VICP Registry Case Source Bundle Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_10-vv-00398 Package ID: USCOURTS-cofc-1_10-vv-00398 Petitioner: Shea Kylie Sullivan Filed: 2010-06-28 Decided: 2015-03-27 Vaccine: HPV Vaccination date: 2007-06-27 Condition: rheumatoid arthritis Outcome: denied Award amount USD: AI-assisted case summary: On June 28, 2010, Shea Kylie Sullivan filed a petition seeking compensation under the National Vaccine Injury Compensation Program, alleging that she suffered various arthritis-like injuries after receiving the Human Papillomavirus (HPV) vaccine. Ms. Sullivan was nearly sixteen years old when she received her first dose of the Gardasil vaccine on June 27, 2007, followed by two more doses in August 2007 and January 2008. Approximately two to three months after her last vaccination, in late March or early April 2008, she began experiencing knee pain, which progressed to pain in multiple joints. She was subsequently diagnosed with rheumatoid arthritis (RA). Ms. Sullivan alleged that the HPV vaccine caused her RA. The respondent, the Secretary of Health and Human Services, denied entitlement. The Special Master, Brian H. Corcoran, reviewed the record, which included medical records, affidavits, and expert testimony. Petitioner's expert, Dr. Richard Roseff, proposed theories of molecular mimicry and aluminum adjuvant effects, drawing analogies to other vaccines and diseases. Respondent's expert, Dr. Carlos Rosé, testified that there is no scientific support for an association between the Gardasil vaccine and rheumatic disease and that the proposed mechanisms were not scientifically sound. The court also considered the Chao study, which found no increased risk of RA following Gardasil vaccination. Special Master Corcoran found that Ms. Sullivan failed to establish causation under the three prongs of the Althen test: a reputable medical theory, a logical sequence of cause and effect, and a proximate temporal relationship. The Special Master found Dr. Roseff's theories unpersuasive and not supported by reliable evidence, noting the lack of record support linking the vaccine to her RA and finding the temporal relationship too long. Therefore, Ms. Sullivan's petition for entitlement was denied on March 27, 2015. A subsequent decision on July 17, 2015, awarded attorney's fees and costs totaling $75,500.00 based on a stipulation between the parties, with $50,500.00 payable to Petitioner and her former counsel, LeClairRyan, and $25,000.00 payable to Petitioner and her current counsel, Nelson Mullins. Theory of causation field: Petitioner Shea Kylie Sullivan alleged that the HPV vaccine caused her rheumatoid arthritis (RA). The Special Master found that Petitioner failed to establish causation under the three prongs of the Althen test. Petitioner's expert, Dr. Richard Roseff, proposed theories of molecular mimicry and aluminum adjuvant effects, citing studies on other vaccines and diseases, but the Special Master found these theories unpersuasive and not supported by reliable evidence, noting the lack of direct scientific support linking the Gardasil vaccine to RA and the significant temporal gap between vaccination and symptom onset. Respondent's expert, Dr. Carlos Rosé, testified that there is no scientific support for an association between the Gardasil vaccine and rheumatic disease. The Special Master also considered the Chao study, which found no increased risk of RA following Gardasil vaccination. The petition was denied. Petitioner's counsel was Sarah McIntee of Nelson Mullins Riley & Scarborough, LLP. Respondent's counsel was Alexis Babcock. Special Master was Brian H. Corcoran. A subsequent stipulation awarded attorney's fees and costs totaling $75,500.00. Public staged source text: ================================================================================ DOCUMENT 1: USCOURTS-cofc-1_10-vv-00398-cl-extra-2673406 Date issued/filed: 2013-06-30 Pages: 1 Docket text: Supplementary opinion from CourtListener cluster 2673406 -------------------------------------------------------------------------------- In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 10-398V Filed: June 30, 2013 ************************************* SHEA KYLIE SULLIVAN, * TO BE PUBLISHED * Petitioner, * Finding of Fact; Human Papillomavirus * Vaccination (HPV); Joint Pain v. * Inflammation; Rheumatoid * Arthritis; Timing of Onset of Symptoms; SECRETARY OF HEALTH * Contemporaneous Medical Records versus AND HUMAN SERVICES, * Testimony * Respondent. * * ************************************* Sarah Reimers, LeClairRyan, Washington, DC, for Petitioner; Alexis B. Babcock, United States Dep’t of Justice, Washington, DC, for Respondent. RULING REGARDING FINDING OF FACT1 Zane, Special Master. This matter is before the special master to resolve a factual dispute and make a finding of fact as to the timing of the onset of medical symptoms of joint and muscular aches and pains, that Petitioner, Ms. Shea Sullivan (“Petitioner”), allegedly experienced before, around or after she received the Human Papillomavirus (“HPV”) vaccinations on June 27, 2007, August 29, 2007, and January 4, 2008. Petitioner filed her petition for compensation pursuant to the 1 Because this ruling contains a reasoned explanation for the special master's action in this case, the special master intends to post it on the website of the United States Court of Federal Claims, in accordance with the E-Government Act of 2002, Pub. L. No. 107-347, 116 Stat. 2899, 2913 (Dec. 17, 2002). All decisions of the special masters will be made available to the public unless they contain trade secret or commercial or financial information that is privileged and confidential, or medical or similar information whose disclosure would clearly be an unwarranted invasion of privacy. When such a decision or designated substantive order is filed, a party has 14 days to identify and to move to redact such information before the document’s disclosure. Absent a timely motion, the decision shall be made available to the public in its entirety. Upon the filing of a timely motion to redact, along with a proposed redacted version of the decision, if the special master, upon review, agrees that the identified material fits within the categories listed above, the special master shall redact such material from the decision made available to the public. 42 U.S.C. § 300aa–12(d)(4); Vaccine Rule 18(b). 1 National Childhood Vaccine Injury Act (“Vaccine Act”), 42 U.S.C. § 300aa-1, et seq.,2 claiming that the HPV vaccines she received in 2007-08 caused her to suffer joint and body pain and joint inflammation and eventually led to her being diagnosed with rheumatoid arthritis.3 Petition at 3- 4; Transcript of January 24, 2012 Fact Hearing (“Tr.”) at 176. A fact issue arose regarding the timing of the onset of symptoms. Despite that the medical records indicate it was more than three months after she received her third vaccine that Petitioner visited the doctor complaining of joint pain, Petitioner asserted her symptoms began earlier. Petitioner claimed that she began to experience pain in her shoulder and swelling in her wrists and fingers in the latter half of 2007 after receiving her first and second vaccinations but before receiving her third vaccination. The timing of the onset of symptoms is a material fact because the medical experts’ conclusions regarding temporal relation could change if the onset of Petitioner’s symptoms began earlier than stated in the medical records. To resolve this issue, a fact hearing was conducted in January 2012, at which Petitioner and her parents, Dennis and Sandy Sullivan, testified. As explained herein, based on the record as a whole, the special master finds that, as set forth in the medical records, Petitioner’s symptoms of joint and muscle aches and pains following her receipt of the HPV vaccines began in late March or early April 2008 as stated in the medical records. The medical records are clear, internally consistent, and complete. In reaching her finding, the special master observed Petitioner and her parents as they testified. Each had a detailed recollection of the onset of the knee pain in March-April 2008 that was consistent with the medical records. But, other than the knee pain, the witnesses’ testimony regarding the timing and onset of other post-vaccine joint pain was vague and confusing and, thus, cannot be accepted. Furthermore, Petitioner’s failure to visit a doctor despite experiencing such joint pain is inconsistent with her and her parents’ vigilance in addressing Petitioner’s health issues, especially when those issues might affect her athletic performance. Finally, her activities, in particular, her affirmatively seeking and beginning work at a fast food restaurant, which required her to stand for long periods and the constant use her hands, is inconsistent with her suffering the type of pain which she described. I. PROCEDURAL BACKGROUND Petitioner filed her claim on June 28, 2010, three years after she received her first HPV vaccination. P’s Ex. 3 at 2. In February 2011, Petitioner filed her expert report and a one-page 2 Part 2 of the Vaccine Act established the National Vaccine Injury Compensation Program, 42 U.S.C. § 300aa-10 through § 300aa-34 (2006) (“Vaccine Program”). 3 “Rheumatoid arthritis” is defined as a chronic systemic disease primarily of the joints, usually polyarticular, marked by inflammatory changes in the synovial membranes and articular structures and by muscle atrophy and rarefaction of the bones. In late stages deformity and ankylosis develop. The cause is unknown, but autoimmune mechanisms and virus infection have been postulated. Dorland’s Medical Dictionary 157 (32d ed. 2012). 2 supplemental expert report. P’s Exs. 14 and 15. Petitioner’s expert concluded that there was a strong possibility that her disease process resulted from her HPV vaccinations. P’s Ex. 14. But, Petitioner’s expert acknowledged that there was still a possibility that Petitioner’s development of rheumatoid arthritis was due to a random event. P’s Ex. 14. In a later-filed, supplemental report Petitioner’s expert opined that he believed there was a probability that Petitioner’s disease process resulted from her HPV vaccines. P’s Ex. 18. On May 16, 2011, Respondent filed her expert report. R’s Ex. A. In that report, Respondent’s expert opined, inter alia, that there was not a medically-appropriate temporal relation because three months had lapsed between the last vaccination and the onset of joint pain as reflected in the medical records. R’s Ex. A at 6. Petitioner disputed this, filing her third affidavit, in which she asserted that her symptoms began with, inter alia, shoulder pain the latter part of 2007 after she received her first, then second vaccinations. P’s Ex. 21. This prompted the fact hearing held on January 24, 2012. Although originally the issue was identified as relating to the timing of onset of symptoms before, around and after the time of Petitioner’s receipt of HPV vaccines, at the hearing, the focus was entirely on the timing of onset of symptoms after receipt of one or more of the vaccines. As such, the finding of fact here is limited to that issue.4 After the hearing, to ensure that all reasonable and necessary records were filed, Petitioner was ordered to file certain records based on the testimony at the hearing, i.e., Petitioner’s school records, Petitioner’s running journals and excerpts from her social media pages. January 27, 2012 Order. Subsequently, some limited records were filed. Having reviewed the records in April 2013, at a status conference, the special master noted that it appeared some school records were missing. The special master inquired as to whether there was any further documentary evidence would be submitted. Shortly thereafter, Petitioner’s counsel indicated that no additional records were forthcoming. Both parties have filed post-hearing briefs. This case is now ready for determination of a finding of fact as to the timing of onset of symptoms Petitioner experienced following her receipt of the HPV vaccinations. 4 The records do indicate that Petitioner had lower back and possibly shoulder pain prior to receipt of the vaccine, from approximately March 2006 to April 2007, which does not appear to be disputed. P’s Ex. 5 at 35, 36, 39, 42. 3 II. RECORD A. The Documentary Record The documentary record consists of Petitioner’s medical records and certain other records. 1. Medical Records The medical records provide Petitioner’s medical history. Prior to receipt of the HPV vaccinations, Petitioner was generally healthy although she did consult regularly with her doctor regarding various medical problems. P’s Ex. 5 at 8-25. Petitioner had annual bouts of upper respiratory infections, pharyngitis, and otitis media.5 Id. In 2003, Petitioner was evaluated for a three- to four-week persistent headache. P’s Ex. 5 at 26-27. Beginning in March 2006 through at least April 2007, two months before receiving her first HPV vaccine, Petitioner complained to her doctor about persistent, lower, left-sided back pain. P’s Ex. 5 at 35-36, 39, 42. On June 27, 2007, Petitioner had her 16-year-old health maintenance visit with her primary care physician. P’s Ex. 5 at 53. The doctor administered Petitioner’s first HPV vaccine intramuscularly in her left arm. Id. Following this visit, Petitioner did not visit her doctor until April 2008, except to receive her second and third HPV vaccines on August 29, 2007 and January 4, 2008, respectively. P’s Ex. 3 at 3. At these visits, Petitioner did not mention any aches or pains or reactions to the vaccines. Id. Petitioner’s mother did phone the doctor three times during this period when Petitioner experienced other medical problems. First, on August 10, 2007, Petitioner’s mother called the primary care physician’s clinic to report Petitioner was suffering from heart palpitations. P’s Ex. 5 at 54. She did not mention joint or muscle aches or pains. Id. Second, in November 2007, Petitioner’s mother again called regarding coughing Petitioner was experiencing. P’s Ex. 5 at 54. Again, there was no mention of any joint or muscle aches or pains. Id. Third, on the day Petitioner received her third HPV vaccine, January 4, 2008, Petitioner’s mother called the doctor to report that Petitioner had a headache, a sore throat, and abdominal pain. P’s Ex. 5 at 55. There was no mention of any joint or muscle aches or pains. Id. Nearly a month after receiving her third HPV vaccination, in February 2008, the records reflect that Petitioner’s mother again called Petitioner’s primary care physician to report that Petitioner had a headache, sore throat, and abdominal pain. P’s Ex. 5 at 55. Again, there was no mention of any muscle or joint aches or pains. Id. 5 Pharyngitis is defined as inflammation of the pharynx. Dorland’s Illustrated Medical Dictionary 1426 (32d ed. 2012). Otitis media refers to the inflammation of the middle ear. Dorland’s Illustrated Medical Dictionary 1351 (32d ed. 2012). 4 On April 18, 2008, three months after receiving her third HPV vaccination, Petitioner returned to the doctor. P’s Ex. 5 at 56. Petitioner complained of left knee pain, which she reported had been ongoing for one to two weeks. P’s Ex. 5 at 56. Petitioner was referred to an orthopedic physician for an evaluation. Id. Six months later, on October 21, 2008, Petitioner visited an orthopedist, Dr. Eric Lee. P’s Ex. 7 at 1. Petitioner reported that the onset of her left knee pain was in April 2008 and that it had started while running on the beach. P’s Ex. 7 at 7; P’s Ex. 8 at 6. Petitioner returned to her primary care physician in October 2008 as well. P’s Ex. 5 at 56. Petitioner was to have an MRI of her knee the following date. Id. The notes indicate that Petitioner’s parents had noticed swelling in Petitioner’s hands, feet and one arm in the mornings. Id. The notes also refer to Petitioner’s menstrual cycle problems while on birth control pills and note an inquiry regarding a possible relation between the pill and arthritis. Id. Laboratory results, for the most part, were normal, including a normal rheumatoid factor. P’s Ex. 5 at 62. Approximately two weeks later, on November 3, 2008, Petitioner sought a second opinion from another orthopedist, Dr. Scott Graham. P’s Ex. 8 at 6-7. The medical history from that visit describes Petitioner’s pain as beginning approximately seven months earlier, while running on the beach, which would date it back to approximately April 2008. P’s Ex. 8 at 6-7; 11. The examination conducted at that time revealed that Petitioner had no other remarkable symptoms besides her chief complaint, the left knee pain. Id. The results of the physical examination at that time were similar to those of the previous exam by the other orthopedist, Dr. Lee. Compare P’s Ex. 7 at 6-7 with P’s Ex. 8 at 6. Petitioner saw Dr. Graham again on December 1, 2008. P’s Ex. 8 at 11. Petitioner continued to complain of knee pain despite having received a cortisone injection. Id. Dr. Graham recommended and performed arthroscopic knee surgery on Petitioner’s left knee on December 16, 2008. P’s Ex. 8 at 12-13. Petitioner had a post-surgery follow-up with Dr. Graham on February 11, 2009, at which Petitioner reported improvement of her knee pain. P’s Ex. 8 at 25. Dr. Graham’s notes indicate that Petitioner complained of pain in multiple joints i.e., her hands, fingers and ankles. Id. Dr. Graham referred Petitioner to a rheumatologist. Id. While not seeing a rheumatologist, on April 6, 2009, Petitioner did return to her primary care physician complaining of claw hands in the morning and pain in her joints—her hands, knees and shoulders. P’s Ex. 5 at 63. Petitioner raised the issue of a possible causal association between her pain and her HPV vaccine. Id. The doctor’s notes state that Petitioner explained she was raising this “because another friend had a similar complaint” and that one of her “parent[s] looked up on [the] internet 5 cases [and a] class action suit.”6 Id. The record contains an asterisked notation stating that during the orthopedic evaluation in October 2008, Petitioner had made “no comments re joint pain other than knee.” Id. Approximately three months later, on July 13, 2009, Petitioner saw a rheumatologist, Dr. 6 During Petitioner’s testimony at the January 24, 2012 hearing, she denied having any friends with issues and was unsure as to why that was noted in the medical record. Tr. at 93. 5 Thomas Powell. Dr. Powell’s notes reflect that Petitioner gave a one-year history of an inflammatory polyarthritis. P’s Ex. 12, Ex. 10 at13.7 The lab values from Petitioner’s tests were, nonetheless, apparently normal. P’s Ex. 10. Dr. Powell’s impression was that Petitioner likely had seronegative rheumatoid arthritis. P’s Ex. 10 at 13, attached to P’s Ex. 12. A note in her primary care physician’s records dated July 13, 2009, indicated that Petitioner advised her doctor that she had been diagnosed with rheumatoid arthritis that day. P’s Ex. 5 at 64. A phone record dated August 3, 2009 stated that Petitioner’s primary care physician, apparently in response to an inquiry, informed Petitioner’s mother that “no scientific articles link[ed] Gardasil as [a] cause of arthritis.” P’s Ex. 5 at 65. Petitioner’s mother apparently called her primary care physician again on October 23, 2009, as a phone record for that date contains the following entry: “joint pain – shoulder pain per mom Oct 08.” Id. Petitioner had a second rheumatologic consult with Dr. William C. Shiel, Jr. on September 9, 2009. P’s Ex. 11 at 1. Petitioner reported persistent joint pains worsening at night, morning stiffness, difficulty getting out of bed, and an incomplete grip. Id. Dr. Shiel’s notes reflect that the medical history given was that Petitioner’s pains began with left shoulder pain two years earlier, which later involved the right shoulder, and then the wrists, knees, ankles, and fingers. P’s Ex. 11 at 1. Dr. Shiel concluded that Petitioner’s conditions were suggestive of rheumatoid arthritis, which, based on the medical history Petitioner provided, began two years earlier. Id. at 4. 2. Other Documentary Materials In addition to the medical records, Petitioner submitted certain other records. First, Petitioner submitted a pain journal into the record. P’s Ex. 1, Attachment A. Petitioner began keeping this journal in late 2009, over a year and a half following receipt of her last HPV vaccination, the first entry dated November 7, 2009. P’s Ex. 1 at 4. Second, Petitioner submitted certain school records. The school records submitted consisted of her attendance records for three of her four high school years. P’s Ex. 25. The year for which no record was submitted was 2007-08, her sophomore year, the period immediately following receipt of her first and second vaccines and the period when Petitioner received the third vaccine.8 7 Although Dr. Powell’s records were originally submitted as P’s Ex. 10, his consultation report was not submitted with that exhibit. Rather, it was submitted subsequently as an attachment to her second affidavit, P’s Ex. 12. 