VICP Registry Case Source Bundle Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_04-vv-01041 Package ID: USCOURTS-cofc-1_04-vv-01041 Petitioner: Amelia Stone Filed: 2010-10-28 Decided: 2010-05-17 Vaccine: DTaP Vaccination date: Condition: Severe Myoe-elonic Epilepsy of Infancy (SMEI), also known as Dravet Syndrome Outcome: unclear Award amount USD: AI-assisted case summary: Petitioners Jennifer and Gary Stone filed a claim under the National Vaccine Injury Compensation Program on behalf of their daughter, Amelia Stone, who suffers from Severe Myoclonic Epilepsy of Infancy (SMEI), also known as Dravet Syndrome. SMEI is described as an epilepsy syndrome beginning in the first year of life in previously healthy children, resulting in long-lasting seizures associated with fever. Amelia received a DTaP vaccination approximately four months after her birth. Petitioners alleged this vaccination caused her SMEI. At an initial hearing, petitioners' expert, Dr. Marcel Kinsbourne, testified that the DTaP vaccination caused Amelia's SMEI. Respondent's expert, Dr. Michael Kohrman, testified that a genetic predisposition, such as a Chromosome 20 duplication, caused Amelia's SMEI. The Special Master initially found no reliable evidence that factors unrelated to the vaccination caused Amelia's seizure disorder. Subsequently, new genetic research indicated that SMEI is caused by mutations in the Sodium Channel 1α subunit gene (SCN1A). Amelia tested positive for this mutation. A second hearing was held. Respondent's genetics expert, Dr. Gerald Raymond, testified that Amelia's SCN1A gene mutation was the sole cause of her SMEI. Dr. Kinsbourne testified that while SMEI has a genetic component, the DTaP vaccination triggered the seizure and lowered Amelia's seizure threshold. Special Master Gary J. Golkiewicz denied compensation on April 15, 2010, finding that the respondent had demonstrated by a preponderance of the evidence that Amelia's SCN1A gene mutation was more likely than not the 'but for' and 'substantial factor' that caused her SMEI. The Court of Federal Claims, through Senior Judge Margolis, reviewed the Special Master's decision. The Court noted that petitioners had made a prima facie case for compensation. The burden then shifted to the respondent to prove an unrelated factor caused the injury. The Court found that the Special Master applied the incorrect legal standard. Under the Vaccine Act and precedent like de Bazan v. Sec'y of Health & Human Services, the respondent must prove that an unrelated factor was the 'sole substantial factor' or 'principally responsible' for the injury, not merely a 'but for' or 'substantial factor.' The Special Master's finding that the SCN1A mutation was a 'but for' and 'substantial factor' did not meet this higher threshold. The Court rejected respondent's argument that this was harmless error, stating that expert testimony is not a substitute for the Special Master's findings of fact. The Court also rejected respondent's argument that genetic mutations do not fall under the statutory definition of 'factors unrelated,' citing Finley v. Sec'y of Health & Human Servs., which established that the list of unrelated factors is non-exhaustive and that conditions with no known relation to the vaccine, if principally responsible, qualify. Therefore, the Court vacated the Special Master's decision and remanded the case for further proceedings consistent with the correct legal standard. Theory of causation field: Petitioners alleged that the DTaP vaccination administered to Amelia Stone at approximately four months of age caused her Severe Myoclonic Epilepsy of Infancy (SMEI), also known as Dravet Syndrome. Petitioners' expert, Dr. Marcel Kinsbourne, initially supported this theory, stating the DTaP vaccination caused the SMEI. After new genetic research emerged, it was discovered that SMEI is caused by mutations in the SCN1A gene. Amelia tested positive for this mutation. Respondent's expert, Dr. Gerald Raymond, testified that the SCN1A gene mutation was the sole cause of Amelia's SMEI. Dr. Kinsbourne maintained that the DTaP vaccination triggered the seizure and lowered Amelia's seizure threshold. Special Master Golkiewicz found that the SCN1A gene mutation was a 'but for' and 'substantial factor' in causing Amelia's SMEI, denying compensation. The Court of Federal Claims, in reviewing the Special Master's decision, found that the Special Master applied an incorrect legal standard. The Court remanded the case, holding that the respondent must prove an unrelated factor, such as the SCN1A