Loutos v. Secretary of Health and Human Services

REISSUED FOR PUBLICATION
ORIGINAL JAN 9 2017
OSM
U.S. COURT OF FEDERAL CLAIMS
Jfn tbe Wniteb ~tate.s QCourt of jfeberal QCiaints
OFFICE OF SPECIAL MASTERS
No. 03-355V FILED
(to be published)
DEC - 9 20iS
* ** ** ** ***** ** **** ** ** *** U.S. CuURT OF
* FEDCR/\L CLAIM8
PETER LOUTOS, II, and * Special Master Corcoran
RAMONA LOUTOS, as parents and *
natural guardians ofP.A.L., III, a minor, *
* Dated: December 9, 2016
Petitioners, *
* Dismissal of Action; Autism;
V. * DTaP Vaccine; Statute of
* Limitations; Onset of Symptoms
SECRETARY OF HEALTH AND *
HUMAN SERVICES, *
*
Respondent. *
*
* ** ** ** **** ******* ** ** ***

Peter Loutos, JI, and Ramona Loutos, Po11 St. Lucie, FL, prose Petitioners.

Linda Renzi, U.S. Dep ' t of Justice, Washington, DC, for Respondent.

DECISION DISMISSING CLAIM AS UNTIMEL Y 1

On February 19, 2003, Peter and Ramona Loutos, as parents and natural guardians of P.A.L.,
III, a minor ("P.A.L."), filed this action seeking compensation under the National Vaccine Injury
Compensation Program (the "Vaccine Program" or "Program"), 2 alleging that P.A.L. incurred an
encephalopathic injury as a result of vaccines he received in December 1999, later manifesting as

1
Because this decision contains a reasoned explanation for my action in this case, it will be posted on the United States
Court of Federal Claims' website, in accordance with the E-Government Act of2002, 44 U.S.C. § 3501 (2012). As
provided by 42 U.S.C § 300aa- I 2(d)(4)(B), however, the patties may object to the decision's inclusion of cettain kinds
of confidential information. To do so, Vaccine Rule I 8(b) permits each party fo urteen ( 14) days w ithin which to request
redaction "of any information furni shed by that pruty: (I) 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 unwa1Tanted invasion of privacy." Vaccine Rule I 8(b). Otherwise, the decision will be ava ilable to the
public.Id.

2The Vaccine Program comprises Patt 2 of the National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660,
100 Stat. 3758, codified as amended, 42 U.S.C. §§ 300aa-l0 through 34 (20 12) ("Vaccine Act" or " the Act").
Individua l section references hereafter will be to § 300aa of the Act.
autism or an unspecified severe neurologic injury with developmental impact similar to autism.
ECF No. I.

The matter had been set for an entitlement hearing to be held in June 2016, but in the process
of filing pretrial briefs, Respondent requested dismissal of Petitioners' claim, alleging that it was
untimely under the Vaccine Act's three-year statute oflimitations. See Section l 6(a)(2). I provided
Petitioners an opportunity to modify their claim, based upon their representations that the claim
could still be viable under the facts of the case, and that they would also offer revised expert reports
to account for the change in allegations. Petitioners have since filed these reports, along with an
amended petition - but all of these materials continue to rely on and reference the same facts
pertaining to onset that Respondent persuasively argues render the claim time-barred. Having
reviewed the new filings, as well as the parties' briefing on the limitations issue, I hereby GRANT
Respondent's motion to dismiss.

Factual Background

This matter has been pending for more than thirteen years. The Loutoses originally filed a
short form petition on February 19, 2003, as part of the Omnibus Autism Proceeding ("OAP"). 3
ECF No. I. That petition alleged that P.A.L. (born on September 3, 1998) suffered from autism
spectrum disorder ("ASD") as a result of receiving the measles-mumps-rubella ("MMR") vaccine
and/or thimerosal-containing vaccines before he was two years old. On August 25, 2011, and

3 In the OAP, thousands of petitioners' claims that certain vaccines caused autism were joined for purposes of efficient
resolution. A "Petitioners' Steering Committee" was formed by many attorneys who represent Vaccine Program
petitioners, with about I 80 attorneys participating. This group chose six "test" cases to represent the entire docket,
with the understanding that the outcomes in these cases would be applied to cases with similar facts alleging similar
theories. The first theory alleged that the measles portion of the MMR vaccine precipitated autism, or, in the
alternative, that MMR plus thimerosal-containing vaccines caused autism, while the second theory alleged that the
1nercury contained in thimerosal-containing vaccines could affect an infant's brain, leading to autism.

