Garner v. Secretary of Health and Human Services

In the United States Court of Federal Claims

OFFICE OF SPECIAL MASTERS

No. 15-143V

Filed: June 2, 2016

* * * * * * * * * * * * * * * * *

KATELYN GARNER, * TO BE PUBLISHED

*

Petitioner, * Special Master Hamilton-Fieldman

v. *

*

SECRETARY OF HEALTH * Gardasil; Human Papillomavirus (HPV)

AND HUMAN SERVICES, * Vaccine; Statute of Limitations; Premature

* Ovarian Failure (POF); Primary Ovarian

* Insufficiency (POI); First Symptom or

Respondent. * Manifestation of Onset; Menstrual Cycle;

* * * * * * * * * * * * * * * * * Dismissal.

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

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

DECISION 1

This is an action by Katelyn Garner (“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.

1

Because this decision contains a reasoned explanation for the undersigned’s action in this case,

the undersigned intends to post this decision on the website of the United States Court of Federal

Claims, in accordance with the purposes espoused in the E-Government Act of 2002. See 44

U.S.C. § 3501 (2012). Each party has 14 days to request redaction “of any information furnished

by that party: (1) that is a trade secret or commercial or financial in substance and is privileged

or confidential; or (2) that includes medical files or similar files, the disclosure of which would

constitute a clearly unwarranted invasion of privacy.” Vaccine Rule 18(b).

2

The National Childhood Vaccine Injury Act of 1986, 42 U.S.C. §§ 300aa-1 to -34 (2012)

(hereinafter “Vaccine Act”), provides the statutory provisions governing the Program.

1

I. FACTUAL BACKGROUND

Petitioner was born on December 5, 1994 at St. Luke’s Hospital in Chesterfield,

Missouri. Pet’r’s Ex. 1 at 1, ECF No. 6-2. Other than a tonsillectomy and adenoidectomy in

December 2004, which she underwent to treat her recurrent tonsillitis, Pet’r’s Ex. 3 at 21-25,

ECF No. 6-4, Petitioner’s pre-vaccine medical history is unremarkable, see generally id.

Through 2007, her pubertal development appears to have been normal: onset of breast and pubic

hair development occurred in 2006 and 2007, when Petitioner was in sixth and seventh grade.

Id. at 16.

She was administered Gardasil vaccinations on August 9, 2007, August 11, 2008, and

April 13, 2009. Pet’r’s Ex. 2 at 1, ECF No. 6-3; Pet’r’s Ex. 3 at 14, 29.

At well-child visits on August 10, 2006 and August 9, 2007, when Petitioner was 11 and

12 years old, respectively, no abnormalities in pubertal development were noted. 3 Pet’r’s Ex. 3

at 43-44. At her 12-year well-check on August 9, 2007, Petitioner was noted to have had a

Tanner developmental stage of “III-IV”. Id. at 44. At her 13-year-old well-check visit on

August 11, 2008, her pediatrician noted that she was at Tanner Stage II, 4 one to two stages lower

than she had been the year before. Id. Her pediatrician also noted the following regarding the

following regarding Petitioner’s menstruation: “Menses – X1 ? 1 yr ago.” Id.

At her 14 year-old well-check visit on October 2, 2009, Petitioner was documented to

have been Tanner Stage III. Id. at 45. Her pediatrician noted that she had never had a menstrual

cycle. Id.

The record contains no documentation regarding well-child visits for Petitioner’s 15th

year, though Petitioner’s mother has averred that she “took [Petitioner] annually for pediatric

visits.” Pet’r’s Ex. 5 at 1, ECF No. 6-6. Documentation of a visit on July 25, 2011 does not

3

The undersigned was unable to decipher many of the records from East Louisville Pediatrics,

the notes from which were largely illegible. See, e.g., Pet’r’s Ex. 3 at 9.

4 Pubertal development is measured by assessing an individual’s stages of puberty using the

Tanner growth chart, which is “based on pubic hair growth, development of genitalia in boys,

and breast development in girls.” Tanner stage, Stedman’s. For purposes of the ACOG criteria,

the undersigned considers Tanner stages I (child) and II (prepubertal) as showing “no signs of

pubertal development,” and Tanner stags III (early pubescent) and IV (late pubescent) as

showing such signs. Dr. Frankfurter testified that a young woman who has never menstruated

and who has no signs of secondary sexual development by age 13 should be evaluated. Tr. at

377.