gene mutation, was the 'sole substantial factor' or 'principally responsible' for the injury, a higher burden than proving it was merely a 'but for' or 'substantial factor.' The Court noted that genetic mutations, even if not explicitly listed in the statute, can qualify as unrelated factors if they meet the 'principally responsible' standard. The case was remanded for application of the correct legal standard. Public staged source text: ================================================================================ DOCUMENT 1: USCOURTS-cofc-1_04-vv-01041-cl6661302 Date issued/filed: 2010-10-28 Pages: 1 Docket text: lead-opinion -------------------------------------------------------------------------------- OPINION MARGOLIS, Senior Judge. This matter comes before the Court on petitioners’ motion for review, filed on May 17, 2010, of Special Master Gary J. Golkiew-icz’s decision (“Dee.”), filed on April 15, 2010, denying petitioners compensation under the National Vaccine Injury Compensation Program, 42 U.S.C. § 300aa-10, et seq. (the “Vaccine Act”). Because the special master applied the incorrect legal standard in determining whether a “factor unrelated to the administration of the vaccine” caused the alleged injury, the case is remanded for further proceedings consistent with this opinion. I. BACKGROUND Petitioners Jennifer and Gary Stone filed a claim for compensation under the Vaccine Act on behalf of their daughter, Amelia Stone. Amelia suffers from Severe Myoe-elonic Epilepsy of Infancy (“SMEI”), also known as Dravet Syndrome. SMEI is a “particular epilepsy syndrome” that “begins in the first year of life in previously healthy children” and results in “long lasting [seizures] ... associated with fever.” (Dec. at 2 n. 2.) At the initial hearing, petitioners’ expert witness, Dr. Marcel Kinsbourne, testified that Amelia’s SMEI was caused by a DTaP1 vaccination she received about four months after her birth. Respondent’s expert, Dr. Michael Kohrman, testified that Amelia’s SMEI was not caused by the vaccination, but rather by some “genetic predisposition;” Dr. Kohrman “hypothesized that Amelia’s Chromosome 20 duplication or other genetic predisposition caused her to suffer SMEI.” (Id. at 15.) After considering Dr. Kinsbourne and Dr. Kohrman’s testimony, the special master determined that “[n]othing in the record at the time of the first Hearing in this matter provided reliable evidence that Amelia’s seizure disorder was caused by factors unrelated to her vaccination.” (Id.) Sometime after the hearing, Dr. Kohrman alerted the Court to “[n]ew and important data about genetics of vaccine associated encephalopathy and Dravet Syndrome,” published subsequent to his testimony. (Id. at 3.) The data suggested that SMEI is caused not by an adverse reaction to DTaP vaccine, but by a mutation in the Sodium Channel la subunit gene (“SCN1A”). (See id.) Amelia tested positive for the SCN1A gene mutation, and a second hearing was held to allow testimony on “SCN1A gene mutations in general,” and the “medical significance” of Amelia’s particular gene mutation. (See id. at 4.) Respondent’s genetics expert, Dr. Gerald Raymond, testified that Amelia Stone’s SCN1A gene mutation is the sole cause of her SMEI. (Id. at 23-24.) Petitioners’ ex*236pert, Dr. Kinsbourne, testified that although SMEI has a “genetic component,” the DTaP vaccination “triggered the seizure,” and “caused damage by lowering Amelia’s seizure ‘threshold.’ ” (Id. at 26 (quoting Tr. R. 2 at 475).) After considering the parties’ evidence and arguments, the special master concluded that “respondent has demonstrated by a preponderance of the evidence that Amelia’s SCN1A gene mutation was more likely than not the ‘but for’ and ‘substantial factor’ that caused her [SMEI].” (Id. at 52.) Based on that finding, the special master entered judgment for respondent. II. Standard of Review The Vaccine Act provides that “the Court of Federal Claims may set aside the special master’s decision ‘only if the special master’s fact findings are arbitrary and capricious, its legal conclusions are not in accordance with law, or its discretionary rulings are an abuse of discretion.’” Hazlehurst v. Sec’y of Health & Human Servs., 604 F.3d 1343, 1348-49 (Fed.Cir.2010) (quoting Turner v. Sec’y of Health & Human Servs., 268 F.3d 1334, 1337 (Fed.Cir.2001)) (citing 42 U.S.C. § 300aa-12(e)(2)(B)). The Court’s review of the special master’s factual findings is “uniquely deferential;” the Court “may not second-guess the special master’s fact-intensive conclusions, particularly where the