Walther v. Secretary of Health and Human Services

• Citation: 485 F.3d 1146
• Decision Date: 01 May 2007
• Docket Number: No. 2006-5056.,2006-5056.
• Parties: Patricia Ann WALTHER, Petitioner-Appellant, v. SECRETARY OF HEALTH AND HUMAN SERVICES, Respondent-Appellee.
• Court: United States Courts of Appeals. United States Court of Appeals for the Federal Circuit

485 F.3d 1146

Patricia Ann WALTHER, Petitioner-Appellant, v. SECRETARY OF HEALTH AND HUMAN SERVICES, Respondent-Appellee.

No. 2006-5056.

United States Court of Appeals, Federal Circuit.

May 1, 2007.

Richard Gage, Richard Gage, P.C., of Cheyenne, WY, argued for petitioner-appellant.

Mark Curtis Raby, Senior Trial Counsel, Torts Branch, Civil Division, United States Department of Justice, of Washington, DC, argued for respondent-appellee. With him on the brief were Peter D. Keisler, Assistant Attorney General, Timothy P. Garren, Director, Vincent J. Matanoski, Acting Deputy Director, and Gabrielle M. Fielding, Assistant Director.

Before DYK and PROST, Circuit Judges, and McKINNEY, Chief Judge.^*

DYK, Circuit Judge.

Appellant Patricia Ann Walther ("Walther") appeals a decision of the Court of Federal Claims sustaining the decision of a special master denying compensation under the National Childhood Vaccine Injury Act of 1986, 42 U.S.C. § 300aa-1 et seq. (2000) ("Vaccine Act"). Because we conclude that the special master appears to have applied an incorrect legal standard — requiring Walther to eliminate other possible causes of her injury — we vacate the decision and remand for a determination under the correct standard.

BACKGROUND

Walther was a captain in the United States Army at the time of the events in question. On July 31, 1997, she received tetanus-diptheria ("Td"),¹ yellow fever, typhoid, and meningitis vaccinations. On August 6 she also received a rabies vaccination. On August 7 and 8 she experienced trembling in her left hand, weakness, and fatigue. When Walther continued to experience problems with her hands and her left leg, she sought medical treatment, which revealed progressive weakness in both hands and a mild partial paralysis of the left side of her body. On December 12, 1997, Dr. Seth Stankus, a military neurologist, diagnosed her with post-vaccinal acute disseminated encephalomyelitis ("ADEM"). ADEM is a neurological disorder caused by damage to the myelin sheath (fatty covering) insulating the nerve cells in the brain.

Two other neurologists and the Army's Physical Evaluation Board agreed with this diagnosis. Walther was placed on the Army's temporary disability retired list on May 22, 1998. She claims to continue to experience muscular weakness on her left side, fatigue, head tremors, and migraines resulting from ADEM. On July 20, 2000, Walther filed a petition under the Vaccine Act claiming that the Td vaccine caused her ADEM.

The special master held a hearing on May 20, 2005. The government's primary contention was that Walther did not suffer from ADEM. Walther presented the testimony of two experts to establish that she suffered from ADEM. The government introduced contrary testimony from two other experts. The government also contended that, even if Walther suffered from ADEM, it was not caused by the Td vaccine. On the causation question, Walther's expert, Dr. Vera Byers, opined that "it is more likely than not that [Walther's] diagnosed ADEM was produced by the tetanus toxoid-diptheria vaccination she received" because: (1) the medical literature confirmed that it was biologically plausible for Td vaccine to cause ADEM; (2) Walther developed her symptoms during the medically accepted timeframe — within six days of receiving the vaccine; (3) the other vaccines Walther received were unlikely to have caused her illness for reasons specific to each vaccine. J.A. at 73.

On the question of causation Walther also relied on her medical records, which reflected the opinions of her treating physicians that her condition was caused by a vaccination, and the report of another expert (Dr. Kinsbourne) in which he opined that "to a reasonable degree of medical certainty . . . Dr. Walter's ADEM . . . w[as] caused by the tetanus toxoid vaccination that she received." J.A. at 63. Petitioner also relied on two other special master decisions that held that the tetanus vaccine caused ADEM. See Kuperus v. Sec'y of Health & Human Servs., 2003 WL 22912885 at *1 (Fed.Cl.2003) (special master) (DTaP); Johnson v. Sec'y of Health & Human Servs., 2000 WL 1141582 at *10 (Fed.Cl.2000) (special master) (Td).

