VICP Registry Case Source Bundle Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_15-vv-00369 Package ID: USCOURTS-cofc-1_15-vv-00369 Petitioner: Carmen Moreno Lozano Filed: 2017-08-04 Decided: 2019-01-07 Vaccine: Tdap Vaccination date: 2012-07-15 Condition: acute disseminated encephalomyelitis Outcome: compensated Award amount USD: 1271024 AI-assisted case summary: Carmen Moreno Lozano filed a petition under the National Vaccine Injury Compensation Program alleging that she developed acute disseminated encephalomyelitis (ADEM) due to a Tdap vaccine received on July 15, 2012. Her initial symptoms of fever, body aches, and breast tenderness appeared two weeks after vaccination, followed by more severe weakness, fever, dizziness, vision changes, and neck pain 25 days post-vaccination. An MRI revealed lesions in her brainstem, cerebellum, and white matter, leading to an initial diagnosis of Multiple Sclerosis (MS). However, subsequent tests and the resolution of lesions pointed towards ADEM as the correct diagnosis. After a hearing, the Special Master found that Ms. Lozano had established entitlement to compensation, demonstrating a medically reliable theory connecting the Tdap vaccine to ADEM, a logical sequence of cause and effect, and a proximate temporal relationship. The respondent's argument that the diagnosis was actually Posterior Reversible Encephalopathy Syndrome (PRES) was not supported by the evidence. The case proceeded to damages, and the parties stipulated to an award of $1,199,216.86 in a lump sum for life care expenses, lost earnings, pain and suffering, and past unreimbursable expenses, plus an amount for an annuity to cover future life care plan items. The respondent sought review of the entitlement decision, arguing the Special Master misapplied the Althen test, but the Court of Federal Claims denied the motion, upholding the Special Master's findings. Theory of causation field: Off-Table Public staged source text: ================================================================================ DOCUMENT 1: USCOURTS-cofc-1_15-vv-00369-0 Date issued/filed: 2017-08-30 Pages: 18 Docket text: PUBLIC RULING (Originally filed: 08/04/2017) regarding 43 Ruling on Entitlement (Signed by Special Master Brian H. Corcoran). (sb) Copy to parties. -------------------------------------------------------------------------------- Case 1:15-vv-00369-LAS Document 45 Filed 08/30/17 Page 1 of 18 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 15-369V (not to be published) * * * * * * * * * * * * * * * * * * * * * * * * * CARMEN MORENO LOZANO, * * Petitioner, * Filed: August 4, 2017 * v. * Ruling on Entitlement; Tetanus * Diphtheria-acellular-pertussis SECRETARY OF HEALTH * (“Tdap”) Vaccine; Acute AND HUMAN SERVICES, * Disseminated Encephalomyelitis * (“ADEM”). Respondent. * * * * * * * * * * * * * * * * * * * * * * * * * * * Christina Ciampolillo, Conway Homer, P.C., Boston, MA, for Petitioner. Robert Coleman, U.S. Dep’t of Justice, Washington, DC, for Respondent. RULING ON ENTITLEMENT1 On April 13, 2015, Mrs. Carmen Lozano filed this action seeking compensation under the National Vaccine Injury Compensation Program (the “Vaccine Program”),2 alleging that she developed acute disseminated encephalomyelitis (“ADEM”) due to receipt of the tetanus- diphtheria-acellular-pertussis (“Tdap”) vaccine on July 15, 2012. Petition (“Pet.”) (ECF No. 1) at 1. An entitlement hearing in the matter was held on June 14, 2017. After considering the record as a whole, and for the reasons explained below, I find that Petitioner has carried her burden establishing causation, and therefore has demonstrated entitlement to compensation under the Vaccine Program. 1 Although this Ruling has been formally designated “not to be published,” it will nevertheless be posted on the Court of Federal Claims’s website in accordance with the E-Government Act of 2002, 44 U.S.C. § 3501 (2012). This means the ruling will be available to anyone with access to the internet. As provided by 42 U.S.C. § 300aa-12(d)(4)(B), however, the parties may object to the decision’s inclusion of certain kinds of confidential information. Specifically, under Vaccine Rule 18(b), each party has fourteen days within which to request redaction “of any information furnished by that party: (1) that is a trade secret or commercial or financial in substance and is privileged or confidential; or (2) that includes medical files or similar files, the disclosure of which would constitute a clearly unwarranted invasion of privacy.” Vaccine Rule 18(b). Otherwise, the Ruling in its present form will be available. Id. 2 The Vaccine Program comprises Part 2 of the National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3758, codified as amended at 42 U.S.C. §§ 300aa-10 through 34 (2012) (“Vaccine Act” or “the Act”). Individual section references hereafter will be to § 300aa of the Act (but will omit that statutory prefix). Case 1:15-vv-00369-LAS Document 45 Filed 08/30/17 Page 2 of 18 I. Factual Background Petitioner’s medical history prior to vaccination shows that she was largely healthy. She was, however, pregnant just before she received the vaccine at issue. During (and even prior to) her pregnancy, Mrs. Lozano experienced some symptoms that have been identified by Respondent as relevant to the case. Thus, Petitioner reported some bilateral numbness in her fingers and arms in the second half of her pregnancy, around February 2012. Ex. 6 at 3. Her family also reported that prior to her pregnancy, Mrs. Lozano had experienced an episode of eye drooping, and had on one occasion found it difficult to open a jar. Id. These prior incidences are not addressed in contemporaneous medical records, but were later mentioned at a neurological visit in September 2012, about two months after vaccination. See generally, Ex. 6. On July 14, 2012, Mrs. Lozano gave birth to a baby girl at Community Memorial Hospital (“CMH”) in Ventura, California. Ex. 4 at 151. The next day, while still hospitalized, Petitioner received the Tdap vaccine. Ex. 1 at 1. Two weeks later, on July 30, 2012, Petitioner reported to Ventura County Obstetrics and Gynecology (“VCOG”) complaining of a low grade fever, body aches, and breast tenderness, which she informed treaters had persisted since leaving the hospital. Ex. 3 at 2. The nurse practitioner she saw at this visit suspected that Mrs. Lozano had early mastitis,3 and prescribed medication, while encouraging Petitioner to continue to breast feed. Id. Petitioner thereafter continued to experience the same persistent symptoms, in addition to fatigue. Id. On August 9, 2012 (25 days after vaccination), Mrs. Lozano went to the emergency department at CMH complaining of abdominal pain and difficulty urinating. Ex. 4 at 128-9. Lab work performed at this time showed no signs of infection, so Petitioner’s treaters concluded that her symptoms were likely related to her mastitis and discharged her. Id. at 130. However, Mrs. Lozano’s symptoms continued to worsen, and she therefore returned to the CMH later that day, now reporting increased weakness so severe that she required a family member to inform treaters of her symptoms. Id. at 202-6. At this point, Petitioner’s symptoms (in addition to what she had previously listed) included fever, weakness, feeling off balance, vision changes, neck pain, headache, vomiting, and feeling dizzy. Id. A brain MRI was performed and showed “numerous focal and patchy high signal intensity lesions involving the brainstem, cerebellopontine angles, right cerebellum, basal ganglia, corpus callosum and subcortical white matter,” which suggested to the radiologist that Petitioner possibly had multiple sclerosis (“MS”), ADEM, or vasculitis. Id. at 82. 3 Mastitis is the inflammation of the breast. Dorland’s Illustrated Medical Dictionary 1111 (32 ed. 2003) (hereinafter “Dorland’s”). 2 Case 1:15-vv-00369-LAS Document 45 Filed 08/30/17 Page 3 of 18 Due to the severity of her symptoms, Mrs. Lozano was admitted to CMH for further evaluation, including a consultation with neurologist Dr. Francisco Torres. Ex. 4 at 49. After review of Mrs. Lozano’s symptoms, her lab reports, and her imaging, Dr. Torres opined that Petitioner had possibly experienced an attack of MS that should be treated with Solu-Medrol4 while Petitioner awaited a more comprehensive workup as well as physical therapy for her ambulatory problems. Id. at 45-6. On August 13, 2012, Mrs. Lozano was discharged after it was determined that the steroid treatment was helping with her symptoms. Ex. 4 at 7-9. Her working diagnosis at discharge was MS, but certain evidence that would corroborate the diagnosis was absent: Petitioner’s lumbar puncture had established that she was negative for oligoclonal bands5 (the presence of which are associated with MS), and the results of tests that would reveal the levels of her myelin basic protein antibodies were still pending. Id. Petitioner was instructed to follow up with Dr. Timothy Sheehy, and she did so on August 17, 2012. Id. Dr. Sheehy thought a second opinion was necessary to insure that Petitioner’s diagnosis was fitting given all of her symptoms and test results. Ex. 5 at 19. Before Mrs. Lozano could seek that second opinion, however, she returned to the CMH emergency department on August 27, 2012. She now presented with burning in her chest, slurring of words, hearing changes, and numbness in her tongue. Ex. 4 at 24-31. Petitioner was discharged later that day with a diagnosis of an MS flare, but was instructed to see her primary care physician and undergo a second MRI of the spine. Id. That MRI was performed the next day and showed “[p]atchy areas of altered signal intensity within the thoracic spinal cord…worrisome for foci of demyelination.” Ex. 5 at 20. On September 9, 2012, Mrs. Lozano sought a second opinion from Dr. Barbara Giesser, a neurologist at the University of California Los Angeles Neurology Outpatient Clinic. Dr. Giesser provided a detailed medical history of Petitioner since first manifestation of her symptoms in late July 2012, and recorded that Mrs. Lozano’s current symptoms included; “numbness bilaterally from her chest down to her lower torso, left arm numbness and paresthesias, right arm weakness and paresthesias, right leg weakness, and burning 4 Solu-Medrol is the trademark for a preparation of methylprednisolone sodium succinate, a medication used in emergency situations to increase a patient’s blood level of methylprednisolone. Dorland’s 1731, 1154. Solu-Medrol can be used to treat a myriad of illness, including arthritis and Guillain-Barré syndrome, as it is anti-inflammatory and relieves pain as well. Auch v. Sec’y of Health & Human Servs., No. 12-673V, 2017 WL 1034396, at *2 (Fed. Cl. Spec. Mstr. Jan. 13, 2017); Carrino v. Sec’y of Health & Human Servs., No. 08-0266V, 2013 WL 3328903, at *9 (Fed. Cl. Spec. Mstr. June 6, 2013). 5 Oligoclonal bands are discrete bands of immunoglobulins with decreased electrophoretic mobility; their appearance in electrophoretograms of cerebrospinal fluid when absent in the serum is a sign of possible multiple sclerosis or other diseases of the central nervous system. Dorland’s at 197. 