Court Opinion

ID: 2801701
Source: CourtListenerOpinion
Date Created: 2015-05-19 05:03:22.101398+00
Date Added: 2024-06-11T12:45:36.514441
License: Public Domain

In the United States Court of Federal Claims
                                    OFFICE OF SPECIAL MASTERS
                                              No. 07-046V
                                         Filed: April 20, 2015
                                         (Not to be published)

*************************
                                    *
DIANE DAVIS and ANDREW DAVIS,       *
as parents of JD, 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.  *
                                    *
*************************

                                                    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’ daughter, JD. 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 JD 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).

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
Special Master Denise Vowell issued the decision in Snyder v. HHS, No. 01-162V, 2009 WL
332044 (Fed. Cl. Spec. Mstr. Feb. 12, 2009).

        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

        JD and her twin brother were born on November 26, 2001, by cesarean section. (Ex. 3,
pp. 10-12.) JD 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. 22-28.) At each of these examinations, the notes of
her pediatrician include a neurological assessment indicating “within normal limits.” During
each of these visits, JD received one or more of her routine pediatric vaccinations. (Id., see also
Ex. 4.) On December 9, 2002, when JD was twelve months old, she received a varicella
vaccination, but not the usual MMR immunization. (Ex. 4; Ex. 5, p. 22.)

        After JD’s exam at twelve months of age, there are no notations in the pediatric records
for the next eighteen months. On May 15, 2004, JD’s mother brought her to the pediatrician’s
office with a complaint of fever and a cough. (Ex. 5, p. 21.) A nurse’s note at that time indicates
that JD’s mother was advised regarding the need for “WCC” -- that is, “well child care” -- and
certain immunizations.3 JD’s mother expressed concerns “re any other imm[unization].” (Id.)

       The medical records from Renaissance Pediatrics indicate that JD’s next medical
examination was administered by Dr. Sharon Tucker, on July 20, 2004, when JD was 2½ years
old. (Ex. 5, pp. 11-12.) Her 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, she was not yet

3
    The immunizations were listed as “1st MMR, DTaP #4, IPV #3, Hib #4.” (Ex. 5, p. 21.)
                                                         3
toilet trained. (Id.) Her “mental status” was described as “alert” and “normal,” and her “speech”
was “normal,” as were all the other categories listed in her “neurologic” assessment. (Id.)
Nonetheless, she was referred to an audiologist to evaluate possible “speech delay.” (Id.) Dr.
Tucker noted that JD’s last set of vaccinations were administered when she was twelve months
old, and that JD’s mother again expressed concerns about allowing further vaccinations for her
daughter. 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. 18, p.18.)

        There are no further records from Renaissance Pediatrics until October 7, 2005. (Ex. 17,
p. 20.) However, during that interval of more than fourteen months, JD’s parents did consult
other health care professionals. On May 3, 2005, Dr. Thomas Montgomery, who specializes in
neurodevelopmental pediatrics, performed an evaluation of JD and concluded that she exhibited
a communication disorder and sensory integration disorder. (Ex. 6, p. 3: Ex. 15, p. 6.)

        Officials from JD’s school district in Virginia administered a variety of tests on May 24,
2005, to evaluate her educational needs. (Ex. 8, pp. 1-20.) JD’s psychological evaluation
indicated that her overall cognitive ability was “within the borderline deficient range,” while her
overall independent functioning was “within the deficient range.” (Id., p. 2.) Her receptive
language ability was adequate, but her expressive language ability was considered “low.” (Id.)
The school psychologist opined that JD “appears to have global delays at this time.” (Id., p. 3.)
JD’s speech and language evaluation showed that “all language skills appeared to be severely
delayed.” (Id., p. 11.) Based on this assessment, JD was found to be eligible for special
educational services. (Id., pp. 11-20; see also Ex. 9, for subsequent educational evaluations.)

         On August 22, 2005, JD was examined by Mary Megson, M.D. (Ex. 7, pp. 5-9.) Dr.
Megson opined that JD suffered from high-functioning ASD (i.e., autism spectrum disorder.)
(Id., p. 9.) Based on that assessment, Dr. Megson administered various dietary supplements and
other treatments. (Id., pp. 10, 12.)

       On October 7, 2005, JD returned to Renaissance Pediatrics to receive well child care.
(Ex. 17, p. 20.) At that visit, Dr. Dionne Harewood noted JD’s recent autism diagnosis, and the
multiple nutritional supplements prescribed by Dr. Megson. (Id.)

       On June 11, 2007, officials representing JD’s public school system concluded that she
suffered from various developmental delays, and should continue to receive special education
services. (Ex. 9, pp. 33-34.)

