THOMAS v. SECRETARY OF HEALTH AND HUMAN SERVICES
1:15-vv-00958
Fed. Cl.Jul 6, 2016Background
- Petitioner Nancy Thomas received Tdap on August 29, 2012 and later alleged it caused transverse myelitis (TM); she died September 16, 2015 and the estate, by Donald Maloney, Sr., pursued the Vaccine Program petition.
- Petitioner sought expert review but ultimately did not file an expert report; counsel withdrew after investigating the facts and science and moved to dismiss on June 10, 2016.
- Medical records show ED presentation in September 2012 for visual disturbance, dizziness, and gait complaints; exams, MRIs, and EMG were normal and no treating physician diagnosed TM.
- Neurologic evaluations (including Dr. Neeta Garg) found records inconsistent with TM and no objective findings supporting chronic inflammatory demyelinating polyneuropathy or genetic neuropathy.
- The special master scheduled status conferences, considered petitioner’s inability to substantiate causation, and granted the motion to dismiss for failure to make a prima facie case.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether petitioner proved causation-in-fact linking Tdap to TM | Tdap caused TM following vaccination | Petitioner did not present expert proof or medical-record support of causation | Petition dismissed for failure to establish prima facie causation-in-fact |
| Whether temporal association alone suffices | Temporal proximity supports causation | Temporal association is insufficient without medical theory or expert support | Temporal association insufficient; must show medical theory and logical sequence |
| Whether absence of other causes can prove causation | Arguably supports vaccine causation by exclusion | Absence of other causes does not satisfy affirmative burden to prove causation | Court rejects an exclusion-only approach; requires affirmative proof |
| Whether medical records suffice without expert opinion | Medical records and assertions should be enough | Vaccine Act requires medical opinion or scientific evidence for causation | Court held records alone (and lack of TM diagnosis) are inadequate |
Key Cases Cited
- Althen v. Sec'y of HHS, 418 F.3d 1274 (Fed. Cir. 2005) (sets three-prong test for causation-in-fact under Vaccine Act)
- Grant v. Sec'y of HHS, 956 F.2d 1144 (Fed. Cir. 1992) (absence of other causes does not alone prove causation; need medical/scientific explanation)
- Shyface v. Sec'y of HHS, 165 F.3d 1344 (Fed. Cir. 1999) (petitioner must show vaccine was a substantial factor and but-for cause)