3 Case 1:15-vv-00369-LAS Document 45 Filed 08/30/17 Page 4 of 18 around her left waist. She states that her cognition has declined and that she is thinking slower and forgetting objects, and having short term memory issues.” Ex. 6 at 3-6. Dr. Giesser’s differential diagnosis included post-viral encephalitis/myelitis, with a working diagnosis of “Clinically Isolated Syndrome” (a condition similar to MS), and she prescribed several medications to help improve her ongoing symptoms. Id. Throughout the fall of 2012, Mrs. Lozano continued to see Dr. Sheehy, noting that she was still experiencing the burning sensation from her back to chest with decreased memory, cognition, and depression. Ex. 5 at 13-15. On February 13, 2013, however, a repeat MRI was performed, and it showed dramatic improvement, suggesting that ADEM was a more likely etiology, which was confirmed through later serological findings. Ex. 5 at 7. Since the winter of 2013, Petitioner’s doctors have continued to opine that ADEM is the most likely explanation for Petitioner’s symptoms, which she continues to seek treatment for, given that she has persistent lingering neurological and physical impairments that keep her on disability, despite normal MRI results. No medical records were filed in this case suggesting that any treater doubted, based on the overall medical history, that ADEM was the proper diagnosis, and Mrs. Lozano has experienced no second set of neurologic symptoms that could reflect a flare- up of symptoms that might instead suggest that MS was actually the explanation for her condition. II. Expert Opinions and Testimony The parties both offered expert neurologists to opine on the merits of this case. Each expert provided an expert report and testified at the hearing. A. Dr. Norman Latov Petitioner’s expert, Norman Latov, M.D., Ph.D, submitted two expert reports in this case and also testified at the hearing. See e.g., Ex. 21, dated Nov. 16, 2015 (“Latov Ex. Rep.”); Ex. 23, dated June 13, 2016 (“Latov Supp. Rep.”); Transcript (“Tr.”) at 4-52, 103-6. Dr. Latov attended the University of Pennsylvania to complete his medical and doctorate degree. Tr. at 5; see also Ex. 22, dated Nov. 16, 2015. He completed his residency in neurology and immunology at Columbia University before joining their faculty. Tr. at 5. Dr. Latov is now on the faculty at Weill Cornell Medicine, where he directs a peripheral neuropathy center as well as serving as a professor of neurology and neuroscience, and being an attending neurologist. Id. He has previously conducted research in the area of autoimmune neurological diseases. Id. at 6. Dr. Latov estimates that currently about 30 percent of his time is spent seeing patients, while the rest is dedicated to administrative tasks, teaching, and research. Id. In his clinical practice he commonly treats patients with peripheral neuropathies such as Guillain-Barré syndrome (“GBS”), chronic inflammatory demyelinating polyneuropathy (CIDP), MS, and transverse myelitis. Id. at 7. Due to 4 Case 1:15-vv-00369-LAS Document 45 Filed 08/30/17 Page 5 of 18 the uncommonness of ADEM, Dr. Latov only has had occasional experience in treating the condition p (about one such patient every one to two years) as a part of his duties as an attending physician. Id. at 8. Dr. Latov opined that Mrs. Lozano’s ADEM was the product of her receipt of the Tdap vaccine. Tr. at 8. He began by describing ADEM as an autoimmune demyelinating disease of the central nervous system that attacks the white matter of the brain and spinal cord of its patients. Latov Ex. Rep. at 5. Dr. Latov added that ADEM is known to be triggered most commonly by infection or vaccination. Tr. at 10. He noted that ADEM can be confirmed through lesions on an MRI, inflammatory changes in the spinal fluid, and a corresponding lack of oligoclonal bands (the presence of which would reflect ongoing inflammation originating in the CNS rather than coming from outside it). Id. Javed, A., Chapter 35 - Acute disseminated encephalomyelitis. In C. T. a. J. B. Alex (Ed.), Handbook of Clinical Neurology, 123 (2014), at 709, 711, filed as Ex. 21, Tab F. In keeping with its acute nature, Dr. Latov noted, a hallmark of ADEM is its subsequent resolution – something that can be confirmed by later MRIs. Id. Dr. Latov cited several pieces of medical literature that have observed an association between tetanus-containing vaccines akin to what Mrs. Lozano received and ADEM. See, e.g., W. Huynh, et. al, Post-vaccination encephalomyelitis: literature review and illustrative case, J. Clinical Neuroscience, 15(12) at 1315-22 (2008), filed as Ex. 21, Tab E (“Huynh”); D. Karussis D. and P. Petrou, The spectrum of post-vaccination inflammatory CNS demyelinating syndromes, Autoimmunity Rev. 13(3) at 215-24 (2014), filed as Ex. 21, Tab G (“Karussis”). The Huynh authors performed a medical literature review of studies regarding post-vaccination and post- infectious ADEM. Huynh at 1315. Huynh found that ADEM was associated with several vaccines, including diphtheria-tetanus-polio. Id. at 1316. Karussis also observes an association between tetanus-containing vaccines and ADEM. Karussis at 216. Moreover, Karussis considered the prevailing hypothesis of molecular mimicry as a mechanistic explanation for ADEM’s pathogenesis, describing it as occurring when an “antigen of viral origin cross-react[s] with myelin components (molecular mimicry) and in a secondary manner induce a hyperergic reaction, that leads to the development of disseminated demyelination.” Id. at 217. Dr. Latov also proposed bystander activation as an alternative mechanism, by which components of a vaccine might precipitate or exacerbate an autoimmune reaction from immune cells not specifically responding directly to the vaccine’s antigens, and cited literature to support the concept.6 6 Bystander activation occurs when immune system cells that were previously suppressed, or anergic, are broken down by an existing/ongoing immune response to infection (or an autoimmune response to vaccination), causing immune tolerance created by those cells to similarly be destroyed and thereby allowing the dysregulation of the immune response to continue or expand. Latov Ex. Rep. at 5. In support, Dr. Latov presented two animal studies involving the induction of “experimental autoimmune encephalomyelitis,” or EAE, which provides a model of ADEM. Id. 5 Case 1:15-vv-00369-LAS Document 45 Filed 08/30/17 Page 6 of 18 Dr. Latov next connected his theory to the medical record, in an effort to show it working out in Mrs. Lozano’s circumstances. First, he proposed the Tdap vaccine acted as the trigger initiating Petitioner’s autoimmune response. Tr. at 9. He also recognized that Petitioner had the proper post-vaccination signs, such as trustworthy neurological findings indicating multiple sites of involvement, the presence of demyelinating lesions on her MRIs, an increased number of white blood cells in her CSF fluid, and the absence of oligoclonal bands from the same testing (since their presence would be more likely associated with MS). Id. Finally, and most significantly to Dr. Latov, the lesions observed on Mrs. Lozano’s first MRIs resolved months later, and she has since experienced no additional demyelinating events. Id. Dr. Latov was asked to reconcile the inclusion of MS in Petitioner’s initial differential diagnosis with her treaters’ later conclusion (which he accepted) that the proper diagnosis was ADEM. To do so, he pointed to the same test results and evidence of resolved lesions discussed above. Tr. at 9-10. He also noted that as Mrs. Lozano’s physicians evaluated her condition over time, they acknowledged the need to seek out a variety of treater views in understanding the nature of her illness, thereby increasing his confidence in their ultimate conclusion, as it was the product of thorough medical care. Id. at 50. Petitioner’s treaters eventually changed their diagnosis to ADEM after Mrs. Lozano’s MRIs cleared and she had experienced no subsequent neurological episodes. Id. at 10. He accepted the decisions of her initial treaters to employ medications and treatments used for MS as the safer course, given that MS can worsen significantly if not treated quickly, but noted that such treatments were subsequently abandoned successfully once the clinical evidence better supported the ADEM diagnosis. Id. at 42, 44. In addition to questions about Mrs. Lozano’s diagnosis, Dr. Latov also addressed some of the purported pre-vaccination neurologic symptoms from Petitioner’s pregnancy or before, such as her hand numbness. Latov Ex. Rep. at 6. Dr. Latov rejected the idea that hand numbness was related to Petitioner’s ADEM, and instead proposed that it as likely reflected carpal tunnel syndrome caused by increased tissue swelling common in the latter parts of pregnancy. Tr. at 34. He did concede however, that any undiscovered and preexisting brain lesions that had developed prior to vaccination would have appeared the same in the MRI that Mrs. Lozano had shortly after the onset of her symptoms. Id. at 30-31. Dr. Latov further stated that it would be impossible to know when any of the lesions actually began without prior MRIs. Id. at 31. He nevertheless opined that if the numbness in Mrs. Lozano’s hand was caused by a spinal lesion, he would have expected Mrs. Lozano to have also experienced symptoms in her legs and altered reflex responses, which she did not report in her numerous doctors’ visits during the latter part of her pregnancy. Id. at 34- 35. Researchers have been able to induce EAE by injecting a ganglioside that would target cells that were normally dormant, thus exhibiting bystander activation as a casual mechanism. Id. 6 Case 1:15-vv-00369-LAS Document 45 Filed 08/30/17 Page 7 of 18 Dr. Latov further contested the meaningfulness of other purported instances of neurologic symptoms, such as Petitioner’s family’s report that she once had found it difficult to open a jar, or her late 2011 eye droop. Tr. at 36. He opined that if both of these incidences had been related to a neurological condition, he would have expected other symptoms to have also been present and recorded in the medical record. Id. For example, if the eye droop had been a neurological condition, Dr. Latov opined that Petitioner would have experienced worsening drooping over time - yet there was no evidence in the medical records that the condition persisted or was reported by Petitioner. Id. Finally, Dr. Latov disputed Respondent’s contention that Mrs. Lozano actually was suffering from posterior reversible encephalopathy syndrome (“PRES”) rather than ADEM. Tr. at 47. As Dr. Latov described, PRES is a condition marked by the presence of edema in the posterior part of the brain as revealed on MRIs, and agreed that it was not unreasonable to propose it for someone experiencing symptoms post-partum, as was the case with Mrs. Lozano. Id. at 48. The majority of patients suffering from PRES present with a decreased level of consciousness and have seizures. Id. But here, Dr. Latov maintained, those symptoms were not present in Mrs. Lozano. More importantly, her MRIs showed lesions throughout the spinal cord and brain —not just in the posterior region – and detected no edema, nor had she experienced seizures or decreased consciousness. Id. at 47. In addition, the symptoms that led Mrs. Lozano to go to the ER occurred almost four weeks after she gave birth—whereas in PRES, symptoms would more commonly arise no more than a few days after giving birth (given the relationship of PRES to a retained placenta).7 Id. at 48. In addition, none of Petitioner’s treaters ever concluded that PRES was a reasonable explanation for her condition. Id. at 47. Dr. Latov thus concluded that PRES was an improper diagnosis given Petitioner’s clinical presentation. Id. at 48-49. B. Dr. Thomas Leist Respondent’s expert, Thomas Leist, M.D., Ph.D, submitted one expert report in this case and testified at the hearing. See e.g., Resp’t’s Ex. A, dated Mar. 29, 2016 (“Leist Ex. Rep.”); Tr. at 53-95, 102. Dr. Leist attended the University of Zurich, where he obtained his Ph.D. in immunology and biochemistry as well as a post-doctorate degree in experimental pathologies. Tr. at 53; see 7 A placenta not removed within 30-60 minutes after delivery is known as a retained placenta; if left untreated, a retained placenta can cause a severe infection or blood loss to the mother. Pregnancy week by week: Placenta: How it works, what’s normal, Mayo Clinic (Mar. 13, 2015), http://www.mayoclinic.org/healthy-lifestyle/pregnancy-week-by-week/in-depth/placenta/art-20044425 (last accessed July 21, 2017). In the context of PRES, a retained placenta is often to blame for the toxemia following birth, often causing eclampsia (increased blood pressure), which can ultimately result in PRES. Bartynski. Posterior Reversible Encephalopathy Syndrome, Part 1: Fundamental Imaging and Clinical Features, Am. J. Neuroradiol 29:1036-42 (2008). 