Santini v. Secretary of Health and Human Services

122 Fed. Cl. 102, 2015 U.S. Claims LEXIS 837, 2015 WL 4077254
United States Court of Federal Claims·Decided June 30, 2015·No. 06-725V·Published·Cited by 8 cases

Opinion

National Childhood Vaccine Injury Act, 42 U.S.C. § 300aa; Burden of proof, 42 U.S.C. § 300aa-13; Causation, 42 U.S.C. § 300aa-ll(c)(l)(C)(ii); Review of Special Master’s Decision, 42 U.S.C. § 300aa-12; Severity requirement, 42 U.S.C. § 300aa-ll(c)(l)(D)(i); Significant Aggravation, 42 U.S.C. § 300aa-33.

MEMORANDUM OPINION AND ORDER

BRADEN, Judge.

I. RELEVANT FACTUAL BACKGROUND. 2

On July 6, 2003, Aydien Omidvar (“Ay-dien”) was born to Laurie Omidvar and Esfandiar Santini (“Petitioners”). See Santini v. Sec’y of Health & Human Servs. No. 06-725, 2014 WL 7891507, at *5 (Fed. Cl. Spec. Mstr. Dec. 15, 2014) (“Santini ”).

On September 8, 2003, Aydien was examined by his pediatrician and received a diphtheria, tetanus toxoids, and acellular pertussis vaccine (“DTaP”), without complication. Id. at *6.

*104 On November 7, 2003, when Aydien was four months old, he received a second DTaP vaccination. Id. Prior to receiving the second dose of this vaccine, Aydien presented as a healthy baby. Id. Approximately ten hours after the vaccination, he experienced two seizures, each lasting about two minutes. Id. When a third seizure occurred on the same day, his parents called 911. Id. On arrival of Emergency Medical Services (“EMS”), Ay-dien’s temperature was recorded as 100.8 degrees. Id. Thereafter, Aydien was transported to a local hospital, when EMS personnel observed continuous seizure activity for thirty minutes. Id. Two doses of valium were administered to stop the seizures. Id. Later that same day, Aydien was transported by air ambulance to San Diego Children’s Hospital, where he remained for two days. Id. The admitting doctor recorded that “[t]he etiology of seizures is suspicious for adverse side effect of immunization, despite receiving 2-month immunizations without complications. Other possibilities include infection.” Id. Tests on Aydien’s blood, urine, and cultures revealed normal results. Id. On November 9, 2003, Aydien was discharged with a diagnosis of seizures due to DTaP immunization. Id.

On December 3, 13, and 19, 2003, Aydien suffered other seizures. Id. The last two seizures required Aydien to be admitted to San Diego Children’s Hospital. Id. A December 15, 2003 Magnetic Resonance Imaging (“MRI”) scan, however, revealed no noteworthy abnormalities. Id.

On May 10, 2004, Dr. Boosara Ratana-wongsa, a neurologist at San Diego Children’s Hospital, examined Aydien. Id. Dr. Ratanawongsa’s diagnosis was that Aydien had epilepsy, but was otherwise “developmentally appropriate.” Id. Although Aydien experienced other seizures during the next ten months, he made developmental progress. Id. at *7.

On March 14, 2005, Aydien had an electroencephalogram (“EEG”) that showed “abundant interictal epileptiform discharges,” and was diagnosed with “gross developmental delay.” Id. Anti-seizure medication and the placement of a vagus nervé stimulator failed to control Aydien’s seizures. Id.

II. PROCEDURAL HISTORY.

A. Proceedings Before The Special Master.

On October 20, 2006, Aydien’s parents filed a pro se Petition under the National Childhood Vaccine Injury Act, 42 U.S.C. §§ 300aa-l-34 (“the Vaccine Act”), alleging an “on-Table” claim, pursuant to 42 U.S.C. § 300aa-14. 3 See Santini at *7. The Government countered that Aydien did not suffer an “on-Table” injury, because he did not experience a decreased level of consciousness for twenty-four hours after receiving his first vaccination. Id. The Government also noted that the vaccine administered on November 7, 2003 was the acelullar form, DTaP, further indicating that Petitioners’ claim was not on-Table. Id.

On February 26, 2007, the Government submitted an expert report from Dr. Max Wiznitzer, 4 a pediatric neurologist, concluding that Aydien’s presentation was consistent with “severe myoclonic encephalopathy of infancy (SMEI or Dravet’s syndrome).” Id. On October 2007, Petitioners agreed that Aydien would undergo genetic testing. Id.

On February 6, 2008, the Government filed the results of Aydien’s genetic testing with the Special Master. Id. at *8. On February 28, 2008, Dr. Wiznitzer submitted a letter to the Special Master reporting that Aydien had *105 a genetic mutation that was “consistent with a symptomatic mutation causally related to his clinical diagnosis of [SMEI].” Id.

On April 7,2008, the Government also filed an expert report from Dr. Gerald Raymond 5 that concluded:

Aydien Omidvar is a child who has Severe Myoclonic Epilepsy of Infancy (“SMEI”) or Dravet syndrome secondary to a mutation in his SCN1A gene. 6 This is the sole cause of his epilepsy syndrome including his subsequent developmental delay. It was not caused [ ]or exacerbated by any of the immunizations that he received.

Id.

In October 2007, both of Aydien’s parents underwent genetic testing to determine whether Aydien could have inherited the mutation from one of his parents’ genes. Id. at *7. On December 11, 2008, Petitioners filed the results of their genetic tests: Aydien’s mutation was not inherited, but arose de novo. Id.

On September 21, 2009, Petitioners requested a stay because of two cases pending before the United States Court of Appeals for the Federal Circuit: Stone v. Secretary of Health & Human Services, No. 04-1041V, 2010 WL 1848220 (Fed. Cl. Spec. Mstr. Apr. 15, 2010) and Hammitt v. Secretary of Health & Human Services, No. 07-170V, 2010 WL 3735705 (Fed. Cl. Spec. Mstr. Aug. 31, 2010).

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Santini v. Secretary of Health and Human Services, 122 Fed. Cl. 102, 2015 U.S. Claims LEXIS 837, 2015 WL 4077254 (uscfc 2015).

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