Casey Hocraffer v. HHS - Hepatitis B, Reye’s Syndrome, encephalopathy, mental and physical deficits (2005)

Petitioner Casey Hocraffer filed a petition on January 26, 1999, alleging that two hepatitis B vaccinations administered in 1996 caused her to develop Reye’s Syndrome, encephalopathy, and resulting mental and physical deficits. The petition sought compensation under the National Childhood Vaccine Injury Act of 1986.

Petitioner alleged that she contracted Reye’s Syndrome following the vaccinations, which led to hospitalization and a surgical intervention (lumbar puncture), and that her condition persisted for more than six months. Petitioner was born on February 10, 1981, and received her first hepatitis B vaccination on November 7, 1996, and her second on December 11, 1996.

Prior to her vaccinations, she had a history of various illnesses and injuries, including hospitalizations for dehydration, ovarian cystectomies, and treatment for recurrent urinary tract infections, irritable bowel syndrome, and other injuries. Following her first vaccination, she experienced symptoms including a sore throat, difficulty swallowing, fever, sinus congestion, and headaches, for which she received various treatments.

After her second vaccination, on December 16, 1996, she developed pernicious vomiting and was admitted to the hospital on December 17, 1996. During her hospitalization, laboratory tests showed minimal initial increases in liver enzymes, which later rose significantly, along with higher than normal ammonia levels.

She was tested for various viral agents, including hepatitis A, B, and C, CMV, Epstein-Barr virus, and adenovirus, with results indicating an immune response to hepatitis B but negative for others. A lumbar puncture was performed to rule out infection.

Based on these results, she received a presumptive diagnosis of Reye’s Syndrome. She was discharged on December 22, 1996, with normal liver function.

Following discharge, she continued to have respiratory health problems and, in April 1997, was referred to an infectious disease specialist. She also claimed diminished motor and cognitive skills following her Reye’s Syndrome diagnosis.

Petitioner presented testimony from Dr. Nathaniel Ratnasamy, an infectious disease specialist, and Dr.

James Heubi, a pediatric gastroenterologist and expert on Reye’s Syndrome. They testified that Petitioner had Reye’s Syndrome, that the hepatitis B vaccine could trigger Reye’s Syndrome, and that the vaccination was the only logical temporal trigger for her condition.

Dr. Heubi stated that Reye’s Syndrome typically occurs within 3-7 days of a triggering illness, and Petitioner’s symptoms began five days after her second vaccination.

He also testified that other potential viral causes had been ruled out by testing. Respondent presented testimony from Dr.

Alan I. Brenner, an internist and rheumatologist, who opined that Petitioner did not have Reye’s Syndrome but rather a drug-induced hepatotoxicity or Central Sensitization Syndrome.

He suggested that Petitioner’s earlier gastrointestinal illness or medications like Phenergan could have caused her symptoms. The Special Master dismissed the claim, finding no causal link between the vaccine and Petitioner’s injuries and suggesting alternative causes like medication toxicity or Central Sensitization Syndrome.

The Special Master was not persuaded that there was a clear causal link between Petitioner’s Reye’s Syndrome and the hepatitis B vaccine, stating that Petitioner had not established a likely mechanism of causation or a logical sequence of cause and effect. The Special Master found that Central Sensitization Syndrome and/or medication toxicity were more likely causes.

The Special Master also noted that Petitioner had not established long-term sequelae beyond six months. The United States Court of Appeals for the Federal Circuit reviewed the Special Master’s decision.

The court found the Special Master’s decision to be arbitrary and capricious. The court determined that Petitioner’s experts, Drs.

Ratnasamy and Heubi, provided reliable medical testimony establishing a causal link between the hepatitis B vaccine and Petitioner’s Reye’s Syndrome, hospitalization, and surgical intervention (lumbar puncture). The court noted that while the vaccine was not on the Table of Injuries, Petitioner proved causation-in-fact by demonstrating a logical sequence of cause and effect supported by expert opinion and a strong temporal relationship.

The court agreed with the Special Master that Petitioner did not prove long-term sequelae beyond six months following her recovery from Reye’s Syndrome. The court reversed the Special Master’s decision regarding entitlement for hospitalization and surgical intervention due to the vaccine and remanded the case for further proceedings, encouraging the parties to reach a resolution.

Petitioner’s counsel was not named. Respondent’s counsel was not named.

Special Master LaVon French issued the initial decision. Judge Firestone authored the court's opinion.