Nussman v. Secretary of Health & Human Services
Full Opinion (html_with_citations)
OPINION
Petitioner seeks compensation under the National Childhood Vaccine Injury Act of 1986 (âVaccine Actâ), 42 U.S.C. §§ 300aa-l to -34 (2000 & Supp. IV 2005), for injuries that he alleges resulted from two hepatitis B vaccinations. In a January 31, 2008 decision, the special master denied petitioner entitlement to Vaccine Act compensation. Presently before the court is petitionerâs motion for review of the special masterâs decision. For the reasons set forth below, the court sustains the special masterâs decision.
I. BACKGROUND
A. Factual History
Petitioner Jay Nussman was bom on August 17, 1978.
Academically, in grades four through six, petitioner was a good student, receiving mostly As and Bs in his classes. Ex. 25 at 3-7. During this time, he participated in his schoolâs Academically Talented Program. Ex. 21 at ¶3. Standardized testing placed petitioner between the ninetieth to ninety-ninth percentile nationally in most subject areas in the fourth grade, while in the fifth and sixth grades petitioner scored between the seventy-second to ninety-ninth percentiles in most areas. Ex. 25 at 8-10. According to an educational evaluation performed in March 1993, petitioner began to have difficulty with his school work in the sixth grade, with organization highlighted as a problem. Ex. 23 at 2. However, in the seventh grade, which spanned from 1991 to 1992, petitioner again received mostly As and Bs in his classes. Ex. 25 at 13.
Petitioner received a hepatitis B vaccination on December 10, 1992.
Petitionerâs parents immediately took him to the emergency room at Laurel Regional Hospital in Laurel, Maryland. Id.; Ex. 9 at 11-14; Ex. 22 at ¶ 4. The emergency room physician diagnosed petitioner with âconfusion of unknown etiologyâ and discharged him with instructions to follow up with his pediatrician the next day. Ex. 9 at 12, 14. Petitionerâs pediatrician recommended that petitioner see a pediatric neurologist, and specifically recommended Arnold P. Gold, M.D. Ex. 21 at ¶ 7. Dr. Goldâs first available appointment was not until the middle of February, so, in the meantime, petitionerâs parents took petitioner to see another pediatric neurologistâJoseph Schneider, M.D.
Petitioner was seen by Dr. Gold on February 17, 1993. Ex. 2 at 1-4. Upon completing his physical examination, Dr. Gold concluded that petitioner âshowed no evidence of a neurologic deficit____â Id. at 3. Dr. Gold indicated that petitionerâs January 20, 1993 episode âcould describe a partial seizure or might be of psychogenic etiology.â Id. Dr. Gold then noted that two days prior to the appointment, petitioner underwent an electroencephalogram (âEEGâ), the results of which were mildly abnormal and could have been consistent with a partial seizure disorder. Id. at 4, 16, 19. Thus, given petitionerâs January 20, 1993 episode and the EEG results, Dr. Gold recommended that petitioner have a magnetic resonance imaging (âMRIâ) scan of his brain. Id. at 4. In addition, Dr. Gold recommended that petitioner âbe followed without any maintenance anticonvulsant,â which should âonly be considered in the event of subsequent spells.â Id. Petitioner underwent the MRI scan on February 19, 1993, the results of which were âcompletely normal.â Id. at 19. Dr. Gold apparently related the MRI results to petitionerâs mother, who indicated to Dr. Gold that she âplanned to obtain a formal psychoeducational evaluation [of] her son.â Id.
Based on his parentsâ concerns about his âgeneral memory lapses in and out of school, as well as in academic tasks involving memoryâ and âdeclining grades,â petitioner underwent an educational evaluation in March 1993. Ex. 23 at 2-7; see also Ex. 21 at ¶ 8 (describing petitionerâs increasing difficulty with his Algebra and Spanish classes). The evaluator concluded: âCurrent educational testing shows [petitioner] to be performing within the average range of academic functioning with definite weaknesses in the areas of written language and his ability to work quickly while processing all the information needed.â Ex. 23 at 7. Also in March 1993, petitioner took the New Jersey Grade 8 Early Warning Test. Ex. 25 at 57. He scored within the highest proficiency level in reading and mathematics, and one point outside the highest proficiency level in writing. Id. Petitioner ultimately received three As, four Bs, and five Cs in his eighth grade classes, with two of the Cs being in âMath 8â and âSpanish 8.â Id. at 13.
Petitioner received another hepatitis B vaccination on April 1, 1993.
As a result of petitionerâs second episode, Dr. Gold prescribed the anticonvulsant Tegretol on April 5,1993. Ex. 28 at 5; Ex. 30 at 1. On April 22, 1993, petitioner underwent another MRI scan of his brain, which revealed normal findings for an adolescent male. Ex. 2 at 7,14. Then, either on May 5 or May 7, 1993, petitioner returned to see Dr. Gold. See id. at 7 (May 7, 1993); Ex. 28 at 15 (May 5,1993). Dr. Gold noted petitionerâs recent academic difficulties, about which a Child Study Team had been convened, and recommended a program of psychotherapy. Ex. 2 at 7; Ex. 28 at 15. In addition, Dr. Gold adjusted petitionerâs Tegretol dosage, described his plan to maintain petitioner on Tegretol until age sixteen, and indicated his intent to repeat an MRI scan in six to nine
On May 21, 1993, the Child Study Team classified petitioner as âperceptually impairedâ and adopted an Individualized Education Program to begin the next school year. Ex. 21 at ¶ 10; Ex. 23 at 13; Ex. 25 at 47-51. Then, as recommended by Dr. Gold, petitioner underwent a third MRI scan on December 27, 1993, which revealed a â[s]light asymmetry of the temporal horns and the lateral ventricle.â Ex. 2 at 14; accord Ex. 28 at 47. In a January 21, 1994 letter to petitionerâs pediatrician, Dr. Gold indicated that petitioner should next âbe evaluated electrically and clinically in May 1994.â Ex. 28 at 47.
