pet’rs’ Mem. in Resp. at 16. And since civil actions are limited to $1,000 in damages unless a written election to file a civil action was filed after judgment in our court, 42 U.S.C. § 300aa-11(2)(A)(i)(II), a simple expedient --- such 4 The Federal Circuit recognized that the term “compensation” had different meanings in different portions of the Vaccine Act (and even in the same sentence, see 42 U.S.C. § 300aa-15(e)(1)), and determined that, as used in the election provisions, it referred only to compensatory damages. See Saunders, 25 F.3d at 1034–35. – 4 – Case 1:12-vv-00630-VJW Document 137 Filed 12/21/16 Page 5 of 6 as a direction that the Clerk not file any such election once a petitioner has filed an election to accept interim damages --- would prevent such strategic behavior from succeeding.5 Such a practice is consistent with the approach taken by the Federal Circuit, albeit in nonprecedential orders, where an election to accept judgment made before an appeal was decided, Tembenis v. Sec’y of Health & Human Servs., No. 2103-5029, Order at 5–6 (Fed. Cir. May 16, 2013), and motions for partial summary affirmance of undisputed portions of damages awards, id. at 4; Heinzelman v. Sec’y of Health & Human Servs., No. 2011-5127, Order at 2 (Fed. Cir. June 13, 2012), were apparently treated as the requisite election. In limiting the interim damages award to the capped amount of pain and suffering damages already incurred, the Chief Special Master avoided the potential problem of “a change in the victim’s conditions or expenses,” McAllister v. Sec’y of Health & Human Servs., 70 F.3d 1240, 1243 (Fed. Cir. 1995), and based the award on damages that a “snapshot” later in time would not change, Tembenis v. Sec’y of Health & Human Servs., 733 F.3d 1190, 1195 (Fed. Cir. 2013). Respondent has not identified any background principle of law that would preclude an award of interim damages in general, much less when the damages are fixed and undisputed.6 The Secretary’s final argument concerns a policy matter that is not implicated by this case. Although respondent does not challenge the entitlement ruling below, see Resp’t’s Mot. at 16 n.6, she worries that a future award of interim damages would force her to decide whether to challenge an entitlement ruling before the full damages exposure is known., id. at 16–17. In the oral argument on this motion, petitioners countered that earlier appeals of underlying entitlement rulings are in the best interests of all parties --- reasoning that when a ruling is upheld, petitioners will receive awards earlier, and when overturned, both parties and the court will save time and resources from unnecessary compensation calculations. The Court merely notes that while the availability of interim damages 5 When no election is timely filed, an election to accept judgment is deemed to have been made. 42 U.S.C. § 300aa-21(a). If necessary, the Vaccine Rules, App. B to the Rules of the United States Court of Federal Claims (RCFC), could be amended to ensure that an election to accept interim damages constitutes an election to accept the final judgment. See 42 U.S.C. § 300aa-12(d)(2). 6 The RCFC 54(b) procedure allowing for final judgment to be entered on less than all of the claims presented in an action might be taken to suggest that separate legal theories based on different sets of facts must be present for a judgment to be entered on interim damages. See Liberty Mut. Ins. Co. v. Wetzel, 424 U.S. 737, 742– 43 (1976). This was not raised by the Secretary, and is in any event inconsistent with the Federal Circuit’s holding that judicial review is available for a special master’s decision to defer determining the full extent of interim attorneys’ fees awardable. See Shaw, 609 F.3d at 1373, 1378. – 5 – Case 1:12-vv-00630-VJW Document 137 Filed 12/21/16 Page 6 of 6 could accelerate decisions on both sides --- whether to elect to accept compensation under 42 U.S.C. § 300aa-21(a), and whether to appeal the underlying entitlement ruling under 42 U.S.C. § 300aa-12(e)(1) --- policy considerations are best addressed to the policymaking branch of our government. The Court concludes that the Chief Special Master reasonably interpreted the Vaccine Act to allow for an award of interim damages in this case. The decision under review was a “decision . . . with respect to whether compensation is to be