8 In April 2013, the special master inquired regarding the absence of records relating to Petitioner’s sophomore year, 2007-08, and was advised that Petitioner did not have those records because the school had switched reporting systems. However, the records for the 2006-2007 year, reflect a different reporting system than those for the school years 2008-09 and 2009-10. Thus, it appears the records for 2006-07 were generated under the former system. The records for the school years 2008-09 and 2009-10 reflect a different, presumably new system. Given that apparently the records from both the old and new reporting systems have been provided, it is uncertain as to why records from a single year, albeit the most relevant period for purposes of 6 Third, although Petitioner had indicated that her school trainer would testify and that there were records and notes which reflected her history of injuries, the only record submitted was a note from the high school trainer. P’s Ex. 26. In that note, Petitioner’s high school head athletic trainer, Mr. Ian Sabala, stated that the school had no record of Petitioner having a potential hand injury or hand swelling. P’s Ex. 26. Fourth, Petitioner filed excerpts of screen shots from her Facebook page. P’s Ex. 27. Although Petitioner apparently had some activity during the June 2007-April 2008 period, those screenshots did not appear to include time line postings for that period. P’s Ex. 27 at pdf #20.9 Petitioner had been asked to produce a running journal that she testified she had maintained during her sophomore year. Tr. at 83. Petitioner testified that, most likely, she had discarded this journal. Id. Indeed, it was confirmed later after the April 2013 status conference that she no longer had that journal. B. Testimony At the fact hearing held on January 24, 2012, Petitioner, her mother, Sandy Sullivan, and her father, Dennis Sullivan, testified. Prior to the hearing, an affidavit was submitted for each of Petitioner’s parents. Petitioner submitted three separate affidavits. A summary of the testimony is as follows. 1. Petitioner, Shea Sullivan Petitioner provided testimony through three affidavits as well as in person at the hearing. See generally P’s Exs. 1, 12 and 21 and January 24, 2012 Transcript (“Tr.”) In her first affidavit, dated June 22, 2010, Petitioner stated that prior to receiving the HPV vaccines she was a “healthy and active teenager.” P’s Ex. 1 at 1. She described herself as an athlete “[who] played competitive volleyball, softball, hockey . . . and basketball.” Id. Petitioner stated that she “was captain of [her high school’s] cross country team, and an active participant of the track and field team . . . .” Id. In this affidavit, Petitioner stated that as of June 27, 2007, she had been diagnosed with rheumatoid arthritis. 10 Id. She stated that around September 2008, she was forced to stop participating in all physical activity due to severe chronic body and joint pains. Id. Petitioner’s second affidavit, dated November 11, 2010, was submitted in response to Respondent’s Rule 4 Report. P’s Ex. 12. In that affidavit, Petitioner identified the time frame when she saw Dr. Graham, the orthopedist who performed her knee surgery in December 2008, for a post-surgical appointment as being in February 2009. P’s Ex. 12, ¶ 1. Petitioner attached Dr. Powell’s consultation report, which had not been provided with his records, and stated that this case, would be unavailable regardless of which system was in effect during that year. 9 The facebook excerpts indicate Petitioner had posted “likes” for the 2008 period. 10 As explained infra, Petitioner subsequently acknowledged in her second affidavit that she had not been diagnosed until July 2009. P’s Ex. 12, ¶ 2. 7 she had been diagnosed with inflammatory arthritis in July 2009. P’s Ex. 12, ¶ 2. Petitioner’s third affidavit, dated July 28, 2011, was filed after Respondent’s expert’s report. P’s Ex. 21. In that affidavit, Petitioner stated that she had experienced pain in her left shoulder shortly after June 2007. P’s Ex. 21, ¶ 2. She also averred that the index finger on her right hand swelled in late 2007 and the beginning of 2008. P’s Ex. 21, ¶ 3. Petitioner stated that she began to experience knee pain and her knee became swollen during her sophomore year and that she went to the doctor in April 2008 regarding her knee. P’s Ex. 21, ¶ 4. Finally, Petitioner also stated that she believed, at least at that time, that these pains were sports related injuries. P’s Ex. 21, ¶ 6. Finally, Petitioner testified at the January 2012 hearing. She described her dedication to sports, in particular to running. Tr. at 14. She testified that she was on the varsity cross country team but not on the varsity track team. Tr. at 138. Petitioner testified about receiving her HPV vaccinations. Tr. at 14, 26, 79. She explained that she experienced pain in her left shoulder in the summer of 2007 after she received her first vaccine and after she had been involved in volleyball camp. Tr. at 17, 19-20. She concluded that the pain was sports-related. Tr. at 19-20, 79. She said that this pain became chronic and that it apparently affected her running stride. Tr. at 20-21. Petitioner stated that the pain did not spread during that season, it did not cause her to stop running and she did not report it to anyone. Tr. at 20-21, 79. Petitioner testified in detail regarding her run on the beach in March-April 2008 with her uncle and how she had been injured during that run. Tr. at 35. Petitioner explained how she had to withdraw from competing in a race shortly thereafter due to her injury. Tr. at 36-38. It was at this point that Petitioner saw the doctor regarding her knee pain. Tr. at 36-38. Petitioner explained that after she injured her knee her running performance declined. Tr. at 34-38. Petitioner’s chronology of doctor’s visits beginning with her visit in April 2008 regarding her knee through her visits to rheumatologists in 2009 was, for the most part, consistent with the medical records. She described going to her primary care physician regarding her knee pain. Although she was referred to an orthopedist, Petitioner decided to take care of her symptoms herself at that time. Tr. at 39. It was only after several months that she returned to her doctor, in October 2008, and went to an orthopedist. Tr. at 42-43. Petitioner explained that the orthopedist, Dr. Graham, performed arthroscopic knee surgery on Petitioner’s left knee in December 2008. Tr. at 46-48. It was in her follow-up appointment with Dr. Graham that the swelling of her joints was clearly evident. Tr. at 88-89. It was at that time that she mentioned the pain in her other joints. Tr. at 48. It was another several months before Petitioner visited a rheumatologist in July 2009. Tr. at 53-56. It was at that time that she was diagnosed with rheumatoid arthritis. Tr. at 53-56. Petitioner also discussed how the pain progressed. She testified in detail regarding her joint pains for the period around her eighteenth birthday, in 2010. Tr. at 62. She especially described how in her senior year of high school, she needed help getting ready for school and had trouble walking. Tr. at 176. 8 2. Petitioner’s Mother, Sandy Sullivan Mrs. Sandy Sullivan, Petitioner’s mother, also provided an affidavit and testified at the hearing. P’s Ex. 23, Tr. at 179. In her affidavit, Mrs. Sullivan said that she recalled Petitioner getting her first HPV vaccine in June 2007. P’s Ex. 23, ¶ 3. Shortly thereafter, Petitioner began to experience shoulder pain while she was at volleyball camp. P’s Ex. 23, ¶ 5. Mrs. Sullivan recalled Petitioner’s pain occurring during a trip to the desert in the winter of 2008. P’s Ex. 23, ¶ 8. Without specificity as to dates, Mrs. Sullivan also remembered the pains becoming so severe that Petitioner was eventually taken to a rheumatologist and diagnosed with rheumatoid arthritis. P’s Ex. 23, ¶¶ 9-11. In her testimony, Mrs. Sullivan acknowledged that at a younger age, Petitioner seemed to have more illnesses than her other children. Tr. at 180-81. Mrs. Sullivan accompanied Petitioner to her doctor’s appointment on June 27, 2007, when she received her first HPV vaccination. Tr. at 185. Immediately after the vaccination, she noted that her daughter’s arm was sore and red but this did not alarm her because the doctor had warned her about that. Tr. at 187. Mrs. Sullivan also testified that she did recall Petitioner having achy pains following volleyball camp, especially in her shoulder, but she was not concerned because it seemed like normal pain related to playing sports or due to her new mattress. Tr. at 188-89. Mrs. Sullivan did not recall any pain in 2007 that was preventing Petitioner from performing normal activities, and Petitioner did not ask her to contact the doctor regarding any such pains. Tr. at 189. As with Petitioner, Mrs. Sullivan vividly remembered the first, real pain experienced by Petitioner as being near the beginning of 2008, which she attributed to running on the beach with Mrs. Sullivan’s brother. Tr. at 193. It was at that point that Mrs. Sullivan concluded Petitioner had suffered a serious injury. Tr. at 221. Her husband took Petitioner to the doctor shortly thereafter in April 2008. Tr. at 194. Although Mrs. Sullivan acknowledged that Petitioner at some point complained about pain in her wrists, fingers and knees, she could not identify the time frame in which this began. Tr. at 190. When Mrs. Sullivan brought Petitioner to her primary care physician in October 2008, Mrs. Sullivan testified that she recalled advising the doctor of Petitioner’s swollen fingers at that time. Tr. at 202-03. Mrs. Sullivan did believe that in the fall of 2008, prior to Petitioner’s surgery in December, Petitioner was still running, but was somewhat uncertain about this, admitting that she was unaware of the particular seasons for specific sports. Tr. at 198. Mrs. Sullivan did attend her daughter’s subsequent visits to Dr. Lee and Dr. Graham, the two orthopedists whose opinions they sought regarding her left knee pain in October and November of 2008. Tr. at 194-95. Mrs. Sullivan did remember that at those visits Petitioner told both doctors that she had other joint pains. Tr. at 195, 197. 3. Petitioner’s Father, Dennis Sullivan Mr. Dennis Sullivan, Petitioner’s father, also provided an affidavit in January 2012 and testified at the hearing. Tr. at 238. In his affidavit Mr. Sullivan recalled that his daughter began to “regularly complain of severe shoulder pain” in the summer of 2007 while she was involved in a volleyball summer camp. P’s Ex. 24, ¶ 4. Mr. Sullivan explained how the shoulder pain was attributed to sports injuries and growing pains. P’s Ex. 24, ¶ 7. During her fall cross country 9 season, Mr. Sullivan worked with Petitioner to correct her form as she held her arms in an awkward position, but he was ultimately unsuccessful. P’s Ex. 24, ¶ 5. Mr. Sullivan also stated that Petitioner’s significant pain began in the spring of 2008, with her knee pain. P’s Ex. 24, ¶ 8. Mr. Sullivan concluded the affidavit stating that over the months that followed Petitioner’s pain worsened and after numerous visits to doctors it was revealed that Petitioner had rheumatoid arthritis. P’s Ex. 24, ¶ 9. At the hearing, Mr. Sullivan testified that Petitioner reported soreness in her shoulder and that “she was having trouble raising it” during her volleyball practices. Tr. at 244. He also stated that this pain continued during her cross country season in the fall of 2007, when he saw her “holding her arms up in an awkward position.” Tr. at 248. Later in his testimony, he said he was unsure whether the pain was causing her to hold her arms up or it was just an awkward running style. Tr. at 271. At one point, he testified that he related Petitioner’s holding her hands in an awkward position while running as being due to her obvious knee pain. Tr. at 253. Mr. Sullivan further testified that Petitioner began complaining about knee pain after running with her uncle on the beach. Tr. at 252. Petitioner told Mr. Sullivan that she felt that the distance they had run and the fact that it was on the sand had contributed to the knee problem. Tr. at 252. He also testified to attending a track meet subsequent to the beach run where Petitioner had to withdraw from her second race due to her knee pain. Tr. at 253. It was following this track meet that he took her to her pediatrician, who gave them a referral to an orthopedist. Tr. at 254. They did not immediately see the orthopedist as her knee pain began to subside. Id. Mr. Sullivan also testified that he recalled Petitioner’s difficulties performing daily activities such as getting ready for school. He was uncertain as to when these began, at one point saying he thought it could have been the end of 2007 but then also saying he thought it was around the time of his brother-in-law’s death in March 2008. Tr. at 275. III. APPLICABLE LEGAL STANDARDS A petitioner must prove, by a preponderance of the evidence, the factual circumstances surrounding her claim. 42 U.S.C. § 300aa-13(a)(1)(A). The special master must “believe that the existence of a fact is more probable than its nonexistence before [she] may find in favor of the party who has the burden to persuade the [special master] of the fact’s existence. In re Winship, 397 U.S. 358, 371-72 (1970) (Harlan, J., concurring, quoting F. James, Civil Procedure at 250-51 (1965)). Mere conjecture or speculation is insufficient to satisfy the preponderance standard. Snowbank Enterprises v. United States, 6 Cl.Ct. 476, 486 (1984). In determining whether a petitioner is entitled to compensation under the Vaccine Act, a special master must consider the record as a whole. 42 U.S.C. § 300aa-13(a)(1). The special master may not make a finding based on the claims of a petitioner that are not substantiated by medical records or medical opinion. Id. The process for finding facts pursuant to the Vaccine Act begins with analyzing the medical records, which are required to be filed with the petition. 42 U.S.C. § 300aa–11(c)(2). As set forth in 42 U.S.C. § 300aa-13(b)(1)(A), a special master shall consider “all . . . relevant medical or scientific evidence contained in the record,” including “any diagnosis, conclusion, medical judgment, or autopsy or coroner’s report . . . regarding the nature, causation, and aggravation of the petitioner’s illness, disability, injury, condition, or 10 death . . . .” In resolving factual issues, the special master must weigh the evidence presented, which may include contemporaneous medical records and testimony. See Burns v. Sec’y of Health & Human Servs., 3 F.3d 415, 417 (Fed. Cir. 1993)(A special master must decide whether to accord greater evidentiary weight to contemporaneous medical records or other evidence, e.g., later- given oral testimony, and such a decision must evince a rational determination). “Medical records, in general, warrant consideration as trustworthy evidence.” Cucuras v. Sec'y of Health & Human Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993). Indeed, records created contemporaneously with the events that they describe are presumed to be accurate as it is recognized that individuals seeking treatment will report the circumstances relating to their symptoms and history accurately to ensure the doctors have all information necessary to treat their ailments. Cucuras, 993 F.2d at 1527-28. Similarly, the doctors recording the histories are paying particular attention to record such histories accurately so that they will be aware of all the patient’s ailments and consider them in determining treatment. Id. As such, particular attention should be paid to contemporaneous medical records and opinions of treating physicians. Capizzano v. Sec’y of Health & Human Servs., 440 F.3d 1317, 1326 (Fed. Cir. 2006); see also Lowrie v. Sec’y of Health & Human Servs., No. 03-1585, 2006 WL 3734216 at *7 (Fed. Cl. Spec. Mstr. Nov. 29, 2006). With regard to medical histories it has been recognized that “careful attention is paid to those contemporaneous histories, which are given prior to any thought of litigation. . . .” Coffelt v. Sec’y of Health & Human Servs., No. 90-591, 1992 WL 158714 at *6 (Fed. Cl. Spec. Mstr. Feb. 24, 1992). When considering the weight to be accorded oral testimony versus contemporaneous records, “[i]t has generally been held that oral testimony which is in conflict with contemporaneous documents is entitled to little evidentiary weight.” Murphy v. Sec’y of Health & Human Servs., 23 Cl.Ct. 726, 733 (1991), aff'd, 968 F.2d 1226 (Fed. Cir.), cert. denied sub nom. Murphy v. Sullivan, 506 US 974 (1992)](citing United States v. United States Gypsum Co., 333 U.S. 364, 396 (1947)) (“Where such testimony is in conflict with contemporaneous documents we can give it little weight, particularly when the crucial issues involve mixed questions of law and fact.”); Montgomery Coca–Cola Bottling Co. v. United States, 615 F.2d 1318, 1327 (Ct.Cl. 1980) (“The subjective intent testimony of the plaintiff can only be seriously considered to the extent it is consistent with the objective evidence.... We also believe that [the testimony of a particular fact witness] is ‘infected with self-interest’ “ and that while his testimony, of course, is admissible it cannot be given the weight accorded it by the trial judge; nor can [that fact witness'] testimony prevail over the inferences unavoidably drawn from the objective documentary evidence....”); 32A C.J.S. Evidence § 1033 (1964)). Records that are clear, consistent and complete should be accorded substantial weight. Lowrie v. Sec’y of Health & Human Servs., No. 03-1585, 2005 WL 6117475 at *20 (Fed. Cl. Spec. Mstr. Dec. 12, 2005). In considering testimony, the special master must assess the demeanor of the witnesses when testifying. Andreu v. Sec’y of Health & Human Servs., 569 F.3d 1367, 1379 (Fed. Cir. 2009). Moreover, to overcome the presumptive accuracy of the written medical records through testimony, the testimony must be “consistent, clear, cogent, and compelling.” Sanchez v Sec’y of Health & Human Servs., No 11-685, 2013 WL 1880825 at *3 (Fed. Cl. Spec. Mstr. Apr. 10, 2013) (citing Blutstein v. Sec’y of Health & Human Servs., No. 90-2808, 1998 WL 408611 at *5 (Fed. Cl. Spec. Mstr. June 30, 1998)). 