VICP Registry Case Source Bundle Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_13-vv-00694 Package ID: USCOURTS-cofc-1_13-vv-00694 Petitioner: Nada Ahmed Filed: 2013-09-18 Decided: 2014-06-06 Vaccine: influenza, haemophilus B influenza, hepatitis A Vaccination date: 2010-10-01 Condition: acute disseminated encephalomyelitis (ADEM) followed by leukodystrophy Outcome: dismissed Award amount USD: AI-assisted case summary: On September 18, 2013, Waheed Ahmed and Nermeen Hassn, as legal representatives of their daughter Nada Ahmed, filed a petition alleging that influenza, Haemophilus B influenza, and hepatitis A vaccines administered on October 1, 2010, caused Nada to suffer acute disseminated encephalomyelitis (ADEM). Nada was born on October 8, 2009. One day after vaccination, she exhibited lethargy, irritability, weakness in all four extremities, and loss of milestones. She was taken to JFK Medical Center, where she was diagnosed with ADEM and truncal ataxia. Subsequent medical records indicated progressive white matter brain disease diagnosed as leukodystrophy of unknown etiology. A pediatric geneticist, Dr. Susan S. Brooks, noted in March 2013 that Nada had ADEM followed by leukodystrophy, long continuous regions of homozygosity, and a family history including a sister who died from mitochondrial DNA depletion syndrome. The parents are first cousins, which increases the possibility of rare recessive disorders. Special Master Laura D. Millman issued a decision on June 6, 2014, dismissing the petition after granting the petitioners' motion for judgment on the administrative record. The Special Master found that the record did not prove that the vaccines caused ADEM, that the ADEM lasted more than six months as required by the Vaccine Act, or that Nada's subsequent leukodystrophy was caused by ADEM or the vaccinations. No treating physician or expert medical report supplied the necessary causation and sequelae evidence, and temporal association alone was deemed insufficient. Petitioners were represented by Mindy M. Roth, and respondent was represented by Julia W. McInerny. No compensation was awarded in the entitlement decision. Subsequently, on July 28, 2014, Special Master Millman issued a decision awarding attorneys' fees and costs. Based on a stipulation of fact between the parties, the court awarded $11,093.00 for attorneys' fees and costs, payable jointly to the petitioners and their counsel, Britcher, Leone & Roth, L.L.C. Theory of causation field: Petitioners alleged that influenza, Haemophilus B influenza, and hepatitis A vaccines administered on October 1, 2010, to Nada Ahmed (age 0.98 years) caused acute disseminated encephalomyelitis (ADEM) followed by leukodystrophy. The public decision does not describe the specific mechanism of causation. Nada presented with lethargy, irritability, weakness, and loss of milestones one day post-vaccination, leading to an initial diagnosis of ADEM and truncal ataxia. Later evaluations revealed progressive white matter brain disease diagnosed as leukodystrophy of unknown etiology. Dr. Susan S. Brooks noted long regions of homozygosity, parental consanguinity, and a sibling death from mitochondrial DNA depletion syndrome, suggesting a possible genetic component. Special Master Laura D. Millman dismissed the petition on June 6, 2014, finding that petitioners failed to prove by a preponderance of the evidence that the vaccines caused ADEM, that the ADEM lasted more than six months, or that the leukodystrophy was a sequela of ADEM or the vaccinations. The decision noted the absence of expert medical reports or treating physician opinions supporting causation and that mere temporal association was insufficient. Petitioners were represented by Mindy M. Roth. On July 28, 2014, Special Master Millman awarded $11,093.00 in attorneys' fees and costs based on a stipulation between the parties. Public staged source text: ================================================================================ DOCUMENT 1: USCOURTS-cofc-1_13-vv-00694-0 Date issued/filed: 2014-06-27 Pages: 5 Docket