CLOER v. SECRETARY OF HEALTH AND HUMAN SERVICES No. 2009-5052.
654 F.3d 1322 (2011)
Melissa CLOER, M.D., Petitioner-Appellant, v. SECRETARY OF HEALTH AND HUMAN SERVICES, Respondent-Appellee.
United States Court of Appeals, Federal Circuit.
August 5, 2011.
Robert T. Fishman, of Denver, CO, argued for petitioner-appellant on rehearing en banc. With him on the brief was Mari , Kaye and Bush, LLC, of Denver, CO. Of counsel on the brief was C. Bush Robert T. Moxley, Robert T. Moxley, P.C., of Cheyenne, WY.
Anisha S. Dasgupta, Attorney, Appellate Staff, Civil Division, United States Department of Justice, of Washington, DC, argued for respondent-appellee on rehearing en banc. With her on the brief were Tony West, Assistant Attorney General, Timothy P. Garren, Director, Mark W. Rogers, Deputy Director, Gabrielle M. Fielding, Assistant Director. Of counsel on the brief were Thomas M. Bondy, Attorney, and Lynn E. Ricciardella, Trial Attorney.
Martin James Martinez, Martinez Law Office, of Napa, CA, amicus curiae on rehearing en banc.
Thomas Neville, Ogborn Summerlin & Ogborn, LLC, of Denver, CO, for amicus curiae Colorado Trial Lawyers Association on rehearing en banc.
Clifford J. Shoemaker, Shoemaker & Associates, of Vienna, VA, for amicus curiae National Vaccine Information Center on rehearing en banc.
Kevin P. Conway, Conway, Homer & Chin-Caplan, P.C., of Boston, MA for amici curiae the Vaccine Injured Petitioners' Bar Association, et al. on rehearing en banc.
Opinion for the court filed by Circuit Judge CLEVENGER, in which Chief Judge RADER and Circuit Judges LOURIE, BRYSON, GAJARSA, PROST, MOORE, and O'MALLEY join. Dissenting opinion filed by Circuit Judge DYK, in which Circuit Judges NEWMAN, LINN, and REYNA join.
CLEVENGER, Circuit Judge.
This case involves the interpretation and application of the statute of limitations in the National Childhood Vaccine Injury Act of 1986, 42 U.S.C. §§ 300aa-1 to -34 ("Vaccine Act"). The statute of limitations provides that if a vaccine-related injury occurred as a result of the administration of a vaccine, "no petition may be filed for compensation under the Program for [a vaccine-related] injury after the expiration of 36 months after the date of the occurrence of the first symptom or manifestation of onset ... of such [vaccine-related] injury." 42 U.S.C. § 300aa-16(a)(2).
Dr. Melissa Cloer received three Hepatitis-B ("Hep-B") vaccinations in 1996 and 1997. Years later, in 2005, Dr. Cloer filed a claim under the National Vaccine Injury Compensation Program ("Vaccine Program"), established by the Vaccine Act, seeking compensation for a multiple sclerosis ("MS") injury she alleged was caused by the administration of the vaccine. The Chief Special Master and Court of Federal Claims dismissed Dr. Cloer's claim as untimely because it was filed more then 36 months after her first symptom of MS occurred in 1997. Cloer v. Sec'y of Health & Human Servs., 85 Fed.Cl. 141 (2008). Dr. Cloer appealed the decision and a panel of this court reversed, ruling in her favor. Cloer v. Sec'y of Health & Human Servs.,
Consistent with the plain meaning of the statute, we hold that the statute of limitations
In Part I below, we briefly address the background against which Congress enacted the Vaccine Act and in particular the statute of limitations chosen by Congress. Part II sets forth the essential facts of the case. In Part III, we discuss the proceedings before the Chief Special Master and the Court of Federal Claims. Part IV states our standard of review. In Part V, we set forth and respond to the three arguments Dr. Cloer presented to the court in her initial briefs and at the initial panel hearing of the case. In Part VI, we address and answer the three specific questions on which we requested additional briefing to the en banc court. Our en banc hearing focused on these questions.
In 1986, Congress established the Vaccine Program to provide compensation for vaccine-related injuries and deaths. See 42 U.S.C. § 300aa-10. The Vaccine Act creates a "no-fault" Federal program for compensating injuries that are either presumed or proven to be causally connected to vaccines. The Vaccine Act arose because "the Nation's efforts to protect its children by preventing disease have been  a success," but "[w]hile most of the Nation's children enjoy greater benefit from immunization programs, a small but significant number have been gravely injured." H.R.Rep. No. 99-908, at 4 (1986), reprinted in 1986 U.S.C.C.A.N. 6344, 6345. However, "at least in part as a result of [the] increase in litigation, the prices of vaccines  jumped enormously." Id. Congress created the Vaccine Program to balance these two primary concerns that the tort system was failing to adequately compensate persons injured from vaccinations that were undergone for the public good and that excessive tort liability was unsustainably raising prices and discouraging vaccine manufacturers from remaining in the market. See id. at 3-7, reprinted in 1986 U.S.C.C.A.N. at 6344-48.