The first theory was rejected in three test case decisions, all of which were subsequently affirmed. See generally
Cedillo v. Sec)' of Health & Human Servs., No. 98-916V, 2009 WL 331968 (Fed. Cl. Spec. Mstr. Feb. 12, 2009), mot.
for review den'd, 89 Fed. Cl. 158 (2009), ajf'd, 617 F.3d 1328 (Fed. Cir. 2010); Hazlehurst v. Sec)' of Health &
Human Servs., No. 03-654V, 2009 WL 332306 (Fed. Cl. Spec. Mstr. Feb. 12, 2009), mot.for review den'd, 88 Fed.
Cl. 473 (2009), ajf'd, 605 F.3d 1343 (Fed. Cir. 2010); Snyder v. Sec'y of Health & Human Servs., No. 01-162V, 2009
WL 332044 (Fed. Cl. Spec. Mstr. Feb. 12, 2009), ajf'd, 88 Fed. Cl. 706 (2009).

The second theory was similarly rejected. Dwyer v. Sec'y of Health & Human Servs., No. 03-1202V, 2010 WL
892250 (Fed. Cl. Spec. Mstr. Mar. 12, 201 O); Kingv. Sec'y of Health & Human Servs., No. 03-584V, 2010 WL 892296
(Fed. Cl. Spec. Mstr. Mar. 12, 201 O); Meadv. Sec'y ofHealth & Human Servs., No. 03-215V, 2010 WL 892248 (Fed.
Cl. Spec. Mstr. Mar. 12, 2010).

Ultimately a total of 11 lengthy decisions by special masters, the judges of the U.S. Court of Federal Claims, and the
panels of the U.S. Court of Appeals for the Federal Circuit unanimously rejected the test case petitioners' claims.
These decisions found no persuasive evidence that the MMR vaccine or thitnerosal-containing vaccines caused autism.
The OAP proceedings concluded in 2010.

2
following the OAP's conclusion, Petitioners' prior counsel filed a status report indicating that
Petitioners were going to proceed with their claim under a different theory - that P.A.L. suffered
from an underlying mitochondrial disorder, and were in the process of obtaining the necessary
expert and evidentiary support for it. ECF Nos. 22 and 23.

Since that time, the Loutoses have filed an amended petition which sets forth the most up-to-
date recitation of their claim. See Amended Petition, dated November 23, 2016 (ECF No. 143)
("Amended Pet."). As the Amended Petition states, the Loutoses base their claim on two vaccines
P.A.L. received at his 15-month well-child pediatric visit on December 17, 1999-the Diphtheria-
Tetanus-acellular Pertussis ("DTaP") and haemophilus influenza type b ("Hib") vaccines -
although the claim as pied focuses on the DTaP vaccine. Amended Pet. at~~ 4, 17-18. By March
2000, the Loutoses began expressing concerns to their pediatrician about P.A.L.'s development,
which had become evident to them at the end of February 2000. Id at~~ 8-9. P.A.L. subsequently
stopped talking and regressed in language, and by the fall of 2000 was diagnosed as having a
chronic encephalopathy. Id. at~~ 10-13. 4

The Amended Petition differentiates between reactions the Loutoses first observed in P.A.L.
after he received the DTaP vaccine and the manifestation of his later developmental regression
and/or autism. Petitioners allege that P.A.L. experienced a fever and rash within days of the
December 1999 vaccinations, which lasted into early January 2000 and which "set [P.A.L.] up for
a severe brain injury." Amended Pet. at~ 5. They note that his reactions to the DTaP vaccine are
similar to those reported to the Vaccine Adverse Event Reporting System ("V AERS") in other
cases (although it does not appear from my review of the record that Petitioners ever filed such a
report in this case, or any of the allegedly similar VAERS reports). 5 Id at~~ 6-7. At the same time,

' P.A.L. received the encephalopathy diagnosis from Dr. Jeffrey Bradstreet, who first began treating P.A.L. in the fall
of2000. Amended Pet. at~ 13; Pet'rs' Ex. 14 at 52. Dr. Bradstreet was a practicing physician who specialized in
children with autism spectrum disorder and attention deficit hyperactivity disorder, and who espoused the belief that
there is a causal link between autism and the MMR vaccine (pmticularly due to what he alleged to be toxic amounts
of mercury contained within the vaccine). See, e.g., Hearing before the Conunittee on Governn1ent Reforn1, June 19,
2002, Serial No. 107-121, available at https://www.gpo.gov/fdsys/pkg/CHRG-107hhrg82358/html/CHRG-
l 07hhrg82358.htm (last visited on Dec. 6, 2016). But treatments promoted by Dr. Bradstreet have not been proven
effective, and even termed dangerous. Trine Tsouderos and Patricia Callahan, Risky Alternative Therapies for Autism
Have Little Basis in Science, Chicago Tribune, Nov. 22, 2009 (chelation therapy and hyperbaric chamber therapy
sessions are unproven and potentially dangerous). Dr. Bradstreet committed suicide on June 19, 2015, sh011ly after
his clinic was raided by state and federal authorities. Michael E. Miller, Anti-Vaccine Doctor behind 'Dangerous'
Autism Therapy Found Dead. Family Cries Foul, Washington Post, June 29, 2015, available at
https://www.washingtonpost.com/news/moming-mix/wp/2015/06/29/anti-vaccine-doctor-behind-dangerous-autism-
therapy-found-dead-fam ily-cries-foul/ (last visited Dec. 6, 2016).

