CHRISTIAN J. MORAN, Special Master.
Joseph D'Angiolini alleges that he experienced an adverse, and possibly allergic, reaction to the hepatitis B vaccination which caused him to develop chronic fatigue syndrome ("CFS"), systemic lupus erythematosus ("SLE"), and autoimmune syndrome induced by adjuvants ("ASIA"). Mr. D'Angiolini seeks compensation pursuant to the National Childhood Vaccine Injury Compensation Program, 42 U.S.C. §§ 300aa-10 through 34 (2012).
Mr. D'Angiolini primarily relies on the testimony of Dr. Frank Vasey, a board certified rheumatologist who has treated Mr. D'Angiolini since 2000, and Dr. Yehuda Shoenfeld, a specialist in autoimmune disease. In their testimony, Doctors Vasey and Shoenfeld discussed Mr. D'Angiolini's alleged injuries including CFS, SLE and ASIA. Mr. D'Angiolini's experts also provided various theories to explain how the hepatitis B vaccine could have caused Mr. D'Angiolini's alleged injuries. Mr. D'Angiolini's diagnoses and causation theories were opposed by respondent's expert witnesses: Dr. Robert W. Lightfoot, also a board certified rheumatologist, and J. Lindsay Whitton, PhD, who specializes in virology and immunology. For the reasons set forth below, Mr. D'Angiolini failed to establish persuasively that he does in fact suffer from any of his alleged injuries, including CFS, SLE and ASIA, and thus, has not demonstrated that he is entitled to compensation.
This decision is organized into the following topics:
This case is one of the oldest cases pending at the Office of Special Masters. This unusually lengthy procedural history certainly does not accord with the quick case processing Congress anticipated.
Mr. D'Angiolini, represented by Clifford Shoemaker, filed his petition on August 4, 1999, alleging that the hepatitis B vaccine caused him to experience an adverse reaction. Pet., filed Aug. 4, 1999, at 1. Around this same time, Mr. D'Angiolini's mother sent a letter to her son's employer initiating a claim for workers' compensation benefits.
Early in the history of Mr. D'Angiolini's claim in the Vaccine Program, his case was included in a group of cases in which attorneys representing petitioners, attorneys from the government, and the Office of Special Masters were attempting to devise a procedure to expedite the resolution of numerous cases involving the hepatitis B vaccine.
One approach was to organize cases by injuries. For example, cases in which the petitioners alleged that hepatitis B vaccine caused demyelinating diseases were treated similarly.
Mr. D'Angiolini's case became, for a period, the lead case to obtain a ruling whether the hepatitis B vaccine can cause chronic fatigue syndrome.
In 2005, Mr. D'Angiolini's attorney worked to present reports from these doctors as well as two French doctors, Romain K. Gherardi and Marc Girard. Counsel explained that he was exploring whether components of the hepatitis B vaccine, including thimerosal, yeast, and aluminum in the adjuvant could contribute to an adverse reaction. Pet'r's Status Rep't, filed Mar. 14, 2005, at 3-4; Pet'r's Status Rep't, filed Apr. 19, 2005. By October 7, 2005, the list of potential experts had grown to eight (the six whom counsel had previously identified plus Charles Poser and Yehuda Shoenfeld). Pet'r's Status Rep't, filed Oct. 7, 2005.
On February 2, 2006, petitioner's counsel filed three reports into the D'Angiolini case file. These reports were written by Drs. Geier, Poser, and Shoenfeld. Exhibits 29-31.
The chief special master reassigned this case and six other cases involving chronic fatigue syndrome to the undersigned on February 21, 2006. A status conference to discuss the many cases involving the hepatitis B vaccine was held on March 27, 2006. In this status conference, it became apparent that an omnibus proceeding to address the claim that the hepatitis B vaccine can cause chronic fatigue syndrome was not needed. By this time, the number of cases involving the hepatitis B vaccine and chronic fatigue syndrome had decreased to a more manageable number of cases shifting the emphasis to develop the record for Mr. D'Angiolini's case specifically.
After Mr. D'Angiolini filed all documents about his medical condition, the parties recognized apparent conflicts among the sources of information.
Because the April 29, 2010 Findings of Fact appeared to resolve the genuine issues of material facts, Mr. D'Angiolini sought an opinion from an expert that a dose of the hepatitis B vaccine harmed him.
The first report came from Dr. Vasey, a rheumatologist who has treated Mr. D'Angiolini since 2000. In this report, Dr. Vasey stated that Mr. D'Angiolini "suffers from a rare Hepatitis B vaccine reaction which has permanently disabled him." Dr. Vasey explained "the obvious explanation for Mr. D'Angiolini's reaction is the known yeast sensitivity documented at age 3 years." Exhibit 83 at 4.
The next report was Dr. Shoenfeld's report.
Dr. Shoenfeld reviewed Mr. D'Angiolini's medical history. He found that the hepatitis B vaccine "unleashed the emergence of [chronic fatigue syndrome], which then evolved into a clear cut diagnosed systemic lupus erythematosus." Exhibit 87 at 8.
In this report, Dr. Shoenfeld also addressed whether the onset of Mr. D'Angiolini's problems occurred within a time for which it was appropriate to infer that a vaccination caused the condition. Dr. Shoenfeld stated "in the past, to show a cause and effect of vaccine autoinflammatory reaction, we assumed that the period between the vaccine and the reaction has to be somewhere between 3 weeks. . . to 3 months. Better analysis of the cases of ASIA taught us that the period may extend to months or even years."
On February 2, 2011, Mr. D'Angiolini filed a three-page supplemental report from Dr. Vasey. Dr. Vasey provided three theories to explain a possible causal connection between the hepatitis B vaccinations and Mr. D'Angiolini's injury. Exhibit 93.
These reports were discussed at a status conference. The Secretary indicated that she intended to obtain a responsive report.
The Secretary filed a report from Dr. Lightfoot, a rheumatologist. His report starts with a comprehensive description of Mr. D'Angiolini's medical history. Exhibit A at 4-14. Dr. Lightfoot goes on to question or to disagree outright with statements of Mr. D'Angiolini's experts. For example, Dr. Lightfoot quotes Dr. Shoenfeld as stating that Mr. D'Angiolini has a "`clear cut diagnosed SLE,'" but Dr. Lightfoot asserts that Dr. Shoenfeld's statement is "simply a misstatement of fact. SLE is not the diagnosis of any other clinician." Exhibit A at 16, quoting exhibit 87 at 8.
Dr. Lightfoot emphasized that in 1996, which was before Mr. D'Angiolini was vaccinated, his obsessive compulsive disorder "was interfering with his care" and "his neuropsychiatric state was deteriorating before the vaccination." Exhibit A at 18. Dr. Lightfoot found "nothing to document a sudden change or worsening of petitioner's symptoms coincident with each vaccination."
Dr. Vasey's next report challenged Dr. Lightfoot's representation that Mr. D'Angiolini did not change dramatically after his vaccination. Dr. Vasey wrote that Mr. D'Angiolini, "despite some psychological problems, functioned at a high level and was well liked at his job as a mental health technician and could play and teach guitar. Promptly after his hepatitis B vaccinations he could do neither." Exhibit 94 (report dated May 16, 2011) at 3.
Dr. Shoenfeld also responded to Dr. Lightfoot's April 27, 2011 report by writing a short report in which Dr. Shoenfeld cited 41 articles.
The next status conference was held on July 13, 2011. The parties discussed a June 7, 2011 order that had posed questions to Dr. Vasey and Dr. Shoenfeld and instructed Mr. D'Angiolini to obtain supplemental responses from them. The two recent reports (exhibits 94 and 95), although filed after the June 7, 2011 order, were actually written before June 7, 2011. When asked why Dr. Vasey and Dr. Shoenfeld did not address the questions in the June 7, 2011 order, Mr. D'Angiolini's attorney stated that he did not recall seeing the June 7, 2011 order and, therefore, had not sent the order to the experts. Thus, in the July 13, 2011 status conference, Mr. D'Angiolini was directed, again, to file supplemental reports from Dr. Vasey and Dr. Shoenfeld.
In addition, the parties started to plan for a hearing. The parties anticipated that the earliest mutually convenient dates would be in January or February 2012. In a subsequent status conference, the parties selected February 13-14, 2012. Orders, filed July 13, 2013 and Sept. 13, 2013.
Mr. D'Angiolini filed the requested supplemental reports from Dr. Vasey and Dr. Shoenfeld on September 7, 2011. The questions posed to Dr. Vasey were primarily about his understanding of Mr. D'Angiolini's health. In response to those questions, Dr. Vasey stated "I agree with Dr. Lightfoot that at no time when I cared for [Mr. D'Angiolini] did he meet the criteria for lupus." Exhibit 96 at 1. Dr. Vasey stated that he did not know if Mr. D'Angiolini was allergic to yeast.
Like Dr. Vasey, Dr. Shoenfeld also responded to the questions contained in the June 7, 2011 order. In response to a question about a yeast allergy, Dr. Shoenfeld stated "[t]he yeast allergy, if it exists, is not important for the claim of a long life [chronic fatigue syndrome] following the vaccine. . . . I believe that the case of the CFS [is] not due [to] yeast allergy but due to adjuvant effect." Exhibit 97 at 1. The adjuvant effect was part of Dr. Shoenfeld's answer to a question about elevated immunoglobulin levels. He stated that the adjuvant effect caused chronic stimulation of Mr. D'Angiolini's immune system and this chronic stimulation was manifest in high levels of immunoglobulins.
In addition, Dr. Shoenfeld responded to questions about Mr. D'Angiolini's diagnosis. Dr. Shoenfeld cited five medical records that supported the lupus diagnosis. He also cited four doctors who diagnosed Mr. D'Angiolini as having chronic fatigue syndrome. Exhibit 97 at 2.
Since Mr. D'Angiolini had filed four reports (two from Dr. Shoenfeld and two from Dr. Vasey), the Secretary had an obligation to disclose Dr. Lightfoot's response before any hearing. The Secretary submitted a supplemental report from him as exhibit R on October 6, 2011. In response to Dr. Vasey, Dr. Lightfoot noted a simple difference in opinion regarding Mr. D'Angiolini's health before and after vaccination. Exhibit R at 1.
For Dr. Shoenfeld, Dr. Lightfoot's response was more involved. Dr. Lightfoot questioned whether aluminum as an adjuvant in the vaccine could cause the harm as theorized by Dr. Shoenfeld. Dr. Lightfoot questioned the validity of the macrophage myofasciitis condition and did not understand how aluminum, which Dr. Shoenfeld said was deposited into muscles, could cause neurologic problems, like cognitive impairments. In addition, Dr. Lightfoot noted that Dr. Shoenfeld had not explained very well why he stated that Mr. D'Angiolini suffered from lupus, especially since Dr. Vasey had agreed that Mr. D'Angiolini did not suffer from lupus. Exhibit R.
Dr. Lightfoot's report dated October 4, 2011, was anticipated to complete the series of pre-trial reports. Thus, the undersigned issued a lengthy order, requiring the submission of briefs before the hearing. The purpose of the order was to afford the parties an opportunity to center their evidentiary presentations. This concentration would particularly assist Mr. D'Angiolini because, as the petitioner, he bore the burden of proof and because his attorney had not previously tried a case in the Vaccine Program. The order required Mr. D'Angiolini to set forth his evidence on each disputed element of his case, starting with the diagnoses and continuing through each of the three
On December 22, 2011, Mr. D'Angiolini filed a two-page supplemental report from Dr. Shoenfeld with four articles. Exhibit 132. A more significant submission was Mr. D'Angiolini's pre-trial brief on January 5, 2012.
The January 5, 2012 brief presented Mr. D'Angiolini's view of his case. Primarily based upon the April 29, 2010 Findings of Fact, Mr. D'Angiolini summarized the relevant facts of his medical history. He asserted that within one week of the first dose of the hepatitis B vaccine, he was feeling "flu-ish." Pet'r's Br. at 2, citing Findings of Fact at 24. He made a similar assertion, regarding his reaction to the second dose.
In regard to the appropriate diagnosis for Mr. D'Angiolini, he claimed that he suffered from autoimmune syndrome induced by adjuvant, chronic fatigue syndrome, systemic lupus erythematosus, and fibromyalgia. Pet'r's Br. at 5. For ASIA, CFS, and lupus, Mr. D'Angiolini cited to some evidence in which medical records purportedly identified the sign or symptom fitting the relevant diagnostic criterion.
For the medical theory causally connecting the hepatitis B vaccination to any injury suffered by Mr. D'Angiolini, his brief was relatively short. It covered this topic in a single paragraph, discussing the adjuvant. Based upon Dr. Shoenfeld's reports, Mr. D'Angiolini asserted:
For the logical sequence of cause and effect, Mr. D'Angiolini stated that he was relying upon Dr. Shoenfeld. In addition, Mr. D'Angiolini identified various doctors who linked his health problems to his hepatitis B vaccination.
For the appropriate temporal relationship, Mr. D'Angiolini stated that Dr. Shoenfeld's report indicated that an autoinflammatory reaction can be anywhere from "weeks to months, even years." Mr. D'Angiolini also asserted that he "manifested [an] autoinflammatory reaction within one (1) week of receiving his first dose of Hepatitis B vaccine."
Finally, Mr. D'Angiolini presented his witness list. He included Dr. Shoenfeld, Dr. Vasey, and Dr. Harold Buttram.
The day after Mr. D'Angiolini filed his pre-trial brief, he filed a 30-page report from Dr. Buttram. Exhibit 153. As alluded to earlier, Mr. D'Angiolini eventually withdrew this report. Hence, the details of Dr. Buttram's opinion are largely irrelevant to the outcome of the case. However, the submission of Dr. Buttram's report disrupted the progression of the case.
A status conference was held on January 9, 2012. Mr. D'Angiolini's attorney represented that he had not solicited Dr. Buttram's report. Rather, Mr. D'Angiolini's mother had contacted Dr. Buttram and obtained it. Mr. D'Angiolini's attorney stated that he told Mr. D'Angiolini and his mother that he would file the report, although it might delay the case. As Mr. D'Angiolini's attorney expected, the Secretary's attorney expressed concern about needing to respond to the report from a new expert so quickly.
The temporary solution was to divide the hearing. On February 12-13, 2012, Dr. Shoenfeld, Dr. Vasey, and Dr. Lightfoot would testify. On a different date, Dr. Buttram and an expert retained by the Secretary would testify. In light of this plan, the Secretary was instructed to respond to Mr. D'Angiolini's pre-trial brief, but to set aside Dr. Buttram's report temporarily. Order, filed Jan. 20, 2012.
The Secretary filed her pre-hearing brief on January 19, 2012. She disputed each of the four potential diagnoses Mr. D'Angiolini had proposed (ASIA, lupus, CFS, and fibromyalgia). Resp't's Br. at 5-8. As to the medical theory, the Secretary quoted the portion of Mr. D'Angiolini's brief quoted above. The Secretary argued that Dr. Shoenfeld's adjuvant-based theory was not reliable.
For the proximate temporal relationship, the Secretary also challenged Mr. D'Angiolini's proof. The Secretary stated "Dr. Shoenfeld opined that the earliest onset time for [an autoinflammatory] reaction is three weeks."
After the Secretary's brief, Mr. D'Angiolini filed 19 articles, exhibits 155-73. Although all discussed ASIA, Mr. D'Angiolini did not submit an expert report explaining the significance of those articles.
A lengthy pre-trial conference was held on February 1, 2012. Three topics dominated the discussion. First, the Secretary questioned whether she was given adequate notice of the newly filed articles. Second, Mr. D'Angiolini's version of his medical history was inconsistent with the Findings of Fact on the important topic of his health in the days immediately after the hepatitis B vaccinations. For example, while Mr. D'Angiolini cited to page 24 of the Findings of Fact for the proposition that he felt "flu-ish" after the second dose of the vaccine, this portion of the findings of fact merely presented Mr. D'Angiolini's claim. However, his claim was not accepted. The next paragraph begins "[a] preponderance of the evidence does not support a finding that Mr. D'Angiolini was feeling flu-ish." This discrepancy jeopardized Mr. D'Angiolini's claim because if his symptoms were fundamental to his expert's opinion, then his expert's opinion could not be accepted.
The third topic at the February 1, 2012 pre-trial conference was the timing prong from
Under these circumstances, Mr. D'Angiolini requested a suspension of the hearing and his request was granted. The Secretary was given a deadline for Dr. Lightfoot's next supplemental report to respond to the recently filed articles about ASIA. The Secretary was also given a deadline to submit an initial report from Lindsay Whitton, who was responding to Dr. Buttram's report.
The Secretary filed Dr. Whitton's report on March 15, 2012, as exhibit V. Because his report responded to Dr. Buttram's report, which was later withdrawn, most of Dr. Whitton's comments do not affect the outcome of the case. The Secretary, however, has not withdrawn Dr. Whitton's report and he offered a small amount of testimony at the hearing.
