Phuong Dinh v. HHS - Hepatitis B, chronic eczema, also called atopic dermatitis (2022)

Filed 2016-02-04Decided 2022-03-11Vaccine Hepatitis B
dismissed

Case summary [AI summaries can sometimes make mistakes]

On February 4, 2016, Phuong Dinh filed a petition on behalf of her child, C.N., seeking compensation under the National Vaccine Injury Compensation Program. The petition alleged that C.N. developed chronic eczema, also known as atopic dermatitis (AD), as a result of receiving the HiB, Prevnar 13, Rotarix, and Pediarix vaccines on May 29 and June 26, 2013, when he was approximately two to three months old.

Petitioner alleged that C.N. experienced fever and crying after the May 29, 2013 vaccinations, followed by red spots and dry skin that later became itchy. Medical records from that day noted "dry cheeks + scalp" and "eczema—vaseline." Petitioner further alleged that after the June 26, 2013 vaccinations, C.N. again experienced fever, cried excessively, and developed red spots that turned into reddish-purple patches.

Medical records from July 15, 2013, diagnosed C.N. with moderate to severe atopic dermatitis. Subsequent medical records documented ongoing symptoms, diagnoses of cow milk protein allergy, and various treatments.

Petitioner's expert, Dr. Joseph Bellanti, proposed a theory that the vaccines could cause AD through immune dysregulation and inflammation, citing studies on immune cells and vaccine adjuvants.

Respondent's expert, Dr. Gary Rachelefsky, argued that AD predated vaccination and that vaccines do not cause AD, citing literature refuting the alleged association.

Chief Special Master Brian H. Corcoran reviewed the medical records and expert reports.

The court found that C.N.'s AD symptoms, specifically dry cheeks and scalp, were noted on May 29, 2013, the same day he received his two-month vaccines, indicating that some form of eczema was present before vaccination. The court determined that Petitioner failed to establish the first Althen prong (a medical theory causally connecting the vaccination and the injury) because Dr.

Bellanti's theory lacked sufficient reliable evidence and was undermined by literature, including a meta-analysis by Ayasse. Furthermore, the court found that C.N.'s AD likely already existed before the May 29, 2013 vaccinations, failing the second Althen prong (a logical sequence of cause and effect showing the vaccination was the reason for the injury).

The court also found that the proximate temporal relationship was not established, as the onset likely predated vaccination. The claim was dismissed for failure to meet the burden of proof.

Petitioner was represented by Renee J. Gentry of the Vaccine Injury Clinic, George Washington Univ.

Law School, and Respondent was represented by Sarah B. Rifkin of the U.S.

Dep’t of Justice.

Theory of causation

Petitioner alleged that C.N. developed chronic eczema (atopic dermatitis or AD) as a result of receiving the HiB, Prevnar 13, Rotarix, and Pediarix vaccines on May 29 and June 26, 2013. Petitioner's expert, Dr. Joseph Bellanti, proposed a theory that vaccines could cause AD through immune dysregulation and inflammation, citing studies on immune cells and vaccine adjuvants, and the presence of contaminants in vaccines. Respondent's expert, Dr. Gary Rachelefsky, argued that AD predated vaccination and that vaccines do not cause AD, citing literature refuting the alleged association. Chief Special Master Brian H. Corcoran denied entitlement, finding that C.N.'s AD symptoms preceded the vaccinations, as evidenced by medical records noting "dry cheeks + scalp" and "eczema—vaseline" on May 29, 2013. The court found Petitioner failed to establish the first Althen prong (a medical theory causally connecting the vaccination and the injury) due to insufficient reliable evidence and undermining literature, including the meta-analysis by Ayasse. The court also found that C.N.'s AD likely already existed before the vaccinations, failing the second Althen prong (a logical sequence of cause and effect showing the vaccination was the reason for the injury), and that the temporal relationship was not established as onset likely predated vaccination. The claim was dismissed. Petitioner was represented by Renee J. Gentry, and Respondent by Sarah B. Rifkin. The decision was issued on March 11, 2022.

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