OPINION AND ORDER
I. Introduction
This case is before the court under the National Childhood Vaccine Injury Act
Under the guise of the great sleuth Sherlock Holmes, Sir Arthur Conan Doyle once posited that “when you have eliminated the impossible, whatever remains, however improbable, must be the truth.”
After a hearing held July 7-8, 2003, the Special Master concluded that petitioners did not meet their burden of demonstrating legal causation-in-fact under the Act. More particularly, the Special Master found that while petitioners had demonstrated that vaccine reactions hypothetically could trigger systemic onset JRA similar to Richelle’s, petitioners failed to satisfy the burden of proof that Richelle’s condition in this specific case was in fact triggered by a vaccine. Pafford v. Sec’y of the Dep’t of Health and Human Servs., No. 01-0165V,
Upon review of the Special Master’s opinion and the entire record, and for the reasons addressed more thoroughly below, the court concludes that the Special Master has satisfied the applicable legal standard in finding that the petitioners did not meet their statutory burden of proving Richelle’s March 1998 vaccination was the cause-in-fact of Richelle’s subsequent systemic onset JRA.
II. Background
Riehelle Pafford was bom January 30, 1993. She received regular medical care from Dr. Jay Schmidt, and the Special Master noted “nothing remarkable” about Richelle’s early development. On August 5, 1993, when Riehelle was just more than six months old, Dr. Schmidt administered her first DTP, OPV and Hib vaccinations.
During November and December 1997, when Riehelle was almost four years old, she was treated for otitis, an inflammation of the ear marked by pain, fever, hearing difficulty and vertigo. Dr. Schmidt noted that she complained of a cold lasting two months. Pet.’s Ex. 3 at 20. Three months later, on March 5, 1998 Riehelle visited Dr. Schmidt with complaints of a cold and diarrhea that had lasted about three days. One week later, on March 12, Riehelle returned to Dr. Schmidt with inflamed tonsils bearing white patches. She also ran a fever of 101-102 degrees Fahrenheit. Dr. Schmidt diagnosed Riehelle with tonsillitis and conducted another throat culture that was negative for strep throat. Pet.’s Ex. 3 at 13-15. On March 24, Riehelle returned for a follow-up visit, during which Dr. Schmidt noted that her tonsils were no longer inflamed and had regressed in size from the recent exam. Id. at 11. Riehelle was noted to be “doing well” and was “suffering no symptoms of illness;” she was an active child with healthy physical and mental development. Id. During this March 24 visit, Riehelle received a DTaP vaccination, her fourth OPV vaccination, and her second MMR vaccination. It is this series of vaccinations (the March 1998 vaccinations) that petitioners have placed at issue in this case.
Eleven days later, on April 4, 1998, Riehelle complained of fever and neck pain. Her fever abated the next day, but her neck pain persisted. She developed a diffuse pink, macular rash and whitish spots on her tongue that may have been Koplik’s spots
Six days later, on April 13, Richelle was treated at the emergency room in United Medical Center, Cheyenne, Wyoming; she had a 103.9 degree fever and a blanching red maculopapular rash on the palms and soles of her hands, upper legs, chest and upper abdominal area. She was vomiting upon arrival and refused intake of fluids. The consulting physician, Dr. Valorie Bell, noted that Richelle was tearful and crying, and Dr. Bell “could not localize any tenderness specifically because she cried everywhere she was touched.” Pet.’s Ex. 5 at 16. Dr. Bell also noted that “[t]he rash was very viral in character and I did not feel it was related to her immunizations but suggested a [complete blood count] to see if it supported the viral picture.” Id. By the time that Richelle was admitted to the hospital floor from the emergency room, her fever had abated to 97.2 degrees and the rash “had greatly diminished by that time.” Id. at 8. She was by then “playful and happy.” Id. at 16. Dr. Schmidt noted that the “fever and rash abated quite remarkably and rapidly” and he sensed that the rash was related to the fever. Id. at 8-9. At this time, Richelle also tested positive for a mycoplasma infection, and Dr. Bell thought that this was responsible for the April 13 symptoms. See Pet.’s Ex. 4 at 79. Upon discharge, Richelle was afebrile and “her rash, for the most part, had disappeared.” Pet.’s Ex. 5 at 9.
