Appeal from the United States Court of Federal Claims in case no. 99-VV-639, Judge Nancy B. Firestone. Appeal from the United States Court of Federal Claims in case no. 99-VV-644, Judge Nancy B. Firestone.
The opinion of the court was delivered by: Prost, Circuit Judge.
Before RADER, Chief Judge, PROST and O'MALLEY, Circuit Judges.
Opinion for the court filed by Circuit Judge PROST.
Opinion concurring-in-part, dissenting-in-part filed by Circuit Judge O'MALLEY.
The government appeals the combined decision of the United States Court of Federal Claims ("Claims Court") reversing a special master's decision denying Mona Porter's and Claudia Rotoli's petitions for compensation under the National Vaccine Injury Compensation Program ("Vaccine Act"), 42 U.S.C. §§ 300aa--1 to --34. The special master concluded that Ms. Porter and Ms. Rotoli did not prove by a preponderance of the evidence that the hepatitis B vaccine-which they both received in three doses in the 1990s-caused them to suffer autoimmune hepatitis ("AIH"). The Claims Court, incorrectly applying Andreu v. Secretary of Health & Human Services, 569 F.3d 1367 (Fed. Cir. 2009), set aside the special master's
findings in their entirety on the ground that the special master allegedly erred by considering the credibility of the petitioners' expert witness. Having rejected the special master's findings, the Claims Court entered its own findings and determined that both Ms. Porter and Ms. Rotoli were entitled to recover for their AIH under the Vaccine Act. We conclude that the Claims Court's interpretation of Andreu was legally erroneous and inconsistent with this court's precedent. We further conclude that the special master's determination that the petitioners were not entitled to compensation under the Vaccine Act was not arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law. As such, we reverse and remand with instructions to affirm the special master's determination that neither petitioner is entitled to recover under the Vaccine Act.
The two appeals before us present overlapping legal and factual issues. The first, case number 2010-5162, concerns petitioner Mona Porter. Ms. Porter was born on September 28, 1962. The first date in her medical history that has relevance to this case is May 15, 1991. On that day, Ms. Porter's dermatologist prescribed minocycline for Ms. Porter's acne. Minocycline is well-known in the literature to cause AIH. On May 11, 1992, her dermatologist indicated that she should "finish off" her minocycline dosage and then discontinue treatment with the drug.
On July 8, 1992, Ms. Porter received the first of three doses of the hepatitis B vaccine. She also had a liver function blood test that day. Her liver function tests were within the normal range. Ms. Porter's second dose was administered on August 7, 1992. The record does not indicate whether she had any blood work performed on that day. Ms. Porter received her final vaccine dose on February 5, 1993. A liver function test performed on March 1 revealed that her liver enzymes were elevated well beyond the normal range. The liver function test was repeated four days later and yielded comparable results. Blood tests from this date indicated that Ms. Porter was immune to hepatitis B and was not infected with hepatitis A, B, or C.
On March 11, 1993, Ms. Porter started feeling nauseated, itching, and turning yellow. She visited a doctor who was her employer's colleague, but the office did not create a record of this visit. Ms. Porter next saw a gastroenterologist, Dr. Richard Gilmore. At the initial visit, Dr. Gilmore's impression was that Ms. Porter suffered from "acute hepatitis of undetermined etiology. The possibility that this is related to her vaccine cannot be excluded." He prescribed a steroid to minimize the body's immune response, and requested additional blood work. The blood work, which was performed on April 1, 1993, was consistent with a diagnosis of AIH. A liver function test showed that Ms. Porter's liver enzymes had decreased but were still above normal. In light of these test results, a liver biopsy was performed on May 14, 1993. The pathologist and Dr. Gilmore interpreted the results as being consistent with AIH.
AIH continued to affect Ms. Porter for several additional years. On August 4, 1999, she filed a petition seeking compensation under the Vaccine Act. See 42 U.S.C. §§ 300aa-I et seq.
