The opinion
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 07-049V
Filed: May 27, 2015
(Not to be published)
*************************
*
DIANE DAVIS and ANDREW DAVIS, *
as parents of LD, a minor, *
*
Petitioners, * Petitioners’ Motion for a Ruling on the
* Record; Insufficient Proof of Causation;
v. * Vaccine Act Entitlement; Denial Without
* Hearing
SECRETARY OF HEALTH AND *
HUMAN SERVICES *
*
Respondent. *
*
*************************
Patricia A. Finn, P.C., Piermont, NY, for Petitioners.
Ann D. Martin, U.S. Department of Justice, Washington, DC, for Respondent.
DECISION
HASTINGS, Special Master
This is an action seeking an award under the National Vaccine Injury Compensation
Program (“the Program”)1 on account of an injury to the Petitioners’ son, LD. For the reasons
stated below, I conclude that the Petitioners are not entitled to such an award.
I
THE APPLICABLE STATUTORY SCHEME
Under the National Vaccine Injury Compensation Program (“Program”), compensation
awards are made to individuals who have suffered injuries after receiving certain vaccines.
There are two separate means of establishing entitlement to compensation. First, if an injury
specified in the “Vaccine Injury Table” (“Table”), originally established by statute at §300aa-
14(a) and later modified, occurred within the applicable time period after vaccination, as
prescribed in the Table, then the injury may be presumed to qualify for compensation. §300aa-
13(a)(1); §300aa-11(c)(1)(C)(i); §300aa-14(a). If a person qualifies under this presumption, he
or she is said to have suffered a “Table Injury.”
1
The applicable statutory provisions governing the National Vaccine Injury Compensation Program are found in
42 U.S.C. § 300-10 et seq. (2006 ed.). Hereinafter, for ease of citation, all “U.S.C.” references will be to 42 U.S.C.
(2006 ed.).
1
Alternatively, if no Table Injury can be shown, the petitioner may gain an award by
instead showing that the vaccine recipient’s injury was actually caused by the vaccination in
question. 42 U.S.C. §300aa-13(a)(1); §300aa-11(c)(1)(C)(ii).
II
THE OMNIBUS AUTISM PROCEEDING
This case concerning LD is one of more than 5,400 cases filed under the Program in
which it has been alleged that a child’s disorder known as “autism,” or a similar disorder, was
caused by one or more vaccinations. A brief summary of one aspect of that history is relevant to
this Decision.
In anticipation of dealing with such a large group of cases involving a common factual
issue--i.e., whether vaccinations can cause autism--the Office of Special Masters (“OSM”)
devised special procedures. On July 3, 2002, the Chief Special Master, acting on behalf of the
OSM, issued a document entitled the Autism General Order # 1,2 which set up a proceeding
known as the “Omnibus Autism Proceeding” (OAP). In the OAP, a group of counsel selected
from attorneys representing petitioners in the autism cases, known as the Petitioners’ Steering
Committee (“PSC”), was charged with obtaining and presenting evidence concerning the general
issue of whether those vaccines can cause autism, and, if so, in what circumstances. The
evidence obtained in that general inquiry was to be applied to the individual cases. (Autism
General Order # 1, 2002 WL 31696785, at *3, 2002 U.S. Claims LEXIS 365, at *8.)
Ultimately, the PSC elected to present two different theories concerning the causation of
autism. The first theory alleged that the measles portion of the MMR vaccine can cause autism,
in situations in which it was alleged that thimerosal-containing vaccines previously weakened an
infant’s immune system. 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
the thimerosal-containing vaccines can directly affect an infant’s brain, thereby substantially
contributing to the development of autism. The second theory was presented in three additional
“test cases” during several weeks of trial in 2008.
On February 12, 2009, decisions were issued concerning the three “test cases” pertaining
to the PSC’s first theory. In each of those three decisions, the petitioners’ causation theories
were rejected. I issued the decision in Cedillo v. HHS, No. 98-916V, 2009 WL 331968 (Fed. Cl.