After she had gone home, Richelle experienced recurring fever and rash over the next two weeks and increasingly complained of joint pain. On April 30,1998 she returned to Dr. Bell, who noted that Richelle had a 102.9 degree fever, a painful, swollen right elbow and left knee, and a recurrence of the earlier rash. While Dr. Bell had previously thought that Richelle’s rash, joint pain and fever “were all due to mycoplasma,” by this point it “seem[ed] the illness has extended longer than would be expected with mycoplasma. Pet.’s Ex. 4 at 79. Although Dr. Bell noted that the joint discomfort associated with mycoplasma can last for weeks, the rash and fever do not usually relapse to the extent that Richelle experienced. Id. at 80. Instead, Dr. Bell “strongly suspeet[ed] systemic onset JRA as the cause of the month long recurrent rash, fever and discomfort.” Id. Richelle’s lab results revealed an elevated sedimentation rate of 80, mild anemia, and negative ANA and rheumatoid factor tests.
Richelle subsequently embarked on a medication regime to treat her JRA. Dr. Bell’s diagnosis was later corroborated by Dr. Hollister, a pediatric rheumatologist at Children’s Hospital in Denver, Colorado. Despite treatment, Richelle’s disease remained active with recurrent arthritis through at least the next two years.
In 2001 Richelle’s parents filed a petition for compensation under the Vaccine Act. It was their theory that Richelle’s JRA was caused by her adverse reactions to the vaccines that she received in March 1998. The Special Master who reviewed Richelle’s case conducted a two-day hearing with both parties’ experts, and filed a decision denying compensation to the Paffords on July 16, 2004. Pafford, No. 01-0165V,
III. The Vaccine Act
The Vaccine Act provides a program by which individuals who claim to have been injured by certain vaccines may be compensated for their injury. The program was created in large part to preempt tort litigation against vaccine manufacturers and provide compensation to injured individuals without requiring the rigorous burdens of proof associated with products liability litigation, including causation, negligence, and product defectiveness. See generally Stevens v. Sec’y of the Dep’t of Health and Human Servs., No. 99-594V,
On the other hand, if the claimed injury is not an on-Table injury — as is the case here with Riehelle’s systemic onset JRA — then the petitioners may still seek compensation provided they are able to prove causation-in-fact. § 300aa-11(c)(1)(C)(ii); Grant,
IV. The Special Master’s Decision
As an initial matter, the Special Master endeavored to clarify just what systemic onset JRA, or Still’s disease, is. See Pafford, No. 01-0165V at 5-6,
The Special Master then proceeded to evaluate petitioners’ causation-in-fact claim. Citing Grant, the court organized the legal criteria of the causation-in-fact analysis into two overriding considerations. “First, a petitioner must provide a reputable medical theory causally connecting the vaccination and the injury----Second, a petitioner must also prove that the vaccine actually caused the alleged symptoms in her particular case.” Id. at 7. The first prong of this evaluation was distilled to concentrate on the “biologic plausibility” of the petitioners’ theory “by proffering a scientific pathogenesis underlying the alleged causal relationship.” Id. Generally, the Special Master noted, biologic plausibility is established through epidemiological studies, peer-reviewed published arti
Ultimately, this two-pronged approach was tailored as “(I) Is it biologically plausible that one or more of the vaccinations in question can cause Still’s disease?; and, (ii) Did one or more of [Richelle’s] vaccinations result in her Still’s disease?” Id As to the initial prong, the court concluded that petitioners had proven by a preponderance of the evidence that it is indeed biologically plausible for one or more of the vaccinations at issue to cause the onset of Still’s disease. Id. at 9. Generally, both parties’ experts agreed that certain individuals have a genetic predisposition to Still’s disease. One of the hallmarks of the disease, according to these experts, is an increase in the expression of pro-inflammatory cytokines,
Having concluded that petitioners carried their burden for the first prong, the Special Master then evaluated their effort to prove that Richelle’s systemic onset JRA was in fact an autoimmune response triggered by the over-production of cytokines specifically induced by her March 1998 vaccinations, consistent with petitioners’ proffered mechanism. The court concluded that there was ample evidence of a literal temporal relationship between the vaccinations and Richelle’s subsequent symptomatic expression of Still’s disease. She seemed to demonstrate “typical post-vaccinal side effects” from the MMR vaccine in early April, eleven days after the vaccination. Id. at 11-12. Through the first week in April 1998, her symptoms appeared to be ordinary side effects of the vaccine, including fever, neck pain, rash and fatigue.
