Alayna McDonald v. HHS - HPV, chronic fatigue (2023)

On June 16, 2015, Craig and Mary Beth McDonald, on behalf of their minor daughter Alayna McDonald, filed a petition seeking compensation under the National Vaccine Injury Compensation Program. They alleged that Alayna McDonald suffered from mitochondrial and methylation/glutathione dysfunction, causing or exacerbating chronic fatigue, after receiving multiple doses of the human papillomavirus (HPV) vaccine (Gardasil) in 2012.

Alayna McDonald later became the proper petitioner upon turning 18. The petition's theory evolved to allege that the HPV vaccine doses caused a toxic reaction due to undisclosed vaccine ingredients.

After extensive litigation involving sixteen expert reports, the parties briefed their positions for a ruling on the record. Chief Special Master Brian H.

Corcoran issued the decision on March 7, 2023, denying the claim. Alayna McDonald was born on April 9, 1998, and was fourteen years old at the time of vaccination.

Her medical history included hypertrophy of her lower limb, exercise-induced asthma, allergic rhinitis, and migraine headaches. She received her first HPV vaccine dose on June 14, 2012, the second on August 17, 2012, and the third on December 26, 2012.

The medical records from the vaccination period did not document any post-vaccination reaction or symptoms consistent with the alleged chronic fatigue. Petitioner's parents maintained she began experiencing fatigue-like symptoms in the summer of 2012, with sleepiness increasing in the fall.

The first medical record noting allegedly vaccine-related symptoms was from January 31, 2013, when Alayna reported mood changes, trouble falling asleep, and waking fatigued. She was assessed with mood changes and referred for counseling.

By March 13, 2013, she complained of general fatigue and school performance issues. Laboratory tests showed a positive Lyme antibody, and she was diagnosed with infectious mononucleosis and fatigue.

Letters from her physician noted she was being followed for mononucleosis and Lyme disease, associated with extreme fatigue. By April 19, 2013, she continued to report intermittent fatigue and concentration issues.

Thyroid tests were negative. A urology evaluation in May 2013 noted her "ongoing health issues" began in November 2012, nearly three months after the second dose.

She saw an infectious disease specialist in June 2013, reporting persistent fatigue since December 2012; the specialist opined her Lyme test was a false-positive and found no infectious explanation. In August 2013, she underwent a sleep study diagnosing moderate daytime somnolence and idiopathic hypersomnia.

A naturopathic practitioner, Peter Procuik, M.D., suggested in August 2013 that her symptoms might be associated with the HPV vaccine, and by December 2013 stated it was the "most likely reason" and proposed homeopathic treatments. In late 2014, another naturopathic physician, Nancy O’Hara, M.D., proposed that Petitioner's fatigue could be due to "impaired mitochondrial/metabolic/glutathione function" and "dysregulation of many internal systems." In early 2015, lab tests showed a positive Lyme disease result, and Dr.

O'Hara maintained that "mitochondrial and methylation/glutathione dysfunction [was] causing or exacerbating the chronic fatigue," also suggesting an MTHFR mutation. Petitioner's initial expert reports from Drs.

Judy Mikovits, Francis Ruscetti, and Karyemaître Aliffe were abandoned. Petitioner's primary expert, Dr.

Arthur Brawer, a rheumatologist, opined that the HPV vaccine caused a chronic "Gardasil induced illness" due to a toxic reaction from "non-antigenic ingredients" like organosiloxanes, which he claimed were added to clarify the vaccine and had a history of human toxicity, referencing silicone breast implant issues. He acknowledged that autoimmune mechanisms were not the cause.

Respondent's experts, Dr. Andrew MacGinnitie, an immunologist, and Dr.

Kendall Wallace, a toxicologist, refuted this theory. They stated there was no reliable evidence that organosiloxanes are in the HPV vaccine or cause such symptoms, noting that vaccine package inserts did not list them and that the vaccine's cloudiness upon agitation undermined the need for clarification.

Dr. MacGinnitie also questioned the existence of "HPV induced illness" as a recognized condition and noted that large-scale studies showed no increased risk of autoimmune diseases after HPV vaccination.

Dr. Wallace emphasized the scientific consensus that organosiloxanes pose minimal risk and that any potential presence in the vaccine would be in minuscule amounts.

Petitioner's other expert, Dr. Ernest Chiodo, a physician and toxicologist, proposed an alternative theory that the vaccine's adjuvant, amorphous aluminum hydroxyphosphate, could instigate disease by causing elevated plasma cytokine levels.

However, this theory was also found unsubstantiated and bordered on the discredited "ASIA" theory. Chief Special Master Corcoran found that Petitioner failed to establish a credible medical theory connecting the HPV vaccine to her chronic fatigue, did not prove a logical sequence of cause and effect, and did not demonstrate a medically acceptable temporal relationship.

The court denied the claim, finding that Petitioner did not preponderantly establish that the HPV vaccine caused her alleged injury. Petitioner was represented by Phyllis Widman of Widman Law Firm, LLC, and Respondent was represented by Mallori Openchowski of the U.S.

Department of Justice. The decision was issued by Chief Special Master Brian H.

Corcoran.