U.L. v. HHS - MMR, autistic disorder (2018)
Case summary [AI summaries can sometimes make mistakes]
Petitioners Eva J. Coiro-Lorusso and Nicola Lorusso filed a petition on January 4, 2002, on behalf of their son, U.L., alleging that the MMR vaccine administered on January 19, 1999, when U.L. was one year old, caused his autistic disorder.
The petition was filed under the National Vaccine Injury Compensation Program. U.L. also received another concurrent vaccine at that time.
The public decision does not specify the type of the second vaccine. This case was part of a "mini-omnibus" proceeding involving 23 cases, all of which agreed to be bound by the lead decision in V.J.M. v.
Secretary. The central theory of causation in this mini-omnibus was that residual human DNA fragments and HERV-K endogenous retrovirus fragments in the rubella component of the MMR vaccine triggered autism through insertional mutagenesis or autoimmunity.
This theory was primarily advanced by petitioners' expert, Dr. Theresa Deisher.
Chief Special Master Nora Beth Dorsey issued a decision on August 31, 2017, which was later refiled in redacted form on February 7, 2018, denying entitlement. The decision found that Dr.
Deisher's "autism change point" study had significant methodological limitations, including an ecological design, data accuracy issues, and flawed statistical analysis. The proposed mechanisms of insertional mutagenesis, retrograde transport, microvesicle transport, and hematopoietic stem cell uptake of vaccine-strain DNA were found to be either undeveloped or contradicted by the absence of supporting experiments.
Dr. Deisher conceded that the role of HERV-K retroviruses in disease was "observational" and unknown.
Furthermore, numerous epidemiological studies overwhelmingly rejected a causal association between the MMR vaccine and autism. Based on these findings, the Special Master concluded that petitioners failed Prong One of the Althen test, which requires a reliable medical theory of causation.
Consequently, U.L.'s petition was dismissed, along with the other cases in the mini-omnibus, on the same day and for the same reasoning. The public decision does not detail the specific clinical story of U.L. beyond the vaccination date and the alleged condition, nor does it mention specific treatments or the names of counsel for either party.
Theory of causation
Petitioners alleged that residual human DNA fragments and HERV-K endogenous retrovirus fragments in the MMR vaccine triggered autistic disorder in U.L. through insertional mutagenesis and autoimmunity. This theory was advanced by petitioners' expert, Dr. Theresa Deisher, who conducted a "change point" study analyzing autism prevalence data against vaccine introduction dates. The Special Master found Dr. Deisher's study to have significant methodological limitations, including an ecological design and data accuracy issues. The proposed mechanisms of insertional mutagenesis and autoimmunity were deemed undeveloped or unsupported by evidence. Numerous epidemiological studies were cited that rejected a causal link between the MMR vaccine and autism. The Special Master concluded that petitioners failed to establish a reliable medical theory of causation (Althen Prong One), leading to the dismissal of the case.
Source PDFs
USCOURTS-cofc-1_04-vv-00258