LD v. HHS - Varicella, autism and related conditions (2015)

On January 19, 2007, Diane and Andrew Davis, as parents of LD, a minor, filed a petition for vaccine injury compensation. They alleged that LD's varicella vaccination, administered on December 9, 2002, when he was twelve months old, caused his autism and related conditions.

LD and his twin sister were born on November 26, 2001. Throughout his first year, LD's routine pediatric vaccinations were accompanied by neurological assessments that were within normal limits.

He received the varicella vaccine at his twelve-month well-child visit but not the MMR vaccine. In January and December 2003, his neurological assessments remained without deficits.

By July 2004, at a two-year well-child visit, LD had a six-word vocabulary, was not toilet trained, and was referred for possible speech delay. His mother declined further vaccinations.

Five weeks later, on August 23, 2004, she brought him to the pediatrician with concerns about "autistic behaviors, not a lot of eye contact, not progressing with speech." The pediatrician noted that LD aligned toys, disliked loud noises, banged his head during tantrums, mumbled, preferred to play alone, and preferred to be fed. The pediatrician recorded "developmental delay" and referred LD for neurological and audiological assessments.

In September 2004, a neurologist concluded LD had "autistic tendencies" and a communication disorder, noting his poor eye contact, preference to stay in his own world, and lack of meaningful language despite walking at around one year of age. A December 2004 school evaluation found his overall developmental age to be twelve months, with significant delays in fine motor, cognitive, and language development.

In December 2004, Dr. Mary Megson examined LD and noted that while his first year of development seemed normal, his trajectory changed afterward.

She observed that a gluten-free/casein-free diet, started in October 2004, had helped some symptoms. A 2012 genetics evaluation by Dr.

Virginia Proud noted LD carried a complex I mitochondrial mutation, which could contribute to autism spectrum disorder, but was not likely the sole cause. Dr.

Proud's history also noted the mother's concern at six months of age regarding fever, irritability, and diarrhea reportedly associated with immunizations, after which LD lost some skills and the ability to sit up. The initial petition was filed as a Short-Form Autism Petition, alleging MMR and/or thimerosal-containing vaccines caused autism.

However, LD had never received the MMR vaccine, and the varicella vaccine contains no thimerosal. The case was stayed pending the Omnibus Autism Proceeding.

Petitioners' counsel, Herbert Waichman, withdrew in February 2012, stating there was "no reasonable basis to proceed forward." After a period of pro se representation and further delays, attorney Patricia Finn was substituted in January 2014. In November 2014, the petitioners clarified that the varicella vaccine was the alleged cause, with first symptoms appearing in July 2004, approximately eighteen months after vaccination.

Special Master Hastings ordered an expert report within 90 days, expressing "grave doubts" about a reasonable basis for the claim. No expert report was filed.

On February 16, 2015, petitioners filed a Motion for Ruling on the Record. Special Master Hastings denied compensation on May 27, 2015, finding that no physician in the medical records opined that LD's autism was vaccine-caused, no expert report was filed, and the three prongs of the Althen standard for causation were unmet.

Specifically, there was no medical theory connecting the varicella vaccine to autism, no logical cause-and-effect sequence, and the eighteen-month interval between vaccination and symptom onset did not constitute a proximal temporal relationship. Attorneys' fees were awarded at $5,369.84, plus $2,000 in petitioners' out-of-pocket costs, totaling $7,369.84.