Greenberg v. Secretary of Health and Human Services ( 2015 )

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OFFICE OF SPECIAL MASTERS
No.08-0024V FILED
Filed: Dccember 08, 2014
(Not for Publication) DEC - 8 2014
:t * * * * r. * * * *,t * * * :f ,f :f t U.S. COURT OF
FEDERALCLAIMS
IIOWARD GREENBERG and
DENISE GREENBERG,
parents of JG, a minor, * Decision Dismissing "Table
* Encephalopathy" Claim; Statute
Petitioners, * of Limitations
SECRETARY OF HEALTH AND
HUMAN SERVICES,
Respondent.
* * )t * :f :i :t,f :1. :t * * +,t * r. * t * * :1. :i
Howard and Denise Greenberg, Kihei, HI, pro se petitioners.
Lynn Ricciardella, U.S. Department oJ Justice, Washington, DC, for respondent'
DECISION
HASTINGS, Speciol Master
This is an action in which Petitioners, Howard and Denise Greenberg, seek an award
under the National Vaccine Injury Compensation Program (hereinafter "the Program"'), on
account of their son JG's autism spectrum disorder ('ASD"), which they contend was the result
ofa "Table Injury Encephalopathy" that occurred after an MMR vaccination on April 13,2004.
Because (1) their "Table Encephalopathy" claim was not timely filed, and (2) they have failed to
show the existence of a Table Encephalopathy in JG, I hereby dismiss this petition.
I
THE APPLICABLE STATUTORY SCHEME
Under the National Vaccine Injury Compensation Program, compensation awards are
made to individuals who have suffered injuries after receiving vaccines. In general, to gain an
award, a petitioner must make a number of factual demonstrations, including showing that an
individual received a vaccination covered by the statute; received it in the United States; suffered
he appficable statutory proyisions defining the Program are found at 42 U.S.C. S 300aa-10 et seq. (2006 ed.).
I
l
llereinafter, for case ofcitation, all $ references will be to 42 U.S.C. (2006 ed ).
t
a se ous, long-standing injury; and has received no previous award or settlement on account of
the injury. Finally - and the key question in most cases under the Program - the petitioner must
also establish a causal linkbelween the vaccination and the injury. In some cases, the petitioner
may simply demonstrate the occurrence of what has been called a "Table Injury." That is, it may
be shown that the vaccine recipient suffered an injury ofthe type enumerated in the "Vaccine
Injury Table," corresponding to the vaccination in question, within an applicable time period
following the vaccination also specified in the Table. If so, the Table Injury is presumed to have
been caused by the vaccination, and the petitioner is automatically entitled to compensation,
unless it is alfirmatively shown that the injury was caused by some factor other than the
vaccination. g 300aa-13(a)(1)(A); $ 300aa-11(c)(lXC)(i); $ 300aa-14(a); $ 300aa-13(a)(1)(B).
In other cases, the vaccine recipient may have suffered an injury nol of the type covered
in the Vaccine Inj ury Table. In such instances, an altemative means exists to demonstrate
entitlement to a Program award. That is, the petitioner may gain an award by showing that the
recipient's injury was "caused-in-fact" by the vaccination in question. $ 300aa-13(a)(1)(B); $
300aa-l l(c)(1)(C)(ii). In this case, however, the Petitioners eventually chose to allege only a
Table Injury. Thus, the standards for proving a "causation-in-fact" case are not relevant.
u
THE OMNIBUS AUTISM PROCEEDING ("OAP")
A. General
This case is one of more than 5,600 cases filed under the Progtam in which petitioners
alleged that conditions known as "autism" or "autism spectrum disorders" C'ASD') were caused
by one or more vaccinations. A special proceeding known as the Omnibus Autism Proceeding
("OAP') was developed to manage these cases within the Olfice of Special Masters ('OSM). A
detailed history of the controversy regarding vaccines and autism, along with a history ofthe
development of the OAP, was set forth in the six entitlement decisions issued by three special
masters as "test cases" for two theories of causation litigated in the OAP (see cases cited below),
and will only be summarized here.
A group called the Petitioners' Steering Committee was formed in 2002 by the many
attorneys who represented Vaccine Act petitioners who raised autism-related claims. About 180
attorneys participated in the PSC. Their responsibility was to develop any available evidence
indicating that vaccines could contribute to causing autism, and eventually to present that
evidence in a series of "test cases," exploring the issue of whether vaccines could cause autism,
and, if so, in what circumstances. Ultimately, the PSC selected a group of attomeys to present
evidence in two different groups of"test cases" during many weeks oftrial in 2007 and 2008' In
the six test cases, the PSC presented two separate theories on the causation ofASDs' The first
theory alleged rhat the measle.s portion of the measles, mumps, rubella (MMR) vaccine could
cause ASDs. That theory was presented in three separate Program test cases during several
weeks of trial in 2007. The second theory alleged that the mercury contained in thimerosal-
conlaining vaccines could directly affect an infant's brain, thereby substantially contributing to
the causation of ASD. That theory was presented in three additional test cases during several
r.r.eeks of trial in 2008.
Decisions in each ofthe three test cases pertaining to the PSC'slrs/ theory rejected the
petitioners' causation theories. Cedillo v.l1I1E No. 98-916V, 2009 WL 331968 (Fed. Cl. Spec.
Mstr. Feb. 12,2009),aff'd,89 Fed. Cl. 158 (2009),aff'd,617 F.3d 1328 (Fed. Cir.2010);
Hazlehurst v. 11115, No. 03-654V, 2009 WL 332306 (Fed. Cl. Spec. Mstr. Feb. 12,2009), alf'd
88 Fed. Cl. 473 (2009), aff'd,604 F.3d 1343 (Fed. Cir. 2010); Snyder v. Hl1S, No. 01--162V,
2009 WL 332044 (Fed. Cl. Spec. Mstr. Feb. 12,2009), aff'd,88 Fed. Cl. 706 (2009).' Decisions
in each ofthe three "test cases" pertaining to the PSC's second rheory also rejected the
petitioners' causation theories, and the petitioners in each ofthose three cases chose not to
appeal. Dwyer v. HHS, No. 03-1202V ,2010 WL 892250 (Fed. Cl. Spec. Mstr. Mar. 12,2010);
King v. HHS, No. 03-584V, 2010 WL 892296 (Fed. Cl. Spec. Mstr. Mar 12,2010); Mead v.
HI1S, No. 03-215V, 2010 WL 892248 (Fed. Cl. Spec. Mstr. Mar. 12,2010).
The "test case" decisions were comprehensive, analyzing in detail all ofthe evidence
presented on both sides. The three test case decisions conceming the PSC'sf,'sl theory
(conceming the MMR vaccine) totaled more than 600 pages of detailed analysis, and were
solidly affirmed in many more pages of analysis in three different rulings by three different
judges of the United States Court of Federal Claims, and then in two rulings by two separate
panels ofthe United States Court ofAppeals for the Federal Circuit. The three special master
decisions conceming the PSC's second theory (conceming vaccinations containing the
preservative "thimerosal") were similarly comprehensive.
All told, the l1 lengthy written rulings by the special masters, the judges of the U.S.
Court of Federal Claims, and the panels of the U.S. Court ofAppeals lor the Federal Circuit
unanimously rejected lhe petitioners' claims, hnding no persuasive evidence that either the
MMR vaccine or thimerosal-containing vaccines could contribute in any way to the causation of
auttsm.
