In December 2016, I wrote an article in The Legal Intelligencer to explain the unique, and often times, crippling statute of limitations provisions set forth by the National Vaccine Injury Compensation Program (42 U.S.C. Sections 300aa-1 to 300aa-34). Since that time, major changes to the Vaccine Injury Table were implemented by a rule change through the Federal Register. The rule change temporarily allows for previously time-barred claims to be resurrected and prosecuted if they meet certain criteria, while also easing the burden of proof for two of the most widespread vaccine injuries.

NVICP Statute of Limitations Recap

The statute of limitations in vaccine-injury cases is not state specific. Since the jurisdiction of these cases is the U.S. Court of Federal Claims in Washington, D.C., a global statute of limitations of three years from the first manifestation of symptoms governs all NVICP cases, 42 U.S. Code Section 300aa–16(a)(2). If the vaccine injury is a death, then the statute of limitations is two years from the date of death or four years from the first manifestation of symptoms that resulted in the death.

In addition, there is no discovery rule and no minor's tolling statute. No exceptions. Perhaps the most perplexing aspect about the VICP is that it was created by the National Childhood Vaccine Injury Act (42 U.S.C. Sections 300aa-1 to 300aa-34), yet it fails to offer the maximum amount of opportunity to minors who may have been injured by vaccines to seek legal recourse.

2017 Federal Register Rule Change

The U.S. Department of Health and Human Services and the Health Resources and Services Administration publishes the Vaccine Injury Table that lists all the vaccines that are covered within the NVICP. On occasion, the Vaccine Injury Table will go through proposed rule changes through the Federal Register to add or subtract various vaccines or injuries to the Vaccine Injury Table. Some of the most common vaccines that are currently listed on the Vaccine Injury Table are the tetanus, MMR, chicken pox, influenza, pneumonia and Gardasil vaccines.

To file a case in the VICP, the injured person must have received one of the vaccines listed on the Vaccine Table. Despite recent adverse events associated with the shingles vaccine (Zostavax®), such cases cannot be filed in the NVICP since the vaccine is not listed on the Vaccine Injury Table. In order to add Zostavax to the Vaccine Injury Table, a proposed rule change would need to be made to the table through a notice of proposed rulemaking.

On July 29, 2015, the Secretary of Health and Human Services published in the Federal Register a Notice of Proposed Rulemaking to amend the regulations governing the National Vaccine Injury Compensation Program by proposing revisions to the Vaccine Injury Table. The secretary based the table revisions primarily on the 2012 Institute of Medicine (IOM) report, ''Adverse Effects of Vaccines: Evidence and Causality,'' the work of nine HHS work groups who reviewed the IOM findings, and consideration of the Advisory Commission on Childhood Vaccines' recommendations. The secretary then amended the Vaccine Table through the changes in this final rule. These changes will apply only to petitions for compensation under the NVICP filed after this final rule becomes effective.

Guillain-Barre Syndrome and Shoulder Injury Cases Just Got Easier

The central purpose of the rule change was to add Guillain-Barré Syndrome and SIRVA injuries to the vaccine chart. Guillain-Barré syndrome (GBS) is a disorder in which the body's immune system attacks part of the peripheral nervous system. The first symptoms of this disorder include varying degrees of weakness or tingling sensations in the legs. In many instances, the symmetrical weakness and abnormal sensations spread to the arms and upper body. These symptoms can increase in intensity until certain muscles cannot be used at all and, when severe, the person is almost totally paralyzed.

The second injury, “SIRVA,” is an acronym which stands for “shoulder injury related to vaccine administration.” Quite simply, it results when a person suffers a shoulder injury (brachial plexus, brachial neuritis, frozen shoulder, shoulder tendon tears, etc.) when the vaccine is administered into various portions of the shoulder. Oftentimes, this is caused when the vaccine is administered in the wrong location of the shoulder.

The rule change, which took effect on Feb. 21, states that anyone who receives the seasonal influenza vaccine and experiences an onset of GBS between three and 42 days thereafter, will be given the presumption of causation in the NVICP. In addition, anyone who suffers a SIRVA injury within 48 hours of receipt of any vaccine on the Vaccine Injury Table, will also be given the presumption of causation.

More Claims Are Temporarily Eligible

According to the Federal Register, the same statute of limitations requirements set forth above continue to apply to the additions to the Vaccine Table. However, the rule change now opens the door to previously time-barred GBS and SIRVA claims.

