Mitchell Valentine v. HHS - Influenza, alleged transverse myelitis and left-leg lymphedema (2025)

On April 18, 2017, a petition was filed on behalf of Mitchell Valentine, then a minor, seeking compensation under the National Childhood Vaccine Injury Act. Mitchell alleged that a Fluvirin influenza vaccine administered on August 30, 2015, caused him to develop transverse myelitis (TM), which in turn caused lymphedema of his left leg.

The respondent disputed entitlement, arguing that Mitchell had not proven he suffered from TM and that the medical record instead supported primary lymphedema unrelated to vaccination. Joseph Vuckovich, Esq., of Mctlaw, represented the petitioner, and Eleanor Hanson, Esq., of the U.S.

Department of Justice, represented the respondent. Special Master Mindy Michaels Roth issued the decision on January 13, 2025, denying entitlement.

The decision was publicly filed on February 7, 2025. Mitchell Valentine had been a healthy child with no prior significant medical issues.

Twenty-two days after receiving the flu vaccine, on September 21, 2015, he presented to his pediatrician with one day of left leg numbness. He had played soccer the previous day and stumbled.

His pediatrician suspected a spinal lesion and admitted him to Children's Hospital of Pittsburgh. During his hospitalization from September 21 to September 25, 2015, he experienced tingling in his right lower extremity, numbness in his left lower extremity, left leg weakness, and shooting pain from his left calf to behind his knee.

Neurologic examination revealed slightly decreased left lower-extremity strength, left ankle clonus, and upgoing left toe, with difficult-to-assess diminished sensation in both feet. He had no bladder or bowel changes.

Objective testing, including brain MRI, spine MRI (which showed Schmorl's nodes and disc changes but no cord lesion), EMG, and CSF studies, were all normal or negative. Despite these findings, a presumptive diagnosis of early transverse myelitis was made based on his symptoms and recent upper-respiratory symptoms.

He received five days of IV methylprednisolone followed by an oral prednisone taper, and his left-leg weakness improved. The discharge diagnosis was weakness of the left lower extremity.

By October 2015, he was described as having "improving transient myelitis." On December 3, 2015, his parents reported he was "completely fine" with no neurological complaints and was playing soccer. However, Dr.

Alper noted left ankle swelling and a few beats of clonus. Further evaluation at Children's Hospital showed no significant neurologic abnormalities, with X-rays revealing diffuse ankle and knee swelling but no bone or joint abnormality, and a normal venous Doppler.

On February 20, 2016, Mitchell returned to Children's Hospital with left-leg swelling that had worsened over the preceding weeks. He reported no numbness, weakness, tingling, or incontinence.

Imaging for deep vein thrombosis was negative. Thoracic and lumbar spine MRIs were normal and negative for transverse myelitis.

A pelvic MRI showed left iliac vein compression by the right iliac artery, suggesting May-Thurner syndrome. He had full strength, intact sensation, and normal reflexes.

The discharge diagnosis was lower-extremity swelling. He was advised to wear compression stockings and follow up at the vascular clinic.

Subsequent evaluations by vascular specialists, including Dr. McEnaney and Dr.

Andrew McCormick, focused on the leg swelling. Dr.

McEnaney considered May-Thurner syndrome versus primary lymphedema. By May 2016, Mitchell had persistent left-leg swelling from hip to toes.

Lymphoscintigraphy showed obstructed lymphatic flow, consistent with lymphedema. Dr.

McCormick concluded that Mitchell fit the category of primary lymphedema, possibly puberty-driven lymphedema praecox, and noted limited data suggesting external steroid use could trigger progression in lymphatic disease. Petitioner's neurologic expert, Dr.

Allan Rubenstein, opined that Mitchell had mild, early, asymmetric transverse myelitis following vaccination, and that the subsequent lymphedema resulted from this TM through abnormal sympathetic nervous-system function or reinnervation. Petitioner also relied on Dr.

Tejas Shah, who proposed that vaccination caused an excessive systemic inflammatory response leading to secondary lymphedema. Respondent's experts disagreed.

Dr. Michael Sweeney testified that Mitchell did not have transverse myelitis due to the lack of MRI or CSF evidence of spinal cord inflammation, absence of a sensory level, minimal objective sensory loss, and no bowel or bladder dysfunction.

Dr. Caitlin Hicks opined that lymphedema is a lymphatic system disease, not a nervous system disease, and that literature did not connect influenza vaccine to lymphedema or TM to secondary lymphedema, concluding Mitchell most likely had primary lymphedema praecox.

Special Master Mindy Michaels Roth denied entitlement, finding that Mitchell had not proven transverse myelitis. She noted the presumptive nature of the initial diagnosis, the consistently normal objective tests, and the treating physicians' later questioning of the TM diagnosis.

Because the TM diagnosis was not proven, the theory that TM caused lymphedema failed. The Special Master also found the independent systemic-inflammation theory underdeveloped and unsupported.

She concluded that petitioner failed all three prongs of the Althen test: no reliable theory linked the flu vaccine to his lymphedema, no logical sequence of cause and effect was established, and no persuasive medically appropriate timeframe was shown. The case was dismissed, and no compensation was awarded.