Krenik v. Secretary of Health and Human Services

OR|G|NAL
In the United States Court of Federal Claims
OFF|CE OF SPECIAL MASTERS
No. 03-2755V
Filed. July 25, 2014 JUL 25 2014
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vALE KREN¢K, parent of * i=eoenr\i_ c\_Au\/ls
V.K., a minor, *
Petiti0ner, * Autism; Statute of Limitations;
* Untimely Fi|ed
v. *
SECRETARY OF THE DEPARTMENT *
OF HEALTH AND HU|\/|AN SERV|CES, *
Respondent. *
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Vale Krenik, Plano, TX, pro se petitioner.‘
Linda Renzi, Esq., U.S. Dept. of Justice, Washington, DC, for respondent.
oEcisioN?
Vowell, Chief Special l\/laster:
Vale Krenik ["petitioner"] filed a "Short-Form" petition for vaccine
compensation3 under the National Chi|dhood Vaccine injury Act"* ["Vaccine Act"]
1 l\/lr. Krenik is an attorney licensed to practice in Texas, as reflected by his Texas bar number on
his fiiings.
2 Because this decision will be published, in accordance with Vaccine Rule 18(b), petitioner has
14 days to identify and move to redact medical or other information, the disclosure of which would
constitute an unwarranted invasion of privacy. lf, upon review, l agree that the identified material
fits within this definition, l will redact such material from public access.
3 By electing to file a Short-Form Autism Petition for Vaccine Compensation, petitioner, who was
then represented by counsel, alleged that:
[a]s a direct result of one or more vaccinations covered under the National
Vaccine injury Compensation Program, the vaccine in question has developed a
neurodevelopmental disorder, consisting of an Autism Spectrum Disorder or a
similar disorder. This disorder was caused by a measles-mumps-rubella (l\/ll\/|R)
vaccination; by the "thimerosal" ingredient in certain Diphtheria-Tetanus-
Pertussis (DTP), Diphtheria-Tetanus-acellular Pertussis (DTaP), Hepatitis B, and
Hemophilus lnfluenza Type B (H|B) vaccinations; or by some combination of the
two.
on behalf of his son, V.K., on December 1, 2003.5 No medical records were filed
with the petition Based on the "short form" petition, the case was included in the
Omnibus Autism Proceeding ["OAP"], and, in effect, stayed until litigation of the
test cases was completed.€
|. Procedura| History.
After resolution of the OAP test cases,7 petitioners in OAP cases were
asked if they wished to proceed with or dismiss their claims.a On December 21,
2012, petitioner’s counsel filed a motion asking that he be permitted to withdraw
as attorney of record because he believed there was no reasonable basis to
Autism General Order #1, filed July 3, 2002, Exhibit A, l\/laster Autism Petition for vaccine
Compensation at 2 which can be found on the court’s website at
http://wvvw.uscfc.uscourts.gov/sites/default/files/autism/Autism+General+Order1.pdf.
4 The National Vaccine injury Compensation Program comprises Part 2 of the Nationai Childhood
Vaccine injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755, codified as amended, 42 U.S.C.
§§ 300aa-10 et seq. (2006). Hereinafter, individual section references will be to 42 U.S.C.
§ 300aa of the Vaccine Act.
5 Custody of V.K. is shared between his parents. See Petitioner's Exhibit ["Pet. Ex."] 3, pp. 130-
64 (V.K.’s parents’ final divorce decree filed as part of V.K.’s pediatric records). V.K.’s mother
has not joined in the vaccine injury claim. See Letter, filed into the record by Specia| l\/laster
Hastings on Nov. 10, 2005 [Docket Event 10].
6 See Notice, issued Jan. 8, 2004, at 1-2 (The OAP was "a general inquiry by the Office of
Specia| l\/lasters ("OSl\/l") regarding the possible causal relationship between certain vaccinations
. . . and autistio spectrum disorders or similar neurodevelopmentai disorders."). Proceedings in
the other cases in the OAP were stayed pending the outcome of the test case litigation.
7 The Petitioners’ Steering Committee ["PSC"], an organization formed by attorneys representing
petitioners in the OAP, litigated six test cases presenting two different theories on the causation
of Autism Spectrum Disorders ["ASDs"]. Decisions in all six cases rejected petitioners’ causation
theories. The Theory 1 cases are Cedi'//o v. Sec’y, HHS, No. 98-916V, 2009 WL 331968 (Fed. Cl.
Spec. l\/lstr. Feb. 12, 2009), aff’d, 89 Fed. Cl. 158 (2009), aff’d, 617 F.3d 1328 (Fed. Cir. 2010);
Haz/ehurst v. Sec’y, HHS, No. 03-654V, 2009 WL 332306 (Fed. Cl. Spec. l\/lstr. Feb. 12, 2009),
aff’d, 88 Fed. Cl. 473 (2009), aff’d, 604 F.3d 1343 (Fed. Cir. 2010); Snyder v. Sec’y, HHS, No. 01-
162V, 2009 WL 332044 (Fed. Cl. Spec. l\/lstr. i``~eb. 12, 2009), aff’d, 88 Fed. Cl. 706 (2009).
Petitioners in Snyder did not appeal the decision of the U.S. Court of Federal Ciaims. The Theory
2 cases are Dwyer v, Sec’y, H/-IS, No. 03-1202V, 2010 WL 892250 (Fed. Cl. Spec. l\/lstr. l\/iar. 12,
2010); K/``ng v. Sec’y, HHS, No. 03-584V, 2010 WL 892296 (Fed. Cl. Spec. l\/lstr. i\/iar. 12, 2010);
Mead v. Sec’y, HHS, No. 03-215V, 2010 WL 892248 (Fed. Cl. Spec. l\/lstr. Mar. 12, 2010). The
petitioners in each of the three Theory 2 cases chose not to appeal
8 Because the attorney then representing petitioner had a large number of OAP cases, he was
allowed to work with the petitioners in his cases on an extended timetable to determine if they
wished to continue with their claim, resulting in a delay in ascertaining whether l\/lr. Krenik wished
to proceed with V.K.’s case.
ignoring the Federal Circuit’s clear holding in C/oer /// that the Vaccine Act
does not include a discovery rule,23 petitioner claims that a discovery rule is
applicable because the "Vaccine Compensation Act falls within the Federal Tort
C|aims Act" (FTCA) which allows a discovery rule. Pet. Response at 4.