Thus, the proceedings in the six "test cases" concluded in 2010. Thereafter, the
Petitioners in this oase, and the petitioners in other cases within the OAP, were instructed to
decide how to proceed with their own claims. The vast majority of those autism petitioners
elected either to withdraw their claims or, more commonly, to request that the special master
presiding over their case decide their case on the written record, uniformly resulting in a decision
rejecting the petitioner's claim for lack ofsupport. However, a small minority of the autism
petitioners have elected to continue to pursue their cases, seeking other causation theories and/or
other expert witnesses. A few such cases have gone to trial before a special master, and in the
cases ofthis type decided thus far, all have resulted in rejection ofpetitioners' claims that
vaccines played a role in causing their child's autism. See, e.g.,Il'addell v. HI1S, No. 10-316V,
201,2 WL 482929 | (Fed. Cl. Spec. Mstr. Cambell-Smith Sept. 19, 2012) (autism not caused by
MMR vaccination); Henderson v. Ir'HS, No. 09-616V, 2012WL 5194060 (Fed. Cl. Spec. Mstr.
Vowell Sept. 28,2012) (autism not caused by pneumococcal vaccination); Franklin v. l/HS, No.
99-855V,2013 WL 3755954 (Fed. Cl. Spec. Mstr. Hastings May 16,2013) (MMR and other
vaccines found not to contribute to autism): Coombs v. I1llS, No. 08-818V, 2014 WL 1677584'] The petitioners in Snyder did not appeal the decision ofthe U.S. Court of Federal Claims.
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(Fed. Cl. Spec. Mstr. Hastings April 8,2014) (autism not caused by MMR or Varivax vaccines).
In addition, some autism claims have been rejected without trial, at times over the petitioners'
objection, in light ofthe failure ofthe petitioners to file an expert repon raising an issue
requiring a hearing. See, e.g., Geppert v. HIIS, No. 00-286V, 2012WL 2500852 (Fed. Cl. Spec.
Mstr. Vowell Sept. 6, 2012); Fessnco v. I1HS, No. 02-1770,2010 WL 4955721 (Fed. Cl. Spec'
Mstr. Hastings Nov. 9, 2010); Fresco v. I/FIS, No. 06-469V, 201 3 WL 364723 (Fed. Cl. Spec.
Mstr. Vowell Jan.7,2013). Judges of this court have affirmed the practice of dismissal without
trial in such a case. Eg., Fesanco v. HH9,2011 WL 1891701 (May 16, 2011) (Judge Braden).
In none of the post-test case rulings has a special master orjudge found any merit in an
allegation that any vaccine can contribute to causing autism.
B. Relevunce of OAP to this case
This case, however, is quite different from the cases cited in the OAP test cases and the
other cases cited in the OAP discussion above. The issue here is nol whether vaccines "caused-
in-tact" JG's autism, but whether JG suffered aTable Injury, namely "encephalopathy," with the
first symptoms ofthat encephalopathy occurring within the Table time period after vaccination.
I ultimately conclude below JG did nol suffer a "Table Encephalopathy. But it should be
stressed that the evidence upon which I have relied in making my decisions is limited to the
evidence set forth in fftis case. I include this section concerning the OAP only to show why this
case, filed in 2008, was not processed in the usual manner ofnon-autism cases. Rather, because
this case involved a child who had been diagnosed with autism, the processing of this case was
delayed, along with the other 5,000 autism cases, to await the final outcome ofthe autism "test
cases". Then, when the "test cases" were finalized in 2010, individual petitioners such as the
Greenbergs were given a generous period of time to decide whether to abandon their claims or to
develop a theory of their own case.
Only after Petitioners filed their Amended Petition on January 21, 2014, did the focus of
this case change to a Table Injury, namely a Table Inj ury Encephalopathy allegedly associated
with JG vaccinations of April 13,2004.
Thus this case does nol concem whether autism can be causedby the vaccinations that
JG received, but only with whether JG suffered a Table Encephalopathy with the first symptoms
of that encephalopathy within the Table time period after his MMR vaccination, and whether
Petitioners' Table Encephalopathy claim was timely filed.
III
PROCEDURAL HISTORY OF THIS CASE
On January 14, 2008, Petitioners filed a "Short-Form Autism Petition for Vaccine
Compensation" under the National Vaccine Injury Compensation Program, on behalfoftheir
son, JG. (See Petition ("Pet") at 1.) The case was originally assigned to Special Master Gary
Golkiewicz. Q.,lotice of Assignment filed Jan. 14, 2008, ECF No. 2.)
Respondent's counsel filed a response on Feb. 25, 2008, opposing the petition.
Petitioners filed JG's medical records and other exhibits on March 20,2008, and many
other exhibits on many dates thereafter.s
By filing the "Short-Form Autism Petition", Petitioners in effect alleged that JG suflered
from autism, and that his autism was caused by either or both (1) the MMR (measles, mumps,
rubella) vaccine , and (2) vaccines containing "thimerosal", a mercury-based preservalive
contained in a number of childhood vaccines until about 1999 (but removed from most childhood
vaccines soon after that year). Autism General Order #1 , Exhibit A, Master Autism Peition for
Vaccine Compensation,2002WL31696785, at *8 (Fed. Cl. Spec. Mstr. July 3,2002), available
at http://www.usct'c.uscourts.eov/node/2718. They also were in effect, making their case part of
the Omnibus Autism Proceeding (OAP). As a result, while the parties awaited the results of the
"test cases" in the OAP, no formal proceedings were conducted to resolve the case for a
considerable period of time. On June 3, 2008, the case was reassigned to Special Master John
Edwards; on August l, 2008, the case was reassigned to Special Master Christian Moran; and
then on Novemb er 7 ,2011 , the case was reassigned to the docket of Special Master Denise
Vowell, one of the three special masters handling the OAP and the autism "test cases."
As will be detailed below, in their many different documents filed in this case,
Petitioners' theory of causation has varied. However, on January 9, 2013, Petitioners filed an
expert report by Dr. Kevin M. Passer. (Pet. Ex. 23.) Dr. Passer stated that in his professional
opinion, "the descriptions provided by IPetitioners] as to the observable reactions oftheir 12
month old are consistent with an acute attack of Encephalopathy or Encephalitis," and that JG's
diagnosis ("PDD-NOS", a type of autism) is "a diagnosis which could apply to a child following
a bout of Encephalopathy." (Pet. Ex. 23 aI3.) Although Dr. Passer did not specifically refer to
the Vaccine Act, his report appears to allege that JG suffered a "Table Encephalopathy" as a
result of his MMR vaccine at 12 months of age, on April 13, 2004.
On June 14,2013, Petitioners expressed dissatisfaction with their attorney, Mr. Peck.
Accordingly, Mr. Peck was relieved of the duties ofcounsel on June 21, 2013, and Petitioners
proceeded pro .se thereafter.
Because it was not clear to Chief Special Master Vowell on what theory or theories
Petitioners wished to proceed, in an Order dated November 25,2013, she ordered Petitioners to
file an amended petition that clearly stated the causation theory or theories they were alleging.