Spec. Mstr. Feb. 12, 2009). Special Master Patricia Campbell-Smith issued the decision in
Hazlehurst v. HHS, No. 03-654V, 2009 WL 332306 (Fed. Cl. Spec. Mstr. Feb. 12, 2009).
Special Master Denise Vowell issued the decision in Snyder v. HHS, No. 01-162V, 2009 WL
332044 (Fed. Cl. Spec. Mstr. Feb. 12, 2009).
2
The Autism General Order # 1 is published at 2002 WL 31696785, 2002 U.S. Claims LEXIS 365
(Fed.Cl.Spec.Mstr. July 3, 2002). I also note that the documents filed in the Omnibus Autism Proceeding are
contained in a special file kept by the Clerk of this court, known as the “Autism Master File.” An electronic version
of that File is maintained on this court's website. This electronic version contains a “docket sheet” listing all of the
items in the File, and also contains the complete text of most of the items in the File, with the exception of a few
documents that are withheld from the website due to copyright considerations or due to § 300aa-12(d)(4)(A). To
access this electronic version of the Autism Master File, visit this court's website at www.uscfc.uscourts.gov. Select
the “Vaccine Claims” page, then the “Autism Proceeding” page.
2
Those three decisions were later each affirmed in three different rulings, by three
different judges of the U.S. Court of Federal Claims. Hazlehurst v. HHS, 88 Fed. Cl. 473 (2009);
Snyder v. HHS, 88 Fed. Cl. 706 (2009); Cedillo v. HHS, 89 Fed. Cl. 158 (2009). Two of those
three rulings were then appealed to the U.S. Court of Appeals for the Federal Circuit, again
resulting in affirmances of the decisions denying the petitioners’ claims. Hazlehurst v. HHS, 604
F. 3d 1343 (Fed. Cir. 2010); Cedillo v. HHS, 617 F. 3d 1328 (Fed. Cir. 2010).
On March 12, 2010, the same three special masters issued decisions concerning three
separate “test cases” pertaining to the petitioners PSC’s second causation theory. Again, the
petitioners’ causation theories were rejected in all three cases. King v. HHS, No. 03-584V, 2010
WL 892296 (Fed. Cl. Spec. Mstr. Mar. 12, 2010); Mead v. HHS, No. 03-215V, 2010 WL 892248
(Fed. Cl. Spec. Mstr. Mar. 12, 2010); Dwyer v. HHS, No. 03-1202V, 2010 WL 892250 (Fed. Cl.
Spec. Mstr. Mar.12, 2010). None of the petitioners elected to seek review of any of those three
decisions.
III
BACKGROUND
A. Facts
LD and his twin sister were born on November 26, 2001, by cesarean section. (Ex. 3, pp.
10-12.) LD received regular “well child” medical examinations at Renaissance Pediatrics during
the first year of life: at three days of age (11/30/01), six weeks (1/8/02), two months (2/15/02),
four months (4/5/02), six-and-one-half months (6/12/02), nine months (9/4/02), and twelve
months (12/9/02). (Ex. 4; Ex. 5, pp. 34-40.) At each of these examinations, the notes of his
pediatrician include a neurological assessment indicating “within normal limits.” During each of
these visits, LD received one or more of his routine pediatric vaccinations. (Id., see also Ex. 4.)
On December 9, 2002, when LD was twelve months old, he received a varicella vaccination, but
not the usual MMR immunization. (Ex. 4; Ex. 5, p. 34.)
LD received medical care for minor childhood illnesses in January and December of
2003. (Ex. 5, p. 33.) On January 31 and December 3, 2003, his neurological assessment
indicated “[without] deficits.” (Id.) On January 5, 2004, there is a notation in the pediatric
record stating: “2 YO chart audit completed. Needs 2 YO [well child care] (last WCC on 12/2)
and needs DTAP #4, IPV #3, MMR #1, HIB #4. Letter mailed.” (Ex. 5, p. 42.) On July 3,
2004, the medical records from Renaissance Pediatrics, in Chesapeake, Virginia, indicate that
LD’s mother brought him to the pediatrician’s office for treatment of a rash. (Ex. 5, pp. 26-27.)
