Althen v. Sec’y of HHS
418 F.3d 1274 (Fed. Cir. 2005)
Authored by David W. Rifkin
Statement of Facts: On March 28, 1997, Margaret Althen (“Althen”) received tetanus toxoid (“TT”) and hepatitis A vaccinations. Within a matter of eighteen days after the administration of the vaccines, Althen began to experience headaches, painful eye movements, and blurred vision in her right eye, which progressed to a complete loss of sight in that eye. She was diagnosed with optic neuritis. Shortly thereafter, Althen began to experience fever, confusion, and neck stiffness. On June 4, 1997, Althen was admitted to the hospital where she was diagnosed with acute disseminated encephalomyelitis (“ADEM”), right optic neuritis, and congenital Duane’s syndrome. From this point forward, Althen’s condition became increasingly worse. On July 2, 1997, Althen returned to the hospital experiencing dizziness and gait instability. The medical staff attributed these symptoms to both encephalitis and ADEM. On July 27, 1998, Althen again began to experience optic neuritis, but this time in her left eye. And on August 6, 2000, Althen suffered a brain seizure. Following a brain biopsy, doctors concluded that Althen had a primary diagnosis of vasculitis with secondary tissue destruction and demyelination consistent with primary angiitis. Althen filed a petition seeking compensation under the National Childhood Vaccine Injury Act of 1986 (“Vaccine Act”) for injuries she suffered as a direct result of the TT vaccination.
Procedural History: The petition for compensation was assigned to the Chief Special Master of the Court of Federal Claims pursuant to 42 U.S.C. § 300aa–10. During an evidentiary hearing, the Special Master denied Althen’s claim for compensation. Applying the Stevens test, the Special Master concluded that despite testimony from a board-certified neurologist that the TT vaccine caused Althen’s injuries and that the onset of her optic neuritis occurred within a medically-accepted time period for a causal connection, because Althen did not provide peer-reviewed literature to support that assertion, she failed to prove causation by a preponderance of the evidence. On a Motion for Review, the Court of Federal Claims reversed, finding Althen sufficiently proved causation and that the Special Master erred as a matter of law in its legal analysis. The government appealed the trial court’s decision to the Federal Circuit.
Questions Presented: First,whether the analytical framework developed in Stevens v. Secretary of Department of Health & Human Services, 99-594V, 2001 WL 387418 (Fed. Cl. 2001) impermissibly raised the burden of proof for showing causation under the Vaccine Act. Second, whether the evidence presented at trial was sufficient to prove by a preponderance of the evidence that the TT vaccination proximately caused Althen’s injuries.
Holdings: First,yes, the Stevens Prongs materially altered the statutory burden of proof under the Vaccine Act and therefore are erroneous as a matter of law. Second,yes, Althen established by a preponderance of the evidence that the TT vaccination caused her central nervous system demyelinating disorder.
Reasoning: The Vaccine Act provides for the establishment of causation in one of two ways: through a statutory presumption of causation under the Vaccine Injury Table (“Table injury”) or by proving causation in fact for an injury not listed in the Vaccine Injury Table (“off-Table injury”). See 42 U.S.C. §§ 300aa–11(c)(1)(C)(ii)(I), –13(a)(1)(A), –14(a). If an injured claimant meets the statutory burden of proving causation under either statutory provision, she will be entitled to judgement as a matter of law. Because Althen sought redress for an off-Table injury, she was required to prove by a preponderance of the evidence that the TT vaccination caused her illness though the use of medical records or medical opinion. The Federal Circuit began by reviewing the Stevens test, an analytical framework developed by the Chief Special Master which required a claimant to prove causation by showing: “(1) medical plausibility; (2) confirmation of medical plausibility from the medical community and literature; (3) an injury recognized by the medical plausibility evidence and literature; (4) a medically-acceptable temporal relationship between the vaccination and the onset of the alleged injury; and (5) the elimination of other causes.” Althen, 418 F.3d at 1279 (citing Stevens, 2001 WL 387418, at *2326). The Federal Circuit rejected prongs two and three of the test. The court held that the Vaccine Act does not preclude a claimant establishing causation in fact in the absence of peer reviewed literature, so prongs two and three impermissibly increased the statutorily prescribed burden of proof. Moreover, the Federal Circuit reasoned that requiring Althen to support her claim with medical literature impeded her ability to prove causation through the use of circumstantial evidence and contravened Congress’s longstanding intent in resolving ambiguities in favor of injured claimants. However, the court upheld the remainder of the Stevens test as it merely recited well-established precedent.
The Federal Circuit affirmed the Court of Federal Claims’s reversal and reiterated its finding that the Chief Special Master’s duties do not include crafting a legal standard to be used in causation in fact cases. If a question of law arises regarding the interpretation or implementation of the Vaccine Act, answering that question is a matter for the courts, not the Special Master. In elaborating on the causation requirement, the Federal Circuit articulated a three-part test under which Vaccine Act claimants may establish causation by presenting: “(1) a medical theory causally connecting the vaccination and the injury; (2) a logical sequence of cause and effect showing that the vaccination was the reason for the injury; and (3) a showing of a proximate temporal relationship between vaccination and injury.” Althen, 418 F.3d at 1278. Applying these factors, the Federal Circuit found that Althen met the statutory burden for establishing causation by a preponderance of the evidence and concluded that the government failed to prove that factors unrelated to the TT vaccine were principally responsible for her resulting injuries.