Congress noted "for the relatively few who are injured by vaccines — through no fault of their own — the opportunities for redress and restitution [were] limited, time-consuming, expensive, and often unanswered." Id. at 6, reprinted in 1986 U.S.C.C.A.N. at 6347. In response, Congress created the Vaccine Program to be "simple, and easy to administer" while also being "expeditious and fair." Id. at 7, 12, reprinted in 1986 U.S.C.C.A.N. at 6348, 6353. To compensate injured persons quickly and fairly, the Vaccine Act exempted petitioners from the tort requirements of demonstrating that a manufacturer was negligent or that a vaccine was defective. Id. at 12-13, reprinted in 1986 U.S.C.C.A.N. at 6353-54. For some injuries which the medical profession at large recognized as especially likely to be caused by vaccine administration, Congress exempted petitioners from the burden of proving causation. Id. In sum, while the Vaccine Act does not prohibit a petitioner from going to state court after completion or unfair delay of the compensation proceedings, the Vaccine Program was intended
The legislative history shows that Congress considered alternative statutes of limitation for claims filed in the Vaccine Program. The House of Representatives version, H.R. 1780, introduced on March 27, 1985, provided that "any claim under this title that is filed more than two years after the first manifestation of a vaccinerelated injury shall be barred." National Childhood Vaccine-Injury Compensation Act of 1985, H.R. 1780, 99th Congress § 2112(a) (1985). A subsequent Senate bill, S. 827, introduced on April 2, 1985, took a different approach. Unlike H.R. 1780, S. 827 did not trigger the statute of limitations upon the occurrence of the first manifestation of an injury. Instead, it provided that actions for compensation "shall be barred if the petitioner fails to file the action ... within 5 years after the occurrence of the compensable complication or residual effect of the illness, disability [or] injury." National Childhood Vaccine Injury Compensation Act of 1985, S. 827, 99th Congress § 2106(a) (1985). In addition, the 5 year statute did not apply at all if a petitioner could demonstrate that she either (a) did not receive the parent information about vaccines required under the bill, or (b) did not know the complication or effect of her injury was compensable under the program. Id. § 2106(b). S. 827 set forth a Vaccine Table, listing specific vaccines, specific injuries, and specific time periods for the first symptom or manifestation of onset of a listed injury after administration of a vaccine. Compensation was required if a petitioner could meet the specified time periods for a listed vaccine and injury. But if a petitioner could not meet the time period requirements, the petitioner could still prevail if "the petitioner demonstrates on the basis of credible evidence" that the injury "suffered by petitioner was caused by a vaccine listed in the Vaccine Injury Table." Id. § 2105(a)(2). The Senate bill thus incorporated both strict liability and causation in fact liability.
Ultimately, Congress settled on the former of the two approaches. H.R. 5546 (September 18, 1986) followed the approach of H.R. 1780, and provided that if a vaccine-related injury occurred as a result of the administration of a vaccine listed on the Vaccine Injury Table, "no petition may be filed for compensation under the Program after the expiration of 36 months after the date of the occurrence of the first symptom or manifestation of onset ... of such injury." National Childhood Vaccine Injury Act of 1986, H.R. 5546, 99th Congress § 2116(a)(1)(B) (1986). Both the House and Senate passed H.R. 5546, as incorporated into S. 1744, and the statute of limitations was signed into law on November 14, 1986 as part of the National Childhood Vaccine Injury Act of 1986. Pub.L. No. 99-660, 100 Stat. 3743 (1986).
The legislative record is thus clear that Congress chose to trigger the statute of limitations from the date of the occurrence of the first symptom or manifestation of onset of an injury, not from the date of the injury itself. Further, Congress was alerted to the consequences of its choice. For example, at a July 18, 1985 Senate Hearing before the Committee on Labor and Human Resources, the president of Dissatisfied Parents Together ("DPT") submitted testimony comparing the different pending
From the above, we note that the Vaccine Act, as enacted, reflects a specific decision by Congress that the Act's statute of limitations would begin to run not on the date of injury (as is sometimes seen in other contexts), but on the date that injury first became symptomatic or manifested.
The essential facts of this case are undisputed. Petitioner Melissa Cloer is a physician with MS.
In 1998, about a year after her final vaccination, Dr. Cloer sought treatment from Dr. Michael Andrew Meyer, an expert in the field of neurology with a specialty in MS. After an MRI examination, Dr. Meyer noted "probable early inactive non-progressive CNS [central nervous system] demyelination/MS," although he explained that her situation did not meet "formal diagnostic criteria for clinically definite MS." Cloer, 85 Fed.Cl. at 144. Even so, because the MRI revealed lesions on the white matter of her central nervous system, Dr. Meyer concluded that Dr. Cloer could have MS, Singular Sclerosis, Lyme Disease, and/or acute disseminating encephalomyelitis, along with other demyelinating processes. Id. at 143. Before the Chief Special Master, Dr. Meyer testified that Dr. Cloer suffered from MS in
On May 6, 1999, Dr. Cloer received a neurological examination from Dr. Ted Colapinto. Cloer, 85 Fed.Cl. at 144. Dr. Colapinto noted Dr. Cloer's medical history and recorded her complaints of numbness in her face, arms and legs, and her difficulty in walking. Id. He concluded that Dr. Cloer's symptoms likely represented a demyelinating disease, commenting that "[Dr. Cloer] is having waxing and waning neurological symptoms in multiple areas of her body. I fear that this may likely represent demyelinating disease." Sp. Mstr. Op., 2008 WL 2275574, at *6. Dr. Cloer continued to suffer from numerous, but somewhat fleeting, symptoms. In May 2004, Dr. Cloer applied for and was awarded monthly Social Security disability benefits. Dr. James P. Metcalf conducted a comprehensive medical examination at the time and noted that appellant "first beg[a]n to have some symptoms consistent with MS in 1997," although her "symptoms waxed and waned until the fall of 2003 when she beg[a]n to have manifestations of the full blown disease." Id. at *2.
Dr. Cloer claims that even in 2003 upon receiving a diagnosis of MS she remained unaware of any causal association between the Hep-B vaccine and MS. Dr. Cloer testified that she first became aware of the possible link when she read an editorial and prospective French study in the September 2004 issue of Neurology. Cloer Aff., J. App'x 270-71; see also Robert T. Naismith, M.D. & Anne H. Cross, M.D., Does the hepatitis B vaccine cause multiple sclerosis?, 63 Neurology 772 (Sept. 2004); and Miguel A. Hernán, M.D. et al., Recombinant hepatitis B vaccine and the risk of multiple sclerosis, 63 Neurology 838 (Sept.2004). On October 11, 2004, Dr. Cloer reported to the Vaccine Adverse Event Reporting System that she had experienced numbness and tingling after her first two Hep-B vaccinations, followed by "Lhermitte's" approximately one month after her third vaccination. Sp. Mstr. Op., 2008 WL 2275574, at *1-2. Dr. Cloer subsequently filed her petition for compensation for a vaccine injury on September 16, 2005. Cloer, 85 Fed.Cl. at 144.