5 VAERS is a national vaccine safety surveillance program co-sponsored by the Centers for Disease Control and
Prevention and the Food and Drug Administration, and allows individuals who believe they may have experienced a
vaccine reaction to make a report of the incident. See https://vaers.hhs.gov/index (last visited Dec. 6, 2016). Although
in this case Petitioners appear to cite these VAERS reports principally to corroborate the timing of their allegations,
the value ofa specific VAERS repmt as evidence in proving causation in a Vaccine Program case is extremely limited.
Tompkins v. Sec'y of Health and Human Servs., No. I 0-261 V, 2013 WL 3498652, at * 16 (Fed. Cl. Spec. Mstr. June

3
however, Petitioners also take pains to allege that P.A.L. 's "severe brain injury" became apparent
only by late February 2000 or early March 2000. Id at~~ 5, 8-9. Thus, they formally propose that
the onset of P.A.L.'s injury was "delayed" to late February or early March 2000. Id at~ 16. 6

Procedural History

Petitioners began filing medical records in support of their claim after its initiation in 2003.
See, e.g., ECF Nos. 12, 15, and 19. The case's progress was largely stayed during the pendency of
the OAP hearings (and indeed, no work at all was performed on this case between 2004 and 2007).
On September 7, 2011, Petitioners' counsel withdrew, and for the past five years Petitioners have
been pro se litigants. There were numerous subsequent delays in the case.

In 2014, the Loutoses filed two expert repo1ts supporting their causation theory - one from
Janet Kern, PhD (Pet'rs' Ex. 52), and a second from Lisa Rankin, MD (one of P.A.L.'s treating
physicians) (Pet'rs' Ex. 53). ECF No. 82. Both reports identified December 1999 as the start of
P.A.L. 's reaction to the DTaP vaccine. Thus, Dr. Kern (a neuroscientist) opined in her repo11 that
P.A.L.'s reaction manifested within 48 hours, and that his symptoms subsequently progressed and
worsened to include brain damage, resulting in a subsequent diagnosis of encephalopathy. ECF
No. 82-1 at 5-6. She further expressed the view that P.A.L showed a progressive and sequential
pattern of regression into ASD as a result of these December 1999 vaccines, and that the
encephalopathy was a factor in his ASD (along with his alleged mitochondrial dysfunction).

Dr. Rankin's expert repo11 similarly opined in favor of Petitioners' causation theory based
on the same conception of onset occurring in December 1999. Dr. Rankin proposed that P.A.L. 's
symptoms began within 48 hours of his receipt of the DTaP vaccine, "and continued from that
point on progressed [sic] to the point of having multiple office visits over the next three months
leading up to his 18 month check [March 2000]." ECF No. 82-2 at I. Thus, as of 2015, both of
Petitioners' experts had embraced causation theories rooted in the factual assumption that P.A.L.'s
reaction to the vaccines he had received began in December 1999 - first the neurologic injury of
encephalopathy, proximately followed by developmental problems that later manifested.

The case was assigned to me in early 2015. Over the next several months, Petitioners
briefed, and I decided, a long-pending interim fees request (see Decision, dated December 18,

21, 2013) ("V AERS is a stocked pond," and its individual repmis lack scientific reliability), motion for review den 'd,
117 Fed. Cl. 713 (2014).

6 Petitioners also have alleged that P.A.L. had a number of underlying conditions that the DTaP vaccine likely
exacerbated, including (a) mitochondrial dysfunction, (b) deficient glutathione levels, (c) and an MTHFR genetic
deficiency, all of which made him more susceptible to a neurologic reaction to the vaccine. Amended Pet. at~~ 14,
17. They have not, however, formally alleged a significant aggravation claim in their Amended Petition- although,
for purposes of my analysis, their claim would still be time-baned since the Petitioners rely on December 1999 and
January 2000 reactions as part of their claim that P.A.L. 's underlying conditions were impacted by the DTaP vaccine.

4
2015 (ECF No. 120)). More importantly, the matter was finally set for hearing on June 9, 2016,
and a pretrial order was issued for the filing of prehearing memoranda and trial-related materials.
Scheduling Order, dated December 17, 2015 (ECF No. 119).