7 Case 1:15-vv-00369-LAS Document 45 Filed 08/30/17 Page 8 of 18 also, Ex. B, dated Mar. 29, 2016. He also completed a post-doctorate at the University of California, Los Angeles and attended medical school in the United States at the University of Miami. Id. He then completed a residency in neurology at Cornell University before becoming a fellow at the National Institute of Health. Tr. at 54. Dr. Leist is board certified in neurology and currently serves as a professor of neurology at Thomas Jefferson University in Philadelphia, Pennsylvania as well as directing the MS center and guiding the MS or the neuro-immunology fellowship program. Id. at 53. As a part of this role, he sees about 2,700 patients diagnosed with MS (whether solely or as part of a differential diagnosis), as well as seeing patients in tertiary care hospitals affiliated with Thomas Jefferson University Hospital. Id. at 57. Dr. Leist opined that Mrs. Lozano actually had PRES, and that it was not caused by the Tdap vaccine she received in July 2012. Leist Ex. Rep. at 9. He based this conclusion on Mrs. Lozano’s rapid onset of neurological symptoms after giving birth—rather than following vaccination— stressing that PRES is a known vascular complication following pregnancy, especially with late onset preeclampsia. Id. at 9-10. Although Mrs. Lozano was not formally diagnosed with preeclampsia during her pregnancy, she exhibited elevated blood pressure during the first week of August 2012 (or about two weeks after she gave birth), and shortly before the onset of her neurological symptoms. Id. at 9. But in his view, a mother’s blood pressure should be lower in the post-partum phase, thereby corroborating the possibility that she was experiencing a vascular-related condition. Tr. at 69. In response to the fact that PRES was never considered for Petitioner by any of her treating physicians, Dr. Leist pointed to Petitioner’s initial MRI from August 2012. The radiologist who performed the MRI included vasculopathy (a broad category that would include PRES) in the differential diagnosis. Tr. at 62. Moreover, he proposed, if Mrs. Lozano’s condition were demyelinating he would have expected to see evidence of the lesions in subsequent brain MRIs given Mrs. Lozano’s ongoing neurological sequelae. Id. at 63. Instead, the lesions had completely resolved, leading Dr. Leist to prefer PRES as the diagnosis congruent with Mrs. Lozano’s clinical picture. Id. Dr. Leist admitted that outside of the radiologist’s statement, none of Petitioner’s physicians ever subsequently considered PRES or vasculitis as the proper diagnosis, but he opined that this was because her physicians had not given sufficient weight to the fact that she was post- partum at the time of her presenting symptoms. Id. at 99. III. Procedural History As noted above, this case was filed on April 13, 2015. Within three months, the majority of medical records had been filed, along with a statement of completion and Respondent’s Rule 4(c) Report. Over the next year, both parties filed expert reports and medical literature, along with a few pieces of outstanding medical records. During this time, Petitioner attempted to engage Respondent in settlement discussions by making a demand, but these efforts were unsuccessful. 8 Case 1:15-vv-00369-LAS Document 45 Filed 08/30/17 Page 9 of 18 I accordingly set this matter down for a hearing on June 24, 2017. Order, dated June 29, 2016 (ECF No. 27). The briefing and hearing occurred as scheduled, and this case is now ripe for a decision. IV. Applicable Legal Standards A. Petitioner’s Overall Burden in Vaccine Program Cases To receive compensation in the Vaccine Program, a petitioner must prove either: (1) that he suffered a “Table Injury” – i.e., an injury falling within the Vaccine Injury Table – corresponding to one of the vaccinations in question within a statutorily prescribed period of time or, in the alternative, (2) that his illnesses were actually caused by a vaccine (a “Non-Table Injury”). See Sections 13(a)(1)(A), 11(c)(1), and 14(a), as amended by 42 C.F.R. § 100.3; § 11(c)(1)(C)(ii)(I); see also Moberly v. Sec’y of Health & Human Servs., 592 F.3d 1315, 1321 (Fed. Cir. 2010); Capizzano v. Sec’y of Health & Human Servs., 440 F.3d 1317, 1320 (Fed. Cir. 2006).8 In this case, Petitioner does not assert a Table claim. For both Table and Non-Table claims, Vaccine Program petitioners bear a “preponderance of the evidence” burden of proof. Section 13(1)(a). That is, a petitioner must offer evidence that leads the “trier of fact to believe that the existence of a fact is more probable than its nonexistence before [he] may find in favor of the party who has the burden to persuade the judge of the fact’s existence.” Moberly, 592 F.3d at 1322 n.2; see also Snowbank Enter. v. United States, 6 Cl. Ct. 476, 486 (1984) (mere conjecture or speculation is insufficient under a preponderance standard). Proof of medical certainty is not required. Bunting v. Sec’y of Health & Human Servs., 931 F.2d 867, 873 (Fed. Cir. 1991). In particular, a petitioner must demonstrate that the vaccine was “not only [the] but-for cause of the injury but also a substantial factor in bringing about the injury.” Moberly, 592 F.3d at 1321 (quoting Shyface v. Sec’y of Health & Human Servs., 165 F.3d 1344, 1352-53 (Fed. Cir. 1999)); Pafford v. Sec’y of Health & Human Servs., 451 F.3d 1352, 1355 (Fed. Cir. 2006). A petitioner may not receive a Vaccine Program award based solely on his assertions; rather, the petition must be supported by either medical records or by the opinion of a competent physician. Section 13(a)(1). In attempting to establish entitlement to a Vaccine Program award of compensation for a Non-Table claim, a petitioner must satisfy all three of the elements established by the Federal 8 Decisions of special masters (some of which I reference in this ruling) constitute persuasive but not binding authority. Hanlon v. Sec’y of Health & Human Servs., 40 Fed. Cl. 625, 630 (1998). By contrast, Federal Circuit rulings concerning legal issues are binding on special masters. Guillory v. Sec’y of Health & Human Servs., 59 Fed. Cl. 121, 124 (2003), aff’d 104 F. App’x 712 (Fed. Cir. 2004); see also Spooner v. Sec’y of Health & Human Servs., No. 13- 159V, 2014 WL 504728, at *7 n.12 (Fed. Cl. Spec. Mstr. Jan. 16, 2014). 9 Case 1:15-vv-00369-LAS Document 45 Filed 08/30/17 Page 10 of 18 Circuit in Althen v. Sec’y of Health & Human Servs., 418 F.3d 1274 (Fed. Cir. 2005): “(1) a medical theory causally connecting the vaccination and the injury; (2) a logical sequence of cause and effect showing that the vaccination was the reason for the injury; and (3) a showing of proximate temporal relationship between vaccination and injury.” Althen, 418 F.3d at 1278. Each of the Althen prongs requires a different showing. Under Althen prong one, petitioners must provide a “reputable medical theory,” demonstrating that the vaccine received can cause the type of injury alleged. Pafford, 451 F.3d at 1355-56 (citations omitted). To satisfy this prong, a petitioner’s theory must be based on a “sound and reliable medical or scientific explanation.” Knudsen v. Sec’y of Health & Human Servs., 35 F.3d 543, 548 (Fed. Cir. 1994). Such a theory must only be “legally probable, not medically or scientifically certain.” Id. at 549. Petitioners may satisfy the first Althen prong without resort to medical literature, epidemiological studies, demonstration of a specific mechanism, or a generally accepted medical theory. Andreu v. Sec’y of Health & Human Servs., 569 F.3d 1367, 1378-79 (Fed. Cir. 2009) (citing Capizzano, 440 F.3d at 1325-26). Special masters, despite their expertise, are not empowered by statute to conclusively resolve what are essentially thorny scientific and medical questions, and thus scientific evidence offered to establish Althen prong one is viewed “not through the lens of the laboratorian, but instead from the vantage point of the Vaccine Act’s preponderant evidence standard.” Id. at 1380. Accordingly, special masters must take care not to increase the burden placed on petitioners in offering a scientific theory linking vaccine to injury. Contreras v. Sec’y of Health & Human Servs., 121 Fed. Cl. 230, 245 (2015) (“[p]lausibility . . . in many cases may be enough to satisfy Althen prong one” (emphasis in original)), vacated on other grounds, 844 F.3d 1363 (Fed. Cir. 2017). But this does not negate or reduce a petitioner’s ultimate burden to establish his overall entitlement to damages by preponderant evidence. W.C. v. Sec’y of Health & Human Servs., 704 F.3d 1352, 1356 (Fed. Cir. 2013) (citations omitted).9 The second Althen prong requires proof of a logical sequence of cause and effect, usually supported by facts derived from a petitioner’s medical records. Althen, 418 F.3d at 1278; Andreu, 569 F.3d at 1375-77; Capizzano, 440 F.3d at 1326; Grant v. Sec’y of Health & Human Servs., 956 F.2d 1144, 1148 (Fed. Cir. 1992). In establishing that a vaccine “did cause” injury, the opinions and views of the injured party’s treating physicians are entitled to some weight. Andreu, 569 F.3d at 1367; Capizzano, 440 F.3d at 1326 (“medical records and medical opinion testimony are favored in vaccine cases, as treating physicians are likely to be in the best position to determine whether a 9 Although decisions like Contreras suggest that the burden of proof required to satisfy the first Althen prong is less than the other two, there is ample contrary authority for the more straightforward proposition that the first Althen prong (as a component of the overall test) simply requires application of a preponderance evidentiary standard when evaluating if a reliable and plausible causation theory has been established. Broekelschen v. Sec’y of Health & Human Servs., 618 F.3d 1339, 1350 (Fed. Cir. 2010). 10 Case 1:15-vv-00369-LAS Document 45 Filed 08/30/17 Page 11 of 18 ‘logical sequence of cause and effect show[s] that the vaccination was the reason for the injury’”) (quoting Althen, 418 F.3d at 1280). Medical records are generally viewed as particularly trustworthy evidence, since they are created contemporaneously with the treatment of the patient. Cucuras v. Sec’y of Health & Human Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993). However, medical records and/or statements of a treating physician’s views do not per se bind the special master to adopt the conclusions of such an individual, even if they must be considered and carefully evaluated. Section 13(b)(1) (providing that “[a]ny such diagnosis, conclusion, judgment, test result, report, or summary shall not be binding on the special master or court”); Snyder v. Sec’y of Health & Human Servs., 88 Fed. Cl. 706, 746 n.67 (2009) (“there is nothing . . . that mandates that the testimony of a treating physician is sacrosanct – that it must be accepted in its entirety and cannot be rebutted”). As with expert testimony offered to establish a theory of causation, the opinions or diagnoses of treating physicians are only as trustworthy as the reasonableness of their suppositions or bases. The views of treating physicians should also be weighed against other, contrary evidence also present in the record – including conflicting opinions among such individuals. Hibbard v. Sec’y of Health & Human Servs., 100 Fed. Cl. 742, 749 (2011) (not arbitrary or capricious for special master to weigh competing treating physicians’ conclusions against each other), aff’d, 698 F.3d 1355 (Fed. Cir. 2012); Caves v. Sec’y of Dept. of Health & Human Servs., No. 06-522V, 2011 WL 1935813, at *17 (Fed. Cl. Spec. Mstr. Apr. 29, 2011), mot. for review den’d, 100 Fed. Cl. 344, 356 (2011), aff’d without opinion, 475 Fed. App’x 765 (Fed. Cir. 2012). The third Althen prong requires establishing a “proximate temporal relationship” between the vaccination and the injury alleged. Althen, 418 F.3d at 1281. That term has been equated to the phrase “medically-acceptable temporal relationship.” Id. A petitioner must offer “preponderant proof that the onset of symptoms occurred within a timeframe which, given the medical understanding of the disorder’s etiology, it is medically acceptable to infer causation.” de Bazan v. Sec’y of Health & Human Servs., 539 F.3d 1347, 1352 (Fed. Cir. 2008). The explanation for what is a medically acceptable timeframe must also coincide with the theory of how the relevant vaccine can cause an injury (Althen prong one’s requirement). Id. at 1352; Shapiro v. Sec’y of Health & Human Servs., 101 Fed. Cl. 532, 542 (2011), recons. den’d after remand, 105 Fed. Cl. 353 (2012), aff’d mem., 2013 WL 1896173 (Fed. Cir. 2013); Koehn v. Sec’y of Health & Human Servs., No. 11-355V, 2013 WL 3214877 (Fed. Cl. Spec. Mstr. May 30, 2013), mot. for review den’d (Fed. Cl. Dec. 3, 2013), aff’d, 773 F.3d 1239 (Fed. Cir. 2014). 