Petitioners' Amended Petition, filed on January 21,2014, alleges only aT able
Encephalopathy claim. That filing points to vaccinations of April 13, 2014, as injuring JG, and
cites the regulatory language applicable to a Table Encephalopathy. Therefore, I will address
only that allegation of a Table Encephalopathy.*
r Petitioners filed exhibits numbered I through8 on March 20,2008, and then a separate set ofexhibits numbered I
through 7 on September 15,2008. Thus, when referring to any exhibits numbered I to7, I will refer to either the 3-
20-08 or 9- 15-08 filing dates. After September of2008, Petitioners filed exhibits numbered l6 through 142 on
various dates.
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On May 16,2014, this case was reassigned to the unde$igned liom Special Master Vowell.
IV
PETITIONERS' CAUSATION THEORY
As previously noted, Petitioners' theory ofcausation in this case has varied over time.
As noted, by filing a Short-Form Autism petition, on January 14,2008, Petitioners automatically
elected to be part of the Omnibus Autism Proceeding ["OAP"]. Additionally, by filing a Short-
Form Autism petition, Petitioners were deemed to be alleging that:
[a]s a direct result ofone or more vaccinations covered under the National
Vaccine Injury Compensation Program, [JG] developed a neurodevelopmental
disorder, consisting ofan Autism Spectrum Disorder or a similar disorder. This
disorder was caused by a measles-mumps-rubella (MMR) vaccination; by the
"thimerosal" ingredient in certain Diphtheria-Tetanus-Pertussis (DTP),
Diphtheria-Tetanus-acellular Pertussis (DTaP), Hepatitis B, and Hemophilus
Influenza[e] Type B (HIB) vaccinations; or by some combination of the two.
Autism General Order #1, Exhibit A, Master Autism Petition for Vaccine Compensation, 2002
WL 31696785, at *8 (Fed. Cl. Spec. Mstr. July 3,2002),available at
http ://www. uscfc.uscourts. gov/no de 127 I 8.
In their March 2008 filings, Petitioners stated that their claim "is not solely based on"
JG's receipt ofvaccines containing thimerosal, but rather that he was injured because ofhis
inability to "digest" the vaccines. (Petitioners' Statement Regarding Respondent's Report, filed
as Petitioners' Exhibit ["Pet. Ex."] I on March 20, 2008.) They noted that "a recent hair test
[showedl mercury toxicity along with other toxic metals and deranged minerals," and that results
of other testing led them to believe that JG's "autism is directly correlated to his inability to
digest the contents of the vaccines." (Statement Regarding Onset, filed as Pet. Ex. 2.) Their
filings also suggested that JG has symptoms associated with mitochondrial disorders and that
*"* working with doctors to confirm whether he has such a disorder. (See Pet. Exs. 1 and
f;t
Petitioners' February 2012 Iheory of causation statement (Pet. Ex. I 7) noted that they "do
not believe that any one vaccine caused [JG] to become autistic," but that "it was the vaccine
schedule meaning all ofthe vaccines he received contributed to him becoming autistic."
However, on January 9,2013, Petitioners seemed to change and narow their causation
theory in this case, when they filed an expert report by Dr. Kevin M. Passer. (Pet. Ex. 23.) Dr.
Passer stated that in his professional opinion, "the descriptions provided by [Petitioners] as to the
observable reactions oftheir 12 month old boy are consistent with an acute attack of
Encephalopathy ot Encephalitis," and that JG's diagnosis (PDD-NOS, a form of autism) is "a
diagnosis which could apply to a child following a bout of Encephalopathy." (Pet. Ex. 23 at 3.)
Although Dr. Passer did not specifically refer to the Vaccine Act, his report appears to be
alleging that JG suffered a "Table Encephalopathy" as a result ofhis MMR vaccine, at l2
months ofage, on April 13,2004.
Because it was not clear to Chief Special Master Vowell on what theory or theories
Petitioners wished to proceed, in an Order dated November 25,2013, she ordered Petitioners to
file an amended petition that clearly stated the causation theory or theories they were alleging.
Petitioners' Amended Petition, filed on January 21,2014, alleges only a Table
Encephalopathy claim. That filing points to vaccinations of April 13,2004, as injuring JG, and
cites the regulatory language applicable to aTable Encephalopathy. Therefore, I will address
only that allegation of a Table Encephalopathy.)
V
SUMMARY OF F'ACTS AND EVIDENCE RELEVANT TO PETITIONERS'
TABLE ENCEPHALOPATHY CLAIM
A. Medical records
JG was bom on April 10,2003. JG had his one-year well-child visit on April 13,2004,
three days after his first birthday. (Pet. Ex. 3, filed 3-20-08, p. 1l.) He passed all ofthe
applicable developmental milestones, and was assessed as a well child. He received the
allegedly causal vaccine at this visit: MMR as well as a Varivax vaccine. (ld.,pp. 1-2, 11.)
The pediatric records indicate that between JG's one-year and 18-month well-child visits,
Petitioners made three phone calls to his pediatrician. On April 23,2004, Mrs. Greenberg called
and conveyed that JG was very fussy with swollen gums due to his molars coming in. He did not
have a fever, and Petitioners were advised to give him Advil. (,ld, p. 15.) The next call occurred
on May 28,2004, and was initiated by Mr. Greenberg. He reported that JG was having a
reaction due to an overload of vitamin C. JG had non-itchy, little bumps on his leg, stomach, and
arms. Petitioners were advised to monitor his condition and decrease his vitamin C intake.
Additionally, if his skin looked dry, Petitioners were to apply moisturizer. (ld.) The final call
was placed on June 4, 2004. After having a small amount of peanuts, JG began wheezing and
his mother was concemed it was an allergic reaction. (ld ,p.9.) Petitioners were instructed to
obtain albuterol syrup and told to have JG avoid all nuts, including peanut butter. (1d )
On July 13, 2004, at his fifteen-month well-child visit, JG was described as a well-child
with ahistory of bronchospasms. He received his fourth Hib vaccine at this visit. The history
indicates there were no reactions to his prior shots, and that he had been experiencing wheezing
for six weeks, which corresponds to the possible allergic reaction to peanuts. JG was reported to
be walking without support, drinking from a cup, self-feeding, stacking blocks, and indicating
wants without crying. (1d, p. I 1.)
5
In the version ofthe Vaccine Injury Table applicable to this case, there is a Table Injury of "Encephalopathy" for
the MMR yaccine,but no Table lnjury ofany kind listed for the varicella vaccine, which JG received on April 13,
2004, along with his MMR vaccination. Thus, obviously, Petitioners' only potential Table Injury claim is a Table
Encephalopathy refated to the MMRvaccine. 42 C.F.R. $ 100.3(a).
JG's eighteen-month well-child visit occuned on October 13,2004. The history reported
that he was doing well and, again, that he had experienced no reaction to his prior shots. He
received his fourth DTaP and pneumococcal vaccines at this visit. Petitioners refused consent
for the influenza vaccination. JG was assessed as a well-child, who walked well, kicked and
threw balls, and used 3 words other than mama and dada. (1d., p. 10.)
At his two-year well-child visit on April 12,2005, JG was assessed as a well child, but
ooncerns were raised about his development. It was noted that he only sometimes used two-
word phrases, had tantrums, and exhibited screeching. Petitioners were instructed to schedule a
re-evaluation of his speech and behavior in six months if no progress had been made. (1d., p.
10.)
By the time of a developmental evaluation on January 5, 2006, JG's development was
clearly significantly abnormal. He was diagnosed with "Pervasive Developmental Disorder -
Not Otherwise Specified" (PDD-NOS), a form of autism. (Pet. Ex. 5, p. 5, filed on March 20,
2008.)