Petitioner is incorrect. The FTCA allows "civil actions on claims against
the United States . . . for injury or loss of property, or personal injury or death
caused by the negligent or wrongful act or omission of any employee of the
Government while acting within the scope of his office or employment." 28
U.S.C.A. § 1346(b)(1). The Vaccine Act does not "fall within" the FTCA. lt is a
separate no-fault tort reform program in which "wrongfulness" or negligence is
irrelevant. C|aims filed under the Vaccine Act are subject to its statute of
limitations as set forth in § 16(a), not the FTCA’s statute of limitations (28
U.S.C.A. § 2401(a)).
Petitioner urges me to ignore C/oer and find that a discovery rule is
allowed under the Vaccine Act. l decline to do so.
4. Equitable Tolling and Equitable Estoppel.
Petitioner also argues that alleged misconduct by the CDC is a basis to
apply equitable tolling and equitable estoppel in V.K.’s case. Pet. Response at 5.
Assuming, arguendo, that the allegations of misconduct are true, such actions do
not automatically result in the tolling of the statute of limitations. Petitioner has
failed to show that the alleged actions of the CDC prevented him from filing his
petition before the expiration of the statute of limitations.
a. Requirements for Equitable Tolling and Equitable Estoppel.
ln C/oer ///, the Federal Circuit held "equitable tolling under the Vaccine
Act due to unawareness of a causal link between an injury and administration of
a vaccine is unavailable." 654 F.3d at 1345, However, the Circuit specifically
noted that the petitioner in C/oer did not argue that she was the victim of fraud or
duress. ld. at 1344. Because the petitioner alleges misconduct by "employees
of the Respondent" (Pet. Response at 5), and such conduct might, conceivably,
warrant tolling or estoppel on equitable grounds, l examine what petitioner must
demonstrate to warrant application of either equitable tolling or equitable
estoppel.
"[T]he doctrine of estoppel is a judicial remedy by which a party may be
precluded by his own actor omission, from asserting a right to which he
otherwise would have been entitled." Henry v. United States, 14 Cl. Ct. 795, 799
23 in C/oer ///, the Federal Circuit held that the Vaccine Act does not include either an explicit or
implied discovery rule. 654 F.3d at 1337 (en banc), cert. den/``ed, C/oer v. Sebe/ius, 132 S. Ct.
1908 (2012). The Circuit’s holding is unambigu0us.
11
(1988), aff’d, 870 F.2d 634 (Fed. Cir. 1989). The party relying upon equitable
estoppel must show that she reasonably relied to her detriment on the opposing
party’s misrepresentations. Heckler v. Community Health Services of Crawford
Coum‘y, /nc., 467 U.S. 51, 59 (1988) (citing Restatement (Second) of Torts §
894(1) (1979)); See, e.g., Lyng v. Payne, 476 U.S. 926, 935 (1986) (holding
detrimental reliance was not shown).
ln finding that equitable tolling applies to a federal statute of limitations,
the Supreme Court cited cases involving equitable estoppel. ln/i//'n, 498 U.S. at
96 n.4 (citing G/us v. Brook/yn Eastern District Termina/, 359 U.S. 231 (1959);
Holmberg v. Armbrecht, 327 U.S. 392 (1946)).24 Observing that federal courts
have employed equitable relief sparingly, the Supreme Court indicated that the
equitable tolling of federal statutes of limitations has been allowed "where the
claimant has actively pursued his judicial remedies by filing a defective pleading
during the statutory period or where the complainant has been induced or
tricked by his adversary’s misconduct into allowing the filing deadline to
pass." Irwin, 498 U.S. at 96 (emphasis added). Petitioner here alleges
misconduct on the part of respondent.
The basis for petitioner’s claim is that, during an October 2003 visit to the
CDC when he and two other people were provided access to the Vaccine Safety
Datalink ["VSDL"],% they discovered data which showed an "increase of relative
risk of autism . . . [that] is significant" for children who had received thimeroal-
containing DTaP vaccines. Pet. Response at 2. When l\/lr. Krenik and his two
colleagues returned in January 2004, they were denied access to the full records
of these children and some information previously available was "blacked out,"
and that "one contractor testified at [an] August lOl\/l[%] hearing that he was
ordered to destroy data sets ‘to protect privacy."’ Pet. Response at 3 (quoting a
book by David Kirby, Evidence of Harm).
l need not determine if petitioner’s allegations are true because, even if
completely accurate, petitioner has not shown they prevented him from timely
filing his petition.
24 As one of my colleagues observed, the Supreme Court appeared to include equitable estoppel,
which sets aside the statute of limitations as a subset of equitable tolling. See Young v. Seo’y,
HHS, 1994 WL 879450, at *4-5 (Fed. Cl. Spec. l\/lstr. Aug. 26, 1994).
25 The VSDL is a database that was "created in 1991 by the CDC to link medical events, vaccine
history (by manufacturer and lot number), and demographic information from several health
maintenance organizations providing a method for monitoring vaccine safety issues.” Dwyer,
2010 WL 892250, at *67 n.284 (citing T. Verstraeten, et al., Safety of Thimerosa/-Conta/``ning
\/accines: A Two-Phased Study of Computerized Hea/th Maintenance Organizat/'on Databases,
PEDiATRics 112(5): 1040 (2003), filed as exhibit 247 on the Petitioners’ l\/laster List in the Theory
2 OAP test cases)r
26 ioivi stands for tne institutes er iviedieine. see king v. seey, HHs, Ne. 03~584v, 2011 wt
5926126, at 13 n.10 (Fed. Ci. Spec. l\/lstr. Sept. 22, 2011) (information regarding the lOl\/l).
12
Since the vaccine Act’s statute of limitations is not triggered by the
discovery of a causal connection between vaccine and injury, misconduct or
misrepresentations in late 2003 or early 2004 cannot be the reason petitioner did
not timely file V.K.’s claim. Based on petitioner’s own statements about onset of
V.K.’s autistic behaviors when V.K. was two years of age, the claim should have
been filed by no later than June 2003. in arguing equitable estoppei, petitioner
references events that allegedly occurred five to six months § the statute of
limitations had expired. Thus, even if the alleged misconduct were sufficient to
estop the government from asserting the statute of limitations bar to this petition,
petitioner had already missed his filing deadline before the misconduct occurred
Petitioner filed his petition on December 1, 2003, at least one month before he
claims he and his team were denied access and given only altered scientific data
(January 2004).
