108 Fed. Cl. 743
Fed. Cl.2013Background
- Petitioner LaKeysha Isaac seeks compensation under the Vaccine Act for Guillain-Barré Syndrome (GBS) allegedly caused by a Td vaccine administered September 15, 2005 (and Hepatitis A vaccine; Hep A claim later dismissed).
- Special Master Abell presided, later reassigned to Special Master Lord who held a causation hearing on July 27, 2010.
- Petitioner’s expert Dr. Tornatore urged molecular mimicry as the causal mechanism linking Td vaccine to GBS; Respondent Dr. Leist attributed GBS to a preceding gastrointestinal illness.
- Court records introduced Institute of Medicine (IOM) prepublication/2011 material suggesting uncertain or evolving views on Td vaccine–GBS causation, influencing the evidentiary framework.
- Special Master Lord found Tornatore’s testimony unreliable, rejected molecular mimicry as the causal theory, and found the Hep A claim abandoned; petition was denied under the Althen prong framework; court reviews for arbitrary/abusive discretion under the Vaccine Act.
- The decision at issue is the denial of entitlement for the tetanus vaccination claim, which the court affirms on appeal.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether Petitioner proved a medical theory linking Td vaccine to GBS | Isaac showed a biologically plausible theory (molecular mimicry) | Leist countered with lack of mechanism and evidence | No; theory unreliable under Althen Prong 1 |
| Whether the evidence supports a causal link given IOM findings | IOM data do not bar causation and support Dr. Tornatore | IOM later deemed Pollard/Selby unreliable for causal link | No; IOM reconsideration undermined Tornatore’s reliance |
| Whether the Hep A claim was properly abandoned | Hep A claim remained a viable theory | Petitioner effectively abandoned Hep A causation | Grants dismissal of Hep A claim |
| Whether the Special Master applied the proper standard of review under Althen | Master followed Althen test and not an epidemiological bar | Master properly weighed reliability of expert and evidence | Yes; Althen framework applied correctly |
| Whether there was an abuse of discretion in evaluating Dr. Tornatore’s testimony | Master mischaracterized testimony and relied on IOM changes | Master properly discounted unreliable testimony | No; decision not arbitrary or capricious |
Key Cases Cited
- Althen v. Sec’y of Health & Human Servs., 418 F.3d 1274 (Fed. Cir. 2005) (three-prong test for off-Table causation; medical theory, logical sequence, temporal relation)
- Knudsen ex rel. Knudsen v. Sec’y of Health & Human Servs., 35 F.3d 543 (Fed. Cir. 1994) (avoid requiring conclusive biological mechanism; causation may be inferred)
- Capizzano v. Sec’y of Health & Human Servs., 440 F.3d 1326 (Fed. Cir. 2006) (overlap of evidence to satisfy multiple Althen prongs)
- Moberly ex rel. Moberly v. Sec’y of Health & Human Servs., 592 F.3d 1315 (Fed. Cir. 2010) (preponderant evidence standard; expert credibility within Vaccine Act framework)
- Hibbard v. Sec’y of Health & Human Servs., 698 F.3d 1355 (Fed. Cir. 2012) (arbitrary, capricious review; deferential standard for special masters)