Hibbard v. Secretary of Health & Human Services
2012 U.S. App. LEXIS 22618
| Fed. Cir. | 2012Background
- Hibbard developed dysautonomia after a flu vaccination in November 2003; doctors reported POTS and symptoms of autonomic dysfunction.
- A Mayo Clinic study linked POTS with limited autonomic neuropathy in about half of patients, influencing the causal theory.
- Two days of hearings before a special master; competing expert reports proposed autonomic neuropathy (Dr. Morgan) vs. lack of autonomic signs (Dr. Chaudhry).
- Special master concluded the record did not prove autonomic neuropathy and denied compensation under the Vaccine Act as an off-Table injury.
- Court of Federal Claims and then the Federal Circuit affirmed the denial, applying the Althen burden-shifting framework.
- The decision centers on whether Hibbard’s dysautonomia is due to autonomic neuropathy caused by the vaccine; without neuropathy, causation fails.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether Hibbard proved autonomic neuropathy. | Hibbard argues vaccine-induced autonomic neuropathy caused her dysautonomia. | Defendant contends objective testing shows no autonomic neuropathy. | No; record supports no autonomic neuropathy. |
| Proper application of Althen burden shifting in off-Table cases. | Althen three-part test suffices; need not prove abdominal actual causation if theory plausible and no alternative cause shown. | Must prove actual causation by preponderance; the government failed to identify a likely alternative cause. | The petition fails because no autonomic neuropathy proven and no alternative cause required to be identified by the government. |
| Propriety of relying on the Mayo Clinic study to infer autonomic neuropathy. | Study supports link between POTS and autonomic neuropathy in many patients, bolstering causation. | Study is limited and not dispositive; individual testing did not show neuropathy. | The evidence does not overcome the lack of objective signs of autonomic neuropathy in Hibbard. |
Key Cases Cited
- Althen v. Secretary of Health & Human Servs., 418 F.3d 1274 (Fed.Cir.2005) (three-part causation test for off-Table injuries)
- Broekelschen v. Secretary of Health & Human Servs., 618 F.3d 1339 (Fed.Cir.2010) (injury focus before causation framework; context-dependent application)
- Lombardi v. Secretary of Health & Human Servs., 656 F.3d 1343 (Fed.Cir.2011) (preponderance burden in vaccine causation, causal framework)
- Moberly v. Secretary of Health & Human Servs., 592 F.3d 1315 (Fed.Cir.2010) (off-Table causation standard and evidence review)
- Porter v. Secretary of Health & Human Servs., 663 F.3d 1242 (Fed.Cir.2011) (Althen framework and preponderance standard reaffirmed)
- Stone v. Secretary of Health & Human Servs., 676 F.3d 1373 (Fed.Cir.2012) (purpose and scope of causation analysis under Althen)
- Cloer v. Secretary of Health & Human Servs., 654 F.3d 1322 (Fed.Cir.2011) (Althen pleading requirements and preponderance standard clarified)
- Locane v. Secretary of Health & Human Servs., 685 F.3d 1375 (Fed.Cir.2012) (deferential review of special master’s fact-findings)
- Andreu v. Secretary of Health & Human Servs., 569 F.3d 1367 (Fed.Cir.2009) (causation analysis considerations in Vaccine Act cases)
- Cedillo v. Secretary of Health & Human Servs., 617 F.3d 1328 (Fed.Cir.2010) (arbitrary and capricious review standard for special masters)