Minh Le v. HHS - Tdap, transverse myelitis (2023)

On August 29, 2016, Minh Le filed a petition for compensation under the National Vaccine Injury Compensation Program, alleging that he developed transverse myelitis (TM) as a result of a tetanus-diphtheria-acellular pertussis (Tdap) vaccination administered on May 20, 2014. Petitioner is 46 years old.

Respondent argued against compensation, stating the case was not appropriate for compensation under the Vaccine Act. The central issues were whether the Tdap vaccine can cause TM, whether Petitioner's TM was caused by the vaccination, and whether the time between vaccination and symptom onset was medically acceptable to infer causation.

Petitioner contended he provided preponderant evidence satisfying all three prongs of the Althen standard, while Respondent argued Petitioner failed to provide sufficiently reliable evidence of causation. Transverse myelitis is described as a rare clinical syndrome where an immune-mediated process causes neural injury to the spinal cord, resulting in weakness, sensory alterations, and autonomic dysfunction.

It can be acute or subacute, with acute presentations typically developing over hours and worsening over one to several days. Symptoms can include bilateral weakness, sensory symptoms below the lesion level, and bowel/bladder dysfunction.

TM can be accompanied by MRI signaling abnormalities, CSF pleocytosis, and oligoclonal bands. Its pathogenesis is likely autoimmune, and it has been associated with viral infections, autoimmune disorders, and vaccinations.

Petitioner received the Tdap vaccine on May 20, 2014, for a finger laceration. Four days later, on May 24, 2014, he presented to the emergency department with inability to walk or feel while urinating, reporting stiffness and pain in his lower extremities that began the previous evening.

Medical records indicated progressive worsening of symptoms, including bilateral lower extremity weakness and urinary retention. An MRI of the thoracic and lumbar spine revealed abnormal signal extension in the spinal cord, and CSF analysis showed slightly elevated protein and two oligoclonal bands.

Petitioner was diagnosed with TM and treated with IV Solu-Medrol and a prednisone taper. He underwent inpatient rehabilitation and outpatient therapy, continuing to experience fatigue, stiffness, and bladder issues.

Petitioner's experts, Dr. John Conomy, Dr.

Maria Chen, Dr. Lawrence Steinman, and Dr.

M. Eric Gershwin, opined that the Tdap vaccine caused Petitioner's TM.

Dr. Conomy and Dr.

Steinman proposed molecular mimicry as the mechanism. Dr.

Chen proposed an allergy or hypersensitivity immune response, and Dr. Gershwin proposed an innate immune response.

Respondent's experts, Dr. Jeffrey Gelfand and Dr.

Thomas Forsthuber, opined that the Tdap vaccine was not causally related to Petitioner's TM. Dr.

Gelfand questioned the molecular mimicry theory and the timing of onset, suggesting the symptoms were too rapid for vaccine causation. Dr.

Forsthuber also rejected the proposed theories, criticizing the methodology used to support molecular mimicry and arguing that adaptive immunity is required for TM. The Special Master found that Petitioner established by a preponderance of the evidence that his Tdap vaccine caused his TM.

The Special Master found molecular mimicry to be a sound and reliable theory for vaccine-induced TM, supported by medical literature and prior program decisions. The hypersensitivity and innate immune response theories were not found to be supported by preponderant evidence.

The Special Master determined that Petitioner's symptoms, including difficulty walking and bladder dysfunction, began approximately 48 to 72 hours after vaccination, which is a medically acceptable timeframe to infer causation. The Special Master also noted the absence of alternative causes and the support from treating physicians for vaccine causation.

Therefore, Petitioner was found entitled to compensation, with a separate damages order to be issued. Petitioner was represented by Maximillian J.

Muller of Muller Brazil, LLP, and Respondent was represented by Alec Saxe of the U.S. Department of Justice.

Special Master Nora Beth Dorsey issued the ruling.