VICP Registry Case Source Bundle Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_08-vv-00801 Package ID: USCOURTS-cofc-1_08-vv-00801 Petitioner: Carter Rose Filed: 2008-11-10 Decided: 2014-05-15 Vaccine: DTaP Vaccination date: Condition: severe myoclonic epilepsy of infancy (“SMEI”); Dravet syndrome; SCN1A sodium channel mutation Outcome: dismissed Award amount USD: AI-assisted case summary: On November 10, 2008, Tracy Rose, as parent of minor Carter Rose, filed a petition alleging that the DTaP vaccine caused Carter to develop severe myoclonic epilepsy of infancy (SMEI), also known as Dravet syndrome, and developmental delays. The petition was initially assigned to Special Master Richard B. Abell. The respondent filed a Rule 4(c) Report on May 21, 2009, noting Carter's diagnosis with a sodium channel mutation. The case was stayed on August 5, 2009, pending the outcome of related cases, Snyder and Harris. The case was subsequently transferred to Special Master Patricia E. Campbell-Smith on March 30, 2010. Proceedings included the deposition of the director of Athena Diagnostics Lab, which had determined Carter has an SCN1A mutation. Petitioner filed an expert report from Dr. John Gaitanis on October 7, 2011, and respondent filed reports from her experts, Dr. Raymond and Dr. Sachdeo, on February 29, 2012. Special Master Campbell-Smith noted in an order on May 22, 2012, that petitioners' allegations of significant aggravation of SMEI had previously failed in similar cases. The case was transferred to Special Master Laura D. Millman on May 28, 2013. On July 25, 2013, interim attorneys' fees and costs totaling $80,385.22 were awarded based on a stipulation. On January 29, 2014, Special Master Millman questioned the basis for proceeding, citing seven similar cases where petitioners had lost, particularly concerning the alleged aggravation of SCN1A mutations by vaccinations. On April 4, 2014, the Special Master ordered Dr. Gaitanis to respond to the respondent's experts' reports and to explain deficiencies in his own report, including reliance on fever-induced seizures when Carter did not have a fever, the one-year delay between vaccination and the first objective sign of brain injury, and the basis for claiming significant aggravation. The Special Master also ordered blood testing of Carter's parents. On May 12, 2014, petitioner filed an unopposed motion to dismiss the petition, stating an inability to secure evidence to prove entitlement to compensation and that further proceedings would be unreasonable. Special Master Millman granted the motion and dismissed the case on May 15, 2014. A subsequent decision on September 16, 2014, awarded final attorneys' fees and costs of $11,600.00 based on a stipulation between the parties, payable to petitioner and Conway, Homer & Chin-Caplan, P.C. Theory of causation field: Petitioner alleged that the DTaP vaccine caused severe myoclonic epilepsy of infancy (SMEI), also known as Dravet syndrome, and developmental delays, linked to an SCN1A sodium channel mutation. The case was filed on November 10, 2008, by Tracy Rose on behalf of minor Carter Rose. Respondent's expert reports were filed by Dr. Raymond and Dr. Sachdeo, and petitioner's expert was Dr. John Gaitanis. The public decision does not describe the specific medical theory connecting the vaccine to the alleged injury, nor does it detail the mechanism of action. The petitioner's expert report was found to have deficiencies, including reliance on facts not in the record and an unexplained delay between vaccination and objective signs of brain injury. The Special Master noted that similar allegations concerning SCN1A mutations had universally failed in prior cases. Petitioner ultimately moved to dismiss the petition, stating an inability to secure evidence to prove entitlement to compensation. The case was dismissed on May 15, 2014, by Special Master Laura D. Millman. Final attorneys' fees and costs of $11,600.00 were awarded on September 16, 2014, based on a stipulation between petitioner (represented by Ronald C. Homer) and respondent (represented by Althea W. Davis). Public staged source text: ================================================================================ DOCUMENT 1: USCOURTS-cofc-1_08-vv-00801-0 Date issued/filed: 2014-06-05 Pages: 4 Docket text: PUBLIC DECISION (Originally filed: 05/15/2014) regarding 87 DECISION of Special Master Signed by Special Master Laura D Millman. (tlj) Copy to parties. -------------------------------------------------------------------------------- Case 1:08-vv-00801-UNJ Document 88 Filed 06/05/14 Page 1 of 4 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 08-801V May 15, 2014 To Be Published * * * * * * * * * * * * * * * * * * * * * * * * * * * * * TRACY ROSE, Parent of CARTER ROSE, * a Minor, * * Petitioner, * * v. * DTaP vaccine; SCN1A