Steven Forrest And Nicole Forrest, On Behalf Of E.M.F. v. HHS - DTaP, Sudden Infant Death Syndrome (SIDS) (2017)
Case summary [AI summaries can sometimes make mistakes]
On January 14, 2010, Steven and Nicole Forrest, as representatives of the estate of their minor daughter E.M.F., filed a petition under the National Vaccine Injury Compensation Program. They alleged that E.M.F. died on January 14, 2008, as a result of receiving the Diphtheria-Tetanus-acellular-Pertussis (DTaP), inactivated polio (IPV), Haemophilus influenzae type b (Hib), Pneumococcal conjugate (PCV), and Rotavirus vaccinations on January 10, 2008.
Petitioners were represented by Jessica W. Hayes of the Murray Law Firm.
Respondent was represented by Heather L. Pearlman and Ryan D.
Pyles of the U.S. Department of Justice.
Special Master Thomas L. Gowen issued a decision on August 10, 2017, denying entitlement to compensation.
E.M.F. was born on August 28, 2007. Her medical history included reflux diagnosed at two months old.
Following her first set of DTaP, pneumococcal, Hib, IPV, and rotavirus vaccinations on October 29, 2007, she developed a fever of 103°F, fussiness, and vomiting. Her parents noted behavioral changes and a decrease in her usual smiling and interaction.
On November 19, 2007, she was taken to the emergency room with fever and congestion, and was later hospitalized with diagnoses including gastroenteritis and pneumonia. She continued to have respiratory issues and vomiting.
On January 10, 2008, at her four-month check-up, E.M.F. received her second set of the same five vaccines. Her parents reported a reaction described as "similar but more intense" than the previous one, including fever ranging from 102°F to 105°F, crying, and inability to sleep.
Over the next two days, she experienced periodic fever and increased vomiting, but her symptoms appeared to taper off by January 13, 2008. On the morning of January 14, 2008, she was described as appearing better and had no fever.
E.M.F. was taken to a new babysitter that morning. At approximately 11:30 a.m., the babysitter found E.M.F. unresponsive, lying prone with apparent spit-up and blood from her nose.
Emergency services were called, and E.M.F. was pronounced dead at 1:14 p.m. The autopsy revealed a small atrial septal defect, lung congestion, and lymphoid hyperplasia.
The medical examiner ruled the cause of death as Sudden Infant Death Syndrome (SIDS). Petitioners' expert, Dr.
Laurel Waters, a pathologist, proposed three theories: (1) the post-vaccine fever acted as an exogenous stressor under the SIDS Triple Risk Model; (2) the vaccines provoked an anamnestic re-challenge immune response; and (3) the vaccines induced a type IV delayed hypersensitivity reaction causing death. Respondent's expert, Dr.
Sara Vargas, a pediatric lung pathologist, countered that the lymphoid hyperplasia observed at autopsy, with mature germinal centers, likely predated the January 10 vaccines and was a residual of the November 2007 pneumonia, citing studies indicating germinal center formation takes eight to twenty-one days. Dr.
Vargas also argued that the type IV hypersensitivity theory was vague and lacked supporting literature for causing sudden death, and that the anamnestic response theory was undermined by E.M.F. appearing to improve before her death. Special Master Gowen rejected all three theories.
He found Dr. Vargas's testimony regarding the timing of lymphoid hyperplasia more persuasive, giving weight to her specialized training.
He found Dr. Waters's type IV hypersensitivity theory too vague and unsupported by literature for causing sudden death.
He also found the anamnestic re-challenge theory unconvincing because E.M.F. appeared to be recovering prior to her death. The Special Master noted that epidemiological evidence, including studies cited by both parties and the Institute of Medicine's conclusions, weighed against a general causal relationship between vaccines and SIDS.
Furthermore, he observed that E.M.F. was found in the prone position, a recognized SIDS risk factor. The Special Master concluded that petitioners failed to meet the preponderance of the evidence standard for all three prongs of the Althen test for causation.
The petition was denied without compensation.
Theory of causation
Petitioners Steven and Nicole Forrest alleged that E.M.F., approximately four months old, died of Sudden Infant Death Syndrome (SIDS) on January 14, 2008, four days after receiving DTaP, IPV, Hib, PCV, and Rotavirus vaccinations on January 10, 2008. Petitioners' expert, Dr. Laurel Waters, proposed three theories: (1) vaccine-induced fever as an exogenous stressor in the SIDS Triple Risk Model; (2) an anamnestic re-challenge immune response to the second vaccine dose; and (3) a type IV delayed hypersensitivity reaction caused by vaccine antigens leading to lymphokine release and death. Respondent's expert, Dr. Sara Vargas, argued that lymphoid hyperplasia found at autopsy predated the vaccines, citing mouse studies indicating mature germinal centers take 8-21 days to form, suggesting it was residual from prior pneumonia. Dr. Vargas also found the type IV hypersensitivity theory vague and unsupported for sudden death causation. Special Master Thomas L. Gowen denied the petition, finding Dr. Vargas's testimony on lymphoid hyperplasia timing more persuasive. He rejected Dr. Waters's theories as lacking a sound medical basis and logical sequence of cause and effect, noting E.M.F. appeared to be improving before death. The Special Master also cited epidemiological evidence against a vaccine-SIDS link and the presence of the prone sleep position as a risk factor. Petitioners failed to establish all three prongs of the Althen test. Attorneys: Jessica W. Hayes for petitioners; Heather L. Pearlman & Ryan D. Pyles for respondent. Decision Date: August 10, 2017.
Source PDFs
USCOURTS-cofc-1_10-vv-00032