LISA D. HAMILTON-FIELDMAN, Special Master.
This is an action by Meghan McSherry ("Petitioner") seeking an award under the National Vaccine Injury Compensation Program (hereinafter "Program").
Petitioner was born on August 30, 1987. Pet'r's Ex. 1 at 1, ECF No. 9-2. In October 1999, Petitioner experienced menarche.
In August 2002, a doctor noted that Petitioner had a "history of irregular menstrual cycles," and observed free fluid and a "cystic" structure during a pelvic ultrasound. Pet'r's Ex. 7 at 60, ECF No. 18-3; see Pet'r's Ex. 5a at 69. A month later, transabdominal and endovaginal imaging confirmed the existence of free fluid, but revealed no "complex cystic structure." Pet'r's Ex. 7 at 57.
Around the same time, Petitioner began a cycle of hormonal oral contraceptive pills ("OCPs") and resumed bleeding every month. Pet'r's Ex. 8 at 2; see Pet'r's Ex. 5a at 69. In the fall of 2003, however, Petitioner's menstrual cycle again became irregular. Pet'r's Ex. 8 at 2. She began another cycle of OCPs,
From October 2004 until January 2005, Petitioner did not menstruate. Id. Petitioner's treating physician set forth a fairly lengthy menstrual history, and summed it up by stating that Petitioner "has had irregular menses or amenorrhea since early 2000" and that a workup had shown an elevated FSH level. Id. Petitioner was diagnosed with secondary amenorrhea due to estrogen deficiency. Id. The treating physician advised discontinuing hormonal intervention, and Petitioner experienced four menstrual periods between then and July 13, 2005. Id. at 10.
Two years later, in July 2007, Petitioner explained to her physician that she suffered from irregular bleeding despite her use of OCPs. Id. at 31. Specifically, Petitioner's flow would be light one month and heavy another, and she would often bleed in the middle of a cycle. Id. Because of this, Petitioner wished to cease taking OCPs and begin using the Nuvaring. Id.
Three months later, in October 2007, Petitioner asked her doctor to resume taking OCPs because she felt the Nuvaring resulted in weight gain. Pet'r's Ex. 5a at 2. Petitioner's physician obliged. Id. At that same visit, Petitioner received the HPV Vaccine. Pet'r's Ex. 2 at 2, ECF No. 9-3.
On August 15, 2008, Petitioner visited the physician again, complaining that she had missed a menstrual period despite her OCPs. Pet'r's Ex. 5a at 4. The physician again administered the HPV Vaccine. Pet'r's Ex. 2 at 2.
On June 15, 2011, at a visit with her physician, Petitioner noted that she was menstruating regularly. Pet'r's Ex. 5a at 33. The physician then administered Petitioner the HPV Vaccine for the final time. Pet'r's Ex. 2 at 2.
Roughly three months later, in September 2011, Petitioner informed her physician that she had experienced abnormally heavy menstruation and cramping. Pet'r's Ex. 5a at 47. The physician prescribed Petitioner another OCP, which Petitioner used until March 2012. Id. at 59.
In September 2012, Petitioner explained that her menstrual cycle had been irregular and that she had observed a gradual increase in upper lip hirsutism. Id. at 69. Three days later, a physician observed that Petitioner's elevated level of FSH indicated premature ovarian insufficiency ("POI").
On October 2, 2012, a physician diagnosed Petitioner with POI. Id. at 75. Petitioner explained that from ages 14 to 24, she had experienced monthly bleeding while taking OCPs, but otherwise had suffered from irregular menstruation. Id. She denied experiencing hot flashes or night sweats at any point. Id. at 76. On November 26, 2013, a complete physical exam confirmed the physician's POI diagnosis. Pet'r's Ex. 5b at 26, ECF No. 14-3.
On February 27, 2014, Petitioner filed the present action alleging that the Human Papillomavirus vaccinations ("Gardasil" or "HPV" vaccines) administered to her on October 26, 2007, August 15, 2008, and June 15, 2011, caused her to suffer from POI. Pet., ECF No. 1.