2

reflect any abnormal development, but it makes no mention of whether Petitioner experienced

menarche. 5 Pet’r’s Ex. 8 at 28, ECF No. 8-2.

On March 14, 2012, when Petitioner 17 years old, her pediatrician at East Louisville

Pediatrics noted that Petitioner had never had a menstrual cycle, and referred her to a

gynecological specialist. Pet’r’s Ex. 3 at 38. Petitioner was seen by gynecologist Dr. Meredith

B. Loveless on April 17, 2012 for an evaluation of primary amenorrhea. 6 Id. at 16; Pet’r’s Ex. 7

at 1-2, ECF No. 6-8. As of this visit, Dr. Loveless documented that Petitioner had never had a

cycle. Pet’r’s Ex. 7 at 1-2. Although she was sexually active, Petitioner had never used

contraception. Id. She was noted to have had “Tanner Stage 5 breast and pubic hair

development.” Id. No evidence of acne, hirsutism or acanthosis nigricans was noted, and no

other abnormalities were noted. Id.

On May 1, 2012, Petitioner was treated again by Dr. Loveless. Pet’r’s Ex. 3 at 20; Pet’r’s

Ex. 6 at 108, ECF No. 6-7. Her treatment records document that she had a “significantly

elevated” FSH level of 81.9. Pet’r’s Ex. 6 at 108. Her chromosomal analysis was normal. Id.

Dr. Loveless diagnosed Petitioner with primary ovarian insufficiency (“POI”) 7 and prescribed

estrogen replacement. Id.

5

Menarche is “the establishment or beginning of menstruation.” Menarche, Dorland’s

Illustrated Medical Dictionary (32nd ed. 2012) (hereinafter “Dorland’s”). Menstruation is “the

cyclic, physiologic discharge through the vagina of blood and mucosal tissues from the

nonpregnant uterus; it is under hormonal control and normally recurs, usually at approximately

four-week intervals, in the absence of pregnancy during the reproductive period (puberty through

menopause of the female of the human.” Menstruation, Dorland’s.

6

Amenorrhea is “absence or abnormal stoppage of the menses.” Amenorrhea, Dorland’s.

Primary amenorrhea is “failure of menstruation to occur at puberty.” Primary Amenorrhea,

Dorland’s. Secondary amenorrhea is “cessation of menstruation after it has once been

established at puberty.” Secondary Amenorrhea, Dorland’s.

7

Although the parties and the undersigned initially used the term, “premature ovarian failure” or

“POF” to define Petitioner’s injury—it became clear from the literature filed by the experts that

POI “is the preferred term for the condition that was previously referred to as [POF]. . . . The

condition is considered to be present when a woman who is less than 40 years old has had

amenorrhea for 4 months or more, with two serum FSH levels (obtained at least 1 month apart)

in the menopausal range.” See Pet’r’s Ex. 15, Tab 1 at 1, Culligan v. Sec’y of HHS, No. 14-318V

ECF No. 53-2 (Lawrence Nelson, Primary Ovarian Insufficiency, 360 New Eng. J. Med. 606,

606 (2009)) (hereinafter “Nelson” with pincites to Petitioner’s pagination); see also Resp’t’s Ex.

A.29, ECF No. 67-1 (also providing Nelson). Therefore, the undersigned will refer to the

condition as POI.

3

After a visit on July 26, 2012, Dr. Loveless again noted Petitioner’s diagnosis of POI.

Pet’r’s Ex. 3 at 17; Pet’r’s Ex. 6 at 105-06. Dr. Loveless noted that Petitioner had undergone two

FSH tests that were “significantly elevated,” which provided additional confirmation of the POI

diagnosis. Pet’r’s Ex. 3 at 17; Pet’r’s Ex. 6 at 90, 97. All testing for autoimmune etiology

returned normal, and Petitioner’s “Period type is normal.” Id. Vitamin D studies and thyroid

levels were normal. Id. An ultrasound revealed that Petitioner had a small uterus with very

small ovaries. Id. Petitioner was continued on estrogen replacement, and Dr. Loveless

recommended she undergo fragile X mutation testing. Id.