11 IV. DISCUSSION Petitioner seeks to supplement and, in some cases, supplant the medical records with her and her parents’ affidavits and testimony offered four years after the pertinent events claiming that her joint pains began much earlier than reflected in the records, during the summer and fall of 2007. As explained below, the medical records are clear and consistent. In fact, the testimony relating to the onset of the knee pain is also consistent with the medical records in establishing the onset of such pain as occurring in March-April 2008. On the other hand, the testimony regarding the alleged onset of pain earlier than March- April 2008, unsubstantiated by the medical records, was vague, confusing and inconsistent. Moreover, the testimony that Petitioner simply ignored these medical symptoms is inconsistent with Petitioner’s and her parents’ practice of vigilantly reporting injuries to the doctor promptly. Petitioner’s testimony of experiencing debilitating joint pain is also inconsistent with her actions of getting a job which would require constant use of her hands during this very period. The medical records, made contemporaneously when medical treatment was sought, are reliable and accorded great weight. Petitioner’s testimony that she experienced earlier aches and pains is not substantiated by the records. As such, the special master finds that this testimony cannot be used to supplant the medical records and alter the date of onset of joint pain of March-April 2008 reflected in the records. Upon consideration of the record as a whole, the special master finds that based on the medical records, the onset of Petitioner’s joint pains and aches following receipt of the HPV vaccinations began in March or April 2008, when Petitioner first reported her knee pain. Ex. 5 at 56; Tr. at 275. A. The Medical Records Are Clear and Consistent That the Onset of Symptoms Occurred in March-April 2008. The special master finds that the medical records are clear and internally consistent. Those records indicate that the first instance she complained of joint and muscle aches and pains following the HPV vaccines occurred in late March or early April 2008, when Petitioner complained of knee pain. P’s Ex. 5 at 56. At that time, she told the doctor that this knee pain had been ongoing for the last one to two weeks. P’s Ex. 5 at 56. The medical records do not reflect any mention of other joint pains until months after her April 2008 visit regarding her knee pain. It was in October 2008 that her parents, not she, mentioned to the doctor that they had observed some swelling in Petitioner’s hands in the mornings. P’s Ex. 5 at 56. The records further indicate that it was not until 2009 following her knee surgery, that Petitioner herself complained of joint pain in her hands, fingers, or ankles when she visited an orthopedist following her knee surgery. P’s Ex. 8 at 25. At this time, Petitioner referred to this as different pain than she had previously experienced with her knee. P’s Ex. 5 at 63. The medical histories provided during Petitioner’s medical consultations consistently reflect that her pain began in March-April 2008. At her doctor’s visit in April 2008, she identified the onset as having been one to two weeks before. P’s Ex. 5 at 56. At her next 12 doctor’s visit in October 2008, when she had a consultation with Dr. Lee, the orthopedist, she reported that her pain had begun in April 2008. P’s Ex. 7 at 7. At her next doctor’s visit in November 2008, to Dr. Graham, the second orthopedist she visited, the history again noted that Petitioner’s symptoms began when she was running on the beach approximately six or seven months earlier, dating to approximately April 2008. P’s Ex. 8 at 6-7; 11. Dr. Graham noted that she had no other remarkable symptoms besides her chief complaint of left knee pain. P’s Ex. 8 at 7. When she next saw her primary care physician in April 2009, for the first time, Petitioner’s chief complaint was reported as having painful claw hands in the morning. P’s Ex. 5 at 63. In the records, Petitioner explained that her knee pain had resolved with the surgery but that she now had different pain in her knees as well as her shoulders and hands. Id. Significantly, at this visit, Petitioner identified the onset of this pain as beginning approximately twelve months earlier, which would place it in April 2008, the same time as her knee pain. Id. In July 2009, when Petitioner went to the first rheumatologist, Dr. Powell, the medical history also reflects that she told him her pain began approximately one year earlier. P’s Ex. 12, Ex. 10-13 attachment thereto. When Petitioner subsequently went back to her primary care physician to report Dr. Powell’s diagnosis, the notes reflect that Petitioner’s mother noted that the first indication of pain was shoulder pain in October 2008. P’s Ex. 5 at 65. Admittedly, there is one notation in the medical records from the last doctor which whom Petitioner consulted in September 2009, Dr. Shiel, a rheumatologist. P’s Ex. 11. Those records indicate that Petitioner gave a history of having joint pain for two years beginning with her left shoulder, which would place the onset at September 2007, much earlier than any of the other medical records. See P’s Ex. 11. There are several reasons why this notation is not considered reliable. First, because the lapse between the onset of any pains was so far removed from this visit, it is understandable that dates given in the medical history would not be as accurate. Indeed, due to this lapse, Petitioner’s memory may not be as accurate in providing a history. Petitioner herself acknowledged this as a possibility. When discussing her symptoms at the hearing, Petitioner admitted to having some difficulty remembering specific times and dates. Tr. at 60-61 (confusion about dates when speaking to Dr. Shiel). Second, alternatively, this notation is likely a gross approximation by Dr. Shiel as to the time frame. Given Dr. Shiel was not consulted until the fall of 2009, pain that began in March or April 2008 would be close to two years old so an approximation of two years could be understandable. In that Dr. Shiel’s notation and the timing of onset was not critical to his diagnosis, such an approximation would be appropriate for him to make. Third and finally, another factor in considering the date in the record was that Petitioner had already begun to contemplate litigation. The medical records indicated that only shortly before this visit, Petitioner told her physician that she associated her condition with the HPV vaccines she received. P’s Ex. 5 at 63. She advised that a friend of hers had complained of 13 similar symptoms and an alleged causal relation with the HPV vaccines. Id. In April 2009, Petitioner reported to her primary care physician that her parents had looked up cases and found indications of a class action suit regarding HPV. P’s Ex. 5 at 63. In August 2009, after consulting Dr. Powell, Petitioner advised her primary care physician that she wanted all her lab results because of the scientific articles that she had read linking HPV to rheumatoid arthritis. P’s Ex. 5 at 65. Petitioner had already begun to contemplate litigation by the time of this second consultation with Dr. Shiel. As such, her statements regarding her medical history to Dr. Shiel with whom she consulted subsequently must be viewed with this in mind as well. As such, they carry less weight than the others. See generally Coffelt, 1992 WL 158714 at *6 (statements given prior to any thought of litigation are reliable). In light of these factors, the testimony and the other medical records, this notation of a two-year onset appears to be an anomaly and not reliable. The other medical records consistently date the pain back to March-April 2008. This includes the medical histories Petitioner herself provided to various doctors until that point. These histories are provided to ensure the proper diagnosis and treatment. Given this, the special master is persuaded that these consistent records and statements made in these records for the purpose of accurate diagnosis and treatment reflect the accurate date as to onset. Curcuras, 993 F.2d at 1527-28. These medical records consistently refer to the onset of pain following the vaccines as starting in March-April 2008. B. The Testimony Is Consistent with the Medical Records Regarding the Onset of Joint Pain Occurring with Her Knee Pain in March-April 2008. In considering and evaluating the testimony of Petitioner and her parents, it was evident that Petitioner and her parents each recalled vividly the incident in March-April 2008 when Petitioner ran on the beach with her uncle and that this was when Petitioner’s joint pain began. Petitioner described how she had gone on a run with her uncle at the beach and that the run was more difficult than usual. Tr. at 35. Despite her belief that she was in very good shape, running ten miles without problems, her knee pain during that run became so severe that at one point she had to stop. Id. Mr. and Mrs. Sullivan’s testimony regarding the onset of the knee pain was consistent with Petitioner’s testimony. Mrs. Sullivan recalled petitioner running on the beach with her brother after which she concluded Petitioner suffered a serious injury that required her to go to the doctor. Tr. at 193-94, 221. Mr. Sullivan also remembered Petitioner began complaining about knee pain after running on the beach with her uncle. Tr. at 252. It was after the subsequent track meet when Petitioner had to withdraw from her second race, that he took her to the doctor. Tr. at 253-54. Mr. Sullivan also testified that Petitioner’s awkward hand positions while running was due to her obvious knee pain. Tr. at 253. The special master had an opportunity to observe the witnesses’ demeanors when describing certain events regarding the onset of pain and, in particular, how accurate, vivid and detailed they recalled the particular knee pain onset events. See Sanchez v. Sec’y of Health & Human Servs., No. 11-685, 2013 WL 1880825 at *3 (Fed. Cl. Spec. Mstr. Apr. 10, 2013 (citing Andreu v. Sec’y of Health & Human Servs., 569 F.3d 1367, 1379 (Fed. Cir. 2009)(an assessment 14 of a fact witness’s credibility may involve consideration of the person’s demeanor while testifying). Petitioner and her parents’ testimony is clear and consistent regarding the onset of pain as occurring when Petitioner ran on the beach in March-April 2008. Based on her observations of the testimony, the special master accords the testimony regarding this onset of knee pain, also consistent with the medical records, great weight. C. The Testimony Regarding the Onset of Pain Earlier Than March-April 2008 Is Unclear, Confusing and Inconsistent and Does Not Establish That It Is More Probable That The Symptoms Began Earlier Than What Is Set Forth in the Medical Records. In contrast to the clear testimony regarding the onset of knee pain in March or April 2008, the testimony regarding the onset of aches and pains claimed to have occurred earlier is not reliable. Citing Lowrie v. Sec’y of Health & Human Servs., No. 03-1585, 2005 WL 6117475 (Fed. Cl. Spec. Mstr. Dec. 12, 2005), Petitioner argues that there are events not contained in the medical records because she did not see the doctor despite having symptoms. Petitioner asserts that this testimony should be used to establish the dates her symptoms began at an earlier time despite no substantiation in the contemporaneous medical records and despite the events occurred approximately four years earlier. Having considered the witnesses and their testimony, and as explained below, the special master finds that the testimony does not establish that it is more probable than not that the onset of certain symptoms occurred earlier than March-April 2008. First, the testimony is unclear and vague as to the timing of the onset of conditions and, thus, not reliable when compared with the clear, consistent contemporaneous medical records. Thomas v. Sec’y of Health & Human Servs., No. 01-645, 2007 WL 470410 at *2 (Fed. Cl. Spec. Mstr, Jan. 23, 2007) (citing Blustein, 1998 WL 40866 at *5). Second, having considered the witnesses’ demeanors, their testimony that they ignored what they themselves describe as significant medical symptoms is inconsistent with their demeanor of vigilantly monitoring Petitioner’s medical condition and reporting any medical symptoms to doctors promptly. Sanchez v. Sec’y of Health & Human Servs., 2013 WL 1880825 at *6. Third, Petitioner’s activities in 2008, in particular her starting a job during that period, is inconsistent with her experiencing the severe medical symptoms described in the testimony. 1. The Testimony Regarding the Onset of Symptoms as Being Earlier Than March-April 2008 Was Vague, Confusing and Inconsistent. The testimony regarding Petitioner’s alleged medical symptoms that were to have begun earlier than reflected in the medical records was vague, confusing and inconsistent. For instance, Petitioner’s testimony regarding the details of how and when the pain affected her running during 2007-08 was confusing. At one point, Petitioner testified that in June 2008 she iced her shoulder every day after practice. Tr. at 40. But, when asked to specify how often she experienced pain in her shoulder that required her to ice it, she could not recall. Tr. at 141-42. She later stated she would only ice it if it was sore. Tr. at 141-42. The testimony regarding the timing of the severity of the shoulder pain was also confusing and inconsistent. Petitioner testified that about two weeks after she got her first vaccine she developed shoulder pain. Tr. at 17. At first, she testified that when she first began 15 to experience the pain in her sophomore year, 2007-08, it would only be in the morning and that it would have dissipated by the afternoon and because she ran in the afternoon, it would not necessarily affect her running at all. Tr. at 18, 88-89. But then at another point in her testimony, in stark contrast, Petitioner testified that the pain was such that it caused her to alter her running stride and, in particular, the positions of her arms. Tr. at 140. And, much of the testimony regarding Petitioner’s aches and their effects relating to her running track was also confusing and inconsistent. Mr. Sullivan recalled that after Petitioner withdrew from the meet in the spring of 2008, she never ran again despite attempts to do so. Tr. at 291. On the other hand, Petitioner said that she started to run again in June 2008 although not to her potential. Tr. at 40. The school records indicate that Petitioner was still signed up and received credit in her junior year, 2008-09, for a period for cross country in the fall and track in the spring. P’s Ex. 25. Petitioner’s original affidavit stated she had been the captain of the cross country team. P’s Ex. 1. But, in her testimony, she said she quit cross country in August 2008, prior to her junior year and prior to being the captain of the team. Tr. at 38-40. On the other hand, Petitioner’s mother seemed to believe that Petitioner was still running up to the time of her surgery, which would have been in December 2008. Compare, e.g., P’s Ex. 24, ¶ 8 with Tr. at 248. And, the medical records from her visits to the two orthopedists, Dr. Lee and Dr. Graham, both indicate that she was running cross country and track. P’s Exs. 8 and 9. Mrs. Sullivan’s testimony regarding the onset and progression of Petitioner’s pains was unclear. At one point, Mrs. Sullivan testified that she thought Petitioner’s pains started near the end of 2007. Tr. at 212. But, upon further inquiry, Mrs. Sullivan said that she knew the problems with Petitioner’s hands which interfered with her daily activities occurred in her junior and senior years, 2008-09 and 2009-10. Tr. at 217-18. But, at another point in her testimony when asked when she actually had begun to assist Petitioner with daily activities, Mrs. Sullivan said she was very bad with dates and could not identify a particular time frame. Tr. at 212, 228, 231. Mr. Sullivan also said he believed that Petitioner had problems with her wrists at some time around the end of the year in 2007. Tr. at 247-49; 305. At another point, he said he thought it was around the same time as when the knee pain started, in March 2008, with the funeral of his brother-in-law. Tr. at 305. But, he, too, admitted that he could not pinpoint a specific event during that time. Tr. at 247-249. Petitioner’s and her parents’ testimony regarding the onset and progression of symptoms being earlier than reflected in the medical records was vague, confusing and inconsistent. Where the details of testimony are not consistent, such testimony cannot be credited especially when it is not substantiated by medical records. Murphy, 23 Cl.Ct at 733; Blustein v. Sec’y of Health & Human Servs., 1998 WL 408611 at *5 (Fed. Cl. Spec. Mstr. June 30, 1998) (to overcome the presumption that written records are accurate, testimony is required to be “consistent, clear, cogent and compelling”). The testimony at the hearing, which is unclear and vague, is not consistent with the history of onset as recorded in the medical records. As such, it does not overcome the presumption that the written medical records are accurate. Parcells v. Sec’y of Health & Human Servs., No. 03-1192, 2006 WL 2252749 at *10 (Fed. Cl. Spec. Mstr. July 18, 2006)(citing Blustein, 1998 WL 408611 at *5). Finally, comparing the testimony regarding the onset of symptoms alleged to have 16 occurred earlier than reflected in the records with the witnesses’ recollections regarding the onset in March-April 2008 and the nature of pain experienced far later leads the special master to find that the testimony regarding early onset is not reliable and cannot be accorded much weight. As already referenced supra, Discussion I.B., the witnesses testified with certainty regarding the onset of Petitioner’s knee pain in March-April 2008. Tr. at 35 (Petitioner); Tr. at 193 (Mrs. Sullivan); Tr. at 252 (Mr. Sullivan). They also testified vividly that during her junior and senior years in high school, in 2008-09 and 2009-10, Petitioner had experienced consistent, multiple pains. Tr. at 69 (Petitioner—in senior year every day woke up sick and struggling); Tr. at 152 (Mrs. Sullivan—recalls in the summer of 2009 had much pain in ankles, knees, wrists and fingers); Tr. at 269 (Mr. Sullivan—as a senior trying to manage pain). These are the very events that are clear in the medical records. This testimony was consistent with the medical records. In contrast, in their testimony regarding the onset of symptoms that were alleged to have occurred earlier than reflected in the medical records, i.e., the alleged onset of pain in the fall or winter of 2007, they were uncertain and vague. The special master cannot rely on these vague statements made with uncertainty and make findings based on them in the absence of records to substantiate these statements. 2. The Testimony, Which Suggests Petitioner and Her Parents Did Not Promptly Seek Medical Attention, Is Inconsistent With Their Practice of Vigilantly Reporting Ailments. Second, the Petitioner’s and her parents’ testimony that during late 2007 and early 2008 they ignored Petitioner’s joint pains is inconsistent with their practice of promptly seeking medical treatment for Petitioner’s ailments. The records indicate that Petitioner’s mother was diligent about contacting doctors regarding Petitioner’s ailments. As the records indicate, Petitioner’s mother called Petitioner’s primary care physician three times during the period she was receiving vaccines, in August of 2007, November 2007 and January 2008 to report various ailments from which Petitioner was suffering. P’s Ex. 5 at 54-55. Mrs. Sullivan reported at various times, coughing and heart palpitations, a stomach ache and sore throat. Id. But, on none of these occasions did Mrs. Sullivan mention any joint aches or pains despite that Petitioner was to have been suffering from them. But, at the same time, the records reflect that Petitioner and her parents were diligent in contacting the doctor regarding other ailments. It “strains reason” that Petitioner and her parents would not also report the joint aches and pains she now claims were occurring during the same times she was reporting other symptoms. Cucuras v. Sec’y of Health & Human Servs., 26 Cl.Ct. 537, 543 (1992), aff’d., 993 F.2d 1525 (Fed. Cir. 1993). Additionally, that Petitioner and her parents would not report these aches and pains when they were occurring is also unreasonable given their past practices of promptly reporting similar joint aches and pains. Petitioner repeatedly visited the doctor between March 2006 and April 2007 for Petitioner’s chronic, left-sided back pain. P’s Ex. 5 at 35, 39, 42. In August 2005, Petitioner visited the doctor because she was reporting that her hands and soles of her feet were sweating excessively. P’s Ex. 5 at 34. Petitioner was astute about reporting these pains. If she had been experiencing such problems, Petitioner would have reported them and sought medical advice. Petitioner’s explanation for not reporting these symptoms was that she did not believe it 17 was important to do so. But, she also testified how they had affected her running position and her running performance. When discussing running, Petitioner explained how dedicated to running she was during that period. Tr. at 83. She described herself as completely involved in running. Id. Given Petitioner’s passion for running, it is impossible to accept that she would have allowed such pain to continue without consulting a doctor. Had Petitioner been experiencing such physical problems that were stifling her running performance, she would report them promptly to her doctor as she reported her other problems.11 Tr. at 113. Petitioner’s alleged failure to consult her trainer or doctor promptly to have her medical problems addressed so she could return to her peak running condition is simply inconsistent with the care to which she paid to her physical condition. Had Petitioner experienced an ailment as she described, she would have sought medical assistance so that she could maintain top running performance. Certainly, the special master believes that Petitioner and her parents sincerely and earnestly testified regarding these matters. But, given their practice of reporting health issues to doctors, that they did not report any symptoms to the doctor during this period indicates that those aches and pains did not begin as early as the Petitioner now asserts. Based on this, the special master finds it is more likely than not that these pains were not occurring during the latter part of 2007 and early 2008 period, before March-April 2008. Doe/17 v. Sec’y of Health & Human Servs., 84 Fed. Cl. 691, 711 (2008); Ryman v. Sec’y of Health & Human Servs., 65 Fed. Cl. 35, 41-42 (2005); Snyder v. Sec’y of Health & Human Servs., 36 Fed. Cl. 461, 465 (1996) (stating that if Petitioner had suffered symptoms immediately following vaccination, it was more likely than not that even his parents’ mention of it would be noted by at least one of medical professionals and that the absence calls into question petitioner’s memory of events, not sincerity), aff’d., 117 F.3d 545, 547-48 (Fed. Cir. 1997). 3. Petitioner’s Activities Following Receipt of the Vaccines Are Inconsistent with Her Experiencing the Pain About Which She Testified as Occurring During the Same Period. Third, Petitioner’s activities during 2008 were inconsistent with the debilitating pain in her joints, especially her hands and shoulders, that Petitioner testified she experienced beginning in late 2007. In her first affidavit Petitioner said she “was forced to stop participating in any and all physical activity due to severe chronic body and joint pains.” P’s Ex. 1, ¶ 5. But, the testimony was also that during this very period she applied for and began work at a fast food restaurant. Tr. at 119-20. That job involved significant standing on her feet and continuous use of hands as Petitioner cleaned the dining room, worked the cash register and filled orders at the drive-thru at various times. Tr. at 28-29, 119-20. Given the physical requirements of the job, it is inconceivable that Petitioner would have sought such work at a time when she was suffering to the extent as described in the testimony. 