Court Opinion

ID: 7800643
Source: CourtListenerOpinion
Date Created: 2022-08-15 17:02:36.88383+00
Date Added: 2024-06-11T16:29:07.547299
License: Public Domain

In the United States Court of Federal Claims
                                 OFFICE OF SPECIAL MASTERS
                                         No. 22-0894V

    JASMIN AUGUSTINE, Parent and                            Chief Special Master Corcoran
    Natural Guardian of S.A., a Minor,

                         Petitioner,                        Filed: August 15, 2022
    v.

    SECRETARY OF HEALTH AND
    HUMAN SERVICES,

                         Respondent.

                    PRE-ASSIGNMENT REVIEW (“PAR”) - INITIAL ORDER

        This matter has been preliminarily assigned to the Chief Special Master while it
goes through the Office of Special Masters’ recently-established PAR process. A
description of that process, and the parties’ obligations thereto, hereby follows. In
accordance with my directives and explanations below, Petitioner shall file the
certified1 records pertaining to the claim on or before September 14, 2022. (30
days)

         A. The PAR Process.

        The Vaccine Act2 includes the statutory requirement that each Petitioner’s initial
submissions, including the petition and the supporting documents, will contain the
Petitioner’s case-in-chief. Section 11(c) of the Vaccine Act requires that each petition be
filed with supporting documentation. Incomplete medical records can result in delays in
processing petitions by the Office of Special Masters and Respondent. Accordingly, the
objective of PAR is to process petitions more efficiently by ensuring that cases are not
assigned to a special master or the Special Processing Unit (“SPU”) until the record is
deemed substantially complete and ready for medical review by HHS personnel.

1
    See Vaccine Rule 2(c)(2)(A) and Vaccine Rule 2(f).
2
 The National Childhood Vaccine Injury Act (“Vaccine Act”), as amended, 42 U.S.C. §§ 300aa-1 to-34,
which established the National Vaccine Injury Compensation Program (“the Program”). Hereinafter, for
ease of citation, all “§” references to the Vaccine Act will be to the pertinent subparagraph of 42 U.S.C. §
300aa (2012).

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        Initially, all newly-filed petitions3 will be assigned to the Chief Special Master’s
docket. The Office of Special Masters will thereafter complete a review of the case
filings to determine if the record is substantially complete as required by Section 11(c) of
the Vaccine Act. The initial PAR review will result in either an Activation Order (if the
medical records and other evidence are substantially complete) or a PAR Scheduling
Order setting forth the remaining filings required to complete the PAR process.4 Once
activated, the case will be assigned to a special master for its adjudication.

        Follow-up scheduling orders will be issued as necessary until substantial
completeness of the record is achieved. Due to the large number of petitions that have
been filed in 2021, the review of cases after the filing of the Statement of Completion
will require additional time. If at the end of 60 days after the Statement of Completion is
filed, no Activation Order or PAR Scheduling Order has been issued, Petitioner may
move for an assignment of the case.

    B. Initial Requirements of PAR Assignment

       The deadline to hold an initial status conference in this case is
SUSPENDED until the PAR process is complete and the Activation and
Reassignment Order has been issued. Respondent’s deadline for filing the Rule
4(c) report is SUSPENDED until further notice. See Vaccine Rule 4(c)(1) (allowing
me to determine the timing for Respondent’s Rule 4(c) report).

    C. Motions for Enlargement of Time.

        If Petitioner is unable to meet any deadline set forth in this Initial Order, a motion
for enlargement of time pursuant to Vaccine Rule 19(b) must be filed.
PLEASE NOTE: During the PAR process, the requirement of Vaccine Rule
19(b)(3), which requires the moving party to discuss the motion with opposing
counsel to indicate whether there is any objection, will NOT be required while the
case is in PAR.

    D. Petitioner’s Supporting Documents.

3
  For additional guidance on information that should be included in the petition, such as the vaccinee’s full
name and date of birth, please refer to Section II(3) of the Guidelines for Practice Under the National
Vaccine Injury Compensation Program at https://www.uscfc.uscourts.gov/sites/default/files/Guidelines-
4.24.2020.pdf .
4
  PAR is intended to function only as a preliminary review with the goal of identifying missing or
outstanding records that are likely to delay resolution of the case when not filed with the petition. PAR
does not address whether a petition was filed in good faith or with a reasonable basis and completion of
PAR does not indicate that the record of the case is fully developed. The f act that a case is activated after
PAR also does not prohibit Respondent or HHS from requesting the filing of additional documents
(although in most cases the obtaining of such additional materials may not be invoked as grounds for the
claim’s delay).

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       The Vaccine Act and the Vaccine Rules require, at a minimum, that the petition
must be supported by all medical and related records potentially relevant to the issue of
whether Petitioner is entitled to an award. The necessary records and affidavits are
further described in Vaccine Rule 2(c) and the Guidelines for Practice Under the
National Vaccine Injury Compensation Program (“Guidelines”).5 Detailed guidance
regarding the filing of these documents can also be found in the Guidelines.

