Kathy Sawvell v. HHS - Pneumococcal, malignant sarcoma (2022)
Case summary [AI summaries can sometimes make mistakes]
Kathy Sawvell, a 65-year-old woman, filed a petition for compensation on May 11, 2020, alleging that the Prevnar 13 vaccination she received on April 10, 2015, caused her to develop a malignant sarcoma. Ms.
Sawvell, who was represented pro se, stated that she received the vaccination in her left arm. She reported a lump in her left arm that appeared around the time of vaccination, which was later diagnosed in November 2018 as a high-grade myxofibrosarcoma.
Ms. Sawvell submitted medical records and her own research, citing various medical institutions and studies, suggesting a link between aluminum adjuvants in vaccines, chronic inflammation, and cancer, specifically sarcomas.
She argued that these animal studies and general medical principles regarding inflammation applied to her case. The respondent, the Secretary of Health and Human Services, argued that the claim was filed outside the statute of limitations and that Ms.
Sawvell failed to provide a credible medical theory connecting the vaccine to her sarcoma, as required under the Althen standard for off-Table claims. The respondent also noted that the vaccination records indicated an injection in the right arm, not the left.
Special Master Christian J. Moran reviewed the case.
The public decision does not describe the specific onset of symptoms, diagnostic tests beyond biopsy and pathology reports, or treatments beyond surgical excision, reconstructive surgery, and radiation therapy. Ms.
Sawvell was unable to secure an expert opinion to support her claim. The Special Master found that Ms.
Sawvell did not meet her burden of proof under the Althen standard. Specifically, she failed to establish a sound medical theory connecting the Prevnar 13 vaccine to sarcoma, as her arguments relied on uncited and unverified claims, and she did not provide evidence to extrapolate findings from animal studies to humans or to explain how Prevnar 13 specifically triggers chronic inflammation leading to cancer.
Furthermore, she failed to establish a logical sequence of cause and effect and did not present any argument or evidence regarding a proximate temporal relationship between the vaccination and her sarcoma. Consequently, her case was dismissed.
Theory of causation
Petitioner Kathy Sawvell, age 65, received a Prevnar 13 vaccination on April 10, 2015, and subsequently developed a high-grade myxofibrosarcoma. As sarcoma is not a listed "on-Table" injury for this vaccine, the claim proceeded as an "off-Table" causation-in-fact claim under the Althen standard. Petitioner, proceeding pro se, argued a theory of causation based on her research suggesting that aluminum adjuvants in vaccines can cause cancer through chronic inflammation and DNA damage, citing animal studies and general medical literature. She also claimed the lump appeared around the vaccination date. Respondent argued the claim was time-barred and that Petitioner failed to establish a credible medical theory. Special Master Christian J. Moran denied compensation, finding Petitioner failed all three prongs of the Althen test. Prong one (causal theory) failed because Petitioner's arguments were based on uncited, unverified assertions and lacked evidence to extrapolate animal study findings to humans or to link Prevnar 13 specifically to chronic inflammation and sarcoma in humans. Petitioner did not provide expert reports or medical records supporting her theory. Prong two (logical sequence of cause and effect) failed because Petitioner did not establish that the vaccine was capable of causing sarcoma. Prong three (proximate temporal relationship) failed due to a complete lack of argument or evidence presented by Petitioner regarding a medically acceptable timeframe. The case was dismissed. Attorneys involved were Kathy Sawvell (pro se) for Petitioner and Emilie Williams for Respondent. Decision date: September 13, 2022.
Source PDFs
USCOURTS-cofc-1_20-vv-00602