if petitioner is alleging that the CDC or other government agencies
concealed evidence of vaccine causation prior to the expiration of the statute of
limitations (an argument he has not clearly made or provided evidence to
support), other sources of information regarding a potential causal connection
between thimerosai-containing vaccines and autism existed
in 2001, the lOi\/i released a report addressing the possibility of a link
between thimerosai-containing vaccines and certain neurodevelopmentai
disorders such as autism. A|though the lOi\/i was unable to conclude if a causal
relationship existed,” it supported calls for the removal of thimerosai from
vaccines, noting that thimerosai had been removed from most vaccines given to
infants, children, and pregnant women, and indicated further removal might be
warranted lOM 2001 Report at 8.
i\/loreover, in July 2002, when the OAP was formed, the order creating the
"short form" petition reflected the expectation that claims cfa causal connection
between thimerosai-containing vaccines and autism would be included in the
omnibus proceeding.zg Additionally, at least one medical journal article was
27 The lOi\/i found "that the evidence [was] inadequate to accept or reject a causal reiationship."
lOl\/i, livirviuNizATioN SAFETY REviEw: THiiviERos/\i_ CoNT/\iNiNG VAcciNEs AND
NEuRooEvELoPi\/\ENTAL DisoRot~:Rs (2001) ["IOI\A 2001 Report"] at 5. A|though the lOi\/i described
the hypothesized association as "not established" and "rest[ing] on indirect and incomplete
information," it categorized the hypothesis as biologica|iy plausible lOi\/i 2001 Report at 4. in a
later 2004 study addressing the question of a link between vaccines and autism, the lOi\/i
recognized the confusion created by the use of the term "biologically plausibie," indicating that it
now used a different system to describe the biological mechanism which might be involved lOi\/l,
liviiviuNizATioN SAAFETY REviEw: Ti~iiiviERosAi_ CoNTAiNiNo VAcciNEs AND NEuRooEvELoPi\/\ENTAL
DISORDERS (2004) ["iOi\A 2004 Report"] at 3. in that later report, the lOi\/i concluded "the evidence
favor[ed] rejection of a causal relationship between thimerosai-containing vaccines and autism.
lOi\/i 2004 Report at 7.
28 Filing the "short form" petition authorized by the order asserted a claim that either the measles,
mumps, and rubeila vaccine or a thimerosai-containing vaccine, or both, caused autism spectrum
disorders. See Autism Generai Order #1, filed July 3, 2002, Exhibit A, i\/laster Autism Petition for
13
published in 2001, raising the hypothesis that autism was a novel form of
mercury poisoning. See, e.g., S. Bernard, et al., Autism: a novel form of mercury
poisoning 56(4): 462-71 (2001), filed as exhibit 262 on Petitioners’ l\/laster List in
the Theory 2 OAP test cases.
There is ample evidence that government agencies were actively and
publically exploring a possible thimerosal-autism connection prior to the alleged
fraudulent activities. The government had requested that the lOM study such a
connection, leading to the 2001 lOl\/l Report, as well as the lOl\/l 2004 Report.
incidentubthere is ample evidence that they are not. Through the OAP, and the
unprecedented level of discovery afforded the litigants prior to the test case
hearings, this court was examining the issue as well. l note that more than 2000
autism petitions had been filed by the time of the alleged misconduct, many
alleging a thimerosal~autism connection. As petitioner noted, the CDC gave his
team full access to VSDL information in October 2003. There is nothing to
indicate the CDC would not have done so earlier if petitioner had asked.
in ln/i//n, the Federal Circuit explained that courts "have generally been
much less forgiving in receiving late filings where the claimant failed to exercise
due diligence in preserving his legal rights" 498 U.S. at 458 (citing Baldwin
County Welcome Center v. Brown, 466 U.S. 147, 151 (1984)). Thus, courts have
found that equitable tolling is not warranted when the needed information could
have been obtained through due diligence from other sources. See, e.g., A.Q.C.
ex rel. Castillo v. United States, 715 F. Supp. 2d 452, 461-62 (S.D.N.Y, 2010)
(holding that the FTCA statute of limitations should not be equitably tolled until
plaintiff discovered her obstetrician was a federal employee, given that the
information could have been obtained from numerous other sources).
As l noted in Part 3, the statutes of limitations in the Vaccine Act and in
the FTCA differ but, even in medical malpractice claims under the FTCA, the
accrual of the statute of limitations is postponed only until "the plaintiff has or
with reasonable diligence should have discovered the critical facts of both his
injury and its cause. Barrett v. United States, 689 F.2d 324, 327 (2d Cir. 1982)
(emphasis added). in Barrett, the government controlled the information
regarding the deceased’s cause of death and did not just fail to come forward
with evidence of misconduct, it actively concealed it by providing the family with a
false cause of death.zg /d. at 330. ln this case, petitioner has failed to prove that
he exercised due diligence in discovering a thimerosal-autism connection.
Even when the facts are viewed in the light most favorable to petitioner, he
has not established that either equitable estoppel or equitable tolling applies to
Vaccine Compensati0n at 2, which can be found on the court’s website at
http://www.uscfc.uscourts.gov/sites/default/files/autism/Autism+General+Order1.pdf).
29 The plaintiff in Barrett was the daughter of an individual who was killed while unknowingly
serving as a test subject in chemical warfare experiments being conducted by the government
/d. at 326
14
V.K.’s claim. Even taking his fraud allegations as true, he is unable to
demonstrate that the governmental activity of which he complains impaired his
ability to timely file V.K.’s claim.
b. Request for Additional Discovery.
Whether thimerosal-containing vaccines can or do cause autism spectrum
disorders is not relevant in deciding whether this claim was timely filed.
Nevertheless, l will briefly discuss the basis for petitioner’s assertions that the
purported thimerosal connection should be reexamined.
Petitioner claims that an unpublished study is evidence of a causal
connection between the use of thimerosal-containing vaccines and the
development of autism. Pet. Response at 1-2; see Pet. Ex. 19 (abstract of
unpublished study titled \/accine Safety Datalink Analys/'s Confirms Link Between
Neurodeve/opment Disorders and Th/'merosal-Containing Childhood vaccines in
the U.S.). Although he does not identify the other two members of the team that
produced the study, the abstract that petitioner filed indicates the study was
authored by David A. Geier, B.A.; Vale Krenik, B.A.; and l\/lark R. Geier, l\/l.D.,
Ph.D. Pet. Ex. 19 at 1. Both the type of study performed and petitioner’s co~
authors cast considerable doubt on the validity of petitioner’s assertions that
exploration of the autism-thimerosal connection is still warranted.
