Kristie Roby v. HHS - Hepatitis B, undifferentiated connective tissue disease versus sine scleroderma (2020)

On February 9, 2015, Kristie Roby filed a petition for compensation under the National Vaccine Injury Compensation Program, alleging that a combined hepatitis A and B vaccination received on June 27, 2013, caused her to develop undifferentiated connective tissue disease and scleroderma sine scleroderma. Initially, she claimed pain, fatigue, and weakness, later amending her petition to allege the vaccination triggered scleroderma.

Petitioner was 40 years old at the time of vaccination and worked as a nurse. Her medical records indicated a history of Raynaud's phenomenon prior to vaccination, with symptoms of joint pain and fatigue appearing shortly after the vaccination.

Over several years, multiple rheumatologists evaluated her, with some suggesting early scleroderma or undifferentiated connective tissue disease, while others believed her symptoms were due to fibromyalgia or PTSD. One expert opined she had no autoimmune disorder.

Petitioner's expert, Dr. Vera Byers, believed the vaccine caused an autoimmune disorder through bystander activation, but conceded there was no literature linking the hepatitis B vaccine to scleroderma and that the mechanism was speculative.

Respondent's expert, Dr. Chester Oddis, concluded that Petitioner did not have scleroderma or any autoimmune disease, and that her symptoms predated the vaccination or were attributable to other causes.

Special Master Herbrina Sanders presided over the case. After reviewing the medical records, expert testimony, and legal standards, the Special Master found that Petitioner had not met her burden of proof for causation.

The Special Master noted that the medical evidence did not establish a clear diagnosis, a scientifically accepted theory of causation linking the vaccine to her condition, or a definitive temporal relationship. Therefore, the petition was denied.

Petitioner was represented by Richard Gage, Richard Gage, PC, and Respondent was represented by Lynn Schlie of the United States Department of Justice.