text: PUBLIC DECISION (Originally filed: 06/06/2014) regarding 20 DECISION of Special Master Signed by Special Master Laura D Millman. (tlj) Copy to parties. -------------------------------------------------------------------------------- Case 1:13-vv-00694-UNJ Document 24 Filed 06/27/14 Page 1 of 5 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 13-694V June 6, 2014 Not to be Published *************************************** WAHEED AHMED and NERMEEN HASSN, * as Legal Representatives of NADA AHMED, * * Petitioners, * Influenza vaccine; haemophilus B * influenza vaccine; hepatitis A vaccine; v. * acute disseminated encephalomyelitis; * leukodystrophy; no expert report; SECRETARY OF HEALTH * petitioners’ motion for judgment on AND HUMAN SERVICES, * administrative record; dismissal * Respondent. * *************************************** Mindy M. Roth, Glen Rock, NJ, for petitioners. Julia W. McInerny, Washington, DC, for respondent. MILLMAN, Special Master DECISION1 On September 18, 2013, petitioners filed a petition under the National Childhood Vaccine Injury Act, 42 U.S.C. §§ 300aa-10–34 (2006), alleging that influenza, haemophilus B influenza, and hepatitis A vaccines administered on October 1, 2010 to their daughter Nada Ahmed 1 Because this decision contains a reasoned explanation for the special master’s action in this case, the special master intends to post this 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, petitioners have 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 1:13-vv-00694-UNJ Document 24 Filed 06/27/14 Page 2 of 5 (“Nada”) caused her to suffer from acute disseminated encephalomyelitis (“ADEM”). Pet. ¶¶ 5, 6. The medical records show that Nada was diagnosed with atypical ADEM, whose onset was one day after her vaccinations. Her initial diagnosis of ADEM was followed by degenerative white matter brain disease that was diagnosed as leukodystrophy, whose etiology is unknown. On December 19, 2013, during the first telephonic status conference with the parties, the undersigned discussed the issue of sequelae in this case. Nada’s ADEM did not last long enough to satisfy the Vaccine Act’s requirement that a vaccine injury last more than six months. 42 U.S.C. § 300aa-10(c)(1)(D)(i). Furthermore, there was no proof in the record that Nada’s ADEM and leukodystrophy are related. On December 19, 2013, the undersigned issued an Order reiterating the substance of the status conference: The complicated part of this case concerns sequelae. After Nada’s brain MRIs showed that her lesions were no longer active, she proceeded to have a white matter brain injury (leukodystrophy), whose cause is still unknown. This white matter brain injury is progressive and causing brain atrophy. Nada’s parents are first cousins, and she has consequently long continuous regions of homozygosity, in which there are many genes with about 33 autosomal recessive genes that are associated with white matter changes and spasticity. Med. recs. Ex. 7, at 1661 (Dr. Susan S. Brooks’ report of March 7, 2013). No doctor, whether pediatric neurologist or geneticist, has given a cause for Nada’s leukodystrophy, even though all of them are aware Nada had ADEM. This suggests to the undersigned that none of Nada’s treating doctors thinks her ADEM caused her leukodystrophy. Order, Dec. 19, 2013, ECF No. 9. Over the next few months, petitioners filed additional medical records but no expert medical report supporting that either Nada’s ADEM lasted more than six months or, when her ADEM lesions were no longer active, her subsequent leukodystrophy was due either to her ADEM or to her vaccinations. On April 10, 2014, petitioners filed a Motion for Judgment on the Administrative Record. Petitioners state in their Motion that Nada had a reaction, i.e., ADEM, to her vaccinations. Mot. J., Apr. 10, 2014, ECF No. 14. They do not discuss in their Motion the statutory requirement that her reaction last more than six months. 