Capizzano v. Secretary of Health and Human Services
440 F.3d 1317 (Fed. Cir. 2006)
Authored by Sean Rowland
Statement of Facts: Appellee Rose Capizzano received her second of three hepatitis B vaccine injections on May 3, 1998. Within hours of receiving this vaccine injection, Ms. Capizzano developed a rash on her abdomen. Over the next few days, Ms. Capizzano also developed stiff and painful joints, symptoms of rheumatoid arthritis (“RA”). Ms. Capizzano’s physician decided that, because some vaccine recipients that have been injured by a prior dose of hepatitis B vaccine have developed worsening symptoms after receiving an additional dose, Ms. Capizzano should not receive her third hepatitis B vaccination. When this case reached the Federal Circuit in 2006, Ms. Capizzano continued to suffer from RA, and she took daily medication to keep the pain, swelling, and stiffness under control. The government does not dispute that Ms. Capizzano is diagnosed with rheumatoid arthritis. Ms. Capizzano seeks compensation for her injuries under the Vaccine Act.
Enacted in 1986, Subchapter XIX of Chapter 6A, Title 42, of the United States Code established the National Vaccine Program within the Department of Health and Human Services (“HHS”). The Vaccine Act created the National Vaccine Injury Compensation Program and established that “compensation may be paid for a vaccine-related injury or death.” 42 U.S.C. § 300aa–10(a). The injured person seeking compensation must establish by a preponderance of the evidence that the injury or death was caused by a vaccine. Id. § 300aa–11(c)(1), –13(a)(1). There are two ways to establish causation. First, a petitioner may demonstrate that her injury is one that is listed in the Vaccine Injury Table, that the injury occurred within the time required by the Table, and that the injury meets the requirements of section 300aa–14(a). Causation is presumed in such a case. Second, if the injury is not listed in the Vaccine Injury Table (“off-Table injury”) the petitioner may prove causation in fact. This must be proved by a preponderance of the evidence.
Procedural History: Ms. Capizzano filed her petition in the Court of Federal Claims under the Vaccine Act on December 15, 2000, seeking compensation for her off-Table injury of rheumatoid arthritis. After Ms. Capizzano filed the petition, the court clerk forwarded the petition to the chief special master who assigned the case to himself. In June of 2003, the chief special master held a hearing. On June 8, 2004, the chief special master ruled that Ms. Capizzano had failed to establish that the hepatitis B vaccination caused her rheumatoid arthritis. The chief special master first concluded that hepatitis B vaccination can cause rheumatoid arthritis. The chief special master then addressed whether Ms. Capizzano’s vaccination caused her rheumatoid arthritis. The chief special master approached this causality question with the following context of recent Federal Circuit caselaw.
On March 23, 2001, the chief special master created a five-prong analytical framework for determining whether a petitioner in an off-Table injury case had met his or her burden of establishing causation-in-fact. The five prongs of that test are: (1) that it is medically plausible for a component of the vaccine to cause the injury alleged; (2) that the association between the vaccine and the alleged injury is reported by peer-reviewed medical literature; (3) that the vaccine suffered an injury which is medically accepted as a possible reaction to the vaccine; (4) that the injury occurred within a medically accepted time period; and (5) that alternate causes were considered but otherwise eliminated. Stevens v. Sec’y of Health & Human Services., No. 99-594V, 2001 U.S. Claims LEXIS 67, *158 (Fed. Cl. Spec. Mstr. Mar. 30, 2001).
On September 30, 2003, the Court of Federal Claims issued its decision in Althen v. Secretary of Health & Human Services, 58 Fed. Cl. 270 (2003) (“Althen II”) in which it concluded that the Stevens framework was contrary to the Vaccine Act and Federal Circuit precedent. 58 Fed. Cl. At 281–3. The Federal Circuit affirmed Althen II on July 29, 2005. Althen v. Secretary of Health & Human Services, 418 F.3d 1274 (Fed. Cir. 2005) (“Althen III”). Althen III was decided after briefing in Ms. Capizzano’s case was completed but before the ultimate decision was made in 2006. This is relevant to Ms. Capizzano’s case because it means that the chief special master made his decision in her case with only Stevens and Althen II to look towards. The Federal Circuit in Althen III affirmed the Court of Federal Claims rejection of the Stevens test. In its stead, Althen III created a three-part test for determining causation-in-fact in off-Table Vaccine Act cases. The three-part Althen III test requires that the petitioner show by a preponderance of evidence that the vaccination brought about the 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.” Althen III at 1278.