Before the Chief Special Master, Dr. Cloer did not challenge the evidence that she had suffered symptoms of MS, and likely the manifestation of onset of MS, more than three years before the filing of her petition, thus time-barring her petition. Instead, Dr. Cloer's primary argument to the Chief Special Master was that the statute of limitations did not begin to run against her until after receipt of a "clinically definite" diagnosis of MS. Dr. Meyer, Dr. Cloer's treating physician, explained that because Dr. Cloer's symptoms did not amount to a clinically definite diagnosis of MS until November 2003, Dr. Cloer was unaware of her injury until this time, and thus also could not have been aware that the Hep-B vaccine caused her injury. Since Dr. Cloer's petition was filed in September 2005, she argued it was filed within the 3 year statute of limitations of when she was first diagnosed with MS. Essentially, Dr. Cloer asked the Chief Special Master to read the phrase "symptom or manifestation of onset" as only triggering upon a symptom or manifestation that is clinically diagnosed as the disease itself.
Relying on precedent of this court, the Chief Special Master rejected Dr. Cloer's theory and held that the statute of limitations begins to run on the occurrence of
Id. at *9.
Just as she did before the Chief Special Master, Dr. Cloer focused her argument at the Court of Federal Claims on her failure to receive a "clinically definite" diagnosis of MS until 2003, elaborating that "because the first set of symptoms may be premature for a definitive diagnosis of a disease, it cannot itself constitute a `vaccine injury.'" She also pointed to 42 U.S.C. § 300aa-11(c)(1)(D)(i), which contains a petition content requirement stating that "a petition for compensation ... for a vaccine-related injury ... shall contain ... an affidavit, and supporting documentation, demonstrating that the person ... suffered the residual effects or complications of such illness, disability, injury, or condition for more than 6 months after administration of the vaccine...." Because of this requirement, she argued that the statute of limitations does not begin to run until a petitioner has suffered the residual effects or complications for more than 6 months after administration of the vaccine. She alleged as a matter of fact that she did not meet this requirement until late in 2003, which if true, would bring her 2005 petition within the statute of limitations. Finally, she asked for relief by way of equitable tolling, notwithstanding our opinion in Brice that equitable tolling is not available under the Vaccine Act. She sought relief under equitable tolling because she was not diagnosed with MS until 2003 and there was no reason for her to suspect a vaccine link to MS until 2004. Cloer, 85 Fed.Cl. at 145, 149.
The Court of Federal Claims rejected Dr. Cloer's arguments. The court understood Dr. Cloer's primary argument to be that a "vaccine-related" injury could not occur based on the first occurrence of a symptom of the injury, but instead would arise from "a physician's ultimate diagnosis" that the "vaccine caused the complained-of specific injury." Id. at 149. The court held her argument "contrary to Markovich, which held that the limitations period begins to run at the first occurrence of a symptom even though an exact diagnosis may be impossible until some future date when more symptoms or medical data are forthcoming." Id. Referring to the trigger for the statute of limitations, the court quoted from Markovich: "Congress intended the limitations period to commence to run prior to the time a petitioner has actual knowledge that the vaccine recipient suffered from an injury that could result in a viable cause of action under the Vaccine Act." Id. (quoting Markovich, 477 F.3d at 1358). The court also relied on the observation in Brice that the statute begins to run "upon the first symptom or manifestation of the onset of injury, even if the petitioner would not have known at
The court held that the Lhermitte sign in 1997 was the first symptom of Dr. Cloer's MS and triggered the statute of limitations, Cloer, 85 Fed.Cl. at 147-49, which the court held is unaffected by the 6 month requirement in 42 U.S.C. § 300aa-11(c)(1)(D)(i). The court found Dr. Cloer's petition is time barred and affirmed the Chief Special Master. The court also noted that Brice bars Dr. Cloer's request for relief by way of equitable tolling of the statute of limitations. Id. at 149, 152.
We review the Special Master's decision under the same arbitrary and capricious standard as did the Court of Federal Claims. 42 U.S.C. § 300a-129(e)(2)(B); Althen v. Sec'y of Health & Human Servs.,
In her initial appeal briefs, Dr. Cloer abandons her argument that no vaccine-related injury can occur before a clinically definite diagnosis is made. Instead, she argues that a "vaccine-related injury" for purposes of the Vaccine Act and its statute of limitations cannot occur until the medical community at large understands and recognizes the causal relationship between the claimed injury and the administration of a vaccine. Dr. Cloer alleges that because an injury cannot be alleged as "vaccine-related" until after this recognition, any other interpretation of the statute of limitations would be unfair. Dr. Cloer also argues that the statute of limitations should not trigger until after a petitioner has suffered from six months of consistent, clinically-related symptoms, citing 42 U.S.C. § 300aa-11(c)(1)(D)(i). Otherwise, because a petitioner is required to attest, as a petition requirement, to residual effects or complications lasting "more than 6 months after the administration of the vaccine," Dr. Cloer argues the statute of limitations would be unfairly reduced to less than 36 months. Finally, Dr. Cloer requests that this court reconsider the holding in Brice that equitable tolling is not available under the Vaccine Act.
As noted above, the panel opinion ruled in Dr. Cloer's favor, accepting her argument that the statute of limitations begins to run upon formation of a consensus in the medical community that a vaccine causes the injury claimed. The panel did not reach Dr. Cloer's other arguments. Because the panel opinion is vacated, we respond to her original arguments in subparts A, B, and C below.