provided under the Program and the amount of such compensation,” authorized by the Vaccine Act, 42 U.S.C. § 300aa-12(d)(3)(A). Petitioners’ entitlement to $250,000 for the past pain and suffering of their daughter B.K.D. is not disputed. Respondent took no position on the criteria employed by the Chief Special Master in determining that an award of interim damages was appropriate, and thus that matter was not before the Court. For the reasons stated above, respondent’s motion for review is DENIED, and the Chief Special Master’s decision awarding interim damages is SUSTAINED. The Clerk shall enter judgment awarding petitioners interim compensation in accordance with that decision. If petitioners file an election to receive this compensation under 42 U.S.C. § 300aa-21(a)(1), they will not be permitted to file a subsequent election to file a civil action under that subsection. IT IS SO ORDERED. s/ Victor J. Wolski VICTOR J. WOLSKI Judge – 6 – ================================================================================ DOCUMENT 5: USCOURTS-cofc-1_12-vv-00630-4 Date issued/filed: 2017-03-31 Pages: 21 Docket text: PUBLIC DECISION (Originally filed: 03/06/2017) regarding 160 DECISION Stipulation/Proffer Signed by Chief Special Master Nora Beth Dorsey. (tlf) Copy to parties. -------------------------------------------------------------------------------- Case 1:12-vv-00630-VJW Document 164 Filed 03/31/17 Page 1 of 21 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 12-630V Filed: March 6, 2017 * * * * * * * * * * * * * * * * * * * * * * * UNPUBLISHED BAILEY DAY * * Case No. 12-630 V Petitioner, * * v. * Chief Special Master Dorsey * SECRETARY OF HEALTH * Damages Award; Neuromyelitis AND HUMAN SERVICES, * Optica (“NMO”); Human Papilloma * Virus (“HPV”) Vaccine; Proffer. Respondent. * * * * * * * * * * * * * * * * * * * * * * * * Anne Carrion Toale, Maglio, Christopher & Toale, Sarasota, FL, for petitioner. Gordon Elliot Shemin, U.S. Department of Justice, Washington, D.C., for respondent. DECISION AWARDING DAMAGES1 On September 24, 2012, Laura Day filed a petition for compensation under the National Vaccine Injury Compensation Program (“the Program”),2 as the legal representative of her then- minor daughter, Bailey Day, in which she alleged that the Gardasil (“HPV”) and FluMist (“influenza”) vaccinations Bailey received on September 28, 2011, caused her to develop multiple sclerosis (“MS”). Petition at 3, ¶11. After the filing of the petition, it was discovered that Bailey actually suffers from a rare autoimmune disorder known as neuromyelitis optica (“NMO”) or Devic’s Syndrome, rather than MS. See Petitioner’s (“Pet’r’s”) Exhibit (“Ex.”) 6 at 13. On November 13, 2015, the undersigned issued a decision finding that petitioner was entitled to compensation. During the time in which this case was being adjudicated, Bailey Day 1 Because this decision contains a reasoned explanation for the action in this case, the undersigned intends 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). In accordance with Vaccine Rule 18(b), petitioner has 14 days to identify and move to redact medical or other information, the disclosure of which would constitute an unwarranted invasion of privacy. If, upon review, the undersigned agrees that the identified material fits within this definition, the undersigned will redact such material from public access. 2 The Program comprises Part 2 of the National Childhood Vaccine Injury Act of 1986, 42 U.S.C. § 300aa. 1 Case 1:12-vv-00630-VJW Document 164 Filed 03/31/17 Page 2 of 21 turned 18 years old and was made the petitioner in her case. On May 31, 2016, the undersigned awarded Bailey interim damages for past pain and suffering in the amount of $250,000.00.3 On March 3, 2017, respondent filed a Proffer on Award of Compensation (“Proffer”). In the Proffer, respondent represented that petitioner agrees with the proffered award. Based on the record as a whole, the undersigned finds that petitioner is entitled to an award as stated in the Proffer. Pursuant to the terms stated in the attached Proffer, the undersigned awards petitioner: (1) A lump sum payment of $1,283,828.14, representing compensation for life care expenses expected to be incurred during the first year after judgment ($305,186.22), lost earnings ($968,386.45), and past unreimbursable expenses ($10,255.47), in the form