VICP Registry Case Source Bundle Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_13-vv-00275 Package ID: USCOURTS-cofc-1_13-vv-00275 Petitioner: Jung Park, M.D. Filed: 2013-04-19 Decided: 2015-02-03 Vaccine: influenza Vaccination date: 2011-09-27 Condition: unilateral sensorineural hearing loss Outcome: compensated Award amount USD: 18679 AI-assisted case summary: Jung Park, M.D., an adult male born on January 15, 1950, filed a petition on April 19, 2013, alleging that an influenza vaccine administered on September 27, 2011, caused him to develop unilateral sensorineural hearing loss in his right ear within two to three hours of vaccination. The respondent was the Secretary of Health and Human Services. The case was brought as an off-Table claim, requiring Dr. Park to prove causation-in-fact. Special Master Laura D. Millman set a deadline of December 11, 2013, for Dr. Park to file an expert report, which was extended multiple times. During a status conference on July 22, 2014, Dr. Park's counsel indicated that a neuro-otologist had not responded and that Dr. Park wished to seek other counsel. On October 8, 2014, Dr. Park moved for a decision on the record and filed a case report as Exhibit 9, which detailed a case of sudden deafness in a young girl following an H1N1 vaccine. Respondent filed her Rule 4(c) Report on October 28, 2014. Special Master Millman granted Dr. Park's motion for a decision on the record and dismissed the petition for failure to prove causation by a preponderance of the evidence, citing 42 U.S.C. § 300aa-13(a)(1)(A). The Special Master noted that Dr. Park did not file a medical expert report and that the submitted case report was insufficient to establish a medical theory of causation, a logical sequence of cause and effect, or a proximate temporal relationship between the trivalent flu vaccine he received and his unilateral hearing loss. The Special Master found that the case report involved a different vaccine, a different patient demographic, a different outcome, and a different treatment response. Dr. Park had been given over a year to find an expert but failed to do so. Subsequently, on January 13, 2015, the parties filed a stipulation of fact regarding attorneys' fees and costs. Special Master Millman issued a decision on February 3, 2015, awarding Dr. Park $18,679.71 for attorneys' fees and costs, consisting of $14,216.00 in attorneys' fees and $4,463.71 in attorneys' costs. The award was to be paid by check jointly to Dr. Park and Maglio, Christopher, & Toale, P.A. Petitioner's counsel was Danielle A. Strait, and respondent's counsel was Lisa A. Watts. Theory of causation field: Petitioner Jung Park, M.D., received an influenza vaccine on September 27, 2011, at age 61. He alleged that this vaccine caused unilateral sensorineural hearing loss in his right ear, which manifested within two to three hours of vaccination. This was an off-Table claim, requiring proof of causation-in-fact. Petitioner failed to provide an expert report to support his claim, despite multiple extensions granted by Special Master Laura D. Millman, who set a deadline of July 28, 2014, for the expert report. The only evidence submitted was a case report (Exhibit 9) concerning a 17-year-old girl who experienced bilateral sudden deafness 14 hours after an H1N1 vaccination and recovered with corticosteroid treatment. The Special Master found this case report insufficient to establish the three prongs of Althen v. Sec'y of HHS: (1) a medical theory connecting the trivalent flu vaccine to unilateral hearing loss, (2) a logical sequence of cause and effect, and (3) a proximate temporal relationship. The case report involved a different vaccine (H1N1 vs. trivalent flu), a different patient (17-year-old girl vs. 61-year-old man), bilateral vs. unilateral hearing loss, and recovery with treatment vs. no recovery. The Special Master dismissed the petition for failure to prove causation by a preponderance of the evidence. On February 3, 2015, Special Master Millman awarded petitioner $18,679.71 for attorneys' fees and costs based on a stipulation of fact between the parties. Petitioner's counsel was Danielle A. Strait, and respondent's counsel was Lisa A. Watts. Public staged source text: ================================================================================ DOCUMENT 1: USCOURTS-cofc-1_13-vv-00275-0 Date issued/filed: 2014-11-18 Pages: 5 Docket text: PUBLIC DECISION (Originally filed: 10/28/2014) regarding 37 DECISION of Special Master Signed by Special Master Laura D Millman. (tlj) Copy to parties. -------------------------------------------------------------------------------- Case 1:13-vv-00275-UNJ Document 38 Filed 11/18/14 Page 1 of 5 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 13-275V October 28, 2014 Not to be Published *************************************** JUNG PARK, M.D., * * Petitioner, * Influenza (flu) vaccine; onset of unilateral * sensorineural hearing loss two to three hours v. * later; no expert in support of allegations; * motion for ruling on the record; dismissal SECRETARY OF HEALTH * AND HUMAN SERVICES, * * Respondent. * *************************************** Danielle A. Strait, Washington, DC, for petitioner. Lisa A. Watts, Washington, DC, for respondent. MILLMAN, Special Master DECISION1 On April 19, 2013, petitioner filed a petition under the National Childhood Vaccine Injury Act, 42 U.S.C. §§ 300aa-10–34 (2006), alleging that influenza (“flu”) vaccine administered on September 27, 2011, caused sensorineural hearing loss (“SNHL”) in his right ear within two or three hours of vaccination. 