A.M. v. HHS - DTaP, autism spectrum disorder (ASD); skin rashes; gliosis; seizure-like activity (2017)

Filed 2016-10-31Decided 2017-11-27Vaccine DTaP
dismissedcognitive/developmental

Case summary [AI summaries can sometimes make mistakes]

A.M., a minor, by her parents and natural guardians Sean and April Miller, filed a petition on July 25, 2016, alleging that their daughter suffered from skin rashes and autism spectrum disorder (ASD) as a result of vaccinations received on June 18, 2014, and August 21, 2014. The parents initially proceeded pro se.

During a status conference on August 25, 2016, they were encouraged to find legal representation and were ordered to file additional medical records. Petitioners were unable to secure an attorney, and the respondent filed a Rule 4(c) Report on January 26, 2017.

Petitioners filed objections to this report on February 23, 2017. Following a Rule 5 conference, the Special Master issued an Order to Show Cause on February 27, 2017, indicating that there did not appear to be a reasonable basis to proceed and setting a deadline of April 28, 2017, for an expert report.

Petitioners requested an extension until October 2017, stating they had difficulty finding an expert and had scheduled an appointment for A.M. at Children's Hospital in Omaha, Nebraska. The Special Master granted this extension.

On September 5, 2017, petitioners filed a status report detailing A.M.'s appointments at the Children's Hospital of Omaha, including medical testing on July 14, 2017, and an MRI of the brain on July 31, 2017. Petitioners stated that A.M. was diagnosed with gliosis and seizure-like activity on August 1, 2017.

They also filed documentation from vaccine manufacturers Glaxo Smith Cline and Merck regarding the ingredients in the DTaP, MMR, and Varicella vaccinations. On October 6, 2017, petitioners attached progress notes from a social worker and physicians, which confirmed A.M. met the criteria for ASD and suggested a strong possibility that the ASD was associated with another medical or genetic condition.

During a status conference on October 27, 2017, the Special Master noted that the additional records were consistent with earlier findings that A.M.'s condition was not vaccine-related. The first notation of developmental delay occurred on May 12, 2015, over eight months after the vaccinations, precluding a temporal association.

The Special Master explained that while the medical records documented A.M.'s conditions, they did not demonstrate a vaccine-related injury. The Special Master also noted that documentation from manufacturers regarding vaccine recommendations did not prove causation.

The Special Master agreed with the respondent that A.M. had not alleged an injury on the Vaccine Injury Table and that the medical records did not support such a claim. Because petitioners could not prove a Table injury, they were required to demonstrate actual causation by preponderant evidence, including a medical theory connecting the vaccination and injury, a logical sequence of cause and effect, and a proximate temporal relationship.

As petitioners were unable to file an expert report and the medical records did not demonstrate a vaccine-related injury, the Special Master found no reasonable basis to proceed and dismissed the petition. The Special Master extended sympathy to the petitioners but stated the decision was based on the evidence.

The decision was issued by Chief Special Master Nora Beth Dorsey on November 27, 2017.

Theory of causation

Petitioners alleged that minor A.M. suffered from autism spectrum disorder (ASD), skin rashes, gliosis, and seizure-like activity as a result of DTaP, Hepatitis A, Hib, and Prevnar vaccinations received on June 27, 2014, and August 21, 2014. The petition was dismissed because petitioners failed to demonstrate a Table injury or actual causation. The Special Master found no temporal association, as the first notation of developmental delay occurred over eight months after the vaccinations. Petitioners were unable to provide an expert report to establish a medical theory connecting the vaccinations to the alleged injuries, a logical sequence of cause and effect, or a proximate temporal relationship, as required by Althen v. Sec'y of Health & Human Servs. The public decision does not describe the specific mechanism of injury or name any experts. The outcome was dismissal, with no award granted. The decision was issued by Chief Special Master Nora Beth Dorsey on November 27, 2017. Petitioners were represented pro se initially, and respondent was represented by Ms. Ann Martin. The theory of causation was identified as Off-Table.

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