Elissa Cascio v. HHS - Pneumococcal, diabetes mellitus, chronic kidney disease, and serum sickness (2015)
Case summary [AI summaries can sometimes make mistakes]
Elissa Cascio filed a petition on February 6, 2014, alleging that she suffered from diabetes mellitus, chronic kidney disease, and serum sickness as a result of receiving two pneumococcal vaccines on February 9, 2011. Ms.
Cascio was 52 years old at the time of vaccination. The medical records from the vaccination date indicated that Ms.
Cascio received one pneumococcal vaccine, identified as Pneumovax 23, a polysaccharide vaccine manufactured by Merck & Co. The record noted the manufacturer and lot number (Merek & Co lot 1296Z exp 20 April 2012) and that it was administered intramuscularly into the left deltoid.
The Vaccine Information Statement for pneumococcal vaccine was reviewed with the patient. Ms.
Cascio reported a localized reaction to the vaccine the following day, describing swelling and bruising at the injection site. She presented to the emergency room two days later with a migraine, low blood pressure, and an erythematous patch on her left deltoid, assessed as an acute localized allergic reaction.
Subsequent visits to the emergency room documented continued localized reaction and induration at the injection site. Ms.
Cascio's affidavit stated she received "a pneumococcal conjugate vaccine" and described symptoms including migraine, low blood pressure, and a persistent lump at the injection site, along with concerns about diabetes, chronic kidney disease, and serum sickness since the vaccination. The respondent investigated the vaccine administered and confirmed it was a Merck Pneumovax 23 vaccine, which is not covered by the National Vaccine Injury Compensation Program (Vaccine Act).
The Special Master issued an Order to Show Cause, directing Ms. Cascio to provide evidence that she received a vaccine covered by the Vaccine Act.
Despite multiple extensions, Ms. Cascio failed to provide any such evidence.
The Special Master, Nora Beth Dorsey, noted that the medical records, including the contemporaneous record of administration by a licensed practical nurse, indicated only one vaccine was given. The Special Master also considered CDC guidelines, which suggest that a 52-year-old would typically receive the Pneumovax 23 (polysaccharide) vaccine, not the conjugate vaccine recommended for children.
The Special Master concluded that Ms. Cascio failed to provide preponderant evidence that she received a vaccine covered by the Vaccine Act.
Consequently, the petition was dismissed for failure to state a claim upon which relief could be granted, as the vaccine administered was not covered by the Vaccine Act. Petitioner's counsel was Rhett Gordon Lunceford.
Respondent's counsel was Gordon Elliot Shemin.
Theory of causation
Petitioner Elissa Cascio, age 52, filed a petition alleging injury (diabetes mellitus, chronic kidney disease, serum sickness) from two pneumococcal vaccines received on February 9, 2011. The respondent, Secretary of Health and Human Services, confirmed through investigation of medical records, including manufacturer and lot number, that petitioner received one dose of Pneumovax 23, a pneumococcal polysaccharide vaccine manufactured by Merck. This vaccine is not covered by the National Vaccine Injury Compensation Program (Vaccine Act). Petitioner was given multiple opportunities to provide evidence of receiving a covered vaccine but failed to do so. The Special Master, Nora Beth Dorsey, found that the contemporaneous medical record documenting the administration of a single Pneumovax 23 vaccine was the most reliable evidence. The Special Master also noted that CDC guidelines indicated a 52-year-old would typically receive the polysaccharide vaccine, not the conjugate vaccine covered by the Act. As petitioner failed to establish she received a covered vaccine, the petition was dismissed for failure to state a claim. Petitioner's counsel was Rhett Gordon Lunceford, and respondent's counsel was Gordon Elliot Shemin. The decision date was September 3, 2015.
Source PDFs
USCOURTS-cofc-1_14-vv-00107