Petitioner returned to see Dr. Gold on April 1 or April 2, 1994, for his âpreviously described seizure disorder.â See Ex. 2 at 5-6 (April 2, 1994); Ex. 28 at 14 (April 1, 1994). Dr. Gold reported that petitioner remained free of seizures and that he planned to maintain petitioner on Tegretol and order supplementary studies. Ex. 2 at 5-6. Dr. Gold contemplated âdecreasing and discontinuing the Tegretol ... after the summer vacation period.â Id. at 6. In addition, Dr. Gold wrote: âRelative to seizures[, petitionerâs father believes that they are related to the hepatitis B vaccination in that the initial seizure occurred three weeks after the first immunization and the second seizure four days after the second vaccination. This time sequence would be highly atypical for a vaccinal encephalopathy.â Id. Notably, Dr. Goldâs record of (1) petitionerâs fatherâs suggestion of a causal relationship between the hepatitis B vaccinations and petitionerâs episodes and (2) his own opinion regarding the suggestion constitute the first mention of such a possibility in the medical records.
Dr. Gold also commented on petitionerâs academic progress in his April 1994 report. Id. at 5. Dr. Gold noted that petitioner received collaborative instruction in English and social studies and that petitioner was in an advanced biology class. Id.; see also Ex. 22 at 8 (noting, in petitionerâs affidavit, that petitioner was âclassified as being a Special Education Student in high school,â which meant he could participate in collaborative classes). Petitioner was on the honor roll in âthe first marking periodâ but had âdifficulties in the second marking period.â Ex. 2 at 5; cf. Ex. 31 at 7 (indicating petitionerâs final grades for each year in high school as mostly As and Bs, with one C in his sophomore year and three Cs in his senior year). Dr. Gold also indicated that petitioner was undergoing successful psychotherapy in weekly sessions. Ex. 2 at 5; see also Ex. 22 at 8 (noting, in petitionerâs affidavit, that petitioner was seeing âa psychologist weekly to work through [his] anxiety and angerâ).
Petitioner had another EEG on April 28, 1994. Ex. 28 at 44-45. In a May 6, 1994 letter to petitionerâs pediatrician, Dr. Gold wrote that while there was âintermittent generalized rhythmical slowing ..., there were no definitive epileptiform discharges observed.â Id. at 44. Dr. Gold concluded that âthere was no evidence of a seizure disorder with only mild nonspecific abnormalities of questionable significance.â Id. Dr. Gold relayed this information, presumably to petitionerâs parents, during a May 31, 1994 telephone call. Id. at 13. During the same telephone call, Dr. Gold reiterated his plan to decrease and ultimately discontinue petitionerâs use of Tegretol after the summer vacation. Id. Although not contemporaneously noted in the medical records, Dr. Gold did begin to taper petitionerâs Tegretol dosage. See id. at 39; Ex. 2 at 11. At mid-dosage, on October 29, 2004, petitioner underwent another EEG, which was âvery mildly abnormal due to rhythmical generalized slowingf,] but at no time were there epileptiform discharges.â Ex. 2 at 11; accord Ex. 28 at 39, 41. Thus, Dr. Gold recommended a continuation of the Tegretol tapering, with a repeat EEG to be done one month after the Tegretol had been discontinued. Ex. 28 at 39.
Petitioner stopped taking Tegretol on December 5, 1994. Ex. 2 at 11. Petitioner asserts that the next day, he felt dizzy and faint in gym class, but did not pass out. Ex. 22 at ¶ 8; see also Ex. 21 at ¶ 11 (indicating, in an affidavit prepared by petitionerâs mother, that petitioner âhad another seizureâ on December 6, 1994). In addition, petitioner reported that upon the discontinuation of the Tegretol, he began to have impulses to hit a wall or the bed, a feeling petitioner recalled
Based upon petitionerâs history and the EEG results, Dr. Gold opted to restart petitioner on Tegretol on December 17, 1994. Ex. 2 at 11; Ex. 28 at 13. During a December 31, 1994 physical examination, Dr. Gold found petitioner to be within normal neurological limits. Ex. 2 at 11. Dr. Gold also noted that petitioner had not had any âspellsâ since restarting the Tegretol. Id. Thus, Dr. Gold opted to maintain the current Tegretol regimen, but suggested that a placebo trial might be appropriate in the future. Id. at 11-12. Dr. Gold recommended further evaluation in April 1995. Id. at 12.
Dr. Gold continued to treat petitioner through at least October 1999. See Ex. 28 at 10-11 (containing Dr. Goldâs handwritten notes of telephone conversations with petitioner and petitionerâs mother in October 1999). Petitioner has also been seen by other physicians since December 1994. For example, petitioner saw Dr. Patel on March 14, 1997, for his hand tremors. Ex. 3 at 1. Of note in Dr. Patelâs report of the examination is the following passage:
The exact etiology of partial complex seizure is unclear to me. There is family history of seizures in his father. The mother has done extensive research to ascertain if [petitionerjs seizures are secondary to Hepatitis B vaccine. No information to support this is available to me at this time.
Id. at 4.
Having graduated from the School of Visual Arts at Syracuse University, petitioner presently works as a graphic designer. Ex. 22 at ¶ 8. Petitioner continues to have âdifficulty remembering information, direction, details, [and] names____â Id. In addition, petitioner continues to take Tegretol and see a neurologist and a psychologist. Id.