The chief special master decided Ms. Capizzano’s case under both the five-prong Stevens framework and under a new four-prong approach that he designed in an attempt to satisfy Althen II. The chief special master’s new four-prong test required Ms. Capizzano to demonstrate one of four types of evidence to satisfy the “logical sequence of cause and effect” requirement established in Althen II. The four types of evidence were: epidemiologic studies, rechallenge, presence of pathological markers or genetic predisposition, or general acceptance in the scientific and medical communities that the vaccination could cause the injury. The chief special master concluded that Ms. Capizzano had failed to prove that the hepatitis B vaccine caused her rheumatoid arthritis. To reach this decision the chief special master rejected the diagnoses of Ms. Capizzano’s treating physicians concluding that their reasoning was based primarily on the temporal relationship between the vaccination and the onset of rheumatoid arthritis. Capizzano I, 2004 U.S. Claims LEXIS 149, at *88.
On December 7, 2004 the Court of Federal Claims rendered its decision on Ms. Capizzano’s appeal of the chief special master’s opinion. Capizzano v. Secretary of Health & Human Services, 63 Fed. Cl. 227 (2004) (“Capizzano II”). The Court of Federal Claims affirmed both the chief special master’s findings of fact and legal conclusions. Id. The court determined that the chief special master’s four-prong test was not contrary to law and that the factual findings were not arbitrary or capricious. Ms. Capizzano timely appealed the Court of Federal Claims’ decision to the Federal Circuit.
Questions Presented: Does the four-prong test for compensation for an off-Table injury employed by the chief special master in Capizzano I meet the requirements set forth under Althen III?
Holdings: No, it does not. The chief special master impermissibly raised the burden of proof placed upon a petitioner in an off-Table injury case by restricting the ways that a petitioner can prove a case. The proper analysis is whether a petitioner in an off-Table injury case establishes a logical sequence of cause and effect by a preponderance of the evidence. The decision of the Court of Federal Claims affirming the decision of the chief special master is vacated and the case is remanded to determine if Ms. Capizzano has proven causation by a preponderance of the evidence.
Reasoning: The Federal Circuit found it to be clear that the chief special master and the Court of Federal Claims denied Ms. Capizzano’s claim because they essentially determined that she had failed to meet Althen III’s second prong by not demonstrating “a logical sequence of cause and effect showing that the vaccination was the reason for the injury.” Althen III, 418 F.3d at 1278. The Federal Circuit emphasized that “to require identification and proof of specific biological mechanisms would be inconsistent with the purpose and nature of the vaccine compensation program.” Id. at 1280. “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.” Id. (emphasis added) Pursuant to this, the Federal Circuit concluded that the chief special master’s four-prong test was contrary to Althen III. “A logical sequence of cause and effect” required by Althen III means that the claimant’s theory of cause and effect must be logical. The chief special master erred by not considering the opinions of Ms. Capizzano’s treating physicians. Any of the physicians’ reliance on the temporal proximity of Ms. Capizzano’s injuries to the administration of the vaccines is not disqualifying.
A claimant needs only to show that it is more likely than not that their injury was caused by the vaccine. The fact that there is a possibility that the vaccination did not cause Ms. Capizzano’s rheumatoid arthritis, which appeared immediately after she received her vaccination, “does not prevent a finding that it is more likely than not that the vaccine caused the RA.” Capizzano, 440 F.3d at 1326–1327.The petitioner need only establish a logical sequence of cause and effect by a preponderance of the evidence.