Scott Valeen v. HHS - Influenza, granulomatosis with polyangiitis (GPA) (2021)

Scott Valeen alleged that an influenza vaccine administered on September 11, 2013, caused him to develop granulomatosis with polyangiitis (GPA). Mr.

Valeen had a history of type 2 diabetes and hypothyroidism. He reported nasal congestion, nosebleeds, and other upper respiratory symptoms starting around September 21 or 25, 2013, which were approximately 10-14 days after his vaccination.

He was diagnosed with GPA in December 2013. To prove his case, Mr.

Valeen relied on the opinion of Dr. Yehuda Shoenfeld, who proposed a theory of causation involving adjuvants in the vaccine or molecular mimicry.

The respondent, the Secretary of Health and Human Services, argued that Mr. Valeen failed to establish a credible theory of causation, a logical sequence of cause and effect, or a proximate temporal relationship between the vaccine and his GPA.

The court found that Mr. Valeen did not meet his burden of proof under the Althen standard for off-Table claims.

Specifically, the court determined that the Fluzone vaccine Mr. Valeen received did not contain adjuvants, undermining Dr.

Shoenfeld's primary theory. Furthermore, the court found Dr.

Shoenfeld's alternative theory of molecular mimicry unpersuasive, as it was underdeveloped and failed to adequately connect the vaccine to GPA, particularly by relying on a comparison to ciliary dyskinesia, a condition Mr. Valeen did not have.

The court also noted the lack of support from treating physicians for a causal link and the ambiguity in the proposed timeframe for symptom onset. Consequently, the court denied Mr.

Valeen's claim for compensation.