On September 6, 2012, Petitioner was treated by geneticist Alexander Asamoah after

having been referred by her pediatrician for assessment of POI. Pet’r’s Ex. 4 at 2, ECF No. 6-5.

Dr. Asamoah noted that “[w]hen [Petitioner] was approximately 12 to 13 years old, she

experienced one day of spotting, but has not had a period since this time.” Id. At the time of the

September 2012 visit, Petitioner was on an estrogen patch, which had resulted in some breast

development. Id. Dr. Asamoah described Petitioner as “a 17-year, 9-month-old female with

[POI] and delayed breast development.” Id. at 3. She had no chromosomal abnormalities. Id. at

4

On October 25, 2012, Dr. Loveless renewed Petitioner’s prescription for estradiol, an

estrogen patch. Pet’r’s Ex. 6 at 2-3. Dr. Loveless noted that Petitioner’s development appeared

normal, that her development was at a Tanner Stage IV, and that she had primary amenorrhea

and POI. Id. at 5-8. When she saw Dr. Loveless again on January 31, 2013, Petitioner had

begun hormone replacement with “Vivelle-Dot,” which had resulted in some breast development

but no vaginal bleeding. Id. at 10-16.

At a visit on May 9, 2013, ultrasound examination revealed a normally-sized uterus and

ovaries. Pet’r’s Ex. 6 at 17- 28. Dr. Loveless noted that Petitioner “began to have vaginal

bleeding in March lasting for about 9 days and spotting. In April she had spotting on the fourth

of [sic] the fifth and then again on the 15th or 16th.” Id. at 23. Dr. Loveless subsequently

described this as “spontaneous onset of menses.” Id. at 24.

Petitioner subsequently experienced semi-regular menstrual periods. Id. at 49. After

menstruating in March of 2013, she menstruated in June 2013, September 2013, November

2013, December 2013, January 2014, and February 2014. Pet’r’s Ex. 6 at 49.

II. PROCEDURAL BACKGROUND

On February 11, 2015, Petitioner filed the present action alleging that the Human

Papillomavirus vaccinations (“Gardasil” or “HPV” vaccines) administered to her on August 9,

2007, August 11, 2008, and April 13, 2009 caused her to suffer from POI. Pet., ECF No. 1.

4

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. 8 In Culligan, Respondent opposed

entitlement to compensation because the first symptom of the petitioner’s POI was

oligomenorrhea, 9 which she had experienced more than three years prior to the filing of her

claim, making it untimely under 42 U.S.C. § 300aa-16(a)(2). See Resp’t’s Rule 4(c) Report at 3-

4, Culligan, ECF No. 20.

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. 10 Id.

On October 1, 2014, Mr. Krueger filed a status report in which he identified eight POI

11

cases to be included in the undersigned’s assessment of timeliness. See Pet’r’s Status Report

8

Once Culligan had been designated as the lead case, all of the filings for the onset proceedings

were completed in the Culligan case, and not in the trailing cases. This section of the procedural

history is therefore derived from the Culligan case. Citations to the Culligan record are so noted.

9

Oligomenorrhea is defined as “menstrual flow happening less often than normal, defined as at

intervals of 35 days to 6 months; called also infrequent menstruation.” Oligomenorrhea,

Dorland’s.

10

Mr. Krueger is counsel for all but one of the petitioners in the omnibus proceeding.

11

Other than the instant case, Petitioner identified Culligan; Alexander v. Sec’y of HHS, 14-

868V; Tilley v. Sec’y of HHS, 14-818V; Fishkis v. Sec’y of HHS, 14-527V; Lydia McSherry v.

Sec’y of HHS, 14-154V; Meghan McSherry v. Sec’y of HHS, 14-153V; Stone v. Sec’y of HHS,

13-289V. Pet’r’s Status Report (Oct. 1, 2014) at 1, ECF No. 23.

5

(Oct. 1, 2014), Culligan. Petitioner subsequently named Culligan as the “test case” for

timeliness. See Pet’r’s Status Report (Nov. 5, 2014) at 1, ECF No. 25.