Statute of Limitations Issue

The timeliness of Petitioners' claim was first raised with me during pretrial briefing last
spring. However, the matter also came up earlier in the case's history (although it was somewhat
forgotten with the passage of time). 7

In July 2008, and while the OAP was pending, Respondent filed a "statement" regarding
the propriety of the matter's inclusion in the OAP. ECF No. 13. In it, Respondent stated that she
could not, based on the existing record, determine whether the claim was timely. Certain medical
records filed in support of the claim suggested that onset of a reaction purportedly resulting in
P.A.L.'s autism and/or developmental problems had occurred between late-December 1999 and
February 2000. Because this matter had been filed on February 19, 2003, however, the claim would
only be timely if onset of P.A.L. 's symptoms occurred no earlier than February 19, 2000.

In response to this statement, the special master then-presiding over this case issued an
order requiring Petitioners (who were at this time still represented by counsel) to address the matter
of the claim's timeliness in a written filing. Order, dated July 28, 2008 (ECF No. 14). Petitioners
filed their response on August 28, 2008 (ECF No. 16). That response asserted that as of a March
6, 2000 well-child pediatric visit, P.A.L. was "developing age appropriately . . . and not
manifesting any signs or symptoms or any significant aggravation of a vaccine injury." ECF No.
16 at 3. They also alleged that the earliest symptom or manifestation of onset of P.A.L.'s injury
occurred no earlier than September 5, 2000, because hospital records revealed that he first began
receiving assessment and treatment for developmental problems at that time. Id If so, Petitioners'
claim would be timely, since onset would have been less than three years from the date of filing.

In January 2009 (and in response to a request from the special master to address the issue
further (see Order, dated September 29, 2008 (ECF No. 17)), Respondent filed a supplemental
statement on the limitations question. Supplemental Statement, dated January 16, 2009 (ECF No.
18) ("Supplemental Statement"). The Supplemental Statement reiterated Respondent's view that
the claim's timeliness remained an unresolved matter, since there was evidence (for example,

7
The inordinate delay in resolving this case is regrettable. Based on review of the entire file, however, I cannot
attribute it to any one factor or party. Rather, a combination of(a) the impact of waiting on the OAP's conclusion, (b)
Petitioners subsequently becoming pro se litigants, burdening them with the challenge of prosecuting a complex
action, and (c) numerous subsequent requests by the Loutoses for extensions of time (see, e.g., Motion for Suspension
of Proceeding, dated January 15, 2015 (ECF No. 97)) all worked in conceit to impede the speedy adjudication of
Petitioners' claim. In addition, the matter was presided over by three special masters, with it only assigned to me in
early 2015. See Transfer Order, dated February 5, 2015 (ECF No. 100).

5
statements made by the Loutoses to treaters) that P.A.L. 's developmental problems manifested as
early as 15 months of age, or in December 1999. Supplemental Statement at 3. As a result,
Respondent took "no position regarding the timeliness of the claim," but reserved the right to raise
"jurisdictional concerns" later, once more of the record had been filed. Id. at 4 n.4.

Pre-hearing briefing this past winter in preparation for the June 2016 entitlement hearing
brought the limitations issue back into contention. Petitioners' prehearing submissions, dated
March 24, 2016 (ECF No. 125), placed onset of the encephalopathy that led to P.A.L's regression
and subsequent developmental problems as having occurred on (or shortly before) December 1999
(and Petitioners' expe1ts relied on that same date of onset). See, e.g., Prehearing Submissions at 2,
6 ("by the time his regression began at 15 months, ... "),and 8. The Loutoses' causation theory
proposed that P.A.L. suffered a series of progressive reactions to the DTaP vaccine beginning
around the time he received it at 15 months of age (December 1999), ultimately culminating in a
severe neurologic injury as corroborated by the fall 2000 encephalopathy diagnosis. Id. at 3-5.

Respondent thereafter requested a status conference in order to discuss whether Petitioners'
factual allegations about the onset of P.A.L. 's symptoms rendered the claim time-barred, and I
scheduled one for April 14, 2016. After it, I issued a Scheduling Order (Order, dated April 15,
2016 (ECF No. 128)) directing Respondent to address the limitations issue further in her pending
prehearing submission.

Respondent filed her pretrial submission on April 25, 2016 (ECF No. 129), including
within it a motion to dismiss ("Motion"). 8 She recounted the law relevant to the Vaccine Act's
limitations period, stressing that a claim begins to run from the "date of the occurrence of the first
symptom or manifestation of onset or of the significant aggravation of such injmy," as would be
medically recognized. Motion at 8, citing Cloer v. Sec'y ofHealth & Human Servs., 654 F.3d 1322,
1335 (Fed. Cir. 2011). She also observed that there is no "discovery rule" under the Vaccine Act
that would otherwise extend the limitations period to when Petitioners knew, or should have
known, of their claim. Motion at 9. Because the facts relevant to Petitioners' claim squarely
identified onset of P.A.L.'s alleged reaction as having occurred as early as December 1999, the
case had been filed two months late. Id. at 9-11.

