John Robert Phillips v. HHS - Influenza, chronic idiopathic thrombocytopenic purpura (2020)

Filed 2016-07-29Decided 2020-12-30Vaccine Influenza
denied

Case summary [AI summaries can sometimes make mistakes]

On July 29, 2016, John Robert Phillips, who was 16 years old at the time, filed a petition for compensation under the National Vaccine Injury Compensation Program. He alleged that an intranasal influenza vaccine and the third dose of the human papillomavirus (HPV) vaccine he received on November 20, 2013, caused him to develop chronic immune thrombocytopenic purpura (ITP).

The petition was filed by Michael A. Firestone of Marvin, Firestone, MD, JD and Associates.

The respondent was the Secretary of Health and Human Services, represented by Voris E. Johnson of the U.S.

Department of Justice. Petitioner's medical records indicated a history of various health issues prior to vaccination, including abdominal pain, impetigo, and a rash.

Following the vaccinations on November 20, 2013, Phillips experienced symptoms such as fever, chills, and body aches, for which he was prescribed antibiotics. His mother noted a persistent rash and a switch in antibiotics.

Approximately 16 weeks later, in March 2014, Phillips presented with bruising, petechiae, and bloody phlegm, leading to a diagnosis of ITP with a platelet count of 7,000. The medical literature and expert opinions in the case agreed that Phillips's ITP was chronic, persisting for over 12 months.

The case proceeded as an "off-Table" claim, meaning Phillips had to prove causation. Petitioner's experts, Dr.

Sohail Ahmed and Dr. Yehuda Shoenfeld, proposed theories of adjuvant-induced autoimmunity and molecular mimicry, suggesting the vaccines triggered his ITP.

Dr. Ahmed specifically focused on the influenza vaccine, while Dr.

Shoenfeld implicated the HPV vaccine, citing its aluminum adjuvant and potential for molecular mimicry. Respondent's experts, Dr.

Joan C. Gill, Dr.

Neil Romberg, and Dr. John Strouse, disagreed with the petitioner's theories.

They cited a lack of scientific evidence linking these specific vaccines to ITP, particularly the live-attenuated influenza vaccine (LAIV) and the HPV vaccine, to chronic ITP. They also emphasized the significant time lapse between vaccination and symptom onset as inconsistent with vaccine-induced ITP.

Special Master Katherine E. Oler reviewed the evidence.

She found that the medical records indicated the onset of ITP symptoms around March 11, 2014, approximately 16 weeks after the November 20, 2013 vaccinations. This timeframe was considered outside the medically acceptable window for vaccine-induced ITP, which experts generally placed between one to six weeks post-vaccination.

The Special Master also found the petitioner's proposed causation theories, adjuvant-induced autoimmunity and molecular mimicry, to be unsupported by the evidence presented, particularly concerning the specific vaccines administered and the diagnosis of ITP. The medical records also showed that treating physicians attributed the ITP onset to a recent upper respiratory infection, not the vaccinations.

Ultimately, the Special Master concluded that John Robert Phillips had not met his burden of proof by a preponderance of the evidence and dismissed his petition on December 30, 2020.

Theory of causation

Petitioner John Robert Phillips, age 16, received an intranasal influenza vaccine and an HPV vaccine on November 20, 2013. He alleged these vaccines caused chronic immune thrombocytopenic purpura (ITP). The public decision does not describe the specific mechanism of action for the alleged causation. Petitioner's experts, Dr. Sohail Ahmed and Dr. Yehuda Shoenfeld, proposed theories of molecular mimicry and adjuvant-induced autoimmunity. Respondent's experts, Dr. Joan C. Gill, Dr. Neil Romberg, and Dr. John Strouse, disputed these theories, citing a lack of scientific evidence and an inappropriate temporal relationship. The Special Master found that the onset of ITP symptoms occurred approximately 16 weeks after vaccination, which is outside the medically acceptable window of one to six weeks for vaccine-induced ITP. The Special Master also found insufficient evidence to support the proposed causation theories and noted that treating physicians attributed the ITP onset to a recent upper respiratory infection. The petition was denied on December 30, 2020.

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