The next two reports from experts concerned ASIA. Dr. Lightfoot's March 19, 2012 report appears as exhibit II. Dr. Lightfoot criticized ASIA, saying "the criteria are so non-specific as to make it unclear whether ASIA is a syndrome at all. It is my feeling that ASIA remains a hypothesis until such time as its proponents can validate their criteria and sharpen them quantitatively." Exhibit II at 3.
Dr. Shoenfeld had a chance to respond. Unfortunately, some (but not all) of Dr. Shoenfeld's criticisms attacked Dr. Lightfoot on a personal level. Exhibit 188.
The final expert report was written by Dr. Shoenfeld to address the temporal relationship. Dr. Shoenfeld's theory was that the adjuvant in a vaccine can cause "chronic and persistent stimulation of the immune system." Exhibit 189 at 2. Differences in number of vaccinations, in the interval between vaccinations, and in the type of vaccinations contribute to a variable development of problems. Dr. Shoenfeld stated "the first signs or symptoms and lab results . . . will be seen progressively and sometimes after months and even years."
Dr. Shoenfeld did not specify when Mr. D'Angiolini's problem began, although Dr. Shoenfeld listed a series of events, spanning from 1997 to 2004, in his report. Exhibit 189 at 4-7. Dr. Shoenfeld did assert that "[a]ny initial reactions experienced by Mr. D'Angiolini should be considered allergic reactions as a result of his allergy to yeast."
Having received these supplemental reports from Dr. Shoenfeld, Mr. D'Angiolini incorporated many of these ideas into his supplemental pre-trial brief filed on June 4, 2012. The Supplemental Brief contained some alterations in most of Mr. D'Angiolini's case, except for the section regarding Althen prong two. In regard to any assertions in the January 5, 2012 brief that were not consistent with the Findings of Fact, Mr. D'Angiolini "expressly rescinded" them. Pet'r's Suppl. Prehr'g Br. at 1 n.1;
Although the brief attempted to identify medical records that indicated Mr. D'Angiolini suffered from signs or symptoms related to ASIA, lupus, and CFS, the significance of many citations was unclear. For example, petitioner referred to a letter from Dr. Black dated March 29, 1999 (exhibit 9 at 2) as evidence for fulfillment of a minor ASIA criteria described as "[t]he appearance of autoantibodies or antibodies directed at the suspected adjuvant." Pet'r's Suppl. Prehr'g Br. at 3. Although Dr. Black's letter indicated an increase in gammaglobulins, there is no indication that these immunoglobulins were of a type directed at the suspected adjuvant. Mr. D'Angiolini also referred to a record from Dr. Buttram as evidence of arthralgia and arthritis where no joint or arthritic pain was indicated. Pet'r's Suppl. Prehr'g Br. at 2, citing exhibit 14 at 4.
The June 4, 2012 brief expanded the theory causally connecting the hepatitis B vaccinations to any of these conditions. In this brief, Mr. D'Angiolini's attorney asserted that the
Pet'r's Suppl. Prehr'g Br. at 7-8.
A final change concerned the temporal relationship, which corresponds to
The parties discussed Mr. D'Angiolini's Supplemental Brief in a status conference on June 12, 2012. The most significant substantive topic was whether the evidence cited in support of a diagnosis actually supported the diagnosis. In this respect, the Secretary contemplated filing a motion for summary judgment with respect to the claim that Mr. D'Angiolini suffered from lupus, although the Secretary eventually declined to pursue this motion.
The discussion about the proper diagnosis prompted Mr. D'Angiolini to file another submission. Although submitted as "exhibit 191," this document is more like a brief in that Mr. D'Angiolini's attorney argued why identified medical records support a diagnosis. Exhibit 191 was more effective and more persuasive than either Mr. D'Angiolini's January 5, 2012 brief or his June 4, 2012 supplemental brief.
The efforts to reschedule the hearing for mutually convenient dates culminated in a June 27, 2012 scheduling order, setting the case for a hearing from January 14, 2013 to January 18, 2013. The parties planned to have Dr. Shoenfeld, Dr. Vasey, and Dr. Lightfoot testify for the three days. Dr. Buttram and Dr. Whitton would testify on the final two days.
Between June 27, 2012 and the next pre-trial conference, which was held on January 3, 2013, there was relatively little activity. Mr. D'Angiolini was awarded approximately $200,000 in attorneys' fees and costs on an interim basis. Decision, filed July 18, 2012. The undersigned submitted two more exhibits into the record. Order, filed July 20, 2012. The parties reported that efforts to settle the case were not successful. Pet'r's Status Rep't, filed Nov. 1, 2012.
Once it appeared certain that the case was proceeding to hearing, the undersigned submitted two additional medical articles into the record. Order, filed Jan. 9, 2013. These articles concerned whether yeast in the hepatitis B vaccine can cause an adverse reaction. Exhibits 1004-05. The parties were alerted to have their experts prepared to testify about these articles.
The hearing began on January 14, 2013, when Mr. D'Angiolini called Dr. Shoenfeld to testify. Dr. Shoenfeld generally testified in accord with his reports. But, Dr. Shoenfeld also presented articles that he had not cited and had not been filed into the record. The Secretary objected because the October 2, 2012 order for pretrial submissions restricted the discussion of articles that had not been filed into the record. Tr. 777-86.
After Dr. Shoenfeld's testimony, Dr. Lightfoot testified. His testimony, too, mostly tracked what he had stated in his reports. The next witness was Dr. Vasey, who appeared via videoconferencing. Dr. Vasey completed his testimony on January 16, 2013.
When these witnesses were testifying, Mr. D'Angiolini was attempting to arrange for Dr. Buttram to testify, as scheduled, on January 17, 2013. Mr. D'Angiolini's attorney eventually learned that Dr. Buttram could not participate for reasons that could not be solved with a simple postponement of his testimony. Consequently, Mr. D'Angiolini withdrew Dr. Buttram's report entirely. While the Secretary acceded to the withdrawal of Dr. Buttram's report, the Secretary maintained that she still intended to call Dr. Whitton to address some aspects of Dr. Shoenfeld's testimony. Tr. 1591-93.
Dr. Whitton was the final witness and he testified on January 17, 2013. He addressed allergy and whether Mr. D'Angiolini was allergic to yeast. Tr. 1594-1662.
After the hearing concluded, the parties chose to submit briefs. Mr. D'Angiolini filed a primary brief, the Secretary filed one brief, and Mr. D'Angiolini filed a reply brief. With the submission of Mr. D'Angiolini's reply brief, the case is ready for adjudication.
Petitioners are required to establish their cases by a preponderance of the evidence. 42 U.S.C. § 300aa-13(1)(a). The preponderance of the evidence standard requires a "trier of fact to believe that the existence of a fact is more probable than its nonexistence before [he] may find in favor of the party who has the burden to persuade the judge of the fact's existence."
Distinguishing between "preponderant evidence" and "medical certainty" is important because a special master should not impose an evidentiary burden that is too high.
Mr. D'Angiolini has established, by a preponderance of the evidence, most of the elements set forth in 42 U.S.C. § 300aa-11(c), including that he received a vaccine listed on the Vaccine Table, the hepatitis B vaccine. The disputed issue is whether the hepatitis B vaccine caused Mr. D'Angiolini an injury.
Here, the parties dispute whether Mr. D'Angiolini suffered any injury for which he seeks compensation. In this circumstance, Mr. D'Angiolini bears the burden of establishing that he suffers from a condition for which he seeks compensation.
After petitioners establish that they suffer from a particular condition, they must establish that the vaccine caused that injury. For causation-in-fact claims, the Federal Circuit set forth a three-prong test.
Mr. D'Angiolini was born in 1966. Tr. 143. When he was approximately 11 or 12 years old, Mr. D'Angiolini had the first symptoms of obsessive compulsive disorder ("OCD"), and was later diagnosed with that disorder. Exhibit 24 at 5-7. A psychologist provided some counseling to him as an adolescent, although the psychologist was primarily seeing Mr. D'Angiolini as part of her work in counseling a member of Mr. D'Angiolini's family. Tr. 88, 108. Mr. D'Angiolini's OCD did not prevent him from graduating from high school. He entered college but did not graduate. Exhibit 16 at 14; Tr. 660.
When he was approximately 20 years old, he started developing headaches three or four times a week. Exhibit 24 at 6. In August and September 1996, Mr. D'Angiolini was experiencing headaches three or four times per week and his OCD behaviors were intensifying. Dr. Debra Roman prescribed Fiorciet for his headaches. Exhibit 23 at 35-36; exhibit 50 pdf 255 (Roman Dep. Tr. 16); Tr. 665-68.
However, in August and September 1996, Mr. D'Angiolini's physical health was otherwise fine. Blood tests were normal. Exhibit 23 at 99-102. He played basketball and rollerbladed. Exhibit 51 pdf 26 (June 7, 2001 W.C. Trial Tr. 14); Tr. 93.
Mr. D'Angiolini was working two jobs. He worked at Pottstown Medical Center as a technician for mental health patients. Tr. 150-51, 409-11. He also worked part-time as a music instructor at Bachman's Music Store, earning about $100 per week. Exhibit 16 at 296-301.
On the other hand, Mr. D'Angiolini's mental health was not good. His psychologist, Nancy Casella, referred him to a psychiatrist, Dori Middleman, because Mr. D'Angiolini's OCD symptoms were increasing and were disruptive to his relationship with his fiancée. The psychologist anticipated that Dr. Middleman would prescribe medications to help Mr. D'Angiolini. Exhibit 56 at 2; Tr. 98;
The first appointment between Dr. Middleman and Mr. D'Angiolini occurred on October 29, 1996. Mr. D'Angiolini was having headaches that were causing him either to arrive late for work or to miss work entirely. Dr. Middleman diagnosed him as having OCD with a sexual compulsion and prescribed Prozac. Exhibit 24 at 5-7; Tr. 6-17.
Mr. D'Angiolini continued to see Dr. Middleman throughout the remainder of 1996, with both in-person and telephone consultations. Mr. D'Angiolini continued to have headaches and Dr. Middleman added another medication, amitriptyline. Exhibit 24 at 7-8.
In January 1997, Mr. D'Angiolini found a new job as a mental health technician at Valley Forge Medical Center. After a pre-employment physical examination, he was found capable of performing the job's duties. Exhibit 16 at 174, 176-78; exhibit 51 at pdf 17 (June 7, 2001 W.C. Trial Tr. 5).
Around this time, Mr. D'Angiolini's engagement was ending. He was both sad and relieved about its end. Tr. 223, 338, 484; exhibit 56 at 2; see also exhibit 24 at 9; exhibit 51 at pdf 153 (May 31, 2002 W.C. Trial Tr. 15); Tr. 544-45. In February 1997, Mr. D'Angiolini told Dr. Middleman that he was having difficulty sleeping and attributed the problem to the end of his engagement. Dr. Middleman stopped amitriptyline and prescribed a different drug, trazodone. Two weeks later, Mr. D'Angiolini was having less anxiety. Exhibit 24 at 9-10; Tr. 24-25.
Mr. D'Angiolini started working at Valley Forge Medical Center on March 3, 1997. Exhibit 51 at pdf 190 (May 31, 2002 W.C. Trial Tr. 52); exhibit 16 at 37. In the context of his employment, he received his first dose of the hepatitis B vaccine on March 18, 1997. Exhibit 16 at 162, 233; Tr. 569-570.
In the days immediately following the March 18, 1997 hepatitis B vaccination, Mr. D'Angiolini continued to work at Valley Forge. Tr. 231-32. His employment records show that between March 14, 1997 and March 27, 1997 (two weeks), he worked 81 hours. Exhibit 16 at 93. His employment records do not show that he missed work due to sickness during these two weeks, but do show absences due to illnesses at other times.
On April 18, 1997, Mr. D'Angiolini received the second dose of the hepatitis B vaccine. Exhibit 16 at 162, 233; Tr. 236, 590. Again, in the days and weeks immediately following this immunization, he maintained his employment.
In May 1997, Mr. D'Angiolini was sleeping 15 hours a day and drinking coffee to stay awake at work. Exhibit 24 at 11 (Dr. Middleman's notes from May 22, 1997); exhibit 51 at pdf 193 (May 31, 2002 W.C. Trial Tr. 55). He was having headaches that were more severe, and that he described as migraines. Exhibit 24 at 11; exhibit 51 at pdf 49 (June 7, 2001 W.C. Trial Tr. 37).
Following Mr. D'Angiolini's visit with Dr. Middleman on May 22, 1997, he did not see her again until September 22, 1997. In this interlude, Mr. D'Angiolini had one visit with a doctor, Joshua Bray, on July 29, 1997.
The Findings of Fact resolved a dispute over Mr. D'Angiolini's health in the summer 1997. Although he maintained that he was fatigued during the summer, Joint Statement, filed October 19, 2009, at 11-12, the Findings of Fact did not credit this testimony. Mr. D'Angiolini did not seek medical attention for being fatigued and on the one occasion when he did seek medical care, Mr. D'Angiolini did not mention fatigue as a problem. Findings of Fact at 27.
On October 6, 1997, Mr. D'Angiolini saw Dr. Middleman and Mr. D'Angiolini told her that he was depressed. This was the first time Dr. Middleman noted "depression" for Mr. D'Angiolini. Exhibit 24 at 12; Tr. 62.
On October 24, 1997, Mr. D'Angiolini received his third dose of the hepatitis B vaccine. Exhibit 16 at 162, 233.
On November 4, 1997, Mr. D'Angiolini requested an appointment with Dr. Middleman on an emergent basis. She saw him the next day. Mr. D'Angiolini stated he was sleeping 12-15 hours per day, not taking care of his apartment, and not tending to his appearance. He reported that he had returned to visiting prostitutes and was tempted to prostitute himself. Exhibit 24 at 13; Tr. 36, 75-76;
November 5, 1997, was also the last date Mr. D'Angiolini worked at Valley Forge Medical Center. Exhibit 51 at pdf 20 (June 7, 2001 W.C. Trial Tr. 8); exhibit 53 ¶ 11. He stopped working because he was both mentally and physically incapable of taking care of himself. He was not showering or shaving. Exhibit 51 at pdf 20-21 (June 7, 2001 W.C. Trial Tr. 8-9). He began a leave of absence from Valley Forge the next day. Exhibit 16 at 118, 150. Mr. D'Angiolini's employment with Bachman's Music Store also terminated around this time.
On November 6, 1997, Mr. D'Angiolini saw Dr. Bray. As mentioned earlier,
Preliminarily, information about Dr. Bray comes from various sources. In July 2003, Mr. D'Angiolini filed records from Dr. Bray as exhibit 17. Although the earliest record authored by Dr. Bray contained in exhibit 17 is a letter dated November 30, 1999,
On December 3, 2007, Mr. D'Angiolini filed records his former attorney had obtained from Dr. Bray's office, covering treatment from July 1997 to February 1998. In total, there were four appointments and Dr. Bray's typed notes appear on 16 lines. Exhibit 61.
On April 16, 2008, Mr. D'Angiolini, again acting through his former attorney, filed three letters from Dr. Bray. The dates of the letters are November 6, 1997, November 13, 1997, and January 22, 1998. Each letter is typed and signed. Two letters are one paragraph and one letter is two paragraphs. Exhibit 73.
On December 19, 2011, Mr. D'Angiolini's current attorney filed a four-page letter that Dr. Bray wrote to an insurance company on May 9, 2002. In this letter, Dr. Bray summarized not only the care that Dr. Bray had provided but also information provided by other doctors. Dr. Bray stated that he last treated Mr. D'Angiolini on May 9, 2002, the date of the letter, although no notes of treatment were provided. Exhibit 131.
Other information about Dr. Bray comes from testimony given in either the workers' compensation proceeding or this claim. In both settings, Mr. D'Angiolini and his mother testified about Dr. Bray's treatment of Mr. D'Angiolini. Although Dr. Bray testified as part of the case for workers' compensation benefits, the scope of the testimony was intended to be limited to when Mr. D'Angiolini learned that the hepatitis B vaccine harmed him.
Dr. Bray graduated medical school in 1948 and became licensed to practice medicine in Pennsylvania in 1950. He was a general practitioner, not board certified in any field, and did not hold himself out as a specialist in any field of medicine. Exhibit 50 at pdf 206 (Bray Dep. Tr. 6). Ms. D'Angiolini described Dr. Bray as "a country doctor. . . . [I]f you had a cold, you didn't make an appointment with him. You just went in and he would see you. . . . First come, first serve." Tr. 491. Mr. D'Angiolini, too, stated that Dr. Bray was "a country guy." Tr. 313;
Mr. D'Angiolini began seeing Dr. Bray in 1987 or 1988. Tr. 313. However, there are no documents reflecting any appointments. Dr. Bray stated that his first appointment with Mr. D'Angiolini was on February 5, 1996, although there are also no documents reflecting this appointment. Exhibit 50 at pdf 208 (Bray Dep. Tr. 8).
