Milik v. Secretary of Health & Human Services
2016 U.S. App. LEXIS 9224
| Fed. Cir. | 2016Background
- A.M., born 1993, received an MMR vaccine on January 29, 1998; within weeks he developed limping and was later diagnosed with developmental delay, spastic diplegia, and extensive white‑matter disease.
- Early contemporaneous records (March–September 1998) include Dr. Maytal’s note diagnosing “longstanding” global developmental delay and MRI reports showing diffuse white‑matter demyelination; later specialists suggested possible vanishing white matter disease.
- Petitioners (Marek and Jolanta Milik on behalf of A.M.) filed a Vaccine Act claim alleging the MMR caused A.M.’s neurological condition; they relied on expert Dr. Souayah and letters from treating clinicians.
- The government’s expert, Dr. Kohrman, attributed A.M.’s condition to a preexisting developmental disorder (likely leukodystrophy/vanishing white matter) with onset before vaccination or to an intercurrent infection rather than the vaccine.
- The special master credited Dr. Kohrman, found petitioners failed Althen prongs two and three (causal sequence and timing), and denied compensation; the Court of Federal Claims affirmed, as did the Federal Circuit.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether Vaccine Act’s review scheme is constitutional (right to Article III de novo review) | Vaccine Act denies Article III de novo review and common‑law remedies after Bruesewitz and Stern | Congress validly provided an Article I adjudicatory scheme with Article III review rights preserved; Bruesewitz’s preemption ruling doesn’t implicate Stern’s separation‑of‑powers holding | Act’s scheme constitutional here; Stern inapplicable and Bruesewitz does not change standard of review |
| Whether MMR vaccine caused A.M.’s injury (causation under Althen) | Vaccine temporally preceded symptoms; no alternative cause identified; expert testimony supports vaccine‑caused encephalopathy | Preexisting developmental delay/demyelinating disease predates vaccine; MRI and contemporaneous exams support non‑vaccine cause; infection plausible alternative | Special master’s factual findings that onset predated vaccine and that Althen prongs 2–3 not met were not arbitrary or capricious; petition denied |
| Admissibility/weight of late clarification by treating neurologist (Dr. Maytal’s letter) | Clarification shows “longstanding” meant ‘‘existing prior to examination’’ and does not fix onset after vaccine | Letter is untimely, litigation‑driven, and inconsistent with contemporaneous record; original “longstanding” indicates earlier onset | Special master reasonably discounted the belated clarification and credited the contemporaneous meaning of “longstanding” |
| Credibility/weight of competing experts (Souayah v. Kohrman) | Souayah’s opinion that white‑matter disease began ~3 weeks after vaccine is persuasive | Kohrman (pediatric neurologist) better explains exams, Denver screening, and MRIs; more experience with pediatric developmental disorders | Special master permissibly credited Kohrman; credibility and fact‑finding are entitled to deference |
Key Cases Cited
- Althen v. Sec’y of Health & Human Servs., 418 F.3d 1274 (Fed. Cir.) (establishes three‑prong test for causation under Vaccine Act)
- Bruesewitz v. Wyeth LLC, 562 U.S. 223 (2011) (Vaccine Act preempts state design‑defect claims against vaccine manufacturers)
- Stern v. Marshall, 564 U.S. 462 (2011) (limits Article I adjudicators’ authority to enter final judgment on certain common‑law claims)
- Broekelschen v. Sec’y of Health & Human Servs., 618 F.3d 1339 (Fed. Cir.) (appellate standard: apply same deferential review as Court of Federal Claims)
- Cedillo v. Sec’y of Health & Human Servs., 617 F.3d 1328 (Fed. Cir.) (special master findings must be upheld if supported by non‑implausible record evidence)