This case was identified for inclusion with other POI cases in an "omnibus proceeding" established to address the question of what constitutes the first symptom or manifestation of POI. See Pet'r's Status Report (Oct. 1, 2014), Culligan, ECF No. 23. The answer to this question is integral to the undersigned's determination of whether each petitioner had filed her claim within the statute of limitations. See 42 U.S.C. § 300aa-16(a)(2) (2012) (requiring that petitions be filed prior to "the expiration of 36 months after the date of the occurrence of the first symptom or manifestation of onset . . . of injury").
The lead case in the proceeding was Culligan.
At a Culligan status conference held on September 23, 2014, the undersigned discussed with the parties the necessity of establishing the date that the statute of limitations began to run in Culligan and other cases alleging an injury of POI caused by Gardasil in order to assess the timeliness of the claims. See Scheduling Order (Sept. 25, 2014) at 1, Culligan, ECF No. 22. The undersigned directed the petitioner in Culligan's counsel, Mark Krueger, who is also counsel in the instant case, to begin the process of identifying other POI claimants for inclusion in an omnibus proceeding focused on the question of timeliness.
On October 1, 2014, Mr. Krueger filed a status report in which he identified eight POI cases
Another 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, Culligan, 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 cases
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, Culligan, ECF No. 37; Scheduling Order (Jan. 30, 2015) at 1, Culligan, ECF No. 36; Pet'r's Status Report (Dec. 29, 2014) at 1, Culligan, ECF No. 31; Scheduling Order (Nov. 24, 2014) at 2, Culligan; Resp't's Status Report (Oct. 28, 2014) at 1, Culligan, 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 of those cases as hypotheticals." Joint Status Report (Jan. 20, 2015) at 1, Culligan, ECF No. 33. To facilitate this process, Petitioner filed summaries of the facts of all twelve POI cases. See Pet'r's Ex. 9, Culligan, ECF No. 34-2.
At a status conference held on January 28, 2015, the undersigned set deadlines for the parties' expert reports regarding timeliness. See Order (Jan. 30, 2015) at 2, Culligan. The experts were directed to address all of the identified timeliness questions separately, "on a question-by-question basis." Id. at 1.
On February 19 and March 3, 2015, three additional cases,
On March 12, March 13, and April 29, 2015, Petitioner filed expert reports and supporting medical literature, all of which were purportedly limited to the issue of timeliness. See Pet'r's Ex. 13, Culligan, ECF Nos. 47-2 to 51-6; Pet'r's Ex. 15, Culligan, ECF Nos. 53-1 to 54-3; Pet'r's Ex. 17, Culligan.
The undersigned convened a status conference on April 1, 2015, after having reviewed Petitioner's expert reports. See Scheduling Order (Apr. 2, 2015) at 1, Culligan, ECF No. 55. The undersigned noted that, "notwithstanding the fact that Petitioner's onset experts have now reviewed the medical records associated with every [POI] case, Respondent's onset expert(s) will review only the cases' factual summaries, the Culligan record, and Respondent's list of hypothetical questions." Id. Also, having expressed some concern about the extent to which Petitioner's expert reports reflected an understanding of the relevant question regarding timeliness, the undersigned reiterated the following:
Id. (full citation omitted).
Respondent then filed an expert report regarding timeliness, as well as relevant medical literature, on May 8, May 28, and June 1, 2015. Resp't's Ex. A to A.32, Culligan, ECF Nos. 57-1 to 59-6, 63-1 to 63-3, 66-1 to 67-4. Respondent's expert report was authored by Dr. David Frankfurter. Resp't's Ex. A at 6, Culligan.
At a status conference held on May 14, 2015, Respondent confirmed that, in preparing his expert report, Dr. Frankfurter had reviewed only the factual summaries submitted by Petitioner (and the medical record from Culligan). See Order (May 15, 2015) at 1, Culligan, ECF No. 61. Mr. Krueger agreed that, notwithstanding the fact that his experts had reviewed all of the medical records in all of the POI cases, "his experts would be referring to the factual summaries rather than to the medical records themselves" at the timeliness hearing. Id.
