VICP Registry Case Source Bundle Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_16-vv-00883 Package ID: USCOURTS-cofc-1_16-vv-00883 Petitioner: A.M. Filed: 2016-10-31 Decided: 2017-11-27 Vaccine: DTaP Vaccination date: 2014-06-27 Condition: autism spectrum disorder (ASD); skin rashes; gliosis; seizure-like activity Outcome: dismissed Award amount USD: AI-assisted case summary: A.M., a minor, by her parents and natural guardians Sean and April Miller, filed a petition on July 25, 2016, alleging that their daughter suffered from skin rashes and autism spectrum disorder (ASD) as a result of vaccinations received on June 18, 2014, and August 21, 2014. The parents initially proceeded pro se. During a status conference on August 25, 2016, they were encouraged to find legal representation and were ordered to file additional medical records. Petitioners were unable to secure an attorney, and the respondent filed a Rule 4(c) Report on January 26, 2017. Petitioners filed objections to this report on February 23, 2017. Following a Rule 5 conference, the Special Master issued an Order to Show Cause on February 27, 2017, indicating that there did not appear to be a reasonable basis to proceed and setting a deadline of April 28, 2017, for an expert report. Petitioners requested an extension until October 2017, stating they had difficulty finding an expert and had scheduled an appointment for A.M. at Children's Hospital in Omaha, Nebraska. The Special Master granted this extension. On September 5, 2017, petitioners filed a status report detailing A.M.'s appointments at the Children's Hospital of Omaha, including medical testing on July 14, 2017, and an MRI of the brain on July 31, 2017. Petitioners stated that A.M. was diagnosed with gliosis and seizure-like activity on August 1, 2017. They also filed documentation from vaccine manufacturers Glaxo Smith Cline and Merck regarding the ingredients in the DTaP, MMR, and Varicella vaccinations. On October 6, 2017, petitioners attached progress notes from a social worker and physicians, which confirmed A.M. met the criteria for ASD and suggested a strong possibility that the ASD was associated with another medical or genetic condition. During a status conference on October 27, 2017, the Special Master noted that the additional records were consistent with earlier findings that A.M.'s condition was not vaccine-related. The first notation of developmental delay occurred on May 12, 2015, over eight months after the vaccinations, precluding a temporal association. The Special Master explained that while the medical records documented A.M.'s conditions, they did not demonstrate a vaccine-related injury. The Special Master also noted that documentation from manufacturers regarding vaccine recommendations did not prove causation. The Special Master agreed with the respondent that A.M. had not alleged an injury on the Vaccine Injury Table and that the medical records did not support such a claim. Because petitioners could not prove a Table injury, they were required to demonstrate actual causation by preponderant evidence, including a medical theory connecting the vaccination and injury, a logical sequence of cause and effect, and a proximate temporal relationship. As petitioners were unable to file an expert report and the medical records did not demonstrate a vaccine-related injury, the Special Master found no reasonable basis to proceed and dismissed the petition. The Special Master extended sympathy to the petitioners but stated the decision was based on the evidence. The decision was issued by Chief Special Master Nora Beth Dorsey on November 27, 2017. Theory of causation field: Petitioners alleged that minor A.M. suffered from autism spectrum disorder (ASD), skin rashes, gliosis, and seizure-like activity as a result of DTaP, Hepatitis A, Hib, and Prevnar vaccinations received on June 27, 2014, and August 21, 2014. The petition was dismissed because petitioners failed to demonstrate a Table injury or actual causation. The Special Master found no temporal association, as the first notation of developmental delay occurred over eight months after the vaccinations. Petitioners were unable to provide an expert report to establish a medical theory connecting the vaccinations to the alleged injuries, a logical sequence of cause and effect, or a proximate temporal relationship, as required by Althen v. Sec'y of Health & Human Servs. The public decision does not describe the specific mechanism of injury or name any experts. The outcome was dismissal, with no award granted. The decision was issued by Chief Special Master Nora Beth Dorsey on November 27, 2017. Petitioners were represented pro se initially, and respondent was represented by Ms. Ann Martin. The theory of causation was identified as Off-Table. Public staged source text: ================================================================================ DOCUMENT 1: USCOURTS-cofc-1_16-vv-00883-0 Date issued/filed: 2017-11-27 Pages: 4 Docket text: PUBLIC DECISION (Originally filed: 10/31/2017) regarding 24 DECISION of Special Master Signed by Chief Special Master Nora Beth Dorsey. (fl) Copy to parties. -------------------------------------------------------------------------------- Case 1:16-vv-00883-NBF Document 25 Filed 11/27/17 Page 1 of 4 REISSUED FOR PUBLICATION . L R~GI!