        Virginia Proud, M.D., who specializes in genetics at the Eastern Virginia Medical School
in Norfolk, examined JD on July 11, 2012. (Ex. 10, pp. 1-5.) Dr. Proud reported that JD “had
behavioral issues and communication disorders and has a diagnosis of autism spectrum * * * She
also has what is described as a complex I mitochondrial homoplastic mutation.” (Id., p. 4.) The
case history recorded by Dr. Proud includes the following:

       At six months of age [JD] did not lose skills but after her immunizations, she had
       fever, crying, and GI problems. She, however, unlike her brother, did not lose
       skills. She continued to do well developmentally * * * She rolled over at 4
       months, sat at 6 months, pulled to stand at 9 months, crawled at 9 months, cruised
       at 12 months, walked at 13 months * * * first word however not until 18 months.
                                                 4
           She currently is talking well. She is going into the fifth grade and does have an
           IEP and is mainstreamed. She does get occupational and speech therapy.

(Ex. 10, p. 3.) Dr. Proud opined in a report dated July 18, 2012, that JD “has a probably
Mitochandrial Disorder with molecularly confirmed Complex-I defect.” (Ex. 10, p. 1.)

       B. Procedural History

       Diane and Andrew Davis (hereinafter “Petitioners”) filed a “Short-Form Autism Petition
for Vaccine Compensation” on January 19, 2007. That filing constitutes an allegation that their
daughter, JD, 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 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 JD’s condition, or whether Petitioners’
claim had been timely filed. (Statement, filed May 27, 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 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.4 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,5 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

4
    Petitioners have never filed an amended petition in response to this order.
5
  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.”
                                                            5
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 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 [JD’s] well-child visits between
twelve and thirty one months of age; records pertaining to the diagnosis of [JD’s] ASD, any
records discussing the cause of [JD’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. 12.)

         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 daughter, 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
Petitioners’ request for additional time. (Order, filed Aug. 7, 2014.)

                                                  6
        On October 30, 2014, Petitioners filed various medical records, consisting of Exhibits 11
through 20, 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:

            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 J.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 various medical records on November 13, 2014, identified as Exhibits 19,
20, and 21.6 Also on November 13, 2014, Petitioners filed a Status Report addressing the issues set
forth in my previous orders, as follows:

           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 JD’s injuries. JD’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 now allege specifically that JD suffered an injury caused by the varicella
vaccination administered on December 9, 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. JD has never received an MMR
           vaccination and the varicella vaccination alleged to have caused JD’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 J.D.’s injury, but that (2)
           the first symptoms of that injury occurred when J.D. was around 2½ years to 2
           years and eight months old, which would have been between April and July of

6
    Unfortunately, exhibit numbers 20 had previously been assigned to different exhibits.
                                                          7
         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 exists a “reasonable basis” for spending further attorney time or costs on
this case. (Order, filed Dec. 3, 2014.)

       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 JD. Instead, on February 16,
2015, Petitioners filed a “Motion for Ruling on the Record,” alleging again that JD’s varicella
vaccination of December 9, 2002, caused her “behavioral issues, communication disorders, and
autism.” Accordingly, I will now rule on the existing record.

    C. Issues for decision

        The timeliness of this Petition need not be resolved. Instead, the only issue that I will
decide is whether the varicella vaccination administered to JD on December 9, 2002, caused
JD’s autism and related conditions.

                                                          III

                                                   DISCUSSION

        In order to qualify for an award under the Program, Petitioners must prove either: 1) that
JD suffered a Table Injury--i.e., an injury falling within the Vaccine Injury Table--corresponding
to one of her vaccinations, or 2) that she 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 JD suffered a “Table Injury,” and in my examination of the
filed medical records, I did not find in the record any evidence that JD suffered a “Table
Injury.”7

        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

7
  The “varicella” vaccine that is alleged to be the cause of JD’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).
                                                            8
not contain a medical expert’s opinion or any other evidence indicating that JD’s autism, or any
other condition, was caused by her 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. Here, because the medical records do not 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 JD suffers; nor have Petitioners
presented a logical sequence of cause and effect showing that the varicella vaccine caused an
injury to JD. Finally, Petitioners have failed to even try to demonstrate that the eighteen-month
interval between the administration of JD’s varicella vaccination and the alleged date of onset of
JD’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 JD suffers from significant neurological problems. She and her
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 JD suffered a Table Injury, or that her
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 (see Appendix B to the Rules of the Court), the Clerk shall enter judgment in accord
with this decision.

                                              ____________________________________
                                                    George L. Hastings, Jr.
                                                    Special Master

                                                 9