medical evidence of causation is in dispute.” Id. “In contrast, under the ‘not in accordance with law1 standard, the court reviews the special master’s legal conclusions de novo.” Rodriguez v. Sec’y of Health & Human Servs., 91 Fed.Cl. 453, 461 (Fed.Cl.2010) (citing Saunders v. Sec’y of Health & Human Servs., 25 F.3d 1031, 1033 (Fed.Cir.1994)). III. Analysis Petitioners argue that the special master erred in finding “respondent’s burden in proving a ‘factor-unrelated’ defense to be identical to petitioner’s burden in proving their prima facie case.” (Pet. Mot. at 14 (citing Dec. at 10) (emphasis in original).) According to petitioners, “the Vaccine Act specifies a higher burden of proof for the respondent when she attempts to establish a factor unrelated defense.” (Id. at 15 (emphasis in original).) Respondent argues that the special master was correct in equating the parties’ respective burdens because “a factor unrelated must be both the ‘but for’ cause and also a ‘substantial factor’ in bringing about the injury.”2 (Resp. Br. at 8-9.) In order to prevail on a non-table3 Vaccine Act claim, the petitioner must make a prima facie showing that the vaccine was “not only a but-for cause of the injury but also a substantial factor in bringing about the injury.” Cedillo v. Sec’y of Health & Human Servs., 617 F.3d 1328, 1338 (Fed.Cir.2010) (quoting Shyface v. Sec’y of Health & Human Servs., 165 F.3d 1344, 1352 (Fed.Cir.1999)). It is well-settled that “the Vaccine Act does not require the petitioner to bear the burden of eliminating alternative causes where the other evidence on causation is sufficient to establish a prima facie case.” Walther v. Sec’y of Health & Human Servs., 485 F.3d 1146, 1150 (Fed.Cir.2007). “If petitioners succeed in establishing a prima facie case of causation, the burden then shifts to the government to prove alternative causation by a preponderance of the evidence.” Cedillo, 617 F.3d at 1338. The Vaccine Act refers to this “alternative causation” as “factors unrelated to the administra*237tion of the vaccine.” 42 U.S.C. § 300aa-13(a)(2)(B). The Act specifies that: ... the term “factors unrelated to the administration of the vaccine”— may, as documented by the petitioner’s evidence or other material in the record, include infection, toxins, trauma (including birth trauma and related anoxia), or metabolic disturbances which have no known relation to the vaccine involved, but which in the particular case are shown to have been the agent or agents principally responsible for causing the petitioner’s illness, disability, injury, condition, or death. Id. (emphasis added). In de Bazan v. Secretary of Health and Human Services, 539 F.3d 1347, 1351-54 (Fed.Cir.2008), the Federal Circuit explained that the standard for proving a “factor unrelated” is higher than the petitioner’s burden of proving a prima facie case. Although a petitioner is required to show that the vaccine was a “substantial factor” in causing his or her injury, “the petitioner need not show that the vaccine was the sole or predominant cause of her injury.” Id. at 1351. The respondent’s burden, by contrast, is to “identify[ ] a particular [unrelated] factor (or factors) and present[] sufficient evidence to establish that it was the sole substantial factor in bringing about the injury.”4 Id. at 1354 (emphasis added). In order to prevail, therefore, the respondent must “exelude[ ] the vaccine as a substantial factor.”5 Id. In our case, the special master found that the petitioners met their burden of proving a prima facie ease under the Vaccine Act. Indeed, the special master specifically noted that “petitioners would have likely demonstrated entitlement to compensation if respondent had not demonstrated that Amelia’s SMEI was caused by the genetic mutation located in her SCN1A gene.” (Dec. at 11.) In so holding, the special master pointed to Simon and Mersburgh, two cases in which he granted Vaccine Act claims based on evidence substantively identical to that which petitioners presented at the initial hearing. (Id. at 15 (citing Tr. R. 2 at 443; Simon v. Sec'y of Health & Human Servs., No. 05-941V, 2007 WL 1772062, at *3 (Fed.Cl. Spec.Mstr. June 1,2007); Mersburgh v. Sec’y of Health & Human Servs., No. 04-997V, 2007 WL 5160384, at *3 (Fed.Cl. July 9, 2007)).) After finding that petitioners had made a prima facie case for compensation, the special master shifted the burden to respondent to prove the existence of a factor unrelated to the vaccine. (See id. at 16.) Consistent with § 300aa-13(a)(2)(B), the special master acknowledged that he