MULLINS v. SECRETARY OF HEALTH AND HUMAN SERVICES
1:19-vv-00320
Fed. Cl.Sep 4, 2024Background
- K.M., born Feb. 27, 2015, received Hib and Prevnar on Feb. 29, 2016 and subsequently developed progressive encephalopathy, seizures, and severe neurologic deficits requiring long‑term care.
- Initial hospitalization in April–May 2016 showed CSF pleocytosis, 11 oligoclonal bands, abnormal EEG, and brain MRIs with multifocal T2 lesions; treating teams provisionally diagnosed presumed ADEM and treated with IV methylprednisolone and IVIG.
- Extensive infectious, metabolic, and genetic workups (including whole exome sequencing) were negative; later MRIs showed progression to a leukodystrophy‑like pattern and global atrophy, prompting consideration—but not confirmation—of a neurogenetic disorder.
- Petitioner alleged the Feb. 29, 2016 Hib and/or Prevnar vaccinations caused K.M.’s acute disseminated encephalomyelitis (ADEM); Respondent disputed diagnosis, timing/onset, and causation.
- Experts for Petitioner (Drs. Steinman and Shuman) opined ADEM caused by vaccine‑triggered molecular mimicry; Respondent’s experts (Drs. Kruer and MacGinnitie) favored an undiagnosed neurogenetic disorder and questioned the molecular‑mimicry proof and temporal window.
- Special Master Nora Beth Dorsey found by preponderant evidence that K.M. had ADEM and that the Hib and/or Prevnar vaccinations were a substantial factor in causing it; entitlement to compensation was awarded.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Proper diagnosis | K.M. has ADEM based on clinical course, CSF pleocytosis and oligoclonal bands, and MRI evolution | K.M. has a neurogenetic/leukodystrophy disorder given MRI progression, poor response to immunotherapy, and treating physicians’ concerns | Diagnosis: preponderant evidence supports ADEM (including rare leukodystrophy‑like ADEM presentations) |
| Onset timing | Onset began in early April (immune markers predated overt decline), within a medically acceptable post‑vaccine window (~32–35 days) | Objective neurologic signs first documented Apr. 22 (53 days post‑vaccine), outside some experts’ preferred window | Held: immune response markers (plasmacytoid cells, oligoclonal bands) support early April onset; timing falls within an acceptable window for vaccine‑related ADEM |
| Althen Prong 1 (mechanism) | Molecular mimicry plausible: (1) phosphoglycerol moieties in Prevnar cross‑react with myelin lipids; (2) CRM197 (Prevnar) and tetanus toxoid (Hib) share epitopes with paranodal/myelin proteins (e.g., neurofascin/MOG) | Sequence similarity and animal models are insufficient to prove human pathogenic mimicry; BLAST E‑values weak; common motifs are ubiquitous | Held: molecular mimicry is a sound and reliable theory here (petitioner’s mechanistic theories—though not proven in lab—are adequate under Program standards) |
| Althen Prongs 2 & 3 (logical sequence & temporal relationship) | Vaccination (alone or with antecedent/concurrent infection) was a substantial factor triggering CNS inflammation culminating in ADEM within an acceptable timeframe | No definitive alternative excluded; infections or an undiagnosed genetic condition more likely causes; onset/timing and lack of treatment response weigh against vaccine causation | Held: logical sequence satisfied (ADEM diagnosis, plausible mechanism, lack of alternative cause after extensive workup), and temporal relationship met given immune‑marker timing and precedent; petitioner entitled to compensation |
Key Cases Cited
- Althen v. Secretary of Health & Human Services, 418 F.3d 1274 (Fed. Cir. 2005) (three‑part test for proving vaccine causation)
- Moberly v. Secretary of Health & Human Services, 592 F.3d 1315 (Fed. Cir. 2010) (preponderance standard and substantial‑factor causation)
- Capizzano v. Secretary of Health & Human Services, 440 F.3d 1317 (Fed. Cir. 2006) (circumstantial evidence and expert opinion can satisfy causation)
- Broekelschen v. Secretary of Health & Human Services, 618 F.3d 1339 (Fed. Cir. 2010) (addressing when diagnosis should be resolved before Althen analysis)
- Shyface v. Secretary of Health & Human Services, 165 F.3d 1344 (Fed. Cir. 1999) (vaccine must be a substantial factor, though not necessarily predominant)