~. NOV 27 2017 OSM 3Jn tbe Wntteb C!Court of eberUa.S.l C OCU!RCT lOaFt mFEDSE'R AL CLAIMS ~tateS' jf OFFICE OF SPECIAL MASTERS Filed: October 31, 2017 FILED * * * * * * * * * * * * * * * * * * * * * * * * * UNPUBLISHED A.M., a Minor, by Parents and * OCT 3 1 2n17 Natural Guardians: SEAN MILLER * and APRIL MILLER, * U.S. COURT OF * No. 16-883V FEDERAL CLAIMS Petitioners, * * V. * Chief Special Master Dorsey * SECRETARY OF HEALTH * AND HUMAN SERVICES, * Autism Spectrum Disorder ("ASD"); * Skin Rashes; Hepatitis; Haemophilus. Respondent. * Influenza Type B ("Hib"); Prevnar; * No Reasonable Basis. * * * * * * * * * * * * * * * * * * * * * * * * * Mr. Sean and Mrs. April Miller, prose. Ms. Ann Martin, U.S. Department of Justice, Washington, D.C., for respondent. DECISION DISMISSING PETITION1 I. Introduction On July 25, 2016, Mr. Sean and Mrs. April Miller ("petitioners") filed a petition on behalf of their minor daughter, A.M., pursuant to the National Vaccine Injury Compensation Program, 42 U.S.C. §§ 300aa-1 to 34 (2012). Petitioners allege that A.M. suffered skin rashes and autism spectrum disorder(" ASD") as a result of vaccinations she received on June 18, 2014,2 and August 21, 2014. Petition at 1. Petitioners filed medical records as Exhibits 1-9 with their petition. 1 Because this unpublished decision contains a reasoned explanation for the action in this case, the undersigned intends to post this decision on the United States Court of Federal Claims' website, in accordance with the E-Government Act of2002, 44 U.S.C. § 3501 note (2012) (Federal Management and Promotion of Electronic Government Services). In accordance with Vaccine Rule 18(b), petitioner has 14 days to identify and move to delete medical or other information, that satisfies the criteria in § 300aa-l 2(d)(4 )(B). Further, consistent with the rule requirement, a motion for redaction must include a proposed redacted decision. If, upon review, the undersigned agrees that the identified material fits within the requirements of that provision, she will delete such material from public access. 2 Respondent correctly notes in his Rule 4(c) Report that the immunization record is slightly inconsistent with the other medical records. The immunization record reflects that A.M. Case 1:16-vv-00883-NBF Document 25 Filed 11/27/17 Page 2 of 4 II. Factual and Procedural History The initial status conference was held on August 25, 2016. During the status conference, petitioners were encouraged to find an attorney to represent them in their case and were ordered to file additional medical records in support of their claim. Order dated August 29, 2016 (ECF No. 7). Petitioners filed additional medical records on September 29, 2016.3 Petitioners were unable to find an attorney to represent them, and respondent was ordered to file a Rule 4(c) Report, which he did on January 26, 2017. On February 23, 2017, petitioners filed a memorandum of objections in response to respondent's report. A Rule 5 conference was held on February 23, 2017, during which the undersigned reviewed respondent's Rule 4(c) Report, petitioners' memorandum of objections to respondent's Rule 4( c) Report, and shared her preliminary findings. She advised that there does not appear to be a reasonable basis to proceed with the case, and an Order to Show Cause was issued. The Order to Show Cause allowed petitioners until April 28, 2017, to file an expert report in their case. Order to Show Cause dated Feb. 27, 2017 (ECF No. 15). On March 27, 2017, petitioners requested an extension until October 2017 to file an expert report, in compliance with the undersigned's February 27, 2017 Order to Show Cause. Petitioners stated that they inquired at several clinics and hospitals near their home in hopes of retaining an expert. When these attempts proved unsuccessful, petitioners set up an appointment for A.M. at Children's Hospital in Omaha, Nebraska. Another status conference was held on April 6, 2017, to discuss petitioners' motion for extension. The undersigned granted petitioners' motion and ordered them to file a status report by Friday, October 20, 2017, updating the Court as to the diagnosis and testing results from A.M.'s medical appointment at the Children's Hospital in Omaha. On September 5, 2017, petitioners filed a status report containing information regarding A.M.'s appointments at the Children's Hospital of Omaha during the summer of 2017. Petitioners stated that during A.M. 's appointment at the Children's Hospital in Omaha on July 14, 2017, she underwent medical testing. Petitioner filed documentation of this visit as Exhibit A. On July 31, 2017, A.M. underwent an MRI of the brain, and petitioners filed her MRI results as Exhibit B. Petitioners stated that A.M. was diagnosed with gliosis and seizure-like activity on August 1, 2017. Petitioners also filed documentation from the vaccine manufacturers Glaxo Smith Cline and Merck regarding the ingredients in the DTaP, MMR, and V aricella vaccinations. On September 18, 2017, petitioners were ordered to file any additional medical records from A.M. 