Locane v. Secretary of Health & Human Services
2011 U.S. Claims LEXIS 1595
| Fed. Cl. | 2011Background
- Petitioner Locane filed Aug 4, 1999 in the Court of Federal Claims for Vaccine Act compensation for Crohn’s disease after hepatitis B vaccinations.
- Special Master Moran found onset of Crohn’s prior to Aug 29, 1997 vaccination, based largely on Dr. Warner’s testimony; Drs. Bellanti and Solny offered contrary timelines.
- Petitioner challenged the timing finding and argued for causation under Althen three-prong test, and also for significant aggravation after vaccination.
- The Special Master proceeded to assess significant aggravation, allowed supplemental briefing and expert reports, and ultimately found no significant aggravation.
- Petitioner sought review in the court of Federal Claims; the court upheld the Special Master’s factual finding and denied entitlement on the merits.
- The court applied the deferential arbitrary-and-capricious standard to the Master’s factual findings and reviewed the legal standards for causation under the Vaccine Act.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether onset predating vaccination was arbitrary or capricious | Locane contends onset occurred after vaccination; argues record shows no preexisting Crohn’s | Warner’s growth-velocity timing and records support preexisting Crohn’s | Not arbitrary; record supports preexisting onset |
| Whether Althen analysis was required after a finding of prior onset | If disease began before vaccination, Althen analysis unnecessary for causation | Court may proceed with significant aggravation analysis and standard causation framework | Althen analysis not required at this stage; proceeding with aggravation analysis is permissible |
| Whether petitioner proved significant aggravation of Crohn’s disease by vaccination | Vaccination aggravated disease; flare-ups post-vaccination support causation | Evidence shows fluctuations typical of Crohn’s; no aggravation attributable to vaccine | Not proven by preponderance; vaccine not shown to significantly aggravate the disease |
| Whether the Special Master properly weighed expert testimony on Crohn’s onset | Bellanti’s immunology background should be persuasive; Warner’s Crohn’s focus should not overshadow | Warner’s Crohn’s expertise more persuasive for disease onset timing | No error; Master’s credibility determinations reasonable and supported by record |
Key Cases Cited
- Althen v. Sec’y of Health & Human Servs., 418 F.3d 1274 (Fed.Cir. 2005) (three-prong causation test for off-Table injuries)
- de Bazan v. Sec’y of Health & Human Servs., 539 F.3d 1347 (Fed.Cir. 2008) (causation-in-fact framework under Vaccine Act)
- Walther v. Sec’y of Health & Human Servs., 485 F.3d 1146 (Fed.Cir. 2007) (presumed vs non-presumed causation pathways under Table/off-Table)
- Loving v. Sec’y of Health & Human Servs., 86 Fed.Cl. 135 (Cl. Fed. 2009) (significant aggravation standard and Loving framework)
- Capizzano v. Sec’y of Health & Human Servs., 440 F.3d 1317 (Fed.Cir. 2006) (positive-reehallenge concept in aggravation analysis)
- Broekelschen v. Sec’y of Health & Human Servs., 618 F.3d 1339 (Fed.Cir. 2010) (role of expert testimony in Vaccine Act decisions)