B. Parental statements and afJidavits
I. Statement of March 13,2008, regarding onset
In their statement regarding onset, Petitioners stated that they "first noted a delay in
[JG's] development at his 2 year immunization check up." (Pet. Ex. 2 at l, filed March 20,
2008.) The pediatrician assured them at that time that JG "still had good eye contact, was by no
means autistic, but was just developing verbally slowly." (1d ) Petitioners thought that the
regression or stalling in his development might be a psychological reaction to the birth of his
younger sister, who at the time was 4 months old, but they nevertheless sought assistance from
an early intervention program. (/d. ) Petitioners did not allege any relevant symptoms in JG any
earlier than at the time of his two-year check-up.
Ultimately, the symptoms first noted by Petitioners at around the time of JG's two-year
visit proved to be early symptoms of autism-he was later diagnosed with PDD-NOS, a form of
autism. (Ex. 5, p. 5, filed on March 20,2008.)
2. Letter of Dr. Frank Baum, dated July 20, 2008
On September 15, 2008, Petitioners submitted exhibits numbered i though 7 . InEx. 2,
Doctor Baum, JG's pediatrician, wrote a "to whom it may concem" letter dated July 20,2008.
Doctor Baum stated that no "red flags" were raised during the modified Denver
Developmental evaluation performed at JG's 18-month well-child visit. (Pet. Ex. 2, fiIed 9-15-
08, p. 1.) In contrast, wrote Dr. Baum, at JG's two-year well-child visit, Dr. Baum found
disturbing symptoms, including JG's failure to play with other children and JG's tendency to
screech and make lots of sounds. (1d ) Doctor Baum noted that he had suggested a re-evaluation
ofJG in six months, a|2.5 yearc ofage, if no further progress had been made in his speech and
behavior skills. (/d) Additionally, Dr. Baum noted that he had"no notations inJG's medical
record ofany unusual vaccine resctions." (ld. at2, emphasis added.)
3. Aljidavit of Petitioners, dated September 13, 2008
Another of the seven documents filed on September 15, 2008, was Ex. I , a joint affidavit
of the Petitioners executed on September 3,2008. In their affidavit, Petitioners indicated that
they first experienced concems about JG's lack of speech development around the time ofhis
two-year well-child visit. (Ex. 1 at 1.) They stated that a report prepared by Dr. Galler-Rim,
following an evaluation ofJG when he was 2 years and 9 months ofage, incorrectly placed onset
of his developmental delay at 18 months. Petitioners stressed that JG was "still progressing
normally" at 1 8 months. (/d.)
4. Petitioners' Interrogatory Responses executed on January 15,2009
On December 9, 2008, Respondent's counsel mailed Petitioners a list ofeight questions.
Petitioners' responses to the questions were filed by Respondent on February 5,2009. (See Ex.
A and Ex. B, filed Feb. 5,2009.)
Petitioners indicated that they first thought their son might be autistic after seeing an
episode of the "Super Nanny" television show that featured an autistic child. The child in the
episode had behaviors similar to those they were observing in JG. Because they saw the episode
about a week or ten days before his already-scheduled two-year well-child visit, they did not
schedule a special appointment with their pediatrician to discuss their concems. (lnterogatory
No. 2.)
Petitioners reported that JG was able to easily repeat words at his 18-month check up, and
believed that his inability to do so was a concern at his 2-year check up. (Intenogatory No. 4.)
C, Expert rcports
L Dr. Kevin Passer
As previously noted, Petitioners filed the expert repofi ofDr. Kevin Passer on January 9,
2013. (Pet. Ex. 23.) Dr. Passer is a board-certified child and adolescent psychiatrist based in
Hattiesburg, MS. He completed his fellowship training at Johns Hopkins. (ld. at l) His expert
report addressed four specific questions: (l) "How is PDD-NOS diagnosed in a 2 year old
patient?" (2) "What are the ranges of OBSERVABLE symptoms for an acute attack of
Encephalopathy or encephalitis in a 1 year old child?" (3) "Can long-term injury that results
lrom an acute attack of Encephalopathy or encephalitis result in observable symptoms that could
be diagnosed as PDD-NOS?" and (4) "Does the parent statement of Denise Greenberg, dated
December 12,2012, fit within descriptive parameters for an attack ofacute Encephalopathy or
encephalitis, by a parent without medical knowledge?" (ld. at l-3.)
After providing short answers to the lour questions that he posed, Dr. Passer concluded
that in his "professional opinion, the descriptions provided by the parent as to the observable
reactions oftheir 12 month old boy are consistent with an acute attack of Encephalopathy or
Encephalitis." (Pet. Ex. 23 at3.) In reaching his conclusion, Dr. Passer stated, he relied upon a
statement of Ms. Greenberg dated December 12,2012, in which she wrote that Petitioners "first
noticed that JG was sick when he had a fever and seemed very sensitive to his sunoundings Iike
to light and sound. He just seemed weak and out of it and very initable." (,Li. A copy ofthe
f)ecember 12,2012, statement was filed in this case on January 27,2014, as Petitioners' Exhibit
140.) That statement, by Ms. Greenberg, however, does r?ol associate her observations with a
particular date or timeframe. It does note that "JG remained in this state of delirium for over a
day." (Ex. 140 at 1.)
2. Dr, John Green, III
Dr. Green is a physician who specializes in Allergy & Environmental Medicine and
Childhood Disorders. His clinic, EverGreen Center PC, is located in Oregon City, OR. (Pet. Ex.
141, filed on January 17,2014,at 1.) In April 2010, Dr. Green wrote a "disability letter" in
which he stated that "[JG] is disabled by inability to communicate effectively, by inordinate,
intractable behaviors, and by multiple complex metabolic problems resulting in metabolic
cncephalopathy." (ld.) In that letter, however, Dr. Green did r?o/ state any opinion as to the
cause of JG's "metabolic encephalopathy," nor did he state that JG's encephalopathy followed
his MMR vaccine. Thus, this expert report provides no support to Petitioners' Table Injury
claim in this case.
VI
PETITIONERS'"TABLE INJURY" CLAIM IS CLEARIY TIME-BARRED
As noted above, under the Vaccine Act, the petitioner bears the burden ofproving a
vaccine-caused injury.6 There are two ways causation may be demonstrated. Firsi, a petitioner
may establish a "Table Injury."' Altematively, a petitioner may prove that a vaccine listed on
the Table actually caused or significantly aggravated an injury (an "off-Table" injury). In this
case, Petitioners allege only that JG suffered a "Table Encephalopathy" lollowing his MMR
vaccination on April 13,2004. (See Amended Petition filed on January 27,2014; pet. Ex. 23.)
To succeed with their Table Encephalopathy claim, petitioners must demonstrate (1) that
their petition was timely filed, and (2) that JG's symptoms satisfl' the statutory definition for a
Table Encephalopathy. Petitioners are able to do neither, as I will demonstrate in this Section VI
of this Decision, plus the following Section VIL
" Petitioners have the burden of demonstrating the facts necessary to show their entitlement to an award by a
"preponderance ofthe cvidence." $ 300aa- 12(aX l XA). Under that standard, the existence ofa fact must be shown
to be "more probable than its nonexistence." In re llinship,391 u.s. 358, 371 (1970) (Harlan, J., concurring).
7
See 5 lt1c1t1C;;42 C.F.R. g 100.3 (2010).