B. Procedural History
Petitioner filed his petition for compensation on July 26, 1999. As noted by the special master, â[a]fter the petition was filed, the case moved slowly.â Nussman, 2008 WL 449656, at *7. The reasons for the slow pace of the proceedings are clearly detailed by the special master and need not be repeated here. See id. at *7-8. Eventually, both parties submitted expert reports from pediatric neurologistsâMarcel Kinsbourne, M.D. for petitioner and S. Robert Snodgrass, M.D. for respondentâand hearings were conducted on March 2 and July 19, 2007. Id. The special master issued his ruling on January 31, 2008, denying petitionerâs claim for compensation. Id. at * 19. Specifically, the special master concluded that a preponderance of evidence showed that (1) petitioner did not fit within the âehallenge-reehallengeâ paradigm because petitioner did not experience adverse reactions to either hepatitis B vaccination, id. at *9; and (2) there was a medical theoryâa delayed hypersensitivity reactionâcausally connecting the vaccinations and petitionerâs episodes, id. at *12-13. However, the special master found that petitioner failed to prove by a preponderance of evidence that (1) there existed a logical sequence of cause and effect connecting the hepatitis B vaccinations to petitionerâs episodes, id. at *13-14; and (2) petitionerâs episodes occurred within a medically acceptable period of time postvaeeination, id. at *14-17. Petitioner filed a motion for review on March 3, 2008, to which respondent responded on April 2, 2008. The court heard argument on July 2, 2008, and the case is now ripe for decision.
II. DISCUSSION
The United States Court of Federal Claims has jurisdiction to review the record of the proceedings before a special master, and upon such review, may:
*117 (A) uphold the findings of fact and conclusions of law of the special master and sustain the special masterâs decision,
(B) set aside any findings of fact or conclusion of law of the special master found to be arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law and issue its own findings of fact and conclusions of law, or
(C) remand the petition to the special master for further action in accordance with the courtâs direction.
42 U.S.C. § 300aa-12(e)(2). In the instant case, petitioner enumerates, pursuant to Vaccine Rule 24, three objections to the special masterâs decision. First, petitioner asserts that the special master held him to an elevated burden of proof by requiring him to prove that his case fit within the challenge-rechallenge paradigm, contrary to the decision of the Federal Circuit in Althen v. Secretary of HHS, 418 F.3d 1274, 1278 (Fed.Cir.2005). Mot. Review (âMot.â) 2. Second, petitioner contends that by virtue of the special masterâs findings, he has proven causation pursuant to Althen. Id Third, petitioner argues that the special master improperly discussed the extent of the sequelae of his injury. Id The court discusses petitionerâs first two objections together, and then addresses petitionerâs third objection.
A. Proving Causation Under the Vaccine Act
Pursuant to 42 U.S.C. § 300aa-13(a)(l), the court shall award compensation if petitioner proves, by a preponderance of evidence, all of the elements set forth in 42 U.S.C. § 300aall(e)(l) and that the illness is not due to factors unrelated to the administration of the vaccine.
In Althen, the Federal Circuit articulated a three-part test, based on prior precedent, explaining what a petitioner must show to prove causation-in-fact under the Vaccine Act:
[Petitioner]^ burden is to show by preponderant evidence that the vaccination brought about [the] injury by providing: (1) a medical theory causally connecting the vaccination and the injury; (2) a logical sequence of cause and effect showing that the vaccination was the reason for the injury; and (3) a showing of a proximate temporal relationship between vaccination and injury.
418 F.3d at 1278. The first prong seeks to demonstrate whether â âthe vaccine(s) at issue cause the type of injury alleged.â â Pafford 451 F.3d at 1355-56 (quoting the decision of the special master as recited by the trial court). The second prong requires a petitioner to show âthat the vaccine was the âbut forâ cause of the harm,â id. at 1356, or, in other words, â âthat the vaccine actually caused the alleged symptoms in [the] particular ease,ââ id. (quoting the decision of the special master as recited by the trial court). Although probative, proof of the third prong is insufficient to prove causation. Althen, 418 F.3d at 1278.
1. The Court Finds No Error in the Special Masterâs Conclusion That Petitioner Established the First Althen ProngââA Medical Theory Causally Connecting the Vaccination and the Injuryâ
Petitioner offered the expert opinion and testimony of Dr. Kinsbourne to supply a
The special master found Dr. Kinsbourneâs evidence regarding a possible medical theory to be both âweak[]â and âflaw[ed].â Nussman, 2008 WL 449656, at *13. Specifically, the special master explained:
In Dr. Kinsbourneâs report, he identified two other theories, an immune complex disease causing serum sickness and an immune complex disease causing vasculitis. Dr. Kinsbourne supplied literature to buttress his opinion and to show his theory that the hepatitis B vaccine can cause a seizure disorder was biologically plausible. After Dr. Kinsbourne withdrew these theories, the relevance of these articles decreased greatly. [Petitioner] did not offer any supplemental exhibits discussing hepatitis B vaccine causing a delayed hypersensitivity reaction following Dr. Kinsbourneâs testimony.
It should be noted that Dr. Kinsbourne backed away from the two theories identified in his own report. Dr. Kinsbourneâs resort to a third choice suggests a lack of critical thinking in his report and calls into question the accuracy of his theory. If delayed hypersensitivity were a theory that scientists were exploring to explain an alleged association between the hepatitis B vaccine and seizures, then Dr. Kinsbourne would probably have presented this theory in his report and discussed it prominently.