The petitioners argued that the onset of Still’s disease within just a few weeks of the March 1998 vaccinations was strong evidence suggesting a causal connection between the two. The Special Master, however, refused to place such great weight on this mere literal temporal relationship, noting that such “is not itself sufficient for Petitioners to meet this Court’s burden of proof by a preponderance of the evidence.” Id. at 13. Since the petitioners in this case seemed to rely solely on the temporal relationship between alleged cause and ultimate effect, the Special Master noted that the one instance in which such temporal evidence is “telling” in a causation-in-fact case is where the manifestation of the claimed injury “falls within an established time period subsequent to an antecedent or triggering event.” Id. However, petitioners failed to demonstrate that Still’s disease necessarily, or at least routinely, manifests symptoms within any certain timeframe following a given triggering event. Id. Therefore, the literal temporal relationship alone was not dispositive: “The link missing from Petitioners’ argument that gave this Court pause was the lack of any defined time period in which one would expect to see the onset of Still’s disease subsequent to a triggering event. Without such a defined time period, the link between the vaccinations and the injury is tenuous.” Id. at 15
Additionally, the Special Master noted that, “[a]ll experts agree that a number of things can trigger Still’s disease.” Id. at 14. In Richelle’s case, along with the March 1998 vaccinations there was evidence of concurrent events, including an ear infection, tonsillitis and the high mycoplasma count, that might have potentially triggered the manifestation of Still’s disease instead of the vaccinations.
Petitioners then filed in this court a motion for review of the Special Master’s decision, generally raising two lines of arguments focusing on the “critical time” element and the alternative causation theory that were the lynehpins of the decision. First, they argue that the Special Master’s opinion was legally flawed because he misinterpreted the appropriate standard of proof that applies when a petitioner introduces evidence of a temporal relationship between alleged cause and effect in a causation-in-fact case. They argue that in this case there was ample evidence that
V. Discussion
At its heart, then, petitioners’ contentions in this court focus squarely on the appropriate standard of proof to which a petitioner should be held in an off-Table Vaccine Program causation-in-faet case. It raises issues regarding both a petitioner’s burden of production, ie. the types of evidence the petitioner must demonstrate to establish a prima facie entitlement to compensation, as well as the burden of persuasion, ie. the degree to which the petitioner must persuade the fact-finder.
A. Jurisdiction And Standard Of Review
Pursuant to 42 U.S.C. § 300aa-12(e), this court may review the Special Master’s decision upon motion by the parties. The court, in turn, may (a) uphold the findings of fact and conclusions of law of the Special Master and sustain the decision, (b) set aside any finding of fact or conclusion of law that is arbitrary, capricious, or an abuse of discretion, or (e) remand the petition to the Special Master for further action. See § 300aa-12(e)(2). These standards, however, vary in application as well as in degree of deference. Under the Act, this court reviews findings of fact according to the “arbitrary and capricious standard,” focusing on whether the Special Master examined the relevant data and articulated a “satisfactory explanation for [his] action including a rational connection between the facts found and the choice made.” Dixon v. Sec’y of the Dep’t of Health and Human Servs.,
B. The Standard Of Proof In Causation-In-Fact Cases
“There is a dearth of precedent discussing the requirements for prima facie causation.” Shyface,
1. Direct Causation
If and when a petitioner has scientific or medical evidence that demonstrates a direct causal relationship between the vaccine and the injury, then proof of causation-in-fact via direct causation is the preferred path. “[Sjpecial masters initially look for direct evidence linking the vaccine to the alleged injury.” Id. Evidence of direct causation may be found in the form of “an epidemiologic study demonstrating a relative risk greater than two ... or dispositive clinical or pathological markers evidencing a direct causal relationship.”
