Olivia Tilley v. HHS - HPV, premature ovarian failure/primary ovarian insufficiency (2022)
Case summary [AI summaries can sometimes make mistakes]
On September 5, 2014, Lisa Tilley filed a petition for compensation on behalf of her minor daughter, Olivia Tilley, under the National Vaccine Injury Compensation Program. The petition alleged that the human papillomavirus (HPV or Gardasil) vaccinations Olivia received on June 26, 2009, August 26, 2009, and August 10, 2011, caused her to suffer from premature ovarian failure (POF).
The respondent, the Secretary of Health and Human Services, argued that Olivia had not met her burden of proof because she had not offered a medical theory causally connecting the HPV vaccines to her injury, her treating doctors did not attribute her condition to the vaccines, and she had not established a temporally appropriate onset. The case involved proceedings regarding the viability of a causation theory under Althen prong one, and subsequently, whether the evidence demonstrated POF with an autoimmune etiology to proceed under prongs two and three.
Despite multiple extensions and opportunities to submit updated medical records and expert reports, Olivia's legal team was unable to present sufficient evidence to establish causation. The Special Master noted that the record lacked persuasive evidence of a Table Injury and that Olivia had not proven by a preponderance of the evidence that her POF was caused by the HPV vaccinations, specifically highlighting the insufficient evidence of an autoimmune nature.
Ultimately, the Special Master found that the medical record was insufficient to prove Petitioner's claim and that Petitioner had not filed sufficient supporting evidence. Consequently, the case was dismissed for insufficient proof.
On November 1, 2022, Petitioner filed an unopposed motion to voluntarily dismiss her claim, requesting a decision dismissing her claim and ending all rights in the Vaccine Program. The public decision does not describe the specific onset of symptoms, diagnostic tests performed, treatments received, or the names of treating physicians.
Petitioner was represented by Mark T. Sadaka of the Law Offices of Sadaka Associates, LLC, and Respondent was represented by Debra A.
Filteau Begley of the U.S. Department of Justice.
The decision was issued by Special Master Herbrina Sanders.
Theory of causation
Petitioner, Olivia Tilley, received the HPV vaccine on June 26, 2009, August 26, 2009, and August 10, 2011, and subsequently developed premature ovarian failure (POF). The case proceeded through multiple stages, including an analysis of Althen prong one regarding the viability of a causation theory, and later, prongs two and three concerning proof of POF with an autoimmune etiology. Respondent argued that Petitioner failed to meet her burden of proof by not offering a medical theory connecting the vaccine to the injury, lacking treating physician attribution, and failing to establish temporal appropriateness. Petitioner was granted multiple extensions to submit updated medical records and antibody test results to support an autoimmune etiology. However, the Special Master found the record lacked persuasive evidence of a Table Injury and insufficient proof that the HPV vaccinations caused the POF, particularly noting the lack of evidence demonstrating an autoimmune nature. Petitioner ultimately filed an unopposed motion to voluntarily dismiss her claim. The public decision does not name specific medical experts or detail the proposed biological mechanism beyond the general concept of an autoimmune etiology. The case was dismissed for insufficient proof. Petitioner was represented by Mark T. Sadaka, and Respondent by Debra A. Filteau Begley. Special Master Herbrina Sanders issued the dismissal decision on November 28, 2022.
Source PDFs
USCOURTS-cofc-1_14-vv-00818