88 F.4th 958
Fed. Cir.2023Background
- Donald Winkler developed Guillain-Barré Syndrome (GBS) after receiving a Tdap vaccination, shortly after which he was also diagnosed with gastroenteritis.
- Winkler filed a petition seeking compensation under the National Vaccine Injury Compensation Program, alleging the Tdap vaccine caused his GBS.
- The Special Master found Winkler failed to prove by preponderant evidence that the Tdap vaccine caused his GBS, despite assuming he met two of the three required causation elements under Althen.
- The Special Master considered that Winkler's gastroenteritis could have been caused by Campylobacter jejuni infection, a known trigger for GBS, though this was not confirmed by lab tests.
- The Court of Federal Claims affirmed the Special Master's denial of compensation, and Winkler appealed to the Federal Circuit.
- The Federal Circuit affirmed, finding no abuse of discretion in the Special Master’s weighing of the evidence and the conclusion that causation by the vaccine was not proven.
Issues
| Issue | Winkler's Argument | Secretary's Argument | Held |
|---|---|---|---|
| Proof required for causation in off-Table GBS | Vaccine was substantial cause of GBS | Gastroenteritis (possibly C. jejuni) likely cause | Winkler failed to prove vaccine caused GBS |
| Need to eliminate alternative causes | Not required to disprove all alternatives | Alternative causes (infection) properly considered | No need to eliminate, but must show vaccine causation |
| Consideration of evidence re: C. jejuni | Evidence was speculative, not proven | Reasonable to consider as possible trigger | Permissible to consider, no finding required |
| Burden of proof regarding alternative causes | Government must prove alternative cause | Petitioner bears burden in first instance | Petitioner's burden to prove causation |
Key Cases Cited
- Althen v. Sec’y of Health & Hum. Servs., 418 F.3d 1274 (Fed. Cir. 2005) (establishes three-prong causation test in vaccine injury cases)
- Munn v. Sec’y of Dep’t of Health & Hum. Servs., 970 F.2d 863 (Fed. Cir. 1992) (sets standards of review for factual and legal determinations in vaccine cases)
- Hines ex rel. Sevier v. Sec’y of Health & Hum. Servs., 940 F.2d 1518 (Fed. Cir. 1991) (no deference review standard for appeals from Court of Federal Claims)
- Porter v. Sec’y of Health & Hum. Servs., 663 F.3d 1242 (Fed. Cir. 2011) (deference to factfinder’s weighing of medical evidence)
- Stone v. Sec’y of Health & Hum. Servs., 676 F.3d 1373 (Fed. Cir. 2012) (evidence of other possible injury sources can be relevant to causation)
- Doe v. Sec’y of Health & Hum. Servs., 601 F.3d 1349 (Fed. Cir. 2010) (failure to meet causation burden differs from duty to rule out alternatives)