Lepore v. Secretary of Health and Human Services
14-640
| Fed. Cl. | Nov 7, 2017Background
- Petitioner Mario LePore received Tdap in right arm on Sept. 14, 2011 and later alleged it caused tendinosis/SIRVA; petition filed July 22, 2014.
- Early contemporaneous records (Sept. 16, 2011) show no complaint about the right shoulder; first orthopedics visit complaining of gradual right shoulder pain occurred Dec. 5, 2012 (≈15 months post‑vaccine).
- Later treating records (2016–2017) contain histories asserting onset within days or 48 hours of vaccination and diagnoses including tendinopathy, mild deltoid atrophy, and speculative macrophagic myofasciitis.
- Respondent denied SIRVA and the special master repeatedly ordered petitioner to produce an expert report; petitioner was warned multiple times that failure to file an expert would risk dismissal.
- Petitioner did not file a qualifying expert report by repeated deadlines and did not respond to respondent’s amended Rule 4(c) report; the special master found the earliest contemporaneous history more credible and that petitioner failed to make a prima facie causation case.
- The petition was dismissed for failure to prosecute, failure to follow court orders, and failure to establish causation in fact.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether petitioner qualifies for Table SIRVA (onset within 48 hours) | LePore asserts SIRVA under the Table and that later medical records showing onset within 48 hours satisfy the Table criteria | HHS points to contemporaneous records showing no right‑shoulder complaint within 48 hours and disputes the late‑made onset history | Denied — contemporaneous records (Sept. 16, 2011) are more credible; petitioner does not meet the Table onset requirement |
| Whether petitioner can prevail without an expert report | LePore contends he need not submit an expert because SIRVA is a Table injury and his treating records suffice | HHS argues petitioner cannot rely solely on allegations or unsupported treating opinions absent a valid expert tying vaccine to injury | Held against petitioner — Vaccine Act bars a ruling based solely on petitioner’s assertions; expert opinion required to establish causation in fact when records are insufficient |
| Credibility of inconsistent medical histories | LePore relies on later treating histories that state early onset after vaccination | HHS emphasizes earlier, contemporaneous histories that lacked any right‑shoulder complaint and therefore undercut later accounts | Court favored earlier contemporaneous records as more reliable and found later inconsistent histories undermined petitioner’s claim |
| Procedural compliance / effect of failure to produce expert | LePore failed to file an expert despite multiple extensions and orders | HHS requested dismissal based on lack of prima facie causation and noncompliance | Petition dismissed for failure to prosecute, failure to comply with court orders, and failure to make a prima facie causation showing |
Key Cases Cited
- Althen v. Sec’y of HHS, 418 F.3d 1274 (Fed. Cir. 2005) (three‑prong test for causation in fact in vaccine cases)
- Grant v. Sec’y of HHS, 956 F.2d 1144 (Fed. Cir. 1992) (affirming need for reputable medical/scientific support and that absence of other causes is not sufficient)
- Shyface v. Sec’y of HHS, 165 F.3d 1344 (Fed. Cir. 1999) (but‑for and substantial‑factor causation requirement)
- Knudsen v. Sec’y of HHS, 35 F.3d 543 (Fed. Cir. 1994) (special masters do not themselves diagnose; decision must be based on record evidence and expert opinion)
- Cucuras v. Sec’y of HHS, 993 F.2d 1525 (Fed. Cir. 1993) (contemporaneous medical records are generally trustworthy)
- United States v. United States Gypsum Co., 333 U.S. 364 (U.S. 1948) (contemporaneous records given weight)
- Burns v. Sec’y of HHS, 3 F.3d 415 (Fed. Cir. 1993) (contemporaneous records principle applied)
- Ware v. Sec’y of HHS, 28 Fed. Cl. 716 (1993) (same)
- Estate of Arrowood v. Sec’y of HHS, 28 Fed. Cl. 453 (1993) (same)