C.L. v. HHS - Influenza, autism spectrum disorder; autoimmune encephalopathy (2015)

On August 1, 2008, Rick and Shelley Lehner filed a petition for compensation under the National Vaccine Injury Compensation Program on behalf of their minor daughter, C.L. Initially, the petition alleged that thimerosal in childhood vaccines caused C.L.'s autism spectrum disorder (ASD).

In 2011, the petition was amended to allege that an influenza vaccine administered on November 25, 2005, caused C.L. to develop voltage-gated potassium channel (VGKC) antibodies, leading to autoimmune encephalopathy and subsequent developmental regression and ASD diagnosis. Petitioners were represented by Sheila A.

Bjorklund of Lommen Abdo Law Firm. Respondent was represented by Traci R.

Patton of the U.S. Department of Justice.

Chief Special Master Denise K. Vowell presided over the case.

C.L. was born prematurely in July 2003. Her medical records documented developmental concerns prior to the influenza vaccination.

At 15 months, a mild gross motor delay was noted. At 18 months, behavioral concerns including temper tantrums were recorded.

By 21 months, parents reported extreme clinginess and insensitivity to stimuli. At her two-year well-child visit on August 9, 2005, C.L. was diagnosed with a language delay, with fewer than twenty words and no sentences, and referred for speech and language evaluation.

In September 2005, a school evaluation found significant language delays, and C.L. was found eligible for special education services for a language disorder, indicating she was already receiving speech therapy and had a diagnosed language disorder before the November 2005 vaccination. C.L. received an influenza vaccination on November 25, 2005.

Her parents reported a low-grade fever and crankiness for several days afterward, treated with Advil, but no contemporaneous medical record documented a reaction. Approximately three and a half weeks later, during an evaluation, her parents stated their concerns began six months prior, placing the onset of concerns in June 2005, five months before the vaccination.

Later therapy sessions showed a gradual continuation and worsening of existing concerns, with no documentation of a sudden change post-vaccination. In February 2006, C.L.'s parents sought a neurology referral due to concerns about staring spells and substantial delays in sensory processing and muscle tone.

Neurological workup, including EEG, MRI, and genetic tests, was normal. C.L. was diagnosed with "encephalopathy, other." No spinal tap was ordered, which the Special Master noted indicated physicians saw no sign of an ongoing inflammatory brain process.

C.L. received a formal ASD diagnosis in June 2006, confirmed by further evaluations. Petitioners' theory evolved to focus on VGKC antibodies and autoimmune encephalopathy.

Testing in October 2008 revealed elevated VGKC antibodies. Dr.

Deborah Renaud diagnosed possible autoimmune encephalopathy and treated C.L. with steroids, IVIG, CellCept, and rituximab. However, VGKC antibody levels fluctuated without consistent correlation to behavioral improvement, and testing for specific pathogenic VGKC-complex proteins (LGI1, CASPR2, Contactin-2) was negative.

Petitioners' expert, Dr. Yuval Shafrir, theorized molecular mimicry from the flu vaccine caused VGKC autoantibodies leading to autoimmune encephalitis.

However, he conceded that only CASPR2, LGI1, and Contactin-2 antibodies were pathogenic, which C.L. did not have. Respondent's expert, Dr.

Joseph Dalmau, testified that VGKC antibodies in general were not reliably linked to autoimmune encephalitis, that only specific antibodies were pathogenic, and that the seasonal influenza vaccine had no proven link to VGKC antibodies. He also noted C.L.'s presentation was unprecedented for autoimmune encephalopathy.

Chief Special Master Vowell issued a decision on July 22, 2015, denying compensation. She found C.L. had symptoms of delayed development and ASD features before the vaccination, that regression was gradual, and that her symptoms were consistent with ASD.

The Special Master found no evidence of autoimmune encephalitis symptoms, and that immunotherapy response was minimal and better explained by ABA therapy and maturation. The petition was denied in its entirety.

On August 4, 2014, a stipulation for interim attorney fees and costs was filed, and the Special Master awarded $117,500.00.