Culligan v. Sec'y of Health & Human Servs.

EMILY CULLIGAN, Petitioner, v. SECRETARY OF HEALTH AND HUMAN SERVICES, Respondent.

No. 14-318V

United States Court of Federal Claims

June 2, 2016

OFFICE OF SPECIAL MASTERS

TO BE PUBLISHED

Special Master Hamilton-Fieldman

Gardasil; Human Papillomavirus (HPV) Vaccine; Statute of Limitations; First Symptom or Manifestation of Onset; Premature Ovarian Failure (POF); Primary Ovarian Insufficiency (POI); Menstrual Cycle; Dismissal

Mark Krueger, Krueger & Hernandez, SC, Baraboo, WI, for Petitioner.

Lara Englund, United States Department of Justice, Washington, DC, for Respondent.

DECISION¹

This is an action by Emily Culligan ("Petitioner") seeking an award under the National Vaccine Injury Compensation Program (hereinafter "Program").² Respondent contends that the petition was untimely filed, and as such should be dismissed. For the reasons set forth below, the undersigned concludes that the petition was untimely filed, and it is therefore hereby dismissed.

I. FACTUAL BACKGROUND

Petitioner was born on June 27, 1984. Pet'r's Ex. 1, ECF No. 7-2. It is unclear whenshe experienced menarche,³ but from a reproductive system standpoint, her puberty and adolescence appear to have been uneventful. By the age of 22, she had settled into regular menstrual cycles of every 28 days, with moderate flow for two days followed by two days of light flow. Pet'r's Ex. 6 at 7,⁴ ECF No. 7-7.

Petitioner briefly used various forms of hormonal contraception, including the NuvaRing, but did not want to use hormones for any length of time "on general principals [sic]." Pet'r's Ex. 5 at 1, ECF No. 7-6. She had a non-hormonal copper Paragard IUD implanted on November 15, 2006, Pet'r's Ex. 6 at 5-6, ECF No. 7-7, which remained in place until she had it removed in February of 2013, Pet'r's Ex. 2 at 8, ECF No. 7-3. She had a history of cystic acne, for which she was prescribed Spironolactone in early 2011, but no history of hirsutism. Id. at 17.

On March 31, 2010, Petitioner saw Laila Sillay, M.D., her gynecologist, for a routine annual examination. Id. at 21-23. She reported menstrual cycles that occurred every 25 days and lasted for 5 days. Id. at 21. She received her first dose of the HPV vaccine. Id. at 22. She received the second dose of the vaccine on June 1, 2010. Id. at 20. On October 4, 2010, she was administered the third dose of the HPV vaccine, and she received a seasonal flu vaccine. Id. at 19.

Petitioner returned to Dr. Sillay on May 10, 2011, again for a routine examination. Id. at 17-18. Her last reported menstrual period was almost three months prior, February 21, 2011, and she reported a six-month history of less frequent, heavier, and longer (7-10 days) menstrual periods. Id. at 17. The assessment was oligomenorrhea⁵ "likely related to spironolactane, PCOS⁶ less likely," and she was given a progestin challenge. Id. at 18. Thefollowing week, on May 16, 2011, she returned complaining of pelvic pain. Id. at 16. It is not clear whether, at that time, she had started the progestin. See id. A pelvic ultrasound was ordered, id., and it showed cysts in both ovaries, id. at 14. The impression was "likely ruptured cyst, resolving." Id. No bloodwork was done. See id.

Petitioner next saw Dr. Sillay on January 15, 2013. Id. at 11-13. She reported that her last menstrual period was August 22, 2012, and that she had regular cycles until two years earlier when she developed oligomenorrhea. Id. at 11. She had been given Provera in May 2011, which resulted in withdrawal bleeding. Id. The assessment was oligomenorrhea, mild acne, and questionable PCOS. Id. at 12. She was given another progestin challenge. Id.

On February 28, 2013, petitioner saw Dr. Sillay for IUD removal and evaluation of amenorrhea. Id. at 8-9. She related a recent history of oligomenorrhea, with cycles every two to three months, and amenorrhea since her wedding in August 2012. Id. at 8. She had not responded to the Provera. See id. Her IUD was removed, and labs were drawn. Id. at 8. A note dated March 4, 2013, indicates that the labs showed elevated FSH and low E2 and progesterone. Id. at 7. She was to repeat the labs; if her FSH was still elevated, she would be referred to a reproductive endocrinologist for Primary Ovarian Insufficiency ("POI"). Id.

Petitioner returned to Dr. Sillay on March 14, 2013 for the repeat labs. Id. at 6. On March 18, 2013, Dr. Sillay made a note that repeat labs had shown "persistently elevated" FSH and low E2, consistent with POI. Id. at 5.

On March 24, 2013, Petitioner consulted with Brandon J. Bankowski, M.D., at Oregon Reproductive Medicine. Pet'r's Ex. 8 at 1-4, ECF No. 17-1. He concurred with Dr. Sillay's POI diagnosis.⁷ Id. at 3. Petitioner and Dr. Bankowski discussed additional testing, includinggenetic testing, as well as testing for antiovarian, thyroid, and adrenal antibodies. Id. They also discussed pregnancy alternatives, including egg donation and gonadotropin IUI. Id. Genetic testing showed a normal female karyotype (46, xx), and was negative for fragile X syndrome. Id. at 5-10. An ovarian antibody screen was also negative. Pet'r's Ex. 3 at 8, ECF No. 7-4.