Dr. Sharon Tucker performed an examination characterized as a “2-year well-child visit,”
on July 20, 2004, when LD was about two years eight months old. (Ex. 5, pp. 24-25.) His
developmental milestones at that time were listed as: “Kicks ball forward, Walks up stairs,
Towers 4 cubes, 6 word vocabulary, Points to 2 pictures, 2 word sentences, Uses spoon/fork,
Removes garment and Feeds doll.” (Id.) However, he was not yet toilet trained. (Id.) His
“mental status” was described as “alert” and “normal,” and his “speech” was “normal,” as were
all the other categories listed in his “neurologic” assessment. (Id.) Nonetheless, he was referred
to an audiologist to evaluate possible “speech delay.” (Id.) Dr. Tucker noted that LD’s last prior
set of vaccinations had been administered when he was twelve months old, and that LD’s mother
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expressed concerns about allowing further vaccinations for her son. Dr. Tucker gave Mrs. Davis
some explanatory materials about vaccines and obtained a signed statement from her indicating
that she understood the potential risks of delaying immunizations. (Id.; see also Ex. 5, p. 23.)
Dr. Tucker examined LD again on August 23, 2004, due to a parental complaint of
“autistic behaviors, not a lot of eye contact, not progressing with speech.” (Ex. 5, p. 15.) More
specifically,
Mom is concerned with patient’s behavior. Mom stated that the patient does not
look her in the eye. Patient aligns his toys in perfect order. Does not like loud
noises. Cannot tolerate baby crying. Patient ban[g]s his head repeatedly when he
is having a tantrum. Mumbles often and jabbers to himself. Patient plays well by
himself. Prefers to have someone feed him.
(Id.) Dr. Tucker recorded her assessment of LD as “developmental delay.” (Id., p. 16.) She
made referrals for audiological and neurological assessments. (Id.)
On September 24, 2004, an audiologist at the Eastern Virginia Medical School in Norfolk
noted LD’s history of speech and language delay, but examined his hearing and concluded that
he displayed “normal peripheral auditory sensitivity.” (Ex. 5, p. 14.)
On September 27, 2004, LD was examined by Ralph Northam, M.D., a neurologist at the
Division of Child & Adolescent Neurology at Children’s Hospital of The King’s Daughters.
(Ex. 6, pp. 1-2.) Dr. Northam recorded the following history:
Developmentally, he walked at around 1 year of age but has never really used
meaningful language. He makes very poor eye contact and tends to not mingle
with other kids. He often stays in his own little world. He is very routine and
order oriented. He has an aversion to loud noises and especially other children
crying. He perhaps uses one or two words that mother can understand; however,
the rest of it is gibberish. He does not have any echolalia. Thus far, he has not
been evaluated by Speech Therapy. He has not shown any interest in potty
training.
(Id.) Dr. Northam concluded that LD had “autistic tendencies,” and that he certainly had a
“communication disorder.” (Id.)
Officials of the Chesapeake Public School System, in Virginia, performed a develop-
mental evaluation of LD on December 13, 2004, when he was two years old. (Ex. 8, pp. 5-15;
Ex. 9, pp. 8-12.) Psychologist Jill Lewis reported that LD’s scores on various tests indicated a
“developmental age of 12 months overall.” (Ex. 8, p. 7.) He exhibited significant delays in fine
motor, cognitive, and language development. (Id., p. 12.) During his speech and language
evaluation, LD demonstrated only “a very limited vocal and verbal repertoire.” (Id., p. 25.)
Based on these observations, the school district authorized special speech and occupational
therapies for LD. (Ex. 8. p. 3; Ex. 9, p. 3.)
