Court Opinion

ID: 4648823
Source: CourtListenerOpinion
Date Created: 2021-01-04 18:01:44.47942+00
Date Added: 2024-06-11T08:01:18.986211
License: Public Domain

In the United States Court of Federal Claims
                                    OFFICE OF SPECIAL MASTERS
                                            No. 17-1476V
                                         (Not to be Published)

*************************
AARON MILLER,               *
                            *
                            *                                             Chief Special Master Corcoran
                Petitioner, *
                            *                                             Dated: November 5, 2020
v.                          *
                            *
                            *                                             Human papillomavirus vaccine;
                            *                                             Autonomic dysfunction;
                            *                                             Hypersomnia;
SECRETARY OF HEALTH AND     *                                             Decision dismissing petition;
HUMAN SERVICES,             *                                             Vaccine Rule 21; RCFC 41.
                            *
                Respondent. *
                            *
*************************

Andrew D. Downing, Van Cott & Talamante, Phoenix, AZ, for Petitioner.

Amanda Pasciuto, U.S. Dep’t of Justice, Washington, DC, for Respondent.

                                  DECISION DISMISSING PETITION 1

       On October 10, 2017, Deborah Miller, on behalf of her minor child A.M., filed a petition
seeking compensation under the National Vaccine Injury Compensation Program (“Vaccine
Program”), 2 alleging that the human papillomavirus (“HPV”) vaccines administered to A.M. on

1
  Although this Decision has been formally designated “not to be published,” it will nevertheless be posted on the
Court of Federal Claims’ website in accordance with the E-Government Act of 2002, 44 U.S.C. § 3501 (2012). This
means that the Decision will be available to anyone with access to the internet. As provided by 42 U.S.C. § 300aa-
12(d)(4)(B), however, the parties may object to the Decision’s inclusion of certain kinds of confidential information.
Specifically, under Vaccine Rule 18(b), each party has fourteen days within which 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). Otherwise, the whole Decision will be available to the public.
Id.
2
 The Vaccine Program comprises Part 2 of the National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660,
100 Stat. 3755 (codified as amended at 42 U.S.C. §§ 300aa-10–34 (2012)) (hereinafter “Vaccine Act” or “the Act”).
All subsequent references to sections of the Vaccine Act shall be to the pertinent subparagraph of 42 U.S.C. § 300aa.
November 23, 2015, and February 8, 2016, caused him to experience an adverse reaction,
including idiopathic hypersomnia, prolonged general fatigue, and autonomic dysfunction. The
case caption was amended in 2018 when A.M. turned 18, making Mr. Miller the Petitioner.

        During the case’s life, Petitioner filed medical records from various treating physicians and
affidavits from witnesses in support of his claim. See e.g., Ex. 4, filed on October 18, 2017 (ECF
No. 6-4); Ex. 7, filed on October 18, 2017 (ECF No. 6-7); Ex. 8, filed on October 18, 2017 (ECF
No. 6-8). Petitioner also submitted expert reports and supporting medical literature. See e.g., Ex.
13, dated April 16, 2018, (ECF No. 15-1); Ex. 15-24, dated June 29, 2018, (ECF No. 19-1 – 19-
10). The case was transferred to me on July 30, 2020, and after an initial review of the file I invited
the parties to propose dates for an entitlement hearing. See September 8, 2020 Docket Entry Order.

        On October 20, 2020, instead of proposing a hearing date, Petitioner filed what he styled a
“Motion for a Decision Dismissing his Petition.” ECF No. 52 (“Motion”). In it, Petitioner requests
that I dismiss his claim prior to issuance of a full written decision, based on his expressed desire
to opt out of the Program and “pursue a third party action in district court” against the manufacturer
of the HPV vaccine. Motion at 2. He also represented that Respondent had no objection to the
requested relief.

        On November 3, 2020 (and despite Petitioner’s prior representation that the dismissal
request was unopposed), Respondent filed a brief in reaction to Petitioner’s Motion. ECF No. 53
(“Response”). Respondent did not dispute his consent to the relief sought in the Motion, but
nevertheless provided a detailed explanation of his assessment for why the case was appropriately
dismissed. Response at 1. In particular, Respondent argued that Petitioner has not established that
he has idiopathic hypersomnia (“IH”). Id. at 3. Further, assuming arguendo that Petitioner actually
had IH, his claim would still fail because he could not provide scientifically reliable and
preponderant evidence establishing his burden under the applicable standard. Id. at 5.