The parties filed their pre-hearing briefs simultaneously on June 1, 2015, see Pet'r's Prehearing Submissions, Culligan, ECF No. 65; Resp't's Prehearing Submissions, Culligan, ECF No. 69; and the hearing took place on June 16 and 17, 2015, see Minute Entry (June 18, 2015), Culligan. Petitioner's experts, Drs. Gersh and Hamiel, and Respondent's expert, Dr. Frankfurter, testified. Tr. at 4, 255, Culligan, ECF Nos. 81, 83.
On July 1, 2015, the undersigned issued an order identifying nine POI cases
On August 28, 2015, Respondent filed a status report in which she stated that she did not intend to contest the undersigned's preliminary findings in any of the presumptively timely cases filed by Mr. Krueger. Resp't's Status Report (Aug. 28, 2015) at 1, Culligan, ECF No. 84. In status reports filed on September 2 and 30, 2015, Petitioner argued that all of the preliminarily precluded cases were, in fact, timely. See Pet'r's Status Report (Sept. 2, 2015) at 2-7, Culligan, ECF No. 85 (addressing Culligan, Chenowith, Garner, Lee, Lydia McSherry, and Madelyne Meylor); Pet'r's Status Report (Sept. 30, 2015) at 1-2, Culligan, ECF No. 87 (addressing Fishkis, Meghan McSherry, Stone).
At a status conference held on October 13, 2015, the undersigned "informed the parties that, for purposes of an onset determination, the [POI] cases [would] be divided [into] two groups: petitioners who never menstruated . . . and the rest of the [POI] petitioners." See Scheduling Order (Oct. 14, 2015) at 1, Culligan, ECF No. 88.
Relevant post-hearing briefing
Section 300aa-16(a)(2) of the Vaccine Act provides that, regarding
42 U.S.C. § 300aa-16(a)(2).
This statute of limitations is not triggered by the administration of the vaccine, but "begins to run on the date of occurrence of the first symptom or manifestation of onset of the vaccine-related injury for which compensation is sought." Cloer, 654 F.3d at 1335. "[E]ither a `symptom' or a `manifestation of onset' can trigger the running of the statute [of limitations], whichever is first." Markovich v. Sec'y of HHS, 477 F.3d 1353, 1357 (Fed. Cir. 2007).
"[I]t is the first symptom or manifestation of an alleged vaccine injury, not first date when diagnosis would be possible, that triggers the statute of limitations." Carson ex rel. Carson v. Sec'y of HHS, 727 F.3d 1365, 1369 (Fed. Cir. 2013), reh'g & reh'g en banc denied, 2013 WL 4528833 at *1. "A symptom may be indicative of a variety of conditions or ailments, and it may be difficult for lay persons to appreciate the medical significance of a symptom with regard to a particular injury." Markovich, 477 F.3d at 1357. While the symptom of an injury must be recognized as such "by the medical profession at large," Cloer, 654 F.3d at 1335, even subtle symptoms that a petitioner would recognize "`only with the benefit of hindsight, after a doctor makes a definitive diagnosis of injury,'" trigger the running of the statute of limitations, whether or not the petitioner or even multiple medical providers understood their significance at the time. Carson, 727 F.3d at 1369-70 (quoting Markovich, 477 F.3d at 1358).
There is no explicit or implied discovery rule under the Vaccine Act. Cloer, 654 F.3d at 1337. The date of the occurrence of the first symptom or manifestation of onset of the alleged vaccine-related injury "does not depend on when a petitioner knew or reasonably should have known anything adverse about her condition." Id. at 1339. Nor does it depend on when a petitioner knew or should have known of a potential connection between an injury and a vaccine. Id. at 1338 ("Congress made the deliberate choice to trigger the Vaccine Act statute of limitations from the date of occurrence of the first symptom or manifestation of the injury for which relief is sought, an event that does not depend on the knowledge of a petitioner as to the cause of an injury."); see Markovich, 477 F.3d at 1358 ("Congress intended the limitation period to commence to run prior to the time a petitioner has actual knowledge that the vaccine recipient suffered from an injury that could result in a viable cause of action under the Vaccine Act." (internal quotation marks omitted)).
