Sue Russell v. HHS - Hepatitis A, tonic-clonic seizure and subsequently developed intractable seizures (2015)

On May 5, 2011, Sue Russell filed a petition on behalf of her minor daughter, K.A., alleging that a hepatitis A vaccine administered on May 23, 2008, caused K.A. to suffer a tonic-clonic seizure within 24 hours, leading to intractable seizures. K.A. was 22 months old at the time of vaccination.

The petition alleged that K.A.'s injuries persisted for more than six months. The case was initially assigned to Special Master Zane, then reassigned to Chief Special Master Vowell, and finally reassigned to Special Master Thomas L.

Gowen. Petitioner initially filed medical records and an affidavit.

Following status conferences, petitioner was ordered to file outstanding medical records and a status report. Petitioner later filed additional exhibits and indicated that K.A.'s physicians were pursuing SCN1A genetic testing.

Petitioner requested and was granted extensions to obtain the testing and produce an expert report. The results of the SCN1A testing were filed on January 15, 2013.

Petitioner's counsel then consulted with an expert and, on March 13, 2013, informed the court that she would not be filing an expert report, opting instead to request a ruling on the record based on written submissions. Petitioner filed a motion for a ruling on the record accompanied by medical literature.

Respondent filed a response. K.A. was born on July 10, 2006, and was exposed in utero to alcohol, tobacco, cocaine, and Seroquel, and her birth mother was HIV positive.

K.A. tested negative for HIV and received antiviral therapy for six weeks. She was discharged to foster care and later adopted by Ms.

Russell. As a newborn, K.A. experienced fine tremors.

She received childhood immunizations without reported incident and appeared to develop normally until approximately nine months of age, when she began exhibiting autistic tendencies. By sixteen months, K.A. had regressed in speech development and engaged in self-stimulating behaviors, including excessive head banging.

In November 2007, she was diagnosed with autism spectrum disorder and began developmental therapy. On May 23, 2008, K.A. received the hepatitis A vaccine.

Petitioner reported that within hours, K.A. became irritable and developed a fever. The following morning, approximately 24 hours after vaccination, K.A. experienced a tonic-clonic seizure that lasted about ten minutes.

At the hospital, an EEG showed high voltage rhythmic activity representing a seizure tendency. In the days following the seizure, K.A. continued to have seizures and mood swings.

Video EEGs conducted in June 2008 showed abnormalities described as implying bilateral cortical dysfunction. K.A. began seeing Dr.

Steve Janousek, a pediatric neurologist, who prescribed several anticonvulsant medications with limited success. In March 2009, an EEG showed moderately to markedly abnormal electrographic seizure activity.

K.A. responded well to Prednisone, and her medication was later changed to intravenous immunoglobulin (IVIG) therapy, which showed significant improvement in her interaction and reduced seizure activity. K.A. continued to receive IVIG therapy every three weeks.

She received her second hepatitis A vaccine on July 17, 2009, without incident. In October 2010, Dr.

Janousek noted behavioral degeneration toward the end of IVIG intervals. K.A. responded well to immunoglobulin therapy, with fewer seizures and improved interaction.

In early 2011, K.A. began seeing an endocrinologist for early puberty. On October 10, 2009, K.A. was seen by pediatric immunologist Dr.

Ralph Shapiro for evaluation of her immune system related to her seizure disorder and IVIG therapy. Lab studies showed no evidence of an inflammatory disorder and negative autoimmune screening.

Dr. Shapiro discussed the possibility of a sodium channel defect (SCN1A gene) with Ms.

Russell. K.A. was tested for the SCN1A mutation in October 2012, and no mutation was detected.

Dr. Shapiro also discussed the possibility of the seizure disorder being a vaccine-related injury and recommended consulting an attorney experienced in the program.

Special Master Gowen found that petitioner failed to establish entitlement to compensation. The Special Master determined that petitioner had not met the three prongs of the Althen test for off-Table claims.

Specifically, the Special Master found that petitioner failed to establish a plausible medical theory connecting the hepatitis A vaccine to the seizure disorder, relying on medical literature without expert explanation. The medical literature submitted did not provide a clear link, and treating physician notes were insufficient to establish causation.

Although K.A. received the vaccine, experienced a seizure within 24 hours, and her condition persisted, the court could not conclude that the vaccine caused the injury. The petition was dismissed on September 9, 2014.

On March 9, 2015, the parties filed a joint stipulation for attorneys' fees and costs. The court awarded $23,850.00 in attorneys' fees and costs, jointly payable to K.A. and her attorney, Kate G.

Westad of Lommen Abdo Law Firm. Petitioner counsel was Sheila A.

Bjorklund and later Kate G. Westad.

Respondent counsel was Linda S. Renzi.

Special Master was Thomas L. Gowen.