                                     PETITIONER’S CLAIM

        Prior to evaluating the merits of Petitioner’s motion, some brief consideration of the
evidentiary support for this claim is required. On April 16, 2018, and December 13, 2018,
Petitioner filed expert reports from Mitchell Miglis, M.D., who specializes in autonomic disorders.
Ex. 13, 31. Dr. Miglis opined that Mr. Miller’s HPV vaccinations likely caused him to develop IH.
Ex. 13 at 16. Besides this expert support, Petitioner marshaled some other proof in support of the
claim. Thus, Petitioner’s treaters associated his increased need for sleep with the HPV vaccine
because of the temporal relationship between the two. Ex. 7 at 20. They also noted that Petitioner’s
symptoms appeared to worsen after the administration of the second dose of the HPV vaccine. Ex.
4 at 1.

                                                  2
        In reaction to Dr. Miglis’s opinion, Respondent filed an expert report from Kiran Maski,
M.D., who challenged the determination that Petitioner has IH, or that IH could be caused by the
HPV vaccine. See Report, filed as Ex. A (ECF No. 25). As Dr. Maski contended, objective sleep
studies performed on Petitioner did not confirm a diagnosis of IH and, as a result, Petitioner could
not establish that he has that condition. See Ex. A. Petitioner thereafter filed a supplemental report
from Dr. Miglis on December 13, 2018, wherein he conceded that Petitioner’s diagnostic testing
did not meet criteria for an IH diagnosis, but maintained that Petitioner still likely developed IH
as a result of HPV vaccination. Ex. 31 at 1-2. Because Dr. Miglis proposed no other diagnosis,
Respondent argues that Petitioner’s claim necessarily fails.

                                                   ANALYSIS

         The provisions under the Vaccine Rules for ending a case before a decision has been issued
are largely inapplicable herein. Petitioner may no longer avail himself of Vaccine Rule
21(a)(1)(A), which governs voluntary dismissals before service of the Rule 4(c) Report, and
Respondent has not stipulated to dismissal under Rule 21(a)(1)(B). In addition, even if the parties
had so stipulated, Petitioner seeks entry of a judgment, whereas Vaccine Rule 21(a) would only
result in an “order concluding proceedings.” Rule 21(a)(3).

        Accordingly, the only remaining channel for the relief Petitioner requests is a “motion
seeking dismissal”—an informal mechanism for ending cases that other petitioners have used,
either because they have determined that the claim cannot succeed, or simply because they choose
not to continue with the claim, but have reached that determination after the time to act under Rule
21 has passed. See, e.g., Goldie v. Sec’y of Health & Human Servs., No. 18-1476V, 2019 WL
6045647, at *1 (Fed. Cl Spec. Mstr. Oct. 11, 2019). Generally, petitioners who wish to dismiss a
case after filing of the Rule 4(c) Report usually include in their dismissal motion an
acknowledgement that the claim cannot succeed. These words are missing from Petitioner’s
Motion – on the contrary, he takes pains to emphasize that he does not believe the claim cannot be
substantiated. Motion at 2. Petitioner does, however, acknowledge that any Decision dismissing
the case at this point will not only be adverse to seeking relief in the Program in the future (based
on this vaccination), but also may well include some comment on the evidence filed. Id. at 2-3.

       Thus, although it is true that the present circumstances do not afford Petitioner a means of
dismissal directly under the Vaccine Rules, dismissal of petitions can still occur at this point in the
claims life. Indeed, the rules of the Court of Federal Claims (which are properly applied herein)3
3
  The Vaccine Rules specifically stated that the Rules of the Court of Federal Claims “apply only to the extent they
are consistent with the Vaccine Rules,” and otherwise empower special masters to “regulate the applicable practice”
under the Vaccine rules “[i]n any matter not specifically addressed” therein. Vaccine Rule 1(b) and (c). Here, I find
that permitting dismissal—in the form stated in this Decision— based on a rule of the Court of Federal Claims is fully
consistent with the Vaccine Rules, given that language of Vaccine Rule 21 does not cover voluntary dismissal by court
order, whereas RCFC 41 does cover voluntary dismissal by court order. Thus RCFC 41(a)(2) addresses a situation not
contemplated by Vaccine Rule 21.

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permit dismissal of claims at a petitioner/plaintiff’s request and “on terms that the court considers
proper.” RCFC 41(a)(2). Accordingly, I find it is appropriate to grant Petitioner’s Motion, even
though it does not contain the customary acknowledgement that the claim cannot succeed in the
Program. Expediency, judicial efficiency, and providing fairness to Vaccine Program claimants—
values that constantly inform the work of special masters in deciding vaccine injury claims—all
counsel in favor of allowing dismissal when requested by a petitioner. Dismissal of the case will
obviate the need to write a lengthy decision, and cut off the prospect of future appeal as well (at
least on matters not pertaining to attorney’s fees), thus further preserving judicial resources.

