Cailen McKown v. HHS - HPV, postural orthostatic tachycardia syndrome (POTS), eczema/atopic dermatitis, and urticaria (2019)

On December 1, 2015, Cailen McKown filed a petition under the National Vaccine Injury Compensation Program, alleging that two doses of the human papillomavirus (HPV) vaccine received on March 20, 2013, and September 3, 2013, along with a hepatitis A vaccine on March 20, 2013, caused or significantly aggravated postural orthostatic tachycardia syndrome (POTS) and skin conditions, including eczema and urticaria. The respondent contested entitlement, and the case was tried before Special Master Brian H.

Corcoran. Petitioner McKown, born January 14, 2000, had a pre-vaccination history that included eczema, dry skin, and recurrent fever blisters.

On March 20, 2013, at a well-child visit, her mother reported recent lightheadedness with position changes and two syncopal episodes in the preceding three months. The pediatrician assessed neurocardiogenic syncope and referred her to cardiology.

At this visit, McKown received her first HPV dose and hepatitis A vaccine without immediate reaction. Approximately five weeks later, on April 26, 2013, she experienced an episode of lightheadedness, headache, and loss of consciousness, leading to an emergency room visit where she was diagnosed with sinusitis and vasovagal syncope.

A cardiologist, Dr. Kenneth Dooley, noted orthostatic blood pressure and pulse changes, and a late May 2013 tilt table test confirmed POTS, for which fludrocortisone was prescribed in July.

McKown's skin complaints emerged in July 2013 with a rash and hives, initially thought to be related to fludrocortisone and later a dairy allergy. Her eczema worsened, and she received her second HPV vaccine dose on September 3, 2013.

Dermatologists diagnosed atopic and contact dermatitis and eczema, with patch testing positive for numerous chemicals. Allergists considered allergic sensitivities or stressors more likely than POTS triggering eczema.

Further evaluations in 2014 by specialists at Emory and the Cleveland Clinic diagnosed atopic dermatitis, chronic urticaria, and other conditions, with skin biopsies showing spongiotic dermatitis consistent with eczema. None of these specialists found evidence of autoimmune vaccine reactions or supported a vaccine connection.

Petitioner's experts, neurologist Dr. Carlo Tornatore and Drs.

Judy Mikovits and Francis Ruscetti, proposed theories linking the HPV and hepatitis A vaccines to autoimmune-mediated POTS and neuroimmune skin inflammation. Respondent's experts, neurologist Dr.

Christopher Gibbons and allergist/immunologist Dr. Andrew MacGinnitie, testified that the vaccines did not cause or worsen eczema or POTS from an immunologic standpoint, and that McKown's symptoms were not indicative of an autoimmune vaccine reaction.

Special Master Corcoran denied entitlement, finding that while McKown's POTS and eczema symptoms worsened after vaccination, this worsening was not vaccine-caused. He concluded that both conditions predated or were emerging around the first vaccination, that petitioner's experts failed to establish a reliable autoimmune mechanism connecting the vaccines to POTS or eczema, that testing did not show expected autoimmune markers, and that treating specialists generally did not support a vaccine connection.

The timing of symptom onset was also found unpersuasive. The petition was denied, and no compensation was awarded.

Clifford J. Shoemaker represented the petitioner, and Debra A.

Filteau Begley represented the respondent.