OPINION AND ORDER
• This case is before the Court for review of the Special Master’s March 4, 2011 decision on remand denying compensation to Scott R. Hammitt, on behalf of his daughter, Rachel Hammitt, under the National Vaccine Injury Compensation Program, 42 U.S.C. §§ 300aa-10 to -34 (“the Vaccine Act”). Mr. Hammitt claims that Rachel’s DTaP (diphtheria, tetanus, and acellular pertussis) vaccination caused her to develop an acute seizure disorder known as Severe Myoclonic Epilepsy of Infancy (“SMEI”). Respondent contends, and the Special Master found, that a genetic component, a mutation of the SCN1A gene, predetermined that Rachel eventually would develop SMEI, whether or not she received the DTaP vaccine. For the reasons addressed below, the Court affirms the Special Master’s decision.
Factual Background
Rachel Hammitt was born on November 9, 2003. Hammitt v. Sec’y of Health & Human Servs., No. 07-170V,
Rachel’s temperature upon admission to the Pediatric Emergency Department of Hillerest Hospital was 100.4 degrees Fahrenheit. Id. The doctors gave Rachel valium, and she stopped seizing but remained stiff for approximately twenty minutes. Id. At 8:45 PM, Rachel was given a CT scan, which was normal. Id. Afterward, Rachel was crying and “moving all four extremities.” Id. (quoting Pet’r’s Ex. 2(b) at 19). By 9:10 PM Rachel was breast feeding, and by 9:30 PM she had fallen asleep in her mother’s arms. Id. At 9:45 PM, Rachel was transferred to Cleveland Clinic Foundation Children’s Hospital (“CCF”). Id. There, doctors noted that Rachel had a “possible adverse event post vaccination” and an “atypical complex febrile seizure.” Id. (quoting Pet’r’s Ex.. 4(a) at 6). One day later, on March 16, 2004, a neurology student examined Rachel, recording that Rachel was alert and cheerful, and noting that a “DTaP reaction seems most likely.” Id. (quoting Pet’r’s Ex. 4(a) at 10). Rachel was then given an electroencephalogram (EEG) test, which was normal. Id. She was diagnosed as having had a complex febrile seizure and was discharged from CCF that day. Id.
On April 22, 2004, at 4:30 AM, Rachel suffered a second seizure. (Pet-¶ 6.) Her parents called 911, and at the hospital where she was taken, her laboratory work and CT scan were found to be within normal limits. Hammitt I, at *2. An EEG test performed at CCF the following day “showed focal epilepsy from the right posterior quadrant, but improved from the previous 24 hours.” Id. (quoting Pet’r’s Ex. 4(b) at 18). The EEG test also showed evidence of a “severe diffuse encephalopathy.” Id. (quoting Pet’r’s Ex. 4(b) at 48). Rachel, however, appeared awake and playful. Id. She was discharged on April 26, 2004 with a prescription for Dilantin and a scheduled follow-up appointment. Id. ■ Thereafter, Rachel continued to suffer intermittent seizures. Id.
On November 12, 2004, Rachel visited her pediatrician for her twelve-month check-up. (Pet’r’s Ex. 3(a) at 25.) Records from that appointment show a diagnosis of epilepsy but report normal growth and development.
CCF’s Department of Neurology performed another EEG test on Rachel on March 4-5, 2005. Hammitt I, at *3. She was assessed as having multiregional epilepsy. Id. Records also note that Rachel suffered mild developmental delay in language. Id.
Genetic testing ordered on May 3, 2005 showed that Rachel has a de novo mutation (appearing for the first time in one family member) in her SCN1A gene. Id. According to the report accompanying the test results, this DNA variant is “associated with a severe phenotype (SMEI or SMEB) rather than a mild or normal phenotype.” Id. (quoting Pet’r’s Ex. 12 at 2). At a follow-up appointment, Dr. Ajay Gupta indicated that Rachel’s “clinical course, EEG, and SCN1A test ... are suggestive of severe myoclonic epilepsy of infancy.” Id. (quoting Pet’r’s Ex. 5 at 48^9).
