Loyd v. Secretary of Health and Human Services
16-811
| Fed. Cl. | Jul 1, 2021Background
- Petitioner (mother Tasha Loyd) filed a Vaccine Program claim alleging C.L.’s chronic immune thrombocytopenic purpura (ITP) was caused by PCV (Prevnar) and/or Hib vaccines administered Aug. 30, 2013.
- C.L. had routine pediatric visits after vaccination; a CBC on Feb. 3, 2014 showed normal platelets (340,000), while the first contemporaneous medical documentation of ITP (petechiae/bruising and low platelets) occurred on June 2, 2014 with counts as low as 1,000–9,600 before treatment.
- Petitioner relies on mother’s testimony, multiple photographs dated Sept–Dec 2013, and expert immunologist M. Eric Gershwin, M.D., who argued onset in Sept. 2013 and invoked molecular mimicry (focusing on Prevnar’s diphtheria-conjugate).
- Respondent presented pediatric hematology and immunology experts (Drs. Strouse and MacGinnitie) and epidemiologic studies (e.g., O'Leary, Tseng) concluding Prevnar is not associated with ITP and that onset likely occurred in May–June 2014.
- The Chief Special Master found the most probative evidence showed likely onset in May 2014 (≈8–9 months post-vaccination), rejected the long subclinical-course theory, found Petitioner’s mechanistic and epidemiologic proof insufficient, and denied entitlement.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Temporal relationship (Althen prong 3) | Onset was within weeks of Aug. 2013 vaccination (Sept. 2013); waxing/waning ITP masked by intercurrent infections, so Feb. 2014 normal CBC was transient. | Medical records and experts show first clear ITP evidence in June 2014; a 8–9 month gap is not a medically-acceptable interval for vaccine causation. | Found onset most likely May 2014; 8–9 month gap fatal to causation—Althen prong 3 not met. |
| Logical sequence / did-cause (Althen prong 2) | Prevnar triggered an autoimmune process that became chronic; clinical course explains gaps in documentation. | No reliable sequence tying Prevnar to initiation of autoimmune platelet destruction; treating records and tests do not support subclinical chronicity beginning in fall 2013. | Plaintiff failed to show a preponderant logical sequence linking the Aug. 2013 vaccination to C.L.’s chronic ITP. |
| Can Prevnar cause ITP (Althen prong 1) | Molecular mimicry and analogy to other vaccines (e.g., DPT/MMR) and manufacturer warnings suggest plausibility; case reports and PDR cited. | Epidemiologic studies show no increased ITP risk after Prevnar; case reports and VAERS are weak; no demonstrated homology or cross-reactivity. | Plausibility acknowledged but insufficient evidence to preponderantly establish Prevnar can cause chronic ITP. |
| Weight of evidence (photos/testimony v. contemporaneous records) | Mother’s testimony and dated photos establish earlier onset not recorded in charts; treating physicians dismissed early concerns. | Contemporaneous medical records and normal Feb. 2014 CBC are more reliable; photos unauthenticated and inconclusive; experts prefer records. | Contemporaneous records and expert testimony outweighed maternal testimony/photos; records deemed more probative. |
Key Cases Cited
- Althen v. Sec'y of Health & Hum. Servs., 418 F.3d 1274 (Fed. Cir. 2005) (three-prong test for proving vaccine causation)
- Moberly v. Sec'y of Health & Hum. Servs., 592 F.3d 1315 (Fed. Cir. 2010) (preponderance standard and substantial-factor causation)
- Knudsen v. Sec'y of Health & Hum. Servs., 35 F.3d 543 (Fed. Cir. 1994) (reputable medical theory need not be fully proven)
- Andreu v. Sec'y of Health & Hum. Servs., 569 F.3d 1367 (Fed. Cir. 2009) (weighing of expert opinion and medical records)
- LaLonde v. Sec'y of Health & Hum. Servs., 746 F.3d 1334 (Fed. Cir. 2014) (plausibility alone insufficient for causation)
- Boatmon v. Sec'y of Health & Hum. Servs., 941 F.3d 1351 (Fed. Cir. 2019) (standards for Althen prong one and weighing evidence)
- Cedillo v. Sec'y of Health & Hum. Servs., 617 F.3d 1328 (Fed. Cir. 2010) (application of Daubert factors to program expert testimony)
- Broekelschen v. Sec'y of Health & Hum. Servs., 618 F.3d 1339 (Fed. Cir. 2010) (credibility of experts and relative persuasiveness govern outcome)
- Shyface v. Sec'y of Health & Hum. Servs., 165 F.3d 1344 (Fed. Cir. 1999) (substantial-factor causation standard)
- Capizzano v. Sec'y of Health & Hum. Servs., 440 F.3d 1317 (Fed. Cir. 2006) (role of medical records and expert proof in Vaccine Act claims)