Id. (citations omitted). The special master found that â[t]hese flaws diminish[ed] Dr. Kinsbourneâs persuasiveness,â which the special master would take into account when evaluating the remainder of Dr. Kinsbourneâs evidence. Id.
The weakness of Dr. Kinsbourneâs evidence notwithstanding, the special master concluded that petitioner satisfied the first prong of Althen. Respondentâs expert, Dr. Snodgrass, opined that while it was âpossibleâ for a hepatitis B vaccination to cause a delayed hypersensitivity reaction, which might manifest as a seizure, he did not find it that it was âlikelyâ or âprobableâ in this case. Mar. Tr. 107, 124. As noted by the special master, a petitioner is not required to prove the proffered medical theory. Nussman, 2008 WL 449656, at *13 (citing Knudsen ex rel. Knudsen v. Secây of HHS, 35 F.3d 543, 549 (Fed.Cir.1994)). Thus, based upon the testimony of Dr. Kinsbourne and Dr. Snodgrass, the special master concluded that petitioner had established, by a preponderance of evidence, a medical theory that could explain how the hepatitis B vaccine could cause petitionerâs episodes. Id. Neither party challenges the special masterâs conclusion, and the court does not find the conclusion âto be arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.â
The special master found that petitioner failed to establish, by a preponderance of evidence, a logical sequence of cause and effect linking the hepatitis B vaccinations to his two episodes, and identified two reasons for the failure. Id. First, the special master held that petitioner had not proven that his case was one of challenge-rechallenge, the theory proposed by Dr. Kinsbourne to explain how the hepatitis B vaccinations did cause petitionerâs episodes. Id. Second, the special master noted that petitionerâs treating physician, Dr. Gold, did not believe that the vaccinations caused petitionerâs episodes. Id. The court addresses each basis for the special masterâs conclusion in turn.
a. The Court Finds No Error in the Special Masterâs Conclusion That Petitioner Did Not Establish That Petitioner Fit Within the Challenge-Re-challenge Paradigm
The special master explained that â[c]hallenge-rechallenge happens when a person (1) is exposed to one antigen, (2) reacts to that antigen in a particular way, (3) is given the same antigen again, and (4) reacts to that antigen similarly.â Id. at *9. Typically, the second reaction is faster and more severe. Id. (citing Mar. Tr. 104); Mar. Tr. 88, 122. As the special master noted throughout his decision, petitioner, through Dr. Kinsbourne, relied heavily on the proposition that petitioner fit within the challenge-reehallenge paradigm. See Nussman, 2008 WL 449656, at *9 (âThe primary, if not exclusive, support for Dr. Kinsbourneâs opinion is that [petitioner]^ case fits a model known as challengereehallenge.â), *13 (â[C]hallenge-rechallenge ... is the primary (if not sole) reason offered in support of his claim.â), *14 (âDr. Kinsbourne relies almost exclusively upon [petitioner]^ presentation as an example of challengereehallenge.â), *19 (âAt its core, the question is whether [petitioner]^ case fits within the challenge-reehallenge paradigm.â). Such reliance was evident in Dr. Kinsbourneâs testimony. See Mar. Tr. 23 (noting that the timing of the second episode âenable[d] me to testify to a causal relationship between the vaccine and the seizuresâ), 23-24 (indicating that petitionerâs second episode âputs the clinical picture into the context of the challenge/rechallenge phenomenon, and that is really the basis on which I make my causation opinionâ), 44 (asserting that â[i]n [petitionerâs] ease, my evidence is the ehallenge/rechallengeâ), 57 (noting that he was ârelying on rechallengeâ).
With respect to petitionerâs first episode, which occurred forty-one days postvaccination, the special master found that petitioner âprovided little persuasive evidence that he had an adverse reaction when âchallengedâ by the first dose of the hepatitis B vaccine.â Nussman, 2008 WL 449656, at *10. The special master explained that although Dr. Kinsbourne testified that an immune-mediated neurological âreaction would manifest between 5 and 42 days,â id. (citing Mar. Tr. 22, 46), he âprovided little basis for his estimate that an adverse reaction to the hepatitis B vaccine could take as long as 42 days,â id. (citing Mar. Tr. 45-47). Thus, the special master concluded that petitioner had not shown, by a preponderance of evidence, that petitioner âsufferfed] from an adverse reaction fromâ the December 10,1992 hepatitis B vaccination. Id.
The special master found the evidence presented in support of rechallenge âeven less persuasive.â Id. First, petitionerâs second episode occurred no more than three days postvaccination. See swpra note 6. As noted by the special master, a three-day interval between vaccination and injury âfalls outside the temporal window estimated by Dr. Kinsbourne.â Nussman, 2008 WL 449656, at * 11. Although the special master indicated that âbecause [petitioner]^ alleged adverse response is to his second exposure to the hepatitis B vaccine, it is conceivable that his response could have been somewhat quicker,â the special master concluded:
[A] quicker response should be close to the previous response. If [petitioner]^ body followed the same immune process*120 after receiving both the first and second doses, then the second reaction would have taken approximately the same amount of time. Although the second reaction may be faster, the second reaction should not be 13 times quicker. The great discrepancy between the timing of the two events suggests that [petitioner] did not have the same reaction.
Id.