After reviewing Respondent's Motion, I held another status conference on May 4, 2016. I
expressed my concern to Petitioners that, based on the recent filings, it was evident that their claim
was not procedurally viable if they intended to argue at hearing that onset of P.A.L.'s symptoms

8 I had also asked Respondent to explain why the limitations issue was only being raised on the eve of trial, rather than
earlier in the case's lengthy history, since it was potentially fatal to the claim and therefore should have been brought
to the attention of the Court far sooner. She did so briefly in her pretrial submission, recounting some of the prior
procedural histmy discussed above from 2008. Motion at 1-2. While it would have been preferable for Respondent to
press this issue more forcefully earlier in the case, the procedural history shows that the question of the limitations
issue was in fact raised, albeit without clear resolution, in 2008 and 2009.

6
began in December 1999. However (and based in particular on the 2008 filings relevant to the
limitations question that had identified September 2000 as the onset time), it was conceivable that
the claim was timely, assuming Petitioners could obtain revised expert opinions consistent with a
revised fact pattern (and of course assuming the evidence supported such allegations as well).
Therefore, and in the interests of providing Petitioners an additional chance to make their case, I
cancelled the June 2016 hearing. Scheduling Order, dated May 9, 2016 (ECF No. 131) at 1. I
ordered Petitioners to respond substantively to Respondent's Motion as well. Order at 2.

Petitioners filed their response to the motion on June 8, 2016 (ECF No. 132) ("Opp.").
They characterized what appeared to be evidence of onset of P.A.L. 's reaction to the December
1999 vaccines as merely establishing "a potential underlying intolerance," but that his real onset
occurred after his March 2000 well-child visit (in which case their claim would not be time-barred).
Opp. at 5. They stressed their identity as prose litigants as possibly contributing to confusion on
Respondent's pmt about the nature of their claim. Id. at 6 ("[a]t no point were Petitioners trying to
establish that the symptoms following the December 17, 1999 visit were the ... result and only
cause" of the alleged injury) (emphasis in original). They also proposed, without citation to
evidence, that P.A.L. had received another vaccine at the March 2000 well-child visit (Id. at 2),
although that allegation was never corroborated by the record and appears to have been dropped,
as it is not mentioned in the Amended Petition. 9

I held yet another status conference on August 3, 2016. After reviewing the parties' filings
on the limitations question, and hearing from them during the conference, I provided Petitioners
with the opportunity to amend their petition and supporting expert reports (assuming the experts
could do so in good faith) to be consistent with their allegations of onset occurring after February
2000, and set deadlines for so doing. Order, dated August 4, 2016 (ECF No. 136). However, I also
stated that Respondent had persuasively established that Petitioners could not advance a claim
involving onset any earlier than February 19, 2000, and that I would otherwise defer ruling
formally on the Motion to Dismiss until I had reviewed what Petitioners filed. Id. at 2.

Petitioners delayed in filing their required amended petition and expert reports until
November. See Dr. Kern's Amended Rep01t, filed November 28, 2016 (ECF No. 144-1)
("Amended Kern Rep."); Dr. Rankins's Amended Opinion Letter, dated November 29, 2016 (ECF
No. 145-1 ); and Amended Pet. But these documents repeat the same fact allegations of vaccine
reactions in December 1999 that first motivated Respondent to request dismissal. See Amended
Pet. at 2 (~ii 5-7). The revised expert rep01ts similarly continue to rely on, or even invoke outright,
P .A.L. 's alleged December 1999 initial symptoms. Thus, Dr. Kern references again the same series
of immediate post-vaccination symptoms from December 1999 as part of the overall causation

9
Respondent for her part has found no evidence in the record that any March 2000 vaccine was ever administered to
P.A.L. See August 22, 2016 Status Report (ECF No. 137).

7
chain that begins with the December 17th vaccinations. See Amended Kern Rep. at 23 ("[a]s time
progressed his symptoms were growing in number and intensity, such that by the end of February,
2000 (approximately 9 weeks after vaccination), he was showing signs of neurological loss")
(emphasis added). Dr. Rankin's updated opinion letter does the same. See ECF No. 145-1 at 1.

Analysis

I. Petitioners' Claim is Time-Barred.

The statute of limitations prescribed by the Vaccine Act is three years, or thirty-six months.
Section 16(a)(2). Thus, the period in which to bring a Program claim terminates "after the
expiration of36 months after the date of the occurrence of the first symptom of manifestation of
onset or of the significant aggravation of such injury." Id. The statute of limitations begins to run
from the manifestation of the first objectively cognizable symptom, whether or not that symptom
is sufficient for diagnosis. Carson v. Sec'y of Health & Human Servs., 727 FJd 1365, 1369 (Fed.
Cir. 2013). Special masters have appropriately dismissed cases that were filed outside the
limitations period, even by a single day or two. See, e.g., Spohn v. Sec'y of Dep't of Health &
Human Servs., No. 95-0460V, 1996 WL 532610 (Fed. Cl. Spec. Mstr. Sept. 5, 1996) (dismissing
case filed one day beyond thirty-six-month limitations period), mot. for review denied, (Fed. Cl.
Jan. 10, 1997), ajf'd, 132 F.3d 52 (Fed. Cir. 1997).

