Tara Evans v. HHS - Rotavirus, alleged rotavirus-associated partial intussusception; abdominal pain and bloody stools; milk protein allergy found more likely (2019)

On December 2, 2015, Tara Evans filed a petition under the National Vaccine Injury Compensation Program on behalf of her minor son, B.E., alleging that the rotavirus vaccination B.E. received on October 20, 2014, caused him to develop a partial intussusception. B.E. was born on August 8, 2014.

The petition was initially assigned to Special Master Gowen, then reassigned to Special Master Hastings, and finally to Special Master Katherine E. Oler.

Respondent filed a Rule 4(c) Report on June 3, 2016, arguing the case was not appropriate for compensation due to insufficient evidence and a lack of a plausible medical theory linking the vaccine to the alleged injuries. Petitioner's expert, Dr.

John Santoro, submitted a report on November 18, 2016, and Respondent's expert, Dr. Chris Liacouras, submitted his report on February 20, 2017.

After a reassignment to Special Master Oler's docket on December 5, 2017, a status conference revealed a discrepancy between the alleged injury in the petition and the injury proposed by Petitioner's expert. Petitioner filed an amended petition in April 2018, identifying partial intussusception as the alleged injury.

Following additional medical records and pre-hearing submissions, an entitlement hearing was held on November 28, 2018. Special Master Oler issued her decision denying entitlement on February 26, 2019, dismissing the petition.

Petitioner was represented by Maximillian J. Muller of Muller Brazil, LLP.

Respondent was represented by Meredith B. Healy of the U.S.

Department of Justice. B.E.'s gastrointestinal issues began before his vaccination.

On September 15, 2014, he presented with congestion, cough, and increased colic. On October 13, 2014, his records noted he had become colicky after switching to Gentlease formula but improved after switching to Nutramigen, with stringy yellow stools noted.

He received the rotavirus vaccine on October 20, 2014. One week later, on October 27, 2014, B.E. presented with persistent abdominal pain and blood in his stool for two days.

His stool was loose, green, and contained blood and clots. An abdominal x-ray and ultrasound performed that day were normal.

Follow-up on October 28 noted some blood in a bowel movement. On October 30, he was seen for diarrhea and nighttime screaming episodes, with records noting "probable vaccine-strain rotavirus illness, now improving," and he was prescribed Neocate formula.

On November 7, he presented to the emergency room with blood in his stool; an abdominal x-ray was normal, and his albumin level was 3.5 g/dL. A stool study on November 12 was positive for occult blood.

At his four-month well exam on December 10, records noted a "reaction to rotavirus with bloody diarrhea" and a plan to avoid further rotavirus immunization, but the exam was otherwise unremarkable. His six-month well exam on February 9, 2015, showed no parental concerns about elimination.

On May 8, 2015, he presented with constipation, which Petitioner stated had been present since the rotavirus vaccination. Records indicated he had switched from Neocate to Nutramigen and had been drinking cow's milk for about a month.

An abdominal x-ray showed moderate retained stool but no intussusception. He continued to have constipation through June.

On June 7, he presented to the emergency department with abdominal pain and fever, diagnosed with pneumonia; an abdominal x-ray again showed moderate retained stool. A barium enema on July 15 for chronic constipation was normal.

On August 27, 2015, he presented with blood and slime in his stool and abdominal pain; an abdominal x-ray was normal. His albumin level on August 29 was 3.6 g/dL.

On September 2, he was seen for chronic retentive constipation, and allergy testing showed a normal reaction to cow's milk allergen. On December 14, 2015, he was hospitalized with difficulty breathing, pale color, severe anemia, and abnormal blood counts after drinking large amounts of whole milk; his parents were advised to exclude dairy from his diet.

Petitioner's expert, Dr. John Santoro, a gastroenterologist, opined that B.E. suffered a partial intussusception five days after the rotavirus vaccine, which resolved spontaneously before imaging.

He based this on timing, symptoms, and the known association between rotavirus vaccine and intussusception. He later expanded his opinion to include the possibility of a second partial intussusception in August 2015 or increased susceptibility after the first event.

Respondent's expert, Dr. Chris Liacouras, a pediatric gastroenterologist, testified that B.E. had a milk protein allergy, not intussusception.

He stated that "partial intussusception" is not a recognized medical diagnosis and that intussusception requires imaging evidence, which B.E. never had. Special Master Oler found Dr.

Liacouras to be better qualified and more consistent than Dr. Santoro, noting Dr.

Santoro's limited experience with young children, his initial oversight of B.E.'s pre-vaccination symptoms, and inconsistencies in his testimony. The Special Master concluded that Petitioner failed to prove B.E. suffered an intussusception, citing the lack of imaging evidence and the fact that B.E.'s abdominal pain predated the vaccination.

She also found that B.E.'s symptoms persisted longer than expected for a spontaneously resolving intussusception and that the August 2015 event occurred outside a medically appropriate timeframe for a vaccine-related injury. The Special Master also found, in the alternative, that Respondent proved B.E. suffered from a milk protein allergy, unrelated to vaccination, supported by formula changes, improvement on Neocate, symptom recurrence with cow's milk, low albumin levels, and severe anemia after milk intake.

The petition was dismissed, and no compensation was awarded.