The first appointment for which there is a record occurred on July 29, 1997,
The next appointment was on November 6, 1997, which was the day after Mr. D'Angiolini stopped working. His mother brought him to see Dr. Bray. Tr. 433, 492. Dr. Bray's typed notes indicate that Mr. D'Angiolini was complaining of "extreme fear, feel[ing] immobilized, afraid to leave the house, not caring for himself or his environment." Exhibit 61. Ms. D'Angiolini testified that Dr. Bray did not perform a physical examination, Tr. 493, and Dr. Bray's notes appear in accord with this recollection. Dr. Bray's impression was "severe depression/adjustment disorder/panic disorder/agoraphobia" and he prescribed amitriptyline and Valium. Exhibit 61.
Dr. Bray wrote a letter addressed "To Whom It May Concern" on November 6, 1997. Dr. Bray stated that Mr. D'Angiolini was under his care for "major depression" and Dr. Bray stated that Mr. D'Angiolini could not work. Exhibit 73 at 3.
A follow up appointment was held seven days later on November 13, 1997. The office notes are two typed lines, indicating that Mr. D'Angiolini had not improved and that Dr. Bray was increasing the dose of amitriptyline. Exhibit 61. The letter associated with this visit is similar. It states that Mr. D'Angiolini is being treated for "major depression" and "panic disorder" and cannot work. Exhibit 73 at 1. Dr. Bray signed Mr. D'Angiolini's application for disability benefits on December 15, 1997. Exhibit 16 at 145-46. In Mr. D'Angiolini's application for disability benefits, Dr. Bray described his symptoms as "crying, unable to stay awake, not caring for self, shortness of breath, dizziness, heart races, chest pain, extreme fear, feel immobilized, afraid to go out."
Dr. Bray's next activity was writing a letter in support of Mr. D'Angiolini's claim for disability benefits on January 22, 1998. There are no office notes associated with this visit and the letter essentially repeats the information in the November 6, 1997 and November 13, 1997 letters. Exhibit 73 at 2; cf. exhibit 16 at 97 (letter from insurance company to Mr. D'Angiolini in response to Dr. Bray's letter).
The last office notes from Dr. Bray are dated February 12, 1998. Dr. Bray recorded that Mr. D'Angiolini was complaining of "severe anxiety and increased symptoms." Dr. Bray prescribed BuSpar and continued other medications. Exhibit 61.
Mr. D'Angiolini continued to see Dr. Middleman and Ms. Casella, the psychologist who was counseling him. They diagnosed him as suffering from OCD, anxiety, and depression. Exhibit 24 at 15, 17; exhibit 61 at 1; Tr. 45-49.
In April 1998, Mr. D'Angiolini reported that he was "quite active" and running. Exhibit 15 at 12;
By the end of April 1998, Mr. D'Angiolini was not taking care of his apartment and the local Board of Health became involved. Mr. D'Angiolini's mother cleaned his apartment and moved her son to her house. Tr. 255-56, 437-38; exhibit 51 at pdf 198 (May 31, 2002 W.C. Trial Tr. 60); exhibit 54 ¶ 32-34 (Ms. D'Angiolini's affidavit describing her observations of Mr. D'Angiolini when he was living with her); exhibit 51 at pdf 39 (June 7, 2001 W.C. Trial Tr. 27) (Mr. D'Angiolini's testimony).
In June, July and August 1998, Mr. D'Angiolini saw Ms. Casella. She believed that he could not work. For the July 1998 form to certify Mr. D'Angiolini's entitlement to disability benefits, Ms. Casella wrote that Mr. D'Angiolini "continues to struggle regularly with sleeping difficulties. He finds that living with parents causes other stress in his life because of sometime volatile relationship with father. Panic attacks continue and he's having difficulty getting himself on a functional schedule." Exhibit 16 at 111. Her diagnoses were "adjustment disorder with depressed mood" and "panic disorder with agoraphobia severe."
On October 10, 1998, Mr. D'Angiolini saw Dr. Gregory Bach, whose letterhead states that he is board certified in family medicine and addiction medicine. Exhibit 5 at 21.
In most respects, the blood work was normal, including a showing that Mr. D'Angiolini did not have antinuclear antibodies. Exhibit 5 at 12-13; exhibit 23 at 87-92. The echocardiogram was basically normal, although it did reveal mild hypokinesis. Exhibit 23 at 115. "Hypokinesis" means abnormally decreased mobility, motor function, or activity. Dorland's Illustrated Medical Dictionary 903 (32nd ed. 2012) ("Dorland's").
On November 10, 1998, Mr. D'Angiolini had an appointment with Dr. Roman for the first time after he received the hepatitis B vaccination. He complained about headaches, nausea, depression/anxiety, and fatigue. Exhibit 23 at 32;
Mr. D'Angiolini told a cardiologist (Dr. Weber) that he was having "dyspnea on exertion when he is doing a strenuous exercise such as heavy lifting or walking while carrying a heavy parcel" for one year. Exhibit 6 at 17 (record dated Nov. 13, 1998). Mr. D'Angiolini's heart was tested in SPECT cardiac perfusion scan on November 20, 1998. The result showed a "mild decrement in LVEF, 44% with questionable borderline inferior wall ischemia." Exhibit 17 at 5. Mr. D'Angiolini was diagnosed as having cardiomyopathy. Exhibit 5 at 6 (report of Dr. Frederic J. Weber);
Mr. D'Angiolini went to the Penn Center for Healing, where Dr. Anne Norris saw him. His chief complaint was "fatigue." The history Dr. Norris obtained recounts that Mr. D'Angiolini had "sudden onset fatigue" in late June 1997. Her record indicates that Mr. D'Angiolini has "been out of work for a year [secondary to] fatigue."
By December 1998, Dr. Middleman had lost touch with Mr. D'Angiolini. She was sufficiently concerned about him that she called Ms. Casella. Exhibit 24 at 19; Tr. 54-55.
After the visit with Dr. Norris in November 1998, Mr. D'Angiolini had one follow-up appointment with her. Exhibit 22 at 2 (Jan. 19, 1999). Following this appointment, there appears to be a gap in visits with doctors. Resumed medical attention began in August 1999.
According to a letter Dr. Bray wrote on June 20, 2002, "[o]n August 3, 1999, while on the internet, I came across information about a fund for people injured by the hepatitis B vaccination. . . . The patient's mother, Cynthia D'Angiolini, came to my office on August 5, 1999[,] and I gave her the information and the name of a Doctor who might be able to help Joseph." Exhibit 16 at 229.
It is worthwhile to interrupt the recitation of Mr. D'Angiolini's medical history with a brief discussion of his legal claims. On August 4, 1999, Mr. D'Angiolini, acting through Attorney Clifford Shoemaker, filed the pending case in the Court of Federal Claims. Also, on November 29, 1999, Mr. D'Angiolini's mother sent a letter notifying Valley Forge Medical Center that the hepatitis B vaccinations harmed her son. Exhibit 16 at 68;
On October 6, 1999, Mr. D'Angiolini saw Dr. Harold Buttram, whose office is in Quakertown, Pennsylvania, which is relatively near Mr. D'Angiolini's home. Exhibit 17 at 125. Dr. Buttram ordered a series of laboratory tests.
Exhibit 17 at 125. Dr. Buttram's letter appears in Dr. Bray's file, although nothing in Dr. Buttram's letter indicates that Dr. Buttram mailed the letter to Dr. Bray.
On November 30, 1999, Dr. Bray wrote another letter to the disability insurance company in support of Mr. D'Angiolini's claim for benefits. This letter is noticeably longer than Dr. Bray's previous letters. One possible explanation is that Mr. D'Angiolini or Mr. D'Angiolini's mother provided Dr. Bray with letters from Doctors Weber (a cardiologist), Bach (a specialist in family medicine and addiction counseling), and Black (a gastroenterologist). In any event, a portion of Dr. Bray's letter states:
Exhibit 17 at 15. At his deposition, Dr. Bray explained that the diagnoses of cardiomyopathy, etc. as well as the diagnoses of chronic fatigue syndrome and depression came from another doctor. Exhibit 50 at pdf 228 (Bray Dep. Tr. 28).
On December 9, 1999, Mr. D'Angiolini saw Dr. Burton A. Waisbren, whose office is located in Milwaukee, Wisconsin.
Dr. Waisbren is board certified in internal medicine. He described himself as having "particular expertise in immunology and infectious diseases and critical care." Exhibit 50 at pdf 8 (Waisbren Dep. Tr. 4). He stated that there is not a certifying body for immunology. He also stated that although there is a certifying body for infectious diseases, he did not attempt to obtain board certification because he had already been teaching infectious disease and immunology for at least 15 years. Exhibit 50 at pdf 17-18 (Waisbren Dep. Tr. at 13-14).
During the December 9, 1999 appointment, Dr. Waisbren obtained information about Mr. D'Angiolini's history, conducted a physical examination, and ordered multiple laboratories studies. He wrote a lengthy case report about Mr. D'Angiolini, which he sent to Dr. Bray. Exhibit 17 at 37-43.
Exhibit 17 at 37. Dr. Waisbren's conclusion was:
Id. at 39. Dr. Waisbren also proposed a "hypothetical analysis." He stated:
Id. at 41. It appears that Dr. Waisbren sent several articles that called into question the safety of hepatitis B vaccine to Dr. Bray. Authors of those articles included Bonnie Dunbar, Barbara Loe Fisher, and Dr. Waisbren.
It appears that Dr. Bray saw Mr. D'Angiolini again in February 2000. Exhibit 17 at 159 (tests for blood collected on February 2, 2000).
Dr. Bray wrote a final letter to the insurance company on May 9, 2002, which was a day that Dr. Bray saw Mr. D'Angiolini. Exhibit 131. The background information about Mr. D'Angiolini's health in 1997 is the same as the history in the February 22, 2000 letter. Dr. Bray, for the first time, summarizes visits with Doctors Bach, Norris, Weber, Black, Day, Buttram, Waisbren, Bellanti, Mandel, and Vasey. However, there is no indication that Dr. Bray was aware of Mr. D'Angiolini's treatment with Dr. Middleman.
Dr. Bray stated that Mr. D'Angiolini "clearly meets the 1982 revised criteria for classification of Systemic Lupus Erythematosus, of the American College of Rheumatology (See attached copy; the patient's objective findings found on physical examination in my office or on lab studies are highlighted for your convenience), involving multiple body systems; central nervous system/neurological, cardiovascular, joint, muscle, renal and mental." Other diagnoses are repeated from the February 22, 2000 letter, including "cardiomyopathy, post encephalomyelitis, neuropathy, [and] depression."
As Dr. Bray mentioned in his May 9, 2002 letter, Mr. D'Angiolini saw other doctors, including Dr. Bellanti, Dr. Mandel, and Dr. Vasey.
The appointment with Dr. Joseph Bellanti was on March 2, 2000. Exhibit 3 at 1. Dr. Bellanti's letter was written to Mr. D'Angiolini's attorney, Mr. Shoemaker,
A few days after seeing Dr. Bellanti, Mr. D'Angiolini passed out while walking and fractured his thumb. Exhibit 13 at 8-9. He had an operation to repair the fracture. Exhibit 14 at 60-62. During the convalescence for his thumb fracture, Mr. D'Angiolini saw Dr. Scott M. Fried. Dr. Fried stated that Mr. D'Angiolini was "back playing the guitar for a number of hours at a time and also the piano. He is really not limited in any activities." Exhibit 19 at 3. Mr. D'Angiolini, in the hearing, denied that he was playing the guitar or the piano.
On July 28, 2000, Mr. D'Angiolini had an appointment with Dr. Buttram. Dr. Buttram's history states that Dr. Waisbren from Wisconsin saw Mr. D'Angiolini in December 1999, and Dr. Waisbren diagnosed Mr. D'Angiolini with "post vaccinal encephalitis and generalized autoimmunity." Dr. Buttram's impression was "post vaccinal encephalitis and severe fatigue." Exhibit 36 at 3-4.
On September 29, 2000, Mr. D'Angiolini saw Frank Vasey, a rheumatologist at the University of South Florida College of Medicine. Exhibit 133 at 18. Dr. Vasey, as discussed below, wrote reports stating that the hepatitis B vaccine harmed Mr. D'Angiolini and testified to that harm at the hearing.
Mr. D'Angiolini's account, as written by Dr. Vasey, begins:
In terms of Mr. D'Angiolini's current problems, Mr. D'Angiolini told Dr. Vasey that he had "chronic fatigue, muscle and joint pain."
Following Dr. Vasey's examination of Mr. D'Angiolini, Dr. Vasey wrote a letter to the judge presiding over Mr. D'Angiolini's claim for workers' compensation benefits pending in Pennsylvania. Dr. Vasey stated "On reviewing his clinical course I believe he suffered an unusual immune mediated reaction to his Hepatitis B vaccine." Dr. Vasey continued: "Because the recognition of this problem is at the case report level[,] well intention[ed] honest physicians could contest my opinion." Dr. Vasey recommended that the judge postpone the hearing scheduled in the workers' compensation claim to accommodate Mr. D'Angiolini's illness and "to allow better understanding of the immunology and epidemiology of the vaccine reactions." Exhibit 133 at 23.
In March 2001, Mr. D'Angiolini again saw Dr. Buttram, whose history noted Mr. D'Angiolini's pending claims for disability benefits and workers' compensation benefits. Dr. Buttram's impressions were hepatitis B and influenza vaccine reactions, myocarditis, encephalomyelitis, neuropathy, chronic fatigue, fibromyalgia, and temporal arteritis. Exhibit 36 at 1-2. Another appointment with Dr. Buttram was on August 7, 2001. Exhibit 14 at 8-10.
In July 2001, Mr. D'Angiolini returned to Dr. Waisbren, whom he had previously seen in 1999. Proceedings in Mr. D'Angiolini's workers' compensation claim may have prompted these appointments as Dr. Waisbren directed his report to Mr. D'Angiolini's attorney.
On September 19, 2001, Mr. D'Angiolini had his second appointment with Dr. Vasey. Exhibit 133 at 17. The third appointment was on July 30, 2003.
On June 3, 2003, Mr. D'Angiolini saw Harold Pretorius, M.D., whose office is in Cincinnati, Ohio. Dr. Pretorius's file includes records from a 1998 test on Mr. D'Angiolini's heart, the May 1999 echocardiogram, and reports from Dr. Weber. Exhibit 40 at 4-11. Dr. Pretorius noted that Mr. D'Angiolini's physician was "Frank Vasi" [sic].
Dr. Pretorius administered a SPECT scan of Mr. D'Angiolini's brain.
On June 30, 2004, Mr. D'Angiolini had an appointment with an office of the Cleveland Clinic located in Naples, Florida. An advanced registered nurse practitioner and Maurice Hanson, a neurologist, saw him at this visit, which appears to have been Mr. D'Angiolini's first visit to the Cleveland Clinic. Exhibit 37 at 22, 29. Dr. Hanson's notes indicate that Mr. D'Angiolini brought with him medical records from other doctors, including Doctors Bray and Bach. Dr. Hanson also recounted that Dr. Bellanti "thought that he had an autoimmune disease related to vaccinations with hepatitis B."
One of these consultations was for a neuropsychological examination, which according to Dr. Hanson, took place in Philadelphia. Following that consultation, Mr. D'Angiolini saw Dr. Hanson again on September 23, 2004. Dr. Hanson determined that the notes from the neuropsychological examination "did not document any evidence of psychosis or a psychiatric disorder."
Dr. Hanson referred Mr. D'Angiolini to a specialist in infectious disease, Margaret J. Gorensek. Dr. Gorensek's history is again relatively lengthy, drawing upon reports of different doctors. She stated "the patient had so many evaluations, so many differing opinions, that there is no one consistent opinion which makes it more suspicious that there really is not any significant opinion." Exhibit 37 at 21. It appears that Dr. Gorensek ordered a series of laboratory tests.
On October 19, 2004, Mr. D'Angiolini had an appointment with Dr. Hanson on an "emergent basis" because of severe headaches. In this record, Dr. Hanson stated that Mr. D'Angiolini had been diagnosed with cardiomyopathy. Dr. Hanson referred Mr. D'Angiolini to Dr. Galatro, a cardiologist. Dr. Hanson's examination of Mr. D'Angiolini on October 19, 2004, was "essentially normal."
On November 19, 2004, Mr. D'Angiolini returned to the Cleveland Clinic and saw Dr. Hanson. Dr. Hanson noted that he (Dr. Hanson) had consulted Dr. Galatro. Whether Dr. Galatro actually saw Mr. D'Angiolini on this date is less clear because her notes do not contain any details. Exhibit 37 at 19. Dr. Hanson, however, recounted that "I rather agree with Dr. Galatro that this is an autoimmune disorder which falls presum[ably] into the lupus category."