of a check made payable to petitioner, Bailey Day. (2) A lump sum payment in the amount of $7,584.74, representing compensation for satisfaction of the State of Indiana Medicaid lien, in the form of a check made payable to petitioner, Bailey Day and Anthem BCBS, Inc. Attn: Anel Mendez 21555 Oxnard Street Mail Drop AC-10C Woodland Hills, CA 91367 Tax ID No. 35-0781558 Policy No: IN0726491 (3) An amount sufficient to purchase the annuity contract described in section II.C. of the Proffer. Proffer at 5. In the absence of a motion for review filed pursuant to RCFC Appendix B, the Clerk of the Court SHALL ENTER JUDGMENT herewith.4 3 Respondent filed a motion for review of this decision on June 30, 2016, and the decision was affirmed by Judge Wolski on December 7, 2017. The final judgment awarding interim damages was entered on January 18, 2017. Because petitioner has already received the maximum amount of pain and suffering damages permitted by the statute, pain and suffering damages are not awarded in this decision. 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. 2 Case 1:12-vv-00630-VJW Document 164 Filed 03/31/17 Page 3 of 21 IT IS SO ORDERED. s/Nora Beth Dorsey Nora Beth Dorsey Chief Special Master 3 Case 1:12-vv-00630-VJW Document 164 Filed 03/31/17 Page 4 of 21 IN THE UNITED STATES COURT OF FEDERAL CLAIMS OFFICE OF SPECIAL MASTERS ____________________________________ ) BAILEY DAY, ) ) Petitioner, ) No. 12-630V ) Chief Special Master Dorsey v. ) ECF ) SECRETARY OF HEALTH AND ) HUMAN SERVICES, ) ) Respondent. ) ) RESPONDENT'S PROFFER ON AWARD OF COMPENSATION I. Items of Compensation A. Life Care Items Respondent engaged life care planner Linda Curtis, RN, MS, CCM, CNLP, and petitioner engaged Tresa Johnson, RN, BSN, CLCP, to provide an estimation of Bailey Day’s future vaccine-injury related needs. For the purposes of this proffer, the term “vaccine related” is as described in the Chief Special Master’s Ruling on Entitlement, filed November 13, 2015. All items of compensation identified in the life care plan are supported by the evidence, and are illustrated by the chart entitled Appendix A: Items of Compensation for Bailey Day, attached hereto as Tab A.1 Respondent proffers that Bailey Day should be awarded all items of compensation set forth in the life care plan and illustrated by the chart attached at Tab A. Petitioner agrees. 1 The chart at Tab A illustrates the annual benefits provided by the life care plan. The 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. -1- Case 1:12-vv-00630-VJW Document 164 Filed 03/31/17 Page 5 of 21 B. Lost Earnings The parties agree that based upon the evidence of record, Bailey Day has suffered past loss of earnings and will suffer a loss of earnings in the future. Therefore, respondent proffers that Bailey Day should be awarded lost earnings as provided under the Vaccine Act, 42 U.S.C. § 300aa-15(a)(3)(B). Respondent proffers that the appropriate award for Bailey Day’s lost earnings is $968,386.45. Petitioner agrees. C. Pain and Suffering On May 31, 2016, the Chief Special Master issued a decision awarding compensation on an interim basis, awarding pain and suffering in the amount of $250,000.00. An amended judgment for this component of damages entered on January 18, 2017. This item of compensation has been paid. Therefore, respondent proffers that petitioner is not entitled to any additional compensation for pain and suffering under 42 U.S.C. § 300aa-15(a)(4). Petitioner agrees. D. Past Unreimbursable Expenses Evidence supplied by petitioner documents her expenditure of past unreimbursable expenses related to her vaccine-related injury. Respondent proffers that petitioner should be awarded past unreimbursable expenses in the amount of $10,255.47. Petitioner agrees. E. Medicaid Lien Respondent proffers that Bailey Day should be awarded funds to satisfy a State of Indiana lien in the amount of $7,584.74, which represents full satisfaction of any right of subrogation, assignment, claim, lien, or cause of action the State of Indiana may have against any individual as a result of any Medicaid payments the State of Indiana has made to or on behalf of Bailey Day from the date of her eligibility for benefits through the date of judgment in this case -2- Case 1:12-vv-00630-VJW Document 164 Filed 03/31/17 Page 6 of 21 as a result of her vaccine-related injury suffered