Petitioner’s assertion that more discovery is necessary to demonstrate
fraud is part of his effort to show that thimerosal causes autism and that a
government cover-up tainted the OAP test cases Petitioner has based his
arguments regarding vaccine causation and request for additional discovery on
an uncompleted study that cannot, by the nature of the study described,
demonstrate a causal connection. l\/loreover, the study’s authors have yet to
produce any study on this topic considered as reliable evidence l find that the
additional discovery requested could not affect the timing problem in this claim,
much less provide reliable evidence of a causal connection.
(1) l\/lisplaced Reliance on an Ecological Study.
Petitioner describes an ecological study performed using data from the
VSDL and claims it shows evidence of a "causal connection between the use of
thimerosal-containing vaccines and the development of autism." Pet. Response
at 2.
in Dwyer, the Theory 2 OAP test case, l discussed the strengths and
weaknesses of several different types of epidemiological studies in
demonstrating causality. See Dwyer, 2010 WL 892250, at *65-67. Petitioner’s
exhibit 19 describes an ecological study examining trend lines comprised of
neurodevelopmental disorders and thimerosal-containing vaccines. Even if the
trend lines are similar, such a study can only show that further study of the two
15
events may be warranted. Dwyer, 2010 WL 892250, at *66-67. "[A]n ecological
study cannot determine if one event is caused by another," and "[i]nterpreting two
similar trend lines in causal terms is called the ‘ecologicai failacy."’ Dwyer, 2010
WL 892250, at *66. in general, ecological studies are more susceptible to bias,
cannot distinguish a small association from no association, and are afforded less
weight than controlled studies. /d. An ecological study is helpful if it rules out a
causal connection but "cannot serve as evidence of causation." /d. Thus, the
"study," which petitioner did not file, would be useless as evidence of causation.
(2) Reliance on Research by the Geiers.
The study’s co~authors, l\/iari< and David Geier, are a father and son team
who have authored numerous studies claiming a causal connection between
vaccines and autism. Their studies connecting the l\/li\/iR vaccine and autism and
thimerosal-containing vaccines and autism were heavily criticized by the lOl\/l in
its 2004 study on vaccines and autism.3° in evaluating an unpublished analysis
authored by the Geiers, which could be the study abstract in Pet. Ex. 19, the lOl\/l
concluded the results were "uninterpretabie and, as such, noncontributory with
respect to causation." lOl\/l 2004 Report at 52, in particular, the lOl\/l noted the
Geiers had not provided the basis for their calculations or a description of their
methods and additional data.m
The Geier studies were also addressed in my Dwyerdecision. l noted that
the only studies which showed a connection between thimerosal-containing
vaccines and autism were studies co-authored by the Geiers. Dwyer, 2010 WL
892250, at *71. Because petitioners’ own expert in the OAP test cases
commented that "the Geier studies were not reliable as evidence," l did not rely
30 The Geiers authored six of the seven studies which reported an association between
thimerosal and autism. See lOl\/l 2004 Report at 51-52, 55~62, 65, 66-83 (Table 9) (discussing
the thimerosal studies in detail). The seventh study (which was not authored by the Geiers) was
an unpubiished, uncontrolled study. /d. at 6-7. The lOl\/l described the Geier studies as having
"serious methodological flaws,” their analytic methods as "nontransparent,” and "their results
uninterpretabie, and therefore noncontributory with respect to causaiity." /d. at 7. The Geiers
submitted the only two studies which reported an association between the l\/|i\/iR vaccine and
autism, and the lOl\/l similarly criticized those studies. ld. at 7; see id. at 83, 86-111 (Table 10),
119-20, 122~23, 126 (discussing the i\/li\/iR studies in detail).
31 in 1993, the Supreme Court concluded the general acceptance test in Frye v. Un/``ted States,
293 F. 1013, 1014 (D.C. Cir. 1923) was superseded by the Federal Ruies of Evidence and held
that the Rules required admitted scientific testimony or evidence to be relevant and reliable
Dauben‘ v. Merre/l Dow Pharmaceut/'ca/s, 509 U.S. 579, 589 (1993); see also Terran v. Sec’y,
HHS, 195 F.3d 1302, 1315 (Fed. Cir. 1999) (indicating it is appropriate for special masters to use
the Daubert factors when assessing the reliability of vaccine causation theories). While
cautioning that the question of scientific validity should focus on principles and methodology
rather than the conclusions reached (Daubert, 509 U.S. at 594~95), the Supreme Court indicated
that one factor to consider is whether a technique or theory can or has been tested (id. at 593).
The Geiers’ consistent failure to provide the data and methodology used in studies which they
claim show vaccine causation greatly undercuts the scientific validity of these studies
16
upon them or discuss them further. /d. The only exception was the Young
study:’z which was introduced after petitioners’ epidemiology expert finished
testifying and was excused. Dwyer, 2010 WL 892250, at *71 & n.301.
Respondent’s experts in epidemiology were highly critical of the Young study.33
Based on their criticisms, l afforded the study "little weight." Dwyer, 2010 WL
892250, at *72.
The special masters who heard the other two test cases came to a similar
conclusion regarding the reliability of the Geier studies. See King, 2010 WL
892296, at *68 (finding all the Geier epidemiological studies to be unreliable);
Mead, 2010 WL 892250, at *39 n.78 (criticizing the Geier studies while noting "a
number of courts have expressed concerns about the reliability of their work").
The special master handling the costs incurred by the PSC to address the
general causation issues involved in Theory 2 refused to pay for the Young
study, finding that it "did not add any value to the petitioners’ causation
presentation in [the] case." King, 2011 WL 5926126, at *9 (emphasis removed).
The special master discussed criticisms of the study, evaluations of prior articles
by the Geiers, and the general credibility of Dr. Geier34 as an expert witness.
King, 2011 WL 5926126, at *9-17. The special master included an extensive list
of vaccine and non-vaccine decisions in which judges and special masters not
only questioned Dr. Geier’s honesty but noted his tendency to offer testimony in
areas which are outside his medical expertise. King, 2011 WL 5926126, at *10-
13. The special master observed that Dr. Geier had little to no expertise in
epidemioiogy?§ Kmg, 2011 wi_ 5926126, at *15-16.
32 The Young study was authored by the Geiers and Dr. Heather Young. Lil2011 WL 892296, at *68 n.101 (indicating the following article oitation: Heather A.Young, David A.
Geier, l\/larl< R. Geier, Thimerosa/ Exposure in infants and Neurodeve/opmenta/ Disorders: An
Assessment of Computer/``zed Medical Records in the l/acc/``ne Safety Data/ink, 15 J.
NEuRoi_oGic/\L Sci. 110 (2008)).
33 Respondent’s experts argued that this study was flawed for a variety of reasons such as the
lack of data which would allow for verification of any calculations, a "mid-stream" change in the
study’s design, poor design for Table 3, and the inclusion of a broad range of differing disorders.
