       In the United States Court of Federal Claims
                             OFFICE OF SPECIAL MASTERS
                                     No. 09-467V
                                (E-Filed: June 7, 2013)

* * * * * * * * * * * * * *
DEMETRICE MATHIS, parent of *                    TO BE PUBLISHED
N.M., a minor,              *
                            *                    Special Master
               Petitioner,  *                    Hamilton-Fieldman
                            *
v.                          *                    Show Cause Order; Results of Genetic
                            *                    Testing for SCN1A Mutation; Diphtheria
SECRETARY OF HEALTH         *                    Tetanus Acellular Pertussis (DTaP)
AND HUMAN SERVICES,         *                    Vaccine; Dravet Syndrome.
                            *
               Respondent.  *
* * * * * * * * * * * * * *

                             ORDER TO SHOW CAUSE1

I. INTRODUCTION AND SUMMARY

       On July 21, 2009, Petitioner Demetrice Mathis (“Petitioner”) filed a petition on
behalf of her daughter, N.M., for compensation under the National Childhood Vaccine
Injury Act of 1986 (the “Act”), 42 U.S.C. § 300aa-10 et seq. (2006). 2 The petition

1
  The undersigned intends to post this Order to Show Cause on the United States Court of
Federal Claims’s website, in accordance with the E-Government Act of 2002, Pub.L.No.
107 347, § 205, 116 Stat. 2899, 2913 (codified as amended at 44 U.S.C. § 3501 note
(2006)). As provided by Vaccine Rule 18(b), each party has 14 days within which to file
a motion for redaction “of any information furnished by that party (1) that is trade secret
or commercial or financial information and is privileged or confidential, or (2) that are
medical files and similar files the disclosure of which would constitute a clearly
unwarranted invasion of privacy.” Vaccine Rule 18(b). In the absence of such motion, the
entire Order will be available to the public. Id.
2
  The National Vaccine Injury Compensation Program comprises Part 2 of the National
Childhood Vaccine Injury Act of 1986, Pub L. No. 99-660, 100 Stat. 3755, codified as
amended, 42 U.S.C. §§ 300aa-10 et seq. (2006). Hereinafter, individual section
references will be to 42 U.S.C. § 300aa of the Vaccine Act.

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alleged that N.M. suffered a seizure disorder as a result of receiving a diphtheria-tetanus-
acellular pertussis (“DTaP”) vaccination on August 10, 2006. On March 22, 2010,
Respondent (the “Secretary”) filed a report pursuant to Vaccine Rule 4(c), maintaining
that compensation was inappropriate and that the Petition should be dismissed. Resp’t’s
Rule 4(c) Rep. at 17-18, ECF No. 13.

        The case was heard before Special Master Dee Lord in Boston, Massachusetts, on
August 11, 2011. Following the hearing, the Court ordered that the parties collaborate to
arrange for N.M.to undergo genetic testing. Order at 1, Aug. 12, 2011, ECF No. 50. In a
Joint Status Report (“JSR”) filed on October 7, 2011, Petitioner notified the Court that
“Demetrice does not consent to any further genetic testing on [N.M.]” JSR, ECF No. 53.
Thereafter, the Court entered into the record Court Exhibits 1-4, and ordered the parties
to file supplemental expert reports “discussing whether and to what extent [N.M.] meets
the diagnostic factors for Dravet syndrome and describing the testing procedures that
would have been used to determine whether [N.M.] has SCN1A gene abnormalities.”
Order at 1, Nov. 21, 2011, ECF No. 55.

       After reviewing those additional reports as well as the remainder of the record as it
existed at that time, Special Master Lord held as follows:

       In sum, Petitioner presented preponderant evidence in support of a theory
       that DTaP vaccine, and its pertussis component in particular, could have
       caused [N.M.]’s seizures. Petitioner also established an appropriate
       proximate temporal relationship between [N.M.]’s receipt of the DTaP
       vaccine and the onset of her initial seizure 36 hours later.

       The evidence of a logical sequence of cause and effect showing that the
       vaccine caused [N.M.]’s injuries does not preponderate in Petitioner’s
       favor, however. Respondent’s expert asserted that [N.M.]’s symptoms
       were consistent with a genetic disorder caused by a point mutation in the
       SCN1A gene. Petitioner’s expert maintained that a genetic cause was
       unlikely, based on [N.M.]’s medical record, but agreed that the results of
       genetic testing could be relevant to his opinion.

       I find that Respondent’s contention is reasonable in light of the facts of the
       case and the known causes of certain epileptic disorders in children.
       Accordingly, Petitioner must furnish evidence that [N.M.] does not have a
       point mutation of the SCN1A gene. Such testing results will determine
       whether the evidence preponderates in Petitioner’s favor under Althen
       Prong 2. Absent results of the genetic testing, which is readily available,
       minimally invasive, and will be paid for by Respondent, Petitioner has not
       provided necessary rebuttal evidence, and has therefore failed to make out
       her case-in-chief.

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       Order to Show Cause at 2, Sept. 18, 2012, ECF No. 61. Rather than arranging for
N.M. to undergo this genetic testing, however, on October 18, 2012, Petitioner filed a
Response to the Court’s Show Cause Order, again arguing that “[N.M.] has provided
preponderant evidence that [ ] she does not suffer an SCN1A mutation” and therefore no
genetic testing is necessary. Pet’r’s Resp. at 4, Oct. 18, 2012, ECF No. 67. Petitioner
also conditioned her consent to the genetic testing as follows:

        The petitioner is willing to move forward with genetic testing if there is
        assurance that this court will rely on the statements of the former special
        master in her September 18, 2012 order to show cause: If [N.M.] is tested
        and the evidence showed that she does not have an SCN1A genetic
        mutation, she will be found entitled to compensation.