We first address Dr. Cloer's primary argument on appeal that a "vaccine-related" injury only arises upon a medically established causal link between an injury and the vaccine in question. Our analysis must begin with the plain language of the statute. The Vaccine Act states that "if a vaccine-related injury or death occurred as a result of the administration of such vaccine, no petition may be filed for compensation under the Program for such injury after the expiration of 36 months after the date of the occurrence of the first symptom or manifestation of onset" of injury. 42 U.S.C. § 300aa-16(a)(2). The plain language of the Vaccine Act thus requires injured parties to file Vaccine Program petitions within 36 months of the date of
The Act defines "vaccine-related injury or death" as:
42 U.S.C. § 300aa-33(5). As both Dr. Cloer and the government recognize, this definition does not provide definitive guidance for us on the specific argument put forward by Dr. Cloer. However, "[a]s a rule, a definition which declares what a term `means' ... excludes any meaning that is not stated." Burgess v. United States, 553 U.S. 124, 130,
The Vaccine Act provides a Vaccine Injury Table of vaccines and the injuries commonly associated with the use of each vaccine. See 42 U.S.C. § 300aa-14; see also 42 C.F.R. § 100.3(a) (containing updated Table). For injuries listed in the Table, generally referred to as "Table injuries," a petitioner need only prove that the first symptom or manifestation of onset occurred within the time period after vaccine administration set forth in the Vaccine Injury Table in order to receive compensation, see 42 U.S.C. § 300aa-11(c)(1)(C)(i), unless the government can prove that a factor unrelated to the vaccination actually caused the illness, disability, or condition. See Pafford v. Sec'y of Health & Human Servs.,
A "vaccine-related injury" is the subject of the petition for compensation in both Table and non-Table cases. For Table injury cases, the statute specifically defines for each vaccine the "vaccine-related" injuries for which compensation is assured. For example, a petitioner who suffers from a symptom of an anaphylactic shock injury within four hours of receiving a DTaP vaccine is presumed to have been injured by the vaccine. See 42 C.F.R. § 100.3(a). But for non-Table injuries, a petitioner must file an affidavit and supporting documentation demonstrating that the "vaccine-related injury" for which compensation is sought was caused by a vaccine.
42 U.S.C. § 300aa-16(a)(2) (emphasis added).
Dr. Cloer would read "vaccine-related injury" throughout the Vaccine Act to require that the alleged injury must be objectively recognized by the medical community as related to the vaccine before it can be deemed a "vaccine-related injury." Accordingly, the statute of limitations would not begin to run on prospective petitioners until after this recognition is established. However, the statute is clear that only "[a] person who has sustained a vaccine-related injury ... may, if the person meets the requirements of subsection (c)(1) of this section [listing the required elements of a petition], file a petition for compensation under the Program." 42 U.S.C. § 300aa-11(b)(1)(A) (emphasis added). Under Dr. Cloer's view that no vaccine-related injury exists until there is consensus in the medical community of a causal link between an injury and a vaccine, the key element of the petition for compensation — the vaccine injury — does not arise until the requisite medical consensus exists. For example, in this case, it is agreed that even now there is not medical consensus of a causal link between the Hep-B vaccine and MS. Thus, under Dr. Cloer's definition of vaccine-related injury, she, like the great majority of non-Table injury petitioners, would lack standing to file a petition until the requisite medical consensus arises. Any construction that would result in a party suffering from a non-Table injury to be unable to file a petition because the alleged injury is not recognized by the medical community at large cannot be what Congress intended.
The correct interpretation of the term "vaccine-related injury" is plain from the language of the statutory provisions that set forth the statute of limitations and the requirements for a petition. For Table injury cases where causation is presumed, the vaccine-related injury is the injury specified in the Vaccine Injury Table for which a petitioner seeks compensation. For non-Table injury cases where the petitioner must establish causation, the vaccine-related injury is the injury which the petitioner avers is caused by the vaccine. The statute of limitations on its face requires a petition for compensation to be filed within 36 months after the date of occurrence of the first symptom or manifestation of onset of vaccine-related injury. The statutory language, however, begs the question of the test for recognition of the existence of a symptom or manifestation of onset of an injury. In short, who decides if a symptom or manifestation of an injury has occurred? We were faced with, and decided, that question in Markovich. 477 F.3d at 1360.
In that case, the parents of a child sought compensation for seizure disorders suffered by the child after administration of a vaccine. On the day of administration of the vaccine, July 10, 2000, the child began to rapidly blink her eyes. The eye-blinking episodes continued for more than a month and culminated in a grand mal seizure. Id. at 1354-55. Under recognized standards of the medical profession at large, the eye-blinking episodes were symptoms of the seizure activity for which compensation was sought. The government argued that the first of such symptoms, on July 10, 2000, triggered the statute of limitations and required dismissal of the petition, which had been filed more than three years from the July 10 date. The petitioners argued for a subjective test to determine when the first symptom occurs. Accordingly, they argued that the symptom of the injury had to be understood as such by the parents. Because they thought the first blinking episodes were simply everyday events meaning the child was tired, they argued that the statute of limitations did not begin to run until August 30, 2010, when they became aware that their child had an injury. Under their view of how a symptom should be
Markovich thus resolved the dispute:
477 F.3d at 1360.
We thus held that the first symptom or manifestation of onset of a vaccine-related injury is "the first event objectively recognizable as a sign of a vaccine injury by the medical profession at large." Id. The analysis and conclusion in Markovich is correct. The statute of limitations in the Vaccine Act begins to run on the date of occurrence of the first symptom or manifestation of onset of the vaccine-related injury for which compensation is sought, and the symptom or manifestation of onset must be recognized as such by the medical profession at large.
In order to file a petition, a claimant must attest, inter alia, that she has "suffered the residual effects or complications of such illness, disability, injury, or condition for more than 6 months after the administration of the vaccine." 42 U.S.C. § 300aa-11(c)(1)(D)(i). Dr. Cloer argues that because her symptoms were fleeting, she could never have met this requirement until late 2003 when her symptoms were continuous and related enough to be deemed "residual effects or complications" of her Hep-B vaccinations. The government responds that the petition requirements are wholly separate from the statute of limitations and should not be read to extend the filing date of the petition beyond 36 months.