History of Proceedings
On March 13, 2007, Petitioner Scott Ham-mitt filed a claim in this Court for compensation under the Vaccine Act. Id. at *1. He asserted in his petition that the DTaP vaccination administered to Rachel on March 15, 2004 “caused her to develop a severe seizure disorder and to suffer profound developmental delays.” Id. (quoting Pet. ¶ 3). Between March 2007 and April 2009, Mr.. Hammitt filed 26 exhibits in support of his claim, including expert reports from neurologist Mar-eel Kinsbourne, M.D., and medical literature. Id. Respondent submitted its Rule 4(c) report on April 14, 2008, contending that Mr. Hammitt is not entitled to compensation under the Vaccine Act and that his petition should be dismissed. Id. Citing expert opinions of neurologist Max Wiznitzer, M.D., and neurologist and geneticist Gerald Raymond, M.D., Respondent asserted that Rachel’s SCN1A gene mutation, not her DTaP vaccination, caused her SMEI. Id. Although the Special Master afforded Mr. Hammitt additional time to file an expert response and Mr. Hammitt’s counsel indicated in a status report that he would provide a geneticist’s opinion, Mr. Hammitt ultimately opted not to retain an additional expert witness. Id. Instead, Mr. Hammitt filed a response by Dr. Kinsbourne on April 3, 2009. Id.
On May 14 and 15, 2009, the Special Master held a hearing to elicit expert testimony. Id. Mr. Hammitt presented his case-in-ehief through the testimony of Dr. Kinsbourne, while Respondent presented the testimony of Dr. Wiznitzer in rebuttal. Id. To address Respondent’s contention regarding Rachel’s SCN1A gene mutation, Respondent presented the testimony of Dr. Raymond, and Mr. Hammitt presented the testimony of Dr. Kinsbourne. Id. For expediency, the Special Master heard testimony at the same time in Stone v. Sec’y of Health & Human Servs., No. 04-1041V,
On August 31, 2010, Special Master Gol-kiewicz issued his decision denying compensation to Mr. Hammitt. Id. at *47. In a 54-page opinion, the Special Master found that “Rachel’s SCN1A gene mutation was more likely than not the ‘but for’ and ‘substantial factor’ that caused her Severe Myclonic Epilepsy of Infancy or Dravet Syndrome.” Id. Mr. Hammitt filed a motion for review in this Court, contesting the Special Master’s causation analysis of Respondent’s “factor unrelated” defense, and his conclusion that Rachel’s DTaP vaccination was not a substantial cause of her SMEI. (Pet’r’s Mem. Obj. at 1, Sept. 28, 2010.) Respondent filed a response on October 28, 2010, asking this Court to affirm the Special Master’s decision. (Resp’t’s Resp. to Pet’r’s Mot. for Review at 18, Oct. 28, 2010.) The Court heal’d oral argument on December 16, 2010.
On December 22, 2010, the Court issued an order remanding the case to Special Master
On remand, Mr. Hammitt sought to file new evidence, including an article from a medical journal and letter to the editor intended to link vaccines to SMEI, as well as another report from Dr. Kinsbourne. (Pet’r’s Mot. for Leave to File Evid. on Remand, Jan. 13, 2011.) Mr. Hammitt filed a motion with the Special Master and the Court to allow this evidence. Id. Respondent filed a response to the motion, contending that Mr. Hammitt’s new evidence was untimely, beyond the scope of the Court’s Remand Order, and insufficient to alter the Special Master’s conclusion denying compensation. (Resp’t’s Resp. to Pet’r’s Mot. for Leave to File Evid. on Remand at 3, Jan. 26, 2011.) The Special Master denied the motion because this Court’s Remand Order called for proper evaluation of evidence existing in the record, not further development of the record, and because Mr. Hammitt failed to file this additional evidence earlier in the proceedings, despite knowing of its existence “well in advance of’ the Special Master’s initial decision. (Order Den. Pet’r’s Mot. for Leave to File Evid. on Remand at 2-3, Feb. 3, 2011.) The Special Master also noted that Mi'. Hammitt’s proposed additional evidence “does not appear to support petitioner’s case.” Id.
The parties filed simultaneous briefs on remand with arguments focused on the issues raised in the Remand Order. Mr. Ham-mitt attempted to demonstrate a prima facie ease by addressing the three prongs of Al-then, while arguing that Rachel’s SCN1A gene mutation was not the sole substantial factor that caused her SMEI. (Pet’r’s Br. on Remand 1-2, 8, Feb. 4, 2011.) Respondent contended that the “overwhelming evidence of a non-vaccine cause of Rachel’s seizure disorder — namely, her SCN1A genetic mutation — demonstrates the inadequacy of petitioner’s evidence attempting to establish a prima facie case of vaccine causation under Althen,” and that even if Mr. Hammitt established a prima facie case, Respondent met its burden of proving its “factor unrelated” defense. (Resp’t’s Mem. Resp. Remand Order 1-2, Feb. 4, 2011.)