The second appeal, case number 2010-5163, concerns petitioner Claudia Rotoli.*fn1 Ms. Rotoli was born on January 25, 1969. As pertinent to this case, Ms. Rotoli's medical history began in 1984, a decade before she received the hepatitis B vaccine. From March 1984 to February 1990, Ms. Rotoli was treated for skin rashes, shoulder pain, and severe anxiety. In addition, Ms. Rotoli received treatment for anxiety and depression in 1994. Her symptoms included slow and difficult speech, episodes of blurred vision, chest pains and difficulty thinking. Ultimately, she was treated at a Florida hospital emergency room for confusion, stuttering, and speech difficulty. Her examination at that time included a CT head scan, thyroid profile, and blood count, which were all normal.
On October 10, 1994, Ms. Rotoli received the first dose of the hepatitis B vaccine as well as a flu vaccine. Two days later, she began to experience coughing, congestion, and fever. On October 21, 1994, her doctor recommended that she take cough medicine for these symptoms. She was given the next dose of the hepatitis B vaccine on November 9, 1994. She visited her doctor approximately two months later to be treated for a prolonged upper respiratory infection, bronchitis, and conjunctivitis. She further reported that she began to have pain in her "right upper quadrant" in May 1995. On May 5, 1995, Ms. Rotoli received her final dose of the hepatitis B vaccine. Four days later, she donated blood. On May 19, 1995, the blood service informed her that her donated blood contained an elevated amount of a certain enzyme diagnostic for some forms of liver disease.
Ms. Rotoli sought information about her abnormal liver test results. Blood tests from May 25, 1995 confirmed that she had elevated liver enzyme levels. Ms. Rotoli was diagnosed as having hepatitis of unknown origin. She saw a general practitioner on May 31, 1995 for a follow up. That doctor noted that Ms. Rotoli had a slight tremor in her hand, and ordered additional blood tests, which again confirmed that Ms. Rotoli's liver function was not normal. She subsequently saw Dr. Katz, a gastroenterologist, on June 20, 1995. Dr. Katz thought that Ms. Rotoli might have either a viral illness or AIH and ordered additional blood tests. The test results were consistent with a diagnosis of AIH. On June 29, 1995, Ms. Rotoli had a liver biopsy. This biopsy showed that Ms. Rotoli had chronic, active hepatitis with fibrosis and moderate necrosis. Based on her blood test results and liver biopsy, Dr. Katz diagnosed Ms. Rotoli as having AIH and prescribed a steroid to moderate the reaction of her immune system.
AIH and other health problems continued to plague Ms. Rotoli. In October of 1996, she was further diagnosed with Sjogren's disease. The following year, she was diagnosed with systemic lupus erythematosus, another autoimmune disorder. In 1998, she was diagnosed with central nervous system lupus. She filed a Vaccine Program petition on August 4, 1999, seeking compensation for her AIH and associated injuries.
Ms. Porter's and Ms. Rotoli's cases, along with several other cases in which the petitioners alleged that the hepatitis B vaccine caused them to suffer from AIH, were assigned to the same special master in 2006. The parties agreed to conduct a joint hearing for all of these cases. The special master heard five days of live testimony over two separate sessions. The proceedings focused principally on the competing opinions of the government's two experts, Dr. Burton Zweiman, an immunologist, and Dr. Raymond Koff, a specialist in hepatology, and petitioners' expert, Dr. Joseph Bellanti, an immunologist. The first hearing session was held over three days in September 2007. The second two-day session was held many months later in March 2008. Notably, petitioners did not offer testimony from an expert in gastroenterology or hepatology despite being given an opportunity to do so.
During the hearing, petitioners' expert (Dr. Bellanti) presented a series of theories directed at showing that the hepatitis B vaccine could cause autoimmune hepatitis. The government's experts (Dr. Zweiman and Dr. Koff) disagreed, explaining that "the evidence does not show that the hepatitis B vaccine can cause autoimmune hepatitis." Dr. Koff, who offered the only testimony from a specialist in hepatology, provided further testimony regarding petitioners' individual cases. Regarding Ms. Rotoli, he testified that her June 29, 1995 liver biopsy (eight-and-a-half months after her first vaccination) showed such extensive fibrosis that, in his experience, Ms. Rotoli's hepatitis had to have predated her vaccination. Pertaining to Ms. Porter, he opined that her liver problems were more likely caused by her use of minocycline- a known cause of AIH-than by the hepatitis B vaccine.