Petitioner underwent a pelvic ultrasound on April 19, 2013, which showed a cyst on her right ovary, and a trilaminal endometrium. Id. at 5. A repeat pelvic ultrasound on May 15, 2013, showed a homogenous endometrium. Id. at 3. A third pelvic ultrasound performed on June 6, 2013, showed a likely intraovarian cyst in the right ovary, but was otherwise normal. Pet'r's Ex. 4 at 2, ECF No. 7-5.

II. PROCEDURAL BACKGROUND

On April 18, 2014, Petitioner filed the present action alleging that the Human Papillomavirus vaccinations ("Gardasil" or "HPV" vaccines) administered to her on March 31, 2010, June 1, 2010, and October 4, 2010 caused her to suffer from POI. Pet., ECF No. 1. Petitioner was, and continues to be, represented by Mark Krueger of Krueger & Hernandez, S.C. Pet. at 2. The case was initially assigned to Special Master Christian Moran. Notice of Assignment, ECF No. 2.

Petitioner filed eight medical record exhibits between May 20 and July 21, 2014, see Docket Report; in the interim, the case, along with several others filed by petitioners who had alleged similar injuries caused by Gardasil, was reassigned to the undersigned. See Order Reassigning Case, ECF No. 14. Petitioner filed a statement of completion on July 30, 2014. Statement of Completion, ECF No. 19.

On August 14, 2014, Respondent filed a Rule 4(c) Report and Motion to Dismiss ("Respondent's Report"), in which she contended that Petitioner was not entitled to a Program award. Resp't's Report at 3-5, ECF No. 20. Respondent argued that the first symptom of Petitioner's POI was oligomenorrhea, which Petitioner experienced in "late 2010"; accordingly, Petitioner's claim was untimely under the Vaccine Act's statute of limitations. Id. at 4 (citing 42 U.S.C. § 300aa-16(a)(2) (2012) (requiring that vaccine-related injury petitions be filed prior to "expiration of 36 months after the date of the occurrence of the first symptom or manifestation of onset . . . of such injury")). Respondent also argued that, even if Petitioner's claim was not time-barred, Petitioner had failed to prove causation under Althen v. Sec'y of HHS, 418 F.3d 1274, 1278 (Fed. Cir. 2005). Id. at 4-5.

At a status conference held on September 23, 2014, the undersigned discussed with the parties the necessity of establishing when the statute of limitations began to run in the instantcase-and in the other cases in which Mr. Krueger had alleged that petitioners' POI had been caused by Gardasil vaccinations-in order to assess timeliness. See Scheduling Order (Sept. 25, 2014), ECF No. 22. The undersigned directed Petitioner to begin the process of identifying all of the POI petitioners so that an assessment of timeliness could take place in all of those cases. Id.

On October 1, 2014, Petitioner filed a status report in which she identified eight POI cases⁸ to be included in the undersigned's assessment of timeliness. See Pet'r's Status Report (Oct. 1, 2014). Petitioner subsequently named the instant case as the "test case" for timeliness. See Pet'r's Status Report (Nov. 5, 2014) at 1, ECF No. 25.

A third status conference was held on November 20, 2014, during which the parties agreed that "in all pending [POI] cases . . . an expert hearing [would] be held to address the question of what constitutes 'the first symptom or manifestation of [POI] onset recognized as such by the medical profession at large.'" Scheduling Order (Nov. 24, 2014) at 1, ECF No. 26 (citing Cloer v. Sec'y of HHS, 654 F.3d 1322, 1340 (Fed. Cir. 2011) (en banc)). The undersigned explained that a timeliness determination would be made on the basis of the evidence presented at the Culligan hearing; similar hearings would not be conducted in the other POI cases, all of which would trail Culligan for purposes of timeliness determinations. Id. The undersigned also added four additional POI cases⁹ to the list of cases set to trail Culligan. Id. The undersigned also ordered that all parties seeking to be joined in the omnibus proceeding consent to share their medical records, see Scheduling Order (Nov. 24, 2014) at 2, Culligan, ECF No. 26, and all parties later obliged.

The parties and the undersigned proceeded to identify questions for the experts (to be researched and answered before the hearing) regarding the nature and timing of the first symptom or manifestation of onset of POI in the aforementioned cases. See, e.g., Order (Feb. 18, 2015) at 1, ECF No. 37; Scheduling Order (Jan. 30, 2015) at 1, ECF No. 36; Pet'r's Status Report (Dec. 29, 2014) at 1, ECF No. 31; Scheduling Order (Nov. 24, 2014) at 2; Resp't's Status Report (Oct. 28, 2014) at 1, ECF No. 24. The parties and their experts ultimately agreed that, except in Culligan, in which the entire medical record would be considered by the experts, the experts would "offer opinions regarding the onset issues in the trailing cases by considering the facts...