Unfortunately for most petitioners, epidemiologic studies, dispositive clinical markers or pathological “footprints” are not often available. Epidemiologic studies may be unavailable because “relevant research regarding causation is often extremely limited. A number of factors restrict the medical community’s efforts to conduct such studies including the costliness of the research and the rarity of the illnesses studied.” Id. at *14. Clinical markers may be absent because certain tests were not conducted at the time of sickness or because science has not yet identified acceptable markers. Id. Indeed, in this case petitioners could not present direct evidence supporting the theory of one of its experts because at the time “nobody looked” for the markers that might have supported that theory, i.e., potentially supportive tests were not conducted.
“With few exceptions, the special masters encounter the absence of dispositive epidemiology or vaccine footprints in the vast majority of causation-in-fact cases under the [Vaccine] Program.” Id. In those eases, the petitioner is forced to make his argument employing circumstantial evidence that helps meet the preponderance standard. Such circumstantial evidence may include:
epidemiology (evidencing a relative risk less than two), animal studies, case reports/case series studies, anecdotal reports, manufacturing disclosures, Physician Desk Reference citations, journal articles, institutional findings (such as those reported by the Institute of Medicine), novel medical theories, treating physician testimony, and non-dispositive but inferential clinical and laboratory findings.
Id. The speculative nature of proving causation-in-fact in Vaccine cases with circumstantial evidence requires the petitioner to do much more of the “heavy lifting” than in an on-Table case or even in an off-Table case where there is direct evidence. See Lampe v. Sec’y of the Dep’t of Health and Human Servs.,
Once biologic plausibility has been established, as it was in this case, the petitioner must demonstrate some nexus between the mechanism and the actual condition that shows, more likely than not, that the vaccine caused the condition. See, e.g., Munn v. Sec’y of the Dep’t of Health and Human Servs.,
[Cjonflict also surrounds what amount or combination of evidence sufficiently demonstrates causation generally and in the particular case. Some cases consider the combination of a demonstrated mechanism or medical plausibility and a temporal relationship insufficient---- Others consider the combination of medical plausibility (an accepted or plausible medical theory) and the elimination of alternate causes satisfactory. Some cases suggest plausibility, a medically appropriate temporal relationship, and the elimination of alternate causes suffices to prove causation.
Id. at *20 (citations omitted).
With regard to the temporal relationship between vaccination and the onset of a subsequent condition, there is a distinction drawn between what some courts refer to as the “literal temporal relationship” and a more refined “scientific temporal relationship.” The former refers merely to the period of time between the vaccination and the onset of symptoms; it is a mechanical approach. The latter, however, refers to a more analytic relationship in which the medical or scientific community recognizes a specific period of time following a vaccination within which a certain condition might materialize. See Stevens,
But these elements of causation-in-fact identified in Grant force a question that is key to the case at bar: if a petitioner demonstrates a plausible biologic mechanism and also shows a literal temporal relationship between the vaccination and the manifestation of a subsequent condition, has the petitioner satisfied his burdens? As petitioners contend, it would seem that such production would, at least facially, satisfy the limited requirements that Grant espouses.