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 12 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, 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, 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. 13

Except in Culligan, the experts were to rely on the factual summaries, in lieu of the medical

records themselves, to articulate their opinions regarding timeliness. See Joint Status Report

(Jan. 20, 2015) at 1, Culligan.

12

The four added cases were Chenowith v. Sec’y of HHS, 14-996V; Bello v. Sec’y of HHS, 13-

349V; Olivia Meylor v. Sec’y of HHS, 10-771V; Madelyne Meylor v. Sec’y of HHS, 10-770V.

Id. The petitioners in these cases were all represented by Mr. Krueger.

13

A factual summary for another trailing POF case–Smith, 14-1107V –was also filed in

Culligan. See Order Appendix (Feb. 23, 2015) at 2-3, Culligan, ECF No. 39-1; see also Order

(Jan. 30, 2015) at 1-2, Culligan, ECF No. 36; Order (Jan. 26, 2015), Culligan, ECF No. 35. The

petitioner in Smith was represented by different counsel.

6

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, 14 all filed by Mr. Krueger,

were added to the list of POI trailing cases. See Scheduling Order (Mar. 3, 2015) at 1, Culligan,

ECF No. 45; Scheduling Order (Feb. 19, 2015) at 1, Culligan, ECF No. 38. Mr. Krueger

subsequently filed factual summaries of the three new cases. See Pet’r’s Exs. 10, 11, 12,

Culligan, ECF Nos. 40-2, 41-2, 44-2.

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. 15 The expert reports were authored by Dr. Felice Gersh and Dr.

Orit Pinhas-Hamiel. See Pet’r’s Ex. 13, Tab 1, Culligan; Pet’r’s Ex. 15, Tab 1, Culligan. The

reports filed by Drs. Gersh and Hamiel reflected that they had reviewed the medical records

underlying all of the POI cases. See Pet’r’s Ex. 13, Tab 1 at 12-13, Culligan; Pet’r’s Ex. 15, Tab

1 at 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:

[T]he relevant date, for purposes of assessing onset under Cloer, is not the first

point in time at which a definitive diagnosis could have been made; rather, it is

the time at which the first symptom or manifestation of the allegedly vaccine-

caused injury occurred. The onset experts must make this assessment with the

benefit of hindsight, rather than placing themselves in the shoes of the treating,

14

The cases were Brayboy v. Sec’y of HHS, 15-183V; Garner v. Sec’y of HHS, 15-143V; and

Vakalis v. Sec’y of HHS, 15-134V.

15

Petitioner filed Exhibit 17 via compact disc. See Notice of Intent to File on Compact Disc

(Apr. 29, 2015), Culligan, ECF No. 56.

7

diagnosing physicians. The parties are directed to address this issue as

specifically as possible in their pre-hearing briefs.

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 16 “as

presumptively precluded under the applicable statute of limitations.” Order (July 1, 2015) at 1,

Culligan, ECF No. 79. Culligan was included among the presumptively precluded cases. Id.

The undersigned also identified six cases 17 that appeared to have been timely filed. Id. Having

apprised the parties of these preliminary conclusions, the undersigned granted them additional

time to file status reports identifying the cases in which they intended to contest this

determination, and explaining what they had identified as the first symptom or manifestation of

onset in each of those cases. Id. at 2.

16

The instant case, as well as Culligan, Chenowith, Fishkis, Garner, Lydia McSherry, Meghan

McSherry, Madelyne Meylor, and Laughlin. Order (July 1, 2015) at 1.

17

Alexander, Bello, Brayboy, Olivia Meylor, and Vakalis. Id. The undersigned also identified as

timely Smith, a trailing POF case that had been filed by a different attorney. Id. In Tilley, the

undersigned directed the parties to file additional briefs regarding timeliness. Id.

8

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 18 concluded on January 20, 2016. See Pet’r’s Post Hr’g

Br., Culligan, ECF No. 91; Resp’t’s Post Hr’g Brs., Culligan, ECF No. 94; Pet’r’s Post Hr’g

Reply Br., Culligan, ECF No. 95. Petitioner’s claim is now ready for a determination of the first

symptom or manifestation of onset of the alleged vaccine-related injury; and, relatedly, whether

the Vaccine Act’s statute of limitations bars the claim.