        However, and in accordance with RCFC 41(a)(2), this Decision shall include several
express limitations in order to make it conform to the requirements of Section 12(d)(3) of the Act.
In particular, I find that (as Petitioner has anticipated) Petitioner did not establish his claim by a
preponderance of the evidence. Petitioner’s causation theory had some surface plausibility, but
ultimately was unreliable and not supported by sufficient scientific/medical evidence.

        As acknowledged by Petitioner’s expert, Dr. Miglis, there are no known published case
series of IH caused by the administration of the HPV vaccine. Ex. 13 at 16. He instead relied upon
VAERS (Vaccine Adverse Event Reporting System) data to conclude that there is a causal
connection between HPV vaccine and IH (Id. at 8), even though this type of support is not
sufficient to meet the level of preponderance required in the Program. Dr. Miglis also conceded
that the cause of IH is unknown. Id. at 5. He could, in the end, only speculate that because some
cases have been reported after viral illness, this suggests a possible immune etiology. Id. But
speculation, supported by no more than temporal association, does not satisfy the preponderant
test applied to Program claims. 4 In addition, and as Respondent has observed, Petitioner’s
purported IH is not preponderantly supported by the record. Lack of proof of an alleged injury is
a well-recognized independent basis for dismissal of a claim. Broekelschen v. Sec. of Health &
Human Servs., No. 07-137V, 2009 WL 440624 (Fed. Cl. Spec. Mstr. Feb. 4, 2009), aff’d, 618 F.3d
1339 (Fed. Cl. 2010).

        As a result, after careful review of the record, I find that Petitioner could not preponderantly
establish entitlement to a damages award. Moreover, this dismissal is with prejudice. 5 And I note

4
 I also note that Dr. Miglis testified for a different claimant in a Program case also alleging that the HPV vaccine
caused injury. See, e.g., Otto v. Sec. of Health & Human Servs., No. 16-1144, 2020 WL 4719285 (Fed. Cl. Spec. Mstr.
June 17, 2020). That case went to hearing, and I had the opportunity to see Dr. Miglis and listen to his testimony.
Although I found him a qualified expert overall, I was not persuaded by his arguments about the capacity of the HPV
vaccine to cause injury in that case – and from review of the written reports, I can state that it is highly unlikely I
would have reached a different determination in this case, even though the injury is different, given the overall lack
of reliable scientific/medical evidence associating the HPV vaccine to sleep-related disorders.
5
 Rule 41(a)(2) gives the Court discretion as to whether a dismissal should be with or without prejudice. See Giesecke
& Devrient GmbH v. United States, 146 Fed. Cl. 631, 641 (Fed. Cl. 2020) (“[u]nder Rule 41(a)(2), a voluntary
dismissal by court order is ‘without prejudice’ unless the court finds that the defendant will suffer legal prejudice,

                                                          4
that Respondent has not conceded that the claim possessed reasonable basis, and therefore may
challenge any final fees request in this matter on that ground (although I also note that I was
prepared to permit this matter to be tried, reflecting my admittedly-tentative conclusion after the
case’s transfer that the novelty of injury alleged raised a kind of claim somewhat different than the
many other HPV claims I have adjudicated – a factor that would favor Petitioner in any fees request
that is challenged on reasonable basis grounds).

                                                 CONCLUSION

        Under the Vaccine Act, a petitioner may not receive a Vaccine Program award based solely
on his claims alone. In this case, there is insufficient evidence in the record for Petitioner to meet
his burden of proof, and insufficient reliable scientific proof offered in support of his causation
theory. Therefore, Petitioner's claim cannot succeed and must be dismissed. Section 11(c)(1)(A).

        Accordingly, Petitioner’s Motion for a Decision Dismissing the Case is hereby
GRANTED, and the Petition is dismissed with prejudice. In the absence of a motion for review
filed pursuant to RCFC Appendix B, the clerk of the court SHALL ENTER JUDGMENT in
accordance with the terms of this decision. 6

         IT IS SO ORDERED.
                                                                s/ Brian H. Corcoran
                                                                Brian H. Corcoran
                                                                Chief Special Master

such as when a plaintiff “does not seek dismissal until a late stage” in the litigation”). There are three factors to
consider on whether a dismissal should be with or without prejudice: “(i) the burden on the defendant if the case were
to be dismissed without prejudice; (ii) the progress of the litigation; and (iii) the diligence and good faith of the
plaintiff.” Klamath Irrigation District v. United States, 116 Fed. Cl. 117, 119 (Fed. Cl. 2014).

Here, the late stage of the litigation—a case pending for three years, featuring multiple experts and reports, full fact
discovery, and ample briefing, weighs in favor of dismissal with prejudice.
6
 Pursuant to Vaccine Rule 11(a), the parties may expedite entry of judgment if (jointly or separately) they file notices
renouncing their right to seek review.

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