The court finds no error in the special masterâs conclusion that petitioner did not adversely react to the December 10, 1992 vaccination. The special master found petitionerâs evidence on this point to be minimal, and the court agrees. Furthermore, petitioner does not challenge this conclusion. See Mot. 8 (âFor the purposes of this motion for review, Petitioner will assume that 42 days is too long and that whatever happened after the first dose of vaccine was a different event and had nothing to do with vaccines.â
However, the special masterâs error is of little consequence to his ultimate finding that petitioner does not fit the challenge-rechallenge model. There can only be reehallenge if there was an initial challenge and associated adverse reaction. See Nussman, 2008 WL 449656, at *9. Because the court upholds the special masterâs determination that petitioner has not proven by a preponderance of evidence that petitioner adversely reacted to the December 10, 1992 vaccine, the issue of the existence of reehallenge is moot.
Furthermore, the objection raised by petitioner to the special masterâs focus on the challenge-rechallenge model lacks merit. Petitioner argues that the special master required him to prove that he fit within the challenge-rechallenge paradigm, which would improperly elevate petitionerâs burden of proof. Mot. 5-9. Specifically, petitioner asserts:
No case in the program has ever required that Petitioner demonstrate âchallengerechallenge.â Such a requirement would be an absurdity, particularly for someone who has an obvious reaction to one vaccination. No one would suggest that, in order to prevail in the program, the person should be required to get another vaccination in order to demonstrate âchallenge-rechallenge.â And yet the Special Masterâs decision is clearly based, almost entirely, upon a failure to fit this ease âwithin the challenge-rechallenge paradigm.â
Id. at 5. Despite petitionerâs charges, the court is unable to discern where in his decision that the special master ârequiredâ petitioner to demonstrate âehallenge-reehallengeâ as a condition for receiving compensation. As explained below, petitionerâs assignment of error is wholly unfounded.
First, the challenge-rechallenge model was proffered by petitioner as evidence that the
Second, petitionerâs argument is unavailing because he conflates the first two prongs of the Althen analysis. In his motion, petitioner contends:
While [evidence of challenge-rechallenge] was the evidence that Petitioner was hoping the Special Master would accept in support of there being a medical theory causally connecting the hepatitis B vaccination with a seizure disorder, such evidence proved not to be necessary, since, as the Special Master pointed out, a medical theory WAS proven, albeit with the assistance of respondentâs counsel and respondentâs expert.
Mot. 7. In fact, the medical theory accepted by the special masterâa delayed hypersensitivity reactionâsatisfied only the first prong of Althen. Petitioner remained obligated to establish Althenâs second prong, see Capizzano v. Secây of HHS, 440 F.3d 1317, 1327 (Fed.Cir.2006) (noting that Althenâs second prong âis not without meaningâ), and he thus offered the challenge-reehallenge model to make the required showing. Proof of a medical theory explaining how a vaccine could cause an injury is analytically distinct from proof that a vaccine actually did cause the injury.
Ultimately, petitioner was required to establish the second prong of Althenâthat there was a logical sequence of cause and effect linking the hepatitis B vaccinations to his two episodes. Thus, it was well within the special masterâs discretion to fully consider the challenge-rechallenge model proposed by petitioner to demonstrate the logical sequence of cause and effect. The court finds no error in the special masterâs analysis of petitionerâs proposed challenge-rechallenge model.
b. The Court Finds No Error in the Special Masterâs Consideration of Dr. Goldâs Records in Considering Whether the Hepatitis B Vaccinations Caused Petitionerâs Episodes
Because petitioner was unable to establish the second Althen prong using the challengerechallenge model, it was necessary for him to find an another means to demonstrate the logical sequence of cause and effect connecting the hepatitis B vaccinations to his episodes. Petitioner opted not to present any additional expert testimony on causation, so the special master looked to the records of petitionerâs treating neurologistâDr. Gold. See Nussman, 2008 WL 449656, at * 14. As the binding precedent of the Federal Circuit makes abundantly clear, the medical records and medical opinion of treating physicians are valuable in vaccine cases because âtreating physicians are likely to be in the best position to determine whether âa logical sequence of cause and effect show[s] that the vaccination was the reason for the injury.â â Capizzano, 440 F.3d at 1326 (quoting Althen, 418 F.3d at 1280). Thus, the special master was well within his discretion to evaluate Dr. Goldâs position.
From February 1993, when Dr. Gold began treating petitioner, until early 1994, there is no mention in any of Dr. Goldâs records that either he, petitioner, or petitionerâs parents linked petitionerâs episodes to the hepatitis B vaccinations. In fact, it was not until April 1994 that the hepatitis B vaccinations were mentioned, and only because the issue had been raised by petitionerâs father. See Ex. 2 at 6 (âRelative to seizures[, petitioner]âs father believes that
3. The Court Finds No Error in the Special Masterâs Conclusion That Petitioner Did Not Establish the Third Althen ProngââA Showing of a Proximate Temporal Relationship Between Vaccination and Injuryâ
As noted by the special master, petitioner bears the burden of proving, by a preponderance of evidence, a medically appropriate temporal relationship between his hepatitis B vaccinations and his subsequent episodes. See Nussman, 2008 WL 449656, at *14 (citing Pafford, 451 F.3d at 1358); see also Althen, 418 F.3d 1274 (requiring a petitioner to prove a âproximate temporal relationship between vaccination and injuryâ). Thus, petitioner presented evidence of an appropriate temporal relationship via the report and testimony of Dr. Kinsbourne and certain medical literature relied upon by Dr. Kinsbourne. Nussman, 2008 WL 449656, at *15-16. In his report and testimony, Dr. Kinsbourne indicated that immune-mediated neurological injuries typically occur between five and forty-two days after the first âexposure to the causative agent,â Mar. Tr. 22, and that a three-day interval between a second exposure and subsequent injury is consistent with rechallenge, id. at 23-24; Ex. 20 at 4. Dr. Kinsbourne further testified that a delayed hypersensitivity reaction could, in some eases, âtake six or eight weeks or two months.â Mar. Tr. 52; see also id. at 50 (noting that âdelayed hypersensitivity ... can take weeks and weeks to evolveâ).
