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Cloer v. Secretary of Health and Human Services

May 6, 2010

MELISSA CLOER, M.D., PETITIONER-APPELLANT,
v.
SECRETARY OF HEALTH AND HUMAN SERVICES, RESPONDENT-APPELLEE.



Appeal from the United States Court of Federal Claims in case no. 05-VV-1002, Judge Lawrence J. Block.

The opinion of the court was delivered by: Michel, Chief Judge.

Before MICHEL, Chief Judge, CLEVENGER and DYK, Circuit Judges.

Opinion for the court filed by Chief Judge MICHEL. Dissenting opinion filed by Circuit Judge CLEVENGER.

Petitioner-appellant Melissa Cloer, M.D., appeals the decision of the United States Court of Federal Claims. Cloer v. Sec'y of Health & Human Servs., 85 Fed. Cl. 141 (Fed. Cl. 2008). The decision affirmed the Chief Special Master's report, which denied Dr. Cloer's petition for compensation under the Vaccine Injury Compensation Program ("Vaccine Program") established by the National Childhood Vaccine Injury Act of 1986, 42 U.S.C. §§ 300aa-1 to -34 ("Vaccine Act"), because it was time-barred. See Cloer v. Sec'y of Dep't of Health & Human Servs., No. 05-1002V (Fed. Cl. May 15, 2008).

This case presents the question of whether the Vaccine Act's statute of limitations, 42 U.S.C. § 300aa-16(a)(2), begins running where a claimant experiences a symptom of injury, but where the medical community at large does not recognize that the symptom is related to a vaccine and the claimant has not received medical information suggesting a connection. We hold that the statute of limitations does not begin running in such cases. Thus, we reverse and remand.

I. BACKGROUND

Plaintiff-appellant Melissa Cloer is a physician who is disabled due to multiple sclerosis ("MS"). She had no significant medical issues prior to exhibiting symptoms of demyelinating disease. Dr. Cloer received three Hepatitis B ("Hep-B") immunizations at the University of Missouri Student Health Center. After her first two vaccinations on September 3, 1996 and November 11, 1996, Dr. Cloer experienced some numbness and tingling. Dr. Cloer received her third Hep-B vaccination on April 3, 1997.

About a month after her final vaccination, Dr. Cloer began to experience an electric-like shock sensation in her spine. Medical professionals call this sensation a Lhermitte sign, a common symptom of MS. In September and October 1997, petitioner also lost sensation in her left arm and left hand. Dr. Cloer consulted with her primary care physician, Dr. Pereira, who prescribed Motrin. The symptoms resolved over a short period of time.

When Dr. Cloer experienced additional problems in 1998, she returned to Dr. Pereira. Dr. Cloer underwent further testing, including a magnetic resonance imaging (MRI) scan on May 12, 1998. The MRI scan indicated that possible diagnoses for Dr. Cloer included MS, lyme disease, acute disseminating encephalomyelitis, or other demyelinating processes. A May 15, 1998 medical record specifically noted, "Probable early inactive non-progressive CNS [central nervous system] demylination/MS . . . ."

In 1998, Dr. Cloer was referred to a neurologist, Dr. Meyer, with a specialty in the diagnosis and treatment of MS. Dr. Meyer treated appellant in 1998 for "singular sclerosis" or "early inactive non-progressive CNS demyelinating disease." Dr. Cloer was given a "provisional" diagnosis of MS on November 26, 2003 by her treating neurologist Dr. Wood subsequent to his obtaining Dr. Cloer's medical history and the results of an MRI examination.

In May 2004, Dr. Cloer applied for and was awarded monthly Social Security disability benefits due to her medical condition. As part of her eligibility for benefits, James P. Metcalf, M.D., conducted a comprehensive medical examination 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."

Dr. Cloer first became aware of an association between MS and the Hep-B vaccine when she read an editorial and prospective French study in the September 2004 issue of Neurology. Dr. Cloer reported to the Vaccine Adverse Event Reporting System (VAERS) on October 11, 2004 that she experienced numbness and tingling after her first two Hep-B vaccinations.