Dwyer, 2010 WL 892250, at *71~72. One expert (Dr, Frombonne) noted that the birth cohorts did
not use the same number, with one "outlier" group containing just 2,000 instead of the 40,000
children in most groups, and that invented numbers were added to the 1995 and 1996 data.
Dwyer, 2010 WL 892250, at *71. ln a subsequent letter, Dr. Young admitted that the study lost
statistical significance if either the outlier group or invented numbers were removed, but defended
the use of both. Dwyer, 2010 WL 892250, at *72.
34 l note that Dr. l\/lark Geier’s medical license was suspended in l\/larch 2012. See Bast v. Sec’y,
HHS, No. 01~565V, 2012 WL 6858040, at *1 n.5 (Fed. Cl. Spec. l\/lstr. Dec. 20, 2012).
35 As noted by the Supreme Court in Daubert, the wide latitude afforded to an expert "is premised
on an assumption that the expert’s opinion will have a reliable basis in the knowledge and
experience of his discipline." 509 U.S. at 592. This assumption does not apply when an expert is
opining outside of his discipline
17
With reference to Dr. Geier as an expert witness, special masters have
observed that his credibility has been so compromised that he should not be
employed as an expert in Vaocine Act cases. See, e.g., /l/las/'as v. Sec’y, HHS,
No. 99-697V, 2009 WL 1838979, at *39 (Fed. Cl. Spec. l\/lstr. June 12, 2009).
l\/lore recently, the Geiers’ activities have led to the loss of Dr. Geier’s medical
license in l\/|arch 2012 (see supra note 34) and David Geier’s fine by the State of
l\/laryiand for practicing medicine without a license (see Arango v. Sec’y, /-/HS,
No. 09~318V, 2012 WL 4018028, at *9 n.20 (Fed. Cl. Spec. l\/lstr. Aug. 23,
2012)). See also Res. Reply at 2 n.2.
5. Former Counsel’s Beliefs.
in his last argument regarding why his claim should not be dismissed,
petitioner requests that l strike the admission of his former counsel regarding the
merits of his causation case. Pet. Response at 5.
When seeking to withdraw as attorney of record, petitioner’s former
counsel indicated that he did not believe there was, in light of the decisions in the
OAP test cases rejecting the theories advanced, a reasonable basis to proceed
with petitioner’s claim (l\/lotion, filed Dec. 21, 2012, at 5). Former counsel added
that petitioner disagreed with his belief (Reply, filed Feb. 6, 2013, at 3). When
granting counsei’s motion to withdraw, l found that the personal belief of
petitioner’s former counsel prevented him from adequately representing
petitioner’s interests. However, l expressed no opinion as to the validity of
counsei’s beliefs and have given no weight to his opinion in deciding that this
case was untimely fiied. Because the opinion of former counsel has no effect on
my decision, l decline to grant petitioner’s request.
|V. Conclusion.
Petitioner has the burden to show timely filing. Petitioner has failed to do
so. There is preponderant evidence that this case was not filed within "36
months after the date of the occurrence of the first symptom or manifestation of
onset or of the significant aggravation of such injury" as required by the Vaocine
Act. § l6(a)(2). Furthermore, petitioner has not demonstrated that either
equitable tolling or equitable estoppel preclude application of the statute of
limitations in this case.
This claim is dismissed as untimely fi|ed. The Clerk is directed to
enter judgment accordingly.
lT lS SO ORDERED.
oehise K. vowf i
Chief Special l\/laster
18
continue with the claim.g l\/lotion at 5-6. Respondent’s counsel opposed this
request. First Response, filed Jan. 9, 2013. in her response (id. at 1 n.2) as well
as her response to counsel’s interim fee request (Second Response, filed Jan. 9,
2013, at 2-3), respondent argued that petitioner’s claim was not timely fi|ed,
although she did not make a formal motion to dismiss it.
The case was reassigned to me on March 8, 2013. in response to my
March 21, 2013 order, petitioner’s counsel filed some medical records on April
22, 2013. See Pet. Exs. 1-4. l then granted his request to withdraw and ordered
l\/lr. Krenik (now a pro se petitioner) to file all medical records from V.K.’s birth to
five years of age. Order, issued May 1, 2013, at 1-2. l also cautioned petitioner
that the case appeared to be untimely filed /d. at 3. l\/lr. Krenik requested
additional time and a status conference. l\/lotion, filed July 5, 2013, at 1.
l held a digitally-recorded telephonic status conference on August 1, 2013.
Linda Renzi appeared on behalf of respondent, and pro se petitioner Vale Krenik
was present on the call. During the call, l explained that after V.K.’s medical
records were filed, certain threshold issues, such as whether the case was timely
filed, needed to be addressed Order, issued Aug. 5, 2013, at 1. Since petitioner
informed me that he had experienced difficulty obtaining V.K.’s medical records, l
ordered him to file a list of all medical facilities so l could authorize subpoenas to
collect any missing medical records. /d. at 2.
Petitioner filed medical records on December 26, 2013. See Pet. Exs. 5-
15.1° He also filed a status report indicating problems with some of the medical
records and requesting an additional thirty days "to complete authentication of
records as well as any witness statements." Status Report, filed Dec. 26, 2013,
at 1-2. On January 28, 2014, he filed more medical records, some additional test
results from 2002 and 2003 and an additional copy of V.K.’s autism diagnosis
raise filed ee Per. Ex. 5)_ see Pet_ Exs. 16-13."
The filed records clearly reflect that symptoms of autism were present
more than thirty-six months before the petition was filed. Explaining that the
evidence filed did not demonstrate either "that this case was timely filed . . _ [or]
9 Petitioner’s counsel also requested interim attomeys’ fees and costs. Respondent objected to
the award due to its interim nature and the fact that she believed the case to be untimely filed
Second Response, filed Jan. 9, 2013, at 2~3. After deferring my ruling until the Supreme Court
issued its decision in Set)e//'us v. Cloer, 133 S. Ct. 1886 (2013), l awarded interim attorneys’ fees
and costs. See Decision, issued Jan. 7, 2014.
m Petitioner labeled these medical records as Pet. Exs. 5-14 and A. l redesignated Pet. Ex. A as
Pet. Ex. 15 on January 24, 2014.
" Because l\/lr. Krenik may not have received my January 24, 2014 Order redesignating Pet. Ex.