IO
A. Legol standard: Statute of Limilations
The Vaccine Act's statute of limitations provides that, in the case oi
a vaccine setforth in the Vaccine Injury Table which is administered
after October l, 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 ofthe occurrence of the first symptom or
manifestation ofonset or ofthe significant aggravation of such injury . . .
$ l6(a)(2).
The date ofoccurrence "is a statutory date that does not depend on when a petitioner
knew or reasonably should have known anything adverse about her condition." Cloer v. HHS,
654 1".3d 1322, 1339 (Fed. Cir. 201 l) (en banc), cert. denied, Cloer v. Sibelius,132 S. Ct. 1908(2012). Additionally, the date "does not depend on the knowledge of a petitioner as to the cause
ofan injury." (1d. at 1338.) When drafting the Vaccine Act, Congress rejected a "discovery
rule"-based statute oi limitations, in favor of one that does nol consider knowledge, and runs
solely from the date ofan event, the first symptom or manifestation ofonset. (1d./
In Cloer, the Federal Circuit acknowledged that "equitable tolling"8 applies in Vaccrne
Act cases, but under very limited circumstances, such as when a petitioner was the victim of
fraud or duress, or when a procedurally deficient pleading was timely filed. Cloer,654F.3dat
1344-45. It squarely rejected the applicability ofequitable tolling "due to unawareness ofa
causal link between an injury and administration ofa vaccine." Id. at1345.
B. Application of statute of limitations to Petitioners' Table Encephalopathy claim
Combining the Vaccine Act's 36-month statute of limitations, with its requirement that
the first symptoms of an MMR-caused "Table Encephalopathy" must occur within 15 days of the
vaccination (42 C.F.R. $ 100.3(a)), to be considered timely-filed the petition in this case must
have been filed by April 28,2007--i.e.,3 years and l5 days after the MMR in question. Because
the petition was not filed until January 14, 2008, it was untimely filed.
Petitioners argue that the late filing of their petition should be excused because of
misrepresentations and fraud committed by the United States Govemment. (Petitioners'
Response to Respondent's Motion to Dismiss, filed June 14,2013, at 2; see aiso Amended
Petition, filed Jan. 27 ,2014, aI3.)
In reviewing their allegation, Special Master Vowell noted that the documents which
Petitioners filed conceming the alleged fraud (Exs. 25-139) were generally focused on studies
exploring thimerosal, a mercury-based preservative contained in sorze vaccines, its possible role
in autism, and the govemment's alleged misconduct in certain published anicles and the study
" 1'he doctrine ofequitable tolling is a legal principle that acts to overcome a statute of limitations problem in certain
situations. Ifa case is untimely filed and the doctrine ofequitable tolling applies, then the case will be permitted to
conttnue.
lt
results conceming thimerosal that such articles contained. (Order, issued Nov. 25,2013, aI5.)
She conceded that a few of the documents refer to MMR and autism, but that on their own such
articles could not support an allegation of fraud pertinent to a Table Encephalopathy claim. (1d )
Petitioners were cautioned that if they intended to pursue a Table claim and assert that it should
be considered timely-filed because offraud, they must establish that the alleged fraud is relevant
to the claim. Additionally, because their filed evidence focused primarily on research involving
thimerosal-containing vaccines, Special Master Vowell advised that, if Petitioners intended to
rely on those documents, they must establish that the MMR vaccine that JG received contained
thimerosal. (1d )
In their Amended Petition, filed on January 2't,2014, Petitioners replied that "their son's
HIB, DTaP, IPV, and Hep B contained thimerosal." (Amd. Pet. at 3.) Petitioners did nol argue,
much less establish, that the MMR vaccination JG received contained thimerosal.' Nor did
Petitioners link the alleged fraud to their own Table Encephalopathy claim. Asserting a "Table
Encephalopathy" claim is different than a causation-in-fact claim regarding vaccines and autism,
as Chief Special Master Vowell explained to Petitioners during the November 2013 status
oonference and in her subsequent order. (Order ofNovember 25, 2013.) Establishing fraud
regarding thimerosal and autism, as Petitioners assert occuned via Paul Thorsen and a 2002
Danish study (see Amd. Pet. at 2-3),'0 does ndl warrant an application of equitable tolling to
petitioners' MMR Table Encephalopathy claim.
As discussed in Section VII ofthis Decision below, the/acfs ofthis case do not in uty
event meet the Vaccine Act's standard for demonstrating a Table Encephalopathy. Therefore, I
technically need not determine whether Petitioners have established that fraud occurred or if it is
' ln fact, I am aware, from the autism "test cases" cited above, that the MMR vaccine does ,oI contain thimerosal.
E.g.,Dwyerv. HHS, No.03-1202V, l0l0 WL 892250, at.'171, tu. 635.
'u ln their many exhibits filed in this case, Petitioners allege fraud by a Danish vaccine researcher named Thorsen,
and by others, in regard to the controversy conceming whether thimerosql-conlqining yaccines ("TCVs") can cause
autism. As noted above, this alleged fraud has proven to be irrelevqnl lo this case, in which Petitioners ultimately
relied only upon a theory of a "Table Encephalopathy" after an MMR vaccination of April 13, 2004, since MMR
vaccines do rr.)/ contain thimerosal. Nevertheless, I do not wish to leave the impression in this Decision that
Petitioners havepi'ove, fiaud conceming the theory that TCVs can cause autism. To the contrary, I note that after
weeks oftrial in which some ofthe world's top autism experts testified, in the "test case" decisions, three different
special masters ofthis court, in three separate rulings combining to stretch hundreds ofpages in length, each
stongly rejectedthe idea ofany causal connection between TCVS and autism. See Kirgv. l/11S, No.03-584V,
2010 WL 892296 (Fed. Cl. Spec. Mstr. March 12, 2010) (my own ruling\ Mead v. gHS, No. 03-215V, 2010 WL
892248 (Fed. Cl. Spec. Mstr. March 12, 2010) (ruling by Special Master Campbell-Smith, now ChiefJudge ofthis
Court); and Dwyer v. //l/S, No. 03- 1202V, 2010 WL 892250 (Fed. Cl. Sec. Mstr. March 12, 2010) (ruling by
Special Master Vowell, now ChiefSpecial Master). Each ofthe three opinions rejected the alleged causal
connection for many dllerenl reasons, n addition to the negative epidemiologic studies as to which the Petitioners
in this case allege liaud, And even in the single area of epidemiologic studies, each ofthe three special masters
relied upon zaay epidemiologic studies by different researchers flom different countries. (E.g., King,2010WL
892296, at *63-*67.) Thus, even ifone oreven a few ofthose epidemiologic studies were discredited-and I have
made no ruling concerning that irreleyant assertion in this case-such discrediting clearly would ,?o, discredit the
overqll overwhelming weight of the evidence cited in three test cases cited above, which found no merit to the
alleged fCV-autism connection, based not only upon zary epidemiologic studies, but also upon many other vtays in
which the alleged causal connection was shown to be scientifically highly unlikely.
l2
the type of fraud contemplated by the Federal Circuit in Cloer as invoking equitable tolling in
Vaccine Act cases. Even ifl
were to accept petitioners' arguments and apply equitable tolling
(and thus not dismiss their petition for untimely filing), their Table claim would still have to be
dismissed for failing to meet the Table's injury requirements.