To this court, however, the flaw in that argument is that the Federal Circuit has extended the analysis such that those minimum causation-in-fact elements enunciated in Grant may not be sufficient to establish a prima facie entitlement to compensation, depending on the unique circumstances of a given case. The Federal Circuit has instructed that an actual-causation vaccine petitioner “must prove by a preponderance of the evidence that the vaccine, and not some other agent, was the actual cause of the injury.” Munn,
This deductive reasoning analysis has its origin in traditional tort law. Drawing parallels between the Restatement (Second) of Torts substantial factor standard in negligence cases and the vaccine cases, the Federal Circuit has indicated that “an action is the ‘legal cause’ of harm if that action is [both] a ‘substantial factor’ in bringing about the harm, and that the harm would not have occurred but for the action.” Shyface,
Shyface and Munn, accordingly, seem to require the court to evaluate the record as a whole, and take into account whatever considerations that record may reveal, in determining whether the vaccine is the but-for cause and substantial factor of the subsequent condition. \ Consequently, if the record in a Vaccine caise contains incidents that might put at issue whether the vaccine is a substantial factor contributing to the condition, even in light of the petitioner’s demonstrated biologic mechanism and the literal temporal proximity between vaccine and condition, the Special Master may need to delve beyond the Grant requirements to establish causation-in-fact.
This court therefore concludes that a Special Master does not act contrary to the law and commit reversible error if he determines that a plausible biologic mechanism and a literal temporal relationship, alone, do not establish such a nexus between vaccination and condition that causation-in-fact must obtain. See Shyface,
The court must emphasize that, ultimately, there appears to be no hard and fast rule for what specific, individual elements of proof a petitioner must present in order to establish a prima facie case of causation-in-fact; the rule is really one of reason, in which the Special Master gives greater weight to certain factors in certain cases depending on the facts of that particular case and the medical developments existing at-that time. “Causation in fact under the Vaccine Act is thus based on the circumstances of the particular ease, having no hard and fast per se scientific or medical rules.” Knudsen,
C. Did The Special Master Employ The Proper Standard In Determining That Petitioners Failed To Prove Causation-In-Fact?
Employing this “rule of reason” regarding plausibility and causation-in-fact to the Special Master’s decision in this case, it is clear that the decision withstands legal scrutiny. Arguing that the Special Master impermissibly heightened the legal standard in this case, petitioners claim that “[i]f the vaccine ‘can cause’ the injury via the process recognized, the fact that the process is shown to have occurred is prima facie proof that the ‘timing’ of the injury was a perfect fit for the theory of causation.” Pet.’s Mem. of Objections at 29. This characterization, however, both oversimplifies the standard to which petitioners are held (as discussed above) and misstates what they seem to have actually proven.
First, it does not appear that petitioners ever succeeded in demonstrating that the mechanism of causation they espoused was, in fact, the biological process by which Ric
Instead, petitioners have demonstrated here that it is generally possible for the administration of certain vaccines to cause a reaction that, in certain genetically predisposed vaceinees, might trigger the manifestation of systemic onset JRA, or Still’s disease. They have presented a medically accepted mechanism by which such a result might occur. Specific to Richelle, petitioners have demonstrated that she received a series of vaccines in March 1998, that she experienced a typical temporary reaction to those vaccines, and that shortly thereafter she experienced the symptoms of a permanent condition (Still’s disease). The record also presents evidence that shortly before Richelle received her March 1998 vaccines, she also experienced other temporary ailments that could have “triggered” the manifestation of her Still’s disease according to the same mechanism that petitioners argue the vaccines operated. Petitioners did not offer any evidence that would establish a scientifically accepted or medically recognized time frame between a triggering event (such as the vaccine reactions or the tonsillitis or mycoplasma infection) and the manifestation of symptoms of Still’s disease. And what is also significant, they did not offer evidence that tended to suggest that the vaccines were more likely to be the triggering event in Richelle’s specific case than were her other ailments. In other words, other reasonably possible factors were not eliminated. In light of this entire record, taken as a whole, the court cannot conclude that it was error for the Special Master to decide that petitioners failed to establish by a preponderance of the evidence that the vaccines at issue were the but-for cause and substantial factor inducing injury. Rather, the Special Master was correct to hold that petitioners failed to establish a prima facie entitlement to compensation.
