Locane v. Secretary of Health & Human Services
2012 U.S. App. LEXIS 14304
| Fed. Cir. | 2012Background
- Ms. Locane sought compensation under the Vaccine Act for Crohn's disease allegedly caused or worsened by hepatitis B vaccination.
- Special Master found disease began before vaccination and denied compensation under causation and significant aggravation theories.
- Claims Court affirmed the Special Master’s factual and legal rulings, including preexisting onset and lack of significant aggravation.
- Locane’s vaccination history: Aug. 29, 1997 first dose; Nov. 18, 1997 second dose; Feb. 6, 1998 third dose; Crohn's symptoms followed initial vaccination.
- Medical experts disagreed: Dr. Bellanti supported a temporal link; Dr. Warner argued growth-velocity decline predated vaccination and did not tie to vaccine.
- Court reviewed de novo the legality of the Special Master’s findings of fact and the application of causation standards under the Vaccine Act.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether Crohn's disease onset predated vaccination. | Locane argues symptoms began after vaccination. | Warner testimony supports pre-vaccination onset. | Preponderance showed onset predated vaccination. |
| Whether the Althen causation framework applies given preexisting onset. | Althen analysis should be applied to causation in fact. | Onset established before vaccination; Althen not needed. | Althen analysis unnecessary when onset predates vaccine. |
| Whether Locane proved significant aggravation of Crohn's disease by vaccination. | Vaccination worsened disease course. | Course not worsened by vaccination; flare-ups consistent with disease. | No substantial evidence of significant aggravation; upheld denial. |
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; proximate temporal relation, medical theory, and logical sequence)
- Broekelschen v. Sec’y of Health & Human Servs., 618 F.3d 1339 (Fed. Cir. 2010) (upholds deference to special master on factual determinations; confirms stepwise causation analysis)
- Hodges v. Sec’y of Dep’t of Health & Human Servs., 9 F.3d 958 (Fed. Cir. 1993) (reaffirms deferential review of fact-intensive determinations)
- Locane v. Sec’y of Health & Human Servs., 99 Fed. Cl. 715 (Fed. Cl. 2011) (special master’s finding of pre-vaccination onset affirmed)