C.J.K. v. HHS - Influenza, immune system dysfunction, or hypogammaglobulinemia (2018)

On March 26, 2008, Bret and Sandra Kreizenbeck filed a petition on behalf of their son, C.J.K., seeking compensation under the National Vaccine Injury Compensation Program. They alleged that vaccines administered on April 1, 2005 (DTaP, Hib, PCV, MMR, and varicella) and October 12, 2005 (inactivated influenza vaccine) significantly aggravated C.J.K.'s pre-existing, but asymptomatic, mitochondrial disorder, leading to immune system dysfunction, specifically hypogammaglobulinemia.

The respondent, the Secretary of Health and Human Services, moved for dismissal on the written record. Special Master Brian H.

Corcoran granted the motion and dismissed the case on June 22, 2018. C.J.K. was born on March 23, 2004.

His early development was normal. He received a set of childhood vaccines on April 1, 2005, with no recorded reaction.

In the following months, he experienced gastroenteritis and croup. On October 12, 2005, he received an inactivated influenza vaccine.

Approximately 27 days later, on November 8, 2005, he was seen for congestion and a pediatrician noted "congestion x few months" and diagnosed a speech delay. A subsequent evaluation by an ENT specialist on December 7, 2005, noted that C.J.K.'s mother had observed difficulties for the previous six months, placing the onset of behavioral changes as early as July 2005, predating the October flu vaccine.

C.J.K. was officially diagnosed with autism on March 28, 2006. By 2013, some treaters suggested his autism symptoms had resolved, and he was diagnosed with ADHD.

The Kreizenbecks initially filed a petition alleging autism and immune dysfunction caused by MMR and thimerosal-containing vaccines. After the Omnibus Autism Proceeding test cases failed, they retained attorney Richard Gage and filed an amended petition in February 2012, stating the case was no longer about autism but about immune system dysfunction caused by the October 2005 flu vaccine, specifically hypogammaglobulinemia.

The theory continued to evolve, with expert reports from Dr. Alan Levin (July 2013) suggesting inborn errors of metabolism triggered by April 2005 vaccinations, Dr.

Marcel Kinsbourne (May 2015) arguing the October flu vaccine caused oxidative stress aggravating mitochondrial dysfunction and leading to autistic disorder, and Dr. Richard Boles (March 2016) opining C.J.K. had secondary mitochondrial disease aggravated by vaccination.

By the final memoranda, the claim focused on immune system dysfunction (hypogammaglobulinemia), though experts' reports still addressed autism and developmental injury. Evaluations for immune deficiency yielded conflicting results.

In October 2006, Dr. Dowain Wright found C.J.K.'s immunoglobulin levels to be normal and saw no evidence of immune deficiency.

In April 2008, Dr. Sudhir Gupta diagnosed hypogammaglobulinemia based on low IgG levels, but the underlying test results were not filed, and his records were difficult to decipher.

Further evaluations for mitochondrial disorder by Dr. Marvin Natowicz in February 2013 found mildly elevated serum 3-methylglutaconate, suggesting a possible association with mitochondrial metabolism disorders, but he did not consider the data compelling enough for a muscle biopsy.

Follow-up fibroblast testing in 2014 showed mild dysfunction in one test, which Dr. Natowicz characterized as "more likely a secondary phenomenon." The government presented three expert witnesses.

Dr. Shawn McCandless opined that C.J.K. did not have any mitochondrial disease or inborn error of metabolism, stating extensive testing confirmed the absence of known disorders and that the single mildly positive Ox Phos result was insufficient to establish secondary mitochondrial dysfunction.

Dr. Dean Jones criticized Dr.

Kinsbourne's theory of oxidative stress, stating it demonstrated ignorance of the concepts and that vaccine-induced reactive oxygen species are part of normal physiology. Dr.

Max Wiznitzer concluded C.J.K.'s clinical history was consistent with normal autism trajectories, not vaccine-caused regression, noting C.J.K. had never been recorded as regressing, only failing to progress. Special Master Corcoran dismissed the case, finding that C.J.K. had not been shown to have any mitochondrial disease or dysfunction.

The limited positive test results were insufficient, and Dr. Natowicz himself characterized the condition as a "secondary phenomenon." Dr.

Wright's 2006 finding of normal immunoglobulin levels contradicted Dr. Gupta's later diagnosis, for which test results were not provided.

The Special Master found no evidence of vaccine-caused aggravation, noting the lack of contemporaneous reaction records and that C.J.K.'s illnesses were typical for infants. Furthermore, the medical records suggested behavioral changes began before the October flu vaccine.

The expert opinions supporting the claim were deemed insufficient, conclusory, or based on unreliable theories. The Special Master concluded that the theory presented closely paralleled previously rejected claims and that the expert reports were deficient, allowing for resolution on the papers without a hearing.