Caron v. Secretary of Health and Human Services
15-777
| Fed. Cl. | Oct 2, 2017Background
- Petitioner Heather Caron filed under the National Vaccine Injury Compensation Program on behalf of her son A.C., alleging DTaP-IPV/Hib, MMR, and Varicella vaccines (given Aug 2, 2012) caused Chronic Recurrent Multifocal Osteomyelitis (CRMO) and related symptoms.
- Medical records show repeated pediatric visits from 2009–2012 but no presentation for the relevant symptoms until January 2013 (leg pain, limp), with progressive fevers and multi-joint pain by March–April 2013; biopsies later supported a CRMO diagnosis.
- Petitioner submitted contemporaneous medical records, later affidavits and a ‘‘date book’’ purporting onset in fall 2012; the date book was created well after the events and family affidavits relied on it.
- A Special Master ruled in December 2016 that the contemporaneous medical records more accurately establish onset in January 2013 (five months after vaccination); petitioner sought reconsideration and a ruling on the record.
- Petitioner failed to produce any expert opinion linking the vaccines to CRMO, or supporting a five‑month post‑vaccination onset as medically acceptable; treating physicians did not attribute CRMO to vaccination.
- The Special Master denied reconsideration as procedurally improper and, on the record, dismissed the petition for failure to meet the Althen causation standard and for lack of expert support.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Properness of seeking reconsideration of Onset Ruling | Caron argued the oral testimony and affidavits overcame medical records; asked to reconsider onset finding and hold a hearing | Resp. argued the Onset Ruling was not a final "decision" subject to Vaccine Rule 10 reconsideration and no new evidence/law justified reopening | Reconsideration denied — Onset Ruling was not a final compensatory decision and petitioner presented no new evidence or changed law to meet reconsideration standard |
| Reliability of onset evidence (fall 2012 vs Jan 2013) | Caron relied on her date book and corroborating affidavits asserting fall 2012 onset | Respondent relied on contemporaneous medical records showing first clinical presentation in Jan 2013; argued the date book and affidavits are unreliable | Onset fixed at Jan 2013 based on contemporaneous medical records; later-created date book/affidavits insufficient to rebut records |
| Sufficiency of causation evidence under Althen (off-table claim) | Caron contended vaccine temporal proximity and literature (general vaccine info and varicella/osteomyelitis article) supported causation if onset were sooner | Respondent argued petitioner offered no expert theory, no reputable literature connecting the vaccines to CRMO, and treating doctors did not ascribe CRMO to vaccines | Petition dismissed — petitioner failed all Althen prongs by not providing expert medical theory, logical sequence, or acceptable temporal nexus |
| Relief requested: ruling on the record / hearing | Caron sought a ruling on the record or a hearing to pursue an expert if onset found earlier | Respondent urged denial absent expert evidence and consistent medical records showing later onset | Motion for ruling on the record resulted in dismissal for insufficient proof; motion for further hearing denied because petitioner had no new evidence or experts |
Key Cases Cited
- Capizzano v. Sec’y of Health & Human Servs., 440 F.3d 1317 (Fed. Cir.) (Table injuries presumed; off‑Table claims require proof of causation)
- Pafford v. Sec’y of Health & Human Servs., 451 F.3d 1352 (Fed. Cir.) (vaccination need only be a substantial factor/but‑for cause)
- Shyface v. Sec’y of Health & Human Servs., 165 F.3d 1344 (Fed. Cir.) (expert or scientific evidence required to establish causation)
- Althen v. Sec’y of Health & Human Servs., 418 F.3d 1274 (Fed. Cir.) (three‑part test for causation in off‑Table vaccine claims)
- LaLonde v. Sec’y of Health & Human Servs., 746 F.3d 1334 (Fed. Cir.) (expert testimony must find support in medical literature)
- Stone v. Sec’y of Health & Human Servs., 676 F.3d 1373 (Fed. Cir.) (Althen requires vaccine to be a substantial factor)
- Cedillo v. Sec’y of Health & Human Servs., 617 F.3d 1328 (Fed. Cir.) (reliance on previously-available evidence cannot justify reconsideration when it does not change outcome)
- Hall v. Sec’y of Health & Human Servs., 93 Fed. Cl. 239 (Fed. Cl.) (standard for granting reconsideration under Vaccine Rules)