Primary ovarian insufficiency can begin abruptly, see Tr. at 69; see also Nelson at 2-3; but it may also develop over several years, see Tr. at 70, 198-99, 398; see also Nelson at 2-3; Pet'r's Ex. 17, Tab 50 at 2 (Paolo Beck-Peccaz & Luca Persam, Premature Ovarian Failure, 1 Orphanet J. Rare Diseases, at 2 (Apr. 2006)) (hereinafter "Beck-Peccaz"). Thus, a woman could have symptoms of POI for several years before actually ceasing menstruation or being diagnosed with POI. See Tr. at 70, 198-99, 398; see also Tr. at 319; Nelson at 2-3; Beck-Peccaz at 2. The experts agreed that the symptoms of primary ovarian insufficiency include menstrual irregularities, including primary and secondary amenorrhea, cycle and frequency irregularity, and excessive or prolonged bleeding; delayed menarche; lack of breast development and poor growth velocity; night sweats; hot flashes; sleep disturbances; mood changes; recurring ovarian cysts; arrested puberty; and marked hirsutism. Tr. at 38, 57, 68-69, 319, 366. Most of these symptoms are not "normal" for a woman under the age of 40. Petitioner therefore does not dispute that they can constitute the "first symptom or manifestation of onset" of POI for purposes of the Act's statute of limitations, and there was little discussion of the symptoms beyond their inclusion on the list of symptoms. As to menstrual irregularities and delayed menarche, however, Petitioner and Petitioner's experts dispute that these two conditions should be considered symptoms at all, because many young women experience these conditions at the beginning of their reproductive lives, such that these conditions are considered "normal." See, e.g., Pet'r's Post Hr'g Br. at 2, 4-8; Tr. at 32, 58, 61, 72-73, 170-71; see also Tr. at 380 (Respondent's expert, Dr. Frankfurter, explaining that it is normal for a teenager to have irregularity, albeit within a range). As a result, Petitioner and her experts claim, menstrual irregularity only constitutes a symptom or manifestation of onset of POI when that irregularity is effectively considered secondary amenorrhea. Pet'r's Post Hr'g Br. at 4-5; Pet'r's Post Hr'g Rep. Br. at 3.
By instead finding that "normal" menstrual irregularity is a symptom for purposes of the Act's statute of limitations, Petitioner argues, the undersigned will somehow increase Petitioner's burden of proof. See Pet'r's Post Hr'g Reply Br. at 1-2. The undersigned does not agree. The undersigned does agree, however, that to qualify as the first symptom or manifestation of onset under the Act, a condition must be a symptom of something amiss, however subtle; it cannot be "normal": a symptom is "[a]ny morbid phenomenon or departure from the normal in structure, function, or sensation, experienced by the patient and indicative of disease." Symptom, Stedman's Medical Dictionary (28th Ed. 2013) (hereinafter "Stedman's") (emphasis added); accord Markovich, 477 F.3d at 1360 (observing that eye blinking episodes constituting first symptom of child's seizure disorder "were not normal child behavior"). In order to determine the date of the first symptom or manifestation of onset of the vaccine-related injury, therefore, a method for separating "normal" menstrual irregularities from abnormal symptoms of POI is necessary.
Fortunately, medical literature provided by the parties provides a solution, both simple and elegant. See Resp't's Ex. A.2, ECF No. 57-4 (Comm. on Adolescent Health Care, Am. Coll. of Obstetricians & Gynecologists, Menstruation in Girls and Adolescents: Using the Menstrual Cycle as a Vital Sign, Comm. Op. No. 349 (Nov. 2006)) (hereinafter "ACOG Opinion" or "ACOG Op."); see also Pet'r's Ex. 15, Tab 4. In Cloer and Markovich, the Federal Circuit directed that "the symptom or manifestation of onset must be recognized as such by the medical profession at large." Cloer, 654 F.3d at 1335; Markovich, 477 F.3d at 1360. The ACOG Opinion is an opinion from the Committee on Adolescent Healthcare at the American College of Obstetricians and Gynecologists, together with the American Academy of Pediatrics, entitled "Menstruation in Girls and Adolescents: Using the Menstrual Cycle as a Vital Sign." See ACOG Op. It was issued in November 2006, and "Reaffirmed" in 2009. ACOG Op. at 1. The abstract of the ACOG Opinion provides:
Id. The article goes on to discuss a number of articles and robust epidemiological studies concerning what constitutes "normal menstrual cycles in young females," including age at menarche, and "cycle length and ovulation," id. at 2-3; "abnormal menstrual cycles," including "prolonged interval[s]," id. at 3-4; and "excessive menstrual flow," id. at 4. The article concludes with a chart, reproduced below, that together with one difference applicable to women older than 18, provides comprehensive guidance to the "medical profession at large" about when menstrual irregularities have exceeded "normal" variation to become symptoms of a potential problem. Id. at 4-5. The chart is as follows:
Menstrual periods that:
Id. at 5.