If the petitioners here had been able to demonstrate, as the Special Master indicated, that a temporal relationship in the medical sense existed — that is, that the onset of Richelle’s Still’s disease occurred upon the passage of a medically accepted period of time after her March 1998 vaccination and not after some other potential triggering event-then the weight of petitioner’s circumstantial evidence would have been much stronger and this would be a much closer case. The presence of a medically recognized time frame between the trigger and the manifestation of symptoms, which would causally link the trigger and the condition, would serve here as a sufficient nexus to establish causation-in-fact, and would also have aided the court by eliminating alternative causes.
Petitioners did succeed in demonstrating that Richelle experienced vaccine-specific reactions within a six and fourteen day window that is typical of the five percent or so of the population that experiences such reactions. The Special Master noted these reactions were “typical” and “did not appear out of the ordinary.” At no point, however, do petitioners appear to make the case for an accepted period of time between a “triggering” event and the onset of Still’s disease symptoms, which in this case the Special Master determined to be about three weeks after Richelle’s March 1998 vaccinations. Therefore, while the record appears clear that Richelle experienced a general reaction to the vaccines within a medically recognized time period, the same cannot be said with regard to the onset of her Still’s disease symptoms, which the Special Master concluded to occur within a period distinct from her general vaccine reaction.
Petitioners argue that the expression of Richelle’s initial reaction to the vaccines was the beginning of a “logical’ sequence of cause and effect” that triggered a cascade of symptoms culminating with her Still’s disease. They do not distinguish between Richelle’s initial symptoms in early April 1998 (those the Special Master concluded were “typical post-vaccinal side effects”) and her later symptoms weeks later that the Special Master deemed consistent with the Still’s disease profile. They rely on evidence of an “entire chain of events from vaccination to autoimmune injury [that] occurred in the appropri
D. Abuse Of Discretion
The petitioners also argue that the Special Master abused his discretion by raising the “critical time” issue sua sponte after hearing when neither party had themselves raised it as an issue during the case in chief. But this argument misses the mark because “[i]n general ... the parties are responsible for the traditional tasks of identifying and developing information supporting or opposing an award, securing and presenting fact witnesses and expert testimony, and meeting their respective burdens of proof.” Pet.’s Mem. of Objections at 6 (quoting Guidelines for Practice Under the National Vaccine Injury Compensation Program, § V, available at http://www.uscfc.uscourts.gov/OSM/ OSMGuidelines.pdf). Here, the role of a medically accepted temporal relationship between a vaccination and the onset of a subsequent condition has long been recognized as an important, if not essential element of a petitioner’s burden of proof in Vaccine Program eases. See Hasler,
E. Alternative Causation
Finally, the petitioners challenge the Special Master’s reliance on potential alternative causes of Riehelle’s Still’s disease, which in his view weakened the petitioner’s causation-in-fact case because they never discounted the role of these other causes in the context of the cytokine mechanism that petitioners espoused. Petitioners point to statute and case law
In addition to either establishing an on-Table injury or proving eausation-in-fact, the Vaccine Act requires the fact finder to determine that “there is not a preponderance of the evidence that the ... injury ... is due to factors unrelated to the administration of the vaccine.” Grant,
Apportioning the burden of proof of alternative causation in off-Table cases where the petitioner attempts to establish eausation-infact, however, has been the subject of considerable debate within this Circuit. Compare Wagner v. Sec’y of the Dep’t of Sec’y of the Dep’t of Health and Human Servs.,
Despite potential ambiguities or other decisions from the Court of Federal Claims that may appear facially inconsistent, this court concludes that the overwhelming weight of authority in this Circuit is consistent with traditional notions of tort law that place an initial burden of proof regarding alternative causation on the petitioner — not as part of the § 300aa-13(a)(l)(B) “factor unrelated” test, but rather as part of establishing a prima facie case of eausation-infact. Consistent with the Federal Circuit’s instructions, discussed above, that an actual-causation vaccine petitioner “must prove by a preponderance of the evidence that the vaccine, and not some other agent, was the actual cause of the injury,” Munn,
While this burden is separate and distinct from the § 300aa-13(a)(l)(B) “factor unrelated” examination that the fact finder must conduct once the petitioner has established causation, there may well be overlap in the types of facts that might be considered. See, e.g., Johnson v. Sec’y of the Dep’t of Health and Human Servs.,
“Thus, in a nontable case, the single inquiry is whether the petitioner has established by a preponderance of the record evidence that his or her injury or condition was actually caused by the vaccine.” Johnson,
This conclusion is not inconsistent with other opinions from this court and its predecessor that implicitly place the burden of proof on the government in the § 300aa-13(a)(1)(B) “factors unrelated” analysis. See, e.g., McClendon v. Sec’y of the Dep’t of Health and Human Servs.,
If a prima facie case of entitlement exists, § 300aa-13(a)(l)(B) instructs the fact finder to determine whether a preponderance of the evidence shows that the injury was due to ‘factors unrelated’ to the administration of the vaccine____The Act implicitly places the onus of proving the existence of an alleged alternative cause squarely on the shoulders of the respondent____[I]t is not the petitioners’ burden to disprove all possible alternative causes in order to prevail.
