Keith and Beverly Langland, on Behalf of Their Daughter, M.L.] v. Secretary of Helath and Human Services
109 Fed. Cl. 421
Fed. Cl.2013Background
- Langland petitioners seek Vaccine Act compensation for their daughter, alleging a neurologically regressive reaction and celiac disease after the January 28, 2004 DTaP/IPV vaccines.
- Special Master denied compensation after finding no plausible causal theory under Althen.
- Petition relied on Dr. Frick’s causation theory and physician treating-records; Respondent offered contrary expert, Dr. Warner.
- Special Master found no reliable biological mechanism linking DTaP to celiac disease and emphasized lack of supportive literature.
- Court-appointed review deferred to Special Master’s credibility determinations and concluded petitioners failed to prove causation by preponderance.
- Decision was affirmed; petitioners’ motion for review denied and judgment entered for respondent.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether Althen prong 1 was satisfied by petitioners’ theory. | Langland argues Frick’s immune-insult theory is plausible. | Langland failed to present a reputable medical mechanism. | No; no plausible biological theory proven. |
| Whether treating physicians’ statements support causation. | Langland asserts treating records establish causation. | Records show only temporally associated history. | Not sufficient to prove causation under Althen. |
| Whether temporal proximity alone supports causation-in-fact. | Temporal relation supports causation. | Temporal proximity without mechanism is insufficient. | Temporal proximity alone is insufficient. |
| Whether post-hearing Exhibit 17 can salvage causation. | Exhibit 17 provides speculative support for viral triggers. | Exhibit 17 is speculative and not dispositive. | Exhibit 17 not dispositive; does not establish causation. |
| Whether biomedical literature is required to prove causation under Althen. | Some literature supports vaccine-related triggers. | Literature insufficient to connect DTaP to celiac disease. | Literature not adequate to establish a plausible mechanism. |
Key Cases Cited
- Althen v. Sec'y of Health & Human Servs., 418 F.3d 1274 (Fed. Cir. 2005) (three-prong causation test; need plausible medical theory)
- Capizzano v. Sec'y of HHS, 440 F.3d 1317 (Fed. Cir. 2006) (requires plausible theory; not merely temporal relation)
- Knudsen v. Sec’y of Dep’t of HHS, 35 F.3d 543 (Fed. Cir. 1994) (epidemiological evidence relevant but not dispositive)
- Moberly v. Sec’y of HHS, 592 F.3d 1315 (Fed. Cir. 2010) (credibility and weighing of medical evidence; deference to Master)
- Pafford v. Sec’y of HHS, 451 F.3d 1352 (Fed. Cir. 2006) (three-prong approach; coercing preponderance standard)
- Shyface v. Sec’y of HHS, 165 F.3d 1344 (Fed. Cir. 1999) (alternative causation framework; interplay with Althen)
- Grant v. Sec’y of Dep’t of HHS, 956 F.2d 1144 (Fed. Cir. 1992) (epidemiology and clinical picture; not always definitive)
- Andreu ex rel. Andreu v. Sec’y of HHS, 569 F.3d 1367 (Fed. Cir. 2009) (discusses standard for proving causation)
- Munn v. Sec’y of Dep’t of HHS, 970 F.2d 863 (Fed. Cir. 1992) (highly deferential review of Special Master findings)