11 Case 1:15-vv-00369-LAS Document 45 Filed 08/30/17 Page 12 of 18 B. Law Governing Analysis of Fact Evidence The process for making determinations in Vaccine Program cases regarding factual issues begins with consideration of the medical records. Section 11(c)(2). The special master is required to consider “all [] relevant medical and scientific evidence contained in the record,” including “any diagnosis, conclusion, medical judgment, or autopsy or coroner’s report which is contained in the record regarding the nature, causation, and aggravation of the petitioner’s illness, disability, injury, condition, or death,” as well as the “results of any diagnostic or evaluative test which are contained in the record and the summaries and conclusions.” Section 13(b)(1)(A). The special master is then required to weigh the evidence presented, including contemporaneous medical records and testimony. See Burns v. Sec’y of Health & Human Servs., 3 F.3d 415, 417 (Fed. Cir. 1993) (it is within the special master’s discretion to determine whether to afford greater weight to contemporaneous medical records than to other evidence, such as oral testimony surrounding the events in question that was given at a later date, provided that such determination is evidenced by a rational determination). Medical records that are created contemporaneously with the events they describe are presumed to be accurate and “complete” (i.e., presenting all relevant information on a patient’s health problems). Cucuras, 993 F.2d at 1528; Doe/70 v. Sec’y of Health & Human Servs., 95 Fed. Cl. 598, 608 (2010) (“[g]iven the inconsistencies between petitioner’s testimony and his contemporaneous medical records, the special master’s decision to rely on petitioner’s medical records was rational and consistent with applicable law”), aff’d, Rickett v. Sec’y of Health & Human Servs., 468 F. App’x 952 (Fed. Cir. 2011) (non-precedential opinion). This presumption is based on the linked propositions that (i) sick people visit medical professionals; (ii) sick people honestly report their health problems to those professionals; and (iii) medical professionals record what they are told or observe when examining their patients in as accurate a manner as possible, so that they are aware of enough relevant facts to make appropriate treatment decisions. Sanchez v. Sec’y of Health & Human Servs., No. 11-685V, 2013 WL 1880825, at *2 (Fed. Cl. Spec. Mstr. Apr. 10, 2013); Cucuras v. Sec’y of Health & Human Servs., 26 Cl. Ct. 537, 543 (1992), aff’d, 993 F.2d at 1525 (Fed. Cir. 1993) (“[i]t strains reason to conclude that petitioners would fail to accurately report the onset of their daughter’s symptoms.”). Accordingly, if the medical records are clear, consistent, and complete, then they should be afforded substantial weight. Lowrie v. Sec’y of Health & Human Servs., No. 03-1585V, 2005 WL 6117475, at *20 (Fed. Cl. Spec. Mstr. Dec. 12, 2005). Indeed, contemporaneous medical records are generally found to be deserving of greater evidentiary weight than oral testimony – especially where such testimony conflicts with the record evidence. Cucuras, 993 F.2d at 1528; see also Murphy v. Sec’y of Health & Human Servs., 23 Cl. Ct. 726, 733 (1991), aff’d per curiam, 12 Case 1:15-vv-00369-LAS Document 45 Filed 08/30/17 Page 13 of 18 968 F.2d 1226 (Fed. Cir. 1992), cert. den’d, Murphy v. Sullivan, 506 U.S. 974 (1992) (citing United States v. United States Gypsum Co., 333 U.S. 364, 396 (1947) (“[i]t has generally been held that oral testimony which is in conflict with contemporaneous documents is entitled to little evidentiary weight.”)). However, there are situations in which compelling oral testimony may be more persuasive than written records, such as where records are deemed to be incomplete or inaccurate. Campbell v. Sec’y of Health & Human Servs., 69 Fed. Cl. 775, 779 (2006) (“like any norm based upon common sense and experience, this rule should not be treated as an absolute and must yield where the factual predicates for its application are weak or lacking”); Lowrie, 2005 WL 6117475, at *19 (“[w]ritten records which are, themselves, inconsistent, should be accorded less deference than those which are internally consistent”) (quoting Murphy, 23 Cl. Ct. at 733)). Ultimately, a determination regarding a witness’s credibility is needed when determining the weight that such testimony should be afforded. Andreu, 569 F.3d at 1379; Bradley v. Sec’y of Health & Human Servs., 991 F.2d 1570, 1575 (Fed. Cir. 1993). When witness testimony is offered to overcome the presumption of accuracy afforded to contemporaneous medical records, such testimony must be “consistent, clear, cogent, and compelling.” Sanchez, 2013 WL 1880825, at *3 (citing Blutstein v. Sec’y of Health & Human Servs., No. 90-2808V, 1998 WL 408611, at *5 (Fed. Cl. Spec. Mstr. June 30, 1998)). In determining the accuracy and completeness of medical records, the Court of Federal Claims has listed four possible explanations for inconsistencies between contemporaneously created medical records and later testimony: (1) a person’s failure to recount to the medical professional everything that happened during the relevant time period; (2) the medical professional’s failure to document everything reported to her or him; (3) a person’s faulty recollection of the events when presenting testimony; or (4) a person’s purposeful recounting of symptoms that did not exist. La Londe v. Sec’y of Health & Human Servs., 110 Fed. Cl. 184, 203-04 (2013), aff’d, 746 F.3d 1334 (Fed. Cir. 2014). In making a determination regarding whether to afford greater weight to contemporaneous medical records or other evidence, such as testimony at hearing, there must be evidence that this decision was the result of a rational determination. Burns, 3 F.3d at 417. C. Analysis of Expert Testimony Establishing a sound and reliable medical theory often requires a petitioner to present expert testimony in support of his claim. Lampe v. Sec’y of Health & Human Servs., 219 F.3d 1357, 1361 (Fed. Cir. 2000). Vaccine Program expert testimony is usually evaluated according to the factors for analyzing scientific reliability set forth in Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579, 594-96 (1993). See Cedillo v. Sec’y of Health & Human Servs., 617 F.3d 1328, 1339 13 Case 1:15-vv-00369-LAS Document 45 Filed 08/30/17 Page 14 of 18 (Fed. Cir. 2010) (citing Terran v. Sec’y of Health & Human Servs., 195 F.3d 1302, 1316 (Fed. Cir. 1999). “The Daubert factors for analyzing the reliability of testimony are: (1) whether a theory or technique can be (and has been) tested; (2) whether the theory or technique has been subjected to peer review and publication; (3) whether there is a known or potential rate of error and whether there are standards for controlling the error; and (4) whether the theory or technique enjoys general acceptance within a relevant scientific community.” Terran, 195 F.3d at 1316 n.2 (citing Daubert, 509 U.S. at 592-95). The Daubert factors play a slightly different role in Vaccine Program cases than they do when applied in other federal judicial for a (such as the district courts). Daubert factors are usually employed by judges (in the performance of their evidentiary gatekeeper roles) to exclude evidence that is unreliable and/or could confuse a jury. In Vaccine Program cases, by contrast, these factors are used in the weighing of the reliability of scientific evidence proffered. Davis v. Sec’y of Health & Human Servs., 94 Fed. Cl. 53, 66-67 (2010) (“uniquely in this Circuit, the Daubert factors have been employed also as an acceptable evidentiary-gauging tool with respect to persuasiveness of expert testimony already admitted”). The flexible use of the Daubert factors to evaluate the persuasiveness and reliability of expert testimony has routinely been upheld. See, e.g., Snyder, 88 Fed. Cl. at 742-45. In this matter (as in numerous other Vaccine Program cases), Daubert has not been employed at the threshold, to determine what evidence should be admitted, but instead to determine whether expert testimony offered is reliable and/or persuasive. Respondent frequently offers one or more experts of her own in order to rebut a petitioner’s case. Where both sides offer expert testimony, a special master’s decision may be “based on the credibility of the experts and the relative persuasiveness of their competing theories.” Broekelschen v. Sec’y of Health & Human Servs., 618 F.3d 1339, 1347 (Fed. Cir. 2010) (citing Lampe, 219 F.3d at 1362). However, nothing requires the acceptance of an expert’s conclusion “connected to existing data only by the ipse dixit of the expert,” especially if “there is simply too great an analytical gap between the data and the opinion proffered.” Snyder, 88 Fed. Cl. at 743 (quoting Gen. Elec. Co. v. Joiner, 522 U.S. 146 91997)); see also Isaac v. Sec’y of Health & Human Servs., No. 08-601V, 2012 WL 3609993, at *17 (Fed. Cl. Spec. Mstr. July 30, 2012), mot. for review den’d, 108 Fed. Cl. 743 (2013), aff’d, 540 Fed. App’x 999 (Fed. Cir. 2013) (citing Cedillo, 617 F.3d at 1339). Weighing the relative persuasiveness of competing expert testimony, based on a particular expert’s credibility, is part of the overall reliability analysis to which special masters must subject expert testimony in Vaccine Program cases. Moberly, 592 F.3d at 1325-26 (“[a]ssessments as to the reliability of expert testimony often turn on credibility determinations”); see also Porter v. Sec’y of Health & Human Servs., 663 F.3d 1242, 1250 (Fed. Cir. 2011) (“this court has unambiguously explained that special masters are expected to consider the credibility of expert witnesses in evaluating petitions for compensation under the Vaccine Act”). 14 Case 1:15-vv-00369-LAS Document 45 Filed 08/30/17 Page 15 of 18 D. Consideration of Medical Literature Both parties filed medical and scientific literature in this case, but not all such items factor into the outcome of this decision. While I have reviewed all of the medical literature submitted in this case, I discuss only those articles that are most relevant to my determination and/or are central to Petitioner’s case – just as I have not exhaustively discussed every individual medical record filed. Moriarty v. Sec’y of Health & Human Servs., No. 2015-5072, 2016 WL 1358616, at *5 (Fed. Cir. Apr. 6, 2016) (“[w]e generally presume that a special master considered the relevant record evidence even though he does not explicitly reference such evidence in his decision”) (citation omitted); see also Paterek v. Sec’y of Health & Human Servs., 527 F. App’x 875, 884 (Fed. Cir. 2013) (“[f]inding certain information not relevant does not lead to – and likely undermines – the conclusion that it was not considered”). ANALYSIS I. Althen Prong One As described in detail above, a Program petitioner must show that the vaccine administered “can cause” the alleged injury by proposing a scientifically and medically reliable causation theory. Here, Dr. Latov offered his own opinion as to causation, bulwarked with literature suggesting that tetanus-containing vaccines like the Tdap vaccine Petitioner received have been associated with autoimmune diseases such as ADEM. He also presented two possible mechanisms —molecular mimicry and bystander activation – by which the vaccines could precipitate the autoimmune response. Tr. at 12. Both of these theories have been accepted in other Program cases as reliable causal mechanisms for autoimmune-mediated demyelinating illnesses. Raymo v. Sec’y of Health & Human Servs., No. 11-0654V , 2014 WL 1092274 (Fed. Cl. Spec. Mstr. Feb. 24, 2014) (“[a]lthough the precise biological mechanism has not been determined, molecular mimicry and bystander activation theories are biologically probable”). More specifically, the causal association between vaccines like Tdap and ADEM has been established in many prior Program cases. See e.g., Kennedy v. Sec’y of Health & Human Servs., No. 09-474V, 2012 WL 1929801 (Fed. Cl. Spec. Mstr. May 8, 2012) (petitioner who received the meningococcal and Tdap vaccines and then developed ADEM was entitled to compensation based on the theory of molecular mimicry); Lerwick v. Sec’y of Health & Human Servs., No. 06-847V, 2011 WL 4537874 (Fed. Cl. Spec. Mstr. Sept. 8, 2011) (ADEM and DTaP/Hep B vaccines); Kuperus v. Sec’y of Health & Human Servs., No. 01-0060V, 2003 WL 22912885 (Fed. Cl. Spec. Mstr. Oct. 23, 2003) (awarded compensation in a DTaP/ADEM case based on the theory of 15 Case 1:15-vv-00369-LAS Document 45 Filed 08/30/17 Page 16 of 18 immune-mediated attack); Johnson v. Sec’y of Health & Human Servs., No. 99-0219V, 2000 WL 1141582 (Fed. Cl. Spec. Mstr. July 27, 2000) (ADEM and Td vaccine). As explained in such cases, components of the Tdap vaccine (inactivated diphtheria toxin or tetanus toxoid) have been associated with