on or about October 1, 2011, under Title XIX of the Social Security Act. II. Form of the Award The parties recommend that the compensation provided to Bailey Day should be made through a combination of lump sum payments and future annuity payments as described below, and request that the Chief Special Master’s decision and the Court’s judgment award the following:2 A. A lump sum payment of $1,283,828.14, representing compensation for life care expenses expected to be incurred during the first year after judgment ($305,186.22), lost earnings ($968,386.45), and past unreimbursable expenses ($10,255.47), in the form of a check payable to petitioner, Bailey Day. B. A lump sum payment of $7,584.74, representing compensation for satisfaction of the State of Indiana Medicaid lien, payable jointly to petitioner and Anthem BCBS, Inc. Attn: Anel Mendez 21555 Oxnard Street Mail Drop AC-10C Woodland Hills, CA 91367 Tax ID No. 35-0781558 Policy No: IN0726491 Petitioner agrees to endorse this payment to the State. 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, 2 Should petitioner 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, future lost earnings, and future pain and suffering. 3 In respondent’s discretion, respondent may purchase one or more annuity contracts from one or more life insurance companies. -3- Case 1:12-vv-00630-VJW Document 164 Filed 03/31/17 Page 7 of 21 as illustrated by the chart at Tab A, attached hereto, paid to the life insurance company4 from 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, Bailey Day, only so long as Bailey Day 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 Respondent proffers 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. Petitioner agrees. 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; 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. -4- Case 1:12-vv-00630-VJW Document 164 Filed 03/31/17 Page 8 of 21 2. Life-contingent annuity Petitioner will continue to receive the annuity payments from the Life Insurance Company only so long as she, Bailey Day, 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 Bailey Day’s death. 3. Guardianship Petitioner is a competent adult. Evidence of guardianship is not required in this case. III. Summary of Recommended Payments Following Judgment A. Lump Sum paid to petitioner, Bailey Day: $1,283,828.14 B. Medicaid Lien: $7,584.74 C. An amount sufficient to purchase the annuity contract described above in section II.C. Respectfully submitted, CHAD A. READLER Acting Assistant Attorney General C. SALVATORE D’ALESSIO Acting Director Torts Branch, Civil Division CATHARINE E. REEVES Deputy Director Torts Branch, Civil Division GLENN A. MACLEOD Senior Trial Counsel Torts Branch, Civil Division -5- Case 1:12-vv-00630-VJW Document 164 Filed 03/31/17 Page 9 of 21 /s/ Gordon E. Shemin GORDON E. SHEMIN Trial Attorney Torts Branch, Civil Division U. S. Department of Justice P.O. Box l46, Benjamin Franklin Station Washington, D.C. 20044-0146 Phone: (202) 616-4208 Fax: (202) 353-2988 Dated: March 3, 2017 -6- Case 1:12-vv-00630-VJW Document 164 Filed 03/31/17 Page 10 of 21 Appendix A: Items of Compensation for Bailey Day Page 1 of 12 Lump Sum Compensation Compensation Compensation Compensation Compensation Compensation Compensation Compensation ITEMS OF COMPENSATION G.R. * M Year 1 Years 2-4 Years 5-7 Year 8 Years 9-10 Year 11 Years 12-14 Year 15 2017 2018-2020 2021-2023 2024 2025-2026 2027 2028-2030 2031 BCBS Premium 5% M 1,820.00 1,820.00 1,820.00 BCBS MOP & Deductible 5% 4,000.00 4,000.00 4,000.00 BCBS Bronze Premium 5% M 3,887.04 3,887.04 3,887.04 3,887.04 3,887.04 BCBS Bronze MOP 5% 7,150.00 7,150.00 7,150.00 7,150.00 7,150.00 Medicare Adv Premium 5% M Medicare Adv MOP 5% Medicare Part D 5% M Medicare Part B Premium 5% M Medicare Part B Deductible 5% Medigap G 5% M Neurologist 5% * Mileage: Neurologist 4% 31.96 31.96 31.96 31.96 31.96 31.96 31.96 31.96 Rituximab Infusion 5% * Lab Testing 5% * Lab Work 5% * MRI 5% * Dexa Bone Scan 5% * PCP 5% * Urinalysis 5% * Physical Medicine & Rehab 5% * Mileage: PM&R 4% 23.97 23.97 23.97 23.97 23.97 23.97 23.97 23.97 Urologist 5% * Mileage: Urologist 4% 30.94 30.94 30.94 30.94 30.94 30.94 30.94 30.94 Ultrasound of Bladder 5% * Urodynamic Study 5% * Plastic Surgeon 5% * Mileage: Plastic Surgeon 4% 6.29 6.29 6.29 6.29 6.29 6.29 6.29 6.29 Neurologist - Mayo Clinic 5% * Airfare