We agree with the government that the 6 month requirement is a condition precedent to filing a petition for compensation, not a limitation on the 3 year statute of limitations. The 6 month provision is a petition content requirement to which no reference is made in the statute of limitations. Had Congress intended to adjust the statute of limitations in light of the petition content requirement, we think it would have done so in the statute of limitations. We thus agree with the Court of Federal Claims that there is no support for Dr. Cloer's argument in the text of the Act, nor any in the case law. Congress included the 6 month petition requirement "to limit the availability of the compensation system to those individuals who are seriously injured from taking a vaccine." H.R.Rep. No. 100-391(I), at 699 (1987), reprinted in 1987 U.S.C.C.A.N. 2313-1, -373. Thus, this provision, along with the other petition requirements, is intended to restrict eligibility to the compensation program, not to act as a statutory tolling mechanism for the statute of limitations.
Finally, Dr. Cloer requested in her initial briefs that equitable tolling be made available and applied to the facts of her case, in spite of the binding precedent of Brice. Although the argument was rejected
In an October 25, 2010 order, the court vacated its May 6, 2010 opinion and reinstated the appeal. We requested the parties to file new briefs addressing the following questions:
Upon reviewing the briefs of the parties the court heard argument on May 10, 2011. We now address each question put to the parties.
Whether to incorporate a discovery rule in the Vaccine Act's statute of limitations requires us to decide when the statute of limitations is triggered. Absent a discovery rule, the plain words of the statute trigger the statute of limitations on the date of the first symptom or manifestation of onset of the injury claimed. If, instead, the statute of limitations does not begin to run until a petitioner knows or has reason to know a vaccine has caused her vaccine-related injury, the plain words of the statute must be adjusted. Whether or not to incorporate a discovery rule boils down to a matter of interpretation of the statute of limitations.
As previously stated, the statute of limitations contained in the Vaccine Act reads:
42 U.S.C. § 300aa-16(a). Dr. Cloer makes two arguments for why a discovery rule should be read into the Vaccine Act. First, she argues that the text of the statute of limitations amounts to a discovery accrual rule requiring a claimant to know both the
For the reasons that follow, we conclude that the Vaccine Act does not itself contain a discovery rule, and, applying the relevant analytic tools provided by the Supreme Court, conclude also that a discovery rule cannot be read by implication into the Vaccine Act's statute of limitations. We first address Dr. Cloer's argument that the Act contains its own discovery rule.
Dr. Cloer specifically highlights the phrase "if a vaccine-related injury occurred as a result of the administration of [the] vaccine" in the statute of limitations. Dr. Cloer argues that the inclusion of this phrase in the statute means that a non-Table injury claim does not accrue until the claimant has knowledge that the injury "occurred as a result of the administration of [the] vaccine." Otherwise, Dr. Cloer posits, the phrase would be superfluous. The government counters that the phrase is essential to breathe meaning into the term "vaccine-related injury" as used in the statute of limitations. The government reads the accrual of a non-Table injury (and thus the beginning of the statute of limitations) to arise on the "date of occurrence of the first symptom or manifestation of onset" of the injury the claimant alleges to be "vaccine-related" for having "occurred as a result of the administration of [the] vaccine."
As an initial matter, Dr. Cloer is correct that "we construe statutes, where possible, so as to avoid rendering superfluous any parts thereof." Astoria Fed. Sav. & Loan Ass'n v. Solimino,
We now turn to whether the Vaccine Act statute of limitations is susceptible to an implied discovery rule. As a preliminary matter, we note that the Supreme Court has left open the question of whether a presumption exists that "all federal statutes
The question we must decide is whether, in the context of a no-fault vaccine-injury remedy statute Congress, in the text of the Vaccine Act and considering its overall structure, conveyed its refusal to permit an implied discovery rule. We have already held that Congress did not write an explicit discovery rule into the statute.
Congress enacted the Vaccine Act statute of limitations against the backdrop of state law providing remedies for physical injuries. Indeed, Dr. Cloer points to that body of state law, noting that virtually all of the state laws on the subject incorporate discovery rules into their statutes of limitations. Those discovery rules look to the knowledge of a plaintiff to determine the date upon which the statute of limitations begins to run. From this body of state law, Dr. Cloer argues that Congress must have meant for the Vaccine Act statute of limitations to incorporate a discovery rule.
The contemporaneous existence of that body of state law, however, cuts against Dr. Cloer. First, that body of state law, dealing with fault liability, keys the accrual of the cause of action to the occurrence of the injury for which relief is sought. See, e.g., Colo.Rev.Stat. §§ 13-80-106, 13-80-108 (enacting discovery rule for cause of action otherwise accruing at injury). As with the Federal Tort Claims Act, 28 U.S.C. § 2401(b), those state laws are understood to trigger their statutes of limitations upon the discovery of the existence and the cause of the injury. See United States v. Kubrick,
Examination of the overall structure of the Vaccine Act and its text buttresses our conclusion that a discovery rule cannot be read into the Vaccine Act statute of limitations. First and foremost, Congress selected a specific textual calendar date to trigger the statute of limitations. Nothing in that date, the first occasion of a symptom or manifestation of onset of the injury for which compensation is sought, asks for information about how much knowledge a petitioner had. It is a statutory date that does not depend on when a petitioner knew or reasonably should have known anything adverse about her condition. We have recognized this in our previous cases. See Markovich, 477 F.3d at 1357 (rejecting the argument that eye blinking episodes were insufficient to start the statute of limitations because "the eye blinking symptom could not reasonably alert the Markoviches that anything was wrong."); Wilkerson v. Sec'y of Health & Human Servs.,
The date of the first symptom or manifestation resonates throughout the Vaccine Act. For example, with regard to Table injury cases, the petitioner is supplied in the Vaccine Injury Table with a list of symptoms or manifestations and a list of dates associated with the time of occurrence of each of those symptoms or manifestations. The Table Injury petitioner uses the same single statute of limitations as a non-Table injury claimant, and has 36 months from the date of the first symptom or manifestation in which to file a petition for compensation.
