Janet Cakir v. HHS - DTaP, encephalopathy manifesting with symptoms of attention deficit and hyperactivity disorder ("ADHD") and autism spectrum disorder ("ASD") (2018)

On December 7, 2015, Janet Cakir filed a petition on behalf of her minor son, C.A.C., seeking compensation under the National Vaccine Injury Compensation Program. The petition alleged that a Diphtheria-tetanus-acellular pertussis (DTaP) vaccine administered on October 1, 2012, caused C.A.C. to suffer an encephalopathy with symptoms of attention deficit and hyperactivity disorder (ADHD) and that the vaccine worsened his pre-existing autism spectrum disorder (ASD).

The petition was initially filed pro se, then with counsel, and then pro se again. Special Master Brian H.

Corcoran issued a decision on July 12, 2018, dismissing the case as untimely and for insufficient proof. Petitioner was represented by Janet Cakir, pro se, and Respondent was represented by Lisa Ann Watts of the U.S.

Department of Justice. The factual background indicated that C.A.C. was diagnosed with ASD in July 2010, approximately two years before the DTaP vaccination.

Concerns for possible ADHD were noted in April 2012, prior to the vaccination. Medical records did not show any concerning reaction in the months following the vaccination.

C.A.C. was seen by Dr. Emily Wray on January 10, 2013, for cognitive function treatment related to his ASD, and Dr.

Wray also noted ADHD. In May 2013, Dr.

Andrew Frye described a developmental encephalopathy with characteristics of ASD without a clear etiology, and C.A.C. subsequently underwent a 12-week folinic acid trial that reportedly resulted in improvement. Respondent filed a Rule 4(c) report on November 7, 2016, recommending against compensation.

Petitioner later filed an expert report from Dr. Karen Harum, a treating physician, who opined that C.A.C. began to regress twelve days post-vaccination, with symptoms including hypotonia, loss of focus, and over-focused observation.

Dr. Harum proposed a molecular mimicry theory involving pertussis toxin, cytokine production, disruption of the blood-brain barrier, and cross-reaction between pertussis fimbriae and central nervous system protein.

She also identified potential contributing factors such as chronic antibiotic use, disrupted intestinal microbiome, concurrent sinusitis, unidentified mitochondrial dysfunction, and a family history of autoimmune disorders. However, Dr.

Harum did not file supporting medical literature with her report. Special Master Corcoran dismissed the case primarily on the grounds of untimeliness.

Petitioner alleged symptom onset on October 2, 2012, one day after vaccination, or alternatively, Dr. Harum placed onset twelve days post-vaccination.

Under the Vaccine Act's three-year statute of limitations, the petition filed on December 7, 2015, was more than 36 months after the earliest alleged symptom onset. The Special Master rejected Petitioner's arguments for equitable tolling, finding that allegations of HRSA helpline misrepresentations, "fake cases," changed contact information, and pediatric record fraud did not demonstrate the type of fraud or duress required to toll the statute of limitations.

The Special Master noted that a claimant cannot rely on mistaken advice from court officials and that the evidence presented did not corroborate fraudulent intent by HRSA or pediatricians that prevented timely filing. Furthermore, the Special Master found the claim insufficient on the merits.

The record did not support an acute Table encephalopathy within 72 hours of vaccination. There was no persuasive evidence that the DTaP vaccine caused or significantly aggravated ASD or ADHD, and no treaters other than Dr.

Harum attributed C.A.C.'s condition to vaccination. The Special Master also noted that vaccine-autism causation theories have been repeatedly rejected in the Vaccine Program, citing the Omnibus Autism Proceedings.

The petition was dismissed, and no compensation was awarded.