E.M. v. HHS - DTaP, reactive airway disease (2018)
Case summary [AI summaries can sometimes make mistakes]
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
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.
Source PDFs
USCOURTS-cofc-1_15-vv-01573