III. ANALYSIS

A. Applicable Legal Standard

Section 300aa-16(a)(2) of the Vaccine Act provides that, regarding

a vaccine set forth in the Vaccine Injury Table which is administered after

[October 1, 1998], if a vaccine-related injury occurred as a result of the

administration of such vaccine, no petition may be filed for compensation under

the Program for such injury after the expiration of 36 months after the date of the

occurrence of the first symptom or manifestation of onset . . . of such injury.

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],

18

Briefing addressing Petitioner’s request for interim attorneys’ fees is not relevant to the

timeliness issue and is therefore not included in this discussion.

9

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). 19

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)).

19

Petitioner argues that “POI is a latent injury” and that “the first symptom of onset, in terms of

the applications [sic] of the statute of limitations, can be subtle and can precede manifestation of

onset by months or even years.” Pet’r’s Post Hr’g. Br. at 9. This argument has been made

before: the Court of Federal Claims, in Setnes v. United States, 57 Fed. Cl. 175 (2003), “was

concerned with the very subtle symptoms attributed with autism that can be easily confused with

typical child behavior, and it distinguished the terms ‘symptom’ and ‘manifestation.’”

Markovitch, 477 F.3d at 1357-58. The Setnes court’s interpretation of the “first symptom or

manifestation of onset” language of the statute was rejected by Markovich, a ruling that has since

been reaffirmed by the Federal Circuit en banc in Cloer. 654 F.3d at 1334-1335.

10

B. Symptoms of POI Onset, Including Criteria for Distinguishing “Symptom” from

“Normal”

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

11

injury, therefore, a method for separating “normal” menstrual irregularities from abnormal

symptoms of POI is necessary. 20

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:

It is . . . important for clinicians to have an understanding of bleeding patterns in

girls and adolescents, the ability to differentiate between normal and abnormal

menstruation, and the skill to know how to evaluate young patients’ conditions

appropriately. Using the menstrual cycle as an additional vital sign adds a

powerful tool to the assessment of normal development and the exclusion of

serious pathologic conditions.

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

20

Petitioner also argues that irregular menstruation should not be considered the first symptom

of POI because it “can be explained by other causes.” Pet’r’s Post Hr’g Reply Br. at 2-3. This

argument has been repeatedly rejected by the Federal Circuit, and is equally as unpersuasive

here. A symptom need not be exclusive to the particular injury alleged in order to be “the first

symptom” of that injury for purposes of the Act. See Markovich, 477 F.3d at 1357 (“A symptom

may be indicative of a variety of conditions or ailments, and it may be difficult for lay persons to

appreciate the significance of a symptom with regard to a particular injury.”); see also Carson,

727 F.3d at 1370 (holding that even where “[t]here is no question that speech delay can be

indicative of several conditions, and in some circumstances may even be normal . . . it was not

arbitrary and capricious for the Chief Special Master to find that the severe speech delay . . . was

the first objectively recognizable symptom of autism, the alleged vaccine injury.”)

12

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 Conditions That May Require Evaluation

Menstrual periods that:

• Have not started within 3 years of thelarche[21]

• Have not started by 13 years of age with no signs of pubertal development

• Have not started by 14 years of age with signs of hirsutism[22]

• Have not started by 14 years of age with a history or examination suggestive of

excessive exercise or eating disorder

• Have not started by 14 years of age with concerns about genital outflow tract

obstruction or anomaly

• Have not started by 15 years of age[23]

• Are regular, occurring monthly, and then become markedly irregular[24]

• Occur more frequently than every 21 days or less frequently than every 45 days[25]

21

Thelarche is “the beginning of development of breasts in the female.” Thelarche, Stedman’s.

22

Hirsutism is the “presence of excessive bodily and facial hair, usually in a male pattern,

especially in women.” Hirsutism, Stedman’s.

23

At the hearing, Doctors Hamiel and Gersh opined that an adolescent who has not reached

menarche by age 16 should be evaluated for primary amenorrhea. Tr. at 92, 238. Dr.