A note evidencing a further appointment with Dr. Hanson does not appear in the record. However, Mr. D'Angiolini saw Dr. Galatro on June 22, 2005, which was his most recent visit to the Cleveland Clinic. Dr. Galatro recorded, as part of Mr. D'Angiolini's history, that he "has chronic fatigue syndrome, SLE, and cardiomyopathy." Her assessment includes "[m]ild cardiomyopathy" and "SLE," but not chronic fatigue syndrome. Dr. Galatro prescribed medication for his cardiomyopathy but did not recommend any particular treatment or study specifically for SLE.
When Mr. D'Angiolini testified in April 2008, he stated that he was not functioning very well. Tr. 688. He stated that he had neurological problems and "horrible" physical pain. Tr. 690. When asked about his current doctors, Mr. D'Angiolini stated that he saw Dr. Vasey about twice a year. Tr. 693.
Dr. Vasey's records confirm that he saw Mr. D'Angiolini about twice a year from 2003 to 2009. Exhibit 133 at 1-15. By the time of the hearing in January 2013, Mr. D'Angiolini's most recent appointment with Dr. Vasey was on June 6, 2012. Tr. 1525; exhibit 196.
The Federal Circuit has made clear that special masters have the responsibility "to assess the reliability of testimony, including expert testimony."
These instructions are the basis for a general evaluation of the witnesses who testified at the January 2013 hearing: Doctors Vasey, Shoenfeld, Lightfoot and Whitton.
Among the people who testified, Dr. Vasey stands in a unique position. He actually treated Mr. D'Angiolini. Mr. D'Angiolini first came to Dr. Vasey in 2000, which is approximately three years after the vaccinations at issue. Since 2000, Dr. Vasey has periodically examined, ordered various tests for, and recommended treatment for Mr. D'Angiolini.
As a treating doctor, Dr. Vasey's opinion warrants very careful consideration.
However, there is a difference between a doctor's opinion regarding diagnosis and a doctor's opinion regarding etiology. Doctors "may testify to both [diagnosis and etiology] but the reliability of one does not guarantee the reliability of the other."
In this case, once the relevant question passes beyond diagnosis to causation, Dr. Vasey's opinion becomes much less strong.
In addition to Dr. Vasey's relative unfamiliarity with the immunologic principles undergirding the theory of molecular mimicry, there is also a question about the information provided to Dr. Vasey. As alluded to earlier, Dr. Vasey was not Mr. D'Angiolini's treating doctor in 1997, when he received the hepatitis B vaccines. Mr. D'Angiolini did not start seeing Dr. Vasey until 2000, and, therefore, Dr. Vasey lacks any first-hand knowledge about Mr. D'Angiolini's health in the months following the vaccinations. Dr. Vasey did not contemporaneously see or evaluate Mr. D'Angiolini for his alleged vaccine-related symptoms and complaints. For this aspect of Mr. D'Angiolini's history, Dr. Vasey must rely upon Mr. D'Angiolini and his mother, who, by this time, were convinced that the hepatitis B vaccine harmed him.
The patient's subjective understanding that a vaccine harmed him is understandable. After all, petitioners in the Vaccine Program have been presumed to file their lawsuits alleging that a vaccine caused them some injury in good faith.
At Mr. D'Angiolini's initial appointment with Dr. Vasey, Mr. D'Angiolini provided a history. Since many of the details are important, it is set out at length.
Exhibit 8 at 1.
Many statements in this history are not in accord with the Findings of Fact, which were based upon contemporaneously created medical records that were not available to Dr. Vasey. To start, Mr. D'Angiolini's description of himself as being in "good health" before the March 1997 vaccination leaves out much. Before the vaccination, he was seeing Dr. Middleman because his OCD was contributing to the breakup of his engagement and he was having headaches for which Dr. Middleman was prescribing medications. On the other hand, Mr. D'Angiolini was in "good health" in the sense that he was working at two jobs and did not have any physical impediments.
Mr. D'Angiolini's headaches are important. In 2000, he told Dr. Vasey that after the first vaccination he "developed promptly some headaches." Actually, both Dr. Middleman's and Dr. Roman's notes show that Mr. D'Angiolini was complaining about and being treated for headaches before the vaccination.
Mr. D'Angiolini also told Dr. Vasey that after the first vaccination he developed "flu-like symptoms [that] persisted over weeks," apparently through the next vaccination in April 1997. Mr. D'Angiolini's recitation that he had "flu-like symptoms" in March or April 1997 was found not to be persuasive in the Findings of Fact.
Thus, the information available to Dr. Vasey in 2000 about Mr. D'Angiolini's health in 1997 was inaccurate. The history suggests a dramatic change from good health to a prompt multi-week persistence of flu-like symptoms. As determined in the Findings of Fact, Mr. D'Angiolini suffered from some problems, such as headaches, before the vaccination and his health did not decline drastically until months later. The differences between Mr. D'Angiolini's health before and after vaccination as found, on the one hand, in the Findings of Fact and, on the other hand, in Mr. D'Angiolini's history to Dr. Vasey in 2000, are significant.
In 2000, based in part on the inaccurate information given to him, Dr. Vasey formed an opinion that Mr. D'Angiolini "suffered an unusual immune mediated reaction to his Hepatitis B vaccine." Dr. Vasey communicated this opinion to the judge presiding over Mr. D'Angiolini's claim for workers' compensation benefits in a letter dated October 12, 2000. In this letter, Dr. Vasey wrote that an adverse reaction to the hepatitis B vaccine was recognized "at the case report level." As such, "well[-]intention[ed] honest physicians could contest my opinion." Dr. Vasey recommended an indefinite postponement of Mr. D'Angiolini's workers' compensation trial because of Mr. D'Angiolini's health and "to allow time for better understanding of the immunology and epidemiology of the vaccine reactions." Exhibit 133 at 23.
Dr. Vasey presented essentially this same opinion in his reports submitted for this litigation. Dr. Vasey's fundamental assumptions about Mr. D'Angiolini's health in 1997 did not change in the ensuing ten years. But, these assumptions were not supported by the Findings of Fact. Consequently, Dr. Vasey's opinion about causation, although well intended, cannot be credited.
Dr. Shoenfeld has a very impressive background in medicine, in general, and in immunology, more specifically. Within the specialty of immunology, Dr. Shoenfeld holds himself out as an auto-immunologist, meaning that he has focused on diseases in which the body's immune system attacks itself. Although the Secretary pointed out that "auto-immunology" is not a recognized sub-specialty in the sense that one could not seek treatment by an autoimmunologist as easily as with a rheumatologist, Tr. 1458-60, there is little doubt that if there were such a specialty, Dr. Shoenfeld would qualify.
Dr. Shoenfeld is listed as a contributing author in more than 1,000 articles appearing in peer-reviewed journals. His knowledge of the literature is encyclopedic. He spontaneously recalled articles reporting studies throughout his testimony. E.g. Tr. 1559.
Dr. Shoenfeld has been writing about the possibility that various vaccines cause autoimmune disease since 1996.
Although Dr. Shoenfeld's knowledge about medical articles was detailed, Dr. Shoenfeld had a much less firm grasp on the medical records about Mr. D'Angiolini. For example, Dr. Shoenfeld was not sure that he reviewed Dr. Middleman's records. Tr. 1474. Dr. Middleman was the psychiatrist who was holding appointments with Mr. D'Angiolini in the six months before vaccination and for approximately a year after his third hepatitis B vaccination. Exhibit 24. As the best source for information about Mr. D'Angiolini's health during this critical time, Dr. Middleman's records are very important and underlie many of the Findings of Fact. As such, Dr. Shoenfeld should have certainly reviewed those records.
Dr. Shoenfeld's testimony suggested that he did not know Mr. D'Angiolini's medical history. Dr. Shoenfeld asserted that Mr. D'Angiolini had a "severe reaction" to the first dose of the hepatitis B vaccine. Exhibit 87 at 3. However, his report did not cite to any records documenting this "severe reaction,"
Dr. Lightfoot graduated from medical school in 1961. He followed that education with more intensive focus on rheumatology. In addition to seeing patients, Dr. Lightfoot maintained an academic career, including many years as a professor at the Medical College of Wisconsin. For approximately one decade, he served as the chief of the rheumatology division for that institution. From Wisconsin, he moved to the University of Kentucky in 1987. There, he was a professor and the division director of allergy, immunology and rheumatology until 2003. Exhibit B at 2.
Consistent with his academic positions, Dr. Lightfoot has written approximately 40 articles appearing in peer-reviewed journals. He has also contributed chapters to books. The subject of most of his publications has been rheumatology. Exhibit B at 14-23.
As a rheumatologist, Dr. Lightfoot has seen many people who either have lupus or were suspected to have lupus. Tr. 1128 (approximately 30 percent of Dr. Lightfoot's 1,000 current patients have lupus). This background makes him well qualified to assess whether Mr. D'Angiolini has lupus. However, Dr. Lightfoot has relatively less experience in treating patients with chronic fatigue syndrome or OCD.
Dr. Lightfoot's background was the subject of intense questioning during voir dire. Mr. D'Angiolini's counsel's questions elicited testimony that Dr. Lightfoot had not studied vaccines or their possible adverse effects. Tr. 1081-90. These admissions led to an argument that Dr. Lightfoot was not qualified to express an opinion on the ultimate question in this case, whether the hepatitis B vaccinations harmed Mr. D'Angiolini.
As Mr. D'Angiolini's counsel recognized, even if the objection to Dr. Lightfoot's qualification to opine about whether the vaccine caused Mr. D'Angiolini a disease were sustained, Dr. Lightfoot would remain qualified to testify about whether Mr. D'Angiolini suffered from a particular disease.
Moreover, Dr. Lightfoot's experience seems to make him more qualified than Dr. Vasey to opine on immunologic topics. After the challenge to Dr. Lightfoot's background arose during voir dire, the Secretary elicited additional testimony. Dr. Lightfoot described how rheumatologists treat patients for diseases that are autoimmune in origin, including lupus. In addition, Dr. Lightfoot stated that he reviewed the articles cited by Dr. Shoenfeld and understood the immunologic concepts involved. Tr. 1121-28. Consequently, when Mr. D'Angiolini's attorney interposed objections to specific questions intending to elicit Dr. Lightfoot's opinion regarding causation, Mr. D'Angiolini's objection was overruled.
Dr. Whitton was born in Scotland and obtained the equivalent of a medical degree in 1979. Five years later, he obtained a Ph.D. after studying herpes virus transcription.
In 1989, he joined the Scripps Research Institute in La Jolla, California. At that institution, he has taught neuropharmacology and immunology. He has acted as the editor of
Dr. Whitton's testimony was relatively short because most of the issues on which he had opined had become moot.
The testimony of Doctors Vasey, Shoenfeld, Lightfoot and Whitton are discussed extensively in the following parts, which are organized by condition for which Mr. D'Angiolini seeks compensation. To restate, he claims a yeast allergy, chronic fatigue syndrome, lupus, and ASIA.
Mr. D'Angiolini's claim about his allergy to yeast has fluctuated throughout this litigation. The ebbs and flows are, therefore, discussed in section A. At the end of the day, because Mr. D'Angiolini is putting forward a claim about yeast allergy, general information about yeast and typical allergic reactions is presented in section B. This foundation is the predicate for the conclusion, found in section C, that Mr. D'Angiolini did not establish that the yeast component in the hepatitis B vaccine caused an allergic reaction.
Dr. Shoenfeld's December 26, 2010 report about Mr. D'Angiolini specifically mentions that Mr. D'Angiolini has an allergy to yeast. Exhibit 87 at 3. This notation means that Dr. Shoenfeld was aware of this "fact." However, Dr. Shoenfeld did not identify yeast as a potential mechanism for an adverse reaction. His report focused on the causative role of the aluminum adjuvant.
Unlike Dr. Shoenfeld who did not rely upon a yeast allergy, Dr. Vasey's initial report found the yeast allergy very important. Dr. Vasey stated that Mr. D'Angiolini "was known to be allergic to yeast." Exhibit 83 at 2 ¶ 4. Dr. Vasey did not identify the basis for this statement. Nevertheless, to Dr. Vasey, "the obvious explanation for Mr. D'Angiolini's reaction is the known yeast sensitivity documented at age 3 years."
When Dr. Lightfoot responded to Dr. Vasey's report and Dr. Shoenfeld's report, Dr. Lightfoot carefully called into question the accuracy of the assertion that Mr. D'Angiolini was allergic to yeast.
Given the uncertainty about Mr. D'Angiolini's alleged yeast allergy, the undersigned sought supplemental information from Mr. D'Angiolini's experts about whether each thought Mr. D'Angiolini was allergic to yeast. Dr. Vasey's response was "I don't know. I would not recommend injecting him with yeast." Exhibit 96 at 2.
Dr. Shoenfeld's response was stronger. He dismissed the yeast allergy. He wrote:
Exhibit 97 at 1.
It appeared that these submissions put the alleged yeast allergy to rest. One of petitioner's experts, Dr. Vasey, stated that he did not know whether Mr. D'Angiolini was allergic to yeast. The other of petitioner's experts, Dr. Shoenfeld, stated that any yeast allergy "is not important." Mr. D'Angiolini seemed to agree with the view that the yeast allergy was not relevant. His initial pre-hearing brief, filed on January 5, 2012, did not use the term "yeast" at all.
Mr. D'Angiolini's submission of Dr. Buttram's report on January 6, 2012, brought the yeast allergy to the surface again. In reciting Mr. D'Angiolini's relevant medical history, Dr. Buttram referenced cytotoxic testing, exhibit 153 at 10, and a December 1, 2010 anti-saccharomyces cerevisiae antibody ("ASCA") test,
My diagnoses in the case of Joseph D'Angiolini were:
Id. at 29.
At this point, Mr. D'Angiolini's experts were not consistent. Mr. D'Angiolini's alleged yeast allergy was not significant to Dr. Shoenfeld and Dr. Vasey. But, the yeast allergy was the causative mechanism for Dr. Buttram. Mr. D'Angiolini's own position was not clear. Although Mr. D'Angiolini's attorney had filed Dr. Buttram's report at the request of his client and Ms. D'Angiolini, Mr. D'Angiolini's attorney did not discuss yeast allergy in his Supplemental Prehearing Brief, filed on June 4, 2012.
During the January 3, 2013 pre-trial conference, the undersigned inquired about the yeast allergy. Mr. D'Angiolini's attorney intended to call Dr. Buttram, whose opinion relied upon the yeast allergy. In light of this representation, the undersigned filed, on January 9, 2013, two articles related to yeast allergy. Court exhibits 1004 and 1005.
Before Dr. Buttram testified, Mr. D'Angiolini called Dr. Shoenfeld. Dr. Shoenfeld's view was that yeast is one of four vaccine components that may trigger ASIA. Tr. 770-78, 803, 823. In support of his view, Dr. Shoenfeld cited a recently published article. Exhibit 197 (Maurizio Rinaldi et al.,
This explanation is confusing. Mr. D'Angiolini's alleged yeast allergy was a potential issue throughout the case. In March 2005, Mr. D'Angiolini indicated that because yeast is a component of the hepatitis B vaccine, an allergy to yeast may play a potential role in vaccine-caused CFS. Pet'r's Status Rep't, filed Mar. 14, 2005, at 4. The alleged allergy was mentioned in the Findings of Fact. Dr. Shoenfeld mentioned Mr. D'Angiolini's yeast allergy in his October 12, 2010 report. Exhibit 84. Dr. Shoenfeld, subsequently, stated that Mr. D'Angiolini's chronic fatigue syndrome was "not due [to] yeast allergy, but due to adjuvant effect." Exhibit 97 at 1. After this direct statement from Dr. Shoenfeld that the yeast allergy does not affect his opinion, it seems surprising that a special master's order would provoke additional reflection from Dr. Shoenfeld, given his decades of experience in immunology.
In any event, Dr. Shoenfeld's testimony was provided. Despite the ongoing dispute documented in the experts' supplemental reports and testimony, Mr. D'Angiolini's posthearing briefs do not discuss the validity of his yeast allergy claim.
The process of manufacturing the hepatitis B vaccine involves yeast. Genes from the hepatitis B virus that encode the hepatitis B surface antigen are inserted into common baker's yeast. The growth of the baker's yeast, also known as
However, "[a]s a result of biochemical and biophysical purification, there is no detectible yeast DNA and only trace amounts of yeast proteins (1-5%) in the final vaccine products." Exhibit 1005 (DiMiceli) at 703;
When people who are allergic to yeast encounter yeast, they most likely react within two days. Tr. 943 (Dr. Shoenfeld);
The best way to determine whether someone is allergic to yeast is to test the person with a reliable test. Mr. D'Angiolini has not identified any reliable test demonstrating an allergy to yeast.
