Source: http://legaliq.com/Case/Althen_V_Secretary_Of_Health_And_Human_Services
Timestamp: 2017-04-28 19:58:40
Document Index: 335885202

Matched Legal Cases: ['§ 300', '§ 300', '§ 300', '§ 300', '§ 300', '§ 300', '§ 300']

Althen v. Secretary of Health and Human Services (418 F.3d 1274)
/ Althen v. Secretary of Health and Human Services
Case Name: Althen v. Secretary of Health and Human Services
Citations: 418 F.3d 1274
Docket #: 2004-5146
418 F.3d 1274
Margaret ALTHEN, Petitioner-Appellee,v.SECRETARY OF HEALTH AND HUMAN SERVICES, Respondent-Appellant.
COPYRIGHT MATERIAL OMITTED Kevin P. Conway, Conway, Homer & Chin-Caplan, P.C., Boston, Massachusetts, argued for petitioner-appellee. On the brief was Ronald C. Homer.
Under the Vaccine Act, the Court of Federal Claims reviews the special master's decision to determine if it is "arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law[.]" 42 U.S.C. § 300aa-12(e)(2)(B). Because we review the trial court's legal determination that the special master acted in a manner not in accordance with law de novo, we effectively review the special master's decision under the same standard. See Hines v. Sec'y of Health & Human Servs., 940 F.2d 1518, 1524 (Fed.Cir.1991). While we owe no deference to either the special master or the trial court on questions of law, Whitecotton v. Sec'y of Health & Human Servs., 81 F.3d 1099, 1106 (Fed.Cir.1996), we review the trial court's factual findings for clear error, Hines, 940 F.2d at 1523.
The Act provides for the establishment of causation in one of two ways: through a statutorily-prescribed presumption of causation upon a showing that the injury falls under the Vaccine Injury Table ("Table injury"), see 42 U.S.C. § 300aa-14(a); or where the complained-of injury is not listed in the Vaccine Injury Table ("off-Table injury"), by proving causation in fact, see 42 U.S.C. §§ 300aa-13(a)(1), -11(c)(1)(C)(ii)(I). Althen sought redress for her illness under the Vaccine Act's compensatory provision for off-Table injury. She must prove by a preponderance of the evidence that the TT vaccination caused her malady. See Shyface v. Sec'y of Health & Human Servs., 165 F.3d 1344, 1352-53 (Fed.Cir.1999); Hines, 940 F.2d at 1525; see also 42 U.S.C. § 300aa-13(a)(1). To meet the preponderance standard, she must "show a medical theory causally connecting the vaccination and the injury." Grant v. Sec'y of Health & Human Servs., 956 F.2d 1144, 1148 (Fed.Cir.1992) (citations omitted). A persuasive medical theory is demonstrated by "proof of a logical sequence of cause and effect showing that the vaccination was the reason for the injury[,]" the logical sequence being supported by "reputable medical or scientific explanation[,]" i.e., "evidence in the form of scientific studies or expert medical testimony[.]" Grant, 956 F.2d at 1148. Althen may recover if she shows "that the vaccine was not only a but-for cause of the injury but also a substantial factor in bringing about the injury." Shyface, 165 F.3d at 1352-53. Although probative, neither a mere showing of a proximate temporal relationship between vaccination and injury, nor a simplistic elimination of other potential causes of the injury suffices, without more, to meet the burden of showing actual causation. See Grant, 956 F.2d at 1149. Concisely stated, Althen's burden is to show by preponderant evidence that the vaccination brought about her injury by providing: (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. If Althen satisfies this burden, she is "entitled to recover unless the [government] shows, also by a preponderance of evidence, that the injury was in fact caused by factors unrelated to the vaccine." Knudsen v. Sec'y of Health & Human Servs., 35 F.3d 543, 547 (Fed.Cir.1994) (alteration in original) (citation omitted).
We see no "objective confirmation" requirement in the Vaccine Act's preponderant evidence standard. The statute's language is clear; section 300aa-13(a)(1) instructs that a petitioner must prove causation in fact by a "preponderance of the evidence," substantiated by medical records or medical opinion, as to each factor contained in section 300aa-11(c)(1).6 In turn, section 300aa-11(c)(1)(C)(ii)(I) requires a claimant to provide evidence showing that she "sustained, or had significantly aggravated, any illness, disability, injury, or condition not set forth in the Vaccine Injury Table but which was caused by a vaccine referred to in subparagraph (A)[.]"7 This court has interpreted the "preponderance of the evidence" standard referred to in the Vaccine Act as one of proof by a simple preponderance, of "more probable than not" causation. See Hellebrand v. Sec'y of Health & Human Servs., 999 F.2d 1565, 1572-73 (Fed.Cir.1993) (defining "preponderance" in the context of a Table injury case). The government's suggestion that prong two of Stevens does not impermissibly raise Althen's burden, ignores the legal and practical effect of that test: by requiring medical literature, it contravenes section 300aa-13(a)(1)'s allowance of medical opinion as proof. This prevents the use of circumstantial evidence envisioned by the preponderance standard and negates the system created by Congress, in which close calls regarding causation are resolved in favor of injured claimants. See Knudsen v. Sec'y of Health & Human Servs., 35 F.3d 543, 549 (Fed.Cir.1994) (explaining that "to require identification and proof of specific biological mechanisms would be inconsistent with the purpose and nature of the vaccine compensation program"). While this case involves the possible link between TT vaccination and central nervous system injury, a sequence hitherto unproven in medicine, the purpose of the Vaccine Act's preponderance standard is to allow the finding of causation in a field bereft of complete and direct proof of how vaccines affect the human body.