As noted in Part I above, a significant motive for Congress in enacting the Vaccine Program was to provide an efficient, simple, and easy to administer system for processing vaccine injury claims. We think the triggering mechanism selected by Congress for the statute of limitations promotes those goals, whereas a discovery rule may not. Once it is understood that Congress intended a specific date, rather than a date that would vary depending on the knowledge of a petitioner, to trigger the statute of limitations, it is easily understood that time-consuming debates over
A discovery rule necessarily adjusts the beginning of a statute of limitations to the circumstances of an individual case. The rule typically asks when a plaintiff knew or reasonably should have known of enough facts to proceed with her case. Kubrick, 444 U.S. at 120-22, 100 S.Ct. 352; see also Kach v. Hose,
In our view the personal, plaintiff-oriented approach of a discovery rule is antithetical to the simple, symptom-keyed test expressly required by the Vaccine Act's text. Such a conclusion is not surprising in light of the Vaccine Act's structure as a simplified no-fault administrative scheme. We note further that this conclusion is consistent with Congress's expressed desire that the Vaccine Act be "simple, and easy to administer" as well as "expeditious and fair." See supra part I (discussing legislative history). Under the Vaccine Act as written, two plaintiffs who receive the same vaccine on the same day, and who experience the same medically-recognized symptom of a vaccine-related injury shortly afterwards, also on the same day, begin their limitations periods simultaneously. But under the more capacious analysis of the discovery rule, the start of the limitations period could vary widely based on each plaintiff's personal circumstances. We think these two results so different as to make implication of a discovery rule fundamentally incompatible with the text Congress enacted.
We therefore hold that Congress "conveyed its refusal to adopt a discovery rule... by implication from the text and structure" of the Vaccine Act. TRW, 534 U.S. at 27-28, 122 S.Ct. 441. The statute of limitations begins to run on a specific statutory date: the date of occurrence of the first symptom or manifestation of onset of the vaccine-related injury recognized as such by the medical profession at large.
In our second question for en banc briefing, we asked if Brice should be overruled to permit equitable tolling of 42 U.S.C. § 300aa-16(a)(2). We now answer that question in the affirmative. We therefore overrule Brice and hold that equitable tolling applies to the Vaccine Act. In Part C below, we reach and decide the ground on which Dr. Cloer seeks equitable tolling.
The Supreme Court observed in John R. Sand & Gravel Co. v. United States, 552 U.S. 130, 133,
Any analysis of whether equitable tolling lies against a federal statute of limitations begins with Irwin v. Department of Veterans Affairs,
The first exception to which the government refers provides for the situation when a petition for compensation is improperly filed as a tort claim in a state or federal court. Because a person seeking compensation for a vaccine-related injury must first file under the Vaccine Program, 42 U.S.C. § 300aa-11(a)(2), previous court filings elsewhere are improper and must be dismissed. The date such a dismissed action was filed "shall, for purposes of the limitations of actions prescribed by section 300aa-16 of this title [the 36 month period], be considered the date the petition was filed if the petition was filed within one year of the date of the dismissal of the civil action." 42 U.S.C. § 300aa-11(a)(2)(B).
The second exception to the basic limitations statute raised by the government concerns the provision in the Vaccine Act that deals with petitions for compensation filed after the Vaccine Injury Table is revised. For example, a person who was not eligible for compensation before the Vaccine Injury Table revision may file a petition for compensation under the revision, provided the petitioner's injury occurred no more than 8 years before the date of the revision and the petition is filed not later than 2 years after the effective date of the revision. 42 U.S.C. § 300aa-16(b). This exception was not discussed in Brice.
As for the overall structure of the Vaccine Act, the government points to the many strict time deadlines that regulate cases once they are started. In particular, the government points to the need for special masters to decide cases within 240 days after the filing of a petition, and the bar to suspension of proceedings for more than 150 days. See 42 U.S.C. § 300aa-12(d)(3)(A)(ii),(C).
The correct analysis of the government's "exceptions" points is informed by the Supreme
Holland teaches that exceptions to statutes of limitations do not necessarily rebut the bedrock Irwin presumption in favor of equitable tolling. Exceptions, instead, must be understood in context, for, as in Holland, an exception may signal a beneficent Congressional act, not a rebuttal of the Irwin presumption. In the context of the Vaccine Act, the "exception" seen in 42 U.S.C. § 300aa-11(a)(2)(B) does not counsel against equitable tolling.
As noted above, before a tort suit can be brought for damages, a claimant must seek relief under the Vaccine Program. If a would-be petitioner mistakenly first files a traditional tort suit, the tort suit must be dismissed. 42 U.S.C. § 300aa-11(a)(2)(B). Recognizing that the result of a rule requiring dismissal of premature suits could leave a petitioner nonsuited due to different statutes of limitations for state torts and the Vaccine Act, Congress included a special need provision that would allow the petitioner to benefit from the earlier state filing date when faced with the Vaccine Act's statute of limitations. Similarly, Congress included a provision that tolls state statutes of limitations during the pendency of Vaccine Program action. See 42 U.S.C. § 300aa-16(c). Thus, Congress created a system that provides for a petitioner to have equal access to the Vaccine Program and to state remedies once any filing occurs regardless of the forum.
We think it clear that Congress had a specific concern, unrelated to equitable tolling considerations, in enacting the "exception" in 42 U.S.C. § 300aa-11(a)(2)(B). This provision shows Congressional response to possible confusion regarding the new no-fault compensation system by minimizing the consequence of certain errors. This "exception" is driven by a special need, as was the case in Holland, and does not show a desire by Congress to bar equitable tolling.