11 She said she was running long distances and that, as a result, everything hurt. Id. She explained that she had maintained a running journal so that she could track what she ate and each of her runs. Id. However, when asked to produce it, Petitioner promptly stated she had destroyed it. 18 In sum, there is no doubt that Petitioner has clearly suffered pain as she vividly described. Both her parents verified this. But having endured such pain for at least a few years to the point where she kept a “pain” journal, it is reasonable that Petitioner perceived that the pain began much earlier and has been ongoing much longer than in actuality. Even Petitioner and her parents inherently recognize this because they all testified that during the 2007 time period up until the March-April 2008 time frame no pains were significant to them. Petitioner, who was diligent and sensitive to aches and pains in her body, recognized when she experienced pain and sought medical attention, that being in March-April 2008. The special master does not credit Petitioner’s testimony regarding the timing of onset of pains following receipt of the vaccine, as being earlier than March-April 2008. The contemporaneous medical records are clear and consistent and, thus, should be and are accorded great weight. Curacus, 993 F.2d at 1528. The special master’s assessment of the testimony and demeanor leads the special master to find that the medical records are more reliable and credible than the testimony regarding aches and pains not reflected in the records. See Andreu., 569 F.3d at 1379 (an assessment of a fact witness’s credibility may involve consideration of the person’s demeanor while testifying). Based on the entire record, the special master finds that Petitioner’s first aches and pains and swelling of joints following her receipt of the HPV vaccines were the pains and joint swelling relating to her knee reported to have begun a few weeks before April 18, 2008. V. FINDING OF FACT Accordingly, the special master, in the exercise of her discretion, makes the following finding of fact: 1. Petitioner’s onset of joint pain following her receipt of HPV vaccinations on June 27, 2007, August 26, 2007 and January 4, 2008, occurred somewhere between March and April 2008, in the few weeks prior to April 18, 2008, when she first visited her doctor complaining, inter alia, of pain to her left knee. 19 VI. CONCLUSION The special master hereby enters this finding of fact. The special master makes no conclusion as to the significance of this in the context of Petitioner’s claim. IT IS SO ORDERED. /s/ Daria J. Zane Daria J. Zane Special Master / 20 ================================================================================ DOCUMENT 2: USCOURTS-cofc-1_10-vv-00398-0 Date issued/filed: 2015-03-27 Pages: 29 Docket text: PUBLIC DECISION (Originally filed: 02/13/2015) regarding 69 DECISION of Special Master Signed by Special Master Brian H. Corcoran. (ay) Copy to parties. -------------------------------------------------------------------------------- Case 1:10-vv-00398-UNJ Document 71 Filed 03/27/15 Page 1 of 29 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 10-398V (To Be Published) * * * * * * * * * * * * * * * * * * * * * * * * * * Special Master Corcoran SHEA KYLIE SULLIVAN, * * Filed: February 13, 2015 Petitioner, * * Entitlement Decision; Human v. * Papillomavirus (“HPV”) Vaccine; * Rheumatoid Arthritis (“RA”); SECRETARY OF HEALTH AND * Molecular Mimicry; Homology; HUMAN SERVICES, * Cumulative Effect * Respondent. * * * * * * * * * * * * * * * * * * * * * * * * * * * Sarah McIntee, Nelson Mullins Riley & Scarborough, LLP, Washington, DC, for Petitioner. Alexis Babcock, U.S. Dep’t of Justice, Washington, DC, for Respondent. DECISION DENYING ENTITLEMENT1 On June 28, 2010, Shea Sullivan filed this action seeking compensation under the National Vaccine Injury Compensation Program (the “Vaccine Program”),2 alleging that she incurred a variety of arthritis-like injuries after receipt of the Human Papillomavirus (“HPV”) vaccine. Petition (“Pet.”) (ECF No. 1) at 1, 3-4. After considering the record as a whole, and for the reasons explained below, I find that Petitioner has failed to carry her burden establishing causation, and therefore has not demonstrated entitlement to compensation under the Vaccine Program. 1 Because this decision contains a reasoned explanation for my action in this case, it will be posted on the United States Court of Federal Claims’ website, in accordance with the E-Government Act of 2002, Pub. L. No. 107-347, § 205, 116 Stat. 2899, 2913 (codified as amended at 44 U.S.C. § 3501 note (2006)). 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. To do so, Vaccine Rule 18(b) permits each party fourteen (14) days within which to request redaction “of any information furnished by that party: (1) that is a trade secret or commercial or financial in substance and is privileged or confidential; or (2) that includes medical files or similar files, the disclosure of which would constitute a clearly unwarranted invasion of privacy.” Vaccine Rule 18(b). Otherwise, the decision will be available to the public. Id. 2 The National Vaccine Injury Compensation Program comprises Part 2 of the National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755 (codified as amended, 42 U.S.C.A. § 300aa-10 to 34 (2006)) [hereinafter “Vaccine Act” or “the Act”]. Individual section references hereafter will be to § 300aa of the Act. Case 1:10-vv-00398-UNJ Document 71 Filed 03/27/15 Page 2 of 29 I. Factual Background and Medical History The record in this case consists of Ms. Sullivan’s medical records, a daily self-health log she prepared, affidavits from her as well as her mother and father, the testimony of two experts, and medical or scientific literature submitted by the parties in support of their respective positions. I have reviewed the entire record as required by the Vaccine Act. In this ruling I address the sufficiency of Petitioner’s evidence in support of an award of compensation. A. Petitioner’s Medical History Petitioner was nearly sixteen years old at the time she received her first Gardasil3 vaccination (part of a series of three vaccinations) on June 27, 2007, during a wellness visit to the Pediatric and Adult Medicine Clinic in Tustin, California. Pet’r’s Ex. 5 at 54-55; Pet’r’s Ex. 2 at 2 (birth certificate); Pet’r’s Ex. 3 at 2 (vaccination record). Overall, Ms. Sullivan was assessed at the time as a “well adolescent.” Pet’r’s Ex. 5 at 55. On August 10, 2007, Ms. Sullivan’s mother contacted Valerie Kozak, M.D. (Petitioner’s primary care physician) at Pediatric and Adult Medicine to report that Petitioner appeared to be suffering from heart palpitations. Pet’r’s. Ex. 5 at 55. Ms. Sullivan was apparently seen again on August 29, 2007, when she received her second Gardasil vaccination. Pet’r’s Ex. 3 at 3. There are no subsequent records of any medical visits between August 27, 2007, and the time Petitioner received her third Gardasil vaccination on January 4, 2008. Pet’r’s Ex. 5 at 56. On February 11, 2008, Ms. Sullivan’s mother called Dr. Kozak, this time to report that Petitioner was suffering from a sore throat, headache, and abdominal pain, and Dr. Kozak prescribed an antibiotic. Pet’r’s Ex. 5 at 56. Ms. Sullivan was not seen again by a physician until April 18, 2008 (fifteen weeks after receiving her third Gardasil vaccination), when she reported experiencing left knee pain over the prior one to two weeks. Id. at 57. In the relevant medical history, it was noted that Petitioner ran track at school. Id. On examination, Ms. Sullivan’s left knee proved to be tender medially and in the patella (knee cap) region, but she had full range of motion and the knee was otherwise stable, so she was merely referred to orthopedics for an evaluation (although the medical records do not indicate whether she followed through with the evaluation). Id. Months later, Ms. Sullivan went back to Dr. Kozak for a follow-up visit in October of 2008 regarding the knee pain that she had been experiencing as well as swelling in her hands, feet, and forearms. Pet’r’s Ex. 5 at 56. The possibility of arthritis as an explanation for Petitioner’s symptoms is recorded in the medical history from this visit. Id. Laboratory studies showed normal comprehensive 3 Gardasil is a quadrivalent recombinant vaccine (meaning it is made from genetically engineered material but does not contain live viruses) manufactured from the L1 protein of four strains of HPV (strains 6, 11, 16, and 18). See generally Gardasil Package Insert, available at http://www.fda.gov/BiologicsBloodVaccines/ Vaccines/ ApprovedProducts/UCM094042. 2 Case 1:10-vv-00398-UNJ Document 71 Filed 03/27/15 Page 3 of 29 metabolic panel (“CMP”), complete blood count (“CBC”), and urinalysis results. Id. at 58-63. An antinuclear antibody (“ANA”) screen, double–stranded DNA, smooth muscle antibody, C3 complement, cardiolipin antibodies, thyroid function, and direct antiglobulin tests were also negative for abnormalities. Id. Ms. Sullivan subsequently saw Eric Wei En Lee, M.D. at Orange Orthopedic Medical Group in Orange, California on October 21, 2008, for an orthopedic evaluation. Pet’r’s Ex. 7 at 6-8. As the treatment records from that visit indicate, Petitioner reported that her onset of symptoms had occurred in April 2008 “while running track.” Id. at 6. She also related to Dr. Lee that she had experienced another episode of pain while running on the beach during the same period, and characterized the pain as constant and severe. Id. She specifically reported “objective instability, mechanical popping clicking, weakness, and decreased range of motion.” Id. A physical examination performed on Petitioner revealed “peripheral joint stiffness.” Id. at 7. An examination of her knee in particular revealed no erythema, swelling, drainage, or sign of infection; other aspects of her exam also had normal results, although there was a 1+ effusion and abnormalities with the patellar exam. Id. Dr. Lee diagnosed Ms. Sullivan with a patellofemoral chondromalacia (damage to the patella) and malalignment, as well as mild flexible pes planus (flat feet). Id. Ms. Sullivan underwent an MRI of her knee on October 22, 2008, which showed intact menisci, tendons, and ligaments. Pet’r’s Ex. 7 at 10. A moderate amount of joint effusion was observed (although its etiology was unclear). Id. She returned to Dr. Lee’s clinic for follow-up on October 29, 2008, at which time (taking into account the MRI) she was again diagnosed with left knee patellofemoral chondromalacia, leading Dr. Lee to recommend physical therapy. Id. at 11, 12. On November 3, 2008, Ms. Sullivan presented to Scott Graham, M.D. at South County Orthopedic Specialists in Laguna Woods, California for a second opinion regarding her left knee pain. Pet’r’s Ex. 8 at 6-7. She again reported that her pain had existed since April of 2008 after “running on the beach,” and although she could not remember if there had been a specific injury, she did recall having pain and swelling the next day. Id. The medical records from that visit note that Petitioner’s family history was significant for arthritis, diabetes, cancer, and stroke. Id. at 6. A physical examination showed left knee swelling and tenderness, without warmth, but Petitioner nevertheless demonstrated a full range of motion and no hip irritability. Id. Dr. Graham reviewed the imaging studies and agreed that they were normal except for the presence of effusion. Id. He diagnosed Ms. Sullivan with a possible occult medial meniscal tear, and gave her a cortisone injection. Id. at 7. There was no mention of vaccination in Petitioner’s treatment records from this visit, nor was Gardasil, or any other vaccine, identified as a possible cause of Ms. Sullivan’s injuries. Petitioner had a follow-up visit with Dr. Graham on December 1, 2008. Pet’r’s Ex. 8 at 11. Because she continued to report knee pain despite the cortisone injection she had received in November, surgical intervention was recommended. Id. Ms. Sullivan subsequently underwent arthroscopic knee surgery performed by Dr. Graham on December 16, 2008. Id. at 12-13. Her post-operative diagnoses 3 Case 1:10-vv-00398-UNJ Document 71 Filed 03/27/15 Page 4 of 29 were: (1) medial compartmental synovitis scar tissue, (2) lateral tibial plateau grade III chondral fissure, and (3) suprapatellar plica; follow-up physical therapy was recommended. Id. at 21-24. Ms. Sullivan underwent physical therapy treatments at Knight Physical Therapy in Anaheim, California, but not consistently, and she did not complete all of her sessions. See Pet’r’s Ex. 9 at 2-9. At a session on February 2, 2009, she was noted to be doing well overall, although her knee was more swollen than usual due to standing for an extended period of time at a recent concert, and she was urged to keep up with her therapy. Id. at 11. On February 11, 2009, Ms. Sullivan was seen by Dr. Graham for a post-surgery follow-up. Pet’r’s Ex. 8 at 26. Petitioner now reported that although her knee pain had improved, she was experiencing pain in multiple joints. Id. She thereafter went back to Dr. Kozak on April 6, 2009 (a year after she claims to have first experienced knee pain) with complaints of joint pain in her arms and hands, as well as a new kind of knee pain different from what she had previously experienced. Pet’r’s Ex. 5 at 63. It was now noted (for the first time in the medical records) that Ms. Sullivan “associates [her symptoms] with HPV vaccine.” Id. The contemporaneous medical records specifically note that Petitioner had looked up information regarding the connection between the Gardasil vaccination and rheumatoid arthritis (“RA”) on the internet and reported having found five cases associated with a class action lawsuit regarding the vaccine. Id. Ms. Sullivan returned to Dr. Kozak on July 13, 2009. Pet’r’s Ex. 5 at 64. By this time, Petitioner reported that she had been diagnosed with “inflammatory” arthritis “per rheumatology” (id.), presumably referring to the assessment of Thomas R. Powell, M.D., a rheumatologist in Orange, California, who saw Petitioner that same month. See generally Pet’r’s Ex. 10. She later saw Dr. Kozak again in August, at which time she repeated her concern that the Gardasil vaccine was the cause of her arthritic condition. Pet’r’s Ex. 5 at 65. As a written phone record from August 3, 2009, indicates, Dr. Kozak informed Ms. Sullivan’s mother that there were no scientific articles linking the Gardasil vaccine to arthritis. Id. Laboratory work performed by Dr. Powell showed that Ms. Sullivan’s cyclic citrullinated peptide antibody (“CCP”) (the presence of which is strongly associated with RA) was elevated, while serum protein electrophoresis, rheumatoid factor (“RF”), ANA, CBC, and CMP results were normal. Pet’r’s Ex. 10 at 3-9. On September 9, 2009, Petitioner was seen by William Shiel, M.D., FACP, FACR, at Mission Internal Medicine Group, Inc. in Mission Viejo, California for a rheumatologic evaluation. Pet’r’s Ex. 11 at 1-3. A physical examination was significant for hyperhydrosis of the feet, swollen proximal interphalangeal (“PIP”) joints with decreased flexion, swollen wrists, trace swelling of the knees with decreased flexion to 120 degrees, and tender metatarsophalangeal (“MTP”) joints. Id. at 2-3. Ms. Sullivan’s erythrocyte sedimentation rate (a test used to measure the degree of inflammation present) was slightly elevated at thirty-two. Id. 5-7. RF and ANA tests were negative, while her anti-CCP antibody was strongly positive. Id. Petitioner was diagnosed with symmetric polyarthritis, based on such test results and the generally-observed loss of range of motion of the wrists and PIP joints. Id. at 4. 4 Case 1:10-vv-00398-UNJ Document 71 Filed 03/27/15 Page 5 of 29 Dr. Shiel ultimately felt that Ms. Sullivan’s symptoms were very suggestive of RA, and recommended a number of medications to treat her symptoms. Id. At a follow–up visit with Dr. Shiel on September 25, 2009, Ms. Sullivan complained of “[p]ain all over the joints for [two] years” and was started on medication to treat her symptoms. Pet’r’s Ex. 11 at 10. Imaging studies included a normal bilateral wrist x-ray series, hand x-rays that showed mild periarticular osteopenia, and foot x-rays that showed periarticular osteopenia. Id. at 11-14. Petitioner was thereafter formally diagnosed by Dr. Kozak as suffering from Juvenile Rheumatoid Arthritis (“JRA”).4 Pet’r’s Ex. 5 at 68. An addendum from Ms. Sullivan’s primary care physician on May 19, 2010, stated that she continued to have achy joints and shoulders, and swollen fingers, but her medications had alleviated some of her symptoms. Id. at 69. Those same records note concerns about why Petitioner was “ill” so frequently but offer no explanation. Id. B. Expert Testimony 1. Dr. Richard Roseff – Petitioner’s expert, Richard Roseff, M.D., graduated from Boston University School of Medicine in 1980 (after completing his undergraduate degree at Amherst College). Tr. at 5; ECF No. 12-1 at 3. Dr. Roseff went on to complete his residency at Boston Medical Center, followed by a two-year fellowship in rheumatology at Massachusetts General Hospital. Tr. at 5. Dr. Roseff is board certified in internal medicine and rheumatology but not in pediatric rheumatology. Id. at 6, 43. He is currently a member of the American College of Rheumatology, and he has a rheumatology sub-specialty private practice in Connecticut. Id. at 7. Dr. Roseff has lectured on RA, but he has not published any articles on this topic. Id. Dr. Roseff is also not an immunologist, epidemiologist, or toxicologist, and he has no personal expertise in the subject of vaccine causation. Id. at 80, 136-38. Dr. Roseff’s opinion is based on his review of Petitioner’s medical records, affidavits (from Petitioner as well as her parents), and medical or scientific literature (including articles on vaccine- induced autoimmune illness as well as articles on the latency period5 between vaccination and the development of autoimmune diseases). Tr. at 12. It is not part of Dr. Roseff’s regular practice to see individuals who are under eighteen years of age (as Ms. Sullivan was at the time of her diagnosis). Id. at 43. Additionally, Dr. Roseff could not recall having diagnosed anyone with a vaccine-related arthritic condition as part of his clinical practice. Id. at 76. 4 As both parties’ experts agreed, rheumatoid conditions that begin when a patient is sixteen are typically not classified as juvenile, according to relevant diagnostic criteria. Tr. at 88, 92, 94. Therefore, although Dr. Kozak formally diagnosed Ms. Sullivan with JRA (presumably due to her young age at the time of onset of her symptoms), there is no dispute in this case that RA was the proper diagnosis (see, e.g., Tr. at 66, 94), and I accept it as such for purposes of this decision. 5 Dr. Roseff defined latency period to be the asymptomatic period following exposure. Tr. at 133. 