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-00275-UNJ Document 38 Filed 11/18/14 Page 2 of 5 On September 13, 2013, the undersigned issued an Order setting a deadline of December 11, 2013 for petitioner to file an expert report in support of his allegations. Petitioner made several motions for enlargement of time, which were granted. On May 27, 2014, the undersigned granted petitioner’s fourth motion for enlargement of time, giving petitioner a deadline of July 28, 2014 to file an expert report. On July 21, 20 14, petitioner moved for an extension of time until September 26, 2014 to file an expert report. The undersigned held a telephonic status conference on July 22, 2014, during which petitioner’s counsel mentioned that a neuro-otologist had not responded to her about the case, and her client would like to seek other counsel but did not have another attorney yet. Petitioner’s counsel stated that her client did not give her authority to make a settlement demand. On October 8, 2014, petitioner made a motion for a decision on the record. On that same date, petitioner filed a case report marked as Exhibit 9, consisting of a report of a case of sudden deafness in a young girl following H N vaccine. 1 1 On October 9, 2014, the undersigned held a telephonic status conference, during which petitioner’s counsel stated her client would not settle his case and wanted to preserve his right to sue civilly. On October 28, 2014, respondent filed her Rule 4(c) Report in response to petitioner’s motion for a decision on the record. The undersigned’s law clerk contacted petitioner’s counsel, who stated that petitioner did not wish to file a reply. The undersigned GRANTS petitioner’s motion for a decision on the record and DISMISSES this case for failure to prove the allegations in his petition by a preponderance of the evidence. 42 U.S.C. § 300aa-13(a)(1)(A). FACTS Petitioner was born on January 15, 1950. Med. recs. Ex. 3, at 5. On September 27, 2011, when he was 61 years old, he received flu vaccine. Med. recs. Ex. 1, at 1. Also on September 27, 2011, petitioner saw Dr. Howard Stupak, an ear-nose-throat specialist, complaining of right sudden hearing loss that morning. Med. recs. Ex. 2, at 2. Dr. Stupak diagnosed petitioner with unilateral sensorineural hearing loss and tinnitus. Id. at 4. 2 Case 1:13-vv-00275-UNJ Document 38 Filed 11/18/14 Page 3 of 5 CASE REPORT Petitioner filed Exhibit 9, a case report, as the only evidence in support of his allegations. Hsueh-Hsin Huang, M.D., et al., Bilateral sudden deafness following H1N1 vaccination, 143 Otolaryngology–Head and Neck Surgery 849 (2010). The authors state that acute loss of function of the cochleovestibular2 nerve is a multifactorial disease. Id. at 849. The most common causes are vascular and viral agents, Ménière’s3 disease, or neoplasm. Id. H N 1 1 vaccine, used against influenza A, is newly developed and possibly associated with some neurological complications. Id. They discuss the case of a 17-year-old girl in Taiwan who developed sudden deafness in both her ears 14 hours after H N vaccination. Id. She also 1 1 developed mild dizziness, nausea, and bilateral tinnitus. Id. She had moderate hearing impairment of 55 decibels in both ears. Id. The patient received corticosteroid, dextran, and vitamin B complex. Id. After six days of therapy, her hearing ability improved. Id. After one month, she had a hearing threshold of 30 decibels in both ears. Id. Since bilateral sudden hearing loss is a rare event clinically, the authors speculate that there might be a causal connection between the H N vaccination and the girl’s sudden hearing loss, but they admit that 1 1 the mechanism of how this could occur from H N vaccine is unknown. Id. at 850. They 1 1 propose a theory that this killed virus vaccine induced a latent autoimmune disease in the girl. Id. Since H N is, in the authors’ phrasing, a “novel” vaccine, and there have not been any other 1 1 reports of vaccine-induced sudden hearing loss, the relationship between vaccine agents and neurological defects “has not yet been clearly established.” Id. They rely on the sequence of events in this case to attribute the young girl’s bilateral hearing loss and dizziness to labyrinthitis,4 which the simultaneous occurrence of cochleovestibular symptoms corroborates. Id. They conclude the young girl may have had an adverse reaction to H N vaccine. Id. 1 1 DISCUSSION To satisfy his 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): 2 Cochleovestibular refers “to the cochlea and vestibule of the ear.” Dorland’s Illustrated Medical Dictionary 379 (32d ed. 2012). 