We turn now to the statutory provision that permits a petition for compensation to be filed upon revisions to the Vaccine Injury Table. We reject the government's argument that this "exception" bars equitable tolling of the statute of limitations. This statutory provision is aimed at scientific advances in medicine that enable the establishment of new Table Injuries, for which causation will be presumed. Individual factual circumstances, the grist of equitable tolling claims, played no role in enactment of this provision. We think equitable tolling concepts lie in a different world from the opening to all vaccine recipients
The remaining factor urged by the government to support its view that Congress rebutted the Irwin presumption concerns the detailed time limits governing processing of cases under the Vaccine Program. Those factors, identified above, relate to the speed with which the special master must move in processing cases. Such limits are tight, to be sure, and they serve to meet the Congressional goal of swift and efficient disposition of claims once a petition is filed. These time limits are designed to benefit the petitioner. If a petitioner were to cause some delay in processing of her petition because the government resists her request for equitable tolling, she could not be heard to complain if the time to decide her claim is greater than a petitioner who filed her petition within the 36 month limit. And any delay in getting the merits of a petition underway because of equitable tolling is no greater, if as great, as the delay that would be inherent in resolving disputes about whether a petitioner reasonably should have known of a causal link between her injury and a vaccination. Further, the 36 month period comports with traditional tort remedy statutes of limitations, and is not overly generous. See United States v. Beggerly,
In sum, measuring the Vaccine Act by the standards in Irwin, Brockamp, and Holland, we see no reason to bar equitable tolling of the statute of limitations in the Vaccine Act, and therefore must conclude that there is not "good reason to believe that Congress did not want the equitable tolling doctrine to apply." Brockamp, 519 U.S. at 350, 117 S.Ct. 849.
In the order setting this case for en banc decision, we asked the parties to address whether, if equitable tolling is permitted, the circumstances of this case support equitable tolling. Dr. Cloer took advantage of our invitation and argued, as she has throughout these proceedings, that equitable tolling is appropriate in this case on the ground that she first became aware of the causal link between her MS and the Hep-B vaccine in 2004 when she saw an article in a journal suggesting such a link. She asserts that it is inequitable and unfair to hold her to the 36 month filing period when she had no reason to know, before 2004, of the causal link between her injury and the Hep-B vaccine. She thus posits that equitable tolling in her case, and presumably in other future cases with similar facts, should be a substitute for the discovery rule.
In other words, Dr. Cloer individually asks for the same relief as a matter of equity that Congress has withheld from all petitioners as a matter of law. But we find no basis in equity for doing so. Dr. Cloer has put no argument before this court that, for example, she has been the victim of a fraud, or of duress. See, e.g., Bailey v. Glover,
While we recognize that our holding sharply limits Dr. Cloer's ability to be compensated under the Vaccine Act, this outcome is the result of a policy calculation made by Congress not to afford a discovery rule to all Vaccine Act petitioners and Dr. Cloer's failure to point to circumstances that could justify the application of equitable tolling to forgive her untimely claim. We thus hold that equitable tolling under the Vaccine Act due to unawareness of a causal link between an injury and administration of a vaccine is unavailable.
Accordingly, the judgment below is
DYK, Circuit Judge, dissenting, with whom Circuit Judges NEWMAN, LINN, and REYNA join.
Contrary to the majority, I think it is quite clear that the National Childhood Vaccine Injury Act of 1986, Pub.L. No. 99-660, 100 Stat. 3743, 3755, Title III (1986) (codified at 42 U.S.C. § 300aa-1 to 34) [hereinafter the Vaccine Act], incorporates a discovery rule under which the limitations period does not begin to run until the claimant knew or should have known of a connection between the alleged injury and a vaccine.
It is well established in both state and federal law that a discovery rule should be presumed for limitations purposes for claims similar to those under the Vaccine Act. The Supreme Court has "recognized a prevailing discovery rule ... in [the] two context[s] of latent disease and medical malpractice, `where the cry for [such a] rule is loudest.'" TRW Inc. v. Andrews,
While the majority does not dispute that the Vaccine Act remedy is similar to, and replaces, a medical malpractice or similar remedy, it asserts that the application of a discovery rule to petitions under the Vaccine Act is inappropriate because such a rule would be inconsistent with the language and structure of the Act. Relying on the Supreme Court decision in TRW, the majority points out that "Congress can `convey its refusal to adopt a discovery rule ... by implication from the structure or text of the particular statute.'" Maj. Op. at 1338 (quoting TRW, 534 U.S. at 27-28, 122 S.Ct. 441). The text and the structure of the Vaccine Act, however, do not suggest that Congress rejected a discovery rule. To the contrary, both the text and the structure of the Act confirm that Congress adopted the prevailing discovery rule approach.
Section 300aa-16(a)(2) of the Vaccine Act provides:
42 U.S.C. § 300aa-16(a)(2). Notably, the statute does not provide that the limitations period commences on the date of the injury. Instead, the limitations period commences on the date of the "first symptom or manifestation" of a "vaccine-related injury," making clear that the statute of limitations is triggered only where the claimant knew or should have known of both the injury and its connection to the vaccine. 42 U.S.C. § 300aa-16(a)(2) (emphases added). As the majority recognizes, the terms "symptom" and "manifestation" suggest knowledge or reason to know on the part of the claimant.
Indeed, the limitations provision makes clear that it is not triggered merely by the first symptom of an injury — the injury itself must be related to the vaccine (i.e., a "vaccine-related injury") and must occur "as a result of ... a vaccine." 42 U.S.C. § 300aa-16(a)(2) (emphasis added). The statutory definition of "vaccine-related injury" confirms this point, defining "vaccine-related injury" as "an illness, injury, condition, or death associated with one or more of the vaccines set forth in the Vaccine Injury Table." Id. § 300aa-33(5) (emphasis added). At the time the Vaccine Act was passed, the word "associated" was defined as "closely connected, joined, or united." Webster's Third New Int'l Dictionary 132 (1986). Thus, in order for an injury to be "associated with" a vaccine, there must be some connection between the injury and the vaccine, and there must be a manifestation or symptom of such an injury, i.e., there must be knowledge or reason to know that the injury is vaccine-related.