Hillard reproduces this chart, accompanied with this caution:
Hillard at 8 (emphasis added).
There cannot be a better vehicle for the undersigned to use to sort out "normal" from "symptom" than one designed for that purpose by members of the medical profession themselves. Thus, the undersigned finds that for petitioners who were eighteen years old or younger at the time the condition arose, if the condition qualifies for evaluation on the ACOG chart, it constitutes a symptom for purposes of the Vaccine Act. For petitioners who were over eighteen years old at the time the condition arose, the chart also applies, except that periods that should be evaluated include those that occur more frequently than every 21 days or less frequently than every 34 days. See ACOG Op. at 3.
Finally, as to contraceptives' impact on this analysis, Hillard specifically limited her discussion "only to bleeding on young women who are not taking any hormonal therapy such as birth control." Hillard at 6. All of the experts at the hearing agreed that hormonal therapy would mask POI symptoms. Tr. at 115, 161, 387-88. The ACOG Opinion recommends blood collection for screening before hormonal treatment is begun, ACOG Op. at 4, as did Doctors Hamiel, Tr. at 95-97, and Frankfurter, Tr. at 377, at the hearing; although, both experts acknowledged that such testing is often not performed before hormonal treatment is started. Tr. at 95-97, 112-13, 387-92.
Based on that information, the undersigned makes the following findings regarding how contraceptive use will inform the undersigned's findings on onset for purposes of the statute of limitations:
Petitioner filed her petition on February 27, 2014. The petition is time-barred if "the first symptom or manifestation of onset" of her alleged vaccine injury, POI, occurred before February 27, 2011. Drs. Hersh and Hamiel argue that judging Petitioner's irregularity alone is not a reliable means to determine the first symptom of POI. Pet'r's Ex. 13 at 8, Culligan, ECF No. 47-1; Pet'r's Ex. 15 at 10, Culligan, ECF No. 53-1. Instead, they posit that the statute of limitations did not begin to run until Petitioner's irregularity reached the level of amenorrhea. Pet'r's Ex. 13 at 8, Culligan; Pet'r's Ex. 15 at 10, Culligan.
The undersigned finds that the first symptom of Petitioner's POI occurred no later than the Fall of 2002, when Petitioner reported that she had only experienced menstruation once every three months since the Spring of 2000. At that point, Petitioner's menstrual cycle vital sign was not normal pursuant to three of the ACOG criteria: her menstrual periods (1) were regular before becoming markedly irregular, (2) occurred less frequently than every 45 days, and (3) occurred 90 days apart for at least one cycle. See ACOG Op. at 5. Given her physician's statement in 2005 that Petitioner "has had irregular menses or amenorrhea since early 2000," this date meets even Petitioner's experts' requirements for what constitutes the first symptom or manifestation of Petitioner's POI.
In sum, the undersigned finds that the gap between menstrual periods from Spring of 2000 until Fall of 2002 constituted menstrual irregularity. Accordingly, the gap was the first symptom or manifestation of onset of Petitioner's alleged vaccine-caused injury, POI.
Based on the foregoing analysis, the undersigned finds that the first symptom of Petitioner's injury occurred no later than the Fall of 2002. Because that date precedes the statute of limitations deadline by more than eight years, the undersigned concludes that Petitioner's claim is time-barred. Her petition therefore must be, and is hereby,
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.