In an opinion issued on July 29, 2005, the special master dismissed Walther's petition. He did not reach the question that had been the focus of the hearing — whether Walther suffered from ADEM. Instead, he concluded that Walther had failed to carry her burden to prove that her illness was caused by the Td vaccine. He used a three-part test that required "proof of biologic plausibility between a vaccine and an injury; proof that an injury occurred within a medically-acceptable time period following vaccination; and proof eliminating other potential causes for the injury." Walther v. Sec'y of Health & Human Servs., No. 00-0426V, slip op. at 3-4 (Fed. Cl. July 29, 2005) (special master) (emphasis added) ["Special Master's Decision"].

The government conceded that the Td vaccine was a biologically plausible cause of Walther's ADEM and that her symptoms appeared within a medically-acceptable time period. Special Master Hearing Tr. 26; 35 (May 20, 2005). The government concluded that the petitioner had not adequately established causation for a number of reasons including that "Walther has not adequately eliminated the other vaccines that she received in Summer 1997 as causative agents for her condition." Special Master's Decision at 2 (internal quotation marks omitted). Viewing Dr. Byers's opinion as the only evidence on causation, the special master addressed her testimony directly and found that she was not credible on the causation issue. He "reject[ed] Dr. Byers's opinion" because he "harbor[ed] significant concerns regarding the quality and the substance of Dr. Byers's testimony." Id. at 4. In particular, the special master concluded that Dr. Byers had not stated "a viable proposition that Dr. Walther's [Td] vaccination, rather than one of Dr. Walther's other vaccinations, caused more likely than not [her] condition." Id. at 5 (emphasis added). Additionally, the special master distinguished the two other special master decisions that found that forms of the tetanus vaccine caused ADEM, both of which involved only one vaccine, based on Walther's failure to eliminate the other vaccines as potential causes. Id. at 6.

In seeking review in the Court of Federal Claims, Walther argued that "the special master applied the wrong legal standard for causation." Walther v. Sec'y of Health & Human Servs., 69 Fed.Cl. 123, 124 (2005). The Court of Federal Claims affirmed the special master's decision, finding that it was not arbitrary and capricious. Id. The Court of Federal Claims stated "that the special master denied the petitioner relief because he rejected Dr. Byers' opinion testimony and not because he applied the wrong legal standard," finding that "Dr. Byers failed to persuade the special master that the tetanus component of the Td vaccine was any more likely to have caused the petitioner's ADEM than were any of the other vaccines that she received at or around the same time." Id. at 127-28.

Walther timely appealed the Court of Federal Claims' decision to this court. We have jurisdiction pursuant to 42 U.S.C. § 300aa-12(f). We review the Court of Federal Claims review of the special master's decision without deference. See Pafford v. Sec'y of Health & Human Servs., 451 F.3d 1352, 1355 (Fed.Cir.2006). We review the special master's legal determinations under a non-deferential "not in accordance with law" standard. See id., 451 F.3d at 1355. By contrast, given the special master's role "to perform the fact finding function for the Program," Munn v. Sec'y of Health & Human Servs., 970 F.2d 863, 868 (Fed.Cir.1992), we review factual determinations under the deferential "arbitrary and capricious standard," Pafford, 451 F.3d at 1355.

DISCUSSION

On appeal, the petitioner's primary contention is that the special master applied an incorrect standard requiring her to eliminate other potential causes in order to establish a prima facie case of causation. The special master appeared to require that the petitioner eliminate alternative causes to carry her burden to establish a prima facie case. Not only was the elimination of alternative causes one of the prongs of his three-part causation test, but he also concluded that "the evidence does not demonstrate affirmatively that [Td] vaccine caused actually Dr. Walther's condition" at least in part because he did not believe that Dr. Byers had stated "a viable proposition that Dr. Walther's [Td] vaccination, rather than one of Dr. Walther's other vaccinations, caused more likely than not Dr. Walther's conditions." Special Master's Decision at 5 (emphasis added). Moreover, he distinguished the two other special master's decisions that found that forms of the tetanus vaccine caused ADEM on the grounds that those cases involved only one vaccine whereas "Dr. Walther received concurrently one Table vaccine and many non-Table vaccines, every one of which represented a biologically-plausible explanation for her condition." Id. at 6 (emphasis added).

We conclude that the special master's decision, to the extent that it did place a requirement on the petitioner to establish a lack of alternative causation, was erroneous.

I

In order "to achieve optimal prevention of human infectious diseases through immunization and to achieve optimal prevention against adverse reactions to vaccines," as well as to insure the production of necessary vaccines, Congress enacted the Vaccine Act in 1986. 42 U.S.C. §§ 300aa-1, 300aa-2(a)(5) (2000). The Vaccine Act created the National Vaccine Injury Compensation Program ("Program"), which is administered by the Secretary of Health and Human Services, "under which compensation may be paid for a vaccine-related injury or death." 42 U.S.C. § 300aa-10(a). Petitions seeking compensation under the Vaccine Act are referred in the first instance to the...