Alternatively, a yeast allergy could be suspected, if not confirmed, by experience.
Mr. D'Angiolini first suspected he was allergic to yeast when he was 10 years old and visiting Walt Disney World with his family. He ate a slice of pizza and vomited. From this episode, he concluded that he was allergic to yeast. Tr. 154;
However, when Mr. D'Angiolini was asked about his relevant medical history in the course of seeking treatment, he did not include yeast on those forms. He did list other allergens, such as penicillin and sulfa. Exhibit 17 at 121-22 (letter dated Sept. 13, 1998); exhibit 22 at pdf 4 (notes dated Nov. 17, 1998); exhibit 14 at 29 (questionnaire dated Oct. 6, 1999).
After Mr. D'Angiolini began pursuing compensation for his hepatitis B vaccination (either through a claim for workers' compensation or for Vaccine Program benefits), he began listing yeast among his allergies in histories provided to treating doctors.
No persuasive evidence establishes that Mr. D'Angiolini suffered an adverse reaction to the yeast component in the hepatitis B vaccine. As discussed above, any allergic reaction to yeast would be apparent within approximately a few days of exposure. However, the evidence in this case does not persuasively establish that Mr. D'Angiolini was in ill health in the days immediately following any dose of the hepatitis B vaccine. As discussed in the context of the Findings of Fact, the parties disputed Mr. D'Angiolini's condition after vaccinations. Much of Mr. D'Angiolini's testimony was not credited because it was in either direct or indirect conflict with medical records created contemporaneously. In addition, even Mr. D'Angiolini did not claim that he had an immediate reaction.
For these reasons, the record does not support a finding that Mr. D'Angiolini reacted adversely to the hepatitis B vaccine because of a yeast allergy. Therefore, to be entitled to compensation, Mr. D'Angiolini will need to pursue other avenues.
While the alleged yeast allergy was sometimes a less prominent part of Mr. D'Angiolini's case, his allegation that the hepatitis B vaccine caused him to suffer chronic fatigue syndrome has always been front and center. In 2004, Mr. D'Angiolini's attorney was promoting this case as the lead case about hepatitis B vaccine and chronic fatigue syndrome, although other cases involving the hepatitis B vaccine and chronic fatigue syndrome have proceeded separately. Mr. D'Angiolini and the Secretary presented extensive evidence about chronic fatigue syndrome.
The evidence relates to the following topics. First, there is information about what chronic fatigue syndrome is.
In the phrase "chronic fatigue syndrome," each term contributes to the meaning of the phrase. "Chronic" is defined as "persisting over a long period of time."
Although reports of conditions resembling chronic fatigue syndrome date back many years, chronic fatigue syndrome became more widely known in the 1980s. Tr. 947-49. Many of the articles about chronic fatigue syndrome were published in that decade.
How many people are afflicted with CFS is a matter of some dispute. One study reported that the prevalence of CFS is between 0.4 and 2.0 per cent.
A preliminary question is whether CFS is an appropriate diagnosis for Mr. D'Angiolini. One aspect of his case is to establish, by a preponderance of the evidence, that he actually suffers from a condition that he alleges was caused by a vaccine.
When doctors diagnose a disease, the doctor evaluates the person's signs and symptoms and compares them to the diagnostic criteria. Doctors involved in Mr. D'Angiolini's care have gone through this process with Mr. D'Angiolini and reached inconsistent conclusions. Similarly, the doctors retained in this litigation have also come to different conclusions with respect to Mr. D'Angiolini's diagnosis. Dr. Shoenfeld has opined that Mr. D'Angiolini suffers from CFS. Exhibit 97 at 3; Tr. 801, 828-29. In contrast, Dr. Lightfoot has opined that depression is a better diagnosis. Exhibit A at 14-15, 18; Tr. 1162.
Diagnostic criteria help researchers understand a condition by promoting uniform case definition and case assessment. Without this common understanding, researchers in different disciplines may use different nomenclature, hindering progress in understanding the disease. This was certainly the case for chronic fatigue syndrome, which was given many different names. Exhibit 34 (M.C. Sharpe et al.,
By 1988, researchers proposed the name "chronic fatigue syndrome." These same researchers attempted to define the condition, but their "definition proved to be unsatisfactory in practice."
In 1994, an international chronic fatigue study group authored "a set of research guidelines for use in studies of the chronic fatigue syndrome." Exhibit U (Keiji Fukuda et al.,
The Fukuda criteria include both inclusionary and exclusionary factors (attached hereto as "Appendix A"). First, the person must suffer from "chronic fatigue," meaning "self-reported persistent or relapsing fatigue lasting 6 or more consecutive months." Exhibit U (Fukuda) at 954. This fatigue must be severe enough to cause a "substantial reduction in previous levels of occupational, educational, social, or personal activities."
The subjective and self-reported nature of the fatigue continues to make diagnosing CFS a challenge for doctors. Dr. Shoenfeld explained that there is no laboratory test to diagnose CFS and that it is "very difficult to diagnose chronic fatigue syndrome." Tr. 811.
Chronic fatigue, by itself, does not satisfy the diagnostic criteria for CFS. The person must also have "four or more of the following symptoms . . . concurrently present for ≥6 months: 1) impaired memory or concentration, 2) sore throat, 3) tender cervical or axillary lymph nodes, 4) muscle pain, 5) multi-joint pain, 6) new headaches, 7) unrefreshing sleep, and 8) post-exertion malaise." Exhibit U (Fukuda) at 955. The inclusion of these ancillary features "generated the most disagreement" among the study group. The authors added that the controversy over the ancillary symptoms "underscores the need to establish specific features of the chronic fatigue syndrome and the validity of any chronic fatigue syndrome case definition."
When presented with chronic fatigue, the doctor was expected to evaluate the patient for "underlying or contributing conditions." Exhibit U (Fukuda) at 954. For example, the doctor will test a person's thyroid to see if it is underactive because an underactive thyroid can cause fatigue. If the person suffers from hypothyroidism, the doctor treats it. This patient, although suffering from chronic fatigue, would not fit the diagnostic criteria for CFS. Tr. 1158. Another example is chronic fatigue due to cancer. Tr. 862.
The more challenging question — and the one that is more germane to Mr. D'Angiolini's case — is depression. "It is difficult to interpret symptoms typical of the CFS in the setting of illnesses such as major psychotic depression." Exhibit U (Fukuda) at 957. Depression can make people feel fatigued. Tr. 1346. The Fukuda criteria tried to eliminate people with depression from the group of people satisfying the diagnostic criteria for CFS. Tr. 1161. Fukuda wrote that evaluating doctors should obtain a history that, among other things, "covers medical and psychosocial circumstances at the onset of fatigue [as well as] depression or other psychiatric disorders." The doctor should examine the patient's mental status with "[p]articular attention . . . directed toward current symptoms of depression or anxiety.... Evidence of a psychiatric or neurologic disorder requires that an appropriate psychiatric, psychological, or neurological evaluation be done." Exhibit U (Fukuda) at 954.
In the Fukuda criteria, "[a]ny past or current diagnosis of major depressive disorder with psychotic or melancholic features" "exclude[s] a patient from the diagnosis of unexplained chronic fatigue."
Dr. Lightfoot explained that separating the group of people with depression from the group of people with chronic fatigue syndrome is very difficult. Dr. Lightfoot pointed out that the common, at least partially successful, treatments for CFS are antidepressant medications. Tr. 1345-47.
Dr. Shoenfeld appears to share Dr. Lightfoot's view. Dr. Shoenfeld was listed as a co-author of a paper stating "some of the [Fukuda] criteria are difficult to interpret and opinions differ regarding the classification of chronic fatigue cases with a history of psychiatric illnesses." Exhibit 186 (Nicola Bassi et al.,
As set out above, the CFS criteria include two affirmative aspects, which are chronic fatigue and a mix of ancillary symptoms. Due to the prominence of fatigue in the diagnosis, Mr. D'Angiolini's symptoms relating to chronic fatigue are presented by themselves in section a below. The eight potential ancillary symptoms are collectively discussed in section b.
Determining whether Mr. D'Angiolini was sufficiently fatigued to meet this aspect of the CFS criteria involves two challenging factors. First, there is the definition of fatigue. Dr. Shoenfeld and Dr. Lightfoot consistently discussed that the fatigue involved in CFS is a fatigue so severe that, in Dr. Shoenfeld's analogy, a mother could not rise from bed to take her kindergartener to school. Tr. 753. The fatigue that most people experience from life's typical activities does not qualify as the fatigue present in chronic fatigue syndrome.
Second, there is the challenge in figuring out what symptoms Mr. D'Angiolini experienced approximately 15 years ago. As discussed in the Findings of Fact, in October 1996, Mr. D'Angiolini "did not have any problems with being fatigued." The Findings of Fact mention places in the medical records where Mr. D'Angiolini is described as having problems with sleep, drinking coffee, and reporting tiredness. For example, on March 24, 1997, Mr. D'Angiolini told Dr. Middleman that he was sleeping 15 hours a day. Exhibit 24 at 10. When this record was called to Dr. Shoenfeld's attention, Dr. Shoenfeld stated this episode was not the start of Mr. D'Angiolini's CFS because it "was one event." Tr. 974;
Around this time when Mr. D'Angiolini reported he slept for 15 hours in one day, he was working two jobs. He was maintaining his job as a mental health technician at Valley Forge Medical Center and Hospital and his evaluation from this time indicated that he was performing very well. Exhibit 16 at 31-32.
Mr. D'Angiolini's employment history solves both challenges listed above. First, Fukuda defined the fatigue in CFS as one debilitating enough to cause a "substantial reduction in previous levels of occupational, educational, social, or personal activities." Exhibit U (Fukuda) at 956. In line with this limitation, Dr. Shoenfeld listed not going to work and not playing music as factors contributing to Mr. D'Angiolini's diagnosis for chronic fatigue syndrome. Tr. 848-49;
Second, unlike the accuracy of a psychiatrist's record, which depends largely on the historian's ability to recall what has happened, Mr. D'Angiolini's employment records are objective. These records show that Mr. D'Angiolini worked at both Valley Forge Medical Center and the music store until November 5, 1997. Findings of Fact at 33, citing exhibit 51 at pdf 18 (June 7, 2001 W.C. Trial Tr. 6); exhibit 53 ¶ 11; exhibit 16 at 311.
Consequently, the sudden reduction of Mr. D'Angiolini's employment occurred at the beginning of November 1997. The reason for the decrease in activities is not entirely clear. Dr. Middleman's notes from November 5, 1997, mention sporadic suicidal feelings for four months, visits with prostitutes, not taking care of his apartment, and not changing his clothes. Her notes do not mention any problem with fatigue, tiredness, or lethargy. Exhibit 24 at 13.
The next day, Mr. D'Angiolini's mother brought him to her physician, Dr. Bray. Dr. Bray's entry for this day, which is typed, states that Mr. D'Angiolini complained about "extreme fear, . . . chest pain, [shortness of breath], palpitations, [and] dizziness." Dr. Bray diagnosed Mr. D'Angiolini as suffering from "Severe Depression" and prescribed amitriptyline and Valium. Exhibit 61. Again, Dr. Bray's notes, which appear to be created contemporaneously with the appointment, do not indicate that Mr. D'Angiolini was complaining about fatigue, etc.
Another confounding piece of evidence regarding Mr. D'Angiolini's fatigue is a report from April 1998, when Mr. D'Angiolini went to a local emergency room for a long duration headache with occasional nausea, photophobia, and chest pain. Exhibit 15 at 12. He informed his doctors that he was "active" and "runs."
These factors make determining when Mr. D'Angiolini started having severe fatigue difficult. Dr. Shoenfeld's testimony about playing basketball is tantamount to a concession that Mr. D'Angiolini was not suffering chronic fatigue (let alone chronic fatigue syndrome) in April 1998.
On October 10, 1998, Mr. D'Angiolini saw Gregory Bach, whose letterhead states that he is board certified in family medicine and addiction medicine. Exhibit 5 at 21. Dr. Bach's handwritten notes, which are difficult to decipher, indicate that Mr. D'Angiolini's chief complaints included "sweats, [weight] gain, heart palpitations, twitching, headache, neck stiffness, light sensitivity, light head, confusion, [difficulty with] speech, mood swings, depression." Dr. Bach's impressions included: "1. Fibromyalgia, 2. Chronic fatig. 3. Myopathy."
Dr. Shoenfeld made two inferences from Dr. Bach's recitation of "chronic fatig." First, Dr. Shoenfeld understood that the chronic fatigue must have been present for at least several months. If the fatigue had a shorter duration, the doctor would have said "tiredness of one or two days." Tr. 842. Second, in Dr. Shoenfeld's opinion, Dr. Bach's use of "fatig." is an abbreviation for chronic fatigue syndrome. Tr. 852-53.
Following the visit with Dr. Bach, Mr. D'Angiolini went to the Penn Center for Healing, where Dr. Anne Norris saw him. His chief complaint was "fatigue." The history Dr. Norris obtained recounts that Mr. D'Angiolini had "sudden onset fatigue" in late June 1997. Her record indicates that Mr. D'Angiolini has "been out of work for a year [secondary to] fatigue."
On November 10, 1998, Dr. Roman saw Mr. D'Angiolini at the East Norriton Family Practice. Mr. D'Angiolini was complaining about fatigue. Exhibit 23 at 32;
One of the doctors to whom Dr. Roman referred Mr. D'Angiolini was a cardiologist, Dr. Weber. Mr. D'Angiolini told Dr. Weber that, for one year, he was having "dyspnea on exertion when he is doing a strenuous exercise such as heavy lifting or walking while carrying a heavy parcel." Exhibit 6 at 17 (record dated Nov. 13, 1998). This report implies that Mr. D'Angiolini was exercising, meaning that it is unlikely that he was having the fatigue associated with chronic fatigue syndrome. Dr. Weber's record does not mention fatigue.
As previously stated, the Fukuda guidelines list eight other problems of which four are necessary to establish a diagnosis of CFS. Fukuda qualifies this general list of problems in two respects. The first limitation is that all of the symptoms "must have persisted or recurred during 6 or more consecutive months of illness." Exhibit U (Fukuda) at 954. The second qualification is that the symptoms "must not have predated the fatigue."
Mr. D'Angiolini identified ten records listing memory or concentration as a problem. Pet'r's Suppl. Prehr'g Br. at 3-4. The earliest of these records was created on October 6, 1999. Exhibit 14 at 21-22.
The Secretary asserts that Mr. D'Angiolini began seeing Dr. Middleman before the vaccinations for various problems, including "problems with his memory." Resp't's Posthr'g Br. at 2, citing Findings of Fact 17-22 and exhibit 24 at 5-8.
Mr. D'Angiolini has identified more than 10 medical records that, in his view, indicate that he suffered from post-exertional malaise. Pet'r's Suppl. Br., tab B, at 2. Although Mr. D'Angiolini cited the November 10, 1998 visit with Dr. Roman during which Mr. D'Angiolini complained about fatigue, Dr. Roman's notes do not indicate a problem with post-exertional malaise.
About one year later, which is after Mr. D'Angiolini began seeking compensation in the Workers' Compensation proceeding and in the Vaccine Program, he reported to doctors problems with fatigue after exertion.
Reports of unrefreshing sleep appear throughout Mr. D'Angiolini's medical records. On three occasions in February 1999, which is before he received the first dose of the hepatitis B vaccine, Mr. D'Angiolini told Dr. Middleman about problems with his sleeping. Exhibit 24 at 9-10.
He also told Dr. Middleman about problems with sleeping after the vaccinations. Exhibit 24 at 10-15. When Mr. D'Angiolini saw Dr. Roman in November 1998, he reported lengthy sleeping since summer 1997. Exhibit 23 at 32.
On May 22, 1997, Mr. D'Angiolini told Dr. Middleman that he was having "body aches." Exhibit 24 at 11; Tr. 30. This may have been an isolated instance as Dr. Middleman's records do not report more complaints of muscle pain.
More frequent reports of muscle pain start toward the end of 1999. On October 6, 1999, Mr. D'Angiolini's chief complaint to Dr. Buttram included "constant joint and muscle pain." Exhibit 36 at 15. Dr. Bray listed "aches and pains" in his November 30, 1999 letter. Dr. Waisbren's December 13, 1999 letter mentioned, among other problems, "muscle pains." Exhibit 21 at 9.
The reports about muscle pain from 1999 overlap with reports of joint pain.
As discussed in the Findings of Fact, Mr. D'Angiolini had headaches before his vaccination. His psychiatrist, Dr. Middleman, was prescribing medications to help with his headaches.
Mr. D'Angiolini also experienced headaches after vaccination. See exhibit 23 at 32. However, Mr. D'Angiolini has not persuasively established that the headaches were of a new type or severity.