On March 4, 2011, the Special Master issued his remand decision, again denying compensation to Mr. Hammitt. Hammitt v. Sec’y of Health & Human Servs., No. 07-170V,
On March 25, 2011, Mr. Hammitt again moved for review by this Court, and Respon
Contentions of the Parties
On review, Mr. Hammitt asserts four objections to the Special Master’s remand decision: (1) The Special Master did not apply the Althen test in his analysis of Mr. Ham-mitt’s prima facie case; (2) The Special Master required direct evidence, rather than accepting circumstantial evidence, that Rachel’s DTaP vaccination caused a brain injury; (3) The Special Master failed to apply the Restatement (Second) of Torts in his analysis of the role Rachel’s DTaP vaccination played in causing her SMEI; and (4) The Special Master abused his discretion in denying admission of new evidence regarding a causal link between the DTaP vaccine and seizure disorders. (Pet’r’s Mem. Obj. at 1, Mar. 25, 2011.)
Mr. Hammitt argues that the Special Master “does state that the ‘petitioner failed to prove the prima facie case,’ but reaches this conclusion without any reference to the Al-then test.” Id. at 6. Mr. Hammitt proceeds to explain why his case should satisfy the Althen test, addressing each prong of the test in succession. Id. at 7-10. First, Mr. Hammitt contends that his expert witness, Dr. Kinsbourne, presented “a medical theory causally connecting the vaccination and the injury,” thereby satisfying prong one of Althen. Id. at 7; Althen,
Next, Mr. Hammitt argues that by rejecting Dr. Kinsbourne’s brain injury theory as mere “inference,” the Special Master required direct evidence that Rachel’s vaccination caused brain injury, whereas the Federal Circuit in Althen,
In his third objection, Mr. Hammitt contends that the Federal Circuit in Shyface v. Sec’y of Health & Human Servs.,
Finally, Mr. Hammitt asserts that the Special Master abused his discretion in deciding not to consider additional evidence on remand. Id. at 21. The evidence includes articles by Ann M. McIntosh, Effects of Vaccination on the Onset and Outcome of Dra-vet Syndrome: A Retrospective Study, 9(6) Lancet Neurol, 592 (2010), and by Yuval Shafrir, Vaccination and Dravet Syndrome, 9(12) Lancet Neurol, 1147 (2010), and anoth
Respondent counters that the Special Master correctly found Mr. Hammitt’s evidence inadequate to establish a prima facie ease. (Resp’t’s Resp. to Pet’r’s Mot. Review at 4, Apr. 25, 2011.) Like the Special Master, Respondent maintains that Mr. Hammitt failed to satisfy prong two of Althen because “Dr. Kinsbourne was unable to offer any reliable evidence to support the presence of brain damage, an essential element of his theory.” Id. at 5-6. Respondent argues that the speculative nature of Mr. Hammitt’s evidence, not its circumstantial character, ultimately led the Special Master to reject Mr. Hammitt’s brain damage theory. Id. at 7. Moreover, Respondent argues that based on Doe/11 v. Sec’y of Health & Human Servs.,
Respondent also refutes Mr. Hammitt’s contentions regarding the standards of “legal cause.” Id. at 9-16. Respondent contends that the language of the Vaccine Act supplies the burden of proving causation by a “factor unrelated” to the vaccine: Respondent must show by a “preponderance of the evidence” that the factor unrelated was “principally responsible” for the injury. (Resp’t’s Resp. to Pet’r’s Mot. Review at 11, Apr. 25, 2011 (citing 42 U.S.C. § 300aa-13(a)).) Respondent cites de Bazan’s “sole substantial factor” language as support for this argument, but explains that “sole” should be interpreted in the sense that “the factor unrelated, not the vaccination, is more likely the cause of the injury alleged.” (Resp’t’s Resp. to Pet’r’s Mot. Review at 11 n. 7, Apr. 25, 2011.) When applying these standards to the evidence linking SCN1A gene mutations to SMEI, Respondent argues, Rachel’s gene mutation was the “legal cause” of her SMEI. (Resp’t’s Resp. to Pet’r’s Mot. Review at 12, Apr. 25, 2011.)
Finally, Respondent argues that the Special Master properly exercised his discretion in refusing to admit Mr. Hammitt’s additional evidence on remand. Id. at 17. Respondent reiterates that the submission of new evidence was beyond the scope of the Remand Order, that Mr. Hammitt’s motion to file the evidence was untimely, and that the evidence does not support Mr. Hammitt’s case. Id.
Standard of Review
When reviewing the decision of a special master, this Court employs a de novo standard on legal issues. Broekelschen v. Sec’y of Health & Human Servs.,
Discussion
A The Special Master Applied the Correct Legal Standards in Concluding that Mr. Hammitt’s Petition Must be Denied.