On September 16, 2005, Dr. Cloer filed a claim for compensation under the Vaccine Act, alleging that her Hep-B vaccinations caused or significantly aggravated her latent MS condition. On December 1, 2005, respondent-appellee Health and Human Services ("HHS") moved to dismiss the petition because it was filed after the expiration of the statutorily prescribed limitations period.

Dr. Cloer relied upon affidavits and testimony from Dr. Meyer, a recognized expert in MS. Dr. Meyer explained that when he evaluated Dr. Cloer in 1998 her symptoms were consistent with but not independently diagnostic for clinically definite MS. He noted that symptoms of MS could occur well before a diagnosis of MS is made. Dr. Meyer testified that, in retrospect, the first sign of MS was the Lhermitte sign that the appellant experienced in 1997.

Dr. Meyer did not believe, or even consider, that Dr. Cloer had suffered a vaccine injury when he evaluated her in 1998. Dr. Meyer did not become aware of the association between MS and Hep-B immunization until he was contacted by Dr. Cloer's counsel in late 2005. Dr. Meyer testified that a member of the medical community at large would not have recognized or believed Dr. Cloer had a vaccine injury as of 1999. Having reviewed Dr. Cloer's prior medical records, Dr. Meyer found no indication of a link between her MS and the Hep-B immunizations before 2004. Dr. Meyer's testimony was not rebutted by any expert.

In 2007, the Chief Special Master conducted a telephonic hearing to take Dr. Meyer's testimony. The Chief Special Master issued his decision on May 15, 2008, determining that the first symptom, manifestation of onset, or significant aggravation of Dr. Cloer's MS was the Lhermitte's sign she experienced in 1997. Because Dr. Cloer filed her Vaccine Act petition on September 16, 2005, more than 36 months later, the Chief Special Master dismissed the petition as untimely. The Court of Federal Claims affirmed the Chief Special Master's decision.

Dr. Cloer timely appealed to the Federal Circuit. We have jurisdiction pursuant to 28 U.S.C. § 1295(a)(3).

II. DISCUSSION

A.

Under the Vaccine Act, the Court of Federal Claims reviews the decision of the special master to determine if it is "arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law[.]" 42 U.S.C. § 300aa-12(e)(2)(B); Althen v. Sec'y of Health & Human Servs., 418 F.3d 1274, 1277 (Fed. Cir. 2005). We review legal determinations of the Court of Federal Claims de novo. Althen, 418 F.3d at 1278. To the extent that the Court of Federal Claims adopts factual findings made by the special master, we accord them the same deference as the Court of Federal Claims and review them under the arbitrary and capricious standard as provided in the statute. Munn v. Sec'y of the Dep't of Health & Human Servs., 970 F.2d 863, 870 (Fed. Cir. 1992). While we owe no deference to either the special master or the trial court on questions of law, Whitecotton v. Sec'y of Health & Human Servs., 81 F.3d 1099, 1106 (Fed. Cir. 1996), we review factual findings for clear error, Hines v. Sec'y of Health & Human Servs., 940 F.2d 1518, 1523 (Fed. Cir. 1991).

B.

Congress established the Vaccine Act to increase the safety and availability of vaccines. See 42 U.S.C. § 300aa-1. As part of the Vaccine Act, the Vaccine Program permits claimants to petition to receive compensation for vaccine-related injuries. See § 300aa-100(a). The Vaccine Injury Table lists vaccines that are covered under the Vaccine Act. See §§ 300aa-11(c)(1)(C)(ii), 300aa-14. The Vaccine Injury Table also lists injuries that may arise from these vaccines, which are referred to as Table injuries. § 300aa-14. Other injuries, including MS, are not listed in the Vaccine Injury Table and referred to as non-Table injuries. § 300aa-11(c)(1)(C)(ii).

The Vaccine Act sets forth a statute of limitations: In the case of . . . a vaccine set forth in the Vaccine Injury Table which is administered after October 1, 1988, if a vaccine-related injury 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 or of the significant aggravation of such injury.

