David T. McDaniel v. HHS - Influenza, immune-mediated myopathy, more likely than not dermatomyositis sine dermatitis (2023)

On September 25, 2017, David T. McDaniel filed a petition for compensation under the National Vaccine Injury Compensation Program, alleging that an influenza vaccine administered on December 12, 2016, caused him to develop an immune-mediated myopathy, more likely dermatomyositis sine dermatitis.

Respondent, the Secretary of Health and Human Services, argued against compensation. The parties stipulated that Mr.

McDaniel received the flu vaccine and most likely suffered from an immune-mediated myopathy, but disagreed on the specificity of the diagnosis and the onset of symptoms relative to the vaccination. Petitioner was represented by Douglas Lee Burdette, and Respondent was represented by Debra A.

Filteau Begley. Special Master Nora Beth Dorsey presided over the case.

Mr. McDaniel, born February 5, 1952, had a history of myopia, gammopathy, hyperlipidemia, dermatitis, chronic neck and back pain, and alcoholism.

Prior to vaccination, on December 1, 2016, he presented with a one-month history of fatigue, sore muscles, chills, tingling in his arms and legs, increased weakness, and a feeling of losing muscle tone. Labs revealed elevated AST and ALT.

On December 12, 2016, the day of vaccination, his AST and ALT remained elevated, and he received the flu vaccine (Fluvirin). Four days later, on December 16, 2016, he reported worsening weakness and paresthesias, difficulty walking, and pain.

He was admitted to Good Samaritan Hospital, where his condition was assessed as rhabdomyolysis and generalized weakness, with a differential diagnosis including post-vaccine syndrome or viral-induced autoimmune neuropathy. He also reported a viral flu-like illness approximately two weeks prior to vaccination.

Further evaluation at University of Washington Medical Center led to a discharge diagnosis of autoimmune myositis, possibly dermatomyositis sine dermatitis. Petitioner's expert, Dr.

Thomas M. Zizic, opined that the flu vaccine triggered an autoimmune response through mechanisms like molecular mimicry, leading to dermatomyositis.

He argued that Petitioner's symptoms began within 24 hours of vaccination and that pre-vaccination elevated liver enzymes were due to liver damage, not pre-existing muscle disease. Respondent's expert, Dr.

Mehrdad Matloubian, opined that Mr. McDaniel's muscle disease began before vaccination, citing his pre-vaccination symptoms of fatigue, sore muscles, and loss of muscle tone, as well as elevated AST and ALT.

Dr. Matloubian argued that the elevated enzymes were likely due to muscle injury, not liver disease, and that the onset of symptoms predated the vaccination by several weeks, citing Petitioner's own reports of feeling unwell prior to December 12, 2016.

Dr. Matloubian also contended that the proposed mechanism of molecular mimicry was not supported by evidence linking the flu vaccine to immune-mediated myositis and that viral infections, such as CMV, were potential alternative causes.

Special Master Dorsey found that Mr. McDaniel's immune-mediated myopathy was most likely dermatomyositis sine dermatitis.

She determined that the onset of symptoms occurred as early as November 1, 2016, and by December 4, 2016, predating the vaccination. This finding was based on contemporaneous medical records from multiple providers, which were given more weight than Petitioner's declarations.

The Special Master found Dr. Matloubian's explanation for the elevated AST and ALT levels (due to muscle disease) more persuasive than Dr.

Zizic's (due to liver disease). Regarding causation, the Special Master found that Petitioner failed to establish the first Althen prong (medical theory) because the cited literature did not support molecular mimicry as a causal mechanism for flu vaccine-induced immune-mediated myopathy.

She noted that while flu infections can cause viral myositis, this is typically due to direct muscle infection, not an autoimmune mechanism. Furthermore, the evidence did not establish a link between flu vaccination and autoimmune myositis, nor did it demonstrate molecular mimicry between the vaccine and muscle tissue.

For the second Althen prong (logical sequence of cause and effect), the Special Master found that because onset predated vaccination, the vaccine could not have caused the illness. Even if it had, the presence of a preceding viral-like illness and CMV infection made it difficult to attribute 'but for' causation to the vaccination.

For the third Althen prong (proximate temporal relationship), the Special Master reiterated that onset predated vaccination. She also found Dr.

Zizic's proposed 24-hour onset time frame for molecular mimicry to be unsupported by medical literature or Program case law. Ultimately, Special Master Dorsey concluded that Mr.

McDaniel failed to prove by a preponderance of the evidence that the flu vaccine caused his condition, and therefore, his petition was denied. The decision was issued on July 21, 2023.