I{owever, it is quite clear that this petition, which Petitioners, in their Amended Petition,
have now narrowed to a Table Encephalopathy claim with respect to the MMR vaccination of
April 13, 2004, was filed far out of time with respect to that April 2004 Table Encephalopathy
claim. Nor, even assuming Ihat the Danish study by Thorsen was a fraudulent study, would that
extend the statute of limilations for Petitioners' claim, since that alleged fraud concems the issue
of thimerosal-containing vaccines, and has nothing to do with the issue of whether an MMR
vaccine, which does not contain thimerosal, could cause autism.ll
VII
PETITIONERS CLEARLY HAVE FAILED TO DEMONSTRATE THAT JG
SUFFERED A "TABLE ENCEPHALOPATHY"
A. Introduction
As noted above, I could dismiss this claim either because it was not timely filed, or
because Petitioners have failed to demonstrate that JG suffered a Table Encephalopathy. Thus,
having found in Section VI of this Decision that their petition clearly was not timely filed with
respect to their I'able Encephalopathy claim, I could end my analysis at that point. However, in
the interest ofcompleteness, I will now analyze the merits of the Table Encephalopathy claim. I
llnd that JG drd not suffer a Table Encephalopathy, for the reasons set forth below.
B. Legal standard: Table Encephalopathy
For petitions, such as this one, filed after the modifications to the Vaccine Injury Table
that went into effect on March 24, 1997, "encephalopathy" exists as a Table Injury for MMR
vaccinalions. I will set tbrth the relevant Table Iniurv definition below.'"
' ' Since this case was transferred to me, on May I 6, 2014, I have examined the many documents fi led by Petilioners.
I agree completely with the analysis of Special Master Vowell, in her Order issued on November 25,2013,
conceming Petitioners' Exs. 25-139 and Petitioners' allegations conceming "liaud." As Special Master Vowell
concluded, the allegations in those documents conceming fiaud in the medical community's analysis of thimerosal-
contdining vaccines is irrelevanl to the o/i/.), claim that Petitioners have raised in their Amended Petition, that JG's
MMR vaccination caused a Table Encephaiopathy in April of 1994.
Irunher, I have examined the other documents filed by Petitioners in this case, including, but not limited to,
Exhibits l40 and l4l filed on Januaty 27 ,2014, with theI Amended Petition, and the additional exhibits filed on
September 12, 2014, with duplicative exhibit numbers, Exs. 140-42. Again, I find no evidence of fiaud by anyone
relating to Petitioners"'Table Encephalopathy" claim.
D
The statute itself contains a version of the Vaccine lnjury Table that applied to vaccinations administered prior to
the enactment ofthe Program and for several years after that enactment. See $ 300aa-14(a). However, the Vaccine
Injury Table was administratively modified with respect to Progam petitions, such as this one, that were filed after
March 24, 1997, See 62 Fed. Reg. 7685,7633 (1997); O'Connell v. Shalqlq,'l9F.3d 170(l'rCir. 1996). That
l3
$ 100.3 Vaccine injury table.
(a) In accordance with section 312(b) of the National Childhood Vaccine
Injury Act of 1986, r' + * the following is a table of vaccines, the injuries,
disabilities, illnesses, conditions, and deaths resulting from the administration of
such vaccines, and the time period in which the first symptom or manilestation of
onset or of the significant aggravation of such injuries, disabilities, illnesses,
conditions, and deaths is to occur after vaccine administration for purposes of
receiving compensation under the program:
VACCINE INJURY TABLE
Vaccine lllness, disabiliry, Time period for first symptom or
injury or condition manifestion ofonset or of
covered signifi cant aggravation afler
vaccine administration
Measles, mumps, A. Anaphylaxis or 4 hours
rubella, or any of anaphylactic shock
components
its B. Encephalopathy (or 5-15 days (not less than 5 days
MR,
(e.9, MMR, encephalitis) and not more than l5 days).
M, R) C. Any acute Not applicable
complication or sequela
(including death) ofan
illness, disability,
injury, or condition
referred to above which
illness, disability,
injury, or condition
arose within the time
period prescribed
(b) Qualifications dnd aids to interpretation. The following
qualifications and aids to interpretation shall apply to the Vaccine Injury
Table to paragraph (a) ofthis section:
(2) Encephalopathy. For purposes of paragraph (a) of this section a vaccine
recipient shall be considered to have suffered an encephalopathy only if such
Table modification, along with an earlier administrative modification ofthe Table in 1995 (see 60 Fed. Reg. 7678(1995)), significantly altered the "Table Injury" categories with respect to the MMR vaccination fiom the version of
the Table contained in the statute. The portion ofthe new Table applicable to this case, Iisting "encephalopathy" as
a Table lnjury for the MMR vaccination, appears at 42 C.F.R. $ 100.3(a)(IUXB) ( l0- l -97 edition of C F.R.-all
C.F.R. references in this Decision will be to the l0-l-97 edition of the C.F.R)
t4
recipient manifests, within the applicable period, an injury meeting the description
below of an acute encephalopathy, and then a chronic encephalopathy persists in
such person for more than 6 months beyond the date ofvaccination.
(i) An acute encephalopathy is one that is sufficiently severe so as to require
hospitalization (whether or not hospitalization occurred).
(A) For children less than 18 months of age who present without an
associated seizure event, an acute encephalopathy is indicated by a significantly
decreased level oi consciousness lasting lor at least 24 hours. Those children less
than l8 months of age who present following a seizure shall be viewed as having
an acute encephalopathy if their significantly decreased level of consciousness
persists beyond 24 hours and cannot be attributed to a postictal state (seizure) or
medication.
(D) A "significantly decreased level of consciousness" is indicated by the
presence of at least one of the following clinical signs for at least 24 hours or
greater (see paragraphs (bX2)(iXA) and (b)(2)(i)(B) of rhis section lor applicable
timeframes):
(1) Decreased or absent response to environment (responds, if
at all, only to loud voice or painful stimuli);
(2) Decreased or absent eye contact (does no1 fix gaze upon
family members or other individuals); or
(3) Inconsistent or absent responses to extemal stimuli (does
not recognize familiar people or things).
(E) The following clinical features alone, or in combination, do not
demonstrate an acute encephalopathy or a significant change in either mental
status or level of consciousness as described above: Sleepiness, initability
(fussiness), high-pitched and unusual screaming, persistent inconsolable crying,
and bulging fontanelle. Seizures in themselves are not sufficient to constitute a
diagnosis of encephalopathy. In the absence of other evidence of an acute
encephalopathy, seizures shall not be viewed as the first symDtom or
manilestation of the onset ofan acute encephalopathy.
(il) Chronic Encephalopathy occurs when a change in mental or neurologic status,
first manif'ested during the applicable time period, persists for a period of at least
6 months from the date ofvaccination.
42 C.F.R. g 100.3 (10-l-97 edition of C.F.R.).
l5
Thus, to establish their Table Encephalopathy claim, under the regulatory Ianguage set
forth above, Petitioners must demonstrate that JG manifested an injury encompassed in the
deflnition of an "acute encephalopathy" within 5 to 15 days of his MMR vaccination, and that a
"chronic encephalopathy" was then present for more than 6 months after the acute
encephalopathy. 42 C.F.R. $ 100.3(bX2).''