The literature cited by Dr. Kinsbourne included a case report concerning a seizure occurring thirty days after exposure to the wild hepatitis B virus, and not the hepatitis B vaccination; a letter to the editor describing a febrile seizure developing within one hour postvaccination, which due to its timing could not be a delayed hypersensitivity reaction; an article hypothesizing that certain neurological conditions following infection or vaccination by between one and three weeks may occur as a result of a humoral response instead of a delayed hypersensitivity reaction;
The special master found none of the literature supplied by Dr. Kinsbourne on peti
Based on the expert reports, expert testimony, and medical literature, the special master concluded:
[T]he record does not support a finding that a delayed hypersensitivity reaction to the first dose of the hepatitis B vaccine would occur as many as 41 days after the receipt of the vaccine. Dr. Kinsbourne was not persuasive on this point for several reasons. He admitted that the precise number of days was not critical to his opinion. Tr. 71. Originally, he miscalculated the number of days between the first dose of the hepatitis B vaccine and the episode on January 20, 1993. Tr. 22, 45. He raised the idea of a possible delayed hypersensitivity reaction during cross-examination only after he withdrew two other possible mechanismsâa serum sickness reaction and a vasculitis. Then, when Dr. Kinsbourne introduced the theory of a delayed hypersensitivity reaction, he stretched the limit from six weeks to eight weeks. Tr. 52. Because Dr. Kinsbourne changed his theory several times, none of the theories he presented on this point are persuasive. Therefore, [petitioner] has failed to meet his burden of presenting persuasive evidence that his seizure occurred within an appropriate time frame.
Nussman, 2008 WL 449656, at *16; see also id. at *14 (âEvidence on the temporal relationship is sparse, but it preponderates in favor of finding that the hepatitis B vaccine, if it caused seizures, would cause seizures within 30 days.â). The court finds no error in the special masterâs conclusion.
Furthermore, as noted above, the special master concluded that although a three-day interval between vaccination and injury âfalls outside the temporal window estimated by Dr. Kinsbourne[,] ... because [petitionerâs alleged adverse response is to his second exposure to the hepatitis B vaccine, it is conceivable that his response could have been somewhat quicker.â Id. at *11 (citing Mar. Tr. 121-22 (containing Dr. Snodgrassâs testimony that petitionerâs second episode occurred between one and seven days postvaccination); Augustynski v. Secây of HHS, No. 99-611V, 2007 WL 3033614, at *4-5 (Fed.Cl. Spec.Mstr. Sept. 28, 2007) (concluding that a T-cell response could occur within twenty-four hours of a second hepatitis B vaccination because the petitioner had already been challenged by his first hepatitis B vaccination)). Although the special master ultimately concluded that petitioner did not have an adverse reaction to the April 1, 1993 vaccination, the court has rejected the rationale for that conclusion as unsupported by the record. Thus, the court allows to stand the special masterâs statement that an adverse response to a second hepatitis B vaccination could occur sooner than five days.
In addition, the court notes that there was evidence presented by Dr. Kinsbourne on the appropriateness of a three-day interval. In his expert report, Dr. Kinsbourne opined: âCoincidence is virtually ruled out by the timing of the second seizure, which occurred
4. Petitioner Has Waived His New Argument Isolating the Second Vaccination From the First Vaccination and, in any Event, Petitioner Cannot Prevail on That Argument
Petitioner has failed to prove, as required by Federal Circuit precedent, that taken together, his hepatitis B vaccinations caused his two episodes.
Any fact or argument not raised specifically in the record before the special master shall be considered waived and cannot be raised by either party in proceedings on review of a special masterâs decision. This rule shall not apply to legal arguments raised by the party that stands in the role of the appellee on review.
Respondent is correctâpetitioner waived its new argument by not raising it before the special master. See also Weddel v. Secây of HHS, 23 F.3d 388, 390 n. 2 (Fed.Cir.1994) (noting that âCongress has expressly forbiddenâ the Federal Circuit from considering two arguments that petitioners did not raise before the special master); Jay v. Secây of HHS, 998 F.2d 979, 983 & n. 4 (Fed.Cir.1993) (holding that petitioners had abandoned an argument that they âdid not pursue or defend ... either in their case in chief or on the motions for summary judgmentâ and that it would not consider a legally complex, alternative argument that was first raised on appeal). However, the court will briefly address the argument for petitionerâs benefit.
The second prong of the Althen III test is not without meaning. There may well be a circumstance where it is found that a vaccine can cause the injury at issue and where the injury was temporally proximate to the vaccination, but it is illogical to conclude that the injury was actually caused by the vaccine. A claimant could satisfy the first and third prongs without satisfying the second prong when medical records and medical opinions do not suggest that the vaccine caused the injury, or where the probability of coincidence or another cause prevents the claimant from proving that the vaccine caused the injury by preponderant evidence.
440 F.3d at 1327. Such is the case here. Neither the medical records nor the proffered medical opinion suggest that the April 1, 1993 hepatitis B vaccination actually caused petitionerâs second episode. Thus, petitionerâs new argument concerning causation, if not waived, would fail.
