Forrest v. Secretary of Health and Human Services, 10-32

Background

Petitioners (Steven and Nicole Forrest) filed a Vaccine Act petition alleging their infant E.M.F. died January 14, 2008 from vaccines (DTaP, IPV, Hib, PCV, rotavirus) given January 10, 2008. Petition filed 2010; case tried on entitlement.
Autopsy diagnosed SIDS (sudden infant death syndrome); findings included pulmonary congestion and pulmonary interstitial lymphoid hyperplasia; prior late-November 2007 pneumonia was documented.
Petitioners offered pediatric pathologist Dr. Laurel Waters, who proposed (1) vaccine-induced fever as an exogenous stressor under the Triple Risk Model for SIDS, and primarily (2) a vaccine-triggered type IV (T-cell–mediated) delayed hypersensitivity/anamnestic reaction causing death.
Respondent offered pediatric pathologist Dr. Sara Vargas, who attributed the lung lymphoid hyperplasia to prior pneumonia and testified that germinal center formation/mature lymphoid follicles require longer than the few days between vaccination and death.
Special Master weighed expert credibility, found petitioners failed Althen prongs: Dr. Waters’ theories were under-supported, internally inconsistent, lacked literature linking vaccines to fatal type IV hypersensitivity or to the autopsy findings, and did not provide a coherent mechanism explaining how the immune response caused sudden death.
Decision: entitlement denied; petitioners did not meet the preponderance burden that vaccines caused E.M.F.’s death.

Issues

Issue	Plaintiff's Argument	Defendant's Argument	Held
Whether vaccines given Jan. 10, 2008 caused E.M.F.’s death (causation-in-fact under Althen)	Waters: vaccines provoked fever and an anamnestic type IV delayed hypersensitivity response (lymphokine-mediated apoptosis/arrhythmia) within accepted timeframe	Vargas: autopsy lymphoid hyperplasia predated vaccination (post-Nov pneumonia); no epidemiologic or pathological support that vaccines cause SIDS or the observed pathology	Denied — petitioners failed all three Althen prongs (theory, logical sequence, timing) due to weak theory, lack of mechanism, and timing inconsistent with formation of mature germinal centers
Whether temporal proximity (4 days) supports causation	Petitioners: short interval supports re-challenge/hypersensitivity link	Respondent: temporal association alone insufficient; autopsy evidence indicates chronic process predating vaccines	Denied — timing without a persuasive mechanism is insufficient to establish causation
Reliability/weight of expert testimony	Petitioners: Dr. Waters’ pathology opinion and selected literature support causation	Respondent: Dr. Vargas’ pediatric lung pathology experience and literature rebut Waters; Waters lacked supporting literature/experience on lung germinal center timing	Court credited Vargas over Waters; Waters’ opinion found speculative and unsupported
Whether lymphoid hyperplasia on autopsy indicates vaccine-caused fatal immune reaction	Petitioners: lymphoid hyperplasia consistent with hypersensitivity and supports vaccine causation	Respondent: degree and maturity of lymphoid changes are consistent with prior pneumonia and require longer formation time than claimed	Held it likely reflected preexisting/older pulmonary inflammation (post-Nov pneumonia), not an acute vaccine-caused hypersensitivity leading to death

Key Cases Cited

Althen v. Sec’y of Health & Human Servs., 418 F.3d 1274 (Fed. Cir. 2005) (three-prong test for causation-in-fact in Vaccine Program cases)
Moberly v. Sec’y of Health & Human Servs., 592 F.3d 1315 (Fed. Cir. 2010) (preponderance standard and burden for vaccine causation)
Knudsen v. Sec’y of Health & Human Servs., 35 F.3d 543 (Fed. Cir. 1994) (requirement that petitioners provide a reputable medical/scientific explanation)
Broekelschen v. Sec’y of Health & Human Servs., 618 F.3d 1339 (Fed. Cir. 2010) (role of expert credibility and persuasiveness in Vaccine Program decisions)
Daubert v. Merrell Dow Pharm., 509 U.S. 579 (U.S. 1993) (factors for evaluating reliability of expert scientific testimony)