A as Pet, Ex. 15 before he filed these additional medical records, he used exhibit numbers 15-17.
l redesignated these exhibits as Pet. Exs. 16~18. See Show Cause Order, issued Feb. 4, 2014,
at 3 n.9.
any extraordinary circumstances warranting equitable tolling," l ordered petitioner
to show cause why the petition should not be dismissed as untimely filed. Show
Cause Order, issued Feb. 4, 2014, at 5.
Petitioner filed his response on l\/larch 6, 2014, asserting that the Centers
for Disease Contro| and Prevention ["CDC"] intentionally altered and denied
access to information which would prove a link between autism and thimerosal in
vaccines. Petitioner’s Response ["Pet. Response"] at 5. Petitioner argues "that
the statutory construction [of the Vaccine Act] needs to be re-evaluated to allow a
discovery rule [and] that grounds exist for both equitable tolling and equitable
estoppel . . . to extend the statute of limitations." /d. at 1.
l ordered respondent to file a reply to petitioner’s response. Respondent
filed her reply on l\/larch 25, 2014, arguing that petitioner’s assertions are
unfounded and false and that, even if true, "petitioner never explains how the
alleged fraud prevented him from timely filing his claim." Respondent’s Reply
["Res. Reply"] at 3. Respondent maintains "[t]he Federal Circuit has made clear
that there is no explicit or implied discovery rule under the Vaccine Act . . . [and]
held that equitable tolling is not a substitute for the discovery rule." /d. at 3-4_
After examining all of petitioner’s arguments, l reject petitioner’s assertion
that the Vaccine Act contains a discovery rule and find nothing to warrant an
application of equitable tolling or equitable estoppel in this case. Having
considered the record as a whole, l find that the petition was filed after the
expiration of the Vaccine Act’s statute of limitations, and that it must, therefore,
be dismissed.
ll. Statute of Limitations.
The Vaccine Act provides that:
in the case of . . . (2) a vaccine set forth in the
Vaccine injury Table which is administered after
October 1, 1988, 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 or of the significant
aggravation of such injury, . . .
§ 16(a)(emphasis added)_
The Court of Appeals for the Federal Circuit has interpreted this statutory
language, affirming that the statute of limitations begins to run on "the date of
occurrence of the first symptom or manifestation of onset of the vaccine-related
injury recognized as such by the medical profession at large." C/oer v. Sec’y,
HHS, 654 F.3d 1322, 1340 (Fed. Cir. 2011) (en banc) ["Cloerll/"]. The Circuit
explained that this date is "a statutory date that does not depend on when a
petitioner knew or reasonably should have known anything adverse about her
condition." /d. at 1339. The date is dependent on when the first sign or symptom
of injury appears, not when a petitioner discovers a causal relationship between
the vaccine and the injury. /d. at 1339~40.
Although the Federal Circuit found that equitable tolling was not warranted
in C/oer, it held that Congress did not create an exemption in the Vaccine Act to
the rebuttable presumption articulated in irwin v. Dep’t of \/eteran Affairs, 498
U.S. 89, 95-96 (1990), that equitable tolling applies to a federal statute of
limitations. C/oer, 654 F.3d at 1340-44 (overruling Brice v. Sec'y, HHS, 240 F.3d
1367 (Fed. Cir. 2001)).
ll|. Ana|ysis.
A. First Symptom or Manifestation of Onset.
To be timely filed under the Vaccine Act’s statute of limitations, this claim
must have been filed within 36 months from the date of the occurrence of "the
first symptom or manifestation of onset or of the significant aggravati0n" of V.K.’s
autism. § 16(a)(2). Since the petition was filed on December 12, 2003, it is
untimely filed if V.K. exhibited symptoms of autism prior to December 12, 2000.
Although V.K.’s records are not complete, the filed records establish that
V.K. exhibited symptoms of autism as least as early as June 2000. According to
an entry in his pediatric records, V.K.’s autism symptoms began when he was
two years old. See Pet. Ex. 14, p. 173. V.K. was two years old from mid-June
1999 until mid-June 2000, as he was born in mid-June 1997; thus, symptoms of
autism likely existed, at the very least, six months prior to December 2000.
l\/loreover, V.K. was diagnosed as "within the severely autistic range" on
November 1, 2000. Pet. Ex. 5, p. 4. At the evaluation that led to the diagnosis,
l\/lr. Krenik indicated that V.K. had been displaying numerous symptoms of
autism.‘z He reported that he was "not sure that [V.K.] ever made good eye
contact." Pet. Ex. 5, p. 2. He recounted that he became concerned when V.K.
"was not developing language other than ‘parroting’” what he heard." Pet. Ex. 5,
p. 2. He described behaviors of dropping objects over and over again, not liking
things to be out of place, enjoying certain textures, not responding to pain, and a
fear of certain noises (id., p. 3), all of which are recognized as symptoms of
12 See White v. Sec'y, HHS, No. 04-337V, 2011 WL 6176064, at *4~9 (Fed. Cl. Spec. |\/lstr. Nov.
22, 2011) (describing symptoms of autism).
13 "Parroting" is another word for "echolalia," the "stereotyped repetition of another person’s words
or phrases.“ DoRL/\No’s |LLusTRATEo l\/lEoicAL DicTioNARY (32d ed. 2012) at 589 Echola|ia is an
autism symptom. l/l/h/'te, 2011 WL 6176064, at *7.
5
autism.
The evaluator, Denise McCallon (Ph.D.), was unable to complete her
assessment of V.K.’s development due to his inability to engage or imitate, and
his inattentiveness, but concluded that his behavior was unmistakably autistic.
Pet. Ex. 5, p. 4. His score of41.5 on the Childhood Autism Rating Scale,a
diagnostic test for autism, placed him in the "severely autistic range." /d.
ln her report, Dr. l\/lcCal|on referenced an earlier evaluation at the Park
Cities Speech, Language, and Hearing Center, showing V.K. was diagnosed with
"[a] severe speech and language disorder" in August 2000. Pet. Ex. 5, p. 3
(quotations omitted). As the Federal Circuit noted in Carson, speech delay
qualifies as "the first objectively recognizable symptom of autism." Carson ex rel.