The modified table applies only to petitions filed under the VICP after the effective date of this final rule. Also, petitions must be filed within the applicable statute of limitations. The general statute of limitations applicable to petitions filed under the VICP, set forth in 42 U.S.C. 300aa–16(a), continues to apply. However, the statute identifies a specific exception to this statute of limitations that applies when the effect of a revision to the Table makes a previously ineligible person eligible to receive compensation or when an eligible person's likelihood of obtaining compensation significantly increases. Under this exception, an individual who may be eligible to file a petition based on the revised Table may file the petition for compensation not later than two years after the effective date of the revision if the alleged injury or death occurred not more than eight years before the effective date of the revision of the table (42 U.S.C. 300aa–16(b)). This is true even if such individual previously filed a petition for compensation, and is thus an exception to the ''one petition per injury'' limitation of 42 U.S.C. 300aa–11(b)(2).

What Does This All Mean?

The rule change carries several important impacts that every attorney must be aware of. First, a GBS or SIRVA will be granted the presumption of causation if the symptoms manifested in the time frames set forth above. If so, then the case will move swiftly to a damages analysis for compensation. This presumption of causation bypasses the need for expert reports or expert hearings, and thus, gets the client a recovery in a more timely manner.

Second, and most critically, the rule change effectively reopens the statute of limitations period for cases that were previously time-barred. The provision that “an individual who may be eligible to file a petition based on the revised Table may file the petition for compensation not later than two years after the effective date of the revision if the alleged injury or death occurred not more than 8 years before the effective date of the revision … ” effectively means that any case where the client developed GBS between three and 42 days after the influenza vaccine, or a SIRVA cases within 48 hours of any table vaccination, that occurred after March 21, 2009, are timely brought if they are filed before March 21, 2019. This exception does not apply to cases that were already filed and adjudicated on the merits.

While the provisions of the federal rule change for vaccine cases can appear to be convoluted to those unfamiliar with vaccine law, the key takeaway is that injuries from vaccines that occurred in 2009 and onward, that were previously rejected or unfiled, may now be filed in the U.S. Court of Federal Claims for compensation with a presumption of causation. This rule change is perhaps the single most important change in the vaccine court in favor of the vaccine injured and gives these individuals an easier path to recovery.

David J. Carney is an attorney at Anapol Weiss. He represents individuals who have suffered adverse events from vaccines, as well as those who have catastrophic personal injuries from hazardous chemical, toxic and environmental exposures, benzene exposures, medical malpractice, motor vehicle accidents and defective products. He can be reached at 215-735-3770 or via email at [email protected].

In December 2016, I wrote an article in The Legal Intelligencer to explain the unique, and often times, crippling statute of limitations provisions set forth by the National Vaccine Injury Compensation Program (42 U.S.C. Sections 300aa-1 to 300aa-34). Since that time, major changes to the Vaccine Injury Table were implemented by a rule change through the Federal Register. The rule change temporarily allows for previously time-barred claims to be resurrected and prosecuted if they meet certain criteria, while also easing the burden of proof for two of the most widespread vaccine injuries.

NVICP Statute of Limitations Recap

The statute of limitations in vaccine-injury cases is not state specific. Since the jurisdiction of these cases is the U.S. Court of Federal Claims in Washington, D.C., a global statute of limitations of three years from the first manifestation of symptoms governs all NVICP cases, 42 U.S. Code Section 300aa–16(a)(2). If the vaccine injury is a death, then the statute of limitations is two years from the date of death or four years from the first manifestation of symptoms that resulted in the death.

In addition, there is no discovery rule and no minor's tolling statute. No exceptions. Perhaps the most perplexing aspect about the VICP is that it was created by the National Childhood Vaccine Injury Act (42 U.S.C. Sections 300aa-1 to 300aa-34), yet it fails to offer the maximum amount of opportunity to minors who may have been injured by vaccines to seek legal recourse.

2017 Federal Register Rule Change

The U.S. Department of Health and Human Services and the Health Resources and Services Administration publishes the Vaccine Injury Table that lists all the vaccines that are covered within the NVICP. On occasion, the Vaccine Injury Table will go through proposed rule changes through the Federal Register to add or subtract various vaccines or injuries to the Vaccine Injury Table. Some of the most common vaccines that are currently listed on the Vaccine Injury Table are the tetanus, MMR, chicken pox, influenza, pneumonia and Gardasil vaccines.

To file a case in the VICP, the injured person must have received one of the vaccines listed on the Vaccine Table. Despite recent adverse events associated with the shingles vaccine (Zostavax®), such cases cannot be filed in the NVICP since the vaccine is not listed on the Vaccine Injury Table. In order to add Zostavax to the Vaccine Injury Table, a proposed rule change would need to be made to the table through a notice of proposed rulemaking.

