A.K. v. HHS - Influenza, Autism Spectrum Disorder (ASD) (2016)

On March 26, 2003, R.K. and L.K. (collectively, the Petitioners) filed a petition for vaccine compensation under the National Vaccine Injury Compensation Program on behalf of their son, A.K., who was born on November 9, 1999. They opted into the Omnibus Autism Proceeding (OAP).

The petition alleged that A.K. suffered from Autism Spectrum Disorder (ASD) as a result of vaccinations. Initially, the case was part of the OAP test cases concerning the theory that thimerosal-containing vaccines cause autism.

However, the Petitioners withdrew from the OAP on April 10, 2008, to pursue an individual case theory. The operative second amended petition, filed April 17, 2013, alleged that A.K.'s two influenza vaccinations, administered on November 2, 2001, and December 3, 2001, either resulted in an encephalopathy or significantly aggravated an existing condition, specifically a mitochondrial disorder, leading to ASD.

Special Master Denise K. Vowell issued a decision on September 28, 2015, denying entitlement.

The Special Master found that the Petitioners failed to establish by a preponderance of the evidence that A.K. had an underlying mitochondrial disorder. The Special Master also found that A.K.'s ASD symptoms predated the influenza vaccinations, citing video evidence and medical records that indicated early signs of ASD as early as 14 months of age, well before the November 2001 vaccinations.

The Special Master concluded that the Petitioners' theories of causation, including those advanced by their experts Dr. Frances Kendall, Dr.

Yuval Shafrir, and Dr. Richard Deth, were speculative and unpersuasive.

The Special Master found that the evidence did not support a link between vaccines and mitochondrial regression or ASD, nor did it establish a challenge-rechallenge reaction or a plausible biological mechanism for injury. The Special Master also found that A.K.'s alleged gastrointestinal issues and MTHFR polymorphisms did not support the Petitioners' claims.

The Petitioners filed a Motion for Review of the Special Master's decision with the United States Court of Federal Claims. On December 18, 2015, Judge Susan G.

Braden issued a Memorandum Opinion and Final Order denying the Petitioners' motion, affirming the Special Master's decision. The court found that the Special Master's factual findings were not arbitrary or capricious and that the Petitioners failed to establish causation in fact under the Althen standard.

The court also addressed and rejected the Petitioners' constitutional arguments and their motion for judicial estoppel. The Petitioners appealed this decision to the United States Court of Appeals for the Federal Circuit, which affirmed the denial of the claim without opinion on December 9, 2016.

Subsequently, the Petitioners sought attorneys' fees and costs. Special Master George L.

Hastings issued a decision on August 31, 2017, awarding $225,702.10 in fees and costs, a reduction from the requested amount, finding that the appeal to the Federal Circuit and certain aspects of the post-hearing litigation lacked a reasonable basis. The Petitioners sought review of this decision, which was denied by Judge Braden on February 12, 2016, and later affirmed by the Federal Circuit.

A subsequent opinion on February 29, 2016, addressed redaction requests. A final opinion on January 26, 2018, denied the Petitioners' motion for review of the attorneys' fees decision, upholding the Special Master's findings regarding the reasonableness of the appeal and the reduction in fees.