Dustin Harlow v. HHS - Influenza, Melkersson-Rosenthal syndrome (2023)

Dustin Harlow, a 31-year-old adult, filed a petition on May 4, 2020, alleging that an influenza vaccine administered on June 3, 2017, caused him to develop Melkersson-Rosenthal syndrome (MRS). Mr.

Harlow reported that two days after receiving the flu vaccine, he experienced swelling of his lower lip and right eyelid. His condition persisted, leading to treatment by various specialists, including an ENT specialist who prescribed steroids and ordered a CT scan, which showed soft tissue swelling and a mildly enlarged lymph node.

An allergy and immunology specialist, Dr. Patrick Win, initially proposed MRS as a possible diagnosis but stated it was unlikely related to the flu vaccine.

A punch biopsy of Mr. Harlow's lip revealed granulomatosis mucositis.

Dr. Rebecca Chibnall, a dermatologist, also suspected MRS and noted in October 2018 that Mr.

Harlow was unable to receive the flu shot as it likely precipitated his condition, advising on herd immunity. Mr.

Harlow's medical records extend to January 2020, and he testified via affidavit that he continues to experience facial nerve paralysis and has been deemed "undeployable" by the Air Force. The Secretary of Health and Human Services disputed the claim, initially stating Mr.

Harlow had not offered an expert report. Mr.

Harlow subsequently submitted a report from his retained expert, Dr. Eric Gershwin, who proposed a theory that the flu vaccine triggered an immune response involving chemokines, which, due to a hypothetical genetic defect in chemokine receptors in Mr.

Harlow's facial tissues, caused immune cells to traffic to the affected area, leading to inflammation and MRS. The Secretary, through expert Dr.

Jonathan Miner, argued that Mr. Harlow's theory lacked adequate support, emphasizing the absence of epidemiological studies or case reports linking the flu vaccine to MRS.

Dr. Miner noted that while MRS can have a genetic basis, Mr.

Harlow was not tested for genetic abnormalities. Special Master Christian J.

Moran reviewed the parties' submissions, including expert reports and legal briefs, and determined that Mr. Harlow failed to establish a credible medical theory connecting the flu vaccine to his condition, which is a critical requirement for off-Table claims under the Althen test.

The Special Master found Dr. Gershwin's theory lacked sufficient empirical support and was not persuasive, particularly given the limited understanding of MRS etiology and the absence of literature linking vaccines to the condition.

Although Mr. Harlow experienced symptoms within two days of vaccination, the Special Master found the evidence regarding the timing prong to be thin and ultimately academic, as the failure to establish a medical theory rendered the case moot.

The petition was denied compensation. The decision was issued on December 6, 2023.