I invited Petitioners to attempt to correct their claim because they maintained it was possible
to do so. I also took note of the fact that in 2008, Petitioners had asserted that onset of P.A.L.'s
symptoms did not actually begin until September 2000. However, as their recently-filed revised
expe1t repo1ts, amended petition, and b1ief reveal, this is not the case. All of these documents
continue to rely on allegations about PAL's initial December 1999 reactions as integral to their
overall claim, and record documents corroborate the pediatric appointments at which time the
reactions allegedly occurred. See Pet'rs' Ex. 32 at 16-17; Ex. 8 at 1 (showing pediatric visits from
December 1999 and January 2000). Thus, Respondent's objections about the timeliness of the
claim herein remain more than valid.

Petitioners have attempted to differentiate the earlier facts suggesting a reaction to the DTaP
vaccine from later-documented instances of PAL's developmental problems, characterizing the
former as evidencing vaccine "intolerance" that is somehow distinguishable from onset of his
outward developmental and/or autism symptoms. But the law on this is matter is firm and
persuasive - the first sign or related symptom constitutes onset, even ifthat sign is not recognized
as such. Carson, 727 FJd at 1369.

The nature of the claim at issue bears on resolution of the limitations question. This is not a
case in which Petitioners are arguing that onset was the first manifestation of P.A.L.'s autism,

8
whether diagnosed or simply observed (and persuasive law suggests it is the latter that triggers a
Vaccine Program claimant's claim). See, e.g., White v. Sec '.Y of Health & Human Servs., No. 04-
337V, 2011WL6176064, at* 10-11 (Fed. Cl. Spec. Mstr. Nov. 22, 2011) (in claim alleging autism
as injury, definitive diagnosis or health care provider opinion is not required to trigger running of
limitations period). Rather, the Loutoses argue that an encephalopathy was triggered by P.A.L.'s
DTaP vaccination (as evidenced in patt by the symptoms he displayed not long after the
vaccination), and that in turn the neurologic injury caused by the encephalopathy resulted in his
developmental problems and/or autism. Amended Pet. at 3, 18 (P.A.L.'s injuries ai·e "due to the
encephalopathy caused by the DTaP vaccine administered to him on December 17, 1999").

An alleged encephalopathy can be the basis for a Table or Non-Table claim. However, the
Table's precise definition of the term "simply does not encompass every type of brain dysfunction
to which the broader meaning of 'encephalopathy' applies.'' Wright v. Secy of Health & Human
Servs., No. 12-423V, 2015 WL 6665600, at *6 (Fed. Cl. Spec. Mstr. Sept. 21, 2015); Fester v.
Sec'y of Health & Human Servs., No. 10-243V, 2013 WL 5367670, at *21, n. 5 (Fed. Cl. Spec.
Mstr. Aug. 27, 2013). Thus, as noted by former Chief Special Master Vowell, the term
encephalopathy, "as commonly used in the medical community, encompasses a much broader
class of injuries than the more stringent definition of acute encephalopathy found in the QAI
[qualifications and aids to interpretation].'' Wright, 2015 WL 6665600, at *5 (citing Waddell v.
Sec'y of Health & Human Servs., No. 10-316V, 2012 WL 4829291, at *6 (Fed. Cl. Spec. Mstr.
Sept. 19, 2012)).

Petitioners' amended petition does not appear to assert a Table encephalopathy claim, 10 and
therefore more kinds of evidence can be considered in dete1mining if one occurred. See, e.g., Miller
v. Sec'y ofHealth & Human Servs., No. 02-235V, 2015 WL 5456093, at *23 (Fed. Cl. Spec. Mstr.
Aug. 18, 2015) (quoting Respondent's expe1t in that matter as defining encephalopathy to mean
generally that "there's something wrong with the brain"). It does not matter how severe the initial
reaction was. Smith v. Sec'y a/Health & Human Servs., No. 02-93V, 2006 WL 5610517, at *5
(Fed. Cl. Spec. Mstr. July 21, 2006) ("the Vaccine Act does not distinguish between subtle and
pronounced symptoms for determining the point of onset"), mot. for review den 'd, 2006 WL
5624674 (Fed. Cl. Nov. 16, 2006).

