Heidi Sharpe v. HHS - DTaP, significant aggravation of preexisting DYNC1H1-associated seizure disorder; infantile spasms/West syndrome; developmental delay (2022)
Case summary [AI summaries can sometimes make mistakes]
On January 27, 2014, Heidi Sharpe filed a petition under the National Childhood Vaccine Injury Compensation Program on behalf of her minor child, L.M. The petition alleged that the DTaP vaccine, administered on February 10, 2011, along with ActHIB and Prevnar, caused L.M. to suffer a significant aggravation of a preexisting seizure disorder associated with a DYNC1H1 genetic mutation, leading to infantile spasms/West syndrome and developmental delay.
L.M. was born on July 26, 2010, and her development was normal at six months of age. She had received prior vaccinations without incident.
Records indicated a possible URI and rash in January 2011, and some reports noted possible pre-vaccination episodes of unresponsiveness. Following the February 10, 2011 vaccinations, L.M. reportedly developed a fever, became floppy, and was difficult to wake.
On February 15, 2011, L.M. experienced a seizure and was transferred to St. Vincent Hospital, where an EEG revealed hypsarrhythmia, confirming infantile spasms/West syndrome.
L.M. continued to experience seizures and developmental problems. Petitioner's experts, Dr.
Robert Shuman and Dr. Richard Boles, opined that the vaccines aggravated L.M.'s condition.
Dr. Shuman suggested a preexisting structural brain abnormality and immune activation, while Dr.
Boles argued the specific location of L.M.'s DYNC1H1 mutation predicted a milder course that was worsened by vaccination. Respondent's experts, Dr.
Maria Descartes and Dr. John Zempel, attributed L.M.'s condition to the DYNC1H1 mutation and epileptic encephalopathy, disputing vaccine-induced worsening.
Initially, Special Master Brian H. Corcoran denied entitlement on November 5, 2018, finding the petitioner had not shown the vaccines significantly worsened the expected course of the DYNC1H1-associated disorder.
This decision was affirmed by Senior Judge Nancy B. Firestone on April 18, 2019.
However, the Federal Circuit vacated and reversed in part, remanding the case for further consideration of the significant aggravation claim. On remand, Chief Special Master Corcoran granted entitlement on February 19, 2021, finding the evidence, particularly the contemporaneous clinical sequence of fever, seizure activity, and subsequent deterioration, was just preponderant enough.
On June 23, 2022, Chief Special Master Corcoran adopted respondent's proffer and awarded damages totaling $1,494,239.24. This included $1,460,032.14 for L.M.'s estate (covering first-year life care expenses, lost future earnings, and pain and suffering), $4,391.40 for past unreimbursable expenses, and $29,815.70 to satisfy a Medicaid lien, plus an amount for an annuity.
Theory of causation
Petitioner alleged that Pediarix (DTaP/hepatitis B/IPV), ActHIB, and Prevnar vaccines administered on February 10, 2011, to L.M. (then approximately six and a half months old) caused a significant aggravation of a preexisting seizure disorder associated with a DYNC1H1 genetic mutation, resulting in infantile spasms/West syndrome and developmental delay. Petitioner's experts, Dr. Robert Shuman (pediatric neuropathologist) and Dr. Richard Boles (geneticist), proposed that the vaccines, particularly the DTaP component, triggered immune activation and cytokine production, precipitating seizures in a vulnerable child with a preexisting encephalopathy or a milder genetic mutation course. Respondent's experts, Dr. Maria Descartes (geneticist) and Dr. John Zempel (pediatric neurologist/epileptologist), attributed L.M.'s condition to the DYNC1H1 mutation and epileptic encephalopathy, arguing the vaccines did not worsen her course. Initially denied, entitlement was granted on remand after the Federal Circuit vacated and reversed in part the prior decision. Chief Special Master Brian H. Corcoran ultimately found the evidence preponderant enough, citing the contemporaneous clinical sequence of fever, seizure activity, and subsequent deterioration following vaccination. The final award was $1,494,239.24, including specific amounts for life care, lost earnings, pain and suffering, expenses, and a Medicaid lien, with the remainder to purchase an annuity. Attorneys for Petitioner included Curtis R. Webb and later Voris Johnson. Attorneys for Respondent included Amy Kokot and later Voris Edward Johnson.
Source PDFs
USCOURTS-cofc-1_14-vv-00065