to Mayo Clinic 4% 1,463.20 1,463.20 1,463.20 Hotel to Mayo Clinic 4% 599.37 599.37 599.37 Rental Car Mayo Clinic 4% 212.73 212.73 212.73 Case 1:12-vv-00630-VJW Document 164 Filed 03/31/17 Page 11 of 21 Appendix A: Items of Compensation for Bailey Day Page 2 of 12 Lump Sum Compensation Compensation Compensation Compensation Compensation Compensation Compensation Compensation ITEMS OF COMPENSATION G.R. * M Year 1 Years 2-4 Years 5-7 Year 8 Years 9-10 Year 11 Years 12-14 Year 15 2017 2018-2020 2021-2023 2024 2025-2026 2027 2028-2030 2031 Parking Mayo Clinic 4% 12.00 12.00 12.00 Meals Mayo Clinic 4% 192.00 192.00 192.00 Neuro-opthalmologist 5% Mileage: Neuro-opthal 4% 15.98 15.98 15.98 15.98 15.98 15.98 15.98 15.98 Visual Field Exam 5% * Optic Nerve Imaging 5% * Opthalmologist 5% * Mileage: Opthalmologist 4% 6.29 6.29 6.29 6.29 6.29 6.29 6.29 6.29 Glasses 4% 150.00 150.00 150.00 150.00 150.00 150.00 150.00 150.00 Inpatient Rehab 4% * Panniculectomy 0% 10,000.00 Mastopexy 0% 7,500.00 Brachioplasty 0% 6,500.00 PT Eval 4% * PT/ Aqua Therapy 4% * OT Eval 4% * OT 4% Gabapentin 5% * M 120.00 120.00 120.00 Carbamazepine 5% * M 120.00 120.00 120.00 Tamsulosin 5% * M 120.00 120.00 120.00 Amitriptyline 5% * M 120.00 120.00 120.00 Prednisone 5% * M 120.00 120.00 120.00 Ondansteron 5% * M 120.00 120.00 120.00 Biotin 4% 60.80 60.80 60.80 60.80 60.80 60.80 60.80 60.80 Vit D3 4% 30.39 30.39 30.39 30.39 30.39 30.39 30.39 30.39 B12 4% 38.29 38.29 38.29 38.29 38.29 38.29 38.29 38.29 Tylenol 4% 26.97 26.97 26.97 26.97 26.97 26.97 26.97 26.97 Omeprazole 4% 197.91 197.91 197.91 197.91 197.91 197.91 197.91 197.91 Calcium 4% 17.37 17.37 17.37 17.37 17.37 17.37 17.37 17.37 Adj Bed 4% 1,500.00 1,500.00 Mattress Cover 4% 20.79 20.79 20.79 20.79 20.79 20.79 20.79 20.79 Case 1:12-vv-00630-VJW Document 164 Filed 03/31/17 Page 12 of 21 Appendix A: Items of Compensation for Bailey Day Page 3 of 12 Lump Sum Compensation Compensation Compensation Compensation Compensation Compensation Compensation Compensation ITEMS OF COMPENSATION G.R. * M Year 1 Years 2-4 Years 5-7 Year 8 Years 9-10 Year 11 Years 12-14 Year 15 2017 2018-2020 2021-2023 2024 2025-2026 2027 2028-2030 2031 Hoyer Lift 4% 1,099.00 1,099.00 Hoyer Slings 4% 180.00 180.00 180.00 180.00 180.00 180.00 180.00 180.00 Walker 4% 168.82 168.82 168.82 Exercise Platform 4% 444.77 Balance Ball 4% 7.66 7.66 Bosu 4% 109.00 109.00 Resistance Bands 4% 24.99 8.33 8.33 8.33 8.33 8.33 8.33 8.33 Free Weights 4% 50.26 Ankle Weights 4% 45.00 Diapers 4% M 1,048.23 1,048.23 1,048.23 1,048.23 1,048.23 1,048.23 1,048.23 1,048.23 Wipes 4% M 247.66 247.66 247.66 247.66 247.66 247.66 247.66 247.66 Gloves 4% M 130.96 130.96 130.96 130.96 130.96 130.96 130.96 130.96 Sheet Protector 4% 41.58 41.58 41.58 41.58 41.58 41.58 41.58 41.58 Disp Underpads 4% 238.13 238.13 238.13 238.13 238.13 238.13 238.13 238.13 Reusable Underpads 4% 155.88 155.88 155.88 155.88 155.88 155.88 155.88 155.88 Antibacterial Gel 4% 95.40 95.40 95.40 95.40 95.40 95.40 95.40 95.40 AFOs 4% * Hand/ Wrist Splints 4% * Reacher 4% 32.29 5.38 5.38 5.38 5.38 5.38 5.38 5.38 Allowance for Aids 4% 150.00 50.00 50.00 50.00 50.00 50.00 50.00 50.00 Power WC 4% * Power WC Maint 4% * Cushion 4% * Cushion Cover 4% 60.00 30.00 30.00 30.00 30.00 30.00 30.00 30.00 Manual WC 4% 1,747.50 1,747.50 1,747.50 Manual WC Maint 4% 59.91 59.91 59.91 59.91 59.91 59.91 59.91 59.91 Cushion 4% 84.00 42.00 42.00 42.00 42.00 42.00 42.00 42.00 Cushion Cover 4% 60.00 30.00 30.00 30.00 30.00 30.00 30.00 30.00 WC Pack 4% 24.00 12.00 12.00 12.00 12.00 12.00 12.00 12.00 Ramp 4% 115.99 115.99 Case Mngt 4% M 3,960.00 3,960.00 2,970.00 2,970.00 2,970.00 2,970.00 2,970.00 2,970.00 Case 1:12-vv-00630-VJW Document 164 Filed 03/31/17 Page 13 of 21 Appendix A: Items of Compensation for Bailey Day Page 4 of 12 Lump Sum Compensation Compensation Compensation Compensation Compensation Compensation Compensation Compensation ITEMS OF COMPENSATION G.R. * M Year 1 Years 2-4 Years 5-7 Year 8 Years 9-10 Year 11 Years 12-14 Year 15 2017 2018-2020 2021-2023 2024 2025-2026 2027 2028-2030 2031 Counseling 4% * Home Mods 4% 77,307.00 Modified Van 4% 63,826.35 51,010.08 51,010.08 Ancillary Services: Housekeeping 4% M 3,444.00 3,444.00 3,444.00 3,444.00 3,444.00 3,444.00 3,444.00 3,444.00 Ancillary Services: Lawn Care 4% 392.40 392.40 392.40 392.40 392.40 392.40 392.40 392.40 Ancillary Services: Heavy Lawn Care 