5 Case 1:10-vv-00398-UNJ Document 71 Filed 03/27/15 Page 6 of 29 Dr. Roseff’s opinion began with testimony about RA, which he characterized as an “inflammatory polyarthritis of unclear etiology.” Pet’r’s Expert Report dated Feb. 2, 2011 at 3 [hereinafter “Roseff Report”]; see also Tr. at 10. As Dr. Roseff explained, RA has several patterns of onset, but classically results in a symmetric (meaning bilateral) inflammation of joints associated with stiffness and pain that, if left untreated or treated inadequately, can result in disability and even mortality. Tr. at 10. The majority of individuals who develop RA fall into the same demographic as Petitioner (i.e., young adult females), although Dr. Roseff later clarified that he believed Ms. Sullivan fell on the younger end of that spectrum. Id. at 10-11. Dr. Roseff acknowledged that certain hereditary and environmental factors may place an individual at higher risk for developing RA (Tr. at 2), and that Ms. Sullivan’s illness could have been caused by such non-vaccine related factors. Addendum to Pet’r’s Expert Report, dated Feb. 9, 2011 (ECF No. 12-3) at 2 [hereinafter “Roseff Amended Report”]. However, Dr. Roseff opined that it was unlikely that Petitioner’s RA could be attributed to this type of random occurrence. Tr. at 17. He initially reached this conclusion after reading various reports from the Gardasil Vaccine Adverse Event Reporting (“VAERS”) database concerning the experiences of other individuals who developed RA after receiving the Gardasil vaccine – suggesting to him a correlation between the two. Id. at 18. He later admitted, however, that the VAERS database is a passive reporting system permitting anyone to report an adverse event, regardless of whether a medical professional has concluded that the adverse event can be linked to vaccination. Id. at 46. As additional support for his causation opinion, Dr. Roseff pointed to findings from clinical studies included in the Gardasil vaccine package insert, which indicated that of the 9,412 individuals receiving placebo, two developed RA, while of 10,706 individuals who had received Gardasil, six developed this condition. Roseff Report at 3. Dr. Roseff characterized such numbers as a “disturbing trend,” while admitting that they were nevertheless small and not otherwise corroborated by any statistical evidence from any specific scientific or medical studies regarding the Gardasil vaccine (or even the HPV vaccine more generally). Id. at 3, 8. Dr. Roseff opined that because various viral antigens have been implicated in the development of RA, “[b]y extension, it is reasonable to suppose that immunizations can also be potential environmental triggers for RA development.” Roseff Report at 3. As evidence of this concept, Dr. Roseff asserted that “[i]t had been known for years that exposure to the rubella vaccine represents a causal link to a chronic arthritis resembling RA in a small percentage of patients.” Id. (emphasis added). Dr. Roseff also cited an article6 involving an attempt to link human parvovirus B19 to development of RA and acute inflammatory arthritis in genetically predisposed individuals. Tr. at 21-22. Although no studies have linked the wild HPV virus to the development of RA, Dr. Roseff testified that the vaccine 6 B. J. Cohen, M. M. Buckley, J. P. Clewley, V. E. Jones, A. H. Puttick & R. K. Jacoby, Human Parvovirus Infection in Early Rheumatoid and Inflammatory Arthritis, 45 Annals of Rheumatic Diseases 832 (1986) (Pet’r’s Ex. 37). 6 Case 1:10-vv-00398-UNJ Document 71 Filed 03/27/15 Page 7 of 29 was different because an individual is exposed to four strains of HPV all at once – meaning that the vaccinated individual is “getting a pretty heavy dose of the papilloma virus.” Id. at 77-78. For the precise mechanism by which the Gardasil vaccine could result in the development of RA, Dr. Roseff proposed molecular mimicry. Tr. at 76. Under Dr. Roseff’s theory, (a) components of the Gardasil vaccine present to the body an antigen,7 (b) resulting in an immune response (the development of B cell lymphocytes), (c) which in turn produce antibodies to the viral sequences in the vaccination that will in the future protect the body from a wild HPV infection. The body, however, may also have homologous protein sequences that will also be attacked by the same antibodies, thereby resulting in the onset of autoimmunity (where the body is attacking its own tissue).8 Id. at 76-77. In reaching this conclusion that the Gardasil vaccination could cause cross-reactions leading to the onset of autoimmunity, Dr. Roseff relied on Kanduc, D., Penta- and Hexapeptide Sharing Between HPV16 and Homo Sapiens Proteomes, 1 Int’l J. Med. and Med. Sci. 383, 386-87 (Sept. 2009) (ECF No. 65-3) (Pet’r’s Ex. 36) [hereinafter “Kanduc”], which examined the cross-reactivity potential of HPV-16 (one of the strains of HPV included in the Gardasil vaccination) and finding that it shares thousands of identical peptide motifs with human proteomes.9 Kanduc at 386. Dr. Roseff opined that, based on Kanduc, there is likely sufficient homology between the viral components of the Gardasil vaccine and human proteins for the development of autoimmune illness. Tr. at 19-20. Dr. Roseff also proposed an alternative mechanism for how the Gardasil vaccine could produce an autoimmune response leading to the development of RA. He testified that aluminum contained in the Gardasil vaccine10 could be implicated in the development of RA, opining that as aluminum is “gobbled up” by white blood cell macrophages, the process can stimulate an immunostimulatory cascade. Tr. at 77. Dr. Roseff acknowledged, however, that this aspect of his opinion was based solely on a single article11 published by Judicial Watch, an advocacy organization, rather than a verifiable scientific 7 An antigen is defined as “any substance capable, under appropriate circumstances, of inducing a specific immune response and of reacting with the products of that response, that is, with specific antibody or specifically sensitized T lymphocytes, or both.” Dorland’s Illustrated Medical Dictionary 103 (32d ed. 2012) [hereinafter Dorland’s]. 8 Dr. Roseff admitted that he did not know what particular amino acid chain was relevant in triggering the autoimmune response that he alleges could have caused Ms. Sullivan’s RA. Tr. at 80. 9 A proteome is defined as “the complete set of proteins produced from the information encoded in a genome.” Dorland’s at 1535. 10 “Gardasil itself contains 225mcg of aluminum.” Pet’r’s Ex. 35 at 8. Aluminum acts as an adjuvant in the Gardasil vaccine (similar to many other common vaccines), meaning that it is a substance that enhances the body’s immune response to an antigen. See Dorland’s at 32 (defining adjuvant). 11 Judicial Watch Special Report: Examining the FDA’s HPV Vaccine Records – Detailing the Approval Process, Side- Effects, Safety Concerns and Marketing Practices of a Large-Scale Public Health Experiment (June 30, 2008) (ECF No. 65- 2) (Pet’r’s Ex. 35) [hereinafter “Judicial Watch”]. The Judicial Watch article notes that unspecified testing reports showed that Merck had tested the Gardasil vaccine against an aluminum-containing placebo, and the authors of the article argue that “[u]sing a reactive aluminum-containing placebo instead of a non-reactive saline base can make vaccines seem safer than they may actually be.” Judicial Watch at 8. The Judicial Watch article further indicated that the Merck study had identified a difference in terms of initial side effects (such as injection site reaction) among the ten percent of individuals who received 7 Case 1:10-vv-00398-UNJ Document 71 Filed 03/27/15 Page 8 of 29 study.12 Id. at 71-72, 78. Dr. Roseff cited no other literature supporting his assertion that aluminum in vaccines could cause injury. Id. at 79-80. One factual issue that Dr. Roseff’s opinion attempted to address was the lengthy time gap between when Ms. Sullivan received the three separate Gardasil vaccines (between June 27, 2007, and January 4, 2008) and when her symptoms actually began. (As noted below, after an onset hearing held by the prior special master presiding over this case, a fact ruling was issued determining that onset of Ms. Sullivan’s illness occurred sometime in “late March or early April 2008, in the few weeks prior to April 18, 2008.” See Sullivan v. Sec’y of Health & Human Servs., No. 10-398V, 2013 WL 4011056, at *16 (Fed. Cl. Spec. Mstr. June 30, 2013) [hereinafter “Ruling Regarding Finding of Fact”]). Dr. Roseff acknowledged that the first time Petitioner sought care for her knee problem was on April 18, 2008, at which time she reported experiencing knee problems for only a week or two. Tr. at 44-45. Dr. Roseff admitted that he could not distinguish which of three Gardasil vaccinations that Petitioner received was the primary cause of her RA, but argued that the build-up of all three vaccinations in her system could have been the instigating factor. Tr. at 69. However, he acknowledged that he could identify no particular study to support the conclusion that the series of Gardasil vaccines that Petitioner received could have had such a “cumulative effect.” Id. at 85. Dr. Roseff also acknowledged that if the first vaccine that Ms. Sullivan received in June 2007 represented the beginning of this proposed build-up, the timeframe between her initial vaccination and onset of her alleged injury in April 2008 was greater than two months (Id. at 54), but he maintained that even the ten months between the first vaccination to onset would not be so long as to exonerate the Gardasil vaccination as having caused Ms. Sullivan’s illness. Id. at 73. To support his opinion regarding the lengthy temporal gap between vaccination and onset in this case, Dr. Roseff attempted to analogize Ms. Sullivan’s circumstances to studies of other diseases featuring long latency periods, such as Lyme arthritis. Tr. at 23.13 In the case of Lyme arthritis, exposure to an antigen (caused by a tick bite that introduces a bacterium into the body) can result in inflammatory arthritis with onset months after initial exposure. Id. The bacterium replicates in the what Dr. Roseff characterized as the “true placebo” (saline) versus other individuals who received the aluminum-containing vaccine. Tr. at 79. “By its own account, Judicial Watch is a ‘non-profit, non-partisan, tax-exempt 501(c)(3) organization which as a public interest law firm specializes in deterring, monitoring, uncovering, and addressing public corruption in government.’” Judicial Watch, Inc. v. U.S. Dep't of Justice, 185 F. Supp. 2d 54, 57 (D.D.C. 2002). 12 Indeed, Dr. Roseff admitted that he did not know whether the Judicial Watch article was authored by a doctor, or whether its conclusions or methodology were peer-reviewed by the scientific community. Tr. at 51. The authors of the Judicial Watch article themselves acknowledge that “Judicial Watch was not and is not interested in proving causality,” indicating that “[o]nly science can do that.” Judicial Watch at 20. 13 For this aspect of his opinion, Dr. Roseff relied upon an article by Allen C. Steere & Lisa Glickstein, Elucidation of Lyme Arthritis, 4 Nature Reviews Immunology 143 (2004) (ECF No. 59-3) (Pet’r’s Ex. 31). But when asked whether this study provided him with merely a hypothesis, or if in fact he believed that it was more likely than not that this is what happened to Ms. Sullivan, Dr. Roseff admitted that he did not know because the matter had not been studied adequately to answer the question. Tr. at 59. 8 Case 1:10-vv-00398-UNJ Document 71 Filed 03/27/15 Page 9 of 29 individual’s system, ultimately finding its way to the synovium (or the joint capsule) and causing an inflammatory arthritis which may persist despite successful antibiotic treatment of the infection. Id. at 23, 59. Molecular mimicry has been offered to explain the process by which this arthritic reaction occurs. Pet’r’s Ex. 31 at 5. Dr. Roseff acknowledged, however, that this analogy was limited in its application. For individuals who develop Lyme arthritis, the bacterial infection has been found to be present in the joint capsule, and thus at the locus of the arthritis. Tr. at 24. By contrast, Dr. Roseff was unaware as to whether synovial biopsies had ever been conducted on individuals who had received the Gardasil vaccine and then developed RA, to see if, in fact, there was evidence of any components of the vaccine similarly present, acknowledging that the failure to find them present would greatly weaken his argument. Id. Dr. Roseff went on to discuss another article addressing a case study that considered from a retrospective standpoint the records of ten lupus patients to evaluate the length of time in which each individual developed lupus after receipt of the Hepatitis B vaccine. See N. Agmon-Levin, Y. Zafrir, Z. Paz, T. Shilton, G. Zandman-Goddard & Y. Shoenfeld, Ten Cases of Systemic Lupus Erythematosus Related to Hepatitis B Vaccine, 18 Lupus 1192, 1194-96 (2009) (ECF No. 39-4) (Pet’r’s Ex. 32) [hereinafter “Agmon-Levin”]. The researchers found that there was variable timing for onset of disease following vaccination, ranging from a few days to as long as a year, with an average time of onset around two months post-vaccination. Id. at 1193; Tr. at 27. Dr. Roseff opined that based on such results, Ms. Sullivan’s initial development of knee symptoms about two months after exposure to her last Gardasil vaccine was a reasonable timeframe. Tr. at 28. In addition, Dr. Roseff also cited an article evaluating a rise in an autoimmune form of diabetes (Type 1, insulin dependent diabetes mellitus (“IDDM”)) in children in Finland following the introduction of the Hemophilus influenza B vaccine, finding an increase in the diagnosis clustering in a period starting at about the thirty-eighth month mark from the date of vaccination and lasting approximately six months. Tr. at 32; see John Barthelow Classen & David C. Classen, Clustering of Cases of Insulin Dependent Diabetes (IDDM) Occurring Three Years After Hemophilus Influenza B (HiB) Immunization Support Causal Relationship Between Immunization and IDDM, 35 Autoimmunity 247, 250-52 (2002) (ECF No. 59-2) (Pet’r’s Ex. 30) [hereinafter “Classen”]. He also referred to a prospective cohort study which attempted to evaluate the possibility of an autoimmune response following annual influenza (“flu”) vaccination in healthy adults by looking at the change in antibodies post-vaccination, using blood samples taken prior to vaccination and then at one month and six months post-vaccination. Tr. at 29-30; see N. Toplak, T. Kveder, A. Trampus-Bakija, V. Subelj, S. Cucnik, & T. Avcin, Autoimmune Response Following Annual Influenza Vaccination in 92 Apparently Healthy Adults, 8 Autoimmunity Reviews 134, 137-38 (2008) (ECF No. 59-1) (Pet’r’s Ex. 29) [hereinafter “Toplak”]. While the flu vaccination generally did not alter the percentage of healthy adults with positive autoantibodies, the Toplak researchers found that six months post-vaccination, approximately thirteen percent of patients either had higher titers of antibodies or developed new antibodies. Tr. at 30; Toplak at 2. Dr. Roseff focused on the presence of antibodies and postulated that six months post- 9 Case 1:10-vv-00398-UNJ Document 71 Filed 03/27/15 Page 10 of 29 exposure to a vaccination could actually be too soon to look for manifestations of clinical disease. Tr. at 30. Dr. Roseff admitted that none of these studies involved the HPV vaccine generally (or the Gardasil vaccine more specifically), but justified his reliance on such studies in the absence of relevant, non-industry-funded, independent studies addressing the specific issue of RA following vaccination with Gardasil. Tr. at 33-34. Dr. Roseff also acknowledged that he knew of no persuasive epidemiologic or biologic evidence directly supporting his theory, but nevertheless opined “that it may just be too early to establish a statistical link.” Roseff Report at 3. He maintained overall that there is “a strong possibility, knowing what we know about immunizations, and Gardasil specifically, that” the vaccinations that Ms. Sullivan received caused her RA. Id.; Tr. at 17. In distinguishing reliable from unreliable studies, Dr. Roseff expressed the general opinion that studies sponsored by the pharmaceutical industry are inherently suspect due to bias. Tr. at 67 (referencing articles that he had read regarding bias in studies sponsored by the pharmaceutical industry); see also Joel Lexchin, Lisa A. Bero, Benjamin Djulbegovic & Otavio Clark, Pharmaceutical Industry Sponsorship and Research Outcome and Quality: Systematic Review, 326 BMJ 1167 (2003) (ECF No. 30) (Pet’r’s Ex. 33) [hereinafter “Lexchin”]. He specifically questioned the scientific methodology of certain such studies. See, e.g., Tr. at 68. Thus, he opined that early studies sponsored by Merck, which did not observe harmful effects associated with the Gardasil vaccination, were tainted – both generally by Merck’s involvement, as well as more specifically by the failure to use what he referred to as a “true placebo” group. Id. at 73. He testified that there were six initial studies conducted by Merck that purported to compare individuals who received the Gardasil vaccination to a placebo group, but only one study used a saline placebo (which Dr. Roseff deemed as the most scientifically reliable control) while most of the others used an aluminum-containing placebo (which he viewed as not a true placebo). Id. at 25. Dr. Roseff thus expressed the opinion that this group of studies was ultimately not reliable. Id. at 73. 2. Dr. Carlos Rosé – Respondent’s expert, Daniel Carlos Rosé, M.D., graduated in 1977 from the University of Buenos Aires School of Medicine in Argentina, completing his residency in internal medicine at the University’s hospital. Tr. at 87; Resp’t’s Ex. B. He then went on to an adult rheumatology fellowship in the National Institute of Rehabilitation; Department of Medicine, Rheumatology Division, Buenos Aires. Tr. at 87. In 1987, Dr. Rosé finished a pediatric residency at Thomas Jefferson University in Philadelphia, Pennsylvania, which was followed by a fellowship in pediatric rheumatology at Children’s Hospital of Philadelphia. Id. Dr. Rosé is board-certified in pediatrics as well as pediatric and adult rheumatology. Id. He is currently a Professor of Pediatrics at Thomas Jefferson University where he teaches pediatric rheumatology to medical students, residents, adult fellows, and pediatric fellows, and he also lectures and publishes papers on the topic of RA. Id. at 89. He is a reviewer for several journals and on the editorial board for Rheumatology International. Id. at 89-90. He also serves on various Data Safety Monitoring Committees – also known as Data Safety 10 Case 1:10-vv-00398-UNJ Document 71 Filed 03/27/15 Page 11 of 29 Monitoring Boards (which are committees of independent experts responsible for monitoring patient safety and treatment efficacy data during ongoing clinical trials).14 Id. at 90. Dr. Rosé has been treating rheumatology patients for over thirty years. Tr. at 88. Since 1989 he has practiced at the duPont Hospital for Children in Wilmington, Delaware, where he is currently the Head of Pediatric Rheumatology with supervisory responsibility over four pediatric rheumatologists. Tr. at 86-88. As part of his rheumatology practice, Dr. Rosé sees patients at least twice a week, ranging from infants to young adults. Id. at 88. Dr. Rosé diagnoses both RA and JRA because he sees patients up to eighteen years of age, and the relevant diagnostic criteria require a diagnosis of RA (rather than JRA) if onset occurred after the patient was sixteen years of age.15 Id. at 90-91. On average, Dr. Rosé estimated that he sees approximately one hundred and fifty rheumatology patients per month. Id. at 88. Relying on his experience treating patients with rheumatologic disease, Dr. Rosé formulated his opinion in this case after reviewing Petitioner’s medical records, affidavits from Petitioner as well as her parents, and pertinent medical or scientific literature. Resp’t’s Expert Opinion Report dated Mar. 9, 2011 (ECF No. 19-1) [hereinafter “Rosé Report”] at 1; Resp’t’s Expert Opinion Supplementary Report dated Apr. 30, 2011 (ECF No. 19-1) [hereinafter “Rosé Supplementary Report”]; Tr. at 91-92. Based on this review, Dr. Rosé formed an opinion that it is more likely than not that the series of Gardasil vaccinations that Ms. Sullivan received were unrelated to the onset and development of her RA. Tr. at 92, 94. Dr. Rosé began by providing an overview of arthritis generally, and RA more specifically. Dr. Rosé explained that RA is a disease of unknown etiology, with one hundred percent of cases being idiopathic. Tr. at 95. He indicated that RA is a uniform disease (although many rheumatologists distinguish between individuals with RA who are seronegative versus those who are seropositive).16 Id. at 93. Dr. Rosé expressed the view that while infections can cause arthritis, most recent research identifies genetic factors, rather than environmental factors, as the most likely mechanisms associated with the development of RA (although he acknowledged that these findings may be influenced by the relative ease of studying such genetic factors as opposed to environmental factors). Id. at 96. Dr. Rosé opined that there is no scientific or medical support for an association between the Gardasil vaccination and rheumatic disease. Rosé Report at 5-6. He indicated that although several 14 Dr. Rosé is currently involved in two such committees, and he has experience dealing with both committees responsible for overseeing clinical trials funded by the pharmaceutical industry and committees responsible for overseeing non-industry sponsored clinical trials. Tr. at 90-91. 