Spahn v. Secretary of Health and Human Services
09-386
| Fed. Cl. | Jul 31, 2017Background
- Petitioner Forrest Spahn (born 1991) had pre-existing OCD and related developmental issues; received a Td vaccine on June 19, 2007 (alleged 25 µg thimerosal / 12.375 µg inorganic mercury).
- Within months he experienced worsening OCD, school refusal, hospitalization (Nov–Dec 2007), motor and vocal tics, and diagnoses including OCD, tic disorder/Tourette’s, and autistic spectrum disorder/Asperger’s (some provisional).
- Petitioner alleges the Td vaccination significantly aggravated his pre-existing OCD by causing new tics; seeks compensation under the National Vaccine Injury Compensation Program.
- Petitioner offered opinion reports from neurologist Burk Jubelt and toxicologist H. Vasken Aposhian; Respondent offered rebuttal reports from pediatric neurologist Michael Kohrman and toxicologist Jeffrey Johnson.
- Key evidentiary disputes: (1) whether epidemiological and in vitro studies cited by petitioner (Verstraeten, Andrews, Baskin, James, Woods, Li) can be extrapolated to a single 25 µg Td dose in a 15-year-old; (2) dose-response and exposure-route differences; (3) lack of proof petitioner has the alleged CPOX4 genetic susceptibility.
- Special Master found petitioner had multiple opportunities to supplement experts but failed to address major gaps (dose-response, relevancy of cited studies, genetic testing) and granted summary judgment for respondent because petitioner’s expert opinions were conclusory and unreliable.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether petitioner presented a reliable medical theory that the Td vaccine (single 25 µg thimerosal dose) caused tics/significant aggravation | Spahn: epidemiological (Verstraeten, Andrews) and mechanistic/in vitro (Baskin, James) literature + Aposhian’s hypersusceptibility theory support causation | HHS: cited studies involve much greater cumulative doses, different ages, chronic exposures, or different routes; experts failed to address dose-response and relevancy; Aposhian’s genetic claim is unproven and circular | Held: Petitioner’s experts did not provide reliable, case-specific explanations; literature cited is not reasonably extrapolable to Spahn’s facts; theory is insufficient to survive summary judgment |
| Whether petitioner’s experts adequately addressed dose-response and exposure-route differences | Spahn: experts assert link and vulnerability but did not quantify dose-response or reconcile study differences | HHS: experts (Kohrman, Johnson) showed the doses used in studies far exceed petitioner’s exposure and that route/age differences make extrapolation unreliable | Held: Failure to address dose-response and exposure-route gaps is fatal; petitioner did not rebut these expert critiques |
| Whether petitioner’s reliance on in vitro studies (Baskin, James) supports causation in vivo | Spahn: in vitro findings show thimerosal can cause DNA damage / glutathione depletion, suggesting neurotoxicity | HHS: in vitro doses were orders of magnitude higher than vaccine exposure and authors warned results do not mimic in vivo vaccine exposures | Held: In vitro work was not shown to be applicable to a single intramuscular vaccine dose in a 15-year-old and is insufficiently probative |
| Whether Aposhian’s CPOX4 hypersusceptibility theory creates a triable issue | Spahn: CPOX4 could render petitioner hypersusceptible to mercury, explaining causation | HHS: No evidence petitioner has CPOX4; Aposhian’s reasoning is circular and relies on inapposite chronic-exposure studies | Held: Without genetic testing or a principled bridge to single-dose exposure, the hypersusceptibility theory is speculative and unreliable |
Key Cases Cited
- Althen v. Sec’y of Health & Human Servs., 418 F.3d 1274 (Fed. Cir. 2005) (petitioner must provide a reputable medical explanation connecting vaccine to injury)
- Jay v. Sec’y of Health & Human Servs., 998 F.2d 979 (Fed. Cir. 1993) (motions for summary judgment apply in Vaccine Program)
- Simanski v. Sec’y of Health & Human Servs., 671 F.3d 1368 (Fed. Cir. 2012) (special master may decide whether evidence suffices to proceed to hearing)
- Cedillo v. Sec’y of Health & Human Servs., 617 F.3d 1328 (Fed. Cir. 2010) (petitioners must demonstrate reliability of expert opinions)
- Novartis Corp. v. Ben Venue Laboratories, Inc., 271 F.3d 1043 (Fed. Cir. 2001) (conclusory expert opinions insufficient to withstand summary judgment)
- Henrickson v. ConocoPhillips Co., 605 F. Supp. 2d 1142 (E.D. Wash. 2009) (toxicology opinion excluded for failure to address dose-response and apply accepted methodology)