myelin destruction through an immune mediated attack. Kuperus, 2003 WL 22912885, at *9. This can occur when antigens in these components resemble a component of the myelin in the brain, ultimately triggering an immune response. Id. at *8. Dr. Latov’s testimony and reports supported this idea, proposing molecular mimicry and bystander activation as mechanisms for the autoimmune reactions, and by citing studies recognizing vaccination as a preceding event to ADEM, allowing him to opine that the association was more than coincidental. Tr. at 12, Latov Supp. Rep at 4. I find the theory similarly persuasive, and reliable from medical and scientific standpoint. Nor has Respondent adequately rebutted it.10 Accordingly, Petitioner has met the first Althen prong. II. Althen Prong Two The primary challenge mounted by Respondent to the evidence offered for the second, “did cause” prong of the Althen test was his argument that ADEM was not the correct diagnosis (since if so, Petitioner’s showing as to the first Althen prong regarding ADEM would be irrelevant). I find, however, that Petitioner has persuasively established that the record evidence best supports the ADEM diagnosis. Consideration of the history of Petitioner’s treatment best illustrates the propriety of her ADEM diagnosis. Although Mrs. Lozano’s treaters initially included MS as part of the differential diagnosis (and did so properly in Dr. Latov’s view, given the risks posed by MS), her subsequent clinical progression ultimately led them away from MS and toward ADEM. This was based on the resolution of Petitioner’s lesions, as well as lab test results obtained closer in time to onset of her symptoms - the absence of oligoclonal bands in her CSF fluid, plus an elevated white blood cell count—all of which tended not to confirm an MS diagnosis. The fact that no treaters otherwise appear to have questioned ADEM since the winter of 2013 also suggests that the diagnosis is more likely than not correct. 10 Respondent, via Dr. Leist, did offer evidence from the Institutes of Medicine (“IOM”) positing that “mechanistic evidence regarding an association between diphtheria toxoid or acellular pertussis vaccine and ADEM is lacking.” Leist Ex. Rep. at 8. I accept this evidence, and note that IOM evidence is generally given credence in the Program. Garner v. Sec’y of Health & Human Servs., No. 15-063, 2017 WL 1713184 (Fed. Cl. Spec. Mstr. Mar. 24, 2017) Nevertheless, the overall showing by Petitioner was sufficient to meet her preponderant burden of proof. 16 Case 1:15-vv-00369-LAS Document 45 Filed 08/30/17 Page 17 of 18 Respondent was also unsuccessful in establishing that Mrs. Lozano had symptoms potentially related to her ADEM that began pre-vaccination. By and large, the medical record (and as interpreted by both experts) suggests that these potentially-neurologic symptoms that Petitioner might have experienced, such as a drooping face incident or difficulty opening a jar, are too anecdotal to deem significant, and instead appear to have been recounted by Petitioner and her family members at the time of her initial presentation to treaters in August 2012, in their reasonable effort to explain as exhaustively as possible any antecedent occurrences that might shed light on her then-alarming condition. Dr. Latov’s explanation of the numbness Petitioner experienced prior to vaccination, in the last months of pregnancy as likely related to that pregnancy, was also more persuasive than Respondent’s suggestion that it revealed a preexisting neurologic symptom. Tr. at 19. In addition, these pre-vaccination incidents were not supported by treatment records that would suggest a persistent neurological defect. Instead, the symptoms were only mentioned years after their original occurrence, with no support from contemporaneous medical records that indicate any relationship with her condition following vaccination. Overall, the record does not tie these anecdotal occurrences together in any manner sufficient to conclude that they reveal some preexisting neurologic problem. Finally, Respondent’s expert Dr. Leist proposed that Petitioner’s proper diagnosis was instead PRES, attributable to her then-recent pregnancy. Although this argument had plausibility given the temporal relationship between Petitioner’s pregnancy and subsequent neurologic symptoms, the overall record does not support it.11 The strongest source for PRES as a possibility (besides the fact that Mrs. Lozano’s symptoms post-dated her pregnancy) was the radiologist’s inclusion of vasculitis (a broad category that would encompass PRES, among other things) in his write-up of Petitioner’s first MRI performed in August 2012. But no subsequent treaters considered vasculitis as a possible explanation thereafter. Dr. Leist attempted to bulwark the reliability of the PRES diagnosis by identifying some clinical indicia supporting his preferred diagnosis, but Dr. Latov effectively and more persuasively ruled out PRES as a conclusion not as strongly supported by the medical record as ADEM. 11 I am addressing Respondent’s PRES argument within my Althen prong two discussion, since it relates directly to the accuracy of the ADEM diagnosis, and was in fact offered to contradict it. However, I would reach the same conclusion even if I more rigidly determined that Petitioner had carried her initial burden, and then considered (under the burden-shifting test applied) whether Respondent had carried his burden of establishing an alternative, unrelated cause for Mrs. Lozano’s condition. Heinzelman v. Sec’y of Health & Human Servs., No. 07-01V, 2008 WL 5479123, at *7 (Fed. Cl. Spec. Mstr. Dec. 11, 2008)(“[o]nce…causation is established, the petitioner is entitled to compensation unless the government can show by a preponderance of the evidence that the injury is due to factors unrelated to the vaccine, i.e., an alternative cause”). 17 Case 1:15-vv-00369-LAS Document 45 Filed 08/30/17 Page 18 of 18 Given the above, I conclude that Petitioner provided sufficient preponderant evidence to meet her Althen Two burden. She established a logical sequence of cause and effect from vaccine to injury that is supported by the evidentiary record. III. Althen Prong Three The third Althen prong also finds support in the record. As Petitioner and her expert established, an acceptable range of onset for an autoimmune condition is 2-42 days. Latov Ex. Rep. at 5. Other special masters have ruled in favor of Petitioners attempting to establish onset of ADEM after vaccination within the same range of time. Kennedy, 2012 WL 1929801, at *18 (Petitioner received the vaccine about two weeks prior to the onset of symptoms); Kuperus, 2003 WL 22912885, at *10 (finding that onset between ten and 21 days was appropriate). Here, Petitioner fell squarely within that range, since she experienced her first symptoms about 21 days after receiving the vaccine. Respondent did not establish that this timing was not medically acceptable or unreliable (and as noted above, also failed to establish that onset preceded vaccination). I therefore find that Petitioner has offered preponderant evidence in support of Althen prong three. CONCLUSION Petitioner has established her prima facie case by proving by a preponderance of the evidence for each of the Althen prongs, and is therefore entitled to compensation under the Vaccine Program. In order to guide the parties through the damages phase of the action, a separate damages order will issue. IT IS SO ORDERED. s/Brian H. Corcoran Brian H. Corcoran Special Master 18 ================================================================================ DOCUMENT 2: USCOURTS-cofc-1_15-vv-00369-2 Date issued/filed: 2019-01-07 Pages: 11 Docket text: PUBLIC DECISION (Originally filed: 11/28/2018) regarding 72 DECISION Stipulation/Proffer Signed by Special Master Brian H. Corcoran. (mml) Service on parties made. -------------------------------------------------------------------------------- Case 1:15-vv-00369-LAS Document 76 Filed 01/07/19 Page 1 of 11 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 15-369V (Not to be published) * * * * * * * * * * * * * * * * * * * * * * * * * * Special Master Corcoran CARMEN MORENO LOZANO, * * Petitioner, * Filed: November 28, 2018 * v. * * Decision by Proffer; Damages; SECRETARY OF HEALTH * Acute Disseminated Encephalomyelitis AND HUMAN SERVICES, * (“ADEM”); Diptheria-Tetanus-Acelluar * Pertussis (“Tdap”) Vaccine; Life Care Plan. Respondent. * * * * * * * * * * * * * * * * * * * * * * * * * * * Ronald C. Homer, Conway, Homer, P.C., Boston, MA, for Petitioner. Robert P. Coleman, III, U.S. Dep’t of Justice, Washington, DC, for Respondent. DECISION AWARDING DAMAGES1 On April 13, 2015, Carmen Moreno Lozano filed a petition seeking compensation under the National Vaccine Injury Compensation Program.2 ECF No. 1. Petitioner alleged that she developed acute disseminated encephalomyelitis (“ADEM”) as a result of the diptheria-tetanus- acellular pertussis (“Tdap”) vaccine she received on July 15, 2012. Id. at 1. On July 21, 2015, Respondent filed his Rule 4(c) Report, in which he indicated that he did not find this case to be appropriate for compensation. The parties briefly attempted to engage in 1 This Decision will be posted on the United States Court of Federal Claims website, and in accordance with the E- Government Act of 2002, 44 U.S.C. § 3501 (2012). This means the Decision will be available to anyone with access to the internet. As provided by 42 U.S.C. § 300aa-12(d)(4)(B), however, the parties may object to the published decision’s inclusion of certain kinds of confidential information. Specifically, under Vaccine Rule 18(b), each party has fourteen days within which to request redaction “of any information furnished by that party: (1) that is a trade secret or commercial or financial in substance and is privileged or confidential; or (2) that includes medical files or similar files, the disclosure of which would constitute a clearly unwarranted invasion of privacy.” Vaccine Rule 18(b). Otherwise, the whole Decision will be available to the public in its current form. Id. 2 The Vaccine Program comprises Part 2 of the National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3758, codified as amended at 42 U.S.C. §§ 300aa-10 through 34 (2012) (“Vaccine Act” or “the Act”). Individual section references hereafter will be to § 300aa of the Act (but will omit that statutory prefix). Case 1:15-vv-00369-LAS Document 76 Filed 01/07/19 Page 2 of 11 settlement negotiations but were unable to reach an agreement. Both parties filed expert reports, medical literature, and prehearing briefs over the coming months, and an entitlement hearing was held on June 14, 2017. On August 4, 2017, I issued a ruling finding that Mrs. Lozano had successfully demonstrated entitlement to compensation under the Vaccine Act. ECF No. 43. In an order filed that same day, I directed the parties to resolve the question of what damages Ms. Lozano should receive. Damages Order, ECF No. 44. After almost sixteen months of damages negotiations, Respondent filed a proffer proposing an award of compensation. ECF No. 71. I have reviewed the file, and based upon that review, I conclude that Respondent’s Proffer (as attached hereto) is reasonable. I therefore adopt it as my decision in awarding damages on the terms set forth therein. The Proffer proposes: • A lump sum payment of $1,199,216.86, representing compensation for life care expenses expected to be incurred during the first year after judgment ($17,131.66), lost earnings ($922,617.19), pain and suffering ($200,000.00), and past unreimburseable expenses ($59,468.01), in the form of a check payable to Petitioner; and • An amount sufficient to purchase an annuity contract, subject to the conditions described in the attached Proffer (see Proffer at 3; Proffer App’x A at 1–4), that will provide periodic payments to Ms. Lozano for the items contained in the life care plan. Proffer at 3. These amounts represent compensation for all elements of compensation under Vaccine Act Section 15(a) to which Petitioner is entitled. I approve a Vaccine Program award in the requested amount set forth above to be made to Petitioner. In the absence of a motion for review filed pursuant to RCFC Appendix B, the clerk of the Court is directed to enter judgment herewith.3 IT IS SO ORDERED. /s/ Brian H. Corcoran Brian H. Corcoran Special Master 3 Pursuant to Vaccine Rule 11(a), the parties may expedite entry of judgment by each filing (either jointly or separately) a notice renouncing their right to seek review. 