The Doctrine of Equitable Tolling and Vaccine Claims

The limitations period for the filing of claims under the “Vaccine Act” has kept many from recovering for vaccine-related injuries. The National Childhood Vaccine Injury Act of 1986, 42 U.S.C. ” 300aa-1 to -34 (Vaccine Act), allows a 36-month window from the time a vaccine-related injury manifests itself to the time of filing. Any claim made after that is barred by the relevant statute of limitations. 42 U.S.C. ' 300aa-16(a)(2).

Still, claimants try to stretch the boundaries, offering varying reasons for why their cases should not be time-barred. Recently, in one such case, Cloer v. Secretary of Health and Human Services, 2011 U.S. App. LEXIS 16449 (Fed. Cir. 9/5/11), the U.S. Court of Appeals for the Federal Circuit reversed a Federal Circuit panel decision and found against a woman who had won the right to pursue her claim. That case, while foreclosing the claimant's right to seek redress, also contained the reversal of a precedent set 10 years earlier in Brice v. Secretary of Health & Human Services, 240 F.3d 1367 (Fed. Cir. 2001). The Brice holding had precluded application of the doctrine of equitable tolling in Vaccine Act cases. Going forward, that rule is not necessarily a bar to late filing, though access to the courts for tardy claimants will remain very limited.

The Vaccine Program

Congress set up the National Vaccine Injury Compensation Program (Vaccine Program) in 1986 in response to the rising costs of litigation to vaccine manufacturers, which was leading to increased costs for the vaccines themselves. At the same time, injured vaccine recipients often had difficulty proving causation, though it was known that certain adverse reactions could occur with the administration of certain vaccines. In order to protect an abundant supply of vaccines for the nation's citizens, and to make it easier for injured patients to recover for injuries caused by inoculations, the legislature created the Program. Compensation for vaccine-related injuries is limited under the Program. However, in some cases, if a causal relationship between a particular vaccine and a specific adverse reaction has already been proven to exist, the claimant, in order to recover, will not have to prove the element of causation, or that the vaccine was defective or the manufacturer was negligent. These types of vaccine-caused injuries, known as “Table injuries,” are found in the Vaccine Injury Table (see U.S.C. ' 300aa-14; see also 42 C.F.R. ' 100.3(a) (containing the updated Table)), and compensation will be paid unless the government can prove that the vaccine did not cause the injury complained of. See Pafford v. Secreaty of Health & Human Services, 451 F.3d 1352 (Fed. Cir. 2006). For “non-Table injuries,” a petitioner must prove the injury was caused by the vaccine. See 42 U.S.C. ' 300aa-11(c)(1)(C)(ii). In the case of a non-Table injury, a petitioner must file an affidavit and supporting documentation to demonstrate that the vaccine caused the “vaccine-related injury” for which compensation is sought.

Claims

Vaccine claims are handled by the congressionally created Office of Special Masters, which consists of the Chief Special Master and several associate special masters. It is overseen by the U.S. Court of Federal Claims, which appoints the special masters. Appeals of the special masters' decisions are heard by the Court of Federal Claims.

When Congress was debating the legislation that ultimately created the Vaccine Program, several limitations periods were proposed and rejected ' among them a five-year period running from the time an injury was discovered, and another that imposed no limitation if a parent had not been given adverse event warning information. In the end, a 36-month window, from the time the injury is discovered or manifests itself, was set in place.

The Cloer Case

The petitioner, Dr. Melissa Cloer, is a physician who developed symptoms of multiple sclerosis (MS) a month after she received her third and final dose of Hepatitis-B (Hep-B) vaccine in 1997. These symptoms included what she described as an “electric shock sensation” with “electric-like sensations going down the center of [her] back to both feet with forward head flexion.” This sensation is known as Lhermitte sign, which is recognized in the medical profession as a common early manifestation of MS.

In 1998, about a year after her final vaccination, Cloer learned from neurology specialist Dr. Michael Andrew Meyer that she had “probable early inactive non-progressive CNS [central nervous system] demyelination/MS.” Dr. Meyer was unable at that time to give a definitive diagnosis of MS, as Cloer was still in the early stages of the disease and her symptoms might also have been caused by Singular Sclerosis, Lyme Disease or other disorders. The petitioner saw other doctors over the next few years, but MS was only definitively diagnosed in 2003. Even then, Cloer averred she had no reason to associate her MS with the Hep-B vaccines until she read of a possible link in the September 2004 issue of the publication Neurology. On Oct. 11, 2004, 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. She filed her petition for compensation for a vaccine-related injury on Sept.16, 2005.