Id., at 9.

        The case was transferred to the undersigned on March 4, 2013, 3 and by Scheduling
Order dated March 21, 2013, Respondent was permitted to file a reply to Petitioner’s
Response. In her Reply, filed April 11, 2013, Respondent cites 42 U.S.C. §300aa-
13(b)(1) in support of her argument that “[t]he Court is not bound by the genetic test
result.” Resp’t’s Reply at 6, Apr. 11, 2013, ECF No. 71. Respondent also argues that
“both parties must be granted the opportunity to litigate the impact of the test result on
this case through their respective expert’s testimony,” id., and that the special master
must then evaluate the record as a whole, including the testing, to determine whether
Petitioner is entitled to compensation. Id.

DISCUSSION:

       Proceedings under the Vaccine Act are intended to be user-friendly and less
adversarial than other litigation. RCFC App. B, Rule 3(b)(2); see also Rodriguez v. Sec’y
of Dep’t of Health & Human Servs., 632 F.3d 1381, 1385 (Fed. Cir. 2011) (“[T]he
Vaccine Act provides petitioners with an alternative to the traditional civil forum, applies
relaxed legal standards of causation, and has eased procedural rules compared to other
federal civil litigation.”). At the same time, each party to the proceedings must be
afforded “a full and fair opportunity to present its case.” RCFC App. B, Rule 3(b)(2).
“In receiving evidence, the special master. . .must consider all relevant and reliable
evidence governed by principles of fundamental fairness to both parties.” RCFC App. B,
Rule 8(b)(1). This mandate that a special master’s decision should be premised on a
complete record is also set forth in numerous cases. See, e.g., Hines v. Sec’y of Dep’t of
Health & Human Servs., 940 F.2d 1518, 1525 (Fed. Cir. 1991)(stating that the special

3
 Reassignment was as a result of the resignation of Special Master Dee Lord from
service as a special master.
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master is to consider the relevant evidence in the record as a whole); Isaac v. Sec’y of
Dep’t of Health & Human Servs., 108 Fed.Cl. 743, 768 (2013), appeal docketed, No. 08-
0601V (Fed. Cir. April 2, 2013)(acknowledging that the special master did not exclude
evidence, and “[i]ndeed. . .took the initiative to introduce [evidence]” and gave the
parties opportunity to address the new material).

        In the present case, Special Master Lord twice held that N.M. should undergo
genetic testing to ascertain “whether [N.M.] has SCN1A gene abnormalities.” Order at 1,
Nov. 21, 2011, ECF No. 55; Order to Show Cause at 2, Sept. 18, 2012, ECF No. 61.
Twice Special Master Lord concluded, after thorough review and analysis, that “[t]esting
is necessary in order to adjudicate the claim for compensation properly, complete the
record and give each side a full and fair opportunity to litigate the issues.” Order to Show
Cause at 30, Sept. 18, 2012, ECF No. 61; JSR at 1, Oct. 7, 2011, ECF No. 53. Nothing
has changed in this case since these orders except the special master assigned to preside
over it. That is not the kind of change that warrants providing Petitioner with a third bite
of this particular apple. Without the test results and expert reports interpreting those
results, the record is incomplete and does not support an award of compensation to
Petitioner.

        The Court also cannot provide Petitioner with the “assurance” she requests that
“[i]f [N.M.] is tested and the evidence showed that she does not have an SCN1A genetic
mutation, she will be found entitled to compensation.” Pet’r’s Resp. to Order to Show
Cause at 9, Oct. 18, 2012, ECF No. 67. 4 Just as “fundamental fairness to both parties,”
RCFC App. B, Rule 8(b)(1), requires that “[i]f [N.M.]’s testing reveals a genetic
mutation, Petitioner will have the opportunity to litigate the impact of the mutation on
this claim,” Order to Show Cause at 30, Sept. 18, 2012, ECF No. 61, so too does it
require that if N.M.’s testing does not reveal a genetic mutation, Respondent must be
granted the opportunity to litigate the impact of that test result on the arguments she has
advanced in this case. Only when the test results are available and both parties have had
an opportunity to integrate those results into their respective experts’ testimony, will the
record be complete and ripe for a decision on entitlement.

CONCLUSION/ORDER:

       Petitioner shall file proof that she has submitted N.M. for SCN1A testing no later
than Friday, July 5, 2013. By complying with this order, Petitioner is being given a final

4
  Citing to Order to Show Cause at 28, Sept. 18, 2012, ECF No.61 (“If [N.M.] were tested
and the evidence showed that [N.M.] did not have genetic mutation that could account for
her condition, the evidence presented by Petitioner, although scant, would prevail.”) A
special master is not required to adhere to her previous rulings in a case unless those
rulings have been adopted, explicitly or implicitly, by an appellate court’s judgment.
Exxon Corp. v. United States, 931 F.2d 874, 877 (Fed. Cir. 1991).
                                             4
opportunity to “show cause” why her case should be allowed to continue. Failure to file
such proof will result in the dismissal of Petitioner’s claim.

        If Petitioner does proceed with testing, her expert report discussing the
implications of the test results, along with the test results themselves and any exhibits and
literature upon which the expert report relies, shall be filed no later than 35 days after
Petitioner receives the results of the tests. Respondent’s responsive expert report, with
exhibits and literature, shall be filed no later than 35 days after Petitioner’s expert report
is filed. The record will then be complete, and the special master will take it under
advisement for ruling.


       IT IS SO ORDERED.

                                           s/ Lisa Hamilton-Fieldman
                                           Lisa Hamilton-Fieldman
                                           Special Master




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