The special master denied Ms. Porter's and Ms. Rotoli's petitions, providing alternative rationales for denying each petitioner's claim. Porter v. Sec'y of Health & Human Servs., No. 99-639V, 2008 WL 4483740 (Fed. Cl. Oct. 2, 2008) ("Special Master Porter Op."); Rotoli v. Sec'y of Health & Human Servs., No. 99-644V, 2008 WL 4483739 (Fed. Cl. Oct. 2, 2008) ("Special Master Rotoli Op.").*fn2 After examining Dr. Bellanti's theories at length, as well as considering Dr. Zweiman's and Dr. Koff's testimony, the special master concluded that "none of [Dr. Bellanti's] theories presents a reliable explanation of how the hepatitis B vaccine can cause autoimmune hepatitis." Special Master Porter Op. at *5. Accordingly, he found by a preponderance of the evidence that both petitioners had failed to establish a medical theory causally connecting the hepatitis B vaccine to AIH. Id. at *15-16. In addition, the special master specifically found that Ms. Rotoli failed to establish an appropriate temporal relationship between her vaccinations and AIH in light of Dr. Koff's opinion that her extensive fibrosis could not have developed in eight months. Special Master Rotoli Op. at *17-18. Because petitioners' burden included establishing (1) a medical theory causally connecting the vaccination and the injury; and (2) a proximate temporal relationship between vaccination and injury, Althen v. Sec'y of Health & Human Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005), the special master concluded that both petitioners had failed to demonstrate that the hepatitis B vaccine was the cause in fact of their injuries. Id. at 18; Special Master Porter Op. at *21.
Although he had already concluded that Ms. Porter was not entitled to compensation because she had not established causation in fact, the special master also addressed an independent and wholly distinct reason for denying her claim. Id. at *21-22. The government argued that an alternative cause, i.e., the drug minocycline, induced Ms. Porter's AIH. The special master found that a preponderance of the evidence established that it was more likely than not that the minocycline caused Ms. Porter's AIH.
Petitioners sought review of the special master's decisions in their respective cases in the Claims Court. The Claims Court set aside the special master's factual findings, reasoning that this court's decision in Andreu required that result. Rotoli v. Sec'y of Health & Human Servs., 89 Fed. Cl. 71, 80-82 (2009). The Claims Court read Andreu to mean that a special master may not use credibility determinations to reject a petitioner's theory of causation. Id. at 82. The Claims Court, based on that understanding of our case law, set aside the special master's factual findings on the ground that the special master had "erroneously used his assessment of Dr. Bellanti's credibility . . . as a basis for rejecting Dr. Bellanti's expert testimony regarding causation." Id. at 81-82. Indicating that the special master's credibility determinations "permeated his analysis of the petitioners' claims," the Claims Court set aside the entirety of the special master's factual findings, rather than specific adverse credibility findings. Id. at 82.
Having discarded all of the special master's fact finding because he made credibility assessments about Dr. Bellanti's testimony, the Claims Court entered its own findings based on the record. The court credited Dr. Bellanti's medical theories causally connecting the hepatitis B vaccine to AIH and ruled that petitioners had satisfied their burden with respect to this element of causation in fact. Id. at 83-88. As for the timing of Ms. Rotoli's injuries, the Claims Court found an appropriate temporal relationship between the vaccine and the disease, discounting Dr. Koff's opinion that Ms. Rotoli's liver biopsy demonstrated that her AIH predated her receipt of the vaccine by several years. Instead, the Claims Court credited Ms. Rotoli's alternative theory that substantial "fibrosis might be able to form in as little as sixteen weeks." Id. at 89. The Claims Court also rejected the government's showing that Ms. Porter's AIH was caused by minocycline, instead crediting Dr. Bellanti's testimony that minocycline was not the cause because her symptoms did not improve after discontinuing the drug. Id. at 97-98. The court ultimately concluded that both petitioners were entitled to compensation.
After further proceedings concerning damages, final judgment was entered for petitioners and damages awarded. These appeals followed. We have jurisdiction pursuant to 42 U.S.C. § 300aa-12(f).