For a child younger than 18 months, presenting without an associated seizure event, an
acute encephalopathy is indicated "by a significantly decreased level ofconsciousness . . . lasting
for a1 least 24 hours." $ 100.3(bX2Xi)(A). A significantly decreased level ofconsciousness is
demonstrated by the presence ofone ofthree clinical signs for a period ofat least 24 hours: "(1)
Decreased or absent response to environment (responds, if at all, only to loud voice or painful
stimuli); (2) Decreased or absent eye contact (does not fix gaze upon family members or other
individuals); or (3) Inconsistent or absent responses to external stimuli (does not recognize
familiar people or things)." $ 100.3(bX2Xi)(D). Sleepiness, initability (fussiness), high-pitched
and unusual screaming, persistent inconsolable crying, and bulging fontanelle are not, alone, or
in combination, a demonstration ofan acute encephalopathy. $ 100.3(bX2XE).
An acute encephalopathy is an event "that is sufficiently severe so as to require hospitalization
(whether or not hospitalization occuned)." S 100.3(bX2XD."
A chronic encephalopathy is defined in the QAI in mental or neurologic
as "a change
status, first manifested during the applicable time period, [that] persists for a period ofat least 6
months from the date of vaccination." $ 100.3(b)(2xii).
The clinical signs and symptoms ofan acute encephalopathy were incorporated into the
QAI to "clearly distinguish infants and children with brain dysfunction from those with transient
'lethargy."' Revision of the Vaccine Injury Table, 60 Fed. Reg. at7687. As noted in lttaddell,
by then-Chief Special Master Campbell-Smith,'' the QAI definition of "significantly decreased
levcl of consciousness" implies "a state of diminished alertness that is much more than mere
sleepiness or inattentiveness . . . . [t] requires markedly impaired--or strikingly absent--
responsiveness to environmental or external stimuli, for a sustained period ofat least twenty-four
hours." ll/addell v. HHS, No. 10-316V, 2012WL4829291, at *7 (Fed. Cl. Spec. Mstr. Sept. 19,
20t2).
'' The qAI section of the Vaccine Injury Table, 42 C.F.R. $ 100.3(b), conlains dertnitions for the terms, such as
"encephalopathy," used in the Table. See Althen v. l1F1S, 5 8 Fed. Cl. 270, 280 (2005) , affd, 418 F.3d 1274 (Fed.
Cir. 2005) (noting that the QAI should be used to interpret key terms found in the Table).
'a When revising the QAI definition, it was noted that the hospitalization requirement was not intended "as an
absolute requirement to establish an acute encephalopathy, but rather as an indicator ofthe severity ofthe acute
event." Revision ofthe Vaccine Injury Table, 60 Fed. Reg. 7685,7681 (Fed.20, 1997) (preamble to final rule)
15
On September 19, 2013, ChiefSpecial Master Campbell-Smith was appointed Judge ofthe U.S. Court ofFederal
Claims. On October 21,2013, Judge Campbell-Smith was designated as the ChiefJudge ofthe U S. Court of
Federal Claims.
16
The revised QAI definition aimed to differentiate between the "diminished alertness and
motor activity [] which characterize [a] lethargic infant or child" and the "more serious
impairment of consciousness that is the hallmark of encephalopathy (i.e., obtundation, stupor and
coma)." Revision ofthe Vaccine Injury Table, 60 Fed. Reg. at7687; see also Romano v. HHS,
No.90-1423, 1993WL472879,at *6(Fed. Cl. Spec. Mstr.Nov. l,1993). Therefore, dramatic
or severe symptoms must be present to meet the Table Encephalopathy definition.'"
C. Analysis of Petitioners' Table Encephalopathy claim
Petitioners have clearly failed to show that JG suffered an "acute encephalopathy" as
defined by the regulatory language set forth above, and have also failed to show that he suffered
a "chronic encephalopathy" thereafter. Accordingly, they have clearly failed to show that JG
experienced a "Table Encephalopathy."
I. Acute Encephalopathy
'fhe evidence in the record clearly contradicts the Petitioners' claim that JG suff'ered an
"acute encephalopathy," with onset of symptoms 5 to 15 days after his MMR vaccination of
April I 3, 2004. As noted, Dr. Passer based his diagnosis of an acute encephalopathy, after the
MMR vaccination of April 13,2004, upon a statement of Petitioner Denise Greenberg dated
December 12.2012. which stated that "we first noticed that Joshua was sick when he had a fever
and seemed very sensitive to his sunoundings like to light and sound. He just seemed weak and
out of it and very initable." (Pet. Ex. 23,p.3.) That statement of Ms. Greenberg was later filed
as an atlachment to Petitioners' Amended Petition on January 27,2014. But that statement, does
nol say Ihat such fever and other symptoms occurred at any particular time, much less soon after
the MMR vaccination of April 13,2004. (Amended Petition, Jan.27,2014, p. 5.) Second, even
if those symptoms did occur 5 to I 5 days after the MMR vaccination in question, in fact the
above description by Ms. Greenberg clearly does not match the regulatory definition ofan acute
encephalopathy, set forth above, which requires a "significantly decreased level ofconsciousness
lasting for at least 24 hours," with "decreased or absent response to environment," "decreased or
absent eye contact", or "inconsistent or absent response to external stimuli." (42 C.F.R. $
100.3(bX2).) To the contrary, to the extent that Ms. Greenberg describes JG as "very sensitive to
his sunoundings," and "very irritable," her description is in fact the exacl opposite ofthe Table
Encephalopathy definition quoted above--i.e. "decreased or absent response to environment."
'o See, e.g., ,lay v. HHS,998 F.2d 9'79,981,984 (Fed. Cir. 1993) (noting the Special Master's comment that "[w]ith
an encephalopathy we typically seen at least one dramatic aspect. This aspect is what separates the events liom the
normal range of DTP reactions"; and concluding that the "dramatic aspect" in the case was the child's death):
Gamqche v. HHS, 2'l Fed. Cl. 639,642 ( 1993) (upholding a dismissal decision in which the special master had
concluded that "screaming and crying in and ofthemselves are not conclusive evidence of encephalopathy. IThe
vacinee'sl high-pitched and unusual screaming and inconsolable crying are explainable as a local, systemic reaction
to the DPT vaccine rather than as indicia of encephalopathy.") Watt v. H HS,N}.99-25V,2001 WL 166636, ar *8
(Fed. Cl. Spec. Mstr. Jan. 26, 2001) (citing expert testimony that the symptoms relied upon to establish a Table
Encephalopathy "cannot merely be crying, it cannot--inconsolable crying; it cannot merely be crankiness; it cannot
merely be a nurnber ofthings.").
l'7
Moreover, JG's medical records at Ihe time of the alleged "acute encephalopathy" show
no indication at all of an acute encephalopathy. The records ofthe visit on April 13, 2004, show
no reaction to the vaccination. (Ex. 3, p. I l, filed March 20, 2008.) The pediatric records do nol
show any return visit by JG to his pediatrician in the following weeks. Over the three-month
period after the April 2004 MMR, the records show only three phone calls by his parents.
On April 23,2004, Mrs. Greenberg called and conveyed that JG was very fussy with
swollen gums due to his molars coming in. He did not have a fever, and Petitioners were advised
to give him Advil. (1d, p. 15.) The next call occurred on May 28, 2004, and was initiated by
Mr. Greenberg. He reported that JG was having a reaction due to an overload of vitamin C. JG
had non-itchy, little bumps on his leg, stomach, and arms. Petitioners were advised to monitor
his condition and decrease his vitamin C intake. (ld.) The final call was placed on June 4,2004.
