W.R. v. HHS - DTaP, autism spectrum disorder; alleged encephalopathy, developmental delay, immune/mitochondrial/autoinflammatory injury (2017)

On November 15, 2011, Heather and Walter A. Rogero II, as friends of their minor son W.R., filed a petition under the National Vaccine Injury Compensation Program.

Initially, the petition focused on vaccinations administered on November 19, 2008. After retaining counsel, the claim expanded to include a series of vaccinations administered between November 19, 2008, and May 4, 2010.

The vaccines administered included Pediarix (containing DTaP, hepatitis B, and IPV), Hib, PCV, hepatitis A, varicella, and DTaP. Petitioners alleged that these vaccines, particularly those containing aluminum, caused or aggravated neurological, developmental, gastrointestinal, dermatologic, immune, mitochondrial, and autoimmune injuries.

W.R. was diagnosed with autism spectrum disorder (ASD), but the petitioners argued that his condition was better characterized as vaccine-caused encephalopathy with autistic-like sequelae. W.R. was born on September 10, 2008.

His newborn checkups were unremarkable. On November 19, 2008, at approximately two months of age, he received Pediarix, Hib, and pneumococcal vaccines.

At this visit, he had cradle cap, congestion, cough, sneezing, and green nasal drainage. Developmental testing showed he passed most milestones but failed to turn his head to sound.

Two weeks later, he was seen for eye drainage and rash, with his cradle cap noted as significantly improved and infantile eczema present. By January 3, 2009, he had ongoing cough and congestion.

On January 19, 2009, he received Pediarix and pneumococcal vaccines. His mother reported spitting up after eating and failure to roll over.

He experienced feeding difficulties, failure to thrive, and eczema. In March 2009, he was hospitalized for RSV bronchiolitis and later had an ear infection.

He was referred to early intervention services due to developmental delay. Evaluations in April 2009 noted developmental delay, but his parents reported no specific concerns.

On April 27, 2009, he received Pediarix and pneumococcal vaccines, and his mother reported he was beginning to prop up and rolling over. By June 2009, he failed most developmental milestones and was assessed as underweight and delayed.

A geneticist evaluated him for developmental delays and failure to thrive. Therapy sessions focused on motor skills, and a sluggish pupillary response was noted.

He received a Hib vaccine on August 1, 2009. Allergy testing noted eczema was under control and assessed egg allergy and atopic dermatitis.

Therapy notes in August showed some progress, and his mother canceled further services, believing he was doing well. At his one-year visit on September 24, 2009, he failed most developmental milestones and had mild strabismus.

Records were inconsistent regarding whether he received hepatitis A and varicella, or hepatitis A and Hib vaccines that day. By December 2009, chromosomal testing was normal, but he was four to five months behind on milestones.

At fifteen months, he was noted to be behind in fine motor skills and language, with recommendations for aggressive therapy. On May 4, 2010, at twenty months, he received a DTaP vaccine and was assessed as developmentally delayed.

Follow-up on May 7, 2010, noted no regression or negative symptoms. By June and July 2010, records described failure to thrive, constipation, rhinorrhea, developmental delay, and autism.

A developmental pediatrician found severely delayed language skills and restricted behaviors, meeting criteria for autism risk. A neurologist assessed autistic disorder and ordered an EEG, which was normal.

Another neurologist noted an admitting diagnosis of encephalopathy NOS and Mrs. Rogero's history that W.R. may have been vaccine-injured from aluminum-based vaccines.

Petitioners presented extensive expert testimony from Drs. Mary Megson, Christopher Shaw, Judy Mikovits, Richard Deth, Lawrence Palevsky, Christopher Exley, Helen Ratajczak, Stephanie Seneff, and Suzanne Goh.

Their theories centered on aluminum adjuvants, genetic susceptibility, impaired detoxification, immune activation, oxidative stress, blood-brain-barrier disruption, mitochondrial dysfunction, inflammation, and encephalopathy, often relying on parental affidavits and testimony of regression. Respondent's experts, including Drs.

Andrew MacGinnitie, Jeffrey Johnson, Edward Cetaruk, Max Wiznitzer, and Bruce Cohen, testified that W.R.'s conditions were consistent with autism spectrum disorder and that the petitioners' theories lacked scientific basis. They found no evidence of vaccine-caused immune dysfunction or toxicity from aluminum.

Special Master George L. Hastings, Jr. denied the petition on September 1, 2017.

He found the petitioners' theories to be a "kitchen sink" approach, lacking clarity on the precise injury or mechanism. He prioritized contemporaneous medical records over later parental accounts, noting they did not support claims of dramatic regressions.

The Special Master found respondent's experts to be more qualified and persuasive. He concluded that petitioners failed to demonstrate that aluminum adjuvants cause autism or neurodevelopmental injury, that W.R. had an abnormal immune or mitochondrial reaction or genetic susceptibility, or that the medical literature supported their theories.

The argument that the case was not about autism was rejected, as W.R. clearly had ASD. The claim failed all three prongs of the Althen test for causation-in-fact: no reliable theory connecting vaccines to the alleged injuries, no logical sequence of cause and effect, and no proximate temporal relationship.

No compensation was awarded. Petitioners were represented by Clifford J.

Shoemaker.