Mary Megson, M.D., examined LD and recorded a summary of her findings on
December 20, 2004. (Ex. 7, pp. 17-19.) She noted that:
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[LD] is a 3 year old seen for evaluation of his autism * * *. Mom started him on a
gluten free/casein free diet in October and noticed decreased stims, less toe
walking, better eye contact and less hand flapping. He does tend to line things up,
gets up close to the TV, looks at things out of the corner of his eye. After mom
began the GF/CF diet he regained the use of ten words. He also engages in some
spinning behavior, which has persisted. She began using NDF [a chelating agent],
after which he showed increased attention. The first year of life his language
development was normal with cooing at 3 months, babbling at 6 months, saying
“mama” and “dada” at 10 months. He did hand flap some but had a lot of non-
verbal vocalizations. He does like to be held, likes to be active, is described as
affectionate.
(Id.) Dr. Megson opined that LD suffered from autism, ADHD, yeast of the intestines, “metals,”
and gluten/casein sensitivity. (Id., pp. 18-19.)
Between May 15, 2006 and January 10, 2010, medical personnel at Renaissance
Pediatrics provided medical services for LD, as needed. (Ex. 15, pp. 3-12.) He suffered from
episodes of “strep throat” in 2009. (Id., pp. 4-7.) Also in 2009, LD’s pediatric neurologist
administered an EEG exam, due to his staring spells, and noted certain aberrations, but
concluded that his symptoms were “not classically epileptic.” (Ex. 19, pp. 34-35.) On February
3, 2011, a neurologist at the Children’s Hospital of The King’s Daughters, in Norfolk, Virginia,
Joseph Dilustro, M.D., identified a “developmental venous anomaly [in LD’s] left cerebellar
hemisphere.” (Ex. 11, p. 18.) However, this condition was not threatening, and no intervention
or treatment was indicated. (Ex. 19, p. 39.)
Virginia Proud, M.D., who specializes in genetics at the Eastern Virginia Medical School
in Norfolk, examined LD on July 11, 2012. (Ex. 10, pp. 1-5.) The case history recorded by Dr.
Proud includes the following:
Mom was concerned by 6 months when he had a fever, irritability, and diarrhea
reportedly associated with immunizations and subsequently lost some skills with a
change in his behavior. He began to sit up and lost that skill. By 2 years of age,
in 2003, he saw Dr. Northam who diagnosed him with autism and he was given
Early Infant evaluation and services.
(Ex. 10, p. 2.) Dr. Proud opined in a report dated July 18, 2012, that LD “has a probable
Mitochandrial Disorder with molecularly confirmed Complex-I defect.” (Ex. 10, p. 1.) Dr.
Proud also reported that LD had
a history of staring spells and an abnormal EEG for spike and slow wave in 2009,
diagnosis of autism when he was approximately 3 and an MT-DNA mutation
while it is homoplastic, it can be pathogenic. It [the mutation] does not have a
strong likelihood of being the sole cause of his autism; however, it could certainly
contribute to autism spectrum disorder.
(Id., p. 4.)
5
B. Procedural history
Diane and Andrew Davis (hereinafter, “Petitioners”) filed a “Short-Form Autism Petition
for Vaccine Compensation on January 19, 2007. That filing constituted an allegation that their
son, LD, developed an autism spectrum disorder or a similar neurodevelopmental disorder that
was caused by either the measles-mumps-rubella vaccination (“MMR”), or by the thimerosal
ingredient in other vaccinations covered by the Vaccine Program. See Autism General Order #1,
2002 WL 31696785, at *4, *8 (Fed. Cl. Spec. Mstr. July 3, 2002).
On January 31, 2007, individual proceedings in this case were stayed pending the
conclusion of the Omnibus Autism Proceeding (“OAP”). (Order, filed Jan. 31, 2007.) As the
OAP neared completion, Petitioners were directed to file all of the medical records relevant to
their claim, pursuant to 42 U.S.C. '300aa-11(c)(2). (Order, filed Oct. 15, 2009.) Petitioners
requested, and were allowed, a 90-day enlargement of time to file those records. (Order, filed
March 29, 2010.) Petitioners filed a Notice regarding the format of the medical records, on April
13, 2010, along with a Statement of Completion indicating that all the available relevant records
were included. (Notice and Statement, filed April 13, 2010.) On April 19, 2010, Petitioners
filed Exhibits 1-9, in the form of a “compact disc.”