For this feature Mr. D'Angiolini identified only records from his October 6, 1999 visit with Dr. Buttram. Pet'r's Suppl. Prehr'g Br., tab B, at 3. The list of chief complaints included "intermittent sore throat." Exhibit 14 at 22. Dr. Buttram's handwritten notes repeat this problem. Exhibit 36 at 18.
These records appear isolated. For the December 9, 1999 visit with Dr. Waisbren, there is a no check for sore throat. Exhibit 20 at 21. Dr. Bray's November 30, 1999 letter does not include sore throat.
Like the sore throat symptom just discussed, the only references cited by Mr. D'Angiolini come from the October 6, 1999 visit with Dr. Buttram. Again, these mentions stand in isolation. Dr. Waisbren did not find any problem with Mr. D'Angiolini's lymph nodes. Exhibit 20 at 23. When Mr. D'Angiolini visited the Cleveland Clinic in 2004, Dr. Gorensek found "no significant adenopathy." Exhibit 37 at 22.
Mr. D'Angiolini's assertion that he has CFS suffers from many shortcomings. Primarily, there is a problem determining when his fatigue began. The lack of clarity on this point is a significant flaw because CFS is a disease about fatigue.
Mr. D'Angiolini occasionally linked his abrupt cessation of employment in early November 1997, to fatigue. However, when Mr. D'Angiolini saw doctors in November and December 1997, he described other problems but not fatigue. Furthermore, his running in April 1998, as reflected in the visit to the emergency room, shows that he was capable of sustained physical exercise. Exhibit 15 at 12.
Mr. D'Angiolini's ability to exercise further complicates the assessment of medical records created in the latter half of 1998, when he saw Doctors Bach, Roman, Norris, and Weber. While Mr. D'Angiolini sometimes reported he was having fatigue, he also reported that the fatigue (or shortness of breath) was associated with strenuous activities. Among these doctors, Dr. Norris appears to have been especially solicitous about the possibility that Mr. D'Angiolini suffered from CFS because her notes present information about not only Mr. D'Angiolini's fatigue but also the ancillary symptoms associated with CFS. Her conclusion that Mr. D'Angiolini was not suffering from CFS, therefore, is very valuable.
If Mr. D'Angiolini were given the benefit of the doubt that his chronic fatigue began in July 1998, he would still need to establish that he suffered from four of eight ancillary symptoms to meet the criteria for CFS.
The lack of corroborating ancillary symptoms is significant because not all cases of "chronic fatigue" qualify as "chronic fatigue syndrome." See Lombardi, 656 F.3d 1354 (finding special master was not arbitrary in rejecting petitioner's claim that she suffered from chronic fatigue syndrome). Dr. Shoenfeld recognized the challenges in fulfilling the actual diagnostic criteria for chronic fatigue syndrome when he, as a co-author, wrote "only about 1% of patients who are given the diagnosis in primary care settings meet the criteria for CFS." Exhibit 186 (Bassi) at 79.
Finally, because Mr. D'Angiolini has not persuasively demonstrated that he fits the affirmative portion of the CFS diagnostic criteria, examining the relevant exclusionary factors is not needed. This aspect would be particularly challenging because the Fukuda article distinguishes between "major depressive disorders," and "nonpsychotic or nonmelancholic depression." The former exclude the diagnosis of CFS while the latter permits the diagnosis. Exhibit U (Fukuda) at 955-56. Whether Dr. Lightfoot, who is a rheumatologist, possesses the requisite experience to opine on which side of this line Mr. D'Angiolini falls is quite uncertain.
Mr. D'Angiolini's failure to present preponderant evidence that he suffers from CFS precludes an award of compensation based upon this disease.
If Mr. D'Angiolini had established that he suffered from CFS, his burden would be to show that the hepatitis B vaccines were the cause in fact of his CFS. The Federal Circuit set forth the elements of a causation-in-fact case in
Each of the three prongs of
The first prong of
In his testimony, Dr. Shoenfeld stated that cases of CFS have developed after an infection. Tr. 728. That testimony is accord with Dr. Shoenfeld's November 30, 2005 report. There, he listed several viruses (the Epstein-Barr virus, cytomegalovirus, HHV-6, enterovirus, parvovirus) and several bacteria (mycoplasma, Borrelia, C. pneumonia) as "pathogens known to be involved" in causing CFS. Exhibit 31 at 6. During his testimony, when he was asked about these infectious agents, Dr. Shoenfeld stated he still thinks that the Epstein-Barr virus causes CFS. However, for the remaining items on the list (except possibly the parvovirus), Dr. Shoenfeld averred that they were only "claimed in the literature." Dr. Shoenfeld stated that for these other infectious agents, there was "no stringent evidence," "no epidemiological studies and definitely no[] experimental models." Tr. 960. Dr. Shoenfeld commented that the suggestion that enterovirus causes CFS was offered "when you didn't know what happens." Tr. 959.
Into this mix of potential causative factors, Dr. Shoenfeld added the hepatitis B vaccine. Exhibit 31 at 7; exhibit 87 at 6. At hearing, Dr. Shoenfeld advanced a theory in which the adjuvant in the vaccine (alum) is deposited into the muscles.
For the opinion that aluminum may stay in the muscles into which the vaccine is administered, Dr. Shoenfeld has support. The articles from France about macrophagic myofasciitis indicate that muscle biopsies have shown the presence of aluminum years after vaccination.
Here, the evidence is much more sparse. None of the experts discussed any articles reporting the symptoms of people with macrophagic myofasciitis.
In addition to opining that aluminum in muscles causes chronic fatigue, Dr. Shoenfeld also stated that the aluminum leaves the muscles and is diffused, via the blood, to the brain. In the brain, the aluminum impairs the neurologic functions. Exhibit 97 at 3; Tr. 767. Early in Dr. Shoenfeld's testimony, he stated that he did not have any evidence that the aluminum actually reaches the brain. It was "conceivable." Tr. 768.
Later, Dr. Shoenfeld was presented with a paper, which he had cited in his reports, that "support[s] everything" that Dr. Shoenfeld had said earlier. Tr. 1009, discussing exhibit 107 (K. Redhead et al.,"
Dr. Lightfoot was skeptical about the proposition that aluminum is deposited into the brain. Dr. Lightfoot explained that aluminum, like other minerals, circulates in the bloodstream and part of this passage takes place in the brain. Tr. 1184, 1375-76. Dr. Lightfoot asserted that no one has shown that aluminum "deposits in the brain and inflames the brain." Tr. 1184;
To counter Dr. Shoenfeld's theory that the hepatitis B vaccine can cause CFS, Dr. Lightfoot cited an article from Canada. Exhibit A at 20 (reference 15). In this report, the researchers obtained information about people who reported that they experienced chronic fatigue after receiving a hepatitis B vaccination. The researchers identified 30 people who fit the standard definition for CFS, including the lack of an alternative explanation for the fatigue. Most people reported that their chronic fatigue began within three months of their vaccination.
The researchers found that "there was no evidence linking hepatitis B administration and the appearance of CFS." Exhibit Q (Gilles Delage et al.,
Dr. Lightfoot's testimony on direct examination about this article was less than one page. In short, he stated that the researchers looked for an association between the hepatitis B vaccine and CFS and did not find one. Tr. 1168. Dr. Lightfoot later opined that this work was analogous to reports that the Institute of Medicine creates. Tr. 1403-05.
On the other hand, Dr. Shoenfeld was very critical of the article. He pointed out that the Canadian researchers did not conduct an experiment, meaning they did not inject animals with a vaccine to see what happens. In addition, he suggested that the authors, whose names he did not know, may have reported the results inaccurately because the authors were influenced by either monetary concerns or a fear of reducing the rate of vaccination. Tr. 871-72.
Dr. Shoenfeld's criticisms miss their mark. The attack on the integrity of the researchers lacked any basis. Moreover, the Canadian researchers compared the incidence of people who received the hepatitis B vaccine and, thereafter, developed chronic fatigue syndrome with the incidence of people who received the hepatitis B vaccine but did not develop CFS. Dr. Shoenfeld did not opine that this method of study was not a legitimate basis for conducting an epidemiologic study. Although the Canadian researchers did not experiment on animals, animal studies are not the only method useful in investigating causal relationships.
The evidence surrounding Dr. Shoenfeld's theory that an adjuvant can cause CFS does not support finding the theory reliable. The starting point is that there is no medical knowledge of the cause or causes of CFS. Factors that Dr. Shoenfeld identified as "known" to be associated with CFS in 2005, are no longer accepted. Dr. Shoenfeld's adjuvant theory may turn out to be another example, to use his words, of "theories [proposed] when you didn't know what happened." Tr. 959.
Dr. Shoenfeld's adjuvant theory may have some biologic plausibility in that the macrophagic myofasciitis studies present some basis for finding that aluminum from a vaccine may persist in the muscle. However, the persistence of aluminum does not persuasively explain why the person would suffer chronic fatigue (let alone the ancillary symptoms, such as a loss of memory or headaches). Dr. Shoenfeld's assertion that the aluminum also goes to the brain is not reliable. Dr. Lightfoot's opinion that the aluminum from a vaccine would not (or maybe could not) enter the brain in levels that are physiologically relevant was more persuasive than Dr. Shoenfeld's opinion that it might. This aspect of Dr. Shoenfeld's theory seems particularly lacking in reliable support.
Finally, the Canadian epidemiological study further undermines the conclusion that the hepatitis B vaccine can cause CFS, regardless of the mechanism involved. This study, while not perfect, found that the hepatitis B vaccine was not associated with causing CFS.
For all these reasons, Mr. D'Angiolini has not met his burden of establishing the persuasiveness of Dr. Shoenfeld's theory.
If Mr. D'Angiolini suffered from CFS and if there were a reliable theory to explain how the hepatitis B vaccine can cause CFS, the next step would be to determine the amount of time that is medically appropriate to infer causation.
Part of a petitioner's burden is to present "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."
Dr. Shoenfeld's estimates were essentially boundless. In his report, Dr. Shoenfeld stated "in the past, to show a cause and effect of vaccine autoinflammatory reaction, we assumed that the period of time between the vaccine and the reaction has to be somewhere between 3 weeks . . . to 3 months." Exhibit 87 at 7. Based upon his continued work, including his work on ASIA (discussed below), Dr. Shoenfeld stated that "the period may extend to months and even years, [during when] the adjuvant, loaded into the body, chronically stimulate[s] the immune system."
At the hearing, Dr. Shoenfeld confirmed his written opinion. When asked during cross-examination about the expected timeframe in which symptoms would be manifest, Dr. Shoenfeld responded "The timeframe is variable. It can cause it in weeks['] time. It can cause it in months['] time.... It depends on the number of vaccine[s], . . . and it will depend also on the [recipient's] genetic background." Tr. 875-76. Later, Dr. Shoenfeld opined that "[t]here is no maximum time." Tr. 880.
Dr. Shoenfeld's opinion that any amount of time is medically appropriate may reflect different perspectives from law and medicine.
If Mr. D'Angiolini had established an interval that was medically appropriate, then he would also need to present preponderant evidence that his CFS arose within this timeframe.
As described at length above, Mr. D'Angiolini did not prove, by a preponderance of the evidence, that he ever suffered from CFS. Thus, trying to determine when his CFS began is a counterfactual exercise.
It is true, as Dr. Shoenfeld explained, that the diagnosis of CFS is retrospective in that the symptoms of CFS must persist for at least six months. Thus, at least six months will necessarily elapse before the diagnosis can be made. Tr. 875-79. Nevertheless, with the benefit of a retrospective review of the facts and medical records, the expert should be able to opine when the CFS began.
Dr. Shoenfeld, however, had difficulties saying when Mr. D'Angiolini's CFS began. On direct examination, he stated only that the symptoms arose in a medically appropriate timeframe without offering any specific information about when the symptoms arose, other than saying they arose after the vaccinations. Tr. 812-13. At another point in his testimony, Dr. Shoenfeld stated that he recalled that Mr. D'Angiolini's chronic fatigue started to cause a substantial reduction in his life's activities "definitely after the vaccines," and maybe after the second vaccine, specifically. Tr. 961. This testimony is consistent with the opinion Dr. Shoenfeld presented in his May 30, 2011 report that Mr. D'Angiolini's "CFS is due to the [hepatitis B] vaccine given to him on 3/18/97 and 4/[18]/97." Exhibit 95 at 3.
The problem is that the facts of Mr. D'Angiolini's case do not match Dr. Shoenfeld's opinion. After the second vaccination, which was on April 18, 1997, Mr. D'Angiolini did not reduce his activities due to chronic fatigue. For example, he continued to work at two jobs. Exhibit 16 at 263 (Valley Forge); 305-07 (Bachman's Music Store);
Although Mr. D'Angiolini's initial brief cited the portion of Dr. Shoenfeld's testimony that the CFS possibly began after the second vaccination, Pet'r's Posthr'g Br. at 9, citing Tr. 961;
Mr. D'Angiolini's case that he was suffering from chronic fatigue (if not CFS) is stronger if he were to claim that the fatigue began in approximately August 1998. This argument, which Mr. D'Angiolini has not advanced, would have the advantage of being after Mr. D'Angiolini told a doctor that he was running for exercise. Exhibit 15 at 12;
An August 1998 onset — which is assumed for argument's sake — still presents problems for Mr. D'Angiolini's case. If Mr. D'Angiolini began suffering from chronic fatigue, which was a manifestation of CFS, in August 1998, then approximately ten months would have elapsed after his most recent hepatitis B vaccination, which was on October 24, 1997. An onset of ten months exceeds the amount of time usually presented as a medically appropriate interval. Only Dr. Shoenfeld's boundless timeframe would encompass a ten-month interval.
By now, it should be clear that Mr. D'Angiolini cannot establish "a logical sequence of cause and effect," as set forth in
This finding is reached despite some contrary evidence from Mr. D'Angiolini's treating doctors.
The Secretary argues that these statements are not persuasive. "With respect to treating physician statements, no treating doctor ascribed causation to the hepatitis B vaccine prior to August, 1999. This is significant because it was around this time that either petitioner or his mother `learned that some people believed that the hepatitis B vaccine can cause adverse effects similar to problems experienced by [petitioner].'" Resp't's Prehr'g Br. at 18, quoting Findings of Fact at 37. The Secretary points out that "[r]ecords dated after this point are notably absent of any mention of any of petitioner's pre-vaccination problems, and often reflect that he was in good or excellent health."
Mr. D'Angiolini does little to rebut this argument. The histories presented to Dr. Buttram, Dr. Waisbren, and Dr. Vasey present a stark contrast between Mr. D'Angiolini's health before and after vaccination.
As determined in the Findings of Fact, Mr. D'Angiolini's history from January through November 1997, was complicated. He functioned well enough to work two jobs. Yet, he was also experiencing a worsening of his long-standing OCD requiring prescription medications. And, when Mr. D'Angiolini had a precipitous decline in November 1997, the contemporaneously created records do not say that he experienced fatigue. Consequently, the histories provided to Doctors Buttram, Waisbren and Vasey are not a sound basis for deriving a persuasive medical opinion.
Mr. D'Angiolini is not entitled to compensation on his claim that the hepatitis B vaccination caused him to suffer chronic fatigue syndrome. He has not established that he suffered from chronic fatigue syndrome. He also has not established that there is proximate causal relationship between the hepatitis B vaccine and chronic fatigue syndrome.
Lupus is an autoimmune disease that affects many organs. Tr. 1128. The American College of Rheumatologists issued a set of criteria for classifying lupus in 1982. Tr. 896. Because the lead author of the article announcing these criteria was Eng Tan, the criteria are sometimes known as the Tan criteria. Exhibit T (Eng M. Tan et al.,
As explained earlier,
The evidence relevant to Mr. D'Angiolini's claim that he suffers from lupus comes from a variety of sources, reflecting the extensive medical attention given to him. The primary source is Dr. Vasey, a rheumatologist who has treated him since 2000. Dr. Vasey stated that Mr. D'Angiolini does not have lupus.
When the question is what diagnosis best captures the disease affecting the petitioner, a treating doctor stands in a knowledgeable position. The treating doctor can see, touch, and listen to the patient. This first-hand information may provide insights to the patient's problems that are unavailable to a doctor who is reviewing only medical records. Hence, the views of the treating doctors are entitled to careful consideration when it comes to diagnosis.
While potentially influential, the opinions of treating doctors are not always controlling. The Vaccine Act specifies that special masters are not bound by the diagnosis of a treating doctor.
This case illustrates why a treating doctor's diagnosis cannot bind a special master. Here, as discussed below, the treating doctors reach opposite conclusions. Some doctors have indicated (or suggested) that Mr. D'Angiolini suffers from lupus. Another doctor, Dr. Vasey, has stated that Mr. D'Angiolini does not suffer from lupus. It seems quite unlikely that both positions can be correct. When the evidence is in conflict, the special master may determine what evidence is more persuasive.
