Rodriguez v. Secretary of Health and Human Services
13-253
| Fed. Cl. | Nov 20, 2017Background
- Petitioners William and Brenda Rodriguez filed a Vaccine Act claim on behalf of their son C.R., alleging juvenile dermatomyositis (JDM) was triggered by DTaP, MMR, polio, and varicella vaccines administered August 30, 2011.
- C.R., previously healthy, developed fever, vomiting and within days a persistent rash on knuckles/elbows/knees and later progressive muscle weakness and fatigue; lab work showed elevated ESR and CRP and positive ANA.
- Treated by pediatricians, dermatologist, and Emory rheumatologist; diagnosed with JDM in January 2012 and treated with prednisone and later IVIG; partial remission followed with later relapse in 2015.
- Petitioners offered expert Dr. Eric Gershwin who opined vaccines triggered a Type I interferon–mediated autoimmune cascade in a genetically susceptible child; respondent offered Dr. Carlos Rose who favored an infectious trigger (viral) and emphasized limits of case reports/selection bias.
- Special Master found petitioners met Althen's three-prong test (medical theory, logical sequence, and appropriate temporal relationship) and that respondent failed to prove an alternative cause by preponderant evidence; entitlement to compensation was awarded and case proceeded to damages.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Causation (off‑Table claim) — can vaccines cause C.R.’s JDM? | Vaccines triggered innate/adaptive immune dysregulation (Type I interferon) in genetically susceptible child, producing skin then muscle disease; onset within accepted window. | More likely triggered by contemporaneous viral infection(s); case reports and temporality do not establish causation; dermatologist/clinicians initially diagnosed eczema/viral rashes. | Held for petitioners: Althen prongs satisfied — reputable theory, logical sequence tying August 30 vaccinations to early-September onset, and timing consistent with literature. |
| Onset timing | Parents’ contemporaneous reports and medical records show rash and inflammatory markers within days–weeks after vaccination, progressing to weakness months later. | Some records and dermatologist assessment favored viral/exanthem or eczema; pictures and isolated notes undermined early-onset claim. | Held for petitioners: records + expert testimony established onset shortly after vaccination; respondent’s alternative timing not persuasive. |
| Burden to rebut (alternative cause) | Not required to eliminate all alternatives; once prima facie established, burden shifts to respondent to prove unrelated factor. | Respondent argued viral infection was sole substantial cause. | Held for petitioners: respondent failed to prove an alternative sole substantial cause; viral symptoms occurred after or concurrent with rash and did not rebut vaccine causation. |
| Reliability of expert proof | Dr. Gershwin provided literature-supported immunologic mechanism and case‑level analysis. | Raised issues of selection bias, limits of anecdotal reports, and interpretation of records/photos. | Held: expert testimony and literature were sufficiently reliable and persuasive under Daubert/Althen standards. |
Key Cases Cited
- Capizzano v. Sec'y of Health & Human Servs., 440 F.3d 1317 (Fed. Cir. 2006) (presumption for Table injuries and burden framework)
- Althen v. Sec'y of Health & Human Servs., 418 F.3d 1274 (Fed. Cir. 2005) (three‑prong test for off‑Table vaccine causation)
- Pafford v. Sec'y of Health & Human Servs., 451 F.3d 1352 (Fed. Cir. 2006) (vaccine as substantial factor; causation standard)
- Deribeaux ex rel. Deribeaux v. Sec'y of Health & Human Servs., 717 F.3d 1363 (Fed. Cir. 2013) (respondent burden to prove alternative cause)
- Andreu ex rel. Andreu v. Sec'y of Health & Human Servs., 569 F.3d 1367 (Fed. Cir. 2009) (requirement of reputable medical explanation)
- Knudsen v. Sec'y of Health & Human Servs., 35 F.3d 543 (Fed. Cir. 1994) (case‑by‑case causation inquiry)
- Daubert v. Merrell Dow Pharm., 509 U.S. 579 (1993) (reliability standard for expert testimony)
- LaLonde v. Sec'y of Health & Human Servs., 746 F.3d 1334 (Fed. Cir. 2014) (need for trustworthy expert support for causation theories)
- Stone v. Sec'y of Health & Human Servs., 676 F.3d 1373 (Fed. Cir. 2012) (vaccine must be but‑for and substantial factor)
- Doe v. Sec'y of Health & Human Servs., 601 F.3d 1349 (Fed. Cir. 2010) (limitations on respondent proving alternative causes; idiopathic causes excluded)