2 Case 1:13-vv-00694-UNJ Document 24 Filed 06/27/14 Page 3 of 5 On April 16, 2014, the undersigned issued an Order stating that 42 U.S.C. § 300aa- 11(c)(1)(D)(i) requires that a vaccine injury last more than six months, but “[n]o doctor who has treated Nada and voiced an opinion in the medical records has stated that her leukodystrophy is a sequela of her ADEM, and petitioners have not filed an expert medical report saying her leukodystrophy is a sequela of her ADEM.” Order, Apr. 16, 2014, ECF No. 16. The undersigned ordered respondent to file a response to petitioners’ Motion for Judgment on the Administrative Record by June 2, 2014. On June 2, 2014, respondent filed her Rule 4(c) Report and Response to Petitioners’ Motion for Judgment on the Record. Resp’t’s Resp, June 2, 2014, ECF No. 19. Respondent states petitioners have not made a prima facie case of causation in fact. They have not proved that: her vaccinations caused her ADEM, her ADEM lasted more than six months, her ADEM caused her leukodystrophy, or, if she never had ADEM but only leukodystrophy, the vaccines caused the leukodystrophy. Resp’t’s Resp. at 8–9. On June 4, 2014, the undersigned held a telephonic status conference with the parties and asked petitioners’ counsel if she wanted to file a reply to respondent’s Rule 4(c) Report and Response to Petitioners’ Motion for Judgment on the Record. Petitioners’ counsel stated she would not file a reply. The undersigned GRANTS petitioners’ Motion for Judgment on the Administrative Record and DISMISSES this case. FACTS Nada was born on October 8, 2009. On October 1, 2010, she received influenza, haemophilus B influenza, and hepatitis A vaccines. Med. recs. Ex. 9, at 1755, 1764, 1765. One day post-vaccination, Nada was lethargic, irritable, weak in all four extremities, and had loss of milestones. Med. recs. Ex. 5, at 164. Her parents brought her to JFK Emergency Department. Id. From October 10–12, 2010, Nada was at JFK Medical Center, where she was diagnosed with ADEM and truncal ataxia. Med. recs. Ex. 11, at 1878. A neurology consultation on October 10, 2010 states that Nada’s brain MRI showed bilateral periventricular white matter disease, but her lumbar puncture was negative. Id. at 1895. Another MRI on October 12, 2012 showed brain lesions consistent with but “somewhat atypical” for ADEM. Med. recs. Ex. 5, at 212. A geneticist consulting on Nada’s case noted that “parental consanguity makes a rare recessive disorder possible,” and POLG disorders (mitochondrial recessive disorders) can mimic ADEM. Id. at 287. 3 Case 1:13-vv-00694-UNJ Document 24 Filed 06/27/14 Page 4 of 5 Nada’s MRI on February 22, 2011, showed “dramatic worsening of the previous abnormalities in the white matter.” Med. recs. Ex. 7, at 1615. Dr. Vikram Bhise, a pediatric neurologist, suspected leukodystrophy, with a differential diagnosis of infantile metachromatic leukodystrophy or vanishing white matter disease. Id. at 1618. On June 27, 2011, an MRI showed white matter enhancement indicating a “demyelinating process, leukodystrophy or metabolic process” was more likely than a “demyelinating disease such as [ADEM] or multiple sclerosis.” Id. at 1634. Dr. Bhise found these new results “very unusual,” and he conferred with a colleague at Johns Hopkins, who suspected a mitochondrial disease. Id. at 1638. An August 5, 2011 MRI showed significant, continued increase in white matter signal abnormalities, leading Dr. Bhise to diagnose “an unusual leukodystrophy.” Id. at 1640, 1643. On March 7, 2013, Nada saw Dr. Susan S. Brooks, a pediatric geneticist, who noted that Nada had ADEM followed by leukodystrophy. Med. recs. Ex. 7, at 1661. She had a four- month-old sister who died from a mitochondrial DNA depletion syndrome caused by a homozygous RRM2B mutation. Id. Nada is a heterozygous carrier of the mutation, as are her parents, who are first cousins. Id. Nada has long continuous regions of homozygosity. Id. There are many genes in these regions, with about 33 autosomal recessive genes that are associated with white matter changes and spasticity. Id. Nada’s third brain MRI showed the same white matter involvement but also mild diffuse atrophy and two ring enhancing lesions. Id. Her MRIs showed increased diffuse atrophy. Id. Dr. Brooks’ diagnosis was leukodystrophy of unclear etiology, unexplained white matter disease, and progressive white matter changes. Id. at 1665. DISCUSSION To satisfy their burden of proving causation in fact, petitioners 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. 