Id.
Therefore, in this case, the Special Master committed no error by factoring in to his analysis the unexplained role that causes other than the vaccines at issue may have played in triggering Richelle’s Still’s disease. These alternatives were present in the record and comprised part of the body of evidence that the Special Master was required to weigh in determining whether petitioners had succeeded in demonstrating, based on the record as a whole, that the vaccines at issue were indeed the but-for cause of the condition. Since the petitioners relied exclusively upon circumstantial evidence in proving their case, it was incumbent upon them to discount the role of these potential alternatives in order to prove that the vaccines were, more likely than not, the cause of Richelle’s Still’s disease. Without doing so, or without providing other persuasive evidence that tended to show that the vaccines specifically caused the disease, Richelle’s other prior ailments remained as possible “triggers” that were just as likely as the vaccines to cause her Still’s disease.
VI. Conclusion
For the foregoing reasons, the court AFFIRMS the Special Master’s decision. The court, accordingly, dismisses the petition with prejudice.
IT IS SO ORDERED.
Notes
. Public Health Services Act, § 2111(b)(1)(A) (codified as amended at 42 U.S.C. §§ 300aa-l to - 34).
. Arthur Conan Doyle, The Sign of Four, ch. 6 (1890) (original emphasis omitted).
. The court does not ordinarily make independent findings of fact in these cases, but rather reviews the findings of the Special Master. Accordingly, the factual background that follows is primarily taken from the Special Master's decision.
. The DTP vaccine protects against diptheria, pertussis (whooping cough), and tetanus; the DTaP vaccine, which Riehelle received later, is the same as the DTP but contains an acellular pertussis vaccine and is recommended for children at 18 months and 4-6 years. The OPV is an oral polio vaccine, and the Hib immunization helps prevent diseases caused by Haemophilus influenzae type B, including meningitis. See http://www.medterms.com.
. The MMR immunization is the standard vaccine given to prevent measles, mumps and rubella (German measles). Id.
. Koplik's Spots are "small, irregular, bright red spots on the buccal and lingual mucosa, with a minute blueish white speck in the center of each; seen in the prodromal stage of Measles.” Dor
. "A genetic term for non-antibody proteins released by one cell population on contact with a specific antigen, which act as intercellular mediators, as in the generation of an immune response.” Dorland's at 427-28.