Here, that evidence is found in P.A.L.'s purported reaction to the DTaP vaccine, within 48
hours of its administration, as evidenced by his fever and rep01ted reactions in the days and weeks
immediately after he received the DTaP vaccine. Other petitioners, like the Loutoses, have
similarly relied on evidence of fever or other initial reaction to a vaccination to demonstrate an
underlying encephalopathic process, later manifesting in autism or other developmental problems.

10
Thus, the amended petition references only a "chronic encephalopathy" as the product of P.A.L. 's DTaP vaccination
- even though a Table encephalopathy requires proof of both an acute and chronic encephalopathy. 42 C.F.R. §
100.3(b)(2).

9
See, e.g., Murphy v. Sec'y of Health & Human Servs., No. 05-1063V, 2016 WL 3034047, at *31-
33 (Fed. Cl. Spec. Mstr. Apr. 25, 2016) (no evidence of immediate reaction to vaccination
sufficient to find encephalopathy in non-Table case), mot. for review den 'd, No. 05-1063V (Fed.
Cl. Aug. 15, 2016), appeal docketed, No. 2017-1047 (Fed. Cir. Oct. 14, 2016); R. V. v. Sec'y of
Health & Human Servs., No. 08-504V, 2016 WL 3882519 (Fed. Cl. Spec. Mstr. Feb. 19, 2016),
mot. for review den 'd, 127 Fed. Cl. 136 (Fed. Cl. July 1, 2016), appeal dismissed, No. 16-2400
(Fed. Cir. Oct. 26, 2016).

It is thus common for claimants asserting that a vaccine precipitated an encephalopathy that in
turn manifested developmental problems and/or ASD symptoms to rely on facts relating to a
purported initial reaction to the vaccine to prove the "stmi" of the encephalopathy - to show that
some underlying, immunologic-related reaction was occurring that injured a child's brain. Based
upon my review of Petitioners' recent filings and the record as well, it is evident that Petitioners'
claim relies on P.A.L. experiencing a reaction to the DTaP vaccine in December 1999 and January
2000. See, e.g., Pet'rs' Ex. 8 at 1 (purported January 2000 reaction). There can be no doubt that
Petitioners allege that these occurrences relate to their claim -they reiterated them even after being
put on precise notice of Respondent's limitations objections.

Petitioners unpersuasively object that they were not aware that P.A.L. 's earliest manifestations
of his purpmied injury were vaccine-related, and thus were not cognizant of the existence of their
claim until after February 2000. In so doing, they effectively invoke the "discovery rule," under
which a "statute of limitations does not begin to run until an injured person knew or should have
known that a vaccine had the ability to cause the injury from which she suffered." Johnston v.
Sec'y of Health & Human Servs., No. 11-796, 2013 WL 664709, at *4 (Fed. Cl. Spec. Mstr. Jan.
31, 2013) (emphasis added). But as Respondent's Motion observes, the discove1y rule does not
apply to Vaccine Act cases. Cloer, 654 F.3d at 1339. So even though the Loutoses may not have
recognized that time began to run on their claim before P .A.L. openly exhibited his developmental
problems, their claim as articulated over the past several years clearly is based on symptoms that
began more than three years prior to the case's filing.

The Federal Circuit has held that the doctrine of equitable tolling can apply to Vaccine Act
claims in limited circumstances. Cloer, 654 F.3d at 1340-41. These limited circumstances have
been enumerated to include fraud and duress, but not a lack of awm·eness on a petitioner's pmi that
she might have an actionable claim. Id. at 1344-45 (unawareness of a causal link between the
injury and vaccination was insufficient to justify invocation of equitable tolling). None of the
relevant circumstances that would permit tolling have been shown by Petitioners to apply herein,
however.

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II. Petitioners' Claim Would Likely Not Succeed Even if it Were Not Time-Barred.

I am resolving Petitioners' claim on the basis of a procedural deficiency rather than its
underlying merits. However, my review of the medical records suggests that the claim would not
likely have succeeded even if I had ignored its evident untimeliness and permitted it to go to
hearing. The expert reports offered in support of the theories herein are not especially persuasive, 11
and the medical records do not contain any treater views contemporaneous with the December
DTaP vaccination supporting the conclusion that the vaccine was ever linked to P.A.L.'s purported
reaction or subsequent developmental problems.

