LaLonde ex rel. M.L. v. Secretary of Health & Human Services
2014 U.S. App. LEXIS 5720
| Fed. Cir. | 2014Background
- M.L., born Sept. 24, 2003, received DTaP and other vaccines at his 18-month visit on April 14, 2005; within hours he had high fever, facial swelling, vomiting and was diagnosed with a vaccine adverse reaction including angioedema and anaphylactoid reaction.
- He was hospitalized, discharged, then returned with seizure-like episodes; in the months after vaccination parents and treating physicians observed marked language regression and developmental concerns; MRI scans showed no focal brain damage but later records led to an autism-spectrum classification.
- Petitioner Cynthia LaLonde filed a Vaccine Act claim on behalf of M.L. alleging the DTaP vaccination caused a focal brain injury via an anaphylactic reaction; Dr. Marcel Kinsbourne testified for petitioner proposing a two-phase anaphylaxis and offered three possible mechanisms linking anaphylaxis to focal brain injury.
- The special master found (1) Kinsbourne relied substantially on the mother’s account rather than the medical record and (2) the record did not support a delayed second-phase anaphylactic event or any reliable mechanism tying anaphylaxis to focal brain injury; he rejected petitioner’s causation proof.
- The Court of Federal Claims found the special master erred in discrediting testimony based on reliance on parental statements but held that the error was harmless because petitioner still failed to prove causation by a preponderance; this appeal affirms that decision.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether petitioner proved by preponderance that DTaP caused M.L.’s focal brain injury (non-Table injury) | LaLonde: temporal proximity between anaphylactic reaction and regression plus Dr. Kinsbourne’s proposed mechanisms suffice to establish logical sequence and medical theory without full mechanistic proof | Gov’t: petitioner failed to present reliable medical theory or evidence tying anaphylaxis to focal brain injury; temporal correlation alone is insufficient | Held for government: petitioner failed to meet Althen elements; expert testimony was unsupported and credibility issues fatal to causation proof |
| Whether special master improperly required specification of a single mechanism | LaLonde: Knudsen prohibits demanding identification of a specific biological mechanism; plausible mechanisms are enough | Gov’t: petitioner must present a medically reliable, case-specific explanation supported by literature or reasoning | Held: special master did not demand impossibly specific proof but reasonably required reliable, case-relevant support; petitioner’s proof inadequate |
| Whether reliance on parental account fatally undermined expert testimony | LaLonde: parental account corroborated by sworn affidavit and treating records; reliance acceptable | Gov’t: expert’s dependence on unsworn parental narrative weakened reliability of his conclusions | Held: Court of Federal Claims found special master’s credibility finding erroneous but harmless because overall evidentiary support was lacking |
| Whether remand for additional evidence was required | LaLonde: new evidence developed over six years warrants remand and new hearing | Gov’t: no entitlement absent showing of prior legal error or material new evidence meeting standards | Held: petition denied; court affirmed outcome without remand given petitioner’s failure to carry burden |
Key Cases Cited
- Moberly v. Sec’y of Health & Human Servs., 592 F.3d 1315 (Fed. Cir.) (preponderance requires more than a merely plausible theory; review standard for special master credibility)
- Althen v. Sec’y of Health & Human Servs., 418 F.3d 1274 (Fed. Cir.) (three-prong test for causation in non-Table Vaccine Act claims)
- Knudsen v. Sec’y of Health & Human Servs., 35 F.3d 543 (Fed. Cir.) (mechanistic certainty not required; causation can be established without specific biological mechanism)
- Hibbard v. Sec’y of Health & Human Servs., 698 F.3d 1355 (Fed. Cir.) (petitioners must show medical plausibility and that injury is consistent with proposed theory)
- Capizzano v. Sec’y of Health & Human Servs., 440 F.3d 1317 (Fed. Cir.) (treating physicians’ contemporaneous records are particularly probative)