Boatmon v. Hhs
941 F.3d 1351
| Fed. Cir. | 2019

Background

  • Infant J.B., born four weeks premature, received multiple routine vaccines at his four‑month visit and developed fever the same day; he was found unresponsive the next day and died. Autopsy ruled the death SIDS, but did not examine medullary regions (e.g., arcuate nucleus).
  • Petitioners (Boatmon and Cupid) pursued compensation under the National Vaccine Injury Compensation Program, asserting vaccines substantially contributed to J.B.’s SIDS death.
  • Special Master credited Petitioners’ expert (Dr. Miller), adopting an extension of Kinney’s Triple Risk Model: vaccines trigger cytokine upregulation that impairs medullary 5‑HT function, causing failure of autoresuscitation, and found all three Althen prongs satisfied.
  • The Court of Federal Claims reversed, finding the Special Master applied a legally deficient (too low) standard, criticized reliance on an unaccepted theory and on limited peer review, and concluded Petitioners failed Althen prong one and two.
  • Federal Circuit majority affirmed the Court of Federal Claims’ judgment: while rejecting some of the Court of Federal Claims’ procedural critiques (e.g., requiring citation to other Special Masters or rigid Daubert application), it held Petitioners did not meet the required “reputable, sound and reliable” proof of causation and could not rely on statistical inference alone that J.B. had a brainstem abnormality.
  • Concurrence emphasized adherence to precedent; dissent argued for a more permissive approach (prima facie/common‑sense causation) consistent with the Vaccine Act’s remedial purpose.

Issues

Issue Plaintiff's Argument Defendant's Argument Held
Whether Petitioners proved causation‑in‑fact under Althen Vaccines can be an exogenous stressor via cytokine upregulation impairing medullary 5‑HT; temporal proximity and expert opinion show vaccines likely contributed to death Petitioners’ theory is unaccepted, not shown by reliable human evidence, and temporal association alone is insufficient Held for defendant: Petitioners failed Althen prong one and two; causation not proven by preponderance
Proper evidentiary standard for off‑Table vaccine claims A reasonable or plausible medical theory plus temporal link suffices given scientific uncertainty Petitioners must meet the established Althen/Moberly/Knudsen standard: a reputable, sound, reliable medical explanation by preponderance Held: Special Master applied too low a “reasonable/plausible” standard; correct standard requires more reliable proof
Reliance on statistical inference that decedent had a brainstem 5‑HT defect It is statistically likely (50–70% in SIDS) J.B. had the defect; absence of direct autopsy evidence can be overcome by statistics and expert inference Statistical likelihood alone cannot prove an individual’s underlying vulnerability; autopsy did not examine required medullary regions Held: Statistical inference alone insufficient; Special Master erred in treating likelihood as proof of the individual’s vulnerability
Whether Court of Federal Claims properly invoked Daubert or required Special Masters to follow other Special Masters Petitioners: Daubert is not mandatory; special masters may use but need not follow Daubert; other special masters’ decisions are non‑binding Govt argued Special Master relied on unpeer‑reviewed, unsupported theory and other Special Masters reached contrary conclusions Held: Court of Federal Claims was wrong to suggest Special Masters must follow or distinguish other special‑master decisions or rigidly apply Daubert; but the ultimate judgment upholding reversal was correct on merits (insufficient reliable causation)

Key Cases Cited

  • Althen v. Sec'y of Health & Human Servs., 418 F.3d 1274 (Fed. Cir. 2005) (establishes three‑prong test for causation in vaccine off‑Table cases)
  • Moberly v. Sec'y of Health & Human Servs., 592 F.3d 1315 (Fed. Cir. 2010) (requires reputable medical/scientific explanation and preponderance proof)
  • Knudsen v. Sec'y of Dep't of Health & Human Servs., 35 F.3d 543 (Fed. Cir. 1994) (expert theory must be sound and reliable; statistical likelihood alone insufficient)
  • LaLonde v. Sec'y of Health & Human Servs., 746 F.3d 1334 (Fed. Cir. 2014) (temporal proximity alone does not establish causation)
  • Grant v. Sec'y of Dep't of Health & Human Servs., 956 F.2d 1144 (Fed. Cir. 1992) (proximate temporal association insufficient for causation)
  • Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579 (U.S. 1993) (factors for assessing reliability of expert testimony)
  • Kumho Tire Co. v. Carmichael, 526 U.S. 137 (U.S. 1999) (Daubert inquiry is flexible and applies to all expert testimony)
  • Cedillo v. Sec'y of Health & Human Servs., 617 F.3d 1328 (Fed. Cir. 2010) (special masters may consider Daubert factors but are not strictly bound)
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