On July 29, 2015, the Secretary of Health and Human Services published in the Federal Register a Notice of Proposed Rulemaking to amend the regulations governing the National Vaccine Injury Compensation Program by proposing revisions to the Vaccine Injury Table. The secretary based the table revisions primarily on the 2012 Institute of Medicine (IOM) report, ''Adverse Effects of Vaccines: Evidence and Causality,'' the work of nine HHS work groups who reviewed the IOM findings, and consideration of the Advisory Commission on Childhood Vaccines' recommendations. The secretary then amended the Vaccine Table through the changes in this final rule. These changes will apply only to petitions for compensation under the NVICP filed after this final rule becomes effective.

Guillain-Barre Syndrome and Shoulder Injury Cases Just Got Easier

The central purpose of the rule change was to add Guillain-Barré Syndrome and SIRVA injuries to the vaccine chart. Guillain-Barré syndrome (GBS) is a disorder in which the body's immune system attacks part of the peripheral nervous system. The first symptoms of this disorder include varying degrees of weakness or tingling sensations in the legs. In many instances, the symmetrical weakness and abnormal sensations spread to the arms and upper body. These symptoms can increase in intensity until certain muscles cannot be used at all and, when severe, the person is almost totally paralyzed.

The second injury, “SIRVA,” is an acronym which stands for “shoulder injury related to vaccine administration.” Quite simply, it results when a person suffers a shoulder injury (brachial plexus, brachial neuritis, frozen shoulder, shoulder tendon tears, etc.) when the vaccine is administered into various portions of the shoulder. Oftentimes, this is caused when the vaccine is administered in the wrong location of the shoulder.

The rule change, which took effect on Feb. 21, states that anyone who receives the seasonal influenza vaccine and experiences an onset of GBS between three and 42 days thereafter, will be given the presumption of causation in the NVICP. In addition, anyone who suffers a SIRVA injury within 48 hours of receipt of any vaccine on the Vaccine Injury Table, will also be given the presumption of causation.

More Claims Are Temporarily Eligible

According to the Federal Register, the same statute of limitations requirements set forth above continue to apply to the additions to the Vaccine Table. However, the rule change now opens the door to previously time-barred GBS and SIRVA claims.

The modified table applies only to petitions filed under the VICP after the effective date of this final rule. Also, petitions must be filed within the applicable statute of limitations. The general statute of limitations applicable to petitions filed under the VICP, set forth in 42 U.S.C. 300aa–16(a), continues to apply. However, the statute identifies a specific exception to this statute of limitations that applies when the effect of a revision to the Table makes a previously ineligible person eligible to receive compensation or when an eligible person's likelihood of obtaining compensation significantly increases. Under this exception, an individual who may be eligible to file a petition based on the revised Table may file the petition for compensation not later than two years after the effective date of the revision if the alleged injury or death occurred not more than eight years before the effective date of the revision of the table (42 U.S.C. 300aa–16(b)). This is true even if such individual previously filed a petition for compensation, and is thus an exception to the ''one petition per injury'' limitation of 42 U.S.C. 300aa–11(b)(2).

What Does This All Mean?

The rule change carries several important impacts that every attorney must be aware of. First, a GBS or SIRVA will be granted the presumption of causation if the symptoms manifested in the time frames set forth above. If so, then the case will move swiftly to a damages analysis for compensation. This presumption of causation bypasses the need for expert reports or expert hearings, and thus, gets the client a recovery in a more timely manner.

Second, and most critically, the rule change effectively reopens the statute of limitations period for cases that were previously time-barred. The provision that “an individual who may be eligible to file a petition based on the revised Table may file the petition for compensation not later than two years after the effective date of the revision if the alleged injury or death occurred not more than 8 years before the effective date of the revision … ” effectively means that any case where the client developed GBS between three and 42 days after the influenza vaccine, or a SIRVA cases within 48 hours of any table vaccination, that occurred after March 21, 2009, are timely brought if they are filed before March 21, 2019. This exception does not apply to cases that were already filed and adjudicated on the merits.

While the provisions of the federal rule change for vaccine cases can appear to be convoluted to those unfamiliar with vaccine law, the key takeaway is that injuries from vaccines that occurred in 2009 and onward, that were previously rejected or unfiled, may now be filed in the U.S. Court of Federal Claims for compensation with a presumption of causation. This rule change is perhaps the single most important change in the vaccine court in favor of the vaccine injured and gives these individuals an easier path to recovery.

David J. Carney is an attorney at Anapol Weiss. He represents individuals who have suffered adverse events from vaccines, as well as those who have catastrophic personal injuries from hazardous chemical, toxic and environmental exposures, benzene exposures, medical malpractice, motor vehicle accidents and defective products. He can be reached at 215-735-3770 or via email at [email protected].