Mondello v. Secretary of the Department of Health & Human Services
132 Fed. Cl. 316
| Fed. Cl. | 2017Background
- Paul Mondello received a Twinrix (hepatitis A/B) vaccine on Nov. 15, 2013 and within a week developed malaise then was hospitalized on Nov. 22, 2013 with new-onset seizures and altered consciousness.
- Hospital workup showed EEG abnormalities (right frontal slowing and discharges), MRI with chronic changes, negative CSF for meningitis; urine/toxicology positive for benzodiazepines and marijuana; diagnosis: new-onset seizure with delirium and hyponatremia.
- Treating neurologist Dr. Bourque repeatedly noted the close temporal link between the vaccine and illness and, by March 2016, recorded an opinion that the seizure was likely provoked by a combination of illness from the hepatitis A vaccine and cyproheptadine.
- Petitioner filed a Vaccine Act petition alleging the vaccine caused a seizure disorder but submitted no independent expert report; he did submit two pieces of medical literature and vaccine product information.
- The Special Master dismissed the petition for failure to provide a medical theory/opinion causally linking the vaccine to the injury and cited petitioner’s comorbidities and concurrent substances (e.g., cyproheptadine, CNS depressants) as undermining causation.
- The Court of Federal Claims held the record contained at least some evidence (treating physician opinion and literature) suggesting a theory of causation, and that assigning to petitioner the burden of disproving alternative causes was error; the case was remanded.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether treating physician records can supply the required medical opinion/theory under Althen | Mondello: Dr. Bourque’s notes state the vaccine was a contributing/substantial factor; treating records and temporal sequence suffice without outside expert | HHS: Bourque’s notes lack a specific biological theory and do not unequivocally state vaccine causation; absence of an expert is fatal | Court: Dr. Bourque’s March 2016 note expresses an opinion of causation; treating records can supply causation evidence and case remanded for further consideration |
| Whether petitioner was required to produce an outside expert explaining biological mechanism | Mondello: No; only legal (not scientific) probability and biological plausibility required; temporal and clinical evidence enough | HHS: Petitioner needed a reputable medical explanation beyond temporal association; lack of expert undermines claim | Court: Petitioner need not produce a specific mechanism; absence of expert alone did not require dismissal given some evidence of causation in record |
| Allocation of burden regarding alternative causes (e.g., cyproheptadine, alcohol, comorbidities) | Mondello: Vaccine could be a substantial factor even if other factors contributed; burden to prove alternate cause shifts to government after prima facie showing | HHS: Co-morbidities and other substances make vaccine causation unlikely; emphasized by Special Master | Court: Special Master erred if she required petitioner to eliminate alternative causes; once petitioner makes prima facie showing burden shifts to respondent |
| Whether the Special Master adequately considered petitioner’s submitted literature and records | Mondello: Literature and vaccine info sheets support biological plausibility and were overlooked | HHS: No reversible error; Special Master not required to cite every item if decision shows consideration | Court: Unclear whether Special Master considered the literature; remand required so evidence and weight can be addressed |
Key Cases Cited
- Althen v. Sec’y of HHS, 418 F.3d 1274 (Fed. Cir. 2005) (three-part test for causation under Vaccine Act)
- Capizzano v. Sec’y of HHS, 440 F.3d 1317 (Fed. Cir. 2006) (treating records and circumstantial evidence may satisfy causation prongs)
- Knudsen v. Sec’y of HHS, 35 F.3d 543 (Fed. Cir. 1994) (legal probability standard; specific biological mechanism not required)
- De Bazan v. Sec’y of HHS, 539 F.3d 1347 (Fed. Cir. 2008) (timing standard for causation-in-fact)
- Walther v. Sec’y of HHS, 485 F.3d 1146 (Fed. Cir. 2007) (burden shifts to respondent to prove alternate causes after prima facie case)
- Cedillo v. Sec’y of HHS, 617 F.3d 1328 (Fed. Cir. 2010) (standard of review for special masters’ factfinding)
- Lampe v. Sec’y of HHS, 219 F.3d 1357 (Fed. Cir. 2000) (appellate court will not reweigh facts or reassess credibility)
- Cucuras v. Sec’y of HHS, 993 F.2d 1525 (Fed. Cir. 1993) (contemporaneous medical records are trustworthy evidence)