4% 488.32 488.32 488.32 488.32 488.32 488.32 488.32 488.32 Ancillary Services: Snow Removal 4% 289.87 289.87 289.87 289.87 289.87 289.87 289.87 289.87 Non-Skilled Care 4% M 113,880.00 113,880.00 113,880.00 113,880.00 113,880.00 113,880.00 113,880.00 113,880.00 Lost Earnings 968,386.45 Past Unreimbursable Expenses 10,255.47 Medicaid Lien 7,584.74 Annual Totals 1,291,412.88 134,507.30 133,517.30 188,461.44 135,535.04 138,366.69 135,535.04 188,461.44 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 petitioner for Yr 1 life care expenses ($305,186.22), lost earnings ($968,386.45), and past unreimbursable expenses ($10,255.47): $1,283,828.14. As soon as practicable after entry of judgment, respondent shall make the following payment jointly to petitioner and Anthem BCBS, Inc., as reimbursement for a State of Indiana Medicaid lien: $7,584.74. 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 above in column G.R., 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 twelve monthly installments totaling the annual amount indicated. Case 1:12-vv-00630-VJW Document 164 Filed 03/31/17 Page 14 of 21 Appendix A: Items of Compensation for Bailey Day Page 5 of 12 Compensation Compensation Compensation Compensation Compensation Compensation Compensation Compensation ITEMS OF COMPENSATION G.R. * M Year 16 Year 17 Years 18-20 Year 21 Year 22 Years 23-26 Year 27 Years 28-29 2032 2033 2034-2036 2037 2038 2039-2042 2043 2044-2045 BCBS Premium 5% M BCBS MOP & Deductible 5% BCBS Bronze Premium 5% M 3,887.04 3,887.04 3,887.04 3,887.04 3,887.04 3,887.04 3,887.04 BCBS Bronze MOP 5% 7,150.00 7,150.00 7,150.00 7,150.00 7,150.00 7,150.00 7,150.00 Medicare Adv Premium 5% M 1,044.00 Medicare Adv MOP 5% 6,700.00 Medicare Part D 5% M 1,068.12 Medicare Part B Premium 5% M 1,608.00 Medicare Part B Deductible 5% 183.00 Medigap G 5% M Neurologist 5% * Mileage: Neurologist 4% 31.96 31.96 31.96 31.96 31.96 31.96 31.96 31.96 Rituximab Infusion 5% * Lab Testing 5% * Lab Work 5% * MRI 5% * Dexa Bone Scan 5% * PCP 5% * Urinalysis 5% * Physical Medicine & Rehab 5% * Mileage: PM&R 4% 23.97 23.97 23.97 23.97 23.97 23.97 23.97 23.97 Urologist 5% * Mileage: Urologist 4% 30.94 30.94 30.94 30.94 30.94 30.94 30.94 30.94 Ultrasound of Bladder 5% * Urodynamic Study 5% * Plastic Surgeon 5% * Mileage: Plastic Surgeon 4% 6.29 6.29 6.29 6.29 6.29 6.29 6.29 6.29 Neurologist - Mayo Clinic 5% * Airfare to Mayo Clinic 4% Hotel to Mayo Clinic 4% Rental Car Mayo Clinic 4% Case 1:12-vv-00630-VJW Document 164 Filed 03/31/17 Page 15 of 21 Appendix A: Items of Compensation for Bailey Day Page 6 of 12 Compensation Compensation Compensation Compensation Compensation Compensation Compensation Compensation ITEMS OF COMPENSATION G.R. * M Year 16 Year 17 Years 18-20 Year 21 Year 22 Years 23-26 Year 27 Years 28-29 2032 2033 2034-2036 2037 2038 2039-2042 2043 2044-2045 Parking Mayo Clinic 4% Meals Mayo Clinic 4% Neuro-opthalmologist 5% Mileage: Neuro-opthal 4% 15.98 15.98 15.98 15.98 15.98 15.98 15.98 15.98 Visual Field Exam 5% * Optic Nerve Imaging 5% * Opthalmologist 5% * Mileage: Opthalmologist 4% 6.29 6.29 6.29 6.29 6.29 6.29 6.29 6.29 Glasses 4% 150.00 150.00 150.00 150.00 150.00 150.00 150.00 150.00 Inpatient Rehab 4% * Panniculectomy 0% Mastopexy 0% Brachioplasty 0% PT Eval 4% * PT/ Aqua Therapy 4% * OT Eval 4% * OT 4% Gabapentin 5% * M Carbamazepine 5% * M Tamsulosin 5% * M Amitriptyline 5% * M Prednisone 5% * M Ondansteron 5% * M Biotin 4% 60.80 60.80 60.80 60.80 60.80 60.80 60.80 60.80 Vit D3 4% 30.39 30.39 30.39 30.39 30.39 30.39 30.39 30.39 B12 4% 38.29 38.29 38.29 38.29 38.29 38.29 38.29 38.29 Tylenol 4% 26.97 26.97 26.97 26.97 26.97 26.97 26.97 26.97 Omeprazole 4% 197.91 197.91 197.91 197.91 197.91 197.91 197.91 197.91 Calcium 4% 17.37 17.37 17.37 17.37 17.37 17.37 17.37 17.37 Adj Bed 4% 1,500.00 150.00 150.00 150.00 150.00 Mattress Cover 4% 20.79 20.79 20.79 20.79 20.79 20.79 20.79 20.79 Case 1:12-vv-00630-VJW Document 164 Filed 03/31/17 Page 16 of 21 Appendix A: Items of Compensation for Bailey Day Page 7 of 12 Compensation Compensation Compensation Compensation Compensation Compensation Compensation Compensation ITEMS OF COMPENSATION G.R. * M Year 16 Year 17 Years 18-20 Year 21 Year 22 Years 23-26 Year 27 Years 28-29 2032 2033 2034-2036 2037 2038 2039-2042 2043 2044-2045 Hoyer Lift 4% 1,099.00 109.90 109.90 109.90 109.90 Hoyer Slings 4% 180.00 180.00 