Arlyne Rothenberg v. HHS - Tdap, lipodystrophy (2018)

Arlyne Rothenberg, a 55-year-old woman, filed a petition on July 6, 2015, seeking compensation under the National Vaccine Injury Compensation Program. She alleged that a Tetanus-diphtheria-acellular pertussis (Tdap) vaccine administered on July 21, 2012, caused a variety of autoimmune symptoms, including pain in her joints, bones, and muscles, abdominal cramping, neuropathies in her limbs, gastrointestinal distress, and microcytic anemia, which she claimed resulted in lipodystrophy.

Ms. Rothenberg's medical history was extensive, including anxiety disorder, depression, neuropathic pain, and having undergone gastric bypass surgery in 1993.

She also had a history of osteomalacia secondary to the gastric bypass, bilateral hip pain, hypothyroidism, gluten sensitivity, colitis, anemia, Hashimoto’s disease, chronic kidney disease, and hernia surgery. The medical records did not indicate any immediate reaction to the Tdap vaccine.

Approximately five weeks post-vaccination, she reported itchy skin and bone and muscle pain to Dr. Ira Breit, who noted alopecia, a rash, and vitamin D and iron deficiencies.

In September 2012, she saw Dr. Stephen Honig for severe joint and muscle pain, which she stated had been ongoing for a few months.

Dr. Honig noted her existing osteomalacia and prescribed medication for calcium levels.

By October 2012, her pain had lessened with sun lamp use, but she still experienced bone and muscle pain, and Dr. Honig noted an improvement in vitamin D levels but persistent anemia and a high erythrocyte sedimentation rate.

She also saw Dr. Tibor Moskovits for anemia and ESR increase.

On October 24, 2012, Ms. Rothenberg reported to Dr.

Honig that her symptoms had "exploded" since the July vaccination, but he did not concur with her suspected link. She consulted other specialists, including endocrinologist Dr.

Michael Holick and Dr. Robert Lind, who considered Ehlers-Danlos syndrome but ultimately attributed her symptoms to her underlying osteomalacia and vitamin D deficiency.

In February 2013, she was hospitalized with painful diarrhea and reported her "problems" began six months prior after the Tdap vaccine triggered a "neuropathy," though she also noted similar symptoms occurred annually since her gastric bypass. She was diagnosed with "intestinal malabsorption" and treated for anemia, diarrhea, and vitamin deficiencies.

In March 2013, she was hospitalized again with shortness of breath, headache, and chest and arm pain, diagnosed as a thrombus in the left subclavian vein associated with an intravenous feeding line insertion. The term "lipodystrophy" first appeared in her medical records in October 2013, when she saw dermatologist Dr.

Joseph Jorizzo for a facial growth. In December 2013, she reported "skin thinning" to Dr.

Jorizzo and stated her condition had been "diagnosed to be acquired lipodystrophy," though the record did not contain a prior formal diagnosis. Dr.

Jorizzo's "encounter diagnoses" included "partial lipodystrophy" but he concluded her subcutaneous manifestations were likely from delayed metabolic issues from bariatric surgery. In September 2014, a progress note referenced "lipodystrophy - loss of connective tissue.

Triggered by tetanus shot??" but the primary reason for the visit was insomnia. In May 2015, Dr.

Eric Smouha noted her visit was for "problems with both ears secondary to lipodystrophy" and that she "was diagnosed with lipodystrophy 3 years ago after a DPT shot," which would place the diagnosis before the Tdap vaccination. The Special Master reviewed expert reports from Dr.

Yehuda Shoenfeld for the petitioner and Dr. Arnold Levinson for the respondent.

Dr. Shoenfeld proposed a theory linking vaccines, particularly through aluminum adjuvants and complement system defects, to autoimmune-induced lipodystrophy, suggesting a progressive disease with a long incubation period.

Dr. Levinson disputed that Ms.

Rothenberg ever had lipodystrophy, arguing her symptoms were better explained by her pre-existing conditions, particularly sequelae from her gastric bypass surgery. He also contended that the temporal relationship between the vaccination and the alleged onset of lipodystrophy was too long and that the scientific evidence for vaccine-induced lipodystrophy, especially systemic forms, was lacking.

The Special Master, Brian H. Corcoran, found that Ms.

Rothenberg failed to prove she actually had lipodystrophy, noting the lack of a formal diagnosis in the medical records and that her symptoms were more readily attributable to her pre-existing conditions. He also found her causation theory unreliable and unpersuasive, particularly regarding the temporal relationship, concluding that the alleged onset was not within a medically acceptable timeframe for vaccine causation.

Consequently, entitlement to compensation was denied. Petitioner was represented by John McHugh, and Respondent by Heather L.

Pearlman. The decision was issued on June 7, 2018.