15 Dr. Rosé noted an age distinction between RA and JRA – he indicated that the relevant diagnostic criteria put the age of onset of JRA up to sixteen years of age. Tr. at 88. Accordingly, Dr. Rosé indicated that rheumatoid conditions that begin when a patient is sixteen are not classified as juvenile. Id. 16 Dr. Rosé indicated that seropositive individuals have rheumatoid factor or anti-CCP antibodies in the serum. Tr. at 94. Of those individuals who meet the diagnostic criteria for RA, eighty-five percent are seropositive, as was the case with Petitioner, and fifteen percent are seronegative. Id. 11 Case 1:10-vv-00398-UNJ Document 71 Filed 03/27/15 Page 12 of 29 human infections have arthritis as part of their clinical presentation or are associated with the development of a rheumatoid-like disease, there are no known viral causes of RA. Tr. at 96. Moreover, the wild-type human papillomavirus is not a known cause of acute or chronic arthritis in humans – making it even less likely in his estimation that the Gardasil vaccine could be so associated. Rosé Report at 5-6; Tr. at 98. Although he acknowledged that the Gardasil vaccine contains viral particles from multiple strains of HPV rather than a single strain from the wild type infection, he maintained his view that it was unlikely that the Gardasil vaccine can cause arthritic conditions. Tr. at 99. Dr. Rosé further testified that his view was supported by scientific and medical literature (or at least the absence of negating literature). Dr. Rosé opined that he could not find a single case of RA established to have been caused by the Gardasil vaccination. Tr. at 98-99. Moreover, he expressed the view that if such an association existed, he would expect to have seen it in his clinical practice, but never has. Id. at 98. Indeed, clinical trial data collected to date (from a safety database built with data from spontaneous reporting by those patients who participated in clinical trials and their treating physicians) on the development of autoimmune disease following receipt of a different formulation of the HPV vaccination17 (as well as other vaccinations) illustrated that reporting rates of overall autoimmune events (including RA) did not differ between the vaccinated and control groups. Rosé Report at 3; Tr. at 99 (citing Verstraeten at 6631).18 Dr. Rosé expressed the view that this is among the best evidence available regarding the vaccine’s capacity (or lack thereof) to produce RA, as there currently are not (and may never be) any other case-control prospective epidemiological studies addressing this specific issue. Rosé Report at 3; Tr. at 99-101.19 Dr. Rosé went on to attempt to rebut Dr. Roseff’s proposed mechanism by which RA could result after receipt of Gardasil. Although he agreed with Dr. Roseff’s general characterization of the concept of molecular mimicry, he opined that there was no evidence that this mechanism is implicated in the development of RA; in fact, he indicated that it has not even been discussed in serious scientific or medical literature as a potential mechanism for the development of RA in at least the last ten years, 17 This study involved a collection of “[a]ll completed or ongoing controlled, randomized studies of AS04 adjuvanted HPV- 16/18, HSV and HBV vaccines conducted by GSK Biologics [GlaxoSmithKline, the manufacturer of those vaccines] or collaborators,” with one exception. Thomas Verstraeten, et al., Analysis of Adverse Events of Potential Autoimmune Aetiology in a Large Integrated Safety Database of AS04 Adjuvanted Vaccines, 26 Vaccine 6630, 6631 (2008) (Resp’t’s Ex. A, No. 5) (ECF No. 19-6) [hereinafter “Verstraeten”]. This study collected data on vaccinations containing the AS04 adjuvant; Cervarix (as opposed to Gardasil) is the human papillomavirus-16/18 (HPV-16/18) vaccine from GlaxoSmithKline Biologics that contains this adjuvant. Id. at 6630. Thus, the research referenced in this article involves a different HPV vaccine than that at issue in this case. 18 The “objective of this integrated analysis was to assess safety of AS04 adjuvanted vaccines with regard to adverse events (AEs) of potential autoimmune aetiology, particularly in adolescents and young adults.” Verstraeten at 6630. It thus attempted to address the potential problem with smaller studies, which may not by themselves detect rare events. Id. at 6631. 19 “Reporting rates of overall autoimmune events were around 0.5% and did not differ between the vaccinated and control groups. The relative risk (vaccine/control) was 0.92 [] in the HPV-16/18. Relative risks calculated overall, for disease category or for individual events were closer to 1, and all confidence intervals around the relative risk included 1, indicating no statistically significant difference in event rates between vaccine and control groups.” Rosé Report at 3 (citing Verstraeten). 12 Case 1:10-vv-00398-UNJ Document 71 Filed 03/27/15 Page 13 of 29 even though it was previously considered, a fact he attributed mainly to an evolving understanding of RA. Tr. at 104-05. He also emphasized that (as Dr. Roseff acknowledged in his expert report) the relationship between the development of anti-CCP antibodies associated with RA and their reactivity with host tissues is unclear (thus underscoring that the biological mechanism by which RA develops is not fully understood). Rosé Report at 4; Roseff Report at 3. Dr. Rosé specifically took issue with the assumption that the existence of some homology between peptide chains in human tissue and the components of vaccines logically leads to the conclusion that an autoimmune process will occur. Rosé Report at 4-5; Tr. at 106-07. Dr. Rosé indicated that short peptide homology, referenced in the Kanduc article relied upon by Dr. Roseff in formulating his opinion, “is at most a hypothesis generation step towards a theory of molecular mimicry.” Rosé Report at 4. Moreover, he noted that because there are only a limited number of amino acids in nature that can be assembled in a limited number of ways to make proteins, it is not uncommon to find five amino acids that are homologous merely by chance. Tr. at 107. Dr. Rosé further testified that the Kanduc article made what he termed “extremely far-fetched statements” regarding potential side effects associated with receipt of the HPV vaccine, including setting forth (based on peptide homology) “a whole list of diseases that bear limited relationship with immune responses,” yet even the authors had not suggested or concluded that receipt of the HPV vaccine would result in the development of RA. Id. Dr. Rosé also questioned the logic of Dr. Roseff’s opinion that the series of Gardasil vaccines that Ms. Sullivan received could have cumulatively resulted in the onset and development of her RA. Tr. at 108. Dr. Rosé noted that the vaccine contains only microdoses of aluminum insufficient in volume to have a negative effect in the body, while the protein components of the vaccine would themselves not accumulate in similar fashion (if at all). Id. at 108-09. Alternatively, Dr. Rosé asserted, if Dr. Roseff meant to argue that “more challenge”20 posed by the additional Gardasil vaccinations served to overstimulate Ms. Sullivan’s immune system, then her medical history did not support such a theory because there was no evidence in the treatment record of any instances in which Ms. Sullivan experienced a physiologic response (e.g., a fever) following receipt of vaccination, as would be expected if the vaccinations were affecting her in this manner. Id. at 109. Dr. Rosé then pointed out what he saw as deficiencies in Dr. Roseff’s explanations for the lapse of time between Petitioner’s receipt of the Gardasil vaccinations and her development of RA. Tr. at 97- 98. As a general matter, Dr. Rosé acknowledged that there could be a variable period of time between a viral or bacterial infection (such as Lyme disease) and the development of some arthritic conditions. Id. 20 Challenge-rechallenge is “a paradigm for exploring whether one substance caused an adverse reaction. Under this model, an individual who has had an adverse reaction to the initial vaccine dose (the challenge event) suffers a worsening of symptoms after a second or third injection (the rechallenge event).” Viscontini v. Sec'y of Health & Human Servs., No. 98- 619V, 2011 WL 5842577, at *22 (Fed. Cl. Oct. 21, 2011) (quoting Doe/70 v. Sec'y of Health & Human Servs., 95 Fed. Cl. 598, 603 (2010) (quotations omitted)). 13 Case 1:10-vv-00398-UNJ Document 71 Filed 03/27/15 Page 14 of 29 But he contested Dr. Roseff’s assertion that such conditions were analogous to RA.21 Id. at 97. Moreover, in the case of Ms. Sullivan, he opined that the approximately three-month span between the onset of her first symptoms (around April 2008) and the completion of her Gardasil series (January 4, 2008) seemed too lengthy not to allow for the possibility of some intervening event as the real cause. Rosé Report at 2, 6. In Dr. Rosé’s view, a relationship between the Gardasil vaccine and Ms. Sullivan’s RA would be conceivable only if the period were shorter – two to four weeks between onset and last vaccination. Id. at 6. C. The Chao Study The parties debated the evidentiary significance of an epidemiological study cited by Respondent in rebuttal of Petitioner’s claim. C. Chao, et al., Surveillance of Autoimmune Conditions Following Routine Use of Quadrivalent Human Papillomavirus Vaccine, 271 J. Intern. Med. 193 (2012) (ECF No. 49-4) (Resp’t’s Ex. F) [hereinafter “Chao Study”]. This peer-reviewed observational study22 analyzed a database comprised of the medical histories of approximately 189,000 California women (members of two of Kaiser Permanente’s managed care organizations in the State) to determine whether the studied population developed a variety of autoimmune conditions23 after receiving the Gardasil vaccine. Chao Study at 194. The study monitored individuals for 180 days (six months) after receipt of vaccine one, vaccine two, and vaccine three. Tr. at 100-01; Chao Study at 194-95. As vaccine three was given six months after vaccine one, the total duration of the study was twelve months. Tr. at 100-01; Chao Study at 194-95. The researchers compared the results of the studied vaccinated population with unvaccinated, similarly-situated individuals also enrolled with Kaiser Permanente in Southern California, in order to compare incident rate ratios for the identified autoimmune conditions. Chao Study at 194-95. Based upon the data reviewed, the researchers did not observe an increased risk of 21 Dr. Rosé particularly distinguished Lyme arthritis from RA, noting that Lyme arthritis is a single joint disease with a living microorganism (a bacterium) present in a patient’s joint, whereas in a case such as this a vaccine administered remotely in an arm allegedly produces inflammation in multiple joints throughout the body. Id. at 108. Dr. Rosé acknowledged that in the case of Lyme arthritis, approximately ten percent of children and approximately thirteen percent of adults experience arthritic inflammation despite no evidence of persistent bacterial infection. Id. at 131-32. But he characterized such inflammation not as a dormant/latent condition that hides or takes time to occur, but as a persistent condition that is treatment-resistant, existing even after the initial infection is successfully resolved with antibiotics. Id. at 133-34. 22 In an observational epidemiologic study, researchers analyze groups of individuals who were exposed to a test agent, comparing them with groups not so exposed. Michael D. Green, et al., “Reference Guide on Epidemiology,” in Reference Manual on Scientific Evidence 549, 555-56 (3d ed. 2011). The Chao Study investigators drew inferences about the side effects of Gardasil based on historic data, where the assignment of subjects into a treatment group (women who received the Gardasil vaccine) versus a control group (women who did not) was outside of the investigators’ control. See Chao Study at 194. 23 The diseases monitored in the study included rheumatologic / autoimmune disorders, including immune thrombocytopenia, autoimmune hemolytic anemia, systemic lupus erythematosus, RA, and JRA. Chao Study at 194. 14 Case 1:10-vv-00398-UNJ Document 71 Filed 03/27/15 Page 15 of 29 developing RA (or other autoimmune conditions) following receipt of the Gardasil vaccine.24 Id. at 196, 201; Tr. at 101. While acknowledging that he did not have any special expertise in identifying conflicts of interest in scientific studies (Tr. at 62, 84-85),25 Dr. Roseff asserted that the Chao Study was biased because it had been sponsored by a pharmaceutical company (Merck). Id. at 35-36. In support of his view, Dr. Roseff pointed to articles like Lexchin that in his opinion raised legitimate questions about the impartiality of such pharmaceutical industry-sponsored studies; the article cited selection of an inappropriate comparator to the product being investigated and publication bias as potential explanations for this bias. With regards to the Chao Study, Dr. Roseff specifically questioned the control groups utilized in the study, arguing that he could not ascertain whether it was a valid comparison to the group that received the Gardasil vaccine. Tr. at 35, 38-39, 84-85. He further noted that the rheumatologists who were reviewing the cases of patients who had received the vaccine were not blinded as to that fact – a discrepancy that he proposed could have introduced bias into the study’s results. Id. at 36, 65. At the same time, however, Dr. Roseff acknowledged that the Chao Study set forth many steps that the researchers had taken to help ensure the independence of its results from its sponsor.26 But in his opinion, a prospective, placebo-controlled, double-blinded study would provide far more persuasive evidence regarding the safety of the Gardasil vaccination. Id. at 85. In response, Dr. Rosé argued that the factors cited in the article referenced by Dr. Roseff – inappropriate comparator to the product being investigated and publication bias – were not applicable to the Chao Study. For instance, he argued that the requirement that Merck publish the Chao Study’s findings regardless of outcome lent credibility to its results. Tr. at 110-13, 117. Dr. Rosé also disputed the validity of Dr. Roseff’s concerns regarding the study’s control group. He noted that it would likely have been approved by the Food and Drug Administration (“FDA”) in advance, and in fact appeared to him (from his own review of the Chao Study) that the control group had been carefully selected. Id. at 113-14. Further, Dr. Rosé contested Dr. Roseff’s argument that the only possible persuasive study 24 The database reviewed in the Chao Study identified only four cases of RA within the included vaccinated population, with a frequency of incidence calculated at 4.6 per 100,000 patients a year. Chao Study at 199 (Table 3). By contrast, there were 39 cases observed among the unvaccinated, with an incidence rate of 7.0 for 100,000 patients a year, yielding an incidence rate ratio of 0.71. Id.; see also Tr. at 102. Dr. Rosé explained that this ratio, which is below 1.0, suggests that there is no increase relative to incidence – meaning that the number of vaccinated individuals in the database population experiencing the subsequent onset of RA was statistically insignificant. Tr. at 102. Moreover, it appeared to Dr. Rosé from review of the Chao Study that the researchers had double-checked their results to ensure they had captured all cases of RA or JRA, further supporting the reliability of the findings. Id. at 103. 25 In fact, Dr. Roseff admitted that he lacked the professional background and expertise necessary to intelligently critique the methodology of the study. See, e.g., Tr. at 84-85. 26 Thus, as part of the post-marketing surveillance of the Gardasil vaccine, Merck was required by the Food and Drug Administration (“FDA”) to report the results of the study regardless of outcome. Tr. at 62-63; see also Chao Study at 194. Moreover, the study design and methodology were pre-specified, with the protocol specifically approved by the FDA as well as an independent board, and all of the data was collected and analyzed at the managed care consortium Kaiser Permanente rather than by Merck. Tr. at 63-65; see also Chao Study at 202-03. And after its results were written up, it went through a scientific peer review process in accordance with the protocol set up by the Journal of Internal Medicine (the journal in which the results of the study were published). Tr. at 65. 15 Case 1:10-vv-00398-UNJ Document 71 Filed 03/27/15 Page 16 of 29 regarding the safety of the Gardasil vaccine (in terms of autoimmune side effects, such as RA) would be a prospective, placebo-controlled study using saline for the control group. Id. at 114. Because autoimmune diseases occur so infrequently, such a study would require depriving thousands of control group participants of a vaccine that has been demonstrated to be beneficial – an outcome Dr. Rosé deemed unethical. Id. D. Other Evidence Ms. Sullivan submitted four affidavits regarding the onset of her symptoms, including two from herself. See Pet’r’s Exs. 1, 21. One of Petitioner’s own affidavits indicated that prior to receipt of the Gardasil vaccinations she was “a healthy and active teenager,” but after receiving the vaccinations she “began to experience chronic joint pain, joint inflammation, severe systemic body pain, problems concentrating, memory difficulties, headaches, and changes in [her] personality and temperament.” Id. at 1. Petitioner’s affidavits were supplemented by a daily self-health log (essentially a journal) in which she documented her daily symptoms beginning in January of 2010. Id. at 4-52 (Pet’r’s Ex. A). Petitioner also submitted affidavits from her parents, Sandy and Dennis Sullivan, which included information regarding their understanding of the onset of her symptoms. Pet’r’s Exs. 23, 24. Both sides also offered substantial scientific and medical literature. Ms. Sullivan submitted eleven articles relied upon by Dr. Roseff in formulating an opinion in this case. Respondent cites certain literature submitted by Petitioner, as well as eleven additional articles, relied upon by her expert in formulating his opinion or rebutting Petitioner’s expert. II. Procedural History Ms. Sullivan filed her Petition on June 28, 2010. Pet. at 1. In it, she specifically alleged that she suffers from chronic fatigue, severe joint and body pain, joint inflammation, cognitive impairment, headaches, numbness and tingling in her extremities, and irregular or heavy menstrual cycles which were all caused in fact by the HPV vaccine. Id. at 3-4. Since the filing of the Petition, Ms. Sullivan has alleged more specifically (and offered testimony during the hearing to this end) that her vaccination caused her to develop RA. See, e.g., Pet’r’s Pre-Hr’g Filing (ECF No. 54); Tr. at 17. On September 27, 2010, Respondent filed her Rule 4(c) report denying that Ms. Sullivan was entitled to compensation. ECF No. 7. In the ensuing twelve months, Petitioner filed medical records and both sides submitted expert reports. Thereafter, in September of 2011, the special master previously responsible for this matter scheduled a hearing for January 24, 2012, to resolve factual issues regarding the onset of Petitioner’s condition. ECF No. 26. The onset fact hearing was held as scheduled, with both sides filing pre- and post-hearing memoranda. That hearing included testimony from Petitioner plus her mother and father. See Ruling 16 Case 1:10-vv-00398-UNJ Document 71 Filed 03/27/15 Page 17 of 29 Regarding Finding of Fact at 7. After completion of the hearing and the passage of additional time, the special master issued a Ruling Regarding Finding of Fact on June 30, 2013, determining as follows: Petitioner’s onset of joint pain following her receipt of HPV vaccinations on June 27, 2007, August 26, 2007, and January 4, 2008, occurred somewhere between March and April 2008, in the few weeks prior to April 18, 2008, when she first visited her doctor complaining, inter alia, of pain to her left knee. Ruling Regarding Finding of Fact at 19. In light of the results of this ruling, the parties were directed to file supplemental expert reports incorporating the Court’s factual determinations and evaluating to what extent, if any, their experts’ conclusions were altered as a result. ECF No. 45. Those supplemental reports were submitted in the fall of 2013. The report submitted by Dr. Roseff indicated that the timing outlined in the Ruling Regarding Finding of Fact did not change his opinion regarding the role that Gardasil played in Ms. Sullivan’s ultimate development of rheumatic disease (indicating that there are “precedents in the rheumatic diseases, or in the literature, that support a delay of several months (as opposed to weeks) between exposure to an offending antigen, and onset of disease”). Supplemental Expert Report by Dr. Roseff dated Sept. 16, 2013 (ECF No. 48-1) (Pet’r’s Ex. 28) at 1. In January of 2014, I was assigned to this matter, and I scheduled an evidentiary hearing for July 10, 2014. ECF No. 53. The parties made additional pre-hearing filings and then participated in the hearing as scheduled, concluding the proceeding in a single day, and filing no post-trial briefs. The matter is now ripe for resolution. III. Applicable Legal Standards To receive compensation under the Vaccine Program, a petitioner must prove either: (1) that she suffered a “Table Injury” – i.e., an injury falling within the Vaccine Injury Table – corresponding to one of the vaccinations in question, or (2) that her illness was actually caused by a vaccine (a category of claim often generically referred to as a “non-Table Injury”). See §§ 300aa-13(a)(1)(A),11(c)(1); § 300aa-14(a), as amended by 42 C.F.R. § 100.3; § 300aa-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).27 No Table Injury is alleged in this case, so Ms. Sullivan must prove causation-in-fact. 27 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 decisions 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). 