4 Case 1:13-vv-00694-UNJ Document 24 Filed 06/27/14 Page 5 of 5 Without more, “evidence showing an absence of other causes does not meet petitioners’ 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. Although petitioners allege Nada’s vaccinations caused her ADEM, the medical records do not prove their allegation, and petitioners have not filed an expert medical report in support of their allegations that Nada suffered from ADEM or that the vaccine caused it. The Vaccine Act does not permit the undersigned to rule for petitioners based on their claims alone, “unsubstantiated by medical records or by medical opinion.” 42 U.S.C. § 300aa-13(a)(1) (2006). Moreover, petitioners have not proved that Nada’s ADEM lasted more than six months, as the Vaccine Act requires, or that her subsequent leukodystrophy was caused by either her ADEM or her vaccinations. Petitioners have not satisfied the first prong of Althen in that they have not presented through medical records or an expert medical opinion a theory explaining how Nada’s vaccinations could cause ADEM and/or leukodystrophy. Petitioners have not satisfied the second prong of Althen that there is a logical sequence of cause and effect showing that these vaccines did cause Nada’s ADEM and/or leukodystrophy. Petitioners have not satisfied the third prong of Althen that one day is a medically appropriate time interval to show causation of ADEM and/or leukodystrophy from any or all of her vaccinations. Thus, petitioners have not made a prima facie case of causation. The undersigned GRANTS petitioners’ Motion for Judgment on the Administrative Record. This case is 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.2 IT IS SO ORDERED. June 6, 2014 s/Laura D. Millman DATE 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. 5 ================================================================================ DOCUMENT 2: USCOURTS-cofc-1_13-vv-00694-1 Date issued/filed: 2014-08-19 Pages: 2 Docket text: PUBLIC DECISION (Originally filed: 07/28/2014) regarding 27 DECISION Fees Stipulation/Proffer Signed by Special Master Laura D Millman. (tlj) Copy to parties. -------------------------------------------------------------------------------- Case 1:13-vv-00694-UNJ Document 31 Filed 08/19/14 Page 1 of 2 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 13-694V Filed: July 28, 2014 Not for Publication ************************************* WAHEED AHMED and NERMEEN * HASSN, as Legal Representatives of * NADA AHMED, * * Petitioners, * Attorneys’ fees and costs decision based on * stipulation of fact v. * * SECRETARY OF HEALTH * AND HUMAN SERVICES, * * Respondent. * * ************************************* Mindy M. Roth, Glen Rock, NJ, for petitioners. Julia W. McInerny, Washington, DC, for respondent. MILLMAN, Special Master DECISION AWARDING ATTORNEYS’ FEES AND COSTS1 On July 28, 2014, the parties filed a stipulation of fact in which they agreed on an appropriate amount for attorneys’ fees and costs in this case. In accordance with the General Order #9 requirement, petitioners assert that they 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. Case 1:13-vv-00694-UNJ Document 31 Filed 08/19/14 Page 2 of 2 Petitioners submitted their request for attorneys’ fees and costs to respondent, requesting $11,093.00 for attorneys’ fees and costs. Respondent does not object to this amount. The undersigned finds this amount to be reasonable. Accordingly, the court awards $11,093.00, representing reimbursement for attorneys’ fees and costs. The award shall be in the form of a check payable jointly to petitioners and Britcher, Leone & Roth, L.L.C. in the amount of $11,093.00. 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: July 28, 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