Amy Crutchfield v. HHS - MMR, Type 1 diabetes mellitus (2014)

Amy Crutchfield, born October 17, 1970, filed a petition on January 16, 2009, alleging that an MMR vaccine she received on January 26, 2006 caused her to develop Type 1 diabetes mellitus. Ms.

Crutchfield had a family history of autoimmune diseases including rheumatoid arthritis, myasthenia gravis, and celiac disease, but no family history of diabetes. Her blood glucose was normal at a pre-vaccination examination.

Beginning approximately one to two months after vaccination, she developed increased thirst, weight loss, and hair loss. She was diagnosed with Type 1 diabetes on June 23, 2006 by Dr.

Carol Levy, an endocrinologist. Ms.

Crutchfield's expert, Dr. Yehuda Shoenfeld of Sheba Medical Center in Tel Aviv, proposed two theories: molecular mimicry, under which MMR viral particles were structurally similar to islet cells and triggered an autoimmune response against them; and an anamnestic response, under which the second MMR dose caused a faster and more intense immune reaction.

Special Master Hastings found Dr. Shoenfeld's opinion poorly explained and substantially flawed.

Dr. Shoenfeld never identified which MMR components resembled islet cells, acknowledged that his molecular mimicry theory was "in the way of speculation," and testified that every vaccine could cause any autoimmune disease.

He initially claimed that MMR contains adjuvants — on which his ASIA syndrome theory depended — but acknowledged in a post-hearing brief that it does not. Dr.

Shoenfeld's opinions had been rejected in numerous other vaccine cases, including Lombardi, Shapiro, Hennessey, Doe 54, and Doe 60. Respondent's experts, Dr.

Barry Bercu and Dr. Noel Maclaren, testified that Type 1 diabetes requires years of progressive islet cell destruction before clinical symptoms appear, making onset one to two months after vaccination biologically impossible.

Dr. Maclaren, who had 50 years of experience and had treated more than 20,000 patients with Type 1 diabetes, testified that HbA1c testing, which reflects average blood glucose over several months, showed that islet cell destruction had been underway long before the January 2006 vaccination.

More than twenty large epidemiological studies, including studies by DeStefano (2001), Hviid (2004 and 2006), a German study of 5.5 million MMR doses, and a Danish study of 5 million person-years, found no association between vaccines and Type 1 diabetes. The IOM 2002 report stated that the epidemiological literature favors rejection of a causal relationship between multiple immunizations and Type 1 diabetes.

The IOM 2011 report, submitted post-hearing, specifically examined the MMR vaccine and Type 1 diabetes and found no association. Special Master Hastings denied the petition on April 7, 2014, finding this was not a close case.

Respondent's experts were far more persuasive. Dr.

Maclaren's exceptional qualifications and the HbA1c evidence were the most persuasive considerations. Dr.

Shoenfeld's molecular mimicry theory was flawed and speculative. The epidemiological evidence and IOM reports uniformly found no association.

All three Althen prongs failed. Judge Braden of the Court of Federal Claims affirmed the decision on September 8, 2014, finding the special master's determination not arbitrary or capricious.

The court held that even assuming Dr. Shoenfeld had satisfied Althen prong one as a general proposition, he failed to explain why any MMR vaccine components were molecularly similar to islet cell antigens.

The epidemiological evidence and the IOM report were "nearly dispositive" on prong two. The HbA1c results independently established that islet cell destruction predated the vaccination, defeating prong three.