Grace Drummond v. HHS - HPV, Premature Ovarian Failure/Primary Ovarian Insufficiency (POF/POI) and Postural Orthostatic Tachycardia Syndrome (POTS) (2023)

Filed 2016-06-16Decided 2023-04-21Vaccine HPV
denied

Case summary [AI summaries can sometimes make mistakes]

On June 16, 2016, Grace Drummond, who was 16 years old at the time of vaccination, filed a petition alleging that she developed Premature Ovarian Insufficiency (POI) and Postural Orthostatic Tachycardia Syndrome (POTS) as a result of receiving two doses of the human papillomavirus (HPV) vaccine on July 22, 2013, and October 23, 2013. She also received an influenza vaccine on October 23, 2013.

Petitioner alleged that these vaccinations caused her POI and POTS. The case was litigated, and the Special Master issued a decision on April 21, 2023.

Petitioner's medical history included irregular menses starting in August 2013 and stopping completely by October 2013, along with various other symptoms. Petitioner's experts, Dr.

Felice Gersh and Dr. David Axelrod, argued that the HPV vaccine triggered an autoimmune response through molecular mimicry, leading to POI and POTS.

Dr. Gersh hypothesized that Petitioner's prematurity led to an underdeveloped intestinal microbiome, which, when combined with the HPV vaccine, altered her immune system, resulting in POI.

Dr. Axelrod supported the molecular mimicry theory, suggesting similarities between HPV vaccine peptides and ovarian proteins, and also linked Petitioner's POTS to the HPV vaccine via fibroblast growth factor receptor 3 homology.

He also noted an association between POTS and Ehlers-Danlos Syndrome (EDS), a condition Petitioner also had. Respondent's experts, Dr.

Corrine Welt, Dr. Thomas Forsthuber, and Dr.

Amy Arnold, countered that Petitioner did not meet the diagnostic criteria for POI, citing normal hormone levels and the absence of clear autoimmune markers. Dr.

Welt noted Petitioner's menstrual irregularities coincided with weight loss and that her hormone levels were normal. Dr.

Forsthuber stated there was no reliable evidence for POI or an immune insult to Petitioner's ovaries, and he disputed the molecular mimicry theory's applicability. Dr.

Arnold, an expert in POTS, concluded that Petitioner did not meet the diagnostic criteria for POTS, attributing her symptoms to EDS, and found no evidence linking POTS to autoimmunity or the HPV vaccine. The Special Master reviewed the evidence and expert testimony.

Regarding POI, the Special Master found that Petitioner failed to present preponderant evidence that she suffered from POI, noting inconsistencies in her hormone levels and the lack of clear autoimmune indicators. The Special Master also found that Petitioner's expert, Dr.

Axelrod, failed to establish a viable causation theory for POI, particularly concerning his new focus on AMH antibodies and the flu vaccine, and that his arguments were insufficient. Regarding POTS, the Special Master found that Petitioner did not establish a viable causation theory, noting the lack of a distinct biological mechanism for POTS separate from the POI theory and the inconsistent diagnoses from treating physicians.

The Special Master also found that the temporal relationship between the vaccination and the alleged POTS onset was too remote. Ultimately, the Special Master dismissed the case, finding that Petitioner did not meet her burden of proof for entitlement to compensation for either POI or POTS.

The decision was issued by Special Master Herbrina Sanders.

Theory of causation

Petitioner Grace Drummond, vaccinated with the HPV vaccine on July 22, 2013, and October 23, 2013, alleged that these vaccinations caused her to develop Premature Ovarian Insufficiency (POI) and Postural Orthostatic Tachycardia Syndrome (POTS). Petitioner's experts, Drs. Felice Gersh and David Axelrod, proposed an "off-Table" theory of causation based on molecular mimicry, suggesting that peptides in the HPV vaccine mimicked ovarian proteins, triggering an autoimmune response leading to POI. Dr. Axelrod also linked POTS to the HPV vaccine via molecular mimicry and noted an association with Petitioner's Ehlers-Danlos Syndrome (EDS). Respondent's experts, Drs. Corrine Welt, Thomas Forsthuber, and Amy Arnold, contested the diagnoses and causation theories, arguing against an autoimmune etiology for POI and POTS and questioning the molecular mimicry mechanism. The Special Master, Herbrina Sanders, found that Petitioner failed to establish by preponderant evidence that she suffered from POI, citing inconsistent hormone levels and lack of autoimmune indicators. The Special Master also found that Petitioner did not establish a viable causation theory for POTS, particularly regarding an autoimmune etiology or a proximate temporal relationship to the vaccination. Consequently, the case was dismissed for failure to meet the burden of proof for entitlement.

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