Frankfurter opined that the age of evaluation should be 15 years. Tr. at 365. Both the ACOG

Opinion and Dr. Hillard, author of medical literature introduced by Petitioner, acknowledge that

the traditional definition of primary amenorrhea has been no menarche by age 16. ACOG Op. at

2; Pet’r’s Ex. 15, Tab 4, at 5, ECF No. 53-5 (Hillard, Paula, Menstruation in Adolescents: What

Do We Know? and What Do We Do with the Information?, 27 J. Pediatric Adolescent

Gynecology 309 (2014)) (hereinafter “Hillard” with pincites to Petitioner’s pagination).

However, both articles note that 95-98% of females will have experienced menarche by age 15,

and that delays in evaluating these young women can result in delays in detection and treatment

of significant disorders, including POI. ACOG Op. at 2; Hillard at 6.

24

At the hearing, Dr. Hamiel testified that she would recommend further evaluation of a non-

adolescent woman whose cycle had been regular (21-35 days) and then became irregular (less

frequent than every 35 days). Tr. at 67.

25

For women over the age of 18, this criterion is more frequently than every 21 days or less

frequently than every 34 days. See ACOG Op. at 3; see also Tr. at 39 (documenting Dr.

13

• Occur 90 days apart even for one cycle[26]

• Last more than 7 days

• Require frequent pad or tampon changes (soaking more than one every 1-2 hours)

Id. at 5.

Hillard reproduces this chart, accompanied with this caution:

Failure to evaluate teens who meet the criteria cited in the [ACOG] Opinion can

be a significant disservice to young women, leading to unnecessary discomfort,

embarrassment, poorer quality of life, adverse self esteem, and current or future

health risks such as anemia and low bone mineral density, as well as potential

metabolic and cardiovascular risks. . . . [J]ust as with other vital signs like pulse

and respiration, [menstrual cycle] values outside of statistically derived normal

parameters may signal disease or derangements in normal health.

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. 27

Hamiel’s testimony normal menstrual frequency for a woman in her twenties is 21-35 days).

The undersigned interprets this criterion to apply to frequency over two or more cycles.

26

At the hearing, Dr. Hamiel testified that no menstruation for 90 days is not “normal.” Tr. at

79.

27

To the extent Petitioner argues that this interpretation of the Vaccine Act’s statute of

limitations violates the Fifth Amendment on Equal Protection and Due Process Grounds, see

Pet’r’s Post Hr’g Br. at 11-13, the undersigned concurs with the reasoning articulated in

numerous decisions to the contrary, all of which hold that the Act’s statute of limitations does

not violate the Constitution merely because it bars certain petitioners from bringing a claim

before they knew, or even could have known, that their injuries were vaccine-related. See, e.g.,

Cloer v. Sec’y of HHS, 85 Fed. Cl. 141, 150-51 (2008), rev’d on other grounds, 603 F.3d 1341,

aff’d en banc, 654 F.3d 1322 (Fed. Cir. 2011); Leuz v. Sec’y of HHS, 63 Fed. Cl. 602, 607-12

14

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: 28

1. If the form of contraceptive used was non-hormonal, i.e., a copper IUD without

hormones, 29 condom/diaphragm, spermicide, the ACOG criteria apply as discussed

above, without changes;

2. By definition, a contraceptive is “an agent that diminishes the likelihood of or prevents

conception.” Contraceptive, Dorland’s. Therefore, if the medical records show that a

hormonal contraceptive was prescribed for its primary purpose, that is, for contraception,

rather than as treatment for menstrual irregularities; or if the medical records are silent as

to the purpose of the prescription and the contraceptive use spanned the date on which the

statute of limitations would have begun to run; the statute of limitations will not preclude

the claim;

3. If the medical records indicate that the hormonal contraceptive was prescribed to treat

menstrual irregularities, or if menstrual irregularities were a reason for the medical visit

that resulted in the prescription of the contraceptive, then the undersigned will find that

the menstrual irregularities were not “normal,” but resulted in treatment, and therefore

constituted a symptom for purposes of the statute of limitations.

(2005); Wax v. Sec’y of HHS, No. 03-2830V, 2012 WL 3867161, at *6-8 (Fed. Cl. Spec. Mstr.

Aug. 7, 2012); Blackmon v. Am. Home Prods. Corp., 328 F. Supp. 2d 647, 655-57 (S.D. Tex.