's appointments at the Children's Hospital of Omaha and any other evidence they received the Hepatitis A, Hib, and Prevnar vaccinations on June 27, 2014, rather than June 18, 2014. Compare Petition with Pet'rs' Ex. 2. 3 These records were marked "Supplemental Attachments" and are referenced herein as "Pet'rs' Supp. Att.". 2 Case 1:16-vv-00883-NBF Document 25 Filed 11/27/17 Page 3 of 4 wis.hed for the undersigned to consider. Petitioners filed a status report on October 6, 2017, to which they attached progress notes from Ms. Jairren Flodine, AM. 's social worker, Dr. Howard Needleman, M.D., Dr. Lynne Clure, Ph.D., and Dr. Lois Starr. The progress notes again confirmed that A.M. meets the criteria for ASD and also notes that the clinicians "feel there is a strong possibility that [AM.'s ASD] is associated with another medical/genetic condition." Pet. Ex. F at5, 7. A status conference was held on October 27, 2017, wherein the undersigned discussed with the parties petitioners' recent filings. The undersigned stated that the additional records petitioners filed on September 5, 2017, and October 6, 2017, are consistent with her earlier findings of fact that AM. 's condition is not the result of a vaccine-related injury. The first notation in the medical records of A.M.'s developmental delay occurred on May 12, 2015, when she failed a developmental screening performed by Dr. Niazi. Pet'rs' Supp. Att. 6 at 21. Over eight months passed between the time AM. 's vaccinations and the first notation of her developmental delay, and thus a temporal association cannot be demonstrated. Petitioners were given an opportunity during the October 27, 2017 status conference to ask questions and/or respond to the undersigned's comments. Petitioners pointed out that A.M. was diagnosed with gliosis on August 1, 2017. The undersigned explained that while medical records are informative of AM.'s condition, they do not show evidence that she suffered a vaccine-related injury. Petitioners also pointed out their filings from Glaxo Smith Cline and Merck, which show that the vaccinations AM. received were not recommended for children her age. While the undersigned sympathizes with petitioners, she explained that documentation of the manufacturers' recommendations still does not prove that the vaccinations that AM. received caused the injuries that she suffers. III. Conclusion Given A.M.'s medical history as discussed in both the medical records and respondent's Rule 4( c) Report, the undersigned agrees with respondent that A.M. has not alleged an injury on the Vaccine Injury Table, nor do the medical records support such a claim. Because petitioners cannot prove that AM. suffered a Table injury,4 they are required to demonstrate evidence of actual causation. In order to prevail in their case, petitioners must show by preponderant evidence that the vaccinations A.M. received on June 27, 2014, and August 21, 2014, caused her injuries, by providing: "(l) 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 Health & Human Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005). Petitioners were ordered to file such an expert report by April 28, 2017, and the undersigned has allowed petitioners an additional six months to file the report. Because the medical records do not demonstrate a vaccine-related injury and petitioners have been unable to file an expert report, 4 A Table injury is an injury listed on the Vaccine Injury Table. See 42 U.S.C. § 300aa l l(c)(l)(C); 42 C.F.R. § 100.3. 3 Case 1:16-vv-00883-NBF Document 25 Filed 11/27/17 Page 4 of 4 there is no reasonable basis to proceed and thus the case should be dismissed. The undersigned extends her deepest sympathy to petitioners for the hardships that their family has faced and wishes them the best in the future. However, the undersigned cannot base her decision in the case on her sympathy for petitioners' family, but rather upon the evidence provided in the medical records. Petitioners previously expressed a desire to pursue a civil action in their case. The undersigned has attached documentation, also available on the Court's website,5 which contains information regarding an election to file a civil action. In the absence of a timely filed motion for review pursuant to Appendix B to the Rules of the Court, the Clerk of the Court SHALL ENTER JUDGMENT in accordance with this decision.6 IT IS SO ORDERED. Dated: ID · 3 I · ()017 ~ Nora Beth Dorsey Chief Special Master 5 This information is also available on the Court's website at http://www.uscfc.uscourts.gov/sites/default/files/Guidance%20on%20Exiting%20the%20Vaccin e%20Program.pdf. 6 Pursuant to Vaccine Rule l l(a), the parties may expedite entry of judgment by filing a joint notice renouncing their right to seek review. 4