17 Case 1:10-vv-00398-UNJ Document 71 Filed 03/27/15 Page 18 of 29 Petitioners bear the burden of demonstrating actual causation by preponderant evidence. Cedillo v. Sec’y of Health & Human Servs., 592 F.3d 1315, 1321 (Fed. Cir. 2010); § 300aa-13(a)(1). To do so, a petitioner must provide: “(1) a medical theory causally connecting the vaccination and the injury; (2) a logical sequence of cause and effect showing that the vaccination was the reason for the injury; and (3) a showing of a proximate temporal relationship between vaccination and injury.” Althen v. Sec’y of Health & Human Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005). The preponderance standard requires a petitioner to demonstrate that it is “more likely than not” that the vaccine at issue caused her injury. Moberly, 592 F.3d at 1322 n.2. 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). To determine if the petitioner has carried her burden, I must assess “the record as a whole” and may not make an entitlement decision in her favor based solely on her own claims “unsubstantiated by medical records or by medical opinion.” § 300aa-13(a)(1). Each of the Althen prongs requires a different showing (although the preponderant evidence standard applies to each). 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, 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.” Knudsen, 35 F.3d 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.” Andreu, 569 F.3d at 1380; W.C. v. Sec’y of Health & Human Servs., 704 F.3d 1352, 1356 (Fed. Cir. 2013) (a petitioner “must do more than demonstrate a ‘plausible’ or ‘possible’ causal link between the vaccination and the injury; he must prove his case by a preponderance of evidence”) (citations omitted). Often, however, establishing a sound and reliable medical theory requires that the parties present expert testimony in support of their claims. 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). Cedillo, 617 F.3d at 1339 (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 18 Case 1:10-vv-00398-UNJ Document 71 Filed 03/27/15 Page 19 of 29 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). In other federal judicial fora (such as the district courts), the Daubert factors are 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 determine the persuasiveness of expert testimony has routinely been upheld. See, e.g., Snyder v. Sec’y of Health & Human Servs., 88 Fed. Cl. 706, 742-45 (2009). 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 is employed to determine whether expert testimony offered is reliable and/or persuasive. 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 (1997)). 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”). 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 this regard, the opinions and views of the injured party’s treating physicians are entitled to some weight. Andreu, 569 F.3d at 1367; Capizzano, 440 F.3d at 1326 (“medical records and medical opinion testimony are favored in vaccine cases, as treating physicians are likely to be in the best position to determine whether a ‘logical sequence of cause and effect show[s] that the vaccination was the reason for the injury’”) (quoting Althen, 418 F.3d at 1280). Medical records are generally viewed as trustworthy evidence, since they are created contemporaneously with the 19 Case 1:10-vv-00398-UNJ Document 71 Filed 03/27/15 Page 20 of 29 treatment of the patient. Cucuras v. Sec’y of Health & Human Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993). However, medical records setting forth 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. § 300aa–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, 88 Fed. Cl. at 746 n.67 (“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”). Rather, 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 Dep't of Health & Human Servs., 100 Fed. Cl. 119, 136 (2011), aff'd, 463 F. App'x 932 (Fed. Cir. 2012); Veryzer v. Sec'y of Health & Human Servs., No. 06-522V, 2011 WL 1935813, at *17 (Fed. Cl. Spec. Mstr. Apr. 29, 2011). 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.” 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. denied 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 denied (Fed. Cl. Dec. 3, 2013), aff’d, 773 F.3d 1239 (Fed. Cir. 2014). IV. Analysis I find, based on the existing record and testimony at hearing, that Ms. Sullivan has not met her burden of proof with respect to any of the Althen prongs. A. Althen Prong One At the outset, I note that Dr. Roseff’s testimony on the “can cause” Althen prong one required him to go beyond his immediate professional expertise in the field of rheumatology. By his own 20 Case 1:10-vv-00398-UNJ Document 71 Filed 03/27/15 Page 21 of 29 admission, Dr. Roseff is not an immunologist, and has no demonstrated experience evaluating the effects of any vaccines in causing injury, in his own medical practice or elsewhere.28 And he did not ground his proposed theory for how the vaccine could have resulted in RA with any reference to his own professional experience (such as a study or experiment he participated in, or article he authored, relevant to such testimony). I have heard and considered Dr. Roseff’s testimony despite the above. However, I may take into account an expert’s overall competence in the field upon which he testifies as part of my weighing of the evidence. See, e.g., Walton v. Sec’y of Health & Human Servs., No. 04-503V, 2007 WL 1467307, at *17-18 (Fed. Cl. Spec. Mstr. Apr. 30, 2007) (otolaryngologist not well suited to testify about disciplines other than her own specialty). Dr. Roseff’s lack of expertise on the topic of the capacity of vaccines such as Gardasil to cause injury leads me to give his testimony less weight than I might give the testimony of an expert with greater demonstrated experience in the subject matter. See, e.g., King v. Sec’y of Health & Human Servs., No. 03-584V, 2010 WL 892296, at *78-79 (Fed. Cl. Spec. Mstr. Mar. 12, 2010) (petitioner’s expert far less qualified to offer opinion on general causation issues pertaining to autism than specific issues pertaining to the petitioner’s actual medical history, given the nature of the expert’s qualifications). Putting that aside, I find that the substance of Dr. Roseff’s opinion was unpersuasive and not supported by reliable evidence. He referenced no studies in which the Gardasil vaccine, any other HPV vaccination, or even a single strain of HPV wild virus, has caused RA (or any disease comparable to RA). Instead, he attempted to develop his theory by way of analogy to studies involving arthritic conditions arising after exposure to different viruses (such as the rubella virus or human parvovirus), or studies (like Toplak) observing autoimmune responses after vaccination. See supra Section IB1 (outlining Dr. Roseff’s testimony). In effect, Dr. Roseff argues, (a) other viruses can produce arthritic conditions, and (b) vaccines can cause autoimmunity, therefore (c) it is reasonable to conclude by means of extrapolation from such evidence that the Gardasil vaccine could cause RA. Although there is logic to such reasoning, I do not find that the evidence upon which it is based is sufficiently reliable to bulwark Petitioner’s causation theory with the needed evidentiary ballast. As another special master noted in considering the Althen prong one analysis, “[t]he weight to be given an expert’s opinion is based in part on the size of the gap between the science and the opinion proffered.” 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 at 1339). Here, that gap is too great. The fit between the literature Dr. Roseff cites and the theory he proposes is poor, based on inapposite comparisons involving different 28 Admittedly, Dr. Rosé similarly lacked such qualifications. Because Petitioner bears the burden of proof, however, it is especially important that an expert testifying on her behalf possess sufficient credentials and expertise upon which to base his opinion. Daubert v. Merrell Dow Pharm., Inc., 43 F.3d 1311, 1317 (9th Cir. 1995) (indicating that “[o]ne very significant fact to consider is whether the experts are proposing to testify about matters growing naturally and directly out of research they have conducted independent of the litigation, or whether they have developed their opinions expressly for purposes of testifying”). 21 Case 1:10-vv-00398-UNJ Document 71 Filed 03/27/15 Page 22 of 29 vaccines and different illnesses or untestable premises. Dr. Roseff assumes, without demonstrating, that other viruses that have been scientifically observed to produce arthritic conditions are comparable not only to the HPV wild virus but to the Gardasil vaccine itself (which contains four HPV strains). He also conclusorily reasons that a generalized reaction to one kind of vaccine is comparable to the type of reaction that one would expect to see from an entirely different vaccine. And in some cases, (specifically, with regard to the Classen article purporting to identify a causal link between other vaccines and IDDM), he relies on literature directly relating to theories that have been routinely rejected when offered to establish causation involving the tested vaccine. See, e.g., Meyers v. Sec’y of Health & Human Servs., No. 04-1771V, 2006 WL 1593947, at *5 (Fed. Cl. Spec. Mstr. May 22, 2006) (“[t]his court has previously considered and discredited the theories advanced by Dr. Classen”) (discussing Baker v. Sec’y of Health & Human Servs., No. 99-653V, 2003 WL 22416622, at *33 (Fed. Cl. Spec. Mstr. May 22, 2006)).29 Ms. Sullivan’s overall theory regarding how the Gardasil vaccination could cause RA fails to hold up when analyzed under the Daubert framework used to evaluate the reliability of expert testimony in Vaccine Program cases. It has not been tested, subjected to peer review, or shown to be generally accepted in the relevant medical community. Terran, 195 F.3d at 1316 n.2 (citing Daubert, 509 U.S. at 592-95). While some of the individual pieces of literature cited by Petitioner may meet those criteria, that does not mean that Petitioner’s overall theory (in support of which they are cited) is similarly reliable. In addition, (as noted above) nothing about Petitioner’s theory is derived from Dr. Roseff’s personal expertise, further diminishing its reliability (since he is the theory’s author). And in many instances Dr. Roseff (who appeared to me an honest witness) undercut his opinion with admissions that Ms. Sullivan’s illness may just as likely be of unknown origin. See, e.g., Roseff Report at 3 (indicating that “we cannot exclude the possibility that her development of disease was a random event,” and admitting that “how [molecular mimicry] could result in our patient’s CCP positivity is unclear”). The same considerations apply to Dr. Roseff’s proposed molecular mimicry mechanism. A petitioner may successfully establish causation without proving the mechanism of injury. Knudsen, 35 F.3d at 548-49 (citations omitted). And there are Vaccine Program decisions in which molecular mimicry has been found to be a scientifically acceptable explanation sufficient to meet the preponderant, “more likely than not” evidentiary standard. See, e.g., Tompkins v. Sec’y of Health & Human Servs., No. 10-261V, 2013 WL 3498652, at *22 (Fed. Cl. Spec. Mstr. June 21, 2013) (in the specific context of establishing causation of Guillain-Barré syndrome after vaccination, “[t]he molecular mimicry theory is the one most widely accepted for the agents most frequently accepted as causal”), mot. for review denied, 117 Fed. Cl. 713 (2014); but see Wirt v. Sec’y of Health & Human Servs., No. 11-118V, 2014 WL 1911421, at *9-10 (Fed. Cl. Spec. Mstr. Apr. 18, 2014) (petitioner failed 29 The special master’s decision in Baker specifically discussed the weaknesses of the Classen article cited by Dr. Roseff herein. See Baker v. Sec’y of Health & Human Servs., No. 99-653V, 2003 WL 22416622, at *11 (Fed. Cl. Spec. Mstr. May 22, 2006). 22 Case 1:10-vv-00398-UNJ Document 71 Filed 03/27/15 Page 23 of 29 to satisfy Althen prong one in case in which expert proposed molecular mimicry as a mechanism by which the HPV vaccine could cause RA). A petitioner cannot, however, simply intone the phrase “molecular mimicry” and thereby be deemed to have satisfied her Althen prong one burden. Hennessey v. Sec'y of Health & Human Servs., 91 Fed. Cl. 126, 134-35 (2010) (noting expert’s overly broad application of the molecular mimicry theory made it meaningless). Here, and for the same reasons stated above, Petitioner has not sufficiently connected this aspect of her causation theory to the Gardasil vaccine or her RA to be legally persuasive,30 because she has not offered sufficient reliable proof supporting the concept in this particular factual context. Petitioner offers a few alternative mechanisms, but they are incompletely sketched out at best. Dr. Roseff proposed that aluminum contained in the Gardasil vaccine (as an adjuvant) could be responsible for stimulating an individual’s immune system in a destructive manner (and he ties this argument in with his criticisms of a Merck study that used a placebo containing aluminum). See, e.g., Tr. at 25. Yet he admitted that this theory was highly speculative and based on very little scientific literature, if any. Id. at 60. Indeed, it appears from my review of the record that the only piece of filed literature even mentioning aluminum as a vaccine adjuvant, and the potentially negative impact it could have in causing a reactive disease or condition, is the Judicial Watch article – an advocacy piece with little scientific reliability, and which is conclusory in making this assertion as well. Joiner, 522 U.S. at 146 (“[t]rained experts commonly extrapolate from existing data[,] but nothing in either Daubert or the Federal Rules of Evidence requires a district court to admit opinion evidence that is connected to existing data only by the ipse dixit of the expert.”). Overall, Dr. Roseff has (by his own admission) done no more than opine that it is intellectually conceivable that administration of the Gardasil vaccine could result in the onset and development of RA. But this is insufficient to meet Petitioner’s burden of proof, which (while not requiring scientific certainty) does obligate Petitioner to provide a “legally probable” explanation. Moberly, 592 F.3d at 1322 (quoting Knudsen, 35 F.3d at 548-49). Dr. Roseff’s opinion, and the evidence offered in support of it, do not rise to that level of preponderant proof. See also Wirt, 2014 WL 1911421, at *9 (determining that “[t]here are simply too many unknowns, too many gaps in the analytical process of the theory, [] to conclude that Petitioner has proven a medical theory causally connecting the [HPV] vaccination and the injury [RA].”) (citation omitted). 30 There are also deficiencies with Dr. Roseff’s explanation of homology within the context of the molecular mimicry process he proposed. Dr. Roseff relies on Kanduc for the proposition that one HPV strain of the four contained in the Gardasil vaccine shares peptide sequences with a variety of human proteomes, and therefore the cross-reactivity that would result in RA could conceivably occur. See Tr. at 19-20. But as Respondent pointed out, that HPV strain shares numerous sequences with the human body, perhaps too many to reach the conclusion that molecular mimicry would in fact occur resulting in RA. See Id. at 107. While the law does not require Petitioner to “prove” homology in a Program case, I take note of the fact that Respondent’s challenges to this part of Petitioner’s theory were not rebutted. See, e.g., Id. at 80; Rosé Report at 4; Roseff Report at 3. 23 Case 1:10-vv-00398-UNJ Document 71 Filed 03/27/15 Page 24 of 29 Also relevant to my analysis is the fact that Respondent offered credible and persuasive epidemiologic evidence – the Chao Study – undermining Petitioner’s theory. Unquestionably, a petitioner need not offer epidemiologic proof to establish a reasonable and scientifically-reliable theory under Althen prong one. Capizzano, 440 F.3d at 1325. However, I may properly weigh such evidence against Petitioner’s proof in evaluating whether she has carried her overall burden as to this first Althen prong. Koehn, 2013 WL 3214877, at *25 (“[t]he Federal Circuit has endorsed consideration of epidemiological studies as one factor in the special master’s analysis”);31 see also C.K. v. Sec’y of Health & Human Servs., 113 Fed. Cl. 757, 770 (2013) (a special master may evaluate contradictory evidence offered by Respondent). The Chao Study is directly relevant to Ms. Sullivan’s claim, and is persuasive evidence contradicting her causation theory. The same study has been determined in other Vaccine Program cases (in which it was invoked by Respondent) to be a valid epidemiologic study. See, e.g., C.K., 113 Fed. Cl. at 770; Godfrey v. Sec’y of Health & Human Servs., No. 10-565V, 2014 WL 3058353, at *17 (Fed. Cl. Spec. Mstr. June 11, 2014); Harris v. Sec’y of Health & Human Servs., No. 10-322V, 2014 WL 3159377, at *13-14 (Fed. Cl. Spec. Mstr. June 10, 2014), mot. for review denied, __ Fed. Cl. __ (Sept. 23, 2014). Although the Chao Study is not proof positive (from a legal standpoint) that Gardasil does not “cause” RA (and indeed as a special master I am not empowered to make such a scientific determination), the Chao Study undermines Petitioner’s case that “more likely than not” the vaccine could have that effect. Ms. Sullivan endeavored to call into question the study’s credibility by impugning its source. The argument that a given study’s authorship might impinge on the reliability of its findings is reasonable. See, e.g., Harris, 2014 WL 3159377, at *13 (“the source for Dr. Chao’s funding opens a potential (if ultimately unresolvable) argument that her conclusions are not valid”). But the Supreme Court in Daubert, as well as the cases following it, has provided analytical tools for evaluating the existence of alleged errors in a study’s methodology or analysis that, if present, would illustrate bias better than the unsubstantiated argument that an interested sponsor automatically casts doubt on the honesty of the study’s findings. Daubert, 509 U.S. at 592-95. Therefore, in order to put flesh on the bones of her argument that the Chao Study was biased, Petitioner needed to point out specific elements of the study demonstrating its unreliability. She failed to do so. The Chao Study simply looked at what actually happened to a large group of individuals who received the Gardasil vaccine versus those who did not, performing some subsequent statistical analyses to evaluate the significance of the incidence of autoimmune diseases after vaccination. An argument could be made that a larger sample size was needed to produce more reliable results, but Petitioner does 31 On appeal, the Federal Circuit upheld the special master’s finding in Koehn (which specifically considered the Chao Study) but found that he had misapplied the law in determining that the petitioner had not met her burden under the first Althen prong. Koehn, 773 F.3d at 1244 n.1. In so doing, however, the Federal Circuit did not call into question the special master’s earlier statement on the evidentiary significance of epidemiologic evidence (when offered) in evaluating this prong of the Althen test, nor did it find that the manner in which he had evaluated the weight to be afforded the Chao Study was an element of the error it ruled he had otherwise committed. 24 Case 1:10-vv-00398-UNJ Document 71 Filed 03/27/15 Page 25 of 29 not make that assertion. Hart v. Sec’y of Dep't of Health & Human Servs., 60 Fed. Cl. 598, 608 (2004) (quoting In re Norplant Contraceptive Prods. Liab. Litig., 215 F. Supp. 2d 795, 830 (E.D. Tex. 2002)) (“epidemiological data that is not statistically significant cannot provide a scientific basis for an opinion of causation”). And the low incidence rate ratio for vaccinated individuals who subsequently developed RA (0.71) supports (at least from a statistical standpoint) the Chao Study’s conclusion that Gardasil is highly unlikely to cause RA. See Daubert, 43 F.3d at 1321 (citing DeLuca v. Merrell Dow Pharm., Inc., 911 F.2d 941, 958 (3rd Cir. 1990)) (“[f]or an epidemiological study to show causation under a preponderance standard, ‘the relative risk of ... [the defect or injury] arising from the epidemiological data . . . will, at a minimum, have to exceed ‘2’”).32 Those criticisms of the Chao Study Dr. Roseff did raise, such as the adequacy of its methodological control group, were not backed up by reliable evidence. Dr. Roseff’s complaint that a truly independent study of vaccine safety would have created a blinded control group to receive a “true placebo” (saline) amounts to the assertion that only a randomized control study is trustworthy, as opposed to the observational study set forth in the Chao Study. It may be true that a more scientifically certain (and therefore persuasive) study is conceivable, and it is also the case that observational studies have their own inherent flaws. Dwyer v. Sec’y of Health & Human Servs., No. 03-1202V, 2010 WL 892250, at *64 (Fed. Cl. Spec. Mstr. Mar. 12, 2010) (“[e]very observational epidemiological study has some weaknesses because such studies examine the world as it is”). But (operating from the well-worn maxim that “the perfect is the enemy of the good”)33 the possibility of a better study is not an effective critique of an existing, otherwise valid study. See also Harris, 2014 WL 3159377, at *13 (“a perfect scientific study is not required by the relevant legal standards”). The only other proof that Ms. Sullivan offers to support her causation theories are VAERS reports and data from the Gardasil package insert – none of which are particularly persuasive evidence. Because of their passive nature and unverified claims, VAERS reports are too anecdotal and unscientific to have much probative value in establishing a causation theory.34 Statements contained in 32 The Chao Study’s findings regarding the safety of the Gardasil vaccination are bolstered by the findings from Verstraeten, which compiled data from smaller clinical trials in an effort to identify a correlation between receipt of the HPV vaccination and the subsequent development of autoimmune disease when such data was aggregated (but finding no such association). See Verstraeten at 6630. 