2 CCaassee 11::1155--vvvv--0000336699--LUANSJ D Dooccuummeennt t7 761 F Filieledd 0 111/0/278/1/198 P Paaggee 3 1 o of f1 51 IN THE UNITED STATES COURT OF FEDERAL CLAIMS OFFICE OF SPECIAL MASTERS CARMEN MORENO LOZANO, Petitioner, v. No. 15-369V ECF Special Master Corcoran 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, CNLCP, and petitioner engaged Maureen Clancy, RN, BSN, CLCP, to provide an estimation of Carmen Moreno Lozano’s future vaccine-injury related needs. For the purposes of this proffer, the term “vaccine related” is as described in the Special Master’s Ruling on Entitlement, filed August 4, 2017. 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 Carmen Moreno Lozano, attached hereto as Tab A.1 Respondent proffers that Carmen Moreno Lozano should be awarded all items of compensation set forth in the life care plan and illustrated by the chart attached at Tab A.2 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. 2 The parties have no objection to the proffered award of damages. Assuming the Special Master issues a damages decision in conformity with this proffer, the parties intend to waive their right to seek review of such damages decision, recognizing that respondent reserves his right, pursuant to 42 U.S.C. § 300aa-12(f), to seek -1- CCaassee 11::1155--vvvv--0000336699--LUANSJ D Dooccuummeennt t7 761 F Filieledd 0 111/0/278/1/198 P Paaggee 4 2 o of f1 51 B. Lost Earnings The parties agree that based upon the evidence of record, Carmen Moreno Lozano has suffered past loss of earnings and will suffer a loss of earnings in the future. Therefore, respondent proffers that Carmen Moreno Lozano should be awarded lost earnings as provided under the Vaccine Act, 42 U.S.C. § 300aa-15(a)(3)(A). Respondent proffers that the appropriate award for Carmen Moreno Lozano’s lost earnings is $922,617.19. Petitioner agrees. C. Pain and Suffering Respondent proffers that Carmen Moreno Lozano should be awarded $200,000.00 in actual and projected pain and suffering. This amount reflects that any award for projected pain and suffering has been reduced to net present value. See 42 U.S.C. § 300aa-15(a)(4). Petitioner agrees. D. Past Unreimbursable Expenses Evidence supplied by petitioner documents Carmen Moreno Lozano’s 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 $59,468.01. II. Form of the Award The parties recommend that the compensation provided to Carmen Moreno Lozano should be made through a combination of lump sum payments and future annuity payments as described below, and request that the Special Master’s decision and the Court’s judgment award the following:3 review of the Special Master’s August 4, 2017 decision finding petitioner entitled to an award under the Vaccine Act. This right accrues following entry of judgment. 3 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. -2- CCaassee 11::1155--vvvv--0000336699--LUANSJ D Dooccuummeennt t7 761 F Filieledd 0 111/0/278/1/198 P Paaggee 5 3 o of f1 51 A. A lump sum payment of $1,199,216.86, representing compensation for life care expenses expected to be incurred during the first year after judgment ($17,131.66), lost earnings ($922,617.19), pain and suffering ($200,000.00), and past unreimbursable expenses ($59,468.01), in the form of a check payable to petitioner, Carmen Moreno Lozano. B. An amount sufficient to purchase an annuity contract,4 subject to the conditions described below, that will provide payments for the life care items contained in the life care plan, as illustrated by the chart at Tab A, attached hereto, paid to the life insurance company5 from which the annuity will be purchased.6 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, Carmen Moreno Lozano, only so long as Carmen Moreno Lozano 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. 4 In respondent’s discretion, respondent may purchase one or more annuity contracts from one or more life insurance companies. 5 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. -3- CCaassee 11::1155--vvvv--0000336699--LUANSJ D Dooccuummeennt t7 761 F Filieledd 0 111/0/278/1/198 P Paaggee 6 4 o of f1 51 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. 2. Life-contingent annuity Petitioner will continue to receive the annuity payments from the Life Insurance Company only so long as she, Carmen Moreno Lozano, 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 Carmen Moreno Lozano’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, Carmen Moreno Lozano: $1,199,216.86 B. An amount sufficient to purchase the annuity contract described above in section II.B. 6 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- CCaassee 11::1155--vvvv--0000336699--LUANSJ D Dooccuummeennt t7 761 F Filieledd 0 111/0/278/1/198 P Paaggee 7 5 o of f1 51 Respectfully submitted, JOSEPH H. HUNT Assistant Attorney General C. SALVATORE D’ALESSIO Acting Director Torts Branch, Civil Division CATHARINE E. REEVES Deputy Director Torts Branch, Civil Division HEATHER L. PEARLMAN Assistant Director Torts Branch, Civil Division /s/Robert P. Coleman III ROBERT P. COLEMAN III Trial Attorney Torts Branch, Civil Division U. S. Department of Justice P.O. Box l46, Benjamin Franklin Station Washington, D.C. 20044-0146 Direct dial: (202) 305-0274 Dated: November 28, 2018 -5- CCaassee 11::1155--vvvv--0000336699--ULNASJ DDooccuummeenntt 7716- 1 F iFleilde d0 11/10/72/81/91 8 P aPgaeg e8 1o fo 1f 14 Appendix A: Items of Compensation for Carmen Moreno Lozano Page 1 of 4 Lump Sum Compensation Compensation Compensation Compensation Compensation Compensation Compensation Compensation ITEMS OF COMPENSATION G.R. * M Year 1 Year 2 Years 3-5 Year 6 Year 7 Years 8-10 Year 11 Years 12-21 2018 2019 2020-2022 2023 2024 2025-2027 2028 2029-2038 BCBS Premium 5% M 6 ,713.04 6,713.04 6,713.04 6,713.04 6,713.04 6,713.04 6,713.04 6,713.04 Medicare Part B Deductible 5% Medigap 5% M Medicare Part D 5% M Primary Care 5% * 1 5.00 15.00 15.00 15.00 15.00 15.00 15.00 15.00 Neurologist 5% * 1 20.00 120.00 90.00 60.00 60.00 60.00 30.00 30.00 Urologist 5% * 9 0.00 60.00 30.00 30.00 30.00 30.00 30.00 30.00 Opthal-mologist 5% * 3 0.00 30.00 30.00 30.00 30.00 30.00 30.00 30.00 Future Specialists 5% * 3 0.00 6.00 6.00 6.00 6.00 6.00 6.00 6.00 Labs 5% * 1 5.00 15.00 15.00 15.00 15.00 15.00 15.00 15.00 MRI 5% * 1 50.00 Bladder Ultrasound 5% * 7 5.00 25.00 25.00 25.00 25.00 25.00 25.00 25.00 Gabapentin 5% * 6 0.00 60.00 60.00 60.00 60.00 60.00 60.00 60.00 Folate 5% * 6 0.00 60.00 60.00 60.00 60.00 60.00 60.00 60.00 Myrbetriq 5% * 6 0.00 60.00 60.00 60.00 60.00 60.00 60.00 60.00 Senna 4% 1 7.62 17.62 17.62 17.62 17.62 17.62 17.62 17.62 Advil 4% 4 2.07 42.07 42.07 42.07 42.07 42.07 42.07 42.07 PT 4% * 4 5.00 22.50 22.50 22.50 22.50 22.50 22.50 22.50 ST 4% * 4 5.00 15.00 15.00 15.00 15.00 15.00 15.00 15.00 Acupuncture 4% * 2 10.00 210.00 Massage Therapy 4% 8 40.00 840.00 420.00 420.00 420.00 420.00 Counselor 4% * 1 80.00 180.00 36.00 36.00 36.00 36.00 36.00 36.00 Bilateral Hand Splints 4% 4 5.98 45.98 45.98 45.98 45.98 45.98 45.98 45.98 Cane 4% * 3.00 0.60 0.60 0.60 Walker 4% * Scooter 4% * 1 69.90 33.98 33.98 33.98 33.98 33.98 33.98 33.98 Scooter Batteries 4% * 23.00 23.00 23.00 23.00 23.00 23.00 23.00 Scooter Maint 4% * 15.00 15.00 15.00 15.00 15.00 15.00 15.00 Manual WC 4% * 1 5.90 3.18 3.18 3.18 3.18 3.18 3.18 3.18 Shower Chair 4% 1 00.38 20.08 20.08 20.08 20.08 20.08 20.08 20.08 Hand Held Shower 4% 3 4.15 6.83 6.83 6.83 6.83 6.83 6.83 6.83 Over the Toilet Commode 4% 4 8.21 9.64 9.64 9.64 9.64 9.64 9.64 9.64 CCaassee 11::1155--vvvv--0000336699--ULNASJ DDooccuummeenntt 7716- 1 F iFleilde d0 11/10/72/81/91 8 P aPgaeg e9 2o fo 1f 14 Appendix A: Items of Compensation for Carmen Moreno Lozano Page 2 of 4 Lump Sum Compensation Compensation Compensation Compensation Compensation Compensation Compensation Compensation ITEMS OF COMPENSATION G.R. * M Year 1 Year 2 Years 3-5 Year 6 Year 7 Years 8-10 Year 11 Years 12-21 2018 2019 2020-2022 2023 2024 2025-2027 2028 2029-2038 Portable Grab Bars 4% 2 09.85 13.99 13.99 13.99 13.99 13.99 13.99 13.99 Bed Rail 4% 8 9.00 17.80 17.80 17.80 17.80 17.80 17.80 17.80 Kitchen & Writing Aids 4% 1 47.22 29.44 29.44 29.44 29.44 29.44 29.44 29.44 Grooming Items 4% 1 46.73 29.35 29.35 29.35 29.35 29.35 29.35 29.35 Kotex Pads 4% M 2 27.82 227.82 227.82 227.82 227.82 227.82 227.82 227.82 YMCA 4% M 5 64.00 564.00 564.00 564.00 564.00 564.00 564.00 564.00 Home Health Aide 4% M 5 ,408.00 5,408.00 5,408.00 5,408.00 5,408.00 5,408.00 5,408.00 10,816.00 Mileage: PCP 4% 4 .82 4.82 4.82 4.82 4.82 4.82 4.82 4.82 Mileage: Neurologist 4% 1 9.87 19.87 14.90 9.94 9.94 9.94 4.97 4.97 Mileage: Urologist 4% 1 2.64 8.42 4.21 4.21 4.21 4.21 4.21 4.21 Mileage: Opthalmologist 4% 4 .39 4.39 4.39 4.39 4.39 4.39 4.39 4.39 Mileage: Future Specialist 4% 4 .97 0.99 0.99 0.99 0.99 0.99 0.99 0.99 Mileage: PT 4% 1 3.82 6.91 6.91 6.91 6.91 6.91 6.91 6.91 Mileage: ST 4% 9 .22 3.07 3.07 3.07 3.07 3.07 3.07 3.07 Mileage: Acupuncture 4% 2 7.86 27.86 Mileage: Massage 4% 6 9.55 69.55 34.78 Mileage: YMCA 4% 4 59.65 459.65 459.65 459.65 459.65 459.65 459.65 459.65 Driver's Eval 4% 5 00.00 100.00 100.00 100.00 100.00 100.00 100.00 100.00 Lost Earnings 9 22,617.19 Pain and Suffering 2 00,000.00 Past Unreimbursable Expenses 5 9,468.01 Annual Totals 1 ,199,216.86 15,644.85 14,739.04 14,669.30 14,672.30 14,669.90 14,214.93 19,622.93 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 ($17,131.66), lost earnings ($922,617.19), pain and suffering ($200,000.00), and past unreimbursable expenses ($59,468.01): $1,199,216.86. 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. CCaassee 11::1155--vvvv--0000336699--LUANSJ DDooccuummeenntt 7761 - 1 F i lFedile 0d1 1/017/2/189/1 8 P a Pgaeg 1e0 3 o of f1 41 Appendix A: Items of Compensation for Carmen Moreno Lozano Page 3 of 4 Compensation Compensation Compensation Compensation Compensation Compensation ITEMS OF COMPENSATION G.R. * M Year 22 Years 23-27 Years 28-31 Year 32 Years 33-36 Years 37-Life 2039 2040-2044 2045-2048 2049 2050-2053 2054-Life BCBS Premium 5% M 6,713.04 6,713.04 6,713.04 Medicare Part B Deductible 5% 183.00 183.00 183.00 Medigap 5% M 1,980.00 1,980.00 1,980.00 Medicare Part D 5% M 2,006.52 2,006.52 2,006.52 Primary Care 5% * 15.00 15.00 15.00 Neurologist 5% * 30.00 30.00 30.00 Urologist 5% * 30.00 30.00 30.00 Opthal-mologist 5% * 30.00 30.00 30.00 Future Specialists 5% * 6.00 6.00 6.00 Labs 5% * 15.00 15.00 15.00 MRI 5% * Bladder Ultrasound 5% * 25.00 25.00 25.00 Gabapentin 5% * 60.00 60.00 60.00 Folate 5% * 60.00 60.00 60.00 Myrbetriq 5% * 60.00 60.00 60.00 Senna 4% 17.62 17.62 17.62 17.62 17.62 17.62 Advil 4% 42.07 42.07 42.07 42.07 42.07 42.07 PT 4% * 22.50 22.50 22.50 150.00 150.00 150.00 ST 4% * 15.00 15.00 15.00 150.00 75.00 75.00 Acupuncture 4% * Massage Therapy 4% Counselor 4% * 36.00 36.00 Bilateral Hand Splints 4% 45.98 45.98 45.98 45.98 45.98 45.98 Cane 4% * 0.60 0.60 29.99 6.00 6.00 Walker 4% * 16.15 3.23 Scooter 4% * 33.98 33.98 33.98 339.80 339.80 339.80 Scooter Batteries 4% * 23.00 23.00 23.00 230.00 230.00 230.00 Scooter Maint 4% * 15.00 15.00 15.00 150.00 150.00 150.00 Manual WC 4% * 3.18 3.18 3.18 31.80 31.80 31.80 Shower Chair 4% 20.08 20.08 20.08 20.08 20.08 20.08 Hand Held Shower 4% 6.83 6.83 6.83 6.83 6.83 6.83 Over the Toilet Commode 4% 9.64 9.64 9.64 9.64 9.64 9.64 CCaassee 11::1155--vvvv--0000336699--LUANSJ DDooccuummeenntt 7761 - 1 F i lFedile 0d1 1/017/2/189/1 8 P a Pgaeg 1e1 4 o of f1 41 Appendix A: Items of Compensation for Carmen Moreno Lozano Page 4 of 4 Compensation Compensation Compensation Compensation Compensation Compensation ITEMS OF COMPENSATION G.R. * M Year 22 Years 23-27 Years 28-31 Year 32 Years 33-36 Years 37-Life 2039 2040-2044 2045-2048 2049 2050-2053 2054-Life Portable Grab Bars 4% 13.99 13.99 13.99 13.99 13.99 13.99 Bed Rail 4% 17.80 17.80 17.80 17.80 17.80 17.80 Kitchen & Writing Aids 4% 29.44 29.44 29.44 29.44 29.44 29.44 Grooming Items 4% 29.35 29.35 29.35 29.35 29.35 29.35 Kotex Pads 4% M 227.82 227.82 227.82 227.82 227.82 227.82 YMCA 4% M 564.00 564.00 564.00 564.00 540.00 540.00 Home Health Aide 4% M 10,816.00 16,224.00 16,224.00 21,632.00 21,632.00 21,632.00 Mileage: PCP 4% 4.82 4.82 4.82 4.82 4.82 4.82 Mileage: Neurologist 4% 4.97 4.97 4.97 4.97 4.97 4.97 Mileage: Urologist 4% 4.21 4.21 4.21 4.21 4.21 4.21 Mileage: Opthalmologist 4% 4.39 4.39 4.39 4.39 4.39 4.39 Mileage: Future Specialist 4% 0.99 0.99 0.99 0.99 0.99 0.99 Mileage: PT 4% 6.91 6.91 6.91 Mileage: ST 4% 3.07 3.07 3.07 Mileage: Acupuncture 4% Mileage: Massage 4% Mileage: YMCA 4% 459.65 459.65 459.65 459.65 459.65 459.65 Driver's Eval 4% 100.00 100.00 100.00 100.00 100.00 Lost Earnings Pain and Suffering Past Unreimbursable Expenses Annual Totals 19,639.08 25,034.16 24,994.33 28,486.76 28,363.77 28,263.77 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 ($17,131.66), lost earnings ($922,617.19), pain and suffering ($200,000.00), and past unreimbursable expenses ($59,468.01): $1,199,216.86. 