Bekiaris v. Secretary of Health and Human Services
14-750
| Fed. Cl. | Aug 4, 2017Background
- Petitioner filed a Vaccine Act petition alleging that a third Gardasil (HPV) dose (Aug 25, 2011) caused prolonged hypersensitivity to sweat/soaps, rashes/urticaria, anxiety/panic, hyperactivity, dermatographism, and permanent disfigurement.
- Medical records show transient hives within hours of the 2011 dose and subsequent pruritic rash treated with antihistamines and short prednisone; dermatology records mainly document acne vulgaris with onset in 2007 (pre-vaccine) and later dry skin/xerosis.
- Petitioner did not produce an expert report despite multiple extensions and a one-year deadline to file Dr. Ioannis Moissidis’s report; immunology/allergy records from Greece were not provided to the court.
- On July 7, 2017 petitioner moved for discovery from Merck seeking 2011 Gardasil samples, formulation data, and related clinical/chemical information, arguing the vaccine formula changed after 2011.
- Special Master denied the discovery motion as not "reasonable and necessary," explaining petitioner must first develop medical records and expert opinion to show causation; discovery at this stage would be burdensome and unnecessary.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether discovery from Merck for 2011 Gardasil samples/data is "reasonable and necessary" | Merck should produce 2011 vaccine samples and formulation data because the formula changed and advanced allergy testing requires the 2011 formulation | Discovery is not required; petitioner has not presented expert proof or medical records showing a need for manufacturer data | Denied — discovery not reasonable/necessary given petitioner’s failure to prosecute and absence of expert showing need |
| Whether petitioner met Vaccine Act causation requirements (Althen elements) | Temporal association and clinical symptoms link the vaccine to petitioner’s chronic reactions | Temporal association alone is insufficient; petitioner must prove a medical theory and expert opinion linking vaccine to injuries | Court emphasized petitioner’s burden to prove Althen elements and noted timing alone is insufficient |
| Whether absence of an expert report is excusable and discovery can substitute for expert development | Discovery will allow petitioner’s proposed expert to perform tests and generate causation opinion | Petitioner had years and court-granted time to file expert report; discovery is not a substitute for failing to produce expert evidence | Denied — petitioner must file expert report and medical evidence; discovery cannot replace that duty |
| Whether petitioner’s documented conditions support long-lasting vaccine-caused injury (statutory persistence) | Clinical course of rashes/dermatographism reflects ongoing vaccine-related injury | Medical records show acne predating vaccination; records do not demonstrate rashes/urticaria persisting >6 months or expert linking vaccine to chronic conditions | Court noted records do not establish chronic vaccine-caused injury and highlighted lack of expert proof |
Key Cases Cited
- Althen v. Sec'y of HHS, 418 F.3d 1274 (Fed. Cir. 2005) (sets the three-part test for proving vaccine causation: medical theory, logical sequence showing causation, and proximate temporal relationship)
- Grant v. Sec'y of HHS, 956 F.2d 1144 (Fed. Cir. 1992) (temporal association and absence of other causes are insufficient; petitioners must produce reputable medical/scientific support)
- Knudsen v. Sec'y of HHS, 35 F.3d 543 (Fed. Cir. 1994) (petitioner not required to identify a precise biological mechanism, but must present competent medical opinion tying vaccine to injury)
- Shyface v. Sec'y of HHS, 165 F.3d 1344 (Fed. Cir. 1999) (to prevail petitioner must show vaccine was a substantial factor in causing the injury)