must “analyze respondent’s evidence concerning Amelia’s SCN1A gene mutation as a factor unrelated to her vaccination pursuant to § 13(a)(1)(B)." (Id. (emphasis added).) As such, the special master acknowledged that he would have to “uti-liz[e] the highest standard under the Act.” (Id.) But instead of finding that the SCN1A gene mutation was the “sole” or “principal” cause of Amelia’s SMEI, the special master held that “respondent has demonstrated by a preponderance of the evidence that Amelia’s SCN1A gene mutation was more likely than not the ‘but for ’ and ‘substantial factor’ that caused her [SMEI]....” (Id. at 52 (emphasis added).) Nowhere in *238the opinion does the special master find that Amelia’s genetic mutation was “principally responsible” for or the “sole cause” of her injuries. The special master therefore failed to apply the correct legal standard to respondent’s evidence of a factor unrelated to the vaccine. See 42 U.S.C.A. § 300aa-13(a)(2)(B); de Bazan, 539 F.3d at 1354. In order to enter judgment for respondent, the special master would have to have found that the SCN1A gene mutation was the “sole cause” or “principally responsible” for Amelia’s SMEI. See 42 U.S.C.A. § 300aa-13(a)(2)(B); de Bazan, 539 F.3d at 1354. Respondent concedes that the special master did not expressly find that the vaccine was the sole cause or principally responsible for Amelia’s SMEI. {See Trans, of Oral Argument at 34.) Nonetheless, respondent argues that it was “harmless error,” because “[Dr. Raymond] testified] that the genetic mutation was the sole cause of the seizure disorder in this case.” {Id.) But testimony from respondent’s expert is no substitute for a finding of fact by the special master. See 42 U.S.C. § 300aa-12(d)(3)(A)(i) (“The decision of the special master shall ... include findings of fact and conclusions of law-”). Indeed, without an express determination from the special master that Amelia’s SCN1A mutation was the sole cause of her SMEI, the Vaccine Act precludes entry of judgment for respondent. See de Bazan, 539 F.3d at 1354; see also, e.g., Hargrove, No. 05-0694V, 2009 WL 1220986, at *40. In the alternative, respondent argues that § 300aa-13(a)(2)(B), and therefore also the “principally responsible” standard, is inapplicable here because “Amelia’s genetic mutation is not an infection, toxin, trauma, or metabolic disturbance.” (Resp. Br. at 10.) It is well settled, however, that the list of potential unrelated factors in the Vaccine Act “is not meant to be all-inclusive.” Finley v. Sec’y of Health & Human Servs., 55 Fed.Cl. 355, 361 (Fed.Cl.2003) (citing Hanlon v. Sec’y of Health & Human Servs., 40 Fed.Cl. 625, 631 (Fed.Cl.1998)). Indeed, “factors unrelated ‘may include certain conditions listed, but also may include some other condition which is not listed, so long as that other condition has ‘no known relation to the vaccine involved, but which in the particular case [is] shown to have been the agent ... principally responsible for causing’ the vaccine’s injury.’ ” Id. Respondent does not contest that Amelia’s SCN1A mutation had “no known relation” to the DTaP vaccine. Amelia’s genetic mutation therefore qualifies as a factor unrelated to the vaccine within the meaning of the Vaccine Act. Accordingly, the Court finds that the judgment in favor of respondent must be reversed. IV. Conclusion Petitioners’ motion for review is granted; the case is remanded to the special master for proceedings consistent with this opinion.6 . "DTaP” stands for "Diptheria-Tetanus-acellu-lar-Pertussis.” (Dec. at 2.) . Respondent cites Knudsen v. Sec’y of Health & Human Servs., 35 F.3d 543, 549 (Fed.Cir.1994), for the broad proposition that respondent’s burden is "identical to petitioners' burden of proof.” (Resp. Br. at 9.) But as respondent explains elsewhere in its brief, Knudsen ”equate[s] each parties’ burdens [only] in the sense that both parties must prove their cases by a preponderance of the evidence.” (See id. at 8.) . "The Vaccine Act distinguishes between so-called ‘Table injuries,’ for which causation is presumed when a designated condition follows the administration of a designated vaccine within a designated period of time, and all other injuries alleged to be caused by a vaccine, known as 'off-Table injuries,’ for which causation must be proved in each case.” Moberly v. Sec’y of Health & Human Servs., 592 F.3d 1315, 1321 (Fed.Cir.2010) (citing 42 U.S.C. §§ 300aa-11(c), 300aa-14). In the instant case, petitioners have proceeded under an off-table theory. . See also Whitener v. Sec'y of Health & Human