Bryan Maciel v. HHS - HPV, multiple sclerosis and optic neuritis (2018)

Filed 2015-04-10Decided 2018-10-12Vaccine HPV
denied

Case summary [AI summaries can sometimes make mistakes]

On April 10, 2015, Elias and Kelly Maciel filed a petition on behalf of their son, Bryan Maciel, alleging that he developed multiple sclerosis (MS) and optic neuritis as a result of receiving three doses of the human papillomavirus (HPV) vaccine on August 28, 2013, October 13, 2013, and March 6, 2014. They also alleged that the final dose significantly aggravated his underlying MS.

Bryan was 14 years old at the time of his first vaccination and 14 when he received the last dose. Medical records indicated that Bryan began experiencing blurred vision and headaches approximately one week before his third HPV dose, with symptoms worsening after the vaccination.

He was diagnosed with MS and optic neuritis. The petitioner's expert, Dr.

Carlo Tornatore, opined that the third HPV dose significantly aggravated Bryan's pre-existing MS, possibly by triggering an aberrant immune response during an MS attack, and pointed to elevated eosinophil levels as evidence of a vaccine reaction. The respondent's expert, Dr.

Adil Javed, contended that Bryan's MS and optic neuritis symptoms predated the third HPV dose and were consistent with the natural course of MS, not a vaccine-induced aggravation. Dr.

Javed also disputed the significance of the eosinophil levels and presented studies suggesting no link between the HPV vaccine and MS. Special Master Brian H.

Corcoran denied entitlement, finding that Bryan's MS/optic neuritis symptoms began before the third HPV dose and that the evidence did not establish a plausible causation theory for vaccine-induced aggravation. The Special Master concluded that the symptoms were part of a single MS flare that predated the vaccination and that Bryan did not experience an overall worsening of his condition due to the vaccine.

This decision was affirmed on review by the Court of Federal Claims, which found no legal error or abuse of discretion by the Special Master. The court agreed that the petitioner failed to establish a direct causation claim, as the evidence indicated his symptoms began prior to vaccination.

Furthermore, the court found that the petitioner did not prove significant aggravation, as his symptoms were part of a single MS flare that predated the vaccination, he did not experience an overall worsening of his condition compared to the natural course of MS, and he failed to establish a plausible causation theory linking the HPV vaccine to MS exacerbation. The court also found that the Special Master appropriately weighed the expert testimony, giving due consideration to Dr.

Tornatore's expertise while also acknowledging the limitations of his focus on immunology and the stronger, literature-supported arguments presented by the respondent.

Theory of causation

Petitioner alleged that Bryan Maciel, age 14, developed multiple sclerosis (MS) and optic neuritis, or that the third dose of the HPV vaccine administered on March 6, 2014, significantly aggravated his pre-existing MS. Petitioner's expert, Dr. Carlo Tornatore, opined that the third HPV dose triggered an aberrant immune response, aggravating an ongoing MS attack, citing elevated eosinophil levels as evidence. Respondent's expert, Dr. Adil Javed, contended that MS symptoms predated the third HPV dose and were part of the natural disease course, disputing the significance of eosinophils and presenting literature against a vaccine-MS link. The Special Master denied entitlement, finding that symptoms began before vaccination, no plausible causation theory for aggravation was established, and the symptoms represented a single MS flare predating the vaccine. The Court of Federal Claims affirmed, agreeing that direct causation was not proven, significant aggravation was not established due to the symptoms being part of a single pre-vaccination flare and the lack of a plausible causation theory, and that the Special Master appropriately weighed the expert testimony and medical literature. The case was classified as an Off-Table injury, resulting in a denial of entitlement.

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