Carson v. Sec’y, HHS, 727 F.3d 1365, 1370 (Fed. Cir. 2013). During this earlier
speech eva|uation, V.K. also exhibited "poor eye contact, . . . echo|alia, [and]
minimal direction fo|lowing," all symptoms of autism. Pet. Ex. 5, p. 3; see White,
2011 WL 6176064, at *4-9 (explaining that poor eye contact, echo|alia, and
inability to follow directions are symptoms of autism).
ln summary, the medical records show that V.K. exhibited numerous
symptoms of autism prior to December 12, 2000. There is evidence that V.K.’s
first symptom or manifestation of onset occurred on or before June 2000, and
certainly by August 2000. Thus, the petition was filed months after the expiration
of the Vaccine Act’s statute of limitations
B. Petitioner’s Arguments.
Petitioner is not challenging whether the symptoms described in my show
cause order and discussed in Part A of this decision constitute symptoms of
autism, nor when they first occurred. See Show Cause Order, issued Feb. 4,
2014, at 4-5; Pet. Response, filed l\/lar. 6, 2014. lnstead, he relies on multiple
factual and legal arguments to claim the petition was timely filed or, in the
alternative, that equitable tolling and equitable estoppel are warranted. He also
asserts that it was improper for me to raise, sua sponte, the issue of timeliness
He maintains that l did not provide him with an adequate opportunity to respond
to my Show Cause Order, and he requests that l strike former counsel’s
statements regarding the viability of the claim. Each of petitioner’s arguments is
addressed below.
1. Sua Sponte Consideration of the issue of Timeliness.
Petitioner asserts that it was error for me to issue my show cause order,
sua s,oonte, and claims l have "provided argument appropriate for a Respondent"
and "formulated an opinion on the matter prior to the completion of the final trial."
Pet. Response at 5-6. lt is unclear whether petitioner simply wants more time or
whether he is actually arguing that l must conduct an entitlement hearing prior to
resolving whether the claim was timely filed, or both. He did not ask for more
time to respond to the show cause order.“ Therefore, l focus primarily on the
issue of timely filing as a threshold issue.
Under the Vaccine Act, l am required to issue a decision which includes
findings of fact and conclusions of law as expeditiously as possible.
§ 12(d)(3)(A). While conducting a proceeding, l may require evidence,
information, testimony, and documentation. § 12(d)(3)(B)(i)-(iii). The Vaccine
Act requires that l "afford all interested persons an opportunity to submit relevant
written information" (§ 12(d)(3)(l3)(iv)), but there is "no discovery in a proceeding
on a petition other than the discovery required by the special master"
(§ 12(<1)(3)(3))-
l may conduct a hearing if reasonable and necessary (§ 12(d)(3)(l3)(v)),
but a hearing is not required. The Vaccine Rules“:’ specifically state that l "may
decide a case on the basis of written submissions without conducting an
evidentiary hearing." Vaccine Rule 8(d). The written submissions "may include
a motion for summaryjudgment, in which event the procedures set forth in RCFC
56‘6 will apply" (Vaccine Rule 8(d) (emphasis added)), but there is nothing in the
Vaccine Rules indicating a motion for summaryjudgment is required. l\/loreover,
Rule 56 specifically indicates l may "consider summary judgment on its own after
identifying for the parties material facts that may not be genuinely in dispute."
RCFC 56(f)(3). This is precisely what l did in the show cause order.
Petitioner’s argument is similar to the one advanced by the petitioner in
Reed v. Sec’y, HHS, 69 Fed. Cl. 437, 440 (2005) (arguing that the dismissal for
untimely filing "amounted to an improper use of summaryjudgment, in light of
genuine issues of material fact"). Relying on the allegations as set forth in the
petition, the special master in Reed determined the petition was filed after the
expiration of the statute of limitations. Reed v. Sec’y, HHS, No. 05~575V, 2005
WL 6120643, at *3 (Fed. Cl. Spec. l\/lstr. Jul. 26, 2005). Judge Bruggink affirmed
the special master’s decision, holding that "[t]imely filing is a pre~condition to suit
14 Although l issued the show cause order sua sponte, l note that respondent had previously
raised the issue of untimely filing. As there is no genuine issue of material fact concerning when
the symptoms of autism arose, and respondent had already raised the issue, the show cause
order was an appropriate mechanism to require petitioner to demonstrate some exception to the
statutory requirement for timely filing.
15 The Vaccine Rules, which can be found at Appendix B to the Rules of the United States Court
of Federal Claims ["RCFC"], govern all Vaccine Act proceedings. Vaccine Rule t(a). lf a matter
is not specifically addressed by the Vaccine Rules, the special master of the court "may regulate
the applicable practice, consistent with these rules and with the purpose of the Vaccine Act, to
decide the case promptly and efficiently." Vaccine Rule t(b). "The RCFC apply only to the extent
they are consistent with the Vaccine Rules." Vaccine Rule t(c).
16 Rule 56 allows a party to file a motion for summary judgment at any time until 30 days after the
close of discovery. RCFC 56(b). The moving party must show "there is no genuine dispute as to
any material fact and the movant is entitled to judgment as a matter of |aw." RCFC 56(a).
7
_ . . [and] subject to review at any point in the litigation." Reed, 69 Fed. C|. at
440.
Although the Federal Circuit later held that the Vaccine Act’s statute of
limitations is not jurisdictional and equitable tolling of Vaccine Act claims is
available," to be compensated, petitioner’s claim must be timely filed. Thus,
considerations ofjudicial efficiency may dictate a ruling on the timeliness of
petitioner’s claim prior to addressing vaccine causation. See, e.g., Tucker v.
Sec'y, HHS, No. 03-346V, 2004 WL 950012, at *1, 3-4 (Fed. C|. Spec. l\/lstr. Apr.
15, 2004) (finding it proper to dismiss a petition as untimely filed even though the
issue of vaccine causation was deferred, awaiting the outcome of the OAP test
cases).
Petitioner misunderstands the active role given to special masters in order
to expedite vaccine proceedings."’ Setting forth "a procedure in the Vaccine Act
to decide claims that placed special masters on the front lines" (Snyder, 88 Fed.
C|. at 712), Congress instructed the special master "to be vigorous and diligent in
investigating factual elements necessary to determine the validity of the
petitioner’s claim." H.R. REP. No. 99-908, at 17 (1986), reprinted in 1986
U.S.C.C.A.N. 6344, 6358. As the Federal Circuit noted, "the permissible scope
of the special master’s inquiry is virtually unlimited." Whitecoffon \/. Sec’y, HHS,
81 F.3d1099, 1108 (Fed. Cir. 1996).
Congress created an informal program designed to "avoid hearings and
dispose of cases quickly." Bo/ey, 2008 WL 4615034, at *2. This push for an
expedited conclusion is reflected in Vaccine Rule 5 which requires me to
evaluate the parties’ positions early in the proceeding. See Vaccine Rule 5(a).
