Kelly Arango, Parent Of, Isabela Orozco, A Minor v. HHS - DTaP, infantile spasms, hypsarrhythmia, hypotonia, and developmental delay (2013)

Kelly Arango, on behalf of her minor daughter Isabela Orozco, filed a petition for compensation under the National Vaccine Injury Compensation Program on May 11, 2009. The petition alleged that Isabela suffered injuries as a result of five vaccines administered on March 28, 2008: DTaP, Haemophilus influenzae type b (Hib), inactivated polio virus (IPV), Prevnar (PCV7), and rotavirus.

Isabela was approximately four months old at the time of vaccination. Special Master Sandra Lord denied the petition on August 23, 2012, finding that Isabela did not suffer a Table injury and that causation-in-fact was not established.

Petitioner sought review of this decision, and on February 22, 2013, Judge George W. Miller of the Court of Federal Claims denied the motion for review, affirming the Special Master's decision.

The case was dismissed without compensation. The public decision does not name petitioner's counsel or respondent's counsel.

Isabela Orozco was born on November 27, 2007. She received vaccinations on November 29 and December 28, 2007, without incident.

On March 28, 2008, she received the DTaP, Hib, IPV, Prevnar, and rotavirus vaccines. Approximately six days later, on April 3, 2008, her mother reported symptoms of "zoning out" with eyes rolling back and rhythmical shaking.

An office visit that day confirmed these concerns, and Isabela was taken to Stamford Hospital. She was treated by neurologist Dr.

Philip Overby. An EEG on April 23, 2008, showed an electroclinical seizure with multifocal spikes.

On May 5, 2008, an EEG confirmed hypsarrhythmia, characteristic of infantile spasms. Dr.

Overby diagnosed cryptogenic infantile spasms and prescribed ACTH. Isabela was hospitalized and discharged on May 12, 2008, with a diagnosis of infantile spasms, hypsarrhythmia, hypotonia, and developmental delay.

Over the following three months, Isabela showed improvement, and her seizures ceased. She received a Hib vaccine on July 8, 2008, without adverse reaction.

However, on August 28, 2008, she received a hepatitis B vaccine, and her seizures returned shortly thereafter. Dr.

Henkind noted that Isabela's seizures had returned "within 24 hours of last vaccine given." An EEG on September 18, 2008, revealed abnormalities including hypsarrhythmia. Dr.

Overby restarted ACTH treatment and prescribed Topamax. Isabela's condition has remained unchanged, with delayed development.

Petitioner's theory of causation was that the five vaccines administered on March 28, 2008, constituted either a Table injury (acute encephalopathy within 72 hours of a covered vaccine) or caused infantile spasms and hypotonic-hyporesponsive episodes through causation in fact. Special Master Lord denied the Table injury claim, finding that while Isabela experienced seizures within 72 hours of vaccination, the contemporaneous medical records did not document the additional features required for a Table-qualifying acute encephalopathy, as seizures alone are not sufficient to constitute a diagnosis of encephalopathy according to 42 C.F.R. § 100.3(b)(2)(i)(E).

The Special Master found that Isabela did not suffer an acute encephalopathy within 72 hours of vaccination, only seizures. Regarding the causation-in-fact claim, the Special Master found that the petitioner failed to establish a medical theory causally connecting the vaccines to infantile spasms beyond the temporal relationship.

The onset of seizures approximately six days after vaccination was considered insufficient to establish causation under the Althen standard. Petitioner sought review, arguing that the Special Master applied an incorrect standard for the Table injury analysis.

Judge Miller affirmed the Special Master's ruling, finding no legal error in her application of the Qualifications and Aids to Interpretation (QAI) criteria to the evidence. The petition was denied.