VICP Registry Case Source Bundle
Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_15-vv-01573
Package ID: USCOURTS-cofc-1_15-vv-01573
Petitioner: E.M.
Filed: 2015-12-23
Decided: 2018-08-29
Vaccine: DTaP
Vaccination date: 2012-12-28
Condition: reactive airway disease
Outcome: dismissed
Award amount USD: 

AI-assisted case summary:
On December 23, 2015, Kimberly Bertolucci and Arthur Joseph McCauley III, parents and guardians of E.M., a minor child, filed a petition under the National Vaccine Injury Act of 1986. They alleged that E.M. suffered from reactive airway disease as a result of receiving Diphtheria-Tetanus-acellular Pertussis (DTaP), Hepatitis B (Hep B), inactivated polio (IPV), and rotavirus vaccines on December 28, 2012, and DTaP, IPV, Haemophilus influenza B (HiB), pneumococcal conjugate, and rotavirus vaccines on March 7, 2013. The petition was filed by petitioners' counsel Robert J. Krakow. The respondent was the Secretary of Health and Human Services, represented by Lynn E. Ricciardella. On August 28, 2018, the petitioners filed a motion to dismiss their own petition, stating they believed the vaccines caused the alleged injuries but concluded they could not establish entitlement to compensation under the Vaccine Program. They affirmed understanding that this decision would end their rights in the program and noted anticipation of rejecting the judgment to file a civil action. Chief Special Master Nora Beth Dorsey presided over the case. The Special Master noted that to receive compensation, petitioners must prove either a "Table Injury" or that the vaccine actually caused the injury. The record did not contain evidence of a "Table Injury," nor did petitioners allege one. Furthermore, the Special Master found no persuasive evidence in the record indicating that E.M.'s reactive airway disease was caused by the vaccinations. The public decision does not describe the onset or specific symptoms of E.M.'s reactive airway disease, nor does it detail any medical records or specific diagnostic tests performed. While petitioners submitted expert reports from Drs. Judy Mikovits and Francis Ruscetti, and a supplemental report from Dr. Karyemaitre Aliffe, the Special Master found these reports unpersuasive. Specifically, the report from Drs. Mikovits and Ruscetti was described as "generally confusing and unintelligible," and Dr. Aliffe's report was characterized as "often conclusory" and lacking mechanistic evidence for a plausible causation theory. The Special Master also reviewed the expert report submitted by the respondent from Dr. Andrew MacGinnitie. Ultimately, the Special Master concluded that the petitioners' medical theory of causation fell short of the standards set forth in Althen, and that petitioners failed to demonstrate either a "Table Injury" or that the vaccinations caused E.M.'s injuries. Therefore, the case was dismissed for insufficient proof. The public decision does not specify any award amount or annuity terms, as the case was dismissed.

Theory of causation field:
Petitioners alleged that DTaP, Hepatitis B, IPV, rotavirus, HiB, and pneumococcal conjugate vaccines administered on December 28, 2012, and March 7, 2013, caused E.M. to suffer from reactive airway disease. The Special Master found no evidence of a "Table Injury" and no persuasive evidence that the vaccines caused the alleged injury. Petitioners' expert reports from Drs. Judy Mikovits, Francis Ruscetti, and Dr. Karyemaitre Aliffe were deemed unpersuasive and conclusory, lacking mechanistic evidence. Respondent's expert was Dr. Andrew MacGinnitie. The Special Master concluded that the petitioners' theory of causation failed to meet the standards set forth in Althen. The case was dismissed for insufficient proof by Chief Special Master Nora Beth Dorsey on August 29, 2018. Petitioners were represented by Robert J. Krakow, and respondent by Lynn E. Ricciardella. The theory of causation was determined to be "Off-Table" and unproven.

Public staged source text:

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DOCUMENT 1: USCOURTS-cofc-1_15-vv-01573-0
Date issued/filed: 2018-10-04
Pages: 3
Docket text: PUBLIC DECISION (Originally filed: 08/29/2018) regarding 69 DECISION of Special Master Signed by Chief Special Master Nora Beth Dorsey. (tlf) Service on parties made.
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Case 1:15-vv-01573-UNJ Document 72 Filed 10/04/18 Page 1 of 3
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
Filed: August 29, 2018
* * * * * * * * * * * * * * *
KIMBERLY BERTOLUCCI and * UNPUBLISHED
ARTHUR JOSEPH MCCAULEY III, *
Parents and Guardians of E.M., a Minor, * No. 15-1573V
*
Petitioners, * Chief Special Master Dorsey
*
v. * Pneumococcal Conjugate (Prevnar 13);
* Diphtheria-Tetanus-acellular Pertussis
SECRETARY OF HEALTH * (DTaP); Haemophilus Influenza B (HiB);
AND HUMAN SERVICES, * Hepatitis B (Hep B); Rotavirus;
* Inactivated Polio Vaccine (IPV);
Respondent. * Reactive Airway Disease.
*
* * * * * * * * * * * * * * *
Robert J. Krakow, Law Office of Robert J. Krakow, P.C., New York, N.Y., for petitioners.
Lynn E. Ricciardella, U.S. Department of Justice, Washington, D.C., for respondent.
DECISION1
On December 23, 2015, Kimberly Bertolucci and Arthur Joseph McCauley III
(“petitioners”) filed a petition under the National Vaccine Injury Act of 1986, 42 U.S.C. §§
300aa-10 et seq. (2012) (“Vaccine Act”).2 Petitioners stated that their child, E.M., received
vaccines for Diphtheria-Tetanus-acellular Pertussis (DTaP), Hepatitis B (Hep B), inactivated
polio (IPV), and rotavirus on December 28, 2012, and vaccines for DTaP, IPV, Haemophilus
influenza B (HiB), pneumococcal conjugate, and rotavirus on March 7, 2013. Petition at 4-5.
1 Because this unpublished decision contains a reasoned explanation for the action in this case,
the undersigned intends to post this decision on the United States Court of Federal Claims’
website, in accordance with the E-Government Act of 2002, 44 U.S.C. § 3501 note (2012)
(Federal Management and Promotion of Electronic Government Services). In accordance with
Vaccine Rule 18(b), petitioner has 14 days to identify and move to delete medical or other
information, that satisfies the criteria in § 300aa-12(d)(4)(B). Further, consistent with the rule
requirement, a motion for redaction must include a proposed redacted decision. If, upon review,
the undersigned agrees that the identified material fits within the requirements of that provision,
she will delete such material from public access.
2 The National Vaccine Injury Compensation Program is set forth in 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-1 to -34 (2012) (“Vaccine Act” or “the Act”). All citations in
this decision to individual sections of the Vaccine Act are to 42 U.S.C.A. § 300aa.
1

Case 1:15-vv-01573-UNJ Document 72 Filed 10/04/18 Page 2 of 3
Petitioners alleged that as a result of these vaccines, E.M. suffered from reactive airway disease.
Id. at 7.
On August 28, 2018, petitioners filed a motion for a decision dismissing the petition.
Motion for Decision dated Aug. 28, 2018 (ECF No. 68). Although petitioners maintained their
belief that the vaccines identified in their petition caused the alleged injuries to E.M., they
concluded that they would not be able to establish entitlement to compensation in the Vaccine
Program. Id. Petitioners affirmed that they understand that such a decision will end their rights
in the Vaccine Program. Id. They also noted that they anticipate electing to reject the Vaccine
Program judgment and filing a civil action. Id.
To receive compensation under the Program, petitioners must prove either: 1) that E.M.
suffered a “Table Injury”—i.e., an injury falling within the Vaccine Injury Table—corresponding
to a vaccination, or 2) that E.M.’s injuries were actually caused by a vaccine. See §§ 300aa-
13(a)(1)(A) and 300aa-11(c)(1). An examination of the record did not uncover any evidence that
E.M. suffered a “Table Injury,” nor do petitioners allege that she suffered a “Table Injury.”
Further, the record does not contain any persuasive evidence indicating that E.M.’s reactive
airway disease, or any other injuries, were caused by the vaccinations she received on December
28, 2012, or March 7, 2013.
Under the Vaccine Act, petitioners may not be awarded compensation based solely on
petitioners’ claims. Rather, the petition must be supported by either medical records or by the
opinion of a competent physician. § 300aa-13(a)(1). In this case, the medical records do not
establish causation. Although petitioners filed an expert report from Drs. Judy Mikovits and
Francis Ruscetti, as well as a supplemental report from Dr. Karyemaitre Aliffe, the undersigned
found these reports unpersuasive. As she discussed with the parties during a status conference,
the undersigned found the report from Dr. Mikovits and Ruscetti “generally confusing and
unintelligible,” and she observed that Dr. Aliffe’s report was “often conclusory” and “provide[d]
no mechanistic evidence to support a plausible causation theory.” See Order dated June 6, 2018
(ECF No. 63). After a thorough review of these reports, as well as the expert report submitted by
respondent from Dr. Andrew MacGinnitie, the undersigned concluded that “petitioners’ medical
theory of causation falls decidedly short of the standards set forth in Althen.” Id. at 2.
Accordingly, it is clear from the record in this case that petitioners have failed to
demonstrate either that E.M. suffered a “Table Injury” or that her injuries were caused-in-fact by
her December 28, 2012 or March 7, 2013 vaccinations.
Therefore, this case is dismissed for insufficient proof. In the absence of a motion for
review,3 the Clerk of the Court SHALL ENTER JUDGMENT in accordance with this decision.
IT IS SO ORDERED.
3 Pursuant to Vaccine Rule 11(a), entry of judgment is expedited by the parties’ joint filing of
notice renouncing the right to seek review.
2

Case 1:15-vv-01573-UNJ Document 72 Filed 10/04/18 Page 3 of 3
s/Nora Beth Dorsey
Nora Beth Dorsey
Chief Special Master
3