Because it appeared the petition in this case was filed after the expiration of the
17 C/oer///, 654 F.3d at 1341 n.9, 1344 (Fed. Cir. 2011) (en banc). Following that decision, the
petitioner in C/oer sought attorneys’ fees and costs, and the Federal Circuit held that petitioners in
untimely filed cases are eligible for attorneys’ fees and costs. C/oer v. Sec’y, HHS, 675 F.3d
1358, 1364 (2012) (en banc) ["C/oerll/’]. The Circuit remanded to the Court of Federal Claims
for a determination of whether the petition was filed in good faith and there was a reasonable
basis for the claim /d.; see § 15(e)(1) (requiring good faith and a reasonable basis foran award
of attorneys’ fee and costs for unsuccessful claims). The Supreme Court affirmed the Federal
Circuit’s decision, holding that an untimely filed petition "may qualify for an award of attorney's
fees if it is filed in good faith and there is a reasonable basis for its claim." Sebe/ius v. C/oer, 133
S. Ct. 1886, 1896-97 (2013).
‘“ see Jene Doe v. seo'y, HHs, 76 Feo_ ci. 328, 333 (2007). in the motion for review, petitioner
criticized the special master’s active role in the case, arguing it was contrary to the "traditiona|
role of a judge." Judge Wolski rejected petitioner’s argument See also Bo/ey v. Sec’y, HHS, No.
05-420V, 2008 WL 4615034, at *2-5 (Fed. C|. Spec. l\/lstr. Sept. 9, 2008) (discussing the
legislative history of the Vaccine Act and Congress’s intent in assigning an active role to the
special master); Jane Doe/03 v. Sec’y, /-/HS, No. [redactedj, 2007 WL 2350645, at *3 (Fed. C|.
Spec. l\/lstr. Aug. 14, 2007) (order noting "special masters are not merely passive recipients of
information").
vaccine Act’s statute of limitations, it was not only appropriate, but required, that
l address the question of timeliness.
2. Opportunity to Respond to my Show Cause Order.
Petitioner also asserts that "[i]n no instance did [l] request that evidence of
equitable tolling be delivered." Pet. Response at 5. Petitioner is incorrect. On
February 4, 2014, l informed the parties that the petition appeared to be untimely
filed and allowed petitioner thirty days to file information which would establish
the petition was timely filed or that equitable tolling was warranted. Show Cause
Order at 4-5.
l\/loreover, at least six months earlier on at least two occasions, l informed
petitioner that his claim appeared to be untimely filed and that we would need to
address this issue. See Order, issued l\/lay 1, 2013, at 3; Order, issued Aug. 5,
2013, at 1. /-\lso, respondent raised the issue of timeliness when responding to
petitioner’s former counsel’s request to withdraw from the case and for interim
attorneys’ fees and costs. See First Response, filed Jan. 9, 2013, at 1 n.2;
Second Response, filed Jan. 9, 2013, at 2-3. Thus, petitioner had ample notice
that he would need to establish that his claim was timely filed
On l\/larch 6, 2014, petitioner filed his response to my Show Cause Order.
Rather than requesting additional time, petitioner presented multiple arguments
that the petition was timely filed or equitable tolling and equitable estoppel should
apply. Petitioner requested that l "continue the discovery phase" to allow him to
gather additional evidence of vaccine causation, claiming that such evidence will
support his equitable tolling and equitable estoppel arguments as "evidence of
the existence of a causal link." Pet. Response at 6. Petitioner appears to
conflate the issues of timely filing and vaccine causation in arguing the
applicability of a discovery rule.
Because l am dismissing petitioner’s claim as untimely filed, it is not
necessary to reach the issue of whether V.K.’s condition was vaccine caused.
As l indicated in Section ll and will discuss further in Parts 3 and 4, a causal
connection or knowledge thereof is not required to trigger the statute of
limitations. The lack of knowledge of a causal connection is not grounds for
equitable tolling. Thus, any additional information petitioner may gather
regarding vaccine causation is not relevant to the question of whether the petition
was timely filed However, since petitioner alleges fraud and misconduct by the
CDC and insists more evidence is required to support his argument for equitable
tolling and equitable estoppel, l will address petitioner’s request for additional
discovery in more detail in Part 4 below.
3. Actual Notice and Causal Connection.
Petitioner claims he did not have notice of V.K.’s diagnosis until he
received Dr. l\/lcCallon’s report which was written "well after" the November 1,
2000 evaluation.w Pet. Response at 3. He asserts that the "[s]ymptoms of
[a]utism are shared with any number of conditions [and] are undistinguishable
until an expert diagnoses the collage of symptoms to determine an injury exists."
ld. at 4. ln essence, he argues not only that a diagnosis of autism is necessary
to trigger the running of the statute of limitations, but that he must have had
actual knowledge of the diagnosis
However, it is "the first symptom or manifestation of an alleged vaccine
injury, not the first date when diagnosis would be possible, that triggers the
statute of limitations." Carson, 727 F.3d at 1369. ln Carson, the Federal Circuit
found that speech delay qualified as a first symptom of autism despite the
possibility that it may not be sufficient for a diagnosis of autism, "may be
indicative cfa variety of conditions or ailments," and that a lay person may not
"appreciate the medical significance" of the speech delay. ld. (quoting Markov/``ch
v. Sec’y, HHS, 477 F.3d 1353, 1357 (Fed. Cir. 2007)). Because there is
evidence that V.K. exhibited speech delay and other symptoms of autism months
before his diagnosis, it does not matter when petitioner received notice of V.K.’s
diagnosis.
Petitioner also argues that the Vaccine Act’s "statute of limitations cannot
begin to run until there is some evidence of a causal connection." Pet. Response
at 4. This argument raises anew the same argument unsuccessfully urged by
petitioners in C/oer/z° and the argument adopted by the panel decision in
C/oer l/," which was rejected by the Federal Circuit sitting en banc in C/oer ll
in C/oer, the petitioner contended that the medical community at large had to
recognize a causal connection between a vaccine and an injury in order to trigger
the running of the statute of limitations. The en banc Circuit rejected this
argument and held that the medical community had to recognize a symptom as
one of the injury claimed. Effectively, the construction urged by petitioner would
eliminate the statute of limitations for any injury that the medical community at
large did not yet (or never did) recognize as one caused by a vaccine.
/.22
19 The report itself is not dated, indicating only that the evaluation occurred on November 1, 2000.
See Pet. Ex. 5, p. 2.
2° c/oerv, sec'y, HHs, 35 Fed. ci. 141, 149 (2003>.
2‘ c/oerv. sec’y, HHs, 603 F.3d 1341, 1345-4@<\=@<1.0@¢2010).
22 c/oer, 654 F.3d at 1339-40_
10