Garrett Joseph Giles v. HHS - Hib, death; alleged HHC/HHE and encephalopathy after DPT; RSV bronchiolitis found unrelated factor (1996)

On April 8, 1994, Joseph R. and Lynda M. Giles, as parents and legal representatives of their deceased son, Garrett Joseph Giles, filed a petition under the National Childhood Vaccine Injury Act of 1986.

They alleged that Garrett died on February 9, 1993, as a direct result of Diphtheria-Pertussis-Tetanus (DPT) immunizations he received on February 12, 1992. The petition claimed Garrett suffered anaphylaxis, encephalopathy, and hypotonic-hyporesponsive collapse (HHC) within the time limits specified by the Vaccine Injury Table.

The respondent contended that Garrett's symptoms were caused by respiratory syncytial virus (RSV) bronchiolitis, a factor unrelated to the vaccination, and that he died from respiratory disease and gastroesophageal reflux. The special master denied compensation on September 11, 1996, finding that while petitioners established a prima facie case of encephalopathy, the respondent proved by a preponderance of the evidence that RSV was the principal cause of Garrett's respiratory distress, apnea, and subsequent encephalopathy.

The special master concluded that the DPT vaccination merely coincided with Garrett's RSV infection. On March 7, 1997, Judge Emily C.

Hewitt Horn denied the petitioners' motion for review, affirming the special master's decision. The court found that the special master used the correct preponderance standard for alternative causation, had sufficient evidence to find RSV despite questions about a single positive test, and did not act arbitrarily or capriciously in crediting the respondent's experts.

No compensation was awarded. Garrett was born on December 2, 1991.

After a normal two-week checkup, he was seen on December 20, 1991, for vomiting, but an upper GI barium swallow was negative. On February 12, 1992, at a routine two-month visit, Garrett had a slightly elevated temperature (99.8 degrees) and colic, but his physical examination was otherwise normal.

He received DPT, oral polio (OPV), and Hib immunizations that day. His mother testified that Garrett cried intensely during the vaccination and became fussy afterward.

Upon returning home, she noticed his lips were bluish and his body felt limp. His breathing became wheezy and raspy, and his chest appeared to retract with breathing.

He was taken back to the pediatrician, whose chart noted labored, raspy respirations and cyanotic lips for 15 minutes. Garrett was admitted to Winter Haven Hospital around 4:00 p.m. with a principal diagnosis of bronchiolitis.

His condition worsened, and he experienced respiratory arrest at 6:40 a.m. on February 13, 1992, requiring intubation and transfer to St. Joseph's Hospital in Tampa.

Medical records from Winter Haven Hospital showed two negative RSV tests and one positive RSV test, but the collection time for the positive test was after Garrett had been transferred. Three additional RSV tests at St.

Joseph's Hospital were negative. Dr.

Daniel Plasencia, Garrett's treating physician at St. Joseph's, diagnosed respiratory tract infection likely viral with RSV, respiratory failure, gastroesophageal reflux, and neuromuscular weakness or hypotonia at discharge on February 21, 1992.

However, he later testified for the petitioners that Garrett likely did not have RSV, citing the low statistical chance of a false positive and the atypical course for RSV. Pediatric neurologist Dr.

Jose Fordada III found developmental delay and hypotonia but believed the timing around the DPT vaccination was coincidental. Garrett was hospitalized again in July 1992 with diagnoses including status post viral reaction to DPT, aspiration pneumonia, and muscular hypertonia.

He was hospitalized a final time in February 1993 after vomiting and difficulty breathing. He died on February 9, 1993.

Dr. Plasencia listed the cause of death as respiratory failure with aspiration pneumonia leading to adult respiratory distress syndrome and multiple organ system failure.

Petitioners' expert, pediatric neurologist Dr. Marcel Kinsbourne, opined that Garrett suffered a hypotonic-hyporesponsive episode within hours of vaccination and acute encephalopathy within 72 hours, followed by enduring loss of motor control leading to apnea, aspiration, and death.

He did not support the anaphylaxis theory. Respondent's experts were pediatric neurologist Dr.

Max Wiznitzer and pediatrician/RSV specialist Dr. W.

Paul Glezen. Dr.

Wiznitzer testified that Garrett did not have an HHE, that the records did not show prolonged loss of mental status, and attributed the illness to RSV until proven otherwise, with death due to aspiration from gastroesophageal reflux. Dr.

Glezen testified that Garrett's presentation was consistent with acute respiratory illness or RSV bronchiolitis, noting that RSV can present suddenly with apnea in infants. The special master found that petitioners established a prima facie case of encephalopathy but that respondent proved by a preponderance of the evidence that RSV was the principal cause of Garrett's condition, unrelated to the vaccination.

The court affirmed this decision, finding the special master's reliance on Dr. Glezen's testimony regarding RSV and the clinical course of illness to be reasonable, despite questions about the single positive RSV test.

The court also noted that while Dr. Wiznitzer believed Garrett had a chronic encephalopathy, he attributed the cause to RSV, not the vaccine.