Lombardi v. Secretary of Health and Human Services
2011 U.S. App. LEXIS 18488
| Fed. Cir. | 2011Background
- Lombardi, born Oct 17, 1946, received hepatitis B vaccine doses on Apr 1, 1997; May 6, 1997; and Oct 28, 1997.
- Nov 9 and Nov 14, 1997 Lombardi sought ER care for right flank pain with no identifiable cause found.
- Jan 1998 treatment for ongoing fatigue and right-sided pain; positive ANA with workup for possible SLE; referral to Cleveland Clinic.
- Feb-Mar 1998 evaluations by rheumatologists largely found no autoimmune disease; March 1998 vitamin B12 deficiency and osteopenia/osteoporosis noted.
- Throughout 1998-1999 Lombardi saw multiple physicians; several treated for fatigue, polyneuropathy, and possible vaccine-related issues; SLE later considered by one expert but not diagnosed by treating physicians.
- Special master denied compensation after finding Lombardi failed to prove any of the three claimed injuries (transverse myelitis, chronic fatigue syndrome, SLE) by a preponderance of the evidence; Claims Court and Federal Circuit affirmed.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether injury identification is a prerequisite to Althen causation analysis | Lombardi contends no fixed diagnosis is required before causation. | Government argues the injury must be defined first under Broekelschen. | Broekelschen applied; injury identification prerequisite controlling |
| Whether Lombardi proved any off-Table injury by a preponderance | Lombardi asserts evidence supports transverse myelitis, CFS, or SLE. | Government contends no diagnosis met the required criteria and evidence was insufficient. | No injury proven by preponderance |
| Whether the court properly applied Althen causation analysis after identifying injury | If any injury were identified, vaccination caused it per Althen. | Causation analysis unnecessary without a proven injury; proper burden shifting not allowed. | Althen analysis unnecessary where no injury proven |
| Was the special master's handling of SLE, CFS, and transverse myelitis findings reasonable | Expert opinions supported by criteria should establish injury and causation. | Master reasonably discounted inconsistent or non-diagnostic evidence. | Yes; conclusions not arbitrary or capricious |
Key Cases Cited
- Althen v. Secretary of Health & Human Services, 418 F.3d 1274 (Fed. Cir. 2005) (three-part causation test for off-Table injuries)
- Broekelschen v. Secretary of Health & Human Services, 618 F.3d 1339 (Fed. Cir. 2010) (injury identification prerequisite before Althen analysis)
- Andreu v. Sec'y of Health & Human Servs., 569 F.3d 1367 (Fed. Cir. 2009) (review standard and deference to special masters on factual issues)
- Moberly v. Sec'y of Health & Human Servs., 592 F.3d 1315 (Fed. Cir. 2010) (off-Table causation and medical evidence standards)
- Capizzano v. Sec'y of Health & Human Servs., 440 F.3d 1317 (Fed. Cir. 2006) (credibility and weighing expert testimony)
- Hodges v. Health & Human Servs., 9 F.3d 958 (Fed. Cir. 1993) (review of Special Master's factual conclusions)
- Shyface v. Sec'y of Health & Human Servs., 165 F.3d 1344 (Fed. Cir. 1999) (purpose of Vaccine Act is quick, certain compensation)