3 Méniére’s disease involves “hearing loss, tinnitus, and vertigo resulting from nonsuppurative disease of the labyrinth with edema.” Dorland’s, supra, at 539. 4 Labyrinthitis is “inflammation of the internal ear; it may be accompanied by hearing loss or vertigo.” Dorland’s, supra, at 995. 3 Case 1:13-vv-00275-UNJ Document 38 Filed 11/18/14 Page 4 of 5 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 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. Petitioner must show not only that but for influenza vaccination, he would not have sensorineural hearing loss in his right ear, but also that the vaccine was a substantial factor in causing his illness and, but for the vaccination, he would not have had SNHL. Shyface v. Sec’y of HHS, 165 F.3d 1344, 1352 (Fed. Cir. 1999). Although petitioner alleges that flu vaccination caused his SNHL, the medical records do not prove his allegation. Petitioner thus does not have medical record support for his allegation that that flu vaccine caused his unilateral SNHL. Petitioner did not file a medical expert report in support of his allegation. The Vaccine Act does not permit the undersigned to rule for petitioner based on his claims alone, “unsubstantiated by medical records or by medical opinion.” 42 U.S.C. § 300aa-13(a)(1) (2006). All petitioner has filed purportedly in support of his allegations is Exhibit 9, a case report involving a 17-year-old girl in Taiwan who received a relatively new monovalent flu vaccine, experienced bilateral hearing loss, and recovered from her illness with corticosteroid treatment. Petitioner, a 61-year-old man, received trivalent flu vaccine, experienced unilateral hearing loss, and did not recover from his illness with corticosteroid treatment. The undersigned cannot credit this case report as fulfilling petitioner’s burden to satisfy the three prongs of Althen. The case report provides no explanation of a credible medical theory of how trivalent flu vaccine causes unilateral hearing loss (prong one), that trivalent flu vaccine caused petitioner’s unilateral hearing loss (prong two), and that a two- to three-hour onset after vaccination is a medically appropriate interval to connote causation from trivalent vaccine to unilateral hearing loss (prong three). The discussion in the case report is not sufficient to satisfy the three prongs of Althen. Thus, petitioner has not made a prima facie case of causation. Petitioner had a year, from September 2013 to September 2014, to find an expert to prove his case. He failed to do so. He has had “a full and fair opportunity to present” his case. Vaccine Rule 3(b)(2). 4 Case 1:13-vv-00275-UNJ Document 38 Filed 11/18/14 Page 5 of 5 The undersigned GRANTS petitioner’s motion for a decision on the record and DISMISSES this case for petitioner’s failure to prove the allegations in his petition by a preponderance of the evidence. 42 U.S.C. § 300aa-13(a)(1)(A). 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.5 IT IS SO ORDERED. October 28, 2014 /s/ Laura D. Millman DATE Laura D. Millman Special Master 5 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-00275-1 Date issued/filed: 2015-02-03 Pages: 2 Docket text: PUBLIC DECISION (Originally filed: 01/13/2015) regarding 43 DECISION Fees Stipulation/Proffer Signed by Special Master Laura D Millman. (tlj) Copy to parties. -------------------------------------------------------------------------------- Case 1:13-vv-00275-UNJ Document 46 Filed 02/03/15 Page 1 of 2 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 13-275V Filed: January 13, 2015 Not for Publication ************************************* JUNG PARK, M.D., * * Petitioner, * Attorneys’ fees and costs decision based on * stipulation of fact v. * * SECRETARY OF HEALTH * AND HUMAN SERVICES, * * Respondent. * * ************************************* Danielle A. Strait, Washington, DC, for petitioner. Lisa A. Watts, Washington, DC, for respondent. MILLMAN, Special Master DECISION AWARDING ATTORNEYS’ FEES AND COSTS1 On January 13, 2015, 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 General Order #9, petitioner filed a statement asserting he did not incur any costs in pursuit of his petition. Petitioner submitted his request for attorneys’ fees and costs to respondent. During informal discussions, respondent raised objections to certain items in petitioner’s application. Based on these objections, petitioner amends his application for attorneys’ fees and costs to 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-00275-UNJ Document 46 Filed 02/03/15 Page 2 of 2 $18,679.71, consisting of $14,216.00 in attorneys’ fees and $4,463.71 in attorneys’ costs. Respondent does not object to this amount. The undersigned finds this amount to be reasonable. Accordingly, the court awards $18,679.71, representing reimbursement for attorneys’ fees and costs. The award shall be in the form of a check payable jointly to petitioner and Maglio, Christopher, & Toale, P.A. for $18,679.71. 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: January 13, 2015 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