In the Vaccine Act, Congress established two ways for a petitioner to prove a
If the petitioner suffered an “off-table injury,” however, the petitioner bears the burden of proving eausation-in-fact by the vaccine. 42 U.S.C. §§ 300aa-13 (a)(1), - 14(a); Pafford,
[Petitionerj’s 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.
Althen,
If the petitioner satisfies the three prongs of Althen, he has established a prima facie case, “absent proof that some other factor was the actual cause.” de Bazan,
If the petitioner succeeds in establishing a prima facie case, the burden shifts to respondent to demonstrate by a preponderance of the evidence that a “factor unrelated” to the vaccine “was the sole substantial factor in bringing about the injury.” 42 U.S.C. § 300aa-13(a); de Bazan,
Here, the Special Master applied the above burden-shifting framework for “off-table” eases in his remand decision, first evaluating whether Mr. Hammitt established a prima facie case. Hammitt II, at *4-10. As the Special Master determined, Mr. Hammitt did not establish a prima facie case because of a failure of proof regarding prong two of Al-then. Id. at *8. Indeed, Mr. Hammitt proffered a “medical theory causally connecting the vaccination and the injury,” satisfying prong one. Specifically, “the DTaP vaccination caused Rachel to experience a fever, which caused her to experience a prolonged seizure, which damaged her brain, lowering her seizure threshold and, therefore, facilitating further seizures.” (Pet’r’s Mem. Obj. at 7, Mar. 25, 2011.) Also, given the undisputed fact that Rachel’s first prolonged seizure occurred just hours after the administration of her DTaP vaccination, Mr. Hammitt easily demonstrated a “proximate temporal relationship between vaccination and injury,” as called for in prong three of Althen. Id. at 9.
Mi-. Hammitt could not, however, substantiate his medical causation theory with persuasive evidence that Rachel’s seizure actually produced brain damage, the theory’s vital element that allegedly “lower[ed] [Rachel’s] seizure threshold” and “facilitatefed] further seizures.” Hammitt II, at *7-8. Although Mr. Hammitt’s expert, Dr. Kinsb-ourne, testified that prolonged seizures are “apt to cause brain damage,” Dr. Kinsbourne admitted that Rachel manifested no signs of brain damage. Hammitt I, at *41 (quoting Tr. at 476). Mr. Hammitt’s failure to prove brain damage—especially combined with the convincing testimony of Respondent’s experts that even before her first seizure, Rachel was “destined to develop SMEI” be
Given that Mr. Hammitt did not meet his initial burden, this case presents no need for the burden to shift to Respondent to prove by a preponderance of the evidence that a factor unrelated to the vaccine was the “sole substantial factor” in causing Rachel’s SMEI. See 42 U.S.C. § 300aa-13(a)(l); de Bazan,
As the Special Master noted, the testimony of Respondent’s experts was “well explained, cogent, based upon the knowledge and practices of a clinical geneticist, and supported by the medical literature.” Hammitt I, at *41. Specifically, Respondent’s experts established the following points, which the Special Master found crucial:
— Rachel’s mutation arose de novo;
— the mutation at issue results in a non-conservative amino acid change with the new amino acid having very different physical properties from what is found at the location in non-affected individuals;
— the mutation affects the beginning of the resultant protein, the N-terminus, a functionally important region, as evidenced by a report of only SMEI resulting from mutations in this region;
— the mutation occurs in an area that is well-conserved across species, signaling significant ramifications when altered; and
— there are reports evidencing similar or comparable mutations resulting in SMEI in or near the same location as Rachel’s mutation, and there is an absence of the mutation in the normal population.
Hammitt II, at *8-9. Dr. Raymond testified that these factors, when examined by a geneticist, cumulatively demonstrate that Rachel’s SCN1A gene mutation caused her SMEI. Hammitt I, at *22. Moreover, because Mr. Hammitt’s expert had no experience or special knowledge in genetics, the testimony of Respondent’s experts went “essentially unrebutted.” Hammitt I, at *10; Hammitt II, at *3. For these reasons, the Court agrees with the Special Master’s conclusion that Rachel’s SCN1A gene mutation was solely responsible for Rachel’s SMEI and that Mr. Hammitt’s claim must be denied.
B. Mr. Hammitt’s Contentions Must be Rejected.
First, Mr. Hammitt requests the Court to set aside the Special Master’s decision because the Special Master did not apply the Althen test. (Pet’r’s Mem. Obj. at 6, Mar. 25, 2011.) Mr. Hammitt, however, is mistaken. As discussed above, the Special Master applied the Althen test and found that Mr. Hammitt failed to satisfy prong two of that test. Hammitt II, at *7-8. The Court agrees with the Special Master’s conclusion.