       In order to complete the PAR process, Petitioner shall file certified6 copies
of the following:

    1. Vaccination record(s) (which includes the date and place of
       vaccination, see Vaccine Rule 2(c)(1)(A)(ii));7

    2. Records evidencing diagnosis of alleged vaccine related injury;

    3. Records of treatment prior to vaccination;8

    4. Records evidencing that the vaccine related injury persisted for at
       least six months or resulted in death or inpatient hospitalization and
       surgical intervention;

    5. Records evidencing vaccinee’s general health and condition both
       before and after the implicated vaccination(s);

    6. An affidavit from Petitioner addressing the requirements of §
       11(c)(1), to include the lack of or disposition of any prior civil action;

5
 Both resources can be found on the court’s website under Vaccine Information. The link for the V accine
Rules is http://www.uscfc.uscourts.gov/sites/default/files/170801VaccineRules.pdf.
The link f or the Guidelines is http://www.cofc.uscourts.gov/sites/default/files/GUIDELINES-FOR-
PRACTICE-4212016.pdf
6
 All records required by this order must be certified as a complete and accurate set of records as kept in
the normal course of business by the provider’s custodian of records. See Vaccine Rule 2(c)(2)(A) and
Section E of this Order.
7
 For cases alleging a Shoulder Injury Related to Vaccine Administration (“SIRVA”), Petitioner shall
request and file a vaccination record that includes a notation identifying of the arm of administration of the
vaccine(s) at issue in the case. If Petitioner is unable to obtain this information, an affidavit of
unavailability detailing Petitioner’s efforts to obtain this information shall be filed.
8
 In the case of an infant or child under the age of three at the time the vaccine was administered,
the documents supporting the petition should include all medical records, including laboratory and
genetic testing records, relating to the pregnancy and birth, and all records pertaining to the infant
prior to the vaccination, including those of “well baby” visits. If the vaccine is an older child or an
adult, the filed records should include all records from the primary care provider for three years
prior to the administration of the vaccine(s) alleged to be causal.

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      7. PAR Questionnaire (see section G below), and

      8. Statement of Completion.9

      Depending on the facts and circumstances of the case, Petitioner may be required
to provide additional affidavits or to incorporate or describe additional information in an
affidavit. For example, any required records which are unavailable must be identified
and the reason for their unavailability must be explained in an affidavit. § 11(c)(3);
Vaccine Rule 2(c)(2)(B)(i). Furthermore, “[i]f petitioner’s claim does not rely on medical
records alone but is also based in any part on the observations or testimony of any
person, Petitioner should include the substance of each person’s proposed testimony in
a detailed affidavit(s) supporting all elements of the allegations made in the petition.”
Vaccine Rule 2(c)(2)(B)(ii).

       Once the certified records and affidavit(s) have been filed, Petitioner shall file a
Statement of Completion using the CM/ECF event entitled “Statement of Completion.”
The required records, affidavit(s), and Statement of Completion shall be filed as
set forth in Sections A and E.

      E. Certified Records10

        In order to complete the PAR process, all petitions filed on or after Wednesday,
January 1, 2020, must be filed with certified records sufficient to satisfy Section
11(c) of the Vaccine Act from each medical provider. The records from each medical
provider must be certified as complete by that provider unless documentation is
included stating that the records were obtained pursuant to the Health Information
Technology for Economic and Clinical Health Act (HITECH). In the rare event that a
medical provider or third party record retrieval copy company will not provide the
requested certification, Petitioner’s counsel shall file an affidavit pursuant to Vaccine
Rule 2(c)(2)(B)(i) explaining the unavailability of certified copies of the medical records
and confirming that counsel has filed a complete set of the records as provided by the
medical provider to the attorney. An affidavit by counsel pursuant to Vaccine Rule
2(c)(2)(B)(i) must also be filed in the event that any relevant records are otherwise
missing or unavailable. If a medical facility does not maintain a medical records
certification form, a sample form can be found at http://www.cofc.uscourts.gov/vaccine-
sample-filings.
Note: If medical records were requested prior to January 1, 2020, Petitioner will
not be required to file a certification of records in order to complete the PAR
review process (Petitioner shall submit the request form with the records to
demonstrate that the records were requested prior to January 1, 2020). Only
records requested on or after January 1, 2020, will be subject to the certification
requirement.

9
    See Vaccine Rule 2(f ).
10
    Vaccine Rule 2(c)(2)(A)

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     F. Motions for Authorization to Issue a Subpoena.

       If a Petitioner requires an order for authorization to issue a subpoena, a motion
requesting this authorization shall be filed as soon as possible. The motion shall state
with specificity the name of the medical provider, the address, and all relevant contact
information for the custodian of records.

     G. PAR Medical History Questionnaire.

    As of Wednesday, January 1, 2020, Petitioners will be required to file a completed
PAR Questionnaire in order to complete the PAR process. Petitioner shall file the PAR
Questionnaire as an exhibit, utilizing a Notice of Filing, and selecting the CM/ECF event
entitled “PAR Questionnaire.” The PAR Questionnaire is found at:
http://www.cofc.uscourts.gov/sites/default/files/PAR%20Questionnaire_Fillable%20PDF.
pdf.

     H. PAR Completion - Activation and Reassignment Order.

        Once the pre-assignment review process is complete and all necessary
documentation has been filed, an Activation and Reassignment Order will be issued,
certifying that PAR review is complete. The petition will thereafter be assigned either to
a special master or to the SPU for further proceedings. The special master to whom the
case is assigned will subsequently issue another scheduling or initial order setting forth
additional information and deadlines for further proceedings.

     I. Scheduling Order

      The following is ORDERED: Petitioner shall file certified records required by
Section E of this Order by the deadline set forth on page one of this Order.

      Any questions regarding this order may be directed to Staff Attorney, Francina
Segbefia, at (202) 357-6358, francina_segbefia@cfc.uscourts.gov.11

IT IS SO ORDERED.

                                                          s/Brian H. Corcoran
                                                          Brian H. Corcoran
                                                          Chief Special Master

11
 In the event that a disruption in court operations renders the Office of Special Masters inaccessible, the
parties are directed to consult the website of the United States Court of Federal Claims. Alternatively, the
parties may call the Clerk’s Office, at (202) 357-6366.

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