Respondent filed a Statement, in response, indicating that, based on Exhibits 1-9,
Respondent was unable to determine the date of onset of LD’s condition, or whether Petitioners’
claim had been timely filed. (Statement, filed May 25, 2010.) Respondent also alleged that there
were significant gaps in the medical record and specific records that were lacking. (Id.)
Petitioners did not file any supplemental information, or any response to Respondent’s
Statement, for eighteen months. On November 10, 2011, I filed an Order in this case noting the
outcome of the OAP “test cases,” as described above in Section II, and directing Petitioners to
inform the court if they wished to proceed with their case. If so, Petitioners were ordered to file,
within 30 days, an amended petition that was fully compliant with ' 300aa-11(c), and which
clearly explained their theory of vaccine causation in this case. (Order, filed Nov. 10, 2011.)
There was no response.3 On December 13, 2011, I filed an Order to Show Cause, indicating that
this case would be dismissed if Petitioners failed to file an appropriate response to my Order of
November 10, 2011. On January 6, 2012, I granted Petitioners’ request for a 30-day extension
of time to file an appropriate response. Instead, on February 6, 2012, Petitioners’ counsel,
Herbert Waichman, filed a motion to withdraw as counsel of record,4 and another request for
additional time. Further enlargements of time were allowed, thereafter, until Mr. Waichman was
ultimately relieved of his duties as counsel. (See Orders filed Feb. 7, Feb. 23, and May 21, 2012,
and Jan. 3, 2013.) On January 3, 2013, I filed an Order directed to the now pro se Petitioners,
ordering Petitioners to file, within 30 days, an amended petition that was fully compliant with
' 300aa-11(c), and which clearly explained their theory of vaccine causation in this case.
On January 28, 2013, Petitioners filed a Statement indicating that they were trying to
replace their counsel so that they could continue pursuit of their claim. Petitioners were allowed
additional enlargements of time to file all of the medical records required by ' 300aa-11(c), and
3
Petitioners have never filed an amended petition in response to that order.
4
It is notable that the Motion to Withdraw as Attorney of Record, filed on Feb. 2, 2012, included the following
statement: “In petitioner’s counsel’s view, there is no reasonable basis to proceed forward with petitioner’s case. To
do so would, in counsel’s view, be wasteful of Program resources.”
6
a Statement of Completion. (See Orders filed Feb. 6, May 8, and July 1, 2013.) Each of these
orders allowing enlargements of time included the following instruction: “You must file within
90 days of the date of this Order all available medical records of [LD’s] well-child visits between
twelve and thirty one months of age; records pertaining to the diagnosis of [LD’s] ASD, any
records discussing the cause of [LD’s] ASD, and specialist treatment records.” (Id., pp. 1-2.)
However, nothing was filed.
On September 10, 2013, I filed another Order to Show Cause, stating that Petitioners’
claim would be dismissed if they failed to file the required medical records within 30 days.
Petitioners filed a Response on October 3, 2013, requesting additional time to comply with the
Order to Show Cause. Additional time was allowed. (Order, filed Oct. 24, 2013.)
On January 10. 2014, Petitioners filed a Motion to Substitute Attorney Patricia Finn in
place of the pro se Petitioners. That Motion was granted on January 17, 2014, and Petitioners
were again ordered to file the required medical records. On April 1, 2014, Petitioners filed
Exhibit 10, a medical record of geneticist Virginia Proud, M.D. Petitioners also filed a separate
Statement of Completion indicating that all of the relevant medical records had been filed.
(Statement, filed April 1, 2014.)
On May 19, 2014, Respondent filed a Supplemental Rule 4(c) Report and Motion to
Dismiss, which again detailed the alleged failure by Petitioners to file all of the documentation
required by ' 300aa-11(c). Respondent also objected that Petitioners had never attempted to
establish that their Petition was timely filed, or filed an amended petition articulating Petitioners’
theory of vaccine causation. (Motion to Dismiss, filed May 19, 2014, p. 14.)