Cloer claimed before the Chief Special Master that the three-year statute of limitations period for filing a vaccine injury claim should not be measured from the date of the first onset of symptoms (in this case, 1997), but from the date that a claimant is first diagnosed with a vaccine-related injury. For the petitioner, that would be November 2003, when she was told that she definitely was suffering from MS. Because she submitted her claim to the Vaccine Program in September 2005, Cloer contended that her claim was therefore timely filed. The Chief Special Master and Court of Federal Claims dismissed the claim as untimely. A panel of the Court of Federal Claims reversed, and the government requested a rehearing en banc. There, the panel opinion was vacated, and the court asked for additional briefs from the parties.

In its August 2011 decision following rehearing, Cloer v. Secretary of Health and Human Services, 2011 U.S. App. LEXIS 16449 (Fed. Cir. 9/5/11), the Court of Federal Claims held in favor of the government, rejecting the petitioner's new argument that a “vaccine-related injury” for purposes of the Vaccine Act and its statute of limitations cannot occur until the medical community as a group understands and recognizes the causal relationship between the claimed injury and the administration of a vaccine. In other words, if experts in the larger medical community have not yet discovered that MS can result from the administration of the Hepatitis-B vaccine, how can the average patient be expected to make the causal connection in time to timely file for compensation? However, the court concluded that Congress had considered long and hard before it settled on a limitations period for Vaccine Program claims. According to the court, the “plain meaning of the statute” required it to find that the statute of limitations begins to run on the calendar date of the occurrence of the first medically recognized symptom of onset of the petitioner's claimed injury. Congress knew that some causal connections would be harder to prove than others ' in fact the already well-recognized vaccine-related Table injuries do not require proof of causation for compensation to be paid ' yet it set no different limitations period for Table vs. non-Table injuries. And it did not define a “vaccine-related injury” as one that has been recognized by the medical community as flowing from a particular inoculation.

The court pointed out that “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.” Therefore, because Cloer's first symptom of MS manifested itself in 1997 through the onset of Lhermitte's syndrome, Congress imposed a 36-month filing period from the onset of symptoms to filing, and claims for any injury may be brought even absent medical consensus on causation, the petitioner's claim was time-barred by her filing more than three years after the onset of symptoms.

Next month we will discuss why the Cloer court rejected a 10-year-old precedent foreclosing the possibility of equitable tolling in all vaccine injury cases.

Janice G. Inman is Editor-in-Chief of this newsletter.

The limitations period for the filing of claims under the “Vaccine Act” has kept many from recovering for vaccine-related injuries. The National Childhood Vaccine Injury Act of 1986, 42 U.S.C. ” 300aa-1 to -34 (Vaccine Act), allows a 36-month window from the time a vaccine-related injury manifests itself to the time of filing. Any claim made after that is barred by the relevant statute of limitations. 42 U.S.C. ' 300aa-16(a)(2).

Still, claimants try to stretch the boundaries, offering varying reasons for why their cases should not be time-barred. Recently, in one such case, Cloer v. Secretary of Health and Human Services, 2011 U.S. App. LEXIS 16449 (Fed. Cir. 9/5/11), the U.S. Court of Appeals for the Federal Circuit reversed a Federal Circuit panel decision and found against a woman who had won the right to pursue her claim. That case, while foreclosing the claimant's right to seek redress, also contained the reversal of a precedent set 10 years earlier in Brice v. Secretary of Health & Human Services , 240 F.3d 1367 (Fed. Cir. 2001). The Brice holding had precluded application of the doctrine of equitable tolling in Vaccine Act cases. Going forward, that rule is not necessarily a bar to late filing, though access to the courts for tardy claimants will remain very limited.

The Vaccine Program

Congress set up the National Vaccine Injury Compensation Program (Vaccine Program) in 1986 in response to the rising costs of litigation to vaccine manufacturers, which was leading to increased costs for the vaccines themselves. At the same time, injured vaccine recipients often had difficulty proving causation, though it was known that certain adverse reactions could occur with the administration of certain vaccines. In order to protect an abundant supply of vaccines for the nation's citizens, and to make it easier for injured patients to recover for injuries caused by inoculations, the legislature created the Program. Compensation for vaccine-related injuries is limited under the Program. However, in some cases, if a causal relationship between a particular vaccine and a specific adverse reaction has already been proven to exist, the claimant, in order to recover, will not have to prove the element of causation, or that the vaccine was defective or the manufacturer was negligent. These types of vaccine-caused injuries, known as “Table injuries,” are found in the Vaccine Injury Table (see U.S.C. ' 300aa-14; see also 42 C.F.R. ' 100.3(a) (containing the updated Table)), and compensation will be paid unless the government can prove that the vaccine did not cause the injury complained of. See Pafford v. Secreaty of Health & Human Services , 451 F.3d 1352 (Fed. Cir. 2006). For “non-Table injuries,” a petitioner must prove the injury was caused by the vaccine. See 42 U.S.C. ' 300aa-11(c)(1)(C)(ii). In the case of a non-Table injury, a petitioner must file an affidavit and supporting documentation to demonstrate that the vaccine caused the “vaccine-related injury” for which compensation is sought.

