Pless v. Secretary of Health and Human Services
16-271
| Fed. Cl. | Mar 3, 2017Background
- Petitioner filed a Vaccine Act claim alleging that a May 30, 2014 Tdap vaccination caused paresthesias, weakness, Guillain-Barré syndrome (GBS), somatoform disorder, and neuropathy.
- Medical records from late May–July 2014 show multiple evaluations (neurology, rheumatology, imaging, EMG/NCS, lumbar puncture) with largely normal neurologic exams, normal reflexes, normal EMG/NCS, normal CSF protein, and no evidence of demyelination.
- Treating neurologists repeatedly suspected a somatoform/functional disorder and anxiety as contributors; petitioner’s symptoms improved and she acknowledged anxiety exacerbation.
- Petitioner did not produce an expert report linking the Tdap vaccine to her alleged injuries despite court orders and extensions.
- The special master issued an order to show cause and set deadlines for an expert report; petitioner ultimately moved to dismiss, conceding she could not marshal persuasive evidence to prove entitlement.
- The special master dismissed the petition for failure to establish causation in fact and for lack of supporting medical opinion within the relevant post-vaccination period.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Causation in fact: did Tdap cause petitioner’s neurological injuries? | Tdap triggered chronic paresthesias/GBS and related conditions after May 30, 2014. | Medical records do not support vaccine causation; exams and testing are normal and point to somatization. | Denied — petitioner failed to prove causation by preponderant evidence. |
| Temporal relationship: were symptoms attributable to vaccine within an appropriate window? | Onset alleged in June 2014 (variously described) after May 30 vaccination. | Records show normal neurologic findings through two months and no objective evidence linking onset to vaccine. | Denied — no medically supported onset within a proximate post-vaccination window. |
| Reliance on treating physicians’ opinions | Petitioner relied on treating notes and sought to obtain expert support. | Respondent emphasized treating notes do not attribute GBS/neurologic disease to vaccine; treating doctors suspected somatization. | Treated opinions considered, but none provided medical causation within required timeframe; insufficient without expert analysis. |
| Burden to provide expert proof | Petitioner contended factual record and treating notes suffice; intended to retain expert but failed to timely produce report. | Respondent argued petitioner must supply a reputable medical explanation and expert support to establish causation. | Held for respondent — petitioner’s failure to file an expert report and lack of objective medical proof warranted dismissal. |
Key Cases Cited
- Capizzano v. Secretary of Health & Human Servs., 440 F.3d 1317 (Fed. Cir.) (treating physicians’ opinions warrant serious evaluation)
- Althen v. Secretary of Health & Human Servs., 418 F.3d 1274 (Fed. Cir.) (elements plaintiff must prove for causation in fact)
- Grant v. Secretary of Health & Human Servs., 956 F.2d 1144 (Fed. Cir.) (temporal association alone insufficient; need reputable medical or scientific support)
- Shyface v. Secretary of Health & Human Servs., 165 F.3d 1344 (Fed. Cir.) (vaccine must be a substantial factor in causing injury)
- Broekelschen v. Secretary of Health & Human Servs., 618 F.3d 1339 (Fed. Cir.) (treating physician evidence significance)
- Andreu v. Secretary of Health & Human Servs., 569 F.3d 1367 (Fed. Cir.) (role of medical opinion and proof in Vaccine Program litigation)