33 This phase is attributed to Voltaire and is literally translated as “the best is the enemy of the good.” Bartlett’s Familiar Quotations 343 (125th ed. 1980). 34 As another special master has commented in connection with the evidentiary value of VAERS reports, VAERS is a stocked pond. It only contains reports (many of which are unverified or incomplete) of adverse events after vaccinations. VAERS contains no reports or data about the relative rate of these same events in individuals who have not been vaccinated. Thus, the number of specific adverse events, such as GBS, reported after any vaccine, is meaningless without information about the background rate of that adverse event and information about the number of vaccines administered. Tompkins v. Sec’y of Health and Human Servs., No. 10-261V, 2013 WL 3498652, at *16 (Fed. Cl. Spec. Mstr. June 21, 2013), review denied sub nom., Tompkins v. United States, 117 Fed. Cl. 713 (2014). 25 Case 1:10-vv-00398-UNJ Document 71 Filed 03/27/15 Page 26 of 29 vaccine package inserts do not constitute reliable proof of causation, and cannot be deemed admissions that the vaccines in question have the capacity to harm a particular petitioner in a specific manner. See Werderitsh v. Sec'y of Health & Human Servs., No. 99–319V, 2005 WL 3320041, at *8 (Fed. Cl. Spec. Mstr. Nov. 10, 2005) (quoting 21 C.F.R. § 600.80(l) as saying “[a] report or information submitted by a licensed manufacturer . . . does not necessarily reflect a conclusion by the licensed manufacturer or FDA that the report or information constitutes an admission that the biological product caused or contributed to an adverse effect”).35 The record is therefore insufficient to establish by a preponderance of the evidence Petitioner’s theory that the Gardasil vaccine can cause RA. B. Althen Prong Two There is a notable lack of record support for the second Althen prong – that the Gardasil vaccine “did” cause Ms. Sullivan’s injuries. Petitioner’s contemporaneous medical records provide no evidence – such as a treating physician’s statement, or a test result – supporting the view that the Gardasil series she had received was connected to her RA. There is only the fact that Ms. Sullivan received her last dose of the vaccine in January 2008, and then began to complain of knee-related pain no earlier than late March to early April of 2008 (as the Ruling Regarding Finding of Fact establishes).36 Mere temporal association, without more, is insufficient to establish causation. See Moberly, 592 F.3d at 1323. Here, however, that is all the Petitioner can offer. 35 In any event, as Dr. Rosé noted, the numbers reported on the Gardasil package insert which Dr. Roseff characterized as evidencing a “disturbing trend” merely represented raw data gathered through a self-reporting mechanism after the trial, and do not suggest anything regarding causality - a fact which Dr. Rosé illustrated by referencing other numbers in the Gardasil package insert regarding trials of the vaccine. Based on Dr. Roseff’s same logic, such data would seem to suggest that there were more adverse events following receipt of a saline placebo than there were following receipt of the Gardasil vaccination. Rosé Report at 3; See also Roseff Report at 3. 36 As noted above, the onset issue was the subject of a prior evidentiary hearing conducted by the special master previously assigned to the case, and I have incorporated her ruling in my decision. This fact determination does not serve as “law of the case” (a doctrine that applies more to prior legal determinations in a proceeding) that I must necessarily follow. See generally Banks v. United States, 741 F.3d 1268, 1276 (Fed. Cir. 2014) (indicating that law-of-the-case doctrine “posits that when a court decides upon a rule of law, that decision should continue to govern the same issues in subsequent stages in the same case”) (quoting Christianson v. Colt Indus. Operating Corp., 486 U.S. 800, 815-16 (1988)). Indeed, I am no more formally bound by the onset proceeding than I would be bound by my determinations in a different case, the determinations of a special master in another case, or even a Court of Federal Claims decision. Hanlon, 40 Fed. Cl. at 630. However, neither party asked me to reconsider the Ruling Regarding Finding of Fact prior to the entitlement hearing in this case, nor did Petitioner attempt to argue that newly-discovered or additional proof relevant to onset favored a different outcome. Moreover, Dr. Roseff submitted a supplemental opinion in which he applied the findings from the Ruling Regarding Finding of Fact but still determined that his original opinion was valid. Supplemental Expert Report by Dr. Roseff dated Sept. 16, 2013 (ECF No. 48-1) (Pet’r’s Ex. 28) at 1. Given the above (plus the fact that the Ruling Regarding Finding of Fact is comprehensive and was the result of a proceeding in which both sides had full opportunities to present evidence), in the exercise of my discretion I find that it is appropriate to adopt the Ruling Regarding Finding of Fact herein. See Pacific Gas & Elec. Co. v. United States, 114 Fed. Cl. 146, 149 (2013) (when a successor judge is transferred a case in which a prior order has been rendered, the successor judge “should not overrule the earlier judge’s order or judgment merely because the later judge might have decided matters differently,” but should exercise his discretion in determining if circumstances warrant reopening the previously-determined issue) (quoting United States v. O’Keefe, 128 F.3d 885, 891 (5th Cir. 1997)). 26 Case 1:10-vv-00398-UNJ Document 71 Filed 03/27/15 Page 27 of 29 During the hearing, both experts acknowledged this lack of record support linking Ms. Sullivan’s vaccination to her RA. Aside from a single rheumatologist (who appears to have been merely recounting Mr. Sullivan’s view that her RA was connected to the Gardasil vaccine), none of Petitioner’s treating physicians ever identified Gardasil as a possible cause of her injury. Tr. at 74-75, 138. Dr. Rosé indicated that (based on his own ample experience diagnosing RA) he did not himself see anything in her treatment record that would support such a connection. Id. at 138. Dr. Roseff’s expertise in rheumatology would have made him well-qualified to point out contrary evidence from the record (such as a test result that suggested a connection between the Gardasil vaccine and the development of Ms. Sullivan’s symptoms, even if overlooked by a treating physician), but he admitted he could identify no such evidence either. Id. at 75. Petitioner has thus failed to offer preponderant evidence in support of the second Althen prong. C. Althen Prong Three As I explained above, Ms. Sullivan did not provide a reliable theory for how the Gardasil vaccine could cause RA. Accordingly, she cannot satisfy the third Althen prong either, since the adequacy of the proposed timeframe in which the Gardasil vaccine could have caused the Petitioner’s injury must relate to the medical theory for how this would occur in the first place. Bazan, 539 F.3d at 1352; Shapiro, 101 Fed. Cl. at 542. But even if I had found that Petitioner had provided preponderant evidence in satisfaction of Althen prong one, I would still find that this third prong has not been similarly satisfied. Petitioner inconsistently argued what was a medically acceptable timeframe for onset in this case – sometimes appearing to measure onset from the last in the series of three Gardasil vaccinations she received, while other times suggesting that the series in total had a “cumulative effect,”37 compounding over time from the date of the first or second vaccine in the series. Neither argument was persuasive. Measuring from the last Gardasil vaccination Ms. Sullivan received (January 4, 2008), the onset of her RA symptoms (beginning “somewhere between March and April 2008,” as determined at the onset fact hearing) occurred ten to twelve weeks thereafter. Dr. Rosé proposed, however, that a reasonable timeframe in which any vaccine might conceivably cause some kind of arthritic condition 37 During the hearing, Petitioner at times displayed confusion as to what timeframe she intended to try to prove in which the vaccination resulted in the onset of her RA. Her pre-hearing filings characterized it as a “three month period of time between the onset of symptoms and the vaccine” (Pet’r’s Pre-Hr’g Filing (ECF No. 54)), which is consistent with the Ruling Regarding Finding of Fact. At certain points throughout his testimony, however, Dr. Roseff referred to a two-month latency period as an appropriate temporal relationship between vaccination and onset of Petitioner’s symptoms. See, e.g., Tr. at 28, 33. Dr. Roseff further muddied Petitioner’s argument by indicating that it was not clear to him whether it was the first, second, or third vaccination (or even a “cumulative effect” of all three vaccinations) that ultimately caused Petitioner’s RA. Tr. at 54, 73. 27 Case 1:10-vv-00398-UNJ Document 71 Filed 03/27/15 Page 28 of 29 would be no more than two to four weeks.38 Rosé Report at 6. Given the above, three months appears too long a timeframe in which onset could have occurred. Ms. Sullivan attempted to substantiate three months as medically acceptable, pointing to literature showing purportedly analogous diseases that can be latent for that same period or longer. For instance, Dr. Roseff analogized RA to an inflammatory arthritic condition caused by Lyme disease (an insect-borne bacterial infection). Before being first recognized as a separate entity, Lyme arthritis was initially confused with early RA, so facially this comparison is not inapt. See Allen C. Steere & Lisa, Glickstein, Elucidation of Lyme Arthritis, 4 Nature Reviews Immunology 143 (2004) (Pet’r’s Ex. 31 at 2). But Dr. Rosé persuasively argued that the timeframe for the development of Lyme arthritis was more logically attributed to persistence of inflammation (despite the otherwise successful treatment of the initial infection) rather than latent onset.39 Tr. at 23-24, 131-34. For his part, Dr. Roseff admitted that he could not support the Lyme arthritis analogy with any comparable research involving RA. Id. at 24. Indeed, it appears to some extent that Dr. Roseff chose the Lyme arthritis analogy mainly because it provided an instance of “a long period between infection and development of inflammatory arthritis,” rather than for its demonstrable scientific similarity. Id. at 58. Further, Petitioner cited no evidence suggesting that any component of the vaccine had ever been found in an RA patient’s synovial capsules (in the same manner that the Lyme disease bacteria are found there). The same is true for the other purportedly analogous cases (as referenced in the Toplak or Agmon-Levin articles) involving latency periods cited by Dr. Roseff. The main common ground those articles generally have with present circumstances is the fact that they display a delayed autoimmune response following receipt of a vaccine. Otherwise, they all involve different vaccines and different diseases, and thus cannot be assumed to be scientifically comparable to a sufficient degree to support the theory that Ms. Sullivan could have experienced delayed onset of RA-related symptoms months after any of the series of Gardasil vaccines that she received. Indeed, these pieces of literature themselves are far more limited in the scope of their conclusions (as Dr. Roseff himself specifically admitted with respect to the Toplak article (see, e.g., Tr. at 47-48)). The Toplak article concludes with the specific observation that the flu vaccine did not “increase the percentage of positive autoantibodies in the general healthy adult population,” even if some autoantibody increases were seen at certain temporal points after vaccine administration – increases having “no clear clinical significance.” Toplak at 138; Tr. at 30. 38 Other Vaccine Program cases involving RA or similar arthritic illnesses have found this same general timeframe to be reasonable (although I do not adopt it as the “correct” one, or the only one a petitioner could ever prove). Capizzano v. Sec'y of the Dep't of Health & Human Servs., No. 00-759V, 2006 WL 3419789, at *11 (Fed. Cl. Nov. 8, 2006); Doe/28 v. Sec'y of Dep't of Health & Human Servs., 2009 WL 229665, at *20 (Fed. Cl. Jan. 21, 2009) (finding that petitioner has shown a medically appropriate time interval between receipt of the hepatitis B vaccine and her development of nonspecific arthritis where approximately one month elapsed between petitioner's third hepatitis B vaccination and the onset of her symptoms, and “[t]he interval was so strikingly appropriate that four of her treaters ascribed her condition to the vaccination”). 39 See Allen C. Steere & Lisa Glickstein, Elucidation of Lyme Arthritis, 4 Nature Reviews Immunology 143 (2004) (Pet’r’s Ex. 31) (indicating that “10% of patients with Lyme arthritis develop persistent synovitis, which lasts for months or even several years after the apparent eradication of the spirochete from the joint with antibiotic therapy.”). 28 Case 1:10-vv-00398-UNJ Document 71 Filed 03/27/15 Page 29 of 29 Petitioner was also unable to establish preponderant evidence that the series of three Gardasil vaccinations she received could produce in concert the onset of her RA symptoms in the early spring of 2008. In an attempt to do so, she proposed (through Dr. Roseff’s testimony) something along the lines of a “cumulative effect” or challenge-rechallenge theory – that Ms. Sullivan’s successive vaccinations (whether due to build-up of aluminum in Ms. Sullivan’s body, or simply from her system being primed immunologically) culminated in her initial knee symptoms and ultimate development of RA. But this theory was thinly substantiated and inadequately explained. The record shows absolutely no evidence that Ms. Sullivan experienced any reaction after receipt of the prior two Gardasil vaccines, as Dr. Rosé noted would be expected to have occurred if her immune system was being challenged after each successive vaccination. Tr. at 109; see also Hall v. Sec’y of Health & Human Servs., No. 02-1052V, 2007 WL 3120284, at *7 (Fed. Cl. Sept. 12, 2007) (a petitioner who suffered from a shoulder injury was entitled to compensation based on a challenge-rechallenge theory when petitioner received two doses of the hepatitis B vaccine and after each dose, she experienced problems in her shoulder within two weeks of the vaccination; the amount of time between the first vaccination and the start of her problems was more than the amount of time between the second vaccination and the start of problems; and the reaction to the second vaccination was also more severe). And as discussed above, Dr. Roseff himself did little more than speculate that it was possible that the Gardasil series Ms. Sullivan received could have built up in her body in some manner to result in her initial symptoms, supporting this speculation with unscientific literature like the Judicial Watch article rather than reliable scientific or medical proof. Petitioner thus did not establish that it was more likely than not that the total series of Gardasil vaccinations could cumulatively produce her initial symptoms two to three months after receipt of the final vaccination. Conclusion I have great sympathy for the suffering Ms. Sullivan experienced after receiving the Gardasil vaccinations. However, based on the records filed and testimony at hearing, I cannot conclude that she is entitled to an award of compensation in this case. The Vaccine Act permits me to award compensation only if a Petitioner alleging a “non-Table Injury” can show by medical records or competent medical opinion that the injury was more likely than not vaccine-caused. Here, there is insufficient evidence to support an award of compensation, leaving me no choice but to hereby DENY this claim. In the absence of a timely-filed motion for review (see Appendix B to the Rules of the Court), the Clerk shall enter judgment in accord with this decision. IT IS SO ORDERED. /s/Brian H. Corcoran Brian H. Corcoran Special Master 29 ================================================================================ DOCUMENT 3: USCOURTS-cofc-1_10-vv-00398-1 Date issued/filed: 2015-07-17 Pages: 2 Docket text: PUBLIC DECISION (Originally filed: 6/26/2015) regarding 73 DECISION Fees Stipulation. Signed by Special Master Brian H. Corcoran. (ag) Copy to parties. -------------------------------------------------------------------------------- Case 1:10-vv-00398-UNJ Document 78 Filed 07/17/15 Page 1 of 2 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 10-398V (Not to be published) * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * SHEA KYLIE SULLIVAN, * * Filed: June 26, 2015 Petitioner, * * Decision by Stipulation; Attorney’s v. * Fees & Costs * SECRETARY OF HEALTH AND * HUMAN SERVICES, * * Respondent. * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * Sarah Reimers McIntee, Washington, DC, for Petitioner Alexis Babcock, Washington, DC, for Respondent ATTORNEY’S FEES AND COSTS DECISION1 On June 28, 2010, Shea Kylie Sullivan filed a petition seeking compensation under the National Vaccine Injury Compensation Program. An entitlement hearing was held in this matter on July 10, 2014. I issued a decision denying entitlement on February 13, 2015. On June 26, 2015, counsel for both parties filed a joint stipulation, in regards to attorney’s fees and costs. The parties have stipulated that Petitioner’s former counsel, LeClairRyan, should receive a lump sum of $50,500.00, and Petitioner’s current counsel, Nelson Mullins, should receive a lump sum of $25,000.00 in the form of checks payable to Petitioner and Petitioner’s respective counsel. This amount represents a sum to which Respondent does not object. In 1 Because this decision contains a reasoned explanation for my action in this case, I will post this decision on the United States Court of Federal Claims’ website, in accordance with the E-Government Act of 2002, Pub. L. No. 107- 347, § 205, 116 Stat. 2899, 2913 (codified as amended at 44 U.S.C. § 3501 note (2006)). As provided by 42 U.S.C. § 300aa-12(d)(4)(B), however, the parties may object to the posted decision’s inclusion of certain kinds of confidential information. Specifically, under Vaccine Rule 18(b), each party has 14 days within which to request redaction “of any information furnished by that party: (1) that is a trade secret or commercial or financial in substance and is privileged or confidential; or (2) that includes medical files or similar files, the disclosure of which would constitute a clearly unwarranted invasion of privacy.” Vaccine Rule 18(b). Otherwise, the whole decision will be available to the public. (Id.) Case 1:10-vv-00398-UNJ Document 78 Filed 07/17/15 Page 2 of 2 addition, and in compliance with General Order No. 9, Petitioner has represented that she did incur any reimbursable costs in proceeding on this petition. I approve the requested amount for attorney’s fees and costs as reasonable. Accordingly, an award should be made in the form of a check:  in the amount of $50,500.00 payable jointly to Petitioner and Petitioner’s former counsel, LeClairRyan; and  in the amount of $25,000.00 payable jointly to Petitioner and Petitioner’s current counsel, Nelson Mullins. In the absence of a motion for review filed pursuant to RCFC Appendix B, the clerk of the court SHALL ENTER JUDGMENT in accordance with the terms of the parties’ stipulation.2 IT IS SO ORDERED. /s/ Brian H. Corcoran Brian H. Corcoran Special Master 2 Pursuant to Vaccine Rule 11(a), the parties may expedite entry of judgment by filing a joint notice renouncing their right to seek review.