Mr. Hammitt argues that he satisfies each element of the Althen test because his ease fits the same factual pattern observed in Simon and Mersburgh, both of which resulted in petitioners establishing a prima facie case and receiving compensation. (Pet’r’s Mem. Obj. at 7-8, Mar. 25, 2011.) The factual pattern occurs when, as described in Simon and Mersburgh, “[a]n otherwise healthy [child] receives a vaccination, the vaccine causes a fever, which in turn causes or triggers a complex febrile seizure.” Id. at 8 (quoting Hammitt I, at *10). The Special Master noted in Mersburgh and Hammitt I that “[i]f a case fits this described pattern, as the case at hand does, the undersigned is strongly inclined to find in favor of the petitioner” because according to some medical literature, “prolonged complex seizures are recognized as the antecedent of sequelae.” Id. at 8 (quoting Hammitt I, at *11). Mr. Hammitt argues that because the Special
The outcomes of Simon and Mersburgh, however, have no bearing on Mr. Hammitt’s case. First, Mr. Hammit’s case is distinguishable from Simon and Mersburgh. In Simon, there was “much agreement between the experts_that [the child’s] initial seizure [was] connected to [his] subsequent seizures” and to his development of epilepsy. Simon, at *4. In contrast, Dr. Raymond and Dr. Wiznitzer argued persuasively that Rachel’s first seizure neither injured her brain nor “lowered her seizure threshold.” Ham-mitt I, at *41. Furthermore, in Simon and Mersburgh, although respondents’ experts testified that a genetic predisposition was likely responsible for the children’s epilepsy disorders, respondents presented no concrete evidence of a genetic predisposition. Simon, at *7; Mersburgh, at *3. According to the Special Master, such “speculation” was not enough to rebut either petitioner’s prima fa-cie case. Simon, at *7; Mersburgh, at *3. Genetic testing of Rachel Harritaitt, however, has confirmed that Rachel possesses an SCN1A gene mutation commonly associated with SMEI in the medical profession. Ham-mitt I, at *3. Considering this case’s unique facts and evidence, the Special Master did not err in concluding that Mr. Hammitt failed to establish a prima facie ease.
Second, as Respondent notes in its brief, special masters are not bound by their own previous decisions or the decisions of other special masters, and they “have discretion to evaluate the utility of [the evidence] differently in light of all facts relevant in a specific claim.” Sharpnack v. Sec’y of Health & Human Servs.,
Mr. Hammitt’s next objection is that the Special Master required direct evidence of brain damage, whereas, Mr. Hammitt argues, the Federal Circuit has found circumstantial evidence sufficient. (Pet’r’s Mem. Obj. at 10-12, Mar. 25, 2011.) Here, Mr. Hammitt miseharacterizes the Special Master’s reasoning. The Special Master did not reject Mr. Hammitt’s evidence of brain damage because it was “circumstantial.” He rejected it because it did not satisfy the legal standard, which requires preponderant evidence demonstrating the three prongs of Al-then. See Hammitt II, at *7-8. As stated above, this Court agrees with the Special Master that Mr. Hammitt’s speculation of brain damage failed to satisfy prong two of the Althen test.
Mi’. Hammitt also takes issue with the Special Master’s failure to apply the Restatement (Second) of Torts principles for determining causation. (Pet’r’s Mem. Obj. at 12, Mar. 25, 2011.) Mr. Hammitt is correct that the Federal Circuit has cited the Restatement (Second) of Torts in stating that a petitioner under the Vaccine Act must show “that the vaccine was not only a but-for cause of the injury but also a substantial factor in bringing about the injury.” Shyface,
Mr. Hammitt’s final objection concerns the Special Master’s refusal to consider additional evidence. (Pet’r’s Mem. Obj. at 21, Mar. 25, 2011.) Even after reviewing this evidence, however, the Court reaches the same conclusion as the Special Master that Rachel’s DTaP vaccination was not the cause-in-faet of her SMEI, and her SCN1A gene mutation was the “sole substantial” cause of her SMEI.
Conclusion
For the foregoing reasons, the Special Master’s March 4, 2011 decision denying compensation is AFFIRMED. This Court finds that the Special Master did not err in denying Mr. Hammitt’s claim. Accordingly, Petitioner’s motion for review is DENIED.
Pursuant to Rule 18(b) of the Court’s Vaccine Rules (found in Appendix B), the parties may submit any proposed redactions of confidential or other protected information within fourteen days from the date of this opinion before it is released for publication.
IT IS SO ORDERED.