Marissa Arevalo v. HHS - DTaP, DTaP Table encephalopathy; infantile spasms; severe developmental injury (2018)

On April 22, 2015, Marissa Arevalo, as guardian and mother of her minor daughter R.M.R., filed a petition under the National Childhood Vaccine Injury Act. R.M.R. was born in March 2012 and received a diphtheria-tetanus-acellular pertussis (DTaP) vaccine on May 10, 2012, at approximately two months of age.

Ms. Arevalo alleged that R.M.R. suffered an "encephalopathy" as defined by the Vaccine Table, and also asserted an off-Table claim.

A hearing was held to address the on-Table claim. The Vaccine Table lists "encephalopathy" within 72 hours for the DTaP vaccine.

For children under 18 months, an acute encephalopathy is indicated by a significantly decreased level of consciousness lasting at least 24 hours, which can be shown by decreased or absent eye contact, decreased response to the environment, or inconsistent responses to external stimuli. Factors such as sleepiness, irritability, crying, bulging fontanelle, or seizures alone do not constitute an acute encephalopathy.

The parties agreed that R.M.R. was healthy before the vaccination and after May 15, 2012. Before the May 10, 2012 vaccination, R.M.R. was noted to be healthy by her pediatrician, Dr.

Ho, and was likely able to track objects with her eyes. By Monday, May 14, 2012, R.M.R. was taken to the emergency room due to seizures, which were later confirmed as infantile spasms.

Following the seizures, R.M.R.'s development halted, and she subsequently required a G-tube and wheelchair, with her mother providing constant care. The critical period for determining an on-Table encephalopathy was between 3:00 p.m. on Thursday, May 10, and 3:00 p.m. on Sunday, May 13, 2012.

Special Master Christian J. Moran focused on R.M.R.'s eye contact and responsiveness during this period.

On Monday, May 15, 2012, treating pediatric neurologist Dr. Blas Zelaya recorded Ms.

Arevalo's report that R.M.R. had good eye tracking except in the "last couple of days." This history, taken on Monday, indicated that the decreased eye tracking began on Saturday, May 12, before the 72-hour window closed and before the seizures started early Sunday morning. Ms.

Arevalo testified that she noticed decreased eye tracking on Saturday and that R.M.R. was not responding during playtime. Special Master Moran found that the lack of eye tracking in a two-month-old satisfied the regulatory requirement for decreased or absent eye contact, thus establishing a Table encephalopathy.

While Dr. Zelaya testified that R.M.R. suffered an encephalopathy, his definition was broader than the regulatory one.

The Special Master found that the respondent did not present sufficient evidence to rebut the Table presumption, noting that Dr. Zelaya testified that no other reason for R.M.R.'s infantile spasms was found after extensive investigation.

On December 15, 2016, Special Master Moran ruled that R.M.R. was entitled to compensation for a DTaP Table encephalopathy. The damages phase was resolved by a stipulation and proffer.

Life-care planners M. Virginia Walton, RN, MSN, FNP, CNCLP, and Terry K.

Arnold, RN, CDMS, CRRN, CLCP, CNLCP, were used to estimate R.M.R.'s future needs. The parties agreed that R.M.R. would not be gainfully employed in the future.

On June 12, 2018, Special Master Moran found the proffer reasonable and awarded damages totaling $2,005,508.01. This included a lump sum of $1,437,806.43 payable to Marissa Arevalo as guardian of R.M.R.'s estate for lost future earnings, pain and suffering, and first-year life-care expenses; $3,852.60 payable to Ms.

Arevalo for past unreimbursable expenses; $563,848.98 jointly payable to Ms. Arevalo and the State of Illinois to satisfy the Medicaid lien; and an amount sufficient to purchase a life-contingent annuity for future life-care items.

The annuity payments were subject to a four percent annual growth rate for non-medical items and a five percent annual growth rate for medical items. Petitioner was represented by Peter C.

Beard of Holley, Rosen & Beard. Respondent was represented by Adriana Teitel of the U.S.

Department of Justice.