Servs., No. 06-0477V, 2009 WL 3007380, at *26 (Fed.Cl. Sept. 2, 2009) ("[T]he [p]etition[er] is entitled to compensation, unless [Respondent can proffer preponderant proof that a 'factor unrelated’ was the sole or superseding cause of the injury.”); Hargrove v. Sec'y of Health & Human Servs., No. 05-0694V, 2009 WL 1220986, at *40 (Fed.Cl. Apr. 14, 2009) (same); Heinzelman v. Sec'y of Health & Human Servs., No. 07-0IV, 2008 WL 5479123, at *16 (Fed.Cl. Dec. 11, 2008) (same). . The difference between "substantial factor” and “sole substantial factor" is a meaningful one. Indeed, this Court has consistently awarded compensation in cases where a factor unrelated was a substantial cause, but not the sole substantial cause, of a petitioner's injuries. See, e.g., Hargrove, No. 05-0694V, 2009 WL 1220986, at *37 (granting petition for compensation where vaccine and proposed factor unrelated were "both ... substantial causative factors”); Garcia v. Sec'y of Health & Human Servs., No. 05-0720V, 2008 WL 5068934, at *12 (Fed.Cl. Nov. 12, 2008) (same); Sword v. U.S., 44 Fed.Cl. 183, 188 (Fed.Cl.1999) (same). . Since the case is being remanded to the Special Master for application of the correct legal standard, the Court need not rule on petitioners' objections 2-7. ================================================================================ DOCUMENT 2: USCOURTS-cofc-1_04-vv-01041-cl-extra-985647 Date issued/filed: 2013-06-07 Pages: 1 Docket text: Supplementary opinion from CourtListener cluster 985647 -------------------------------------------------------------------------------- In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 04-1041V Filed: June 7, 2013 Not for Publication ************************************* JENNIFER STONE and GARY STONE, * Parents and Next Friends of AMELIA * STONE, a minor, * * Petitioners, * Attorneys’ Fees & Costs Decision v. * Based on Informal Agreement * SECRETARY OF HEALTH * AND HUMAN SERVICES, * * Respondent. * * ************************************* Richard Gage, Cheyenne, WY, for petitioners. Alexis B. Babcock, Washington, DC, for respondent. MILLMAN, Special Master DECISION AWARDING FINAL ATTORNEYS’ FEES AND COSTS1 On June 7, 2013, the parties informed the undersigned’s law clerk that they reached an agreement on an appropriate amount for attorneys’ fees and costs in this case. In accordance with the General Order #9 requirement, petitioners’ counsel asserts that petitioners did not incur any costs in pursuit of their petition. 1 Because this unpublished decision contains a reasoned explanation for the special master's action in this case, the special master intends to post this unpublished decision on the United States Court of Federal Claims's website, in accordance with the E-Government Act of 2002, Pub. L. No. 107-347, 116 Stat. 2899, 2913 (Dec. 17, 2002). Vaccine Rule 18(b) states that all decisions of the special masters will be made available to the public unless they contain trade secrets or commercial or financial information that is privileged and confidential, or medical or similar information whose disclosure would constitute a clearly unwarranted invasion of privacy. When such a decision is filed, petitioner has 14 days to identify and move to redact such information prior to the document=s disclosure. If the special master, upon review, agrees that the identified material fits within the banned categories listed above, the special master shall redact such material from public access. On May 3, 2013, petitioners filed a Motion for Award of Final Attorneys’ Fees and Reimbursement of Costs requesting $19,242.02 in attorneys’ fees and costs. During informal discussions, respondent raised objections to certain items. Based on these objections, petitioners now amend their request for attorneys’ fees and costs and request $17,800.00 in attorneys’ fees and costs. Respondent does not object to the reduced amount. The undersigned finds this amount to be reasonable. Accordingly, the court awards $17,800.00, representing reimbursement for attorneys’ fees and costs. The award shall be in the form of a check payable jointly to petitioners and Richard Gage, P.C. in the amount of $17,800.00. In the absence of a motion for review filed pursuant to RCFC Appendix B, the clerk of the court is directed to enter judgment herewith.2 IT IS SO ORDERED. Dated: June 7, 2013 /s/ Laura D. Millman Laura D. Millman Special Master 2 Pursuant to Vaccine Rule 11(a), entry of judgment can be expedited by each party, either separately or jointly, filing a notice renouncing the right to seek review. 2