2004); Reilly ex rel. Reilly v. Wyeth, 876 N.E.2d 740, 753-54 (Ill. App. Ct. 2007).

28

This decision expresses no opinion concerning the effect, if any, of contraceptive use on the

question of causation in a POI case.

29

Dr. Frankfurther indicated that non-hormonal copper IUDs may affect the volume of flow but

do not influence the cycle length or frequency. Tr. at 422.

15

C. Application of the Onset Symptom Criteria to the Present Case

Petitioner filed her petition on February 11, 2015. The petition is time-barred if “the first

symptom or manifestation of onset” of her alleged vaccine injury, POI, occurred before February

11, 2012. Dr. Gersh opined that “[t]here is no indication of a symptom of premature ovarian

failure . . . until [Petitioner] presented herself to her doctor in March 2012 indicating that she had

not yet started menarche.” Pet’r’s Ex. 13 at 10, Culligan, ECF No. 47. Dr. Hamiel agreed with

this assessment; she opined that the first symptom or manifestation of onset occurred within a

few months of March 2012 when, at age 17, she reported to her pediatrician that she had never

had a menstrual cycle. Pet’r’s Ex. 15 at 14-15, Culligan, ECF No. 53; Pet’r’s Ex. 3 at 38.

Because it is unclear whether Petitioner ever had a menstrual cycle in this case, the

undersigned will assess timeliness based on two possible factual scenarios. According to notes

taken by her pediatrician during a 14 year-old well-check visit on October 2, 2009, Petitioner had

never had a menstrual cycle. Pet’r’s Ex. 3 at 45. Because thelarche is documented to have

occurred in 2006 and 2007, Petitioner’s menstrual cycles were not yet “abnormal” under the

ACOG Opinion as of the October 2009 visit. See Pet’r’s Ex. 3 at 16 (noting that breast and

pubic hair development occurred in 2006 and 2007, when Petitioner was 12 and 13 years old);

ACOG Op. at 5 (identifying as “abnormal” menstrual periods that “have not started by 13 years

of age with no signs of pubertal development”). Under this “never menstruated” scenario, the

first symptom of Petitioner’s POI would, therefore, have occurred by December 5, 2009, when

Petitioner turned 15 years old without having had a menstrual cycle. See ACOG Op. at 5

(identifying as “abnormal” menstrual periods that “have not started by 15 years of age”).

An alternative interpretation of the medical record reflects that Petitioner had sporadic

menstrual cycles starting in approximately August of 2007, when Petitioner was 12 years old.

See Pet’r’s Ex. 3 at 43 (Pediatrician noting, on August 11, 2008, “Menses – X1? 1 yr ago”);

Pet’r’s Ex. 4 at 2 (geneticist Dr. Asamoah noting that “[w]hen [Petitioner] was approximately 12

to 13 years old, she experienced one day of spotting, but has not had a period since this time”).

The next menstrual cycle is not documented until May 2013, when gynecologist Dr. Loveless

noted that Petitioner “began to have vaginal bleeding in March lasting for about 9 days and

spotting.” Pet’r’s Ex. 6 at 23. Dr. Loveless subsequently described the bleeding that occurred in

March 2013, when Petitioner was 18 years old, as “spontaneous onset of menses.” Id. at 24.

Because the records reflect that Petitioner did not have a menstrual cycle between at least August

2007 and March 2013, the first symptom or manifestation of onset of her POI had occurred by

November 2007, 90 days after her first cycle. See ACOG Op. at 5 (identifying as “abnormal”

menstrual periods that “occur 90 days apart even for one cycle”).

16

IV. CONCLUSION

Based on the foregoing analysis, the undersigned finds that the first symptom of

Petitioner’s injury occurred, at the latest, in December 2009. Because that date precedes the

statute of limitations deadline by over two years, the undersigned concludes that Petitioner’s

claim is time-barred. Her petition therefore must be, and is hereby, 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. 30

/s/ Lisa D. Hamilton-Fieldman

Lisa D. Hamilton-Fieldman

Special Master

30

Pursuant to Vaccine Rule 11(a), the parties can expedite entry of judgment by filing a notice

renouncing the right to seek review by a United States Court of Federal Claims judge.

17