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. ================================================================================ DOCUMENT 3: USCOURTS-cofc-1_15-vv-00369-3 Date issued/filed: 2019-06-28 Pages: 9 Docket text: JUDGE VACCINE REPORTED OPINION re: 79 Order on Motion for Review, Judge Vaccine Order/Opinion. Signed by Senior Judge Loren A. Smith. (mr) Service on parties made. -------------------------------------------------------------------------------- Case 1:15-vv-00369-LAS Document 82 Filed 06/28/19 Page 1 of 9 In the United States Court of Federal Claims No. 15-369V Filed: May 21, 2019 Reissued: June 28, 20191 ) CARMEN MORENO LOZANO, ) ) Petitioner, ) ) Vaccine Case; Motion for Review; Tdap v. ) Vaccine; Althen; Burden of Proof; ) Causation Analysis SECRETARY OF HEALTH AND ) HUMAN SERVICES, ) ) Respondent. ) ) Christina Ciampolillo, Conway Homer, P.C., Boston, MA, for petitioner. Robert Coleman, Vaccine/Torts Branch, Civil Division, United States Department of Justice, Washington, DC, for respondent. OPINION SMITH, Senior Judge: Respondent seeks review of an entitlement decision issued by Special Master Brian H. Corcoran, granting petitioner, Carmen Lozano’s, petition for vaccine injury compensation. Petitioner brought this action pursuant to the National Vaccine Injury Compensation Program, 42 U.S.C. §§ 300aa-10–34 (2012) (“Vaccine Act”), alleging that she developed acute disseminated encephalomyelitis (“ADEM”) due to receipt of the tetanus-diphtheria-acellular-pertussis (“Tdap”) vaccine on June 15, 2012. The Special Master awarded compensation, finding that petitioner carried her burden establishing causation. Lozano v. Sec’y of Health & Human Servs., 2017 SW 3811124 (Fed. Cl. Spec. Mstr. Aug. 4, 2017) (Lozano). Respondent now moves for review of this decision. For the reasons that follow, the Court denies its motion. 1 An unredacted version of this opinion was issued under seal on May 21, 2019. The parties were given an opportunity to propose redactions, but no such proposals were made. Nevertheless, the court has incorporated some minor changes into this opinion. Case 1:15-vv-00369-LAS Document 82 Filed 06/28/19 Page 2 of 9 I. BACKGROUND A brief recitation of the facts provides necessary context.2 Petitioner’s medical history prior to vaccination shows that she was largely healthy, but that she was pregnant just before she received the vaccine at issue. Prior to and during her pregnancy, Mrs. Lozano exhibited some symptoms that were relevant to those at issue post-vaccination. In February of 2012, during her pregnancy, petitioner reported some bilateral numbness in her fingers and arms. Her family further reported that Mrs. Lozano experienced an episode of eye drooping and, on one occasion, experienced difficulty opening a jar prior to her pregnancy. Neither of these instances were addressed in contemporary medical records. On July 14, 2012, Mrs. Lozano gave birth at Community Memorial Hospital (“CMH”) in Ventura, California. On July 15, 2012, while she was still in the hospital, petitioner received a Tdap vaccine.3 Two weeks later, on July 30, 2012, petitioner reported to Ventura County Obstetrics and Gynecology (“VCOG”), complaining of low-grade fever, body aches, and breast tenderness, which she reported had persisted since leaving the hospital. The nurse practitioner suspected early mastitis4 and prescribed medication. Petitioner continued to experience the same persistent symptoms and grew fatigued. On August 9, 2012, twenty-five days after vaccination, Mrs. Lozano went to the emergency room at CMH, complaining of abdominal pain and difficulty urinating. The lab results showed no sign of infection, so petitioner was discharged, and her symptoms were assumed to be related to her mastitis. Her symptoms continued to worsen, and she returned to CMH later that day, reporting increased weakness, fever, feeling off balance, vision changes, neck pain, headache, vomiting, and dizziness. A brain MRI5 was performed and showed “numerous focal and patchy high signal intensity lesions6 involving the brainstem,7 2 As the basic facts here have not changed significantly, the Court’s recitation of the background facts here draws from the Special Master’s earlier opinion in Lozano. 3 Tdap is defined as “tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine.” Dorland’s Illustrated Medical Dictionary 1874 (32nd ed. 2012) (“Dorland’s”). 4 Mastitis is defined as “inflammation of the mammary gland, or breast.” Dorland’s 1111. 5 An MRI is a “magnetic resonance imaging” exam. Dorland’s 1184. 6 A lesion is defined as “any pathological or traumatic discontinuity of tissue or loss of function of a part.” Dorland’s 1025. 7 The brainstem is “the stalklike portion of the brain connecting the cerebral hemispheres with the spinal cord and comprising the mesencephalon, pons, and medulla oblongata.” Dorland’s 248. - 2 - Case 1:15-vv-00369-LAS Document 82 Filed 06/28/19 Page 3 of 9 cerebellopontine8 angles, right cerebellum,9 basal ganglia,10 corpus callosum11 and subcortical white matter,”12 which suggested to the radiologist that petitioner potentially had multiple sclerosis (“MS”),13 ADEM,14 or vasculitis.15 Petitioner was admitted to CMH for further evaluation, including a consultation with neurologist, Dr. Francisco Torres. Upon review of her records, Dr. Torres opined that petitioner 8 Cerebellopontine is defined as “conducting or proceeding from the cerebellum to the pons.” Dorland’s 332. 9 The cerebellum is “the part of the metencephalon that occupies the posterior cranial fossa behind the brainstem and is concerned in the coordination of movements.” Dorland’s 332. 10 Ganglion is defined as “a knot or knotlike mass[;] anatomical terminology for a group of nerve cell bodies located outside the ventral nervous system; occasionally applied to certain nuclear groups within the brain.” Dorland’s 757. 11 Corpus callosum is defined as “an arched mass of white matter, found in the depths of the longitudinal fissure, composed of three layers of fibers, the central layer consisting primarily of transverse fibers connecting the cerebral hemispheres.” Dorland’s 417. 12 White matter, or substantia alba, is defined as “white substance; the white nervous tissue, constituting the conducting portion of the brain and spinal cord; it is composed mostly of myelinated nerve fibers arranged in anterior, posterior, and lateral funiculi in the spinal cord and in a number of named fasciculi in the brain.” Dorland’s 1793. 13 Multiple sclerosis is a disease in which there are foci of demyelination throughout the white matter of the central nervous system, sometimes extending into the gray matter; symptoms usually include weakness, incoordination, paresthesias, speech disturbances, and visual complaints. The course of the disease is usually prolonged, so that the term multiple also refers to remissions and relapses that occur over a period of many years. Dorland’s 1680. 14 Acute disseminated encephalomyelitis is an acute or subacute encephalomyelitis or myelitis characterized by perivascular lymphocyte and mononuclear cell infiltration and demyelination; it occurs most often after an acute viral infection, especially measles, but may occur without a recognizable antecedent. It is believed to be a manifestation of an autoimmune attack on the myelin of the central nervous system. Symptoms include fever, headache, and vomiting; sometimes tremor, seizures, and paralysis; and lethargy progressing to coma that can be fatal. Dorland’s 613. 15 Vasculitis is defined as “inflammation of a blood or lymph vessel.” Dorland’s 2026. - 3 - Case 1:15-vv-00369-LAS Document 82 Filed 06/28/19 Page 4 of 9 had potentially experienced an attack of MS that should be treated with Solu-Medrol16 and physical therapy for her ambulatory problems, while petitioner awaited a more comprehensive workup. Petitioner was discharged on August 13, 2012, after it was determined that steroid treatment was helping with her symptoms. At discharge, her working diagnosis was MS, but lumbar puncture had established that she was negative for oligoclonal bands,17 and results from the tests that would reveal levels of myelin18 basic protein antibodies were still pending. On August 17, 2012, Mrs. Lozano had a follow up appointment with Dr. Timothy Sheehy, who determined that a second opinion was necessary to ensure that petitioner’s diagnosis was correct. On August 27, 2012, Mrs. Lozano returned to the CMH emergency room with burning in her chest, slurred speech, hearing changes, and numbness in her tongue. She was diagnosed with an MS flare and discharged that same day, but CMH instructed her to follow up with her primary care physician for a second spinal MRI. That MRI was performed on August 28, 2012, and showed “[p]atchy areas of altered signal intensity within the thoracic spinal cord . . . worrisome for foci of demyelination.”19 Petitioner sought a second opinion on September 9, 2012, from Dr. Barbara Giesser, a neurologist at the University of California Los Angeles Neurology Outpatient Clinic. At that appointment, Dr. Giesser noted that Mrs. Lozano’s current symptoms included the following: [N]umbness bilaterally from her chest down to her lower torso, left arm numbness and paresthesias,20 right arm weakness and paresthesias, right leg weakness, and burning around her left waist. She states that her cognition has declined and that she is thinking slower and forgetting objects, and having short term memory issues. 16 Solu-Medrol is the “trademark for a preparation of methylprednisolone sodium succinate.” Dorland’s 1731. 17 Oligoclonal bands are defined as “discrete bands of immunoglobulins with decreased electrophoretic mobility; their appearance in electrophoretograms of cerebrospinal fluid when absent in the serum is a sign of possible multiple sclerosis or other diseases of the central nervous system.” Dorland’s 197. 18 Myelin is defined as “the substance of the cell membrane of Schwann cells that coils to form the myelin sheath . . . ; it has a high proportion of lipid to protein and serves as an electrical insulator.” Dorland’s 1218. 19 Demyelination is defined as “destruction, removal, or loss of the myelin sheath of a nerve or nerves.” Dorland’s 486. 20 Paresthesia is “an abnormal touch sensation, such as burning, prickling, or formication, often in the absence of an external stimulus.” Dorland’s 1383. - 4 - Case 1:15-vv-00369-LAS Document 82 Filed 06/28/19 Page 5 of 9 Dr. Giesser’s differential diagnosis included post-viral encephalitis/myelitis,21 22 with a working diagnosis of “Clinically Isolated Syndrome,” and she prescribed several medications to help improve petitioner’s ongoing symptoms. Throughout the fall of 2012, petitioner continued to experience the burning sensation from her back to her chest with decreased memory, cognition, and depression. On February 13, 2013, a repeat MRI showed dramatic improvement, suggesting that ADEM was a more likely etiology, which was confirmed through later serological23 findings. Since the winter of 2013, doctors have continued to opine that ADEM is the most likely explanation for petitioner’s symptoms. As such, she continues to seek treatment for the same, given that she has persistent lingering neurological and physical impairments that keep her on disability, despite normal MRI results. None of the medical records indicate that any of petitioner’s treatment providers doubt her diagnosis. Additionally, Mrs. Lozano never experienced a second set of neurologic symptoms that could reflect a flare-up of symptoms that might suggest that MS was the actual explanation for her condition. Petitioner filed her Petition with the Office of Special Masters on April 13, 2014. See generally Petition. On November 16, 2015 and June 13, 2016, petitioner filed the expert report of Dr. Norman Latov, M.D., Ph.D.24 On March 29, 2016, respondent filed the medical report of Dr. Thomas Leist, M.D., Ph.D.25 An entitlement hearing was held on June 24, 2017, and Special 21 Encephalitis is “inflammation of the brain.” Dorland’s 612. 