We review de novo decisions of the Claims Court arising under the Vaccine Act, applying the same standard of review as the Claims Court applied to its review of the special master's decision. Andreu, 569 F.3d at 1373. We owe no deference to the Claims Court or the special master on questions of law. Id. We uphold the special master's findings of fact unless they are arbitrary or capricious. Broekelschen v. Sec'y of Health & Human Servs., 618 F.3d 1339, 1345 (Fed. Cir. 2010). "'Thus, although we are reviewing as a matter of law the decision of the Claims Court under a non-deferential standard, we are in effect reviewing the decision of the special master under the deferential and capricious standard on factual issues.'" Lombardi v. Sec'y of Health & Human Servs., 656 F.3d 1343, 1350 (Fed. Cir. 2011) (quoting Lampe v. Sec'y of Health & Human Servs., 219 F.3d 1357, 1369 (Fed. Cir. 2000)). We do not reweigh the factual evidence, assess whether the special master correctly evaluated the evidence, or examine the probative value of the evidence or the credibility of the witnesses-these are all matters within the purview of the fact finder. Broekelschen, 618 F.3d at 1349 (citing Munn v. Sec'y of Health & Human Servs., 970 F.2d 863, 871 (Fed. Cir. 1992)). Rather, as long as a special master's finding of fact is "'based on evidence in the record that [is] not wholly implausible, we are compelled to uphold that finding as not being arbitrary or capricious.'" Cedillo v. Sec'y of Health & Human Servs., 617 F.3d 1328, 1338 (Fed. Cir. 2010) (quoting Lampe, 219 F.3d at 1360). It is not our role to "'second guess the Special Master[']s fact-intensive conclusions' particularly in cases 'in which the medical evidence of causation is in dispute.'" Id. (quoting Hodges v. Sec'y of Health & Human Servs., 9 F.3d 958, 961 (Fed. Cir. 1993)).
A petitioner seeking compensation under the Vaccine Act must prove by a preponderance of the evidence that the injury at issue was caused by a vaccine. 42 U.S.C. §§ 300aa--11(c)(1); --13(a)(1). Causation under the Vaccine Act can be shown in one of two ways. The first method of proving causation involves demonstrating that the petitioner sustained an injury in association with a vaccine listed in the Vaccine Injury Table. Id. § 300aa-- 11(c)(1)(C)(i). In such cases, causation is presumed. See Andreu, 569 F.3d at 1374. Alternatively, if the complained-of injury is not listed in the Vaccine Injury Table, the petitioner may seek compensation by proving causation in fact. Moberly v. Sec'y of Health & Human Servs., 592 F.3d 1315, 1321 (Fed. Cir. 2010); see also 42 U.S.C. § 300aa--11(c)(1)(C)(ii). Ms. Porter's and Ms. Rotoli's petitions are based on such "off-Table" injuries. Once causation is established, the petitioner is entitled to compensation unless the government can show by a preponderance of the evidence that the injury is due to factors unrelated to the vaccine, i.e., an alternative cause. Doe v. Sec'y of Health & Human Servs., 601 F.3d 1349, 1351 (Fed. Cir. 2010); see also 42 U.S.C. § 300aa-- 13(a)(1)(B).
When a petitioner has suffered an off-Table injury, we apply the test for establishing causation in fact outlined in Althen:
[The petitioner'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.
418 F.3d at 1278. "[T]he function of a special master is not to 'diagnose' vaccine-related injuries, but instead to determine 'based on the record evidence as a whole and the totality of the case, whether it has been shown by a preponderance of the evidence that a vaccine caused the [petitioner's] injury.'" Lombardi, 656 F.3d at 1351 (quoting Andreu, 569 F.3d at 1382).
On appeal, the government contends that the Claims Court's threshold decision to set aside the special master's fact-finding in its entirety was legally erroneous because this court has consistently recognized the special master's authority to consider and assess the credibility of expert witnesses in evaluating Vaccine Act claims. The government notes that the Claims Court can issue its own fact-finding based on the record only if the special master's underlying decision was arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with the law. The government argues that the special master's factual findings were based on a full and amply reasoned consideration of the record evidence and that no proper basis exists for setting those findings aside under the deferential standard of review.
