Renee Handjis v. HHS - Influenza, transverse myelitis (2022)

Filed 2018-07-17Decided 2022-12-05Vaccine Influenza
dismissed

Case summary [AI summaries can sometimes make mistakes]

On July 17, 2018, Renee Handjis filed a petition alleging that an influenza vaccine administered on December 10, 2015, caused her to develop transverse myelitis (TM). The case was assigned to Special Master Mindy Michaels Roth.

Following discussions about deficiencies in the case, an Order to Show Cause was issued. After reviewing the evidence, Special Master Roth found that Handjis failed to provide preponderant evidence that the flu vaccine caused her TM, leading to the dismissal of her case.

The decision noted several deficiencies. First, proof of vaccination was insufficient; the only record was an entry for a "high dose seasonal" flu vaccine on December 10, 2015, which was unlikely for a 49-year-old, as high-dose vaccines are typically for individuals aged 65 and older.

No contemporaneous medical records or other persuasive documentation of the vaccination were submitted. Second, Handjis failed to establish a definitive diagnosis of TM.

While her local neurologist diagnosed her with TM, objective tests such as MRIs, CSF, and EMG/NCS were normal. Her treating neurologist later expressed uncertainty, stating she had TM "or something very similar to it," and another physician opined her condition was not a "primary neurologic condition." The medical literature submitted by Handjis outlined diagnostic criteria for TM that she did not fulfill.

Third, the court found that her alleged injury did not last the required six months. Her symptoms appeared to resolve by March 4, 2016, when she returned to baseline, and subsequent issues in May 2016 were attributed by her physician to "fatigue related phenomenon superimposed on old microscopic thoracic spine injury," not an exacerbation of TM.

Symptoms reported in 2017 were described as "completely new" or similar to those experienced prior to the alleged vaccine injury. Fourth, Handjis failed to meet the criteria for an off-Table claim under Althen v.

Secretary of Health & Human Services. She did not provide a reputable medical theory connecting the vaccine to TM, a logical sequence of cause and effect, or a proximate temporal relationship.

The public decision does not describe the specific onset of symptoms, the exact nature of the neurological deficits, or the specific treatments received beyond physical therapy. Petitioner's counsel was Lawrence Cohan, and respondent's counsel was Darryl Wishard.

Special Master Mindy Michaels Roth issued the dismissal decision on December 5, 2022.

Theory of causation

Petitioner Renee Handjis alleged that an influenza vaccine administered on December 10, 2015, caused her to develop transverse myelitis (TM). The Special Master dismissed the case, finding insufficient evidence for an off-Table claim. Key deficiencies included: lack of proof of vaccination (only an entry for an unlikely "high dose seasonal" flu vaccine for a 49-year-old); failure to establish a definitive TM diagnosis, as objective tests (MRI, CSF, EMG/NCS) were normal and treating physicians expressed uncertainty; failure to demonstrate injury lasting over six months, with symptoms resolving by March 2016 and later issues attributed to fatigue or other causes; and failure to meet the Althen criteria for causation. Specifically, the petitioner did not provide a reputable medical theory linking the flu vaccine to TM, a logical sequence of cause and effect, or a proximate temporal relationship. The public decision does not name specific medical experts consulted by the petitioner or respondent, nor does it detail the specific mechanism of action proposed for vaccine-induced TM. The case was dismissed by Special Master Mindy Michaels Roth on December 5, 2022, with petitioner's counsel Lawrence Cohan and respondent's counsel Darryl Wishard involved.

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