Claims

Vaccine claims are handled by the congressionally created Office of Special Masters, which consists of the Chief Special Master and several associate special masters. It is overseen by the U.S. Court of Federal Claims, which appoints the special masters. Appeals of the special masters' decisions are heard by the Court of Federal Claims.

When Congress was debating the legislation that ultimately created the Vaccine Program, several limitations periods were proposed and rejected ' among them a five-year period running from the time an injury was discovered, and another that imposed no limitation if a parent had not been given adverse event warning information. In the end, a 36-month window, from the time the injury is discovered or manifests itself, was set in place.

The Cloer Case

The petitioner, Dr. Melissa Cloer, is a physician who developed symptoms of multiple sclerosis (MS) a month after she received her third and final dose of Hepatitis-B (Hep-B) vaccine in 1997. These symptoms included what she described as an “electric shock sensation” with “electric-like sensations going down the center of [her] back to both feet with forward head flexion.” This sensation is known as Lhermitte sign, which is recognized in the medical profession as a common early manifestation of MS.

In 1998, about a year after her final vaccination, Cloer learned from neurology specialist Dr. Michael Andrew Meyer that she had “probable early inactive non-progressive CNS [central nervous system] demyelination/MS.” Dr. Meyer was unable at that time to give a definitive diagnosis of MS, as Cloer was still in the early stages of the disease and her symptoms might also have been caused by Singular Sclerosis, Lyme Disease or other disorders. The petitioner saw other doctors over the next few years, but MS was only definitively diagnosed in 2003. Even then, Cloer averred she had no reason to associate her MS with the Hep-B vaccines until she read of a possible link in the September 2004 issue of the publication Neurology. On Oct. 11, 2004, 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. She filed her petition for compensation for a vaccine-related injury on Sept.16, 2005.

Cloer claimed before the Chief Special Master that the three-year statute of limitations period for filing a vaccine injury claim should not be measured from the date of the first onset of symptoms (in this case, 1997), but from the date that a claimant is first diagnosed with a vaccine-related injury. For the petitioner, that would be November 2003, when she was told that she definitely was suffering from MS. Because she submitted her claim to the Vaccine Program in September 2005, Cloer contended that her claim was therefore timely filed. The Chief Special Master and Court of Federal Claims dismissed the claim as untimely. A panel of the Court of Federal Claims reversed, and the government requested a rehearing en banc. There, the panel opinion was vacated, and the court asked for additional briefs from the parties.

In its August 2011 decision following rehearing, Cloer v. Secretary of Health and Human Services, 2011 U.S. App. LEXIS 16449 (Fed. Cir. 9/5/11), the Court of Federal Claims held in favor of the government, rejecting the petitioner's new argument that a “vaccine-related injury” for purposes of the Vaccine Act and its statute of limitations cannot occur until the medical community as a group understands and recognizes the causal relationship between the claimed injury and the administration of a vaccine. In other words, if experts in the larger medical community have not yet discovered that MS can result from the administration of the Hepatitis-B vaccine, how can the average patient be expected to make the causal connection in time to timely file for compensation? However, the court concluded that Congress had considered long and hard before it settled on a limitations period for Vaccine Program claims. According to the court, the “plain meaning of the statute” required it to find that the statute of limitations begins to run on the calendar date of the occurrence of the first medically recognized symptom of onset of the petitioner's claimed injury. Congress knew that some causal connections would be harder to prove than others ' in fact the already well-recognized vaccine-related Table injuries do not require proof of causation for compensation to be paid ' yet it set no different limitations period for Table vs. non-Table injuries. And it did not define a “vaccine-related injury” as one that has been recognized by the medical community as flowing from a particular inoculation.

The court pointed out that “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.” Therefore, because Cloer's first symptom of MS manifested itself in 1997 through the onset of Lhermitte's syndrome, Congress imposed a 36-month filing period from the onset of symptoms to filing, and claims for any injury may be brought even absent medical consensus on causation, the petitioner's claim was time-barred by her filing more than three years after the onset of symptoms.

Next month we will discuss why the Cloer court rejected a 10-year-old precedent foreclosing the possibility of equitable tolling in all vaccine injury cases.

Janice G. Inman is Editor-in-Chief of this newsletter.