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How do we address COVID-19 vaccine injuries? Two different viewpoints emerge.
As we head into the third year of Covid-19 vaccinations being offered to the public, differing viewpoints have emerged as to how to address compensation for individuals injured by Covid-19 vaccinations.
Recently, a lawsuit was filed against the agency within the U.S. Department of Health & Human Services that handles Covid-19 vaccine injury claims. The litigation alleges that the vaccine program handling Covid-19 vaccine injuries is unconstitutional.
The Vaccine Injured Petitioner’s (VIP) Bar Association provides education and advocacy for the representatives of individuals injured by vaccinations. KLG attorneys, Ed Kraus, Amy Kraus, and Brynna Gang are members of the VIP Bar and KLG founding partner, Ed Kraus, is also on the Board of Directors.
As attorneys that practice only in the Vaccine Injury Compensation Program, we understand the unique challenges faced by an individual injured by a vaccination.
The VIP Bar recently issued a press release which urges that Covid-19 vaccination injury claims be processed in the Vaccine Injury Compensation Program and discusses the recent litigation related to the current program in which Covid-19 vaccination injuries are being reviewed.
Bills to Add Covid-19 Vaccine Injuries to Vaccine Injury Compensation Program (VICP) Introduced in the House
Almost three years after the introduction of Covid-19 vaccines, two Bills (H.R 5142 and H.R.5143) introduced in the House of Representatives aim to make significant changes to the way injuries from Covid-19 vaccinations are handled.
Currently, injuries suspected to stem from Covid-19 vaccinations are handled in a program called the Countermeasures Injury Compensation Program (CICP). You can find our blog about that program, and its differences compared to the Vaccine Injury Compensation Program (VICP) here.
A major drawback of the CICP is the short one-year statute of limitations which requires that claims be filed within a year of vaccination.
Importantly, no later than sixty (60) days after the Bill’s passage, the Secretary of Health & Human Services (HHS) would need to form regulations to add Covid-19 vaccines to the Vaccine Injury Table. This would effectively add Covid-19 vaccination injuries to the VICP, a program that is significantly friendlier to the injured petitioner and provides for greater categories of compensation, including pain and suffering (which is not a source of damages in the CICP).
Appellate Advocacy Secures Lifelong Support for an Injured Child
Kraus Law Group, LLC recently prevailed in securing entitlement to compensation in a case involving an infant girl who developed a seizure disorder shortly after her 9-month-old vaccinations.
Our client, the mother of the child, took her daughter to the emergency room for a significant febrile seizure shortly after her vaccinations. While her daughter initially appeared to recover, her mother noticed that in the weeks after this initial seizure, her baby began acting strangely remote and she seemed to lose developmental milestones that she had previously attained.
A second febrile seizure occurred shortly thereafter. Ultimately, this little girl developed epilepsy and global developmental delays such that she will require complex medical care and constant supervision for the rest of her life.
After litigating this case in the National Vaccine Injury Compensation Program (VICP), The trial judge (known as Special Master in the VICP) denied entitlement, asserting that our client had not established that her daughter’s vaccinations caused the subsequent epilepsy and severe developmental delays.
Shoulder Injuries Following Vaccination (SIRVA)
Shoulder soreness following vaccination is commonly experienced, but not all post- vaccination shoulder pain, particularly if severe, is normal. In the mid 2000’s, two physicians published an article about severe, chronic shoulder pain triggered in two patients by their recent vaccinations. A few years later, another piece of medical literature used the acronym SIRVA, or Shoulder Injury Related to Vaccine Administration, for the first time to refer to these post-vaccination injuries.
SIRVA refers to a set of medical conditions impacting a shoulder following vaccination and can include bursitis, tendinitis, rotator cuff tearing, and adhesive capsulitis, among others. While some individuals experience mild symptoms with a good recovery within a few months, for others, SIRVA injuries may be persistent and require medical interventions like physical therapy, cortisone injections, or even surgery. While the exact mechanism of SIRVA injures is unknown, it is suspected to be caused by improper vaccination administration technique and/or by the inflammatory response triggered by vaccination.
An Association Between Guillain-Barre syndrome and the Seasonal Flu Vaccine
Guillain-