180.00 180.00 180.00 180.00 180.00 180.00 Walker 4% 168.82 24.12 24.12 24.12 Exercise Platform 4% 444.77 Balance Ball 4% 7.66 0.77 0.77 0.77 0.77 Bosu 4% 109.00 10.90 10.90 10.90 10.90 Resistance Bands 4% 8.33 8.33 8.33 8.33 8.33 8.33 8.33 8.33 Free Weights 4% Ankle Weights 4% Diapers 4% M 1,048.23 1,048.23 1,048.23 1,048.23 1,048.23 1,048.23 1,048.23 1,048.23 Wipes 4% M 247.66 247.66 247.66 247.66 247.66 247.66 247.66 247.66 Gloves 4% M 130.96 130.96 130.96 130.96 130.96 130.96 130.96 130.96 Sheet Protector 4% 41.58 41.58 41.58 41.58 41.58 41.58 41.58 41.58 Disp Underpads 4% 238.13 238.13 238.13 238.13 238.13 238.13 238.13 238.13 Reusable Underpads 4% 155.88 155.88 155.88 155.88 155.88 155.88 155.88 155.88 Antibacterial Gel 4% 95.40 95.40 95.40 95.40 95.40 95.40 95.40 95.40 AFOs 4% * Hand/ Wrist Splints 4% * Reacher 4% 5.38 5.38 5.38 5.38 5.38 5.38 5.38 5.38 Allowance for Aids 4% 50.00 50.00 50.00 50.00 50.00 50.00 50.00 50.00 Power WC 4% * Power WC Maint 4% * Cushion 4% * Cushion Cover 4% 30.00 30.00 30.00 30.00 30.00 30.00 30.00 30.00 Manual WC 4% 1,747.50 249.64 249.64 249.64 Manual WC Maint 4% 59.91 59.91 59.91 59.91 59.91 59.91 59.91 59.91 Cushion 4% 42.00 42.00 42.00 42.00 42.00 42.00 42.00 42.00 Cushion Cover 4% 30.00 30.00 30.00 30.00 30.00 30.00 30.00 30.00 WC Pack 4% 12.00 12.00 12.00 12.00 12.00 12.00 12.00 12.00 Ramp 4% 115.99 11.60 11.60 11.60 11.60 Case Mngt 4% M 2,970.00 2,970.00 2,970.00 2,970.00 2,970.00 2,970.00 2,970.00 2,970.00 Case 1:12-vv-00630-VJW Document 164 Filed 03/31/17 Page 17 of 21 Appendix A: Items of Compensation for Bailey Day Page 8 of 12 Compensation Compensation Compensation Compensation Compensation Compensation Compensation Compensation ITEMS OF COMPENSATION G.R. * M Year 16 Year 17 Years 18-20 Year 21 Year 22 Years 23-26 Year 27 Years 28-29 2032 2033 2034-2036 2037 2038 2039-2042 2043 2044-2045 Counseling 4% * Home Mods 4% Modified Van 4% 51,010.08 5,101.01 5,101.01 5,101.01 Ancillary Services: Housekeeping 4% M 3,444.00 3,444.00 3,444.00 3,444.00 3,444.00 3,444.00 3,444.00 3,444.00 Ancillary Services: Lawn Care 4% 392.40 392.40 392.40 392.40 392.40 392.40 392.40 392.40 Ancillary Services: Heavy Lawn Care 4% 488.32 488.32 488.32 488.32 488.32 488.32 488.32 488.32 Ancillary Services: Snow Removal 4% 289.87 289.87 289.87 289.87 289.87 289.87 289.87 289.87 Non-Skilled Care 4% M 113,880.00 113,880.00 142,350.00 142,350.00 142,350.00 142,350.00 170,820.00 170,820.00 Lost Earnings Past Unreimbursable Expenses Medicaid Lien Annual Totals 135,979.81 135,535.04 164,005.04 166,836.69 217,214.61 169,662.98 198,132.98 197,699.06 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 petitioner for Yr 1 life care expenses ($305,186.22), lost earnings ($968,386.45), and past unreimbursable expenses ($10,255.47): $1,283,828.14. As soon as practicable after entry of judgment, respondent shall make the following payment jointly to petitioner and Anthem BCBS, Inc., as reimbursement for a State of Indiana Medicaid lien: $7,584.74. 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 above in column G.R., 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 twelve monthly installments totaling the annual amount indicated. Case 1:12-vv-00630-VJW Document 164 Filed 03/31/17 Page 18 of 21 Appendix A: Items of Compensation for Bailey Day Page 9 of 12 Compensation Compensation Compensation Compensation Compensation ITEMS OF COMPENSATION G.R. * M Year 30 Year 31 Years 32-46 Years 47-54 Years 55-Life 2046 2047 2048-2062 2063-2070 2071-Life BCBS Premium 5% M BCBS MOP & Deductible 5% BCBS Bronze Premium 5% M BCBS Bronze MOP 5% Medicare Adv Premium 5% M 1,044.00 1,044.00 1,044.00 Medicare Adv MOP 5% 6,700.00 6,700.00 6,700.00 Medicare Part D 5% M 1,068.12 1,068.12 1,068.12 554.64 554.64 Medicare Part B Premium 5% M 1,608.00 1,608.00 1,608.00 1,608.00 1,608.00 Medicare Part B Deductible 5% 183.00 183.00 183.00 183.00 183.00 Medigap G 5% M 1,418.88 1,418.88 Neurologist 5% * Mileage: Neurologist 4% 31.96 31.96 31.96 31.96 31.96 Rituximab Infusion 5% * Lab Testing 5% * Lab Work 5% * MRI 5% * Dexa Bone Scan 5% * PCP 5% * Urinalysis 5% * Physical Medicine & Rehab 5% * Mileage: PM&R 4% 23.97 23.97 23.97 23.97 23.97 Urologist 5% * Mileage: Urologist 4% 30.94 30.94 30.94 30.94 30.94 Ultrasound of Bladder 5% * Urodynamic Study 5% * Plastic Surgeon 5% * Mileage: Plastic Surgeon 4% 6.29 6.29 6.29 6.29 6.29 