Dr. Vasey's opinion regarding diagnosis is more persuasive. Three reasons support the strength of Dr. Vasey in this regard. First, Dr. Vasey is a rheumatologist. He regularly treats people with lupus. Tr. 1568. Second, Dr. Vasey saw Mr. D'Angiolini over an extended duration, more than a decade. The combination of these two factors means that Dr. Vasey has both the ability to diagnose lupus and the opportunity to do so. As explained below, the treating doctors who support the lupus diagnosis seem to be comparatively weaker. Finally (but less importantly), Dr. Vasey testified about his opinion. Dr. Vasey's willingness to answer questions about his diagnosis adds a small measure of confidence to it.
Dr. Vasey's experience is an important factor in weighing his opinion. He is board certified in rheumatology. Tr. 1508. People with lupus frequently seek treatment from rheumatologists. Tr. 1129. Dr. Vasey has seen more than 100 patients with lupus in his career. Tr. 1568. Many of these encounters occurred when Dr. Vasey worked at a clinic in Detroit serving an urban African-American population, which he identified as having an increased risk for lupus. Exhibit 86; Tr. 1568.
Another valuable factor is Dr. Vasey's experience with Mr. D'Angiolini in particular. Dr. Vasey first saw Mr. D'Angiolini upon a referral from Mr. D'Angiolini's mother, for whom Dr. Vasey had cared. The first appointment between Dr. Vasey and Mr. D'Angiolini was on September 29, 2000. At this visit, Mr. D'Angiolini gave Dr. Vasey a history, although Mr. D'Angiolini did not provide any medical records. Tr. 1535. After this initial consultation, Dr. Vasey wrote a letter to the judge presiding over Mr. D'Angiolini's claim for workers' compensation benefits. Exhibit 133 at 23.
Dr. Vasey described his findings in a series of medical records, which were submitted as exhibit 133.
Following the third appointment, Dr. Vasey generally saw Mr. D'Angiolini approximately two times per year from 2003 to 2012. Dr. Vasey's most recent appointment was on June 6, 2012. Tr. 1525. Mr. D'Angiolini's attorney asked Dr. Vasey about these visits. Tr. 1514-25. Dr. Vasey did not include lupus as a diagnosis on any of these records.
In the context of presenting an opinion for this litigation, Dr. Vasey was asked to consider whether Mr. D'Angiolini had lupus.
Dr. Vasey maintained this opinion throughout his testimony. He explained:
Tr. 1548-49.
When Dr. Vasey was asked whether Mr. D'Angiolini suffered from lupus when Dr. Vasey first saw him on September 29, 2000, Dr. Vasey again denied the lupus diagnosis. Dr. Vasey stated:
Tr. 1574.
Dr. Vasey's testimony that when he was treating Mr. D'Angiolini, the possibility that Mr. D'Angiolini suffered from lupus was such a remote possibility that it "never . . . crossed [his] mind" is strong evidence that Mr. D'Angiolini did not suffer from lupus. It gains additional strength because when Dr. Vasey was asked to consider whether Mr. D'Angiolini suffered from lupus, Dr. Vasey confirmed that he did not.
Mr. D'Angiolini offers no argument to explain why Dr. Vasey's opinion that he does not suffer from lupus is wrong. Mr. D'Angiolini's briefs do not discuss Dr. Vasey's non-diagnosis at all.
Although Mr. D'Angiolini's post-hearing briefs do not explicitly rely upon medical records from a treating doctor suggesting that Mr. D'Angiolini suffered from lupus, Mr. D'Angiolini referenced these documents during the hearing. Thus, the consideration on this issue necessarily entails review of these sources.
The extent of Dr. Bray's treatment is set out exhaustively above.
Dr. Buttram and Dr. Waisbren reached similar conclusions. Both linked the hepatitis B vaccine to Mr. D'Angiolini's decline in health. Exhibit 17 at 125 (Nov. 1, 1999 letter from Dr. Buttram), 39 (case report from Dr. Waisbren). Dr. Buttram stated that Mr. D'Angiolini suffered from "chronic fatigue and myocarditis."
In his February 22, 2000 letter, Dr. Bray continued to say that Mr. D'Angiolini suffered from depression, although Dr. Bray characterized his depression as secondary to a chronic illness. Dr. Bray added other diagnoses, including "systemic autoimmune disease" and "post encephalomyelitis." Exhibit 17 at 109-10. Later, on May 9, 2002, Dr. Bray added one more diagnosis, SLE. Exhibit 131 at 3.
Thus, Dr. Bray's May 9, 2002 letter constitutes some evidence supporting an assertion that Mr. D'Angiolini suffered from SLE. The challenge comes from trying to weigh this evidence especially in light of the fact that another one of Mr. D'Angiolini's treating doctors, Dr. Vasey, did not see evidence of SLE even though Dr. Vasey's treatment occurred in the same time. Because it appears that the basis for Dr. Bray's conclusion overlaps with Dr. Shoenfeld's rationale, a more extensive discussion of Mr. D'Angiolini's signs and symptoms that arguably support the lupus diagnosis is deferred to section VII.A.4 below.
The context for Mr. D'Angiolini's visits with doctors from the Cleveland Clinic is recounted in section III.C.6, above. The strongest evidence regarding lupus is Dr. Hanson's statement that "I rather agree with Dr. Galatro that this is an autoimmune disorder which falls presum[ably] into the lupus category." Exhibit 37 at 25. In addition on June 22, 2005, Dr. Galatro's impression was "[m]ild cardiomyopathy" and "SLE." Dr. Galatro prescribed medication for Mr. D'Angiolini's cardiomyopathy but did not recommend any particular treatment or study specifically for SLE.
The SPECT scan results from Dr. Pretorius's June 2003 evaluation of Mr. D'Angiolini are discussed in section III.C.5, above. In his assessment of these results, Dr. Pretorius suggests "[l]upus-like cerebritis (evidenced also by positive double-stranded DNA antibodies) related to repeated antigen (vaccine) exposure is most likely in a patient with multiple documented allergies." Exhibit 40 at 2.
In his expert report, Dr. Shoenfeld opined that Mr. D'Angiolini suffered from SLE. Exhibit 87 at 11. He supported his opinion by relying upon four features: a decrease in the amount of complement, the presence of anti-DNA antibodies, a problem in Mr. D'Angiolini's brain, and a problem in Mr. D'Angiolini's heart. Exhibit 87 at 11. Dr. Shoenfeld based his opinion, in part, on the laboratory studies that Dr. Buttram and Dr. Waisbren ordered at the end of 1999.
Dr. Lightfoot's opinion was that Mr. D'Angiolini did not suffer from SLE. Dr. Lightfoot expressed his disagreement with Dr. Shoenfeld's contrary opinion thusly:
Exhibit A at 16.
Dr. Lightfoot's opinion that Mr. D'Angiolini did not suffer from lupus was more persuasive than Dr. Shoenfeld's opinion that he did. As discussed below, Dr. Lightfoot's opinion closely tracks the diagnostic criteria. Dr. Shoenfeld, on the other hand, expanded the criteria beyond what the criteria specify.
In accord with the approach taken in
Complement refers to a series of many proteins located in the blood. Dorland's at 393. Complement is part of the immune system. Tr. 742. When tested by Dr. Waisbren in 1999, Mr. D'Angiolini's complement levels were low. Exhibit 3 at 11.
Dr. Shoenfeld placed the low complement within the "immunologic disorder" criterion of the 1982 criteria for diagnosing lupus. Dr. Shoenfeld frequently brought out the low complement as supporting the SLE diagnosis. Tr. 743, 749, 810, 838, 883, 885. In his initial post-hearing brief, Mr. D'Angiolini discusses the low complement levels. Pet'r's Posthr'g Br. at 21-22. But, Dr. Shoenfeld contradicted his own opinion. Dr. Shoenfeld acknowledged that low complement does not fit in the revised criteria. Tr. 895.
According to Dr. Lightfoot, low complement is not part of the immunological abnormalities that are part of the criteria for lupus. Tr. 1130-31, 1145. He explained that studies have shown that in people with SLE, complement levels float "in and out of normal range." Tr. 1146-47.
Therefore, Dr. Shoenfeld and Dr. Lightfoot agree that the most recent criteria for diagnosing SLE do not use low complement levels as a factor supporting diagnosis. While Dr. Shoenfeld may be correct that low complement would affect the determination using the previous criteria, Dr. Shoenfeld did not explain why the out-of-date criteria should be used. Furthermore, in his reply brief, Mr. D'Angiolini no longer claimed to meet this criterion because of the low complement. Rather, Mr. D'Angiolini argued the positive result on an anti-DNA test fulfilled this criterion. Pet'r's Reply Br. at 19.
In December 1999, Dr. Waisbren tested Mr. D'Angiolini for native DNA antibodies. Exhibit 20 at 34. The result was 59 IU/ML, which was positive. (Positive values started when the result exceeded 55 IU/ML.).
Later testing was not consistent. Another test Dr. Waisbren ordered in July 2001, produced a negative result, meaning that Mr. D'Angiolini had less than 25 IU/ML. Exhibit 20 at 45. Similarly, testing from the Cleveland Clinic from September 2004, was also negative. Exhibit 37 at 3, 10. It is unlikely that the amount of antibodies produced by Mr. D'Angiolini fluctuated. Tr. 1111-12;
Dr. Lightfoot explained that the more likely explanation for the slightly positive test in December 1999 concerns some errors (or artifact) in testing and the need to differentiate between double-stranded DNA and single-stranded DNA. Tr. 1109-11;
The basic definition of "serositis" is "inflammation of a serous membrane."
Exhibit T (Tan) at 1274. "Pericarditis" means inflammation in the fibroserous sac surrounding the heart.
In Dr. Shoenfeld's opinion, Mr. D'Angiolini met the serositis criterion by having cardiomyopathy. The term "cardiomyopathy" means the person has "some kind of pathology in [his or her] heart." Tr. 733;
Dr. Lightfoot maintained that Mr. D'Angiolini did not suffer from pleuritis or pericarditis. Exhibit A at 16.
Mr. D'Angiolini's pretrial submission said "serositis — none." Pet'r's Suppl. Br., tab C, at 2. It is not clear whether Mr. D'Angiolini intended to disagree with his expert's view that cardiomyopathy qualified as part of the lupus criteria.
Regardless of the position taken in Mr. D'Angiolini's brief, Dr. Shoenfeld testified that Mr. D'Angiolini's cardiomyopathy satisfied one of the lupus criteria.
Given that the diagnostic criteria refers to "pericarditis," the lining of the heart muscle and not to the heart generally, it appears that Dr. Shoenfeld's interpretation broadens the criteria. Dr. Vasey shared this view. Dr. Vasey stated that cardiomyopathy does not qualify as pericarditis because they are "different." Tr. 1575.
Consequently, Mr. D'Angiolini does not satisfy the serositis criterion.
With exceptions not pertinent here, the diagnostic criteria for a neurologic disorder in lupus are seizures or psychosis. Exhibit T (Tan) at 1274. "Psychosis," in turn generally refers to "mental disorders in which mental functioning is so impaired that it interferes grossly with the patient's capacity to meet the ordinary demands of life."
By a conventional definition of "psychosis," Mr. D'Angiolini did not have this problem. Between 1996 and 2000, Mr. D'Angiolini was seeing a psychiatrist regularly. Dr. Middleman did not diagnose him as suffering from psychosis.
However, Dr. Shoenfeld does not have the common understanding of "psychosis." To Dr. Shoenfeld, a cognitive impairment is sufficient to be a psychosis. Tr. 897 (Dr. Shoenfeld "when you have cognitive impairment, it may be the equivalent" of psychosis);
Mr. D'Angiolini has not established that "psychosis," as used in the Tan criteria, is so broad that it encompasses his cognitive impairments. Dr. Shoenfeld's stretching of the criteria is not supported by anything beyond Dr. Shoenfeld's own statements.
Mr. D'Angiolini makes two other attempts to fall within the "psychosis" category. First, he maintains that a SPECT scan conducted by Dr. Pretorius in November 1998, shows changes in his brain tantamount to psychosis. See Pet'r's Reply Br. at 19. It is true that Dr. Pretorius interpreted the SPECT scan as showing "Lupus-like cerebritis," exhibit 40 at 2, and Dr. Shoenfeld deferred to this interpretation. Tr. 1035-49. While the SPECT scan may have shown inflammation in Mr. D'Angiolini's brain, inflammation is not the same as psychosis. Moreover, the relative newness of using SPECT scans in diagnosing lupus raises legitimate questions about the accuracy of labeling a particular pattern as consistent with lupus.
Second, Mr. D'Angiolini cites to other reports of "neurological maladies." Pet'r's Reply Br. at 19. But, the various neurologic problems reported by some of Mr. D'Angiolini's treating doctors (for example, headaches) do not fulfill the Tan criteria for lupus.
In short, there is no persuasive evidence that Mr. D'Angiolini had either seizures or psychosis, which are the two alternative ways of fulfilling this criterion.
The lupus criteria include "arthritis" which is defined as "Nonerosive arthritis involving 2 or more peripheral joints, characterized by tenderness, swelling, or effusion." Exhibit T (Tan) at 1274. Evidence that Mr. D'Angiolini met this criterion arguably comes from two difference sources, Dr. Shoenfeld and his medical records.
In Dr. Shoenfeld's report, he identified "muscles involvement[]" as supporting the lupus diagnosis. Exhibit 87 at 11. Dr. Shoenfeld did not specifically list joint problems in this portion of his report, although Dr. Shoenfeld mentioned joints in other portions of the report.
Dr. Lightfoot's response to myalgia was both succinct and persuasive. When asked whether myalgia is evidence of lupus, Dr. Lightfoot said "[m]yalgia is not." Tr. 1143.
Again, Dr. Lightfoot's testimony that myalgia is not a feature of SLE is in accord with the Tan article. Exhibit T (Tan) at 1274. Thus, it is easy to reject Dr. Shoenfeld's opinion, reflected in his written report, that Mr. D'Angiolini's muscle pain is part of SLE.
In his oral testimony, Dr. Shoenfeld also discussed Mr. D'Angiolini's arthralgia as meeting the definition of arthritis. In a medical dictionary, "arthralgia" means "pain in a joint," while "arthritis" means "inflammation of a joint."
Dr. Lightfoot did not accept Dr. Shoenfeld's blurring of arthritis and arthralgia. Tr. 1143. Dr. Lightfoot's opinion stays within the criteria. The criteria use the term "arthritis," not "arthralgia." Consequently, Dr. Shoenfeld's opinion is not persuasive.
In addition to the testimony from Dr. Shoenfeld, Mr. D'Angiolini relies upon notations from his treating doctors.
The strongest evidence that Mr. D'Angiolini suffered from arthritis as defined in the criteria is the May 9, 2002 letter from Dr. Bray seeking disability benefits. The provenance of this letter is set forth above. Dr. Bray reported that he saw Mr. D'Angiolini on May 9, 2002, and conducted a physical examination, revealing "[t]enderness and swelling of the joints of the ankles, knees, and elbows." Exhibit 131 at 4. Dr. Lightfoot acknowledged that joint tenderness meets the definition. Tr. 1424-25.
Years later, Dr. Vasey found that Mr. D'Angiolini did not have joint tenderness. Exhibit 133 at 5 (May 9, 2007), 6 (October 24, 2007), 1 (January 26, 2009).
To recap, in Dr. Shoenfeld's written report, he identified five features of Mr. D'Angiolini in support of the lupus diagnosis. Three (low complement, neurologic involvement, and heart) are definitely out. For the other two (arthritis and anti-DNA antibodies), there is at least a modicum of evidence. However, it is distressing that Dr. Shoenfeld offered opinions that are based upon stretched interpretations of the diagnostic criteria or stretched interpretations of medical records.
In addition to the five features discussed in Dr. Shoenfeld's report, Mr. D'Angiolini asserted that he met other Tan criteria including malar rash, oral ulcers, renal disorder and photosensitivity. The evidence presented for these additional criteria is discussed below.
A rash along the nose, known as a malar rash, is characteristic for lupus. Exhibit T (Tan) at 1274; Tr. 884.
Evidence about Mr. D'Angiolini having a malar rash appears in only three places.
The third source is Dr. Buttram. The March 21, 2001 handwritten notes from Dr. Buttram in the history of present illness section state: "He has been running intermittent fever — running rashes on bridge of nose — temporal arteritis-type headaches." Exhibit 36 at 1. This report, which appears to come from Mr. D'Angiolini as a historian, is confirmed by Dr. Buttram's physical examination in which skin is associated with "lupus-type facial rash." Exhibit 36 at 2.
The problem, however, is that other doctors do not report similarly.