B. Sequelae
The special master concluded his decision with a section entitled âSequela,â which addresses the evidence concerning the impairment to petitionerâs cognitive abilities. Nussman, 2008 WL 449656, at *17-19. Petitionerâs third objection in his motion for review is to the special masterâs entire discussion of sequelae, which petitioner finds to be wholly inappropriate. Mot. 12-14. Specifically, petitioner asserts that a discussion of sequelae is an issue for the damages stage of proceedings, and has no place in an entitlement decision. Id. Respondent counters that evidence of sequelae is relevant to more than just damages, also bearing upon the Vaccine Actâs six-month duration of injury requirement and the credibility of Dr. Kinsbourne. Resp. 17-18. Although the special master provides no indication that he was addressing petitionerâs sequelae in relation to the six-month requirement, he was well within his discretion to include a discussion of sequelae in his decision.
First, the special master made it abundantly clear that his discussion of sequelae was not probative to his causation decision. See Nussman, 2008 WL 449656, at *9 (â[A]l-though resolution of this issue is not required due to [petitionerjâs failure to prove that the hepatitis B vaccine caused his seizure disorder, the evidence about the alleged sequela to [petitionerjâs seizure disorder is discussed in section C.â), *17 (âFinally, because [petitioner] has not established, by a preponderance of the evidence, that the hepatitis B vaccine caused any adverse effect, the question of sequela does not need to be resolved. Nevertheless, some comments about [petitionerjâs claims and his evidence are warranted.â), *19 (âWhether [petitioner] established any sequela to his seizure disorder is not relevant to the more fundamental question of whether [petitioner] established, by a preponderance of the evidence, that the hepatitis B vaccine caused his seizure disorder.â). In essence, the special masterâs discussion constituted dicta. Second, there is no provision in the Vaccine Act that prevents a special master from commenting upon evidence presented by the parties. Indeed, it was petitioner, not the special master, who raised the issue of cognitive impairmentâmanifesting as memory, concentration, and academic difficulties. See Ex. 20 at 2-3, 5; see also Petâr Posthrâg Br. 9 (discussing the evidence petitioner presented regarding sequelae); supra Part I.A (recounting some of petitionerâs difficulties). It is absurd for petitioner to now complain about the special master discussing
III. CONCLUSION
The special master correctly applied the legal standards set forth in the Vaccine Act and Federal Circuit precedent. The court concurs with the special master that petitioner did not satisfy the second or third prongs of the Althen analysis because he failed to prove, by a preponderance of evidence, either a logical sequence of cause and effect or a proximate temporal relationship between the hepatitis B vaccinations and his two episodes. Thus, for the reasons set forth above, the court SUSTAINS the decision of the special master and DENIES petitionerâs motion for review. The clerk is directed to enter judgment accordingly.
IT IS SO ORDERED.
. The facts are derived from petitionerâs exhibits ("Ex.") and the transcript of the July 19, 2007 hearing ("July Tr.").
. As the special master noted in his decision, petitioner did not provide a contemporaneous record of his hepatitis B vaccination. Nussman v. Secây of HHS, No. 99-500V, 2008 WL 449656, at *2 (Fed.Cl. Special Masters Jan. 31, 2008). Petitioners are required to submit with their petition, among other items, "supporting documentationâ that the injured person "received a vaccine set forth in the Vaccine Injuiy Table,â or a statement indicating that such documentation is âunavailable to the petitioner and the reasons for their unavailability.â 42 U.S.C. § 300aa-11(c). Although petitioner's counsel averred in the July 26, 1999 petition that "counsel hereby affirms that he is in the process of obtaining the medical records to be filed," Pet. ¶ 4, a copy of the vaccination recordâa key record in Vaccine Act casesâwas not requested from petitioner's pediatrician until 2004, about five years after he filed the petition and more than two years after petitionerâs pediatrician was required to have kept a copy of the record pursuant to New Jersey law, Nussman, 2008 WL 449656, at *2. However, the special master found, and the court agrees, that there is a preponderance of evidence that petitioner received a hepatitis B vaccination on December 10, 1992. See id. Further, respondent does not contest this finding. See Respât Posthrâg Br. 24 ("[Wjhile it would be preferable to have an actual vaccination record to establish the dates of immunization, respondent is satisfied in this case that the vaccination history submitted by petitioner is - sufficient to prove, at least by a preponderance of the evidence, that petitionerâs first Hep B vaccine occurred on December 10, 1992....â).
. Dr. Gold offered a different description of the referral process in his contemporaneous record. Dr. Gold indicated that petitioner's pediatrician referred petitioner to Dr. Schneider, and that further consultation with Harvey White, M.D., resulted in the referral to Dr. Gold. Ex. 2 at 1.
. As with the December 10, 1992 hepatitis B vaccination, petitioner did not submit a contemporaneous record of the April 1, 1993 hepatitis B vaccination. However, the special master found, and the court agrees, that there is a preponderance of evidence that petitioner received a hepatitis B vaccination on April 1, 1993. See Nussman, 2008 WL 449656, at *4. Further, respondent does not contest this finding. See Respât Posthrâg Br. 24 ("[W]hile it would be preferable to have an actual vaccination record to establish the dates of immunization, respon
. The date of this second episode is not clear from the records. In her first affidavit, signed on December 18, 2006, petitionerâs mother indicated that the episode occurred three days after the vaccination (i.e., April 4, 1993), Ex. 21 at ¶ 9, but in her second affidavit, signed on May 9, 2007, she indicated that the episode occurred during the weekend following the vaccination (i.e., April 3 or April 4, 1993), Ex. 29 at ¶ 1. Further, in a report prepared on March 14, 1997, neurologist Poorvi Patel, M.D. wrote that petitionerâs mother asserted that the second episode occurred the day after the second vaccination. Ex. 3 at 1-2. Because petitionerâs mother telephoned Dr. Gold on April 4, 1993, to report the seizure, July Tr. 239, and because Dr. Gold did not prescribe an anticonvulsant until April 5, 1993, Ex. 28 at 5; Ex. 30 at 1, the only probable dates for the second episode are April 2, April 3, or April 4, 1993. The special master concluded that the episode occurred on April 4, 1993. Nussman, 2008 WL 449656, at *4-5. Although respondent argued in its posthearing brief that petitioner had not proven by a preponderance of evidence the precise date of the second episode, Resp't Posthrâg Br. 24-25, respondent did not contest the special masterâs finding in its response to petitioner's motion for review, Resp't Mem. Resp. Petâr Mot. Review ("Resp.â) 3 (âThree days later, on April 4, 1993, petitioner experienced an event at a friendâs house .... â), 14-17 (discussing the three-day temporal relationship between the second hepatitis B vaccination and the second episode). For the purposes of this decision, it is immaterial whether this second episode occurred on April 2, April 3, or April 4, 1993.