22 Myelitis is “inflammation of the spinal cord, often part of a more specifically defined disease process.” Dorland’s 1218. 23 Serology is defined as the study of the in vitro reactions of immune sera . . . [t]he term is now used to refer to the use of such reactions to measure serum antibody titers in infectious disease (serologic tests), to the clinical correlations of the antibody titer (the ‘serology’ of a disease), and to the use of serologic reactions to detect antigens. Dorland’s 1698. 24 Dr. Latov attended the University of Pennsylvania for both his medical and doctorate degrees. Pet.’s Ex. 22; Transcript of Proceedings (hereinafter “Tr.”) at 5. He completed his residency in neurology and immunology at Columbia University before joining their faculty. Id. He is now on the faculty at Weill Cornell Medicine, where he directs a peripheral neuropathy center, serves as a professor of neurology and neuroscience, and is an attending neurologist. Id. He has previously conducted research in the area of autoimmune neurological diseases. Id. at 6. He estimates that about thirty percent of his time is spent seeing patients, while the rest is dedicated to administrative tasks, teaching, and research. Id. He commonly treats patients with peripheral neuropathies, but only has occasional experience with ADEM. Id. at 7–8. 25 Dr. Leist attended the University of Zurich, where he obtained his Ph.D. in immunology and biochemistry as well as a post-doctorate degree in experimental pathologies. Tr. at 53; Resp.’s Ex. B. He also completed a post-doctorate at the University of California, Los Angeles - 5 - Case 1:15-vv-00369-LAS Document 82 Filed 06/28/19 Page 6 of 9 Master Corcoran granted petitioner’s claim on August 4, 2017, finding that petitioner carried her burden establishing causation. Decision of the Special Master (hereinafter “Dec.”) at 1. Respondent filed its Motion for Review on December 21, 2018. See generally Motion for Review (hereinafter “MFR”). Petitioner filed its Response to respondent’s Motion for Review on January 22, 2019. See generally Response to Respondent’s Motion for Review (hereinafter “Resp.”). Petitioner’s Motion is fully briefed and ripe for review. II. STANDARD OF REVIEW Under the Vaccine Act, this Court may review a special master’s decision upon the timely request of either party. See 42 U.S.C. § 300aa-12(e)(1)–(2). In that instance, the Court may: “(A) uphold the findings of fact and conclusions of law. . . , (B) set aside any findings of fact or conclusion of law . . . found to be arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law . . . , or, (C) remand the petition to the Special Master for further action in accordance with the court’s direction.” Id. at § 300aa-12(e)(2)(A)–(C). Findings of fact and discretionary rulings are reviewed under an “arbitrary and capricious” standard, while legal conclusions are reviewed de novo. Munn v. Sec’y of Health & Human Servs., 970 F.2d 863, 870 n.10 (Fed. Cir. 1992). This Court cannot “substitute its judgment for that of the special master merely because it might have reached a different conclusion.” Snyder ex rel. Snyder v. Sec’y of Dep’t of Health & Human Servs., 88 Fed. Cl. 706, 718 (2009). “Reversal is appropriate only when the special master’s decision is arbitrary, capricious, an abuse of discretion, or not in accordance with the law.” Id. Under this standard, a special master’s decision “must articulate a rational connection between the facts found and the choice made.” Cucuras v. Sec’y of Dep’t of Health & Human Servs., 26 Cl. Ct. 537, 541–42 (1992), aff’d, 993 F.2d 1525 (Fed. Cir. 1993) (citing Burlington Truck Lines, Inc. v. United States, 371 U.S. 156, 168 (1962)). This standard is “highly deferential.” Hines v. Sec’y of Dep’t of Health & Human Servs., 940 F.2d 1518, 1528 (Fed. Cir. 1991). “If the special master has considered the relevant evidence of record, drawn plausible inferences and articulated a rational basis for the decision, reversible error will be extremely difficult to demonstrate.” Id. III. DISCUSSION Althen v. Secretary of Health & Human Services provides the evidentiary burden for petitioners attempting to succeed in a vaccine petition based on causation. See generally Althen and attended medical school at the University of Miami. Id. He completed a residency in neurology at Cornell University before becoming a fellow at the National Institute of Health. Tr. at 54. Dr. Leist is board certified in neurology and currently serves as a professor of neurology at Thomas Jefferson University in Philadelphia, Pennsylvania, as well as directing the MS center and guiding the MS or neuro-immunology fellowship program. Id. at 53. He sees approximately 2,700 patients diagnosed with MS, as well as seeing patients in tertiary care hospitals affiliated with Thomas Jefferson University Hospital. Id. at 57. - 6 - Case 1:15-vv-00369-LAS Document 82 Filed 06/28/19 Page 7 of 9 v. Sec’y of Health & Human Servs., 418 F.3d 1274 (Fed. Cir. 2005). In order to prove causation-in-fact, a petitioner must show by preponderant evidence that the vaccination brought about [petitioner’s] injury by providing: (1) a medical theory causally connecting the vaccination and the injury; (2) a logical sequence of cause and effect showing that the vaccination was the reason for the injury; and (3) a showing of a proximate temporal relationship between vaccination and injury. Id. at 1278. In order to succeed, petitioners must provide a “reputable medical or scientific explanation” for their claim. Id. Within this framework, respondent makes two numbered objections to the August 4, 2017 decision. See MFR at 10, 13. First, respondent asserts that the Special Master erred by failing to require evidence of a logical sequence of cause and effect showing that the vaccination was the reason for the injury. Id. at 10. Second, respondent argues that, by finding petitioner entitled to compensation despite her lack of evidence under Althen prong two, the Special Master created a de facto Table claim, threatening the integrity of the Vaccine Program. Id. at 13. A. Althen Prong Two In its Motion for Review, respondent argues that the Special Master failed to require evidence of a logical sequence of cause and effect showing that the vaccination was the reason for the injury. MFR at 10. In making this argument, respondent contends that “the Special Master addressed the three prongs of Althen before determining which injury petitioner experienced.” Id. at 11. Specifically, respondent alleges that “[i]t was not until the Special Master turned to prong two of the Althen test that he addressed the nature of petitioner’s injury.” Id. (citing Dec. at 16–18). In support of its proposition that the Special Master misapplied Althen, respondent looks to a handful of vaccine cases from the Court of Appeals for the Federal Circuit. Respondent cites to Lombardi v. Secretary of Health and Human Services, which states that when “the existence and nature of the injury itself is in dispute, it is the special master’s duty to first determine which injury was best supported by the evidence presented in the record before applying the Althen test to determine causation of that injury.” 656 F.3d 1343, 1352 (Fed. Cir. 2011) (citation omitted). Lombardi further states that “identification of a petitioner’s injury is a prerequisite to an Althen analysis of causation.” Id. Respondent also cites to Moberly v. Secretary of Health and Human Services, which respondent interprets as standing for the proposition that evidence merely showing a temporal connection between vaccination and injury and absence of another identified cause of the injury is insufficient to demonstrate entitlement to compensation. MFR at 12 (citing Moberly v. Sec’y of Health and Human Servs., 592 F.3d 1315 (Fed. Cir. 2010), reh’g denied, (Fed. Cir. Apr. 13, 2010)). - 7 - Case 1:15-vv-00369-LAS Document 82 Filed 06/28/19 Page 8 of 9 In response, petitioner argues that “there is no strict criteria that must be met, or established factors that must be presented, by petitioner to establish a logical sequence of cause and effect between vaccination and injury.” Resp. at 13. In making this argument, petitioner cites to two of the Federal Circuit’s more seminal cases: Althen v. Secretary of Health and Human Services and Capizzano v. Secretary of Health and Human Services. See generally Althen, 418 F.3d 1274; see also generally Capizzano v. Sec’y of Health and Human Servs., 440 F.3d 1317 (Fed. Cir. 2006). Petitioner first looks to Althen, which states that “the purpose of the Vaccine Act’s preponderance standard is to allow the finding of causation in a field bereft of complete and direct proof [as to] how vaccines affect the human body.” 418 F.3d at 1280. Petitioner also highlights the Federal Circuit’s holding in Capizzano, in which the Court explicitly refused to establish strict criteria requiring petitioners to prove a logical sequence of cause and effect, instead holding that petitioners cannot be required to provide scientific evidence. 440 F.3d at 1325. In addition to citing Federal Circuit precedent, petitioner also looks to the decision of the Special Master in the case at bar, arguing that the Special Master properly engaged in an Althen analysis. As the petitioner points out, Special Master Corcoran “considered lab testing, imaging findings[,] and [the] treating neurologist’s records as consistently supportive of a diagnosis of ADEM.” Resp. at 15. Specifically, the Special Master found that “[p]etitioner has persuasively established that the record evidence best supports the ADEM diagnosis.” Dec. at 16. The Special Master then went on to weigh the evidence that supported a diagnosis other than ADEM against the findings of Mrs. Lozano’s treatment providers, ultimately concluding that the evidentiary record supports a finding that petitioner “established a logical sequence of cause and effect from vaccine to injury.” Id. at 18. It appears to this Court that, while the Special Master may have employed a nontraditional model in outlining his findings, the simple fact that he did not explicitly identify ADEM as the apparent proper diagnosis until analyzing the second prong of Althen is not enough for this Court to overturn his decision. Upon a careful review of the decision and the evidentiary record as a whole, the Court finds that the Special Master’s decision did not violate the bounds of his discretion, and, as such, his findings under Althen prong two were neither arbitrary nor capricious. B. De Facto Table Claim Respondent further argues that because the Special Master misapplied Althen, he created a de facto Table claim, thereby threatening the integrity of the Vaccine Program. While this Court agrees that the decision’s approach does not follow the traditional prong one, prong two, then prong three Althen analysis, the ultimate ruling appears to be correct and the Court does not believe the Special Master erred as a matter of law. The Office of Special Masters is overworked and understaffed, and this Court is consistently impressed with the Special Masters’ ability to meet deadlines and issue quality opinions. Furthermore, the Special Masters’ resilience in the face of innumerable pressures is remarkable. As the Court remains unpersuaded by respondent’s argument regarding the Special Master’s causation analysis, the Court does not believe a de facto - 8 - Case 1:15-vv-00369-LAS Document 82 Filed 06/28/19 Page 9 of 9 Table claim was created or that a single adequate opinion has put the integrity of the Vaccine Program at risk. IV. CONCLUSION This Court finds that the Special Master’s decision was neither an abuse of discretion nor contrary to law, and his findings were neither arbitrary nor capricious. For the foregoing reasons, the Court DENIES respondent’s Motion for Review.26 IT IS SO ORDERED. Loren A. Smith s/ Loren A. Smith, Senior Judge 26 This opinion shall be unsealed, as issued, after June 5, 2019, unless the parties, pursuant to Vaccine Rule 18(b), identify protected and/or privileged materials subject to redaction prior to that date. Said materials shall be identified with specificity, both in terms of the language to be redacted and the reasons therefor. - 9 -