Dr. Vasey testified that he "didn't personally see a butterfly rash." Tr. 1548;
Dr. Bray's and Dr. Buttram's reports of a malar rash constitute some evidence that Mr. D'Angiolini did have this rash at some point. It seems unlikely that a doctor would affirmatively state that he saw something if he actually did not see it.
The Tan criteria define oral ulcers as "[o]ral or nasopharyngeal ulceration, usually painless, observed by a physician." Exhibit T (Tan) at 1274. For this factor, in his prehearing submission, Mr. D'Angiolini relied upon Dr. Bray's letters. Pet'r's Suppl. Br., tab C, at 2.
Although Mr. D'Angiolini appeared not to be putting oral ulcers forward as part of his lupus diagnosis, the Secretary addressed this topic. She maintained that Mr. D'Angiolini did not meet this criterion because on "multiple occasions," Mr. D'Angiolini denied having them. Resp't's Posthr'g Br. at 31.
On November 17, 1998, Mr. D'Angiolini visited Penn Center for Primary Care, where, it appears, Dr. Anne Norris saw him. Under physical examination, Dr. Norris wrote "[negative] oral lesions." Exhibit 22 at 3. Dr. Norris made an identical remark on January 19, 1999.
Other than Dr. Bray's letters, the next report of oral ulcers comes on April 26, 2006. Then, Dr. Vasey reported seeing oral ulcers. Exhibit 133 at 9; Tr. 1518. However, Dr. Vasey did not see mouth ulcers in January 2009, after Mr. D'Angiolini included them on his history. Exhibit 133 at 1; Tr. 1578. Dr. Vasey did not find oral ulcers in October 2007. Exhibit 133 at 6.
Overall, the evidence relating to oral ulcers is sparse at best. Neither Dr. Shoenfeld nor Dr. Lightfoot testified about ulcers at all. Dr. Norris's two records support a finding that in 1998 and 1999, he was not having oral ulcers. Dr. Bray's letters, although less reliable for reasons explained above, provide some modicum of support that Mr. D'Angiolini had oral ulcers in February 2000. Exhibit 17 at 110. Mr. D'Angiolini has not identified other treating doctors who reported similar complaints or who made a similar finding.
Dr. Vasey said oral ulcers "can come and go." Tr. 1578. This statement is in accord with common experience. Mr. D'Angiolini has not met his burden of establishing that three reports of oral ulcers across more than a decade of medical records are sufficient to fulfill the lupus criterion.
Another category of the lupus criteria is renal disorder. This is defined as "a) Persistent proteinuria greater than 0.5 grams per day or greater than 3+ if quantitation not pe[r]formed OR b) Cellular casts — may be red cell, hemoglobin, granular, tubular, or mixed." Exhibit T (Tan) at 1274.
For this aspect, Mr. D'Angiolini cites Dr. Bray. Pet'r's Suppl. Br., tab C at 2, citing exhibit 17 at 110. Mr. D'Angiolini did not cite to an underlying lab report.
Although Dr. Bray's report appears multiple times in the record because it is included in the files of other doctors, Mr. D'Angiolini has not identified any other doctors who stated that he had protein in his urine. Because this criterion requires "persistent proteinuria," it appears that an isolated instance of proteinuria does not satisfy the criteria. Dr. Lightfoot maintained that the evidence of protein in Mr. D'Angiolini's urine was not specific to the certain type of nephritis attributable to SLE. Tr. 1305.
The final category put forward by Mr. D'Angiolini is photosensitivity.
Again, Dr. Shoenfeld seems to stretch a Tan diagnostic criterion. Photosensitivity is defined by Tan as a: "[s]kin rash as a result of unusual reaction to sunlight." Exhibit T (Tan) at 1274. Mr. D'Angiolini's medical records do not indicate any such rash existed. Two distant notations of "light sensitivity," without further detail as to the type or severity of this sensitivity, do not establish that Mr. D'Angiolini suffered from "photosensitivity" as defined by the Tan criteria.
Although Mr. D'Angiolini did not rely upon antinuclear antibodies, the lupus criteria include the presence of antinuclear antibodies. Exhibit T (Tan) at 1274. Dr. Lightfoot stated "[n]inety-five to 97 percent of patients with lupus have a positive ANA." Tr. 1100. As a separate criterion, ANA is "highly sensitive for SLE." Tr. 1132. Dr. Shoenfeld did not counter these assertions in his rebuttal. A commonly used reference book states: "[b]ecause almost all patients with SLE develop autoantibodies, a negative ANA test excludes the diagnosis."
Mr. D'Angiolini's ANA tests have been normal.
The Vaccine Act recognizes that petitioners may establish their claims by submitting either "medical records or . . . medical opinion." 42 U.S.C. § 300aa-13(a). Here, neither the medical records nor the medical opinions support a finding that Mr. D'Angiolini suffers from lupus.
The medical records contain the evaluations of many doctors who treated Mr. D'Angiolini. Although some doctors (notably, Doctors Bray, Hanson, and Galatro) indicated that Mr. D'Angiolini suffered from SLE, other doctors did not agree with this assessment. Among all the treating doctors, the doctor whose opinion was the strongest is Dr. Vasey. Dr. Vasey stated that Mr. D'Angiolini did not suffer from lupus. His opinion, as explained above, is given the most weight because he was capable of diagnosing lupus and had more than a decade to see signs and symptoms of lupus.
The reasons Dr. Vasey gave for not diagnosing Mr. D'Angiolini as having lupus, such as the lack of a malar rash and the lack of a positive ANA, effectively undercut the opinion presented by Dr. Shoenfeld. To support a lupus diagnosis for Mr. D'Angiolini, Dr. Shoenfeld stretched and pulled the diagnostic criteria well past a reasonable point. For example, Dr. Shoenfeld presented no basis for saying that cardiomyopathy qualifies as pericarditis and he presented no basis for saying that cognitive impairments qualify as psychosis. Ultimately, Mr. D'Angiolini's efforts to fit within the lupus criteria are not persuasive.
The finding that Mr. D'Angiolini did not suffer from lupus essentially makes any examination of the
Even if it were found that Mr. D'Angiolini has met his burden on prong 1, his case would falter on prong 2. Since he does not suffer from lupus, all the evidence that he submitted in regard to "a logical sequence of cause and effect" connecting the hepatitis B vaccinations to his lupus is now irrelevant. Similarly, Mr. D'Angiolini cannot establish the third prong of Althen, which concerns temporality. Under this prong, Mr. D'Angiolini is required to establish that his lupus arose in an appropriate temporal proximity to the vaccination. But, this inquiry would be nonsensical because Mr. D'Angiolini has not established the predicate for this analysis, that he has lupus.
Mr. D'Angiolini's final claim is that he suffered from an entity called Autoimmune Syndrome Induced by Adjuvant, sometimes known by its acronym ASIA. As explained in section A, Dr. Shoenfeld's experience in litigation helped him originate this entity. But, the criteria Dr. Shoenfeld has proposed are both vague and evolving as demonstrated in section B. Thus, for the reasons given in section C, Mr. D'Angiolini cannot receive compensation for this entity.
Dr. Shoenfeld is one of the initial proponents of ASIA and his experience contributed to the genesis of ASIA. Dr. Shoenfeld's background, as previously described, is extensive. He is listed as an author for more than 1500 articles published in peer-reviewed journals. Most of these have discussed some aspect of immunology and a sizeable number are about auto-immunity. In addition to his own writing, Dr. Shoenfeld has reviewed manuscripts submitted to prestigious journals as a peer-reviewer and as an editor. Dr. Shoenfeld has organized and lectured at conferences. Exhibit 85. Dr. Shoenfeld has reviewed Vaccine Program cases in which petitioners claimed that a vaccine injured them since at least 2006.
In Dr. Shoenfeld's account, his work as an expert witness sparked his conceptualization of ASIA. In one case, the petitioner was exposed to a vaccine and silicone. A question was whether either the vaccine or the silicone could have caused the petitioner's disease. Dr. Shoenfeld's insight was that in causing the disease, the vaccine and silicone could have worked synergistically. Tr. 996-97. Dr. Shoenfeld saw "two etiologies . . . caus[ing] a very common syndrome."
After Dr. Shoenfeld began configuring this syndrome, he retrospectively recognized other authors had reported findings consistent with ASIA, although these other authors had not used the same terminology. For example, to Dr. Shoenfeld, another manifestation of ASIA was the macrophage myofasciitis syndrome described by Dr. Gherardi. Tr. 814;
In his first article, Dr. Shoenfeld proposed the diagnostic criteria:
Exhibit 88 (Yehuda Shoenfeld and Nancy Agmon-Levin,
For the first major criterion, Dr. Shoenfeld was open to expanding the list of external stimuli beyond the four common external stimuli listed in the article. "There might be additional stimuli which we still did not define." Tr. 905.
The second major criterion, "`typical' clinical manifestations" includes four signs or symptoms. Dr. Shoenfeld stated that a single episode of muscle weakness is sufficient to satisfy the criterion.
Dr. Shoenfeld addressed the minor criteria as well. For the appearance of autoantibodies, Dr. Shoenfeld stated that "any autoantibodies" may appear in patients with ASIA. Tr. 920.
This initial paper did not specify how the criteria related to the diagnosis. For example, it was not clear whether a person needed to satisfy one, two, three or four of the major criteria for a diagnosis of ASIA.
In the context of testifying about the criteria, Dr. Shoenfeld asserted that "in about a year or two when we will revise all the criteri[a], . . . we will add many details . . . when we accumulate more experience and more cases." Tr. 920;
Dr. Lightfoot pointed to many examples of where he saw a lack of precision in the proposed diagnostic criteria. A recurring problem, in Dr. Lightfoot's view, is that the criteria "are sufficiently ill-defined currently that it makes it very difficult to sort of make the diagnosis." Tr. 1174. For example, both arthralgias (joint pain) and myalgias (muscle pain) are subjective symptoms about which many people complain. Tr. 1174-75. Another example is that virtually everyone in this country has received a vaccine. Thus, this factor does not help discriminate people with the disease. Tr. 1178.
To defend ASIA, Dr. Shoenfeld submitted a special issue of the journal
Exhibit 156 at 3. The progression in terminology from "compelling evidence" to "plausible evidence" to "real possibility" suggests that Dr. Hughes's views are inchoate.
In addition to the special issue of
Dr. Lightfoot maintained that the process used in the Zafir article did not actually validate the ASIA criteria. He stated "validation does not mean taking all the patients attorneys have referred to you for an opinion, for example, and seeing if they meet the data set." Tr. 1178. Instead, a proper validation would involve obtaining a "random sample of the population at large." Tr. 1177-78. Obtaining "clean" epidemiological data would, Dr. Lightfoot admits, be a "daunting . . . task," but one that is necessary.
Dr. Shoenfeld has not made a persuasive case that ASIA is a legitimate and generally accepted medical condition. There is no ICD-9 code for ASIA. Tr. 927.
Like Dr. Vasey, Dr. Lightfoot stated that "the ASIA syndrome as a concept is a very interesting hypothesis that needs to be developed." Tr. 1175. Dr. Shoenfeld is working to refine the diagnostic criteria.
The observation that ASIA does not have sufficient current support to be a reliable basis for compensation in the Vaccine Program is not intended as a criticism of Dr. Shoenfeld. The connection between scientific hypotheses and legal evidence was discussed by the Court of Appeals for the Sixth Circuit in a case involving the opinion of an expert who wanted to present a new theory to explain how exposure to welding materials caused Parkinson's disease. The Sixth Circuit reversed the district court's admission of the evidence, reasoning:
Mr. D'Angiolini cannot receive compensation based upon his allegation that he suffers from ASIA. It is not generally accepted in the medical community and its diagnostic criteria do not differentiate between healthy and ill people. In short, Mr. D'Angiolini has failed to establish that Dr. Shoenfeld's opinion regarding ASIA meets the minimum threshold for reliability.
Mr. D'Angiolini presents a sympathetic and complex picture. Before he was vaccinated, he was receiving assistance from a psychiatrist and psychologist for relatively serious issues. But, he was functioning well enough to hold a full-time job as a mental health technician and to work part-time as a music instructor. After receiving two doses of the hepatitis B vaccine, he continued to fulfill his professional obligations. But, his employment stopped after the third dose of the hepatitis B vaccine in 1997.
Mr. D'Angiolini claims that the hepatitis B vaccinations caused the change in his employment and all the other changes in his life and health. For his medical problems, Mr. D'Angiolini has consulted numerous doctors. The doctors have not figured out what is wrong with him.
Although in this litigation Mr. D'Angiolini puts forward an allergy, a syndrome, a disease (lupus), and a newly proposed entity (ASIA), he has failed to establish persuasively that he suffers from any of them. Without a predicate showing that a particular disorder afflicts him, Mr. D'Angiolini cannot receive compensation in the Vaccine Program.
The Clerk's Office is instructed to enter judgment in accord with this decision unless a motion for review is filed.
Prolonged fatigue is defined as self-reported, persistent fatigue lasting 1 month or longer. Chronic fatigue is defined as self-reported persistent or relapsing fatigue lasting 6 or more consecutive months.
The presence of prolonged or chronic fatigue requires clinical evaluation to identify underlying or contributing conditions that require treatment. Further diagnosis or classification of chronic fatigue cases cannot be made without such an evaluation.
The following items should be included in the clinical evaluation.
Routinely doing other screening tests for all patients has no known value. However, further tests may be indicated on an individual basis to confirm or exclude another diagnosis, such as multiple sclerosis. In these cases, additional tests or procedures should be done according to accepted clinical standards.
The use of tests to diagnose the chronic fatigue syndrome (rather than to exclude other diagnostic possibilities) should be done only in the setting of protocol-based research. The fact that such tests are investigational and do not aid in diagnosis or management should be explained to the patient.
In clinical practice, no additional tests, including laboratory tests and neuroimaging studies, can be recommended for the specific purpose of diagnosing the chronic fatigue syndrome. Tests should be directed toward confirming or excluding other etiologic possibilities. Examples of specific tests that do not confirm or exclude the diagnosis of the chronic fatigue syndrome include serologic tests for Epstein-Barr virus, retroviruses, human herpesvirus 6, enteroviruses, and Candida albicans; tests of immunologic function, including cell population and function studies; and imaging studies, including magnetic resonance imaging scans and radionuclide scans (such as single-photon emission computed tomography and positron emission tomography) of the head.
The following conditions exclude a patient from the diagnosis of unexplained chronic fatigue.
The following conditions do not exclude a patient from the diagnosis of unexplained chronic fatigue.
Clinically evaluated, unexplained cases of chronic fatigue can be separated into either the chronic fatigue syndrome or idiopathic chronic fatigue on the basis of the following criteria.
A case of the chronic fatigue syndrome is defined by the presence of the following:
The method used (for example, a predetermined checklist developed by the investigator or spontaneous reporting by the study participant) to establish the presence of these and any other symptoms should be specified.
A case of idiopathic chronic fatigue is defined as clinically evaluated, unexplained chronic fatigue that fails to meet criteria for the chronic fatigue syndrome. The reasons for failing to meet the criteria should be specified.
1. Malar rash
2. Discoid rash
3. Photosensitivity
4. Oral ulcers
5. Arthritis
6. Serositis
7. Renal disorder
8. Neurologic disorder
9. Hematologic disorder
10. Immunologic disorder
11. Antinuclear antibody
Similarly, Mr. D'Angiolini and his mother testified before the workers' compensation judge on three days. He filed this set of transcripts as exhibit 51. A parenthetical specifies the date of the worker's compensation hearing. For example, "June 7, 2001 W.C. Trial Tr. 14" refers to page 14 of the transcript created on June 7, 2001 before the workers' compensation judge.
Second, during the hearing, Mr. D'Angiolini submitted a December 1, 2010 report showing the presence of ASCA to IgA and IgG. Exhibit 198. The experts were consistent that this test provided no information about whether Mr. D'Angiolini had an allergy, which is measured by IgE, to yeast. Tr. 1064-67, 1655.
In Mr. D'Angiolini's posthearing brief, to support the assertion that he had fatigue, Mr. D'Angiolini cites to a portion of Dr. Shoenfeld's testimony in which Dr. Shoenfeld was responding to questions from the undersigned. Pet'r's Posthr'g Br., filed May 21, 2013, at 6, citing Tr. 961-75. The portion of these 14 pages that is most specific about the onset of Mr. D'Angiolini's fatigue is still quite vague:
Tr. 961.
When Mr. D'Angiolini had another echocardiogram at the Cleveland Clinic in 2004, his ejection fraction was 45 percent. Exhibit 37 at 18-20. These results prompted Dr. Lightfoot to testify that he was not sure whether Mr. D'Angiolini actually had a cardiomyopathy. Tr. 1140-41.
Resolving whether Mr. D'Angiolini had a cardiomyopathy is not necessary because a preponderance of the evidence, including Dr. Vasey's testimony, establishes that a general cardiomyopathy does not satisfy the lupus criteria.