. Andy did not provide an affidavit or testify at hearing. Nussman, 2008 WL 449656, at *10. However, special masters are not constrained by the Federal Rules of Evidence, 42 U.S.C. § 300aal2(d)(2)(B); Vaccine Rule 8(c), such as the hearsay rule enunciated in Federal Rule 802. The special master in this case found the testimony of petitionerâs mother to be credible, Nussman, 2008 WL 449656, at *11, and the court will not overturn the special masterâs credibility determination. See Pafford v. Sec'y of HHS, 451 F.3d 1352, 1355-56 (Fed.Cir.2006) (noting that the United States Court of Appeals for the Federal Circuit ("Federal Circuitâ) "accords great deference to a Special Masterâs determination on the probative value of evidence and the credibility of witnessesâ); Lampe v. Secây of HHS, 219 F.3d 1357, 1360 (Fed.Cir.2000) (reaffirming that â âthe probative value of the evidenceâ â and " âthe credibility of the witnessesâ " are " âmatters within the purview of the fact finder' " (quoting Munn v. Sec'y of HHS, 970 F.2d 863, 871 (Fed. Cir.1992))).
. Dr. Gold indicated in a March 15, 2007 typewritten letter that one of petitionerâs parents telephoned him on April 3, 1993, to report a âsecond seizure.â Ex. 28 at 53. As noted by the special master, â[t]his letter holds relatively little persuasive value.â Nussman, 2008 WL 449656, at *5 n. 4. First, the letter was written in 2007, approximately fourteen years after the events at issue. Id.; Ex. 28 at 53. In addition, the letter is not supported by Dr. Gold's handwritten notes, and there is no other indication how Dr. Gold refreshed his recollection. Nussman, 2008 WL 449656, at *5 n. 4; Ex. 28 at 53.
. Subsection (c)(1) requires, among other things, that the following elements be satisfied: (1) that the vaccine in question is set forth in the Vaccine Injury Table (âTableâ); (2) that the vaccine was received in the United States or in its trust territories; (3) that the injured person either sustained an injury as a result of the administration of a Table-designated vaccine for a period of more than six months after the administration of the vaccine, suffered illness, disability, injury, or condition from the vaccine that resulted in inpatient hospitalization and surgical intervention, or died from the administration of the vaccine; and (4) that the petitioner has not previously collected an award or settlement of a civil action for damages arising from the alleged vaccine-related injury or death. 42 U.S.C. § 300aa-l 1(c)(1).
. The court notes that "42â is a typographical error. In the previous paragraph, petitioner asserted that the special master "determined that the onset was 42 days.â Mot. 8. However, the special master actually determined that onset was at forty-one days postvaccination. See Nussman, 2008 WL 449656, at *10 ("[Petitionerl's blackout (or seizure) happened 41 days after he received the vaccination.â).
. While there was preponderant evidence that the second reaction in the challenge-rechallenge model generally occurs faster than the first reaction, it appears that neither party presented evidence regarding how much faster the second reaction would occur.
. Such a finding would have been unlikely because, as the special master noted, both Dr. Kinsbourne and Dr. Snodgrass testified to Dr. Goldâs excellent reputation in treating seizure disorders. See Nussman, 2008 WL 449656, at *14 (citing Mar. Tr. 33, 106).
. As explained by Dr. Snodgrass in his testimony, a humoral response refers to the immune systemâs production of antibodies in response to the introduction of an antigen, while a delayed hypersensitivity reaction is the immune system's production of T lymphocytes (i.e., T-cells) in response to an antigen. Mar. Tr. 115. The responses are entirely distinct. Id.
. The court notes that although petitioner presented medical literature to support his proffered temporal relationship and the special master considered that medical literature, petitioners are not required to provide or cite medical literature to prove causation. Althen, 418 F.3d at 1279-80.
. The special master only briefly referred to the alleged three-day interval outside of the challenge-rechallenge paradigm. First, the special master quoted the definition of "delayed hypersensitivity reactionâ from a medical dictionary: "A delayed hypersensitivity reaction is a reaction 'initiated by antigen-specific T lymphocytes; unlike forms of hypersensitivity mediated by antibodies, it takes one or more days to develop.â â Nussman, 2008 WL 449656, at *12 (quoting Dorland's Illustrated Medical Dictionary 888 (30th ed.2003)). Next, the special master asserted, without citation to the record, that "a delayed hypersensitivity reaction ... requires at least a few days to develop.â Id. at *15. The statements, considered together or in isolation, do not amount to preponderant evidence of a temporal relationship.
. Accordingly, the burden did not shift to respondent to prove an alternative cause for petitionerâs episodes, as petitioner suggests. See Mot. 11 (noting that because petitioner had met its burden to show causation, the burden to prove an alternative cause shifted to respondent).