Alier having a small amount of peanuts, JG began wheezing and his mother was concemed it
was an allergic reaction. (ld.,p 9.) Petitioners were instructed to obtain albuterol syrup and told
to have JG avoid all nuts, including peanut butter. (1d.)
JG's next visit to the pediatrician was on July 13,2004, for his fifteen-month well-child
visit. (/z/., p. 11.) At that visit, JG was described as a well-child with a history of
bronchospasms. The history indicates there were no reactions to his prior shots, and that he had
been experiencing wheezing for six weeks, which corresponds to the possible allergic reaction to
peanuts. JG was repofied to be walking without support, drinking from a cup, self-feeding,
stacking blocks, and indicating wants without crying. (ltl.)
JG's next pediatrician visit, his eighteen-month well-child visit, occurred on October I 3,
2004. (1d., p. 10.) The history reported that he was doing well and, again, had no reaction to his
prior shots. JG was assessed as a well-child, who walked well, kicked and thew balls, and used
3 words other than mama and dada. (1d.)
JG's next pediatrician visit was at his two-year well-child visit on April 12,2005. (1d., p.
I 0.) It was only at that two-year visit that concerns were raised about his development. (1d.)
In sum, JG's medical records for the full year f,ollowing his MMR vaccination offer r4o
evidence whatsoever lfral he suffered a Table Encephalopathy after that vaccination. To the
contrary, the records from both his 15-month and 18-month checks state plainly that he had no
reaction to his prior shots.
In addition, even the first statement about JG made by Petitioners themselves in this case
makes no mention whatsoever of an encephalopathic reaclion or any reaction to the MMR
vaccination of April 2004. On March 20,2008, Petitioners filed their Ex. 2, a Statement
Regarding Onset by Petitioner Denise Greenberg. (Ex. 2.) That statement reports no problems
with JG until shortly before his two-year check-up. (ld.)
In sum, when I evaluate the record of this case as a whole, it becomes completely clear
that JG did ,?ot suffer an "acute encephalopathy."
2. Chronic Encephalopathy
l8
Petitioners assert that JG suffered an acute encephalopathy after his April 2004 MMR
vaccine. Therefore, a chronic encephalopathy must have persisted in JG from then until at least
October 2004, to meet the statutory definition for a Table Encephalopathy.
The evidence, however, clearly demonstrates that JG did not suffer a chronic
encephalopathy that lasted more than six months after his alleged acute encephalopathy. The
medical records from JG's 1S-month well child visit (July 13, 2004) and his l8-month well-child
visit (October 13,2004) indicate that he was a well child, who was developing normally. (Ex.3,
pp. l0-11.) Concems about his development were not raised with his pediatrician until his two-
year well-child visit in April 2005. (Pet. Ex. 3, hled 3-20-08, p. 10.) Additionally, Petitioners'
written statements, affidavit, and interrogatory responses, as well as Dr. Baum's affidavit, all
convey that JC was developing normally up until_sometime around his second birthday, or at
least until sometime after he was l8 months old." (See evidence discussed at pp. 8-9, above.)
In sum, because JG's medical records indicate no neurologic abnormalities in the six-
month period after the vaccination in question, as demonstrated by his routine 15-month and l8-
month well-child visits, he cannot be considered to have suffered a "chronic encephalopathy"
fbllowing the alleged acute encephalopathy triggered by his MMR vaccination. Thus, petitioners
cannot establish that JG meets the Vaccine Act's requirements for a Table Encephalopathy injury
claim.
VIII
CONCLUSION
Petitioners' "Table Encephalopathy" claim is hereby dismissed, because (1) that claim
was not timely filed, and (2) Petitioners have failed to introduce evidence that would establish
that a "Table Encephalopathy" occuned.
Further, Chief Special Master Vowell ordered Petitioners to include in their amended
petition, all of the causation theories on which they wished to proceed. (Order, issued Nov. 25,
2013, at 4-5.) Because Petitioners, in response, filed an Amended Petition that included only an
allegation of a Table Encephalopathy, and they have failed Io establish either that a Table
Encephalopathy occurred or that their Table Encephalopathy claim was timely filed, I must
dismiss this claim.rs
" Petitioners' expert reports do not address whether JG exhibited behaviors consistent with a chronic
encephalopathy. Doctor Passer's report only addresses the presence ofan acute encephalopathy, while Dr. Green's
repo( opines that JG suffered liom a metabolic encephalopathy, and does not identiry such encephalopathy as
caused by or occurring soon after any particular vaccine. Further, as to Dr, Green's report, which opined that JG
suffered a "metabolic encephalopathy," the QAI specifies that "an encephalopathy shall not be considered to be a
condition set forth in the Table if. . . the encephalopathy was caused by an infection, a toxin, a metqbolic
disturbance . . . ." ($ 100.3(bX2)(iii), emphasis added.)
't Because, as demonstrated in Section Vl ofthis Decision, it is clear that Petitioners' Table Encephalopathy claim is
time-b.trred, ar4 as demonstrated in Section VII ofthis Decision, it is clear that Petitioners' Table Encephalopathy
clatm tswithout mellr, it is appropriate for me to decide this case without an evidentiary hearing. $99 Vaccine Rule
8(d) (a special master has discretion to decide a case without an evidentiary hearing when appropriate under the
crrcumstances).
l9
Some additional comments. however. are also in ordcr.
The record ofthis case demonstrates plainly that JG and his family have been through a
tragic ordeal. I have noted the records describing JG's medical history, and the efforts ofhis
family in caring for him. The dedication of JG's family to his welfare is readily apparent to me.
I have no doubt that JG's parents are sincere in their beliefthat vaccines played a role in
causing JG's autism. JG's parents obviously have read the writings ofphysicians who profess to
believe in a causal connection between vaccines and autism. After studying the evidence in this
case, and many other cases (see "test cases" mentioned at p. 3 below), I have seen no persuasive
evidence whatsoever of such a causal connection. Nevertheless, I can understand why JG's
parents found such opinions to be believable under the circumstances. I conclude that the
Petitioners filed this Program claim in good faith.
Thus, I feel deep sympathy for the Greenberg family. Further, I find it unfortunate that
my ruling in this case means that the Program will not be able to provide funds to assist this
family, in caring for their child who suffers from a serious disorder. It is my view that our
society does not provide enough assistance to the families of a// autistic children, regardless of
the cause oltheir disorders. And it is certainly my hope that our society will find ways to ensure
that in the fulure much more generous assistance is available to all such children. Such families
must cope every day with tremendous challenges in caring for their autistic children, and all are
deserving of sympathy and admiration. However, I must decide this case not on sentiment, but
by analyzing the evidence. Congress designed the Program to compensate only the families of
those individuals whose injuries or deaths can be linked causally, either by a Table Injury
presumption or by a preponderance of "causation-in-fact" evidence, to a listed vaccine. In this
case, the evidence advanced by the Petitioners has fallen far short of demonstrating such a link.
Accordingly,^l conclude that the Petitioners in this case are,lol entitled to a Program award on
.lG's behalf. ''
In the absence ofa timely-filed motion for review of this Decision, the Clerk ofthe Court
shall enter j udgment accordingly.
IT IS SO ORDERED.
Geoige L. Hastings,
rs
I also note that the Petitioners filed this case nearly seven years ago. Yet in all that time Petitioners have failed to
file a viablc expen report. They have been given a fair chance to prove that JG's autism was connected to a
vaccination, but have failed to do so.