Petitioners counter that the Claims Court correctly determined that the special master had impermissibly framed his rejection of the petitioners' theory of causation under the rubric of a credibility determination to immunize himself from appellate review. Petitioners contend that this constitutes legal error under Andreu, and provides a basis for the Claims Court to set aside the special master's findings under 42 U.S.C. § 300aa-12(e)(2)(B). Petitioners further contend that they met their burden by establishing the three factors required to show causation in fact under Althen. Finally, Ms. Porter asserts that once she established her prima facie case, the burden shifted to the government to show that the hepatitis B vaccine did not cause her injury. She argues that the special master's conclusion that minocycline caused her injury was arbitrary and capricious.
We first consider whether the Claims Court's wholesale rejection of the special master's fact-finding based on his use of credibility assessments was legally erroneous. The Claims Court cited to this court's decision in Andreu in support of its ruling. In that case, we explained that a special master cannot "cloak the application of an erroneous legal standard in the guise of a credibility determination, and thereby shield it from appellate review." Andreu, 569 F.3d at 1379. The Claims Court here made no determination that the special master applied an erroneous legal standard. Rather, the Claims Court read Andreu to mean that it is inappropriate for a special master to consider a petitioner's expert's credibility in evaluating a petitioner's showing of causation in fact.
The Claims Court's reading of Andreu is incorrect. Indeed, this court has unambiguously explained that special masters are expected to consider the credibility of expert witnesses in evaluating petitions for compensation under the Vaccine Act. Recent decisions of this court subsequent to the Claims Court's opinion here are instructive. In Moberly, we reiterated that a special master may not cloak the application of an erroneous legal standard in the guise of a credibility determination to shield it from appellate review. 592 F.3d at 1325 (discussing Andreu, 569 F.3d at 1379). We went on to clarify that this does not mean that "a special master, as the finder of fact in a Vaccine Act case, is prohibited from making credibility determinations regarding expert testimony." Id. We indicated that "[a]ssessments as to the reliability of expert testimony often turn on credibility determinations" and "[f]inders of fact are entitled-indeed, expected-to make determinations as to the reliability of the evidence presented to them and, if appropriate, as to the credibility of the persons presenting that evidence." Id. at 1326. Our discussion of the issue in Broekelschen is equally clear. In that case, we recognized that "[e]xpert medical testimony is often very important in Vaccine Act cases based on off-Table injuries requiring proof of actual causation." Broekelschen, 618 F.3d at 1347. We again explained that "the special master's decision often times is based on the credibility of the experts and the relative persuasiveness of their competing theories" and such credibility findings "'are virtually unchallengeable on appeal.'" Id. (quoting Lampe, 219 F.3d at 1361). Finally, in Doe, we upheld a special master's factual findings as not arbitrary and capricious "particularly in light of the credibility findings made as to the parties' respective experts." 601 F.3d at 1351. We found no basis for disturbing the special master's credibility findings as to those experts, and again emphasized that "the special master's unique position to see the witnesses and hear their testimony" makes "such credibility assessments . . . 'virtually unreviewable on appeal."' Id. at 1355-56 (quoting Lampe, 219 F.3d at 1362).
In the present cases, the special master recognized that all three experts were well-qualified, but found Dr. Zweiman's and Dr. Koff's testimony to be more persuasive than Dr. Bellanti's in several instances when the experts' opinions were in conflict. Rather than rejecting the special master's findings in their entirety, the Claims Court should have applied the deferential arbitrary and capricious standard of review to these findings. The Claims Court's blanket approach of setting aside the factual findings without ever determining whether the findings were arbitrary and capricious failed to accord the deference to those findings required by the Vaccine Act and constitutes legal error.
Because the Claims Court did not have a proper basis for setting aside the special master's findings of fact and substituting its own findings, we now turn to the special master's findings in order to assess whether they were arbitrary and capricious. The special master made find- ings on each of the three elements of the Althen test for causation in fact, finding that petitioners had failed to carry their burden on each Althen factor. He also made findings regarding the government's evidence of alternative cause with respect to ...