On June 3, 2014, counsel for both parties participated in a status conference to discuss
identification of medical records relevant to Petitioners’ claim. (See Order, filed June 4, 2014.)
Petitioners were instructed to file a status report within 60 days, describing their efforts to file
those records. Petitioners were also instructed to provide basic information regarding their claim
in that status report, including: “the vaccination that allegedly injured their son, the date it was
administered, the first symptoms of the injury, and the date when those symptoms appeared.”
(Id.) Petitioners filed a status report on July 31, 2014, which did not contain the required
information, but argued that an additional ninety days were needed to “provide the Court with an
amended complaint setting forth the allegations of the petition and responding to the Court’s
June 4th Order.” (Status Report, filed July 31, 2014.)
Respondent filed a Response, on July 31, 2014, noting that Petitioners had been provided
with an explicit list of medical records that remained outstanding. However, Respondent also
contended that this case lacked “reasonable basis” to proceed, and should, therefore, be
dismissed immediately. (Response, filed July 31, 2014.) Nonetheless, I decided to grant
Petitioner’s request for additional time. (Order, filed Aug. 7, 2014.)
On October 30, 2014, Petitioners filed various medical records, consisting of Exhibits 11
through 16, along with a request for additional time to file the other outstanding records and to
provide Petitioners’ answers to the specific questions propounded by the court. On October 31,
2014, I filed an Order allowing a two-week enlargement of time. That Order included the
following instructions:
7
Petitioners’ counsel shall study the recently-filed medical records and determine
whether this case was timely-filed. On or before November 13, 2014, petitioners’
counsel shall file the outstanding medical records, and a status report addressing the
timeliness issue. That status report shall specifically identify: 1) the vaccination that
allegedly injured L.D., 2) the date it was administered, 3) the first symptoms of the
injury, and 4) the date when those symptoms appeared.
(Order, filed Oct. 31, 2014.) Petitioners filed medical records identified as Exhibits 17, 18 and 19, on
November 11, 2014. Also on November 13, 2014, Petitioners filed a Status Report addressing the
issues set forth in my previous orders.
With regards to the questions set out by the Court in the June 4, 2014 Order it is
petitioner’s position that the varicella vaccine administered on December 9, 2002 is
the vaccine that allegedly caused LD’s injuries. LD’s speech issues were first noted
at a well child visit on July 20, 2004 when the minor petitioner was 2 years 8 months
old. ***. The petition in this case was filed on January 19, 2007 and the onset of
symptoms did not occur until July 2004, therefore this petition is timely and should
not be dismissed.
Thus, Petitioners alleged specifically that LD’s injury was caused by the varicella vaccination
administered on December 29, 2002, and that the first symptom of that injury appeared about
eighteen months later, in July of 2004. Petitioners also explained the change in their theory of the
case, as follows:
Although this case was originally filed in the OAP, this was an error. The two
theories presented in the OAP cases were (1) that the measles portion of the measles,
mumps, rubella vaccine could cause ASDs and (2) that the mercury contained in
thimerosal-containing vaccines could directly affect an infant’s brain, thereby
substantially contributing to the causation of ASD. LD has never received an MMR
vaccination and the varicella vaccination alleged to have caused LD’s injuries does
not contain thimerosal.
(Status Report, filed Nov. 13, 2014.)
On November 18, 2014, I filed an Order, which contained the following specific instructions:
In Petitioners’ status report filed on November 13, 2014, Petitioners assert that (1)
the varicella vaccine of December 9, 2002, caused L.D.’s injury, but that (2) the
first symptoms of that injury occurred when L.D. was around 2½ years to 2 years
and eight months old, which would have been between April and July of 2004.
However, that assertion leaves a gap of about a year and one half between the
vaccination in question and the onset of symptoms. Petitioners are hereby given
90 days from the date of this order in which to file an expert report that draws a
causal connection between that varicella vaccination and J.D.’s autism.