sodium * channel mutation; severe myoclonic * epilepsy of infancy (“SMEI”); SECRETARY OF HEALTH * Dravet syndrome; petitioner’s AND HUMAN SERVICES, * motion for a decision dismissing * the petition Respondent. * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * Ronald C. Homer, Boston, MA, for petitioner. Althea W. Davis, Washington, DC, for respondent. MILLMAN, Special Master DECISION1 Petitioner filed a petition on November 10, 2008, under the National Childhood Vaccine Injury Act, 42 U.S.C. §§ 300aa-10–34 (2006). Petitioner alleges that diphtheria-tetanus-acellular pertussis (“DTaP”) caused her son Carter Rose (“Carter”) to have severe myoclonic epilepsy and developmental delays. On November 10, 2008, the case was assigned to former Special Master Richard B. Abell. 1 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 categories listed above, the special master shall redact such material from public access. Case 1:08-vv-00801-UNJ Document 88 Filed 06/05/14 Page 2 of 4 On May 21, 2009, respondent filed her Rule 4(c) Report, noting that Carter was diagnosed with a sodium channel mutation. Resp’t Rep. at 9. On July 27, 2009, petitioner filed a Motion to Stay Pending the Outcome of Snyder and Harris. These two cases were pending before Special Master Christian J. Moran on the same issue as the instant action. On August 5, 2009, Special Master Abell granted a stay of the instant action. On March 30, 3010, the case was transferred to former Special Master Patricia E. Campbell-Smith. Further proceedings occurred, including the deposition on April 6, 2011 of the director of the Athena Diagnostics Lab, which had determined that Carter has an SCN1A mutation. On October 7, 2011, petitioner filed the expert report of Dr. John Gaitanis and numerous medical articles. P. Exs. 25-88. On February 29, 2012, respondent filed a CD including the reports of her two experts, Dr. Raymond and Dr. Sachdeo, and accompanying medical literature. On May 22, 2012, Special Master Campbell-Smith filed an Order in which, among other points, she cites cases in which petitioners’ allegations alleging significant aggravation of SMEI have failed. On January 8, 2013, Special Master Campbell-Smith issued an Order setting a hearing date for September 25, and 26, 2013. On May 22, 2013, the parties filed a joint status report, listing five SCN1A cases in which appeals were either pending or deciding, and requesting that the entitlement hearing in the instant action be rescheduled until early 2014. On May 22, 2013, Special Master Campbell-Smith issued an Order cancelling the September 25, and 26, 2013 hearing dates. On May 28, 2013, this case was transferred to the undersigned. On June 14, 2013, petitioner moved for an award of interim attorneys’ fees and costs. On July 24, 2013, the parties stipulated to interim attorneys’ fees of $80,000.00 and petitioner’s costs of $385.22, which the undersigned awarded on July 25, 2013. On July 31, 2013, judgment entered on the decision awarding petitioner’s attorneys’ fees and costs. On January 29, 2014, the undersigned issued an Order recounting seven similar cases,2 all of which petitioners had lost, and questioned whether there was a reasonable basis to proceed in light of the universal failure of petitioners to prove that vaccinations significantly aggravate 2 These seven include: Snyder v. Sec’y of HHS, No. 08-76V, 2014 WL 292399 (Fed. Cir. 2014) (which subsumes Harris v. Sec’y of HHS); Deribeaux v. Sec’y of HHS, 717 F.3d 1363 (Fed. Cir. 2013); Stone v. Sec’y of HHS, 676 F.3d 1373 (Fed. Cir. 2012) (which subsumes Hammitt v. Sec’y of HHS); Barnette v. Sec’y of HHS, 110 Fed. Cl. 34 (Fed. Cl. 2013); Waters v. Sec’y of HHS, No. 08-76V, 2014 WL 300936 (Fed. Cl. Spec. Mstr. Jan. 7, 2014). 2 Case 1:08-vv-00801-UNJ Document 88 Filed 06/05/14 Page 3 of 4 SCN1A mutations. On March 13, 2014, petitioner responded that there was a reasonable basis to proceed. On April 4, 2014, the undersigned issued an Order for petitioner’s expert Dr. Gaitanis to respond to the reports of respondent’s experts Dr. Raymond and Dr. Sachdeo. In addition, the undersigned ordered petitioner to have Dr. Gaitanis explain why he relied on fever-induced seizures in his expert report when Carter did not have a fever when he began seizing. The undersigned ordered petitioner to have Dr. Gaitanis explain how he could say vaccinations significantly aggravated Carter’s epilepsy when the first objective sign of a change in Carter’s brain occurred one year post-vaccination. In addition, the undersigned ordered Carter’s parents to submit their blood to Athena Diagnostics for testing because, if they do not have the same abnormality as Carter, the lab would determine that Carter’s mutation is de novo, which is more severe than inherited abnormalities. On May 12, 2014, petitioner filed an Unopposed Motion for a