Valeria Flores v. HHS - HPV, spinal cord stroke (2015)
Case summary [AI summaries can sometimes make mistakes]
Valeria Flores, a minor, received her first human papillomavirus (HPV) vaccination on April 28, 2008, and her second dose on June 27, 2008. The day after her second vaccination, she began experiencing left-sided weakness, severe headache, and shortness of breath, which progressed to flaccid paralysis and slurred speech.
She also suffered a cardiac arrest and required ventilation. She was diagnosed with a spinal cord stroke, believed to be caused by a blood clot.
Her father filed a petition for compensation under the National Vaccine Injury Compensation Program on July 29, 2010, alleging the HPV vaccine caused her injury. Valeria Flores was later substituted as petitioner upon reaching the age of majority.
The respondent was the Secretary of Health and Human Services. Petitioner was represented by Clifford J.
Shoemaker, and respondent was represented by Debra A. Filteau Begley.
Special Master George L. Hastings initially denied the claim in a decision dated September 12, 2013, finding that the petitioner failed to prove causation-in-fact under the Althen test.
The special master found that the petitioner's expert, Dr. Douglas A.
Kerr, proposed a theory of causation involving genetic predisposition, immune sensitization, and inflammation or platelet aggregation, which was not supported by a preponderance of the evidence. The special master noted that the petitioner could not establish a genetic predisposition, that the blood clot likely originated in an artery rather than a vein as Dr.
Kerr theorized, and that there was no evidence of inflammation or platelet aggregation. The special master also found that medical literature did not support Dr.
Kerr's theory. The court, in an opinion dated March 21, 2014, by Judge Margaret M.
Sweeney, reviewed the special master's decision. The court agreed that the petitioner had not met her burden of proof regarding causation, although it found that the special master had improperly required specific proof of genetic susceptibility.
However, the court upheld the special master's findings that there was no evidence of inflammation or platelet aggregation, which meant the petitioner could not establish a link between the immune response and the blood clot. Therefore, the court denied the petitioner's motion for review and sustained the special master's decision.
On July 24, 2015, Special Master George L. Hastings issued a decision regarding attorneys' fees and costs.
Based on a stipulation between the parties, the decision awarded $137,500.00 for attorneys' fees and costs, representing all available amounts under the program, finding that the petition was brought in good faith with a reasonable basis.
Theory of causation
Petitioner Valeria Flores, age 14, received two doses of the HPV vaccine on April 28, 2008, and June 27, 2008. The day after the second dose, she developed symptoms including left-sided weakness, headache, shortness of breath, flaccid paralysis, and slurred speech, followed by cardiac arrest and requiring ventilation. She was diagnosed with a spinal cord stroke. Petitioner alleged the HPV vaccine caused the stroke. Petitioner's expert, Dr. Douglas A. Kerr, proposed a theory that the HPV vaccine caused a blood clot through immune sensitization, an exuberant immune response, and subsequent inflammation or platelet aggregation, exacerbated by a genetic predisposition to blood clotting. Respondent's experts, Drs. Peter M. Bingham and Joan Cox Gill, found this improbable, noting a lack of clinical evidence for inflammation or platelet aggregation, and suggesting an arterial rather than venous thrombosis. The Special Master denied compensation, finding petitioner failed to prove causation-in-fact under the Althen test. The Special Master found Dr. Kerr's theory unsupported by evidence regarding genetic predisposition, the origin of the clot (arterial vs. venous), and the presence of inflammation or platelet aggregation. The Court of Federal Claims affirmed, agreeing that petitioner failed to establish a logical sequence of cause and effect linking the vaccine to the injury, specifically the absence of evidence for inflammation or platelet aggregation. The court noted the special master improperly required specific proof of genetic susceptibility but found this did not change the outcome. The case was not listed on the Vaccine Injury Table. A subsequent stipulation resulted in an award of $137,500.00 for attorneys' fees and costs on July 24, 2015, based on a finding of good faith and reasonable basis for the claim. Attorneys for petitioner were Clifford J. Shoemaker; respondent was represented by Debra A. Filteau Begley. Special Master was George L. Hastings, and the reviewing judge was Margaret M. Sweeney.