Moreover, the nature of the claim at issue also bears on its merits. Since completion of the
OAP, no petitioner asserting a non-Table claim for autism injuries purportedly related to a vaccine
(and based on a theory not adjudicated in the OAP) has ever succeeded. Hardy v. Sec '.Y of Health
& Human Servs., No. 08-108V, 2015 WL 7732603, at *4-5 (Fed. Cl. Spec. Mstr. Nov. 3, 2015)
(referencing eleven autism claims unsuccessfully tried, plus six that were rejected (over the
petitioners' objections) without trial). Many such cases have involved claims that a preceding
encephalopathy precipitated a developmental injury. See, e.g., R. V., 2016 WL 3882519, at *35-36
(discussing kinds of proof necessary to establish encephalopathy that were lacking); Lehner v.
Sec'y of Health & Human Servs., No. 08-554V, 2015 WL 5443461 (Fed. Cl. Spec. Mstr. July 22,
2015) (petitioners failed to demonstrate that flu vaccine resulted in autoimmune encephalitis). 12
Nor have any petitioners been able to show, based on after-the-fact treater views, that a child even
possessed a mitochondrial disease sufficient to experience a severe vaccine interaction resulting
in autism or a developmental problem. R. V., 2016 WL 3882519, at *33-35; see also Miller, 2015

11 For example, Dr. Kern's Amended Reporl references the concept of"delayed encephalopathy" as allowing for the
possibility that P.A.L. could have experienced an initial insult from the DTaP vaccine, but that his symptoms would
be slow to manifest. Amended Kern Rep. at 9-11. But this the01y still relies on the existence of an "initial acute phase"
(Id. at 9) - meaning that there would have to be some evidence of a reaction closer in time to the vaccination, which
in turn would (again) render the claim time-barred given the facts of this case. In addition, none of Dr. Kern's examples
involve vaccine-mediated injuries, but instead involve disparate occurrences like carbon monoxide poisoning or
hypoxia (oxygen deficiencies), where the impact of the insulting event is less disputed. To show that a DTaP vaccine
could have the same impact, Dr. Kern relies on studies involving pertussis toxin (Id. at 11-13)- even though DTaP is
co1nprised of the inactivated toxoid only, which lacks the same capacity to injure because it contains no more than
residue amounts of the toxin. Mwphy, 2016 WL 3034047, at *12 (acellular version of vaccine involves inactivated
form of pertussis toxin).

12The parents of a vaccinated child have, on only one occasion, successfully established a Table injury - an
encephalopathy- after vaccination that resulted in an autistic-like developmental regression. See, e.g., Wright, 2015
WL 6665600. In Wright, the petitioners met the Table criteria for an "acute encephalopathy" following vaccination
by establishing by preponderant evidence that the vaccinated child experienced a seizure followed by loss of
consciousness shortly after receipt of pertussis-containing vaccine; the severe reaction lasted for more than 24 hours,
with resulting de1nonstrable significant changes in behavior te1nporally close to the titne of vaccine ad1ninistration.
But the special master responsible for that decision (former Chief Special Master Vowell) explicitly noted in her
decision that petitioners would not have been able to establish entitlement under their non-Table claim, because their
expe1t presented a causation opinion that she found "absurd and biologically impossible." Wright, 2015 WL 6665600,
at *2.

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WL 5456093 (petitioners failed to demonstrate that several childhood vaccines aggravated
underlying mitochondrial disease/dysfunction) . 13

CONCLUSION

It is unfortunate that so much time was devoted to a claim that might have been identified as
untimely years ago. But the issue is now squarely before me - and Petitioners have failed to remedy
this core deficiency in their claim. It is, moreover, a deficiency of which they were first placed on
notice eight years ago, and one that I have attempted to provide them a reasonable oppo1tunity to
cure. They have not done so, and although I am cognizant of the Vaccine Program's remedial
character (and the concomitant policy goal of allowing claimants - especially pro se litigants - a
fair chance to prove their claims), such considerations do not ovenide the Act's limitations
provisions where they are applicable.

Accordingly, and for the reasons stated above, I hereby DISMISS this matter.

IT IS SO ORDERED.

13
In a single case - Paluck v. Sec'y of Health & Human Servs., 113 Fed. Cl. 2 10 (20 13), ajj'd, 786 F.3d 1373 (Fed.
C ir. 20 15) - a petitioner whom the parties agreed (or at least, where Respondent did not dispute) had a preexisting
mitochondrial disease was successful in establishing (in a non-Table claim) that certain vaccines significantly
aggravated that disease, resulting in developmental and other neurodegenerative injuries. That fact pattern is
distinguishable from the present circumstances, in which Petitioners would need to prove that P.A.L. had such a
condition - and in which they wou ld, moreover, attempt to do so by relying on after-the-fact testing and expe1t
opinions not contemporaneous to the vaccination. See, e.g., Anderson v. Sec'y of Health & Human Servs., No. 02-
13 14V, slip op. at 35-36 (Fed. Cl. Spec. Mstr. Nov. I, 20 16) (noting the unpersuasive nature of after-the-fact testing
results that revealed a possible mitochondrial disorder when those tests were not conte mporaneous with when
petitioner wou ld have experienced the purpo1ted vaccine reaction), appeal docketed, Dec. 1, 20 16 (Fed. Cl. 20 16).

12