Neurologist - Mayo Clinic 5% * Airfare to Mayo Clinic 4% Hotel to Mayo Clinic 4% Rental Car Mayo Clinic 4% Case 1:12-vv-00630-VJW Document 164 Filed 03/31/17 Page 19 of 21 Appendix A: Items of Compensation for Bailey Day Page 10 of 12 Compensation Compensation Compensation Compensation Compensation ITEMS OF COMPENSATION G.R. * M Year 30 Year 31 Years 32-46 Years 47-54 Years 55-Life 2046 2047 2048-2062 2063-2070 2071-Life Parking Mayo Clinic 4% Meals Mayo Clinic 4% Neuro-opthalmologist 5% Mileage: Neuro-opthal 4% 15.98 15.98 15.98 15.98 15.98 Visual Field Exam 5% * Optic Nerve Imaging 5% * Opthalmologist 5% * Mileage: Opthalmologist 4% 6.29 6.29 6.29 6.29 6.29 Glasses 4% 150.00 150.00 150.00 150.00 150.00 Inpatient Rehab 4% * Panniculectomy 0% Mastopexy 0% Brachioplasty 0% PT Eval 4% * PT/ Aqua Therapy 4% * 70.00 23.33 23.33 23.33 23.33 OT Eval 4% * OT 4% 395.00 131.67 131.67 131.67 131.67 Gabapentin 5% * M Carbamazepine 5% * M Tamsulosin 5% * M Amitriptyline 5% * M Prednisone 5% * M Ondansteron 5% * M Biotin 4% 60.80 60.80 60.80 60.80 60.80 Vit D3 4% 30.39 30.39 30.39 30.39 30.39 B12 4% 38.29 38.29 38.29 38.29 38.29 Tylenol 4% 26.97 26.97 26.97 26.97 26.97 Omeprazole 4% 197.91 197.91 197.91 197.91 197.91 Calcium 4% 17.37 17.37 17.37 17.37 17.37 Adj Bed 4% 150.00 150.00 150.00 150.00 150.00 Mattress Cover 4% 20.79 20.79 20.79 20.79 20.79 Case 1:12-vv-00630-VJW Document 164 Filed 03/31/17 Page 20 of 21 Appendix A: Items of Compensation for Bailey Day Page 11 of 12 Compensation Compensation Compensation Compensation Compensation ITEMS OF COMPENSATION G.R. * M Year 30 Year 31 Years 32-46 Years 47-54 Years 55-Life 2046 2047 2048-2062 2063-2070 2071-Life Hoyer Lift 4% 109.90 109.90 109.90 109.90 109.90 Hoyer Slings 4% 180.00 180.00 180.00 180.00 180.00 Walker 4% 24.12 24.12 24.12 24.12 24.12 Exercise Platform 4% 444.77 29.65 29.65 29.65 Balance Ball 4% 0.77 0.77 0.77 0.77 0.77 Bosu 4% 10.90 10.90 10.90 10.90 10.90 Resistance Bands 4% 8.33 8.33 8.33 8.33 8.33 Free Weights 4% Ankle Weights 4% Diapers 4% M 1,048.23 1,048.23 1,048.23 1,048.23 1,048.23 Wipes 4% M 247.66 247.66 247.66 247.66 247.66 Gloves 4% M 130.96 130.96 130.96 130.96 130.96 Sheet Protector 4% 41.58 41.58 41.58 41.58 41.58 Disp Underpads 4% 238.13 238.13 238.13 238.13 238.13 Reusable Underpads 4% 155.88 155.88 155.88 155.88 155.88 Antibacterial Gel 4% 95.40 95.40 95.40 95.40 95.40 AFOs 4% * Hand/ Wrist Splints 4% * Reacher 4% 5.38 5.38 5.38 5.38 5.38 Allowance for Aids 4% 50.00 50.00 50.00 Power WC 4% * Power WC Maint 4% * Cushion 4% * Cushion Cover 4% 30.00 30.00 30.00 30.00 30.00 Manual WC 4% 249.64 249.64 249.64 249.64 249.64 Manual WC Maint 4% 59.91 59.91 59.91 59.91 59.91 Cushion 4% 42.00 42.00 42.00 42.00 42.00 Cushion Cover 4% 30.00 30.00 30.00 30.00 30.00 WC Pack 4% 12.00 12.00 12.00 12.00 12.00 Ramp 4% 11.60 11.60 11.60 11.60 11.60 Case Mngt 4% M 2,970.00 2,970.00 2,970.00 2,970.00 2,970.00 Case 1:12-vv-00630-VJW Document 164 Filed 03/31/17 Page 21 of 21 Appendix A: Items of Compensation for Bailey Day Page 12 of 12 Compensation Compensation Compensation Compensation Compensation ITEMS OF COMPENSATION G.R. * M Year 30 Year 31 Years 32-46 Years 47-54 Years 55-Life 2046 2047 2048-2062 2063-2070 2071-Life Counseling 4% * Home Mods 4% Modified Van 4% 5,101.01 5,101.01 5,101.01 5,101.01 5,101.01 Ancillary Services: Housekeeping 4% M 3,444.00 3,444.00 3,444.00 3,444.00 3,444.00 Ancillary Services: Lawn Care 4% 392.40 392.40 392.40 392.40 Ancillary Services: Heavy Lawn Care 4% 488.32 488.32 488.32 488.32 Ancillary Services: Snow Removal 4% 289.87 289.87 289.87 289.87 Non-Skilled Care 4% M 170,820.00 170,820.00 170,820.00 170,820.00 170,820.00 Lost Earnings Past Unreimbursable Expenses Medicaid Lien Annual Totals 198,164.06 198,298.83 197,883.71 190,995.11 189,824.52 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 petitioner for Yr 1 life care expenses ($305,186.22), lost earnings ($968,386.45), and past unreimbursable expenses ($10,255.47): $1,283,828.14. As soon as practicable after entry of judgment, respondent shall make the following payment jointly to petitioner and Anthem BCBS, Inc., as reimbursement for a State of Indiana Medicaid lien: $7,584.74. 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 above in column G.R., 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 twelve monthly installments totaling the annual amount indicated.