L.V. v. HHS - Influenza, Autism Spectrum Disorder (ASD) following flu vaccine, possibly aggravated underlying mitochondrial disorder (2016)

On July 11, 2008, Robert and Erica Vernacchio filed a petition on behalf of their son, L.V., seeking compensation under the National Vaccine Injury Compensation Program. They alleged that L.V. received two doses of the influenza vaccine on November 8, 2006, and December 8, 2006, and that these vaccinations caused Autism Spectrum Disorder (ASD) and/or aggravated an underlying mitochondrial disorder.

Petitioner's counsel was Robert Joel Krakow. Respondent was represented by Lynn Elizabeth Ricciardella.

Special Master Brian H. Corcoran presided over the case.

L.V. was born in March 2005. Prior to his vaccinations, L.V. received numerous childhood vaccines and was generally developing appropriately according to his pediatrician.

Records from September 8, 2006, when L.V. was approximately 18 months old and before his flu vaccinations, described him as a "normal child" who was "developmentally appropriate" and "uses spoon and cup." Approximately five days after his second flu vaccine, on December 13, 2006, L.V. was seen by his pediatrician for constipation and an ear infection. The records from this visit noted, for the first time, a concern for "speech delay," though no date for its observation was given, and no mention was made of a reaction to the recent vaccination.

L.V. developed a fever around December 22, 2006, nearly two weeks after his second flu vaccine, which was associated with his ear infection and resolved with treatment. In January 2007, L.V. underwent early intervention assessments and was diagnosed with ASD by Dr.

James Coplan on January 23, 2007. Dr.

Coplan noted that L.V.'s language had "faded and disappeared" around 18-20 months and stated it was "unlikely immunizations played any role" in his condition. The Vernacchios consistently reported to various specialists that L.V.'s developmental regression or plateau began around 18 months of age, which predated his flu vaccinations.

The petitioners presented two primary theories of causation. The first theory alleged that the flu vaccine aggravated a pre-existing mitochondrial disease.

Petitioners' expert, Dr. Frances Kendall, a specialist in biochemical genetics, applied the Morava criteria and scored L.V. between six and seven points, indicating "probable" mitochondrial disease.

She theorized that the flu vaccine created oxidative stress sufficient to push a child with a mitochondrial vulnerability into developmental regression. Respondent's expert, Dr.

Bruce Cohen, a neurologist specializing in mitochondrial disease, scored L.V. at zero under the Morava criteria. He testified that genetic testing and lactate levels were negative for mitochondrial disease, that the Morava criteria were outdated and gave too much weight to nonspecific findings, and that L.V.'s treating physicians at the relevant time found no evidence of mitochondrial disease.

Dr. Kendall conceded that L.V. did not have a primary mitochondrial disease and struggled to identify significant post-vaccination changes.

The public decision does not describe the specific mechanism of mitochondrial disease aggravation or oxidative stress in detail. The second theory proposed by petitioners was autoimmune encephalopathy, with their expert, Dr.

Yuval Shafrir, a pediatric neurologist, arguing that the flu vaccine triggered molecular mimicry. He posited that homology between the influenza hemagglutinin protein and a brain protein (CSPR-2) caused antibodies to attack brain tissue, leading to encephalopathy and regression.

Dr. Shafrir acknowledged that L.V.'s brain had not been tested for CSPR-2, that there was no objective evidence of an autoimmune reaction, and that his cited literature involved different vaccines or illnesses.

Special Master Corcoran noted that Dr. Shafrir had presented a similar theory in a prior case, which was described as "wishful thinking premised on unverified and unsupported assumptions." Special Master Corcoran denied compensation on February 19, 2016.

He found that the evidence did not support the existence of a mitochondrial disease, finding Dr. Cohen's testimony more persuasive and noting the limitations of the Morava criteria.

He also found no evidence of post-vaccination encephalopathy, citing the lack of objective markers and the timing of L.V.'s symptoms relative to the vaccination. The Special Master concluded that the petitioners failed all three prongs of the Althen test for causation.

Specifically, he found that the weight of the contemporaneous medical record showed L.V.'s developmental problems were present before vaccination (failing Althen prong two). He also found that neither expert provided a reliable scientific basis for their theories (failing Althen prong one), and that the onset evidence pointed to before vaccination (failing Althen prong three).

The Special Master also determined that the Loving test for significant aggravation of a preexisting condition could not be satisfied as no mitochondrial disease was established. Judgment was entered dismissing the case.

On July 6, 2015, the parties filed a stipulation for interim attorney's fees and costs, which Special Master Corcoran approved on July 7, 2015, awarding $210,501.84.