Doles v. Secretary of Health and Human Services
17-642
| Fed. Cl. | Apr 26, 2022Background
- Elizabeth Doles received a polio vaccine and then a Tdap vaccine and soon thereafter developed neurological symptoms she alleged were central nervous system demyelination characterized as multiple sclerosis (MS).
- Petitioner’s filings contained shifting expert theories: an early treating physician favored ADEM; Dr. Steel argued focal myelitis/transverse myelitis (TM) triggered by vaccination in a patient with subclinical MS (not that vaccines caused MS); defense expert Dr. Sriram concluded petitioner has MS not caused or aggravated by vaccines.
- The Special Master rejected ADEM and TM, instead finding petitioner had MS and that the vaccinations significantly aggravated that MS, relying principally on the Langer‑Gould epidemiological study.
- The Special Master’s entitlement decision adopted an aggravation theory the parties had not advanced and rested heavily on the Langer‑Gould study without giving the parties an opportunity to address that novel framing.
- The government moved for review challenging the Special Master’s characterization of the injury and the use and interpretation of the Langer‑Gould study.
- The Court of Federal Claims granted review, held the Special Master erred (both procedurally and in his interpretation of the study), vacated the decision, and remanded for further proceedings and opportunity for the parties to address aggravation of MS under correct legal and scientific standards.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether vaccines caused or significantly aggravated petitioner’s neurological injury (off‑Table causation) | Vaccines provoked autoimmune demyelination manifesting as TM; petitioner’s subclinical MS was a risk factor | Vaccines did not cause or aggravate petitioner’s MS or TM; MS was preexisting/unrelated | Remanded: Special Master misstated parties’ theories and must re‑examine causation/aggravation with full opportunity to litigate |
| Proper characterization of petitioner’s condition (ADEM, TM, or MS) | Experts offered competing diagnoses (ADEM or TM in context of subclinical MS) | Defense expert: MS best explains record; TM not a separate vaccine‑caused event | Special Master adopted MS but had no adequate adversarial development for treating case as aggravation of MS; remand required |
| Use and interpretation of Langer‑Gould epidemiological study | Study supports vaccines aggravating subclinical autoimmunity into overt MS (per Special Master’s reading) | Study shows no association between vaccination and MS, especially in patients 50+ and outside short time windows | Court: Special Master misinterpreted the study; it does not support causation for petitioner’s circumstances; reliance was erroneous |
| Procedural fairness / notice when Special Master adopts new theory | N/A (petitioner did not clearly press an aggravation‑of‑MS theory) | Government: lacked notice and opportunity to address new aggravation theory | Held for government: Special Master should have given parties chance to respond; remand ordered for further proceedings |
Key Cases Cited
- Althen v. Sec'y of Health & Hum. Servs., 418 F.3d 1274 (Fed. Cir. 2005) (establishes the three‑part test for causation in Vaccine Act off‑Table cases)
- Knudsen v. Sec'y of Health & Hum. Servs., 35 F.3d 543 (Fed. Cir. 1994) (discusses burden of proof and that causation may be found without detailed biological mechanism)
- Broekelschen v. Sec'y of Health & Hum. Servs., 618 F.3d 1339 (Fed. Cir. 2010) (requires a reputable medical or scientific explanation specific to the petitioner)
- Boatmon v. Sec'y of Health & Hum. Servs., 941 F.3d 1351 (Fed. Cir. 2019) (rejects merely plausible or possible causal theories without supporting evidence)
- Moberly v. Sec'y of Health & Hum. Servs., 592 F.3d 1315 (Fed. Cir. 2010) (evidence must do more than show possibility of causation)
- W.C. v. Sec'y of Health & Hum. Servs., 704 F.3d 1352 (Fed. Cir. 2013) (sets elements for proving significant aggravation under the Vaccine Act)
- Munn v. Sec'y of Dep't of Health & Hum. Servs., 970 F.2d 863 (Fed. Cir. 1992) (standards of review for special master findings)
- Hibbard v. Sec'y of Health & Hum. Servs., 698 F.3d 1355 (Fed. Cir. 2012) (reaffirms preponderance standard for causation)
- Andreu ex rel. Andreu v. Sec'y of Dep't of Health & Hum. Servs., 569 F.3d 1367 (Fed. Cir. 2009) (published research not strictly required to prove causation)
- Sharpe v. Sec'y of Health & Hum. Servs., 964 F.3d 1072 (Fed. Cir. 2020) (discusses standards applicable to significant aggravation claims)