Kira Hughes v. HHS - Tdap, alleged complex regional pain syndrome (CRPS) and/or postural orthostatic tachycardia syndrome (POTS) with chronic pain, leg pain, headaches, fatigue, and palpitations (2021)

On August 3, 2016, Patrice Moczek filed a petition under the National Childhood Vaccine Injury Act on behalf of her then-minor daughter, Kira Hughes. The petition alleged that the human papillomavirus (HPV), meningococcal, and tetanus-diphtheria-acellular-pertussis (Tdap) vaccines administered on August 15, 2013, caused Hughes to suffer from leg pain, headaches, and fatigue, later refined to claims of complex regional pain syndrome (CRPS) and/or postural orthostatic tachycardia syndrome (POTS).

Hughes later became the petitioner after turning eighteen. Initially, the case was dismissed for failure to prosecute, but the Federal Circuit reversed this procedural dismissal, allowing the case to proceed to a merits decision.

Chief Special Master Brian H. Corcoran denied entitlement on the written record, and Senior Judge Eric G.

Bruggink denied review. Before vaccination, Hughes had a history of ovarian cysts, heavy menses, occasional back pain, urinary tract infections, and migraines.

In late 2012, she experienced breathing problems, high heart rate, and dizziness, with anxiety considered explanatory after a normal EKG. In early 2013, she reported dizziness, headaches, and heavy menstrual periods, and was evaluated for knee pain after a fall, with a history of left patella subluxation.

Following vaccination on August 15, 2013, the contemporaneous medical record did not document an immediate reaction. Within a week, Hughes presented with symptoms of a urinary tract infection, flank pain, and nausea, but a urine culture was negative.

Eight days post-vaccination, she saw an OBGYN for lower abdominal pain associated with her menses, which had begun the day before vaccination. An ultrasound was unremarkable.

In September 2013, she was assessed with dysmenorrhea and prescribed oral contraceptives. Hughes's treatment intensified in October 2013, approximately seven to nine weeks post-vaccination.

She reported bilateral leg pain, but a Doppler study showed no deep vein thrombosis. An emergency room visit for leg cramping, headache, and back pain yielded normal test results, with a diagnosis of myalgia or growing pains.

She later saw a physician for leg pain, reporting no weakness, numbness, or sensory changes, and testing was negative for Lyme disease and rheumatoid factor, though muscle enzymes were slightly elevated. Examination findings were noted as inconsistent, with less difficulty observed when Hughes was indirectly observed than when directly examined.

Admitted to the hospital on October 29, 2013, treaters noted multiple vague complaints without evidence of acute inflammatory disorder. Fibromyalgia was considered but deemed unlikely due to her age.

Hughes's mother raised the HPV vaccine as a possible cause, but treaters pushed back against this theory, suggesting anxiety as a likely explanation. In March 2014, a physician listed psychogenic causes, CRPS, chronic fatigue syndrome, Ehlers-Danlos syndrome, or POTS as possibilities.

In April 2014, a hospital noted hypermobility, excessive pain, and fatigue, recommending desensitization and anxiety treatment. In May 2014, a genetics evaluation recommended hydrotherapy and cardiology evaluation with tilt-table testing due to concern for POTS, though the record did not confirm the test was performed.

Several later providers entertained vaccine-related explanations. Dr.

Philip DeMio treated Hughes, proposing Lyme disease, autoimmune and metabolic disorders, and "Gardasil" concerns. Dr.

Freeda Flynn assessed headaches, rash, and palpitations, suggesting a possible Gardasil reaction and later writing that Hughes was being treated for "Gardasil Syndrome." A 2020 Cleveland Clinic neurology excerpt listed associated diagnoses of POTS, sleep disturbance, and insomnia, but did not show specialized testing to corroborate POTS. Petitioner's experts were Dr.

Philip DeMio, Dr. James Lyons-Weiler (Ph.D.), and Dr.

Michael Miller. Dr.

DeMio's report, based on his treatment of Hughes, was found unpersuasive and not qualified to support the causation theory. Dr.

Lyons-Weiler, a Ph.D. scientist, advanced arguments about HPV vaccine safety and immune effects but was not a treating physician and was not qualified to diagnose CRPS or POTS. Dr.

Miller, accepted as qualified to discuss CRPS and POTS, had his application of diagnostic criteria found unsupported by the contemporaneous medical record. Chief Special Master Corcoran denied entitlement on January 4, 2021.

He found that Hughes had not proven, by preponderant evidence, that she suffered from CRPS or POTS. For CRPS, he cited the absence of a close-in-time regional pain syndrome, lack of trauma near vaccination, inconsistent examination findings, and the lack of a CRPS diagnosis by contemporaneous treaters.

For POTS, he found the record lacked typical symptoms immediately post-vaccination, cardiac testing was unrevealing, and the tilt-table test was never performed. He also found the experts and literature insufficient to prove vaccine causation.

Senior Judge Eric G. Bruggink denied review on June 4, 2021.

He held that proof of the asserted injury was a prerequisite to the Althen causation analysis and that the Special Master had rationally compared the diagnostic criteria to Hughes's medical records. The court noted that Dr.

Li's observations undermined the claim of unrelenting pain for CRPS, and that the POTS evidence was weaker due to the lack of determinative testing and unrevealing cardiac tests. The petition was dismissed, and no compensation was awarded.

Petitioner's counsel was Braden Blumenstiel. Respondent's counsel included Kyle Pozza.