The government's postulate that the "heavy lifting" referred to in Lampe v. Secretary of Health and Human Services, 219 F.3d 1357, 1360 (Fed.Cir.2000) (quoting Hodges v. Secretary of Health & Human Services, 9 F.3d 958, 961 (Fed.Cir.1993)), signifies this court's desire to raise the preponderance standard in vaccine cases to that of direct proof similarly fails. Hodges described the difference between causation in the Table — and off-Table contexts:
The special master's role is to apply the law. Questions of law regarding the interpretation or implementation of the Vaccine Act are matters for the courts. See La Buy v. Howes Leather Co., 352 U.S. 249, 256, 77 S.Ct. 309, 1 L.Ed.2d 290 (1957) ("The use of masters is to aid judges in the performance of specific judicial duties, as they may arise in the progress of a cause, and not to displace the court.") (quotation marks and citation omitted). While La Buy described the special master's role in the Article III courts as set out in Federal Rule of Civil Procedure 53(b), the special master's role in the Article I Court of Federal Claims is similarly limited by the Vaccine Act. See Knudsen, 35 F.3d at 549 ("The sole issues for the special master are ... whether it has been shown by a preponderance of the evidence that a vaccine caused [an] injury or that the ... injury is a table injury, and whether it has not been shown by a preponderance of the evidence that a factor unrelated to the vaccine caused the ... injury.") (emphasis added) (citing 42 U.S.C. § 300aa-13(a)(1), (b)(1) (2000)); see also Hodges, 9 F.3d at 961 ("Congress assigned to a group of specialists, the Special Masters ..., the unenviable job of sorting through these painful cases and, based upon their accumulated expertise in the field, judging the merits of the individual claims.") To require Althen to provide medical documentation would contravene the plain language of the statute.
As a preliminary matter, because the special master's decision was not in accordance with law, the trial court was permitted to review the evidence anew and come to its own conclusion. 42 U.S.C. § 300aa-12(e)(2)(B);8 Saunders v. Sec'y of Health & Human Servs., 25 F.3d 1031, 1033 (Fed.Cir.1994). So long as the record contained sufficient evidence upon which to base predicate findings of fact and the ultimate conclusion of causation, which it did, the trial court was not required to remand. The court did not, as the government asserts, controvert a special master's finding regarding alternate causation; no such finding was made. See Althen I, 2003 WL 21439669, at *14 n. 44 ("Whether the hepatitis A vaccine played a role in Mrs. Althen's onset of a demyelinating disorder remains an open question which the court need not address given petitioner's failure to satisfy Prong Two of Stevens."). The court did not err in finding no alternative causation; the government's witnessing doctors provided no evidence rebutting Dr. Smith's testimony of the lack of a known causal relationship between the hepatitis A vaccination and central nervous system demyelinating disorder. See 42 U.S.C. §§ 300aa-13(a)(1)(B), -13(a)(2) (2000) (outlining the government's burden of proving that "factors unrelated[,]" e.g., the hepatitis A vaccination, were "principally responsible" for causing Althen's injury).
Duane's Syndrome is a hereditary eye movement disorder which limits the ability to move the eye outward toward the ear (abduction) and, in most cases, the ability to move the eye inward toward the nose (adduction). Dorland's Medical Dictionary 1816 (30th ed. 2003) (Dorland's). This ailment caused Althen to experience double vision when looking to the left
ADEM is a demyelinating disease affecting the nerve fibers in the nervous system which "occurs most commonly following an acute viral infection ... but may occur without a recognizable antecedent.... It is believed to be a manifestation of an autoimmune attack on the myelin of the central nervous system. Clinical manifestations include fever, headache, vomiting, and drowsiness progressing to lethargy and coma; tremor, seizures, and paralysis may also occur[.]" Dorland's at 610
Encephalitis is inflammation of the brain. Dorland's at 608
Vasculitis is an inflammation of the blood or lymph vessels. Dorland's at 2009. Angiitis is isolated vasculitis of the central nervous systemId. at 82. Althen's illness is generally referred to as a central nervous system demyelinating disorder.
The government opposed the special master's use of theStevens test, both in its brief and at oral argument where it asserted that application of the test is not always consistent with the statute because, in some cases, prong two sets the evidentiary barrier too low.
Section 300aa-13(a)(1) states, in relevant part:
Tetanus toxoid vaccine is referred to in the Vaccine Injury Table, subparagraph (A)
Section 300aa-12(e)(2)(B) states, in relevant part:
(B) set aside any findings of fact or conclusion of law of the special master found to be arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law and issue its own findings of fact and conclusions of law [.]
Debra Ann Knudsen v. Secretary of the Department of Health
Michael Lampe v. Secretary of Health
Melissa Hines v. Secretary of the Department of Health
Toni Saunders v. Secretary of the Department of Health
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Edwin E. Hodges v. Secretary of the Department of Health
David Dale Hellebrand v. Secretary of the Department of Health
James L. Grant v. Secretary of the Department of Health
Margaret Whitecotton v. Secretary of Health
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