The majority asserts that the text of the Vaccine Act is inconsistent with the application of a discovery rule because "the clearly dominant language in the statute of limitations is `the date of occurrence of the first symptom or manifestation of onset.'" Maj. Op. at 1337 (quoting 42 U.S.C. § 300aa-16(a)(2)). Because the majority finds this phrase to be "dominant," it fails to recognize that the phrase "first symptom or manifestation of onset" means nothing standing alone. It can be understood only by looking to the remainder of the language in the limitations provision, which links the "first symptom or manifestation" to "a vaccine-related injury" and requires that such injury occur "as a result" of a vaccine. See 42 U.S.C. § 300aa-16(a)(2).
The majority's novel "dominant language" approach to statutory interpretation is plucked out of thin air and is contrary to Supreme Court precedent, which makes clear that when interpreting a statute, the "[i]nterpretation of a word or phrase depends upon reading the whole statutory text." Dolan v. United States Postal Serv.,
In an effort to support its decision to ignore the statutory text, the majority relies on legislative history supposedly demonstrating that Congress deliberately chose to trigger the limitations period from the date of the first symptom or manifestation of the alleged injury, regardless of whether there is an objective reason to suspect a causal connection between the alleged injury and the vaccine. Even under the questionable assumption that
The majority urges that Congress' rejection of the limitations provision set forth in the Senate bill demonstrates that Congress intended the limitations period to be triggered by the first symptom or manifestation of the alleged injury, regardless of whether there is any reason to suspect a connection between the alleged injury and the vaccine. But Congress' rejection of the exception contained in the Senate bill in no way demonstrates that Congress intended to reject the application of a discovery rule.
First, unlike the Vaccine Act, the Senate bill did not permit a claimant to recover for an injury unless the injury was listed in the Vaccine Injury Table.
Second, the exception to the limitations period in the Senate bill was not a discovery
The application of a discovery rule is compelled by both the structure and history of the Vaccine Act, as well as its language. If the limitations provision were interpreted not to incorporate a discovery rule, claimants like Dr. Cloer would be faced with the odd result that the limitations period would begin to run before a petition could be filed under the Act., i.e., before the cause of action accrued. The majority itself recognizes that "settled law establishes a firm default rule that a cause of action arises at the same time the statute of limitations begins to run on the cause." Maj. Op. at 1333 (citing Graham Cnty. Soil & Water Conservation Dist. v. United States ex rel. Wilson,
The Vaccine Act divides vaccine-related injuries into two types — those which appear in the Vaccine Injury Table ("Table injuries") and those that do not ("non-Table injuries"). See 42 U.S.C. § 300aa-11(c)(1)(C). The same limitations period applies to both Table and non-Table injuries. See id. § 300aa-16(a)(2). For Table injuries, there is no need for the petitioner to establish causation because causation is presumed for injuries listed in the Table. 42 U.S.C. § 300aa-11(c)(1)(C)(i). But where, as here, a claimant seeks compensation for a "vaccine-related injury" not listed in the Table, the petition must contain, among other things, "an affidavit, and supporting documentation, demonstrating that the person who suffered such injury... sustained, or had significantly aggravated, any illness, disability, injury, or condition... which was caused by a vaccine." Id. § 300aa-11(c)(1)(C)(ii) (emphasis added). A claimant's cause of action does not accrue until the time at which the claim becomes enforceable.
The majority urges that a discovery rule would make "the otherwise neutral 36 month time limit ... vary from petitioner to petitioner," Maj. Op. at 1340, and thus undermine this court's decision in Markovich that the statute of limitations begins to run at "the first event objectively recognizable as a sign of a vaccine injury by the medical profession at large," 477 F.3d at 1360. Under a discovery rule, however, the statute of limitations is triggered when the claimant knew or should have known that an injury was vaccine related. Though a claimant's subjective knowledge is certainly sufficient to trigger the statute of limitations, Markovich makes clear that subjective knowledge is not required.
The remedial nature of the Vaccine Act also supports a discovery rule. The Supreme Court has long recognized the canon of construction that remedial legislation should be construed liberally. See, e.g., Atchison, Topeka & Santa Fe Ry. Co. v. Buell,
In any event, it seems quite unlikely that Congress intended the Vaccine Act's statute of limitations to effectively bar more generous state remedies that utilize a discovery rule, but that is also the effect of the majority's decision. The Vaccine Act was not intended to bar state remedies, but to provide an additional system for vaccine injury compensation which would "lessen the number of lawsuits against manufacturers." H.R.Rep. No.
The Vaccine Act plainly requires that a claimant seek a remedy from the Vaccine Injury Compensation Program before attempting to pursue state law claims. See 42 U.S.C. § 300aa-11(a)(2); H.R.Rep. No. 99-908, at 14, 1986 U.S.C.C.A.N. 6344, 6355 (stating that claimants "must complete the compensation proceeding ... before pursuing a civil action"); see also Bruesewitz v. Wyeth LLC, ___ U.S. ___,
In the end, there is nothing in the structure or history of the Vaccine Act that renders a discovery rule inappropriate. In fact, the structure and history of the Act not only confirm, but compel the conclusion that a discovery rule is appropriate.
The injustice of the majority's approach is amply demonstrated by the circumstances in this case. In Dr. Cloer's case, there is no dispute that the first symptom or manifestation of injury occurred in May 1997 when she experienced a Lhermitte sign, which is recognized by the medical profession as a common symptom of MS. The government has submitted no evidence, however, that Dr. Cloer had reason to suspect a connection between multiple sclerosis ("MS") and the Hepatitis B vaccine before 2004. Under the majority's reading of the Act, the limitations period on Dr. Cloer's claim began running on the date of her first symptom of MS, which occurred more than four years before her cause of action accrued. There is simply no indication that Congress intended that the limitations period begin before she had the information necessary to file a petition.
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