. "As with other vaccines, MMR can cause a local reaction with pain and induration at the injection site. Because it is a live virus vaccine, mild illness with symptoms similar to measles, mumps or rubella may occur. About 7-12 days after vaccination, five percent of children develop a fever with temperature greater than 103 degrees, which lasts 1-2 days. A transient rash may occur 7-10 days post vaccination in 5 percent of children (due to the measles and rubella components). Transient lymphadenopathy (rubella component) and rare parotitis (mumps component) have also been described.” Pafford, No. 01-0165V at 11-12 n. 37,
. See Hearing Transcript, filed Aug. 8, 2003, at 171 ("[A]utoimmune disease ... [is] an immune mediated inflammatory disorder. It's a disregulation of certain proinflammatory cells and ... these cells tend to be triggered by something.... [T]hey could be triggered by ... toxic chemicals, viral infections, vaccines ... you name it.”) (Testimony of Dr. Levin), 174-75, 212 (Q: “You would agree, Doctor, that mycoplasma infections have been known to cause other autoimmune diseases, correct?” A: "Yes”) (Testimony of Dr. Levin), 363-65, 436, 460-65 (Q: "You mentioned in your expert report that cytokines can be produced By smoke inhalation, cancer, things like that. You can't identify any of those factors in Richelle Pafford's case, can you?” A: "Well, what about the eight to twelve infections a year? The tonsillitis that she got in March? Is it not there? How about the sinus infection; how [about] the IGM form with mycoplasma?”).
. The Stevens decision has come under some scrutiny by this court, see Althen v. Sec’y of the Dep't of Health and Human Servs.,
Despite Althen’s treatment of Stevens, this court notes that Stevens does take considerable care to explain the Vaccine Act and the manner by which petitioners routinely try to establish causation-in-fact. See id. at *9-23. The court finds Stevens ’ thorough review and discussion of the state of Vaccine Program causation-in-fact jurisprudence extremely useful as an analytic tool and a starting point for analysis.
. "[F]or example, the presence of anterior horn cells on autopsy as evidence of polio contracted from the oral polio vaccine or the presence of the rubella virus in synovial fluid taken from the joints as evidence of a rubella-related arthropathy.” Stevens,
. Specifically, petitioner's expert Dr. Geier opined that the rubella virus contained in the MMR vaccine can produce chronic infection in synovial tissue resulting in the onset of JRA. Dr. Geier stated that direct proof of that infection would be the presence of the rubella virus in the synovial fluid, but the rubella virus was not isolated in any of Richelle’s synovial fluid because those tests were not conducted. See Pafford, No. 01-0165V at 2 n. 2,
. The Special Master did note, however, that indirect tests revealing a high white blood cell count, which were conducted by Richelle’s doctors, correlate with a high cytokine count because white blood cells secrete cytokines. Therefore, a high white blood cell may indicate a corresponding increase in cytokine expression.
. See Wagner v. Sec'y of the Dep’t of Health and Human Servs., No. 90-2208V,
. This is not to say that biologic plausibility combined with literal temporal proximity will not ever satisfy the petitioner's burden of proof. The determination is one to be made by the fact finder in light of the entire record. Indeed, one can imagine a hypothetical case where a completely healthy individual receives a vaccine and suffers some condition shortly thereafter. The Special Master may conclude that, based on the entirety of facts — including the petitioner’s relative health prior to the vaccine — the petitioner has satisfied his burden of proof. This might be the case if there is an absence of alternative causes apparent in the record or the biologic mechanism that petitioner demonstrates is particularly compelling.
. Here, Congress has provided no test by which the courts are to evaluate causation-in-fact claims. The courts, therefore, should be wary to blindly or mechanistically apply a court-made ' test as some sort of talisman that replaces the process of applying the law. See Gasperini v. Center for Humanities, Inc.,
. See Pet.'s Mem. of Objections at 4 n. 6 (quoting Stevens “Petitioners must satisfactorily prove that the onset occurred within a time frame deemed medically appropriate according to the scientific or medical evidence”), 12 (noting that the parties had been directed by the Special
. Petitioners cite to Knudsen and Althen to support their argument. The court notes that those two cases are inapposite to the present matter. Knudsen was an "on-Table” case; Althen was not a case in which potential alternative causes were at issue. See Knudsen,
. The court notes that McClendon concluded that the petitioners had proven by a preponderance of the evidence the existence of a "table seizure disorder” and that the case was therefore an “on-Table” case. The petitioner was not obligated to prove causation-in-fact, but rather the presence of a Table injury. Once a Table injury had been established, therefore, the burden of proof for the § 300aa-13(a)(l)(B) analysis clearly, and properly, shifted to respondent. See McClendon,