Federal Circuit Outlines Elements of Proof Required to Establish Prima Facie Case of Significant Aggravation for Off-Table Vaccine Act Claim

A man received the influenza vaccine. Prior to his vaccination he had no clinical symptoms of multiple sclerosis (MS) or other neurological disorder. Eleven days after his vaccination, the man experienced numbness in his left hand, arm, and the left side of his head and face. An MRI conducted 17 days after his vaccination revealed six inflammatory brain lesions, suggestive of MS. None of the lesions appeared actively inflamed. Generally, most new lesions appear actively inflamed and older lesions do not appear actively inflamed.


The man experienced another episode the following month. He went to a neurologist who, based on his outward symptoms and MRI, diagnosed him with MS and referred him to another neurologist who specialized in MS. At first the specialist speculated that the vaccine might have caused a one-time inflammatory event. However, a subsequent MRI revealed a new actively inflamed lesion. At that point the specialist confirmed the MS diagnosis.


The Vaccine Act created the National Vaccine Injury Compensation Program, which allows people to be compensated upon showing that the person sustained a vaccine injury, or had significantly aggravated a vaccine-related illness, disability, injury, or condition. There are two types of claims under the Vaccine Act: table claims and off-table claims. In a table claim, the person benefits from a statutory presumption of causation upon showing that the injury is listed in the Vaccine Injury Table for the vaccine received and occurred within the time period in the table. In an off-table claim, one where the injury is not listed in the table, the person must prove actual causation by a preponderance of the evidence. MS is not on the Vaccine Injury Table.


The man applied for compensation under the National Childhood Vaccine Injury Act (Vaccine Act) claiming that the influenza vaccine caused his MS or aggravated his undiagnosed, sub-clinical MS. At a hearing before a special master the man’s expert theorized that the influenza vaccine could trigger production of immune cells that are cross-reactive with myelin and therefore attack the person's own nerve cells. The special master denied his claim. The special master concluded that the man had MS prior to receiving the vaccine and therefore the vaccine could not have caused his disease. Additionally, the man did not establish a plausible medical theory that the influenza vaccine causes significant aggravation of multiple sclerosis. The United States Court of Federal Claims affirmed the decision of the special master in part, reversed in part, and remanded.


The United States Court of Appeals for the Federal Circuit affirmed holding that the special master's finding that the claimant had multiple sclerosis before he received the influenza vaccine was not arbitrary or capricious. The special master carefully considered the evidence in the record, drew plausible inferences, and articulated a rational basis for his determination that, more likely than not, petitioner's lesions existed before he received the influenza vaccination.


The special master's finding that the claimant failed to establish a medical theory supporting his claim that the influenza vaccine significantly aggravated his preexisting multiple sclerosis was not arbitrary and capricious. There are different elements of proof required for table claims and off-table claims. Within the types of the claims there are also different elements of proof required for initial onset claims and significant aggravation claims. The United States Court of Appeals for the Federal Circuit had not previously addressed the proof required to establish a prima facie case of significant aggravation for an off-table claim.


The court held that a petitioner in an off-table case must show the vaccine actually caused the significant aggravation—not just that, accepting petitioner's medical theory as sound, the person's condition worsened within a medically-acceptable time frame. A petitioner must prove by preponderant evidence that the vaccination caused significant aggravation by showing: (1) the person's condition prior to administration of the vaccine, (2) the person's current condition (or the condition following the vaccination if that is also pertinent), (3) whether the person's current condition constitutes a “significant aggravation” of the person's condition prior to vaccination, (4) a medical theory causally connecting such a significantly worsened condition to the vaccination, (5) a logical sequence of cause and effect showing that the vaccination was the reason for the significant aggravation, and (6) a proximate temporal relationship between the vaccination and the significant aggravation.


The petitioner failed to produce sufficient evidence required under number four: a medical theory causally connecting such a significantly worsened condition to the vaccination. The special master reasonably considered the lack of evidence connecting the cross-reactivity proposed by the petitioner’s expert to the facts of petitioner's case to weigh against finding that the petitioner’s expert's opinion persuasive. The special master did find persuasive a number of medical journal articles about studies showing that vaccination does not aggravate MS. The court concluded that the special master’s weighing of the evidence was not arbitrary and capricious.


See: W.C. v. Secretary of Health and Human Services, 2013 WL 151714 (C.A.Fed., January 15, 2013) (not designated for publication).


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