Nichole Fankhauser v. HHS - HPV, chest pain, back pain, abdominal pain, vomiting, autonomic neuropathy, fibromyalgia (2014)

Nichole Fankhauser filed a petition on September 8, 2009, alleging that HPV Gardasil vaccines she received on May 24, 2007, June 24, 2008, and September 30, 2008 caused her to develop severe cramping, chest pain, back pain, vomiting, and abdominal pain. She also received hepatitis A and Varivax vaccines on May 24, 2007, and hepatitis A on June 24, 2008.

Ms. Fankhauser's petition was later amended to include autonomic neuropathy and fibromyalgia.

Before vaccination, she had a history of ADHD, confusion, memory problems, and a family history of irritable bowel syndrome. Ms.

Fankhauser's post-vaccination medical history was extensive and involved evaluations by multiple specialists. Her first significant symptom — sharp abdominal pain while playing basketball — occurred on October 1, 2007, approximately five months after her first Gardasil dose, and was attributed by physicians to Mittelschmerz.

Over the following years, she underwent numerous normal diagnostic tests. Her gallbladder was removed in November 2008, but her symptoms did not improve.

Physicians at Duke University noted that her pain improved when she was distracted and identified a considerable stress and anxiety component. In 2011, gastroenterologists attributed her abdominal pain to IBS, Dr.

Sanjay Jain of Johns Hopkins found her symptoms inconsistent with a vaccine adverse reaction, and her cardiologists noted that a possible autonomic disorder appeared to be markedly exacerbated by emotional and psychiatric disorders. By November 2013, Johns Hopkins physicians concluded that her symptoms were most consistent with fibromyalgia, anxiety, panic attacks, and IBS.

Petitioner's expert was Dr. Elizabeth Vaughan, her treating physician, who opined that Ms.

Fankhauser had suffered a toxic reaction to the Gardasil vaccine. Dr.

Vaughan's report did not identify which component of the vaccine was toxic or explain a mechanism by which the vaccine could cause the injury; it lacked scientific basis, contained no supporting studies, and relied on case reports and medical blogs. A treating physician who had attributed petitioner's symptoms to the Gardasil vaccine, Dr.

Webster, subsequently surrendered his medical license following a state medical board investigation. Respondent's expert, Dr.

Edward Cetaruk, a medical toxicologist, analyzed each component of the Gardasil vaccine and concluded that none of them, individually or in combination, could cause a toxic reaction. He also noted that a five-month delay between the first vaccination and the onset of symptoms was inconsistent with a toxic causation theory.

Special Master Dorsey dismissed the petition on November 24, 2014, finding that petitioner had not satisfied any of the three Althen prongs. Under prong one, Dr.

Vaughan's opinion was conclusory, lacked a scientific basis, and failed to set forth a mechanism. Under prong two, she had not shown a logical sequence of cause and effect because she failed to address the diagnoses of IBS, gynecological problems, gallbladder dysfunction, and psychological factors made by petitioner's numerous treating physicians.

Under prong three, she had not addressed the temporal relationship at all, and many of petitioner's complaints were not temporally related to the vaccinations.