Decision Dismissing the Petition, stating, “The petitioner has been unable to secure evidence to prove entitlement to compensation in the Vaccine Program,” and “In these circumstances, to proceed further would be unreasonable.” Pet’r’s Mot. ¶¶ 1, 2. The undersigned GRANTS petitioner’s motion and DISMISSES this case. DISCUSSION To satisfy her burden of proving causation in fact, petitioner must prove by preponderant evidence: “(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 v. Sec’y of HHS, 418 F.3d 1274, 1278 (Fed. Cir. 2005). In Althen, the Federal Circuit quoted its opinion in Grant v. Secretary of Health and Human Services, 956 F.2d 1144, 1148 (Fed. Cir. 1992): A persuasive medical theory is demonstrated by “proof of a logical sequence of cause and effect showing that the vaccination was the reason for the injury[,]” the logical sequence being supported by “reputable medical or scientific explanation[,]” i.e., “evidence in the form of scientific studies or expert medical testimony[.]” Althen, 418 F.3d at 1278. Without more, “evidence showing an absence of other causes does not meet petitioner’s affirmative duty to show actual or legal causation.” Grant, 956 F.2d at 1149. Mere temporal association is not sufficient to prove causation in fact. Id. at 1148. 3 Case 1:08-vv-00801-UNJ Document 88 Filed 06/05/14 Page 4 of 4 The Vaccine Act does not permit the undersigned to rule for petitioner based on her claims alone, “unsubstantiated by medical records or by medical opinion.” 42 U.S.C. § 300aa- 13(a)(1) (2006). Petitioner’s expert Dr. Gaitanis bases his expert opinion on facts not in the record, e.g. fever post-vaccination, or assumes significant aggravation when objective evidence of brain injury was one year post-vaccination. An expert’s opinion is only as good as the basis for it. Perreira v. Sec’y of HHS, 33 F.3d 1375, 1377 (Fed. Cir. 1994). Petitioner has chosen not to pursue her claim in light of the deficiencies in Dr. Gaitanis’s report as well as the scientific evidence, described in depth in the seven cases that have resulted in dismissals of petitioners with the same allegations concerning SCN1A sodium channel mutations. Petitioner has failed to make a prima facie case and moves for a decision dismissing the petition. The undersigned GRANTS her motion. This petition is hereby DISMISSED. CONCLUSION This petition is DISMISSED. 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.3 IT IS SO ORDERED. Dated: May 15, 2014 s/Laura D. Millman Laura D. Millman Special Master 3 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. 4 ================================================================================ DOCUMENT 2: USCOURTS-cofc-1_08-vv-00801-1 Date issued/filed: 2014-10-08 Pages: 2 Docket text: PUBLIC DECISION (Originally filed: 09/16/2014) regarding 93 DECISION Fees Stipulation/Proffer Signed by Special Master Laura D Millman. (tlj) Copy to parties. -------------------------------------------------------------------------------- Case 1:08-vv-00801-UNJ Document 96 Filed 10/08/14 Page 1 of 2 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 08-801V Filed: September 16, 2014 Not for Publication ************************************* TRACY ROSE, * Parent of CARTER ROSE, a Minor, * * Petitioner, * Final attorneys’ fees and costs decision based * on stipulation of fact v. * * SECRETARY OF HEALTH * AND HUMAN SERVICES, * * Respondent. * * ************************************* Ronald C. Homer, Boston, MA, for petitioner. Althea W. Davis, Washington, DC, for respondent. MILLMAN, Special Master DECISION AWARDING FINAL ATTORNEYS’ FEES AND COSTS1 The undersigned awarded interim attorneys’ fees and costs in this case on July 25, 2013. On September 16, 2014, the parties filed a stipulation of fact in which they agreed on an appropriate amount for final attorneys’ fees and costs in this case. Petitioner filed her application for final attorneys’ fees and costs on September 3, 2014. In accordance with the General Order #9 requirement, petitioner asserts that she did not incur any 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. Case 1:08-vv-00801-UNJ Document 96 Filed 10/08/14 Page 2 of 2 final costs. During informal discussions, respondent raised objections to certain items in petitioner’s application. Based on these objections, petitioner amends her application for final attorneys’ fees and costs to $11,600.00. Respondent does not object to this amount. The undersigned finds this amount to be reasonable. Accordingly, the court awards $11,600.00, representing reimbursement for final attorneys’ fees and costs. The award shall be in the form of a check payable jointly to petitioner and Conway, Homer & Chin-Caplan, P.C. in the amount of $11,600.00. 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: September 16, 2014 /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