(Order, filed Nov. 18, 2014.) A status conference was convened on December 3, 2014, with the
participation of counsel for both parties. During that conference, I notified Petitioners’ counsel that,
given Petitioners’ representations in the status report filed in this case on November 13, 2014, I had
grave doubts whether there existed a “reasonable basis” for spending further attorney time or costs on
this case. (Order, filed Dec. 3, 2014.)
8
In response to my Order filed on November 18, 2014, Petitioners did not file an expert report
to support their claim that the varicella vaccination caused an injury to LD. Instead, on February 16,
2015, Petitioners filed a “Motion for Ruling on the Record,” alleging again that LD’s varicella
vaccination of December 9, 2002, caused his “behavioral issues, communication disorders, and
autism.” Accordingly, I will now rule on the existing record.
C. Issue for decision
The timeliness of this Petition need not be resolved. The only issue that I will decide is
whether the varicella vaccination administered to LD on December 9, 2002, caused LD’s autism
and related conditions.
III
DISCUSSION
In order to qualify for an award under the Program, Petitioners must prove either: 1) that
LD suffered a “Table Injury”--i.e., an injury falling within the Vaccine Injury Table--
corresponding to one of his vaccinations, or 2) that he suffered an injury that was “actually
caused” by a vaccine. See 42 U.S.C. §§ 300aa-13(a)(1)(A) and 300aa-11(c)(1).
Petitioners do not claim that LD suffered a “Table Injury,” and in my examination of the
filed medical records, I did not find in the record any evidence that LD suffered a “Table
Injury.”5
The legal standard to establish “actual causation” of an injury by a vaccine requires that a
petitioner must present “1) a medical theory causally connecting the vaccination and the injury;
2) a logical sequence of cause and effect showing that the vaccination was the reason for the
injury; and 3) a showing of a proximal temporal relationship between vaccination and injury.”
Althen v. HHS, 418 F.3d 1274, 1278 (Fed.Cir. 2005).
Under the statute, a petitioner may not be given a Program award based solely on the
petitioner’s claims alone. Rather, the petition must be supported by either medical records or by
the opinion of a competent physician. 42 U.S.C. § 300aa-13(a)(1). In this case, the records do
not contain a medical expert’s opinion, or any other evidence, indicating that LD’s condition was
caused by the varicella vaccine. No physician expressed such an opinion in the records that I
reviewed, and the Petitioners have not pointed to any place in the records where any physician
stated such an opinion. Thus, because the medical records do not seem to support the
Petitioners’ claim, a medical opinion must be offered in support. Petitioners, however, have
offered no such opinion.
Further, none of the three prongs of the Althen standard to establish causation have been
satisfied. Petitioners have not offered a medical theory causally connecting the varicella
vaccination to autism or any other condition from which LD suffers; nor have Petitioners
presented a logical sequence of cause and effect showing that the varicella vaccine caused an
injury to LD. Finally, Petitioners have failed to even try to demonstrate that the eighteen-month
interval between the administration of LD’s varicella vaccination and the alleged date of onset of
5
The “varicella” vaccine that is alleged to be the cause of LD’s condition, is listed on the Vaccine Injury Table, but
there are no “Table Injury” conditions identified regarding the varicella vaccine. 42 C.F.R. ' 100.3(a)(X).
9
LD’s symptoms constitutes the “proximal temporal relationship” that is required by the third
prong of the Althen standard.
IV
CONCLUSION
It is, of course, tragic that LD suffers from significant neurological problems. He and his
family are certainly deserving of sympathy for those difficulties. However, under the law I can
authorize compensation only if a medical condition or injury either falls within one of the “Table
Injury” categories, or is shown by medical records or competent medical opinion to be vaccine-
caused. No such proof exists in the record before me. Accordingly, it is clear from the record in
this case that Petitioners have not demonstrated either that LD suffered a Table Injury, or that
his autism or any other condition was “actually caused” by a vaccination. Therefore, I have no
choice but to hereby DENY this claim. In the absence of a timely-filed motion for review of this
decision, the Clerk shall enter judgment in accord with this decision.
s/ George L. Hastings, Jr.
George L. Hastings, Jr.
Special Master
10