Opinion ID: 4556821
Heading Depth: 2
Heading Rank: 1

Heading: Vaccine Act Petition

Text: On October 30, 2015, Susan Cottingham, on behalf of her then minor daughter, K.C., filed a petition for compensation under the National Vaccine Injury Compensation Program, 42 U.S.C. § 300aa-10, (“Vaccine Act”). The petition alleged that K.C. suffered various physical injuries that were caused by a Gardasil® vaccination she received on July 5, 2012, for the prevention of human papilloma virus (“HPV”). Gardasil® is an FDA-approved vaccine indicated for prevention of numerous “diseases” including HPV. See J.A. 37–59 at 37 (Gardasil® package insert). Gardasil’s® package insert identifies several potential adverse reactions associated with its administration, including headache, dizziness, and syncope. J.A. 40–45. HPV Vaccines are included on the Vaccine Act’s vaccine injury table as of February 1, 2007. 42 C.F.R. § 100.3(e)(7). At the time of petition in October 2015, the Vaccine Injury Table specified no conditions or onset times Case: 19-1596 Document: 36 Page: 3 Filed: 08/19/2020 COTTINGHAM v. HHS 3 for the HPV vaccine. See HHS Vaccine Injury Table, 42 C.F.R. § 100.3(a). 1 The record indicates that Cottingham first contacted counsel about K.C.’s injuries on May 15, 2015. For the next five months, counsel gathered K.C.’s medical records. Counsel also secured an affidavit from K.C. on October 28, 2015. J.A. 32–34. In the affidavit, K.C. declared that she began experiencing the initial symptoms of her alleged vaccine injuries approximately four months after she received the Gardasil® vaccine. J.A. 32. Based on the date that K.C. reported first experiencing symptoms, counsel concluded that the three-year statute of limitations to file a Vaccine Act claim would potentially run on November 1, 2015, and filed Cottingham’s petition on October 30, 2015, before the U.S. Court of Federal Claims (“Claims Court”). The Claims Court appointed a special master to consider the claim. See J.A. 69. The petition alleged that K.C.’s July 5, 2012, vaccination caused her to experience: (1) chronic headaches that began on November 1, 2012; (2) two episodes of fainting, one on March 29, 2013, and one on May 23, 2013; and (3) menstrual difficulties starting in “the latter part of 2013.” J.A. 6–7, J.A. 96–99. By March 15, 2016, Cottingham’s counsel obtained and filed relevant medical records. K.C.’s medical records 1 In 2017, three conditions for the vaccine were added to the Vaccine Injury Table: anaphylaxis with onset in less than four hours; shoulder injury with onset in less than 48 hours, and vasovagal syncope with onset in less than 1 hour. HHS Vaccine Injury Table, 42 C.F.R. § 100.3 (2017). These conditions do not apply to Cottingham’s petition, however, because they apply to petitions filed on or after February 21, 2017. HHS Vaccine Injury Table, 42 C.F.R. § 100.3(e) (2017). Case: 19-1596 Document: 36 Page: 4 Filed: 08/19/2020 4 COTTINGHAM v. HHS consist of numerous medical-examination reports detailing K.C.’s medical history. J.A. 35, 36, 60, 61, 62, 63–67. For example, on November 30, 2012, K.C. complained of headaches “off and [on] all week.” J.A. 35. On January 31, 2013, K.C. again reported a headache. J.A. 61. On March 29, 2013, K.C. reported dizziness, syncope, and headache. J.A. 62. On May 23, 2013, K.C. complained of syncope and headache. J.A. 63–65. On July 25, 2013, K.C. reported experiencing “several episodes of dizziness and passing out.” J.A. 36. And in May 2015, K.C.’s medical reports document a chief complaint of amenorrhea, that K.C. “ha[d] not had a period in [four months]” and another report of K.C. “not [having] a menstrual cycle in [six] months.” J.A. 60, 66– 67. K.C.’s May 14, 2015, medical report documents K.C.’s mother’s “concern[] that the Gardasil series may have had something to do with the recent changes noted in [K.C.’s] menstrual cycle.” J.A. 60. During a March 2016 status conference with the Special Master, counsel for the Appellee Secretary of Human Health and Services (“Secretary”) “noted that reasonable basis for bringing the case may not be present for [Cottingham].” In response, Cottingham’s counsel requested additional time to seek and obtain expert opinion to support the claim. The Special Master granted Cottingham’s request. Between April and October 2016, Cottingham’s counsel contacted two different experts. See J.A. 2. Neither expert provided a favorable opinion, and Cottingham was unable to submit an expert opinion supporting her claim. See id., J.A. 107. On October 7, 2016, Cottingham’s counsel filed a motion to dismiss the petition, and on October 13, 2016, the Special Master issued a decision denying entitlement to compensation.