J.R.S. v. HHS - DTaP, death allegedly from posterior reversible encephalopathy syndrome (PRES) following multiple vaccines (2018)

Ryan L. Swick and Mary M.

Swick, as legal representatives and parents of their deceased minor child, J.R.S., filed a petition under the National Vaccine Injury Compensation Program. J.R.S. was born on May 14, 2011, after 36 weeks and 3 days of gestation.

He experienced brief breathing difficulties requiring intubation for less than 24 hours after birth and had some early feeding difficulties, but gained weight. On July 25, 2011, at approximately ten weeks old, J.R.S. received the hepatitis B, rotavirus, diphtheria-tetanus-acellular pertussis (DTaP), Haemophilus influenzae type b (Hib), inactivated poliovirus (IPV), and pneumococcal conjugate vaccines during a well-child visit.

Concerns at this visit included constipation, which was being managed with glycerin suppositories, and daily early-morning crying. Between the vaccination date and his death, J.R.S. continued to experience episodes of constipation and fussiness.

In early August 2011, he vomited a large amount on one occasion. In the days preceding his death, his mother, father, and two older siblings were ill with colds.

On the evening of August 10, 2011, J.R.S. began coughing, which woke him from sleep. The evidence was inconsistent regarding his sleeping position, but he was found in the prone position with a blanket covering his head.

His mother found him warm, sweaty, pale, limp, and still. She initiated CPR and called 911.

Emergency medical technicians arrived around 10:00 a.m. on August 11, 2011, found no signs of life, transported him to a local hospital, and he was pronounced dead at 10:39 a.m. that day. An autopsy was performed by Deputy State Medical Examiner Dr.

Dennis F. Klein.

A brain specimen was sent to neuropathologist Dr. Patricia A.

Kirby, who reported congestion and focal perivascular hemorrhages in the pons, congested basal meninges with smear subarachnoid hemorrhages, and a persistent but involuting external granular layer in the cerebral cortex. She found no acute or remote hypoxic-ischemic neuronal injury, no cortical lamination anomaly, and white matter within normal limits.

Dr. Kirby concluded that the brain examination did not reveal a central nervous system cause of death and that the findings were consistent with an asphyxial death.

Dr. Klein concluded the cause of death was sudden unexplained infant death, and due to the circumstances of being found prone with a blanket covering his head and the brain findings consistent with asphyxia, he ruled the manner of death undetermined.

The petitioners' expert, neurologist Dr. Walter E.

Kozachuk, proposed that J.R.S. died from posterior reversible encephalopathy syndrome (PRES) caused by the vaccinations and argued against a SIDS diagnosis. He later suggested additional autopsy studies and consultation with other specialists but these were not pursued.

The respondent relied on Dr. Michael H.

Kohrman, a board-certified pediatric neurologist, who disputed the PRES diagnosis, stated the autopsy was consistent with asphyxia or SIDS, and found no evidence linking the death to the vaccines. Special Master Christian J.

Moran denied compensation on February 26, 2018. He found Dr.

Kohrman's credentials stronger than Dr. Kozachuk's, and noted that neither expert had specialized neuropathology or immunology expertise.

The Special Master also considered a Maryland disciplinary reprimand of Dr. Kozachuk, noting his failure to disclose it in a later report, but concluded this did not alter the outcome as the primary issue was the unreliability of the PRES diagnosis.

The Special Master found that J.R.S.'s fussiness was more likely due to constipation, that a single vomiting episode was insufficient to support a PRES diagnosis, and that the petitioners failed to persuasively challenge the neuropathologist's autopsy conclusions. Because the petitioners failed to prove J.R.S. had PRES, the Special Master did not reach the Althen causation analysis.

No compensation was awarded. Petitioners were represented by Richard H.

Moeller of Berenstein, Moore, Heffernan, Moeller & Johnson, L.L.P. Respondent was represented by Ryan D.

Pyles of the United States Department of Justice.