§ 300aa-16(a)(2). The question in this case is whether the 36 month period commences where a petitioner experiences the first symptom of an injury, but where the medical community at large does not recognize that the symptom is related to a vaccine and the claimant has not received medical information suggesting such a connection. If so, Dr. Cloer's appeal is time-barred because she experienced the first symptom of MS in 1997 but did not file her claim until 2005.

Dr. Cloer argues that her appeal cannot be time barred because the "first symptom or manifestation of onset," for the purposes of § 300aa-16(a)(2), is "the first event objectively recognizable as a sign of vaccine injury by the medical profession at large." See Markovich v. Sec'y of Heath and Human Servs., 477 F.3d 1353 (Fed. Cir. 2007). Dr. Cloer interprets Markovich to mean that the medical community at large needs to recognize a link between the injury and the vaccine for the statute of limitations to begin running. We generally agree.

We begin with an analysis of Markovich, where this court considered the standard that should be applied in determining the date of "the occurrence of the first symptom or manifestation of onset . . . ." Id. at 1356. The Markoviches' daughter, Ashlyn, received a series of vaccinations on June 10, 2000, when she was approximately two months old. Id. at 1354. That same day, the Markoviches observed that Ashlyn began to rapidly blink her eyes, but they did not recognize that it was a first symptom of vaccine-related seizures. See id. On August 30, 2000, Ashlyn became unresponsive for about twenty minutes, during which time all of Ashlyn's extremities jerked aggressively. Id. at 1354-35. Ashlyn was treated at the Fairview Ridge Emergency Room, where she was diagnosed with having a grandmal seizure. Id. at 1355.

The Markoviches argued that the standard for the statute of limitations should be subjective and begin running on August 30, 2000, the date they became aware of an injury. Id. at 1356. This court disagreed, holding that an objective standard was consistent with the Vaccine Act language that the statute is triggered by the "first symptom or manifestation of onset." Id. at 1358, 1360. The use of the words "first" and "or" require that the statute of limitations commence with whichever event (i.e., symptom or manifestation of onset) occurs first. Id. at 1358. Thus, this court held that the "'first symptom or manifestation of onset,' for the purposes of § 300aa-16(a)(2), is the first event objectively recognizable as a sign of a vaccine injury by the medical profession at large." Id. at 1360. Because Ashlyn's eye blinking episode was objectively recognizable by the medical profession at large as constituting the first evidence of vaccine injury onset, the statute of limitations began on that date. Id.

Markovich confirms that, under § 300aa-16(a)(2), in general, a symptom must be recognizable by the medical community at large as constituting a vaccine-related injury. As this court expressly held, the limitations period begins at the "first event objectively recognizable as a sign of a vaccine injury by the medical profession at large." See id. (emphasis added). This holding also is consistent with the plain language of the statue of limitations, which specifically applies to injuries that are vaccine-related:

In the case of . . . a vaccine set forth in the Vaccine Injury Table which is administered after October 1, 1988, if a vaccine-related injury 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 or of the significant aggravation of such injury. § 300aa-16(a)(2) (emphasis added). Thus, we hold that, in general, for the purposes of § 300aa-16(a)(2), to be "vaccine-related" the "first symptom or manifestation of onset or of the significant aggravation of such injury" cannot occur until the medical community at large objectively recognizes a link between the vaccine and the injury.

The government's arguments to the contrary are unpersuasive. First, HHS argues that "Congress chose to start the running of the statute before many petitioners would be able to identify, with reasonable certainty, the nature of the injury." See Markovich, 477 F.3d at 1358. However, as the preceding discussion demonstrates, the issue is not whether a petitioner subjectively recognizes an injury as vaccine-related, but rather whether the medical community at large objectively recognizes the injury as vaccine-related. Second, HHS argues that Dr. Cloer's position would essentially "eviscerate" the limitations period provided in the Vaccine Act for most non-Table injuries. HHS alleges that, in many non-Table cases, the first time an injury is causally associated with a vaccine is well after the petition has been filed. Be that as it may, the relevant inquiry for determining when the limitations period begins to run is ...


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