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In Vaccine Act Cases, Where Parties Agree on Injury, Factfinder Must Accept Injury


A 13-year-old boy underwent a complete physical examination. The boy’s doctor determined that the boy was healthy. Following the examination, the boy received the tetanus-diphtheria (Td) vaccine and his third inoculation of the hepatitis B (HepB) vaccine.

 

About 24 hours later, the boy complained to his mother that he was experiencing back pain and numbness in his hands. The boy’s mother immediately took the boy to the emergency room (ER). A board-certified ER physician diagnosed the boy with Guillain-Barré syndrome (GBS), a peripheral nervous system disease that causes descending paralysis from the upper to lower extremities. The boy’s symptoms rapidly escalated. Within hours the boy had difficulty standing or walking, weakness in his arms, and required catheterization. The boy was ultimately transferred to the pediatric intensive care unit of a children’s hospital.

 

Upon admission to the children’s hospital, the boy was described as presenting progressive neuromuscular deterioration and life-threatening respiratory failure. Over the next three months, the boy suffered from a variety of symptoms caused by his illness, including quadriplegia and acute respiratory failure. The boy was discharged from the hospital about three months after he was admitted. The boy’s diagnosis at discharge was transverse myelitis (TM), an inflammatory disease of the spinal cord.

 

TM and GBS are both diseases in which portions of the nervous system are demyelinated, meaning the protective covering that surrounds nerve fibers (known as the myelin sheath) is damaged. TM affects the central nervous system, which is protected by the blood-brain barrier. GBS affects the peripheral nervous system, which is not protected by the blood-brain barrier.

 

The boy’s family filed a claim for compensation under the National Childhood Vaccine Injury Act. The claim alleged that the HepB vaccine and Td vaccine caused the boy’s TM and GBS. In support of the claim, the family submitted affidavits from the doctor, who conducted the physical examination prior to the administration of the vaccines; the board-certified ER physician, who diagnosed the boy with GBS; and the general pediatrician and critical care physician, who treated the boy during his admission to the children’s hospital and ultimately diagnosed the boy with TM.

 

The Secretary of Health and Human Services filed a Vaccine Rule 4 Report indicating that the boy was not entitled to compensation because he had failed to establish, by a preponderance of the evidence, that either vaccine caused his condition. In support of the report, the Secretary submitted the expert report of a pediatric neurologist, who opined that the boy only suffered from TM, not both TM and GBS, and that the time interval – less than 24 hours between the administration of the vaccines and the onset of his TM – was too soon for one or both of the vaccinations to have caused his condition.

 

In response, the family submitted the expert report of a pediatric neurologist, who concluded that the boy developed both GBS and TM caused by a rapid adverse immunological response to both vaccinations. In response, the secretary filed an expert report from an immunologist, who agreed that the boy suffered from both GBS and TM, but disputed the family’s expert pediatric neurologist’s theory of causation and the timing. He opined that 24 hours was not long enough for either TM or GBS to develop from the vaccination.

 

The special master denied compensation. The special master determined that the boy only suffered from TM, not both TM and GPS. The special master then concluded that the boy failed to establish that the TM arose within a medically appropriate timeframe following his vaccinations.

 

The Court of Federal Claims vacated and remanded the decision of the special master. The district court concluded that the special master’s finding of a specific diagnosis was not in accordance with the law. The district court instructed the special master, on remand, to refrain from making a determination regarding the boy’s specific diagnosis.

 

During the pendency of the decision on remand, the Secretary filed a status report disclosing that its expert pediatric neurologist’s medical license was suspended during the time that the expert had provided the government with expert witness services in the case.

 

On remand, the special master again denied compensation. The special master determined that the boy did not suffer from GBS and therefore based analysis solely on the TM diagnosis. The special master also found that the Secretary’s expert pediatric neurologist’s opinion retained some value.

 

The district court vacated and remanded. The district court instructed the special master, on remand, to address the Secretary’s expert pediatric neurologist’s reliability and credibility in light of his misrepresentations regarding his licensure and issue an alternative ruling that completely disregarded all of that expert’s opinions and testimony.

 

On remand, the special master denied compensation for a third time. The special master again determined that the Secretary’s expert pediatric neurologist’s opinion retained some value. The special master also issued an alternative opinion that disregarded the opinions and testimony of the Secretary’s expert pediatric neurologist. That opinion concluded that the boy’s expert failed to establish by a preponderance of the evidence an approximate temporal relationship between the vaccinations and the injury.

 

The district court denied the family’s motion to review the decision of the special master. The district court determined that the special master erred by conducting a threshold inquiry into the specific diagnosis of the boy’s alleged vaccine injury, but that the error was harmless. The district court determined that the special master’s alternate ruling, that 24 hours was too short of a time to develop TM or GBS after vaccination, and contained no error of law or abuse of discretion.

 

The United States Court of Appeals, Federal Circuit, reversed. The court held that the special master committed reversible error in conducting a threshold inquiry into the specific diagnosis of the claimant’s alleged vaccine injury; the special master’s erroneous conclusion that the boy only suffered from TM was harmful; and, on remand, the case would be assigned to a different special master.

 

The special master committed reversible error in conducting a threshold inquiry into the specific diagnosis of the claimant’s alleged vaccine injury by concluding that the boy only suffered from TM and failing to consider relevant evidence related to his GBS. The court held that a special master may opine on the nature of a claimant’s injury only if there is a dispute as to the nature of the injury. The court found that there was no dispute as to the nature of the boy’s injury because both parties’ experts agreed that the boy suffered from TM and GBS. The court concluded that the special master erred by concluding that the boy only suffered from TM and not both TM and GBS.

 

The special master’s erroneous conclusion that the boy only suffered from TM was harmful. Based on this improper diagnosis, the special master did not consider relevant evidence related to GBS. Because TM and GBS are separate diagnoses that affect different parts of the nervous system, the court found that the special master committed reversible error by failing to consider relevant evidence related to GBS. Therefore, remand was required for proper consideration of relevant evidence related to GBS.

 

The case would be assigned to a different special master on remand. The court noted that the case had a lengthy history, including two prior remands, and the special master consistently maintained that the boy only suffered from TM despite specific instructions that he must consider both the TM and GBS diagnoses. The court reasoned that, given that the special master had maintained an erroneous viewpoint throughout the case, despite express instructions to the contrary, the case must be assigned to a different special master on remand.

 

The United States Court of Appeals, Federal Circuit, reversed the denial by the Court of Federal Claims of the family’s motion to review the special master’s denial of compensation.

 

See: Contreras v. Secretary of Health and Human Services, 2017 WL 24643 (C.A.Fed., January 3, 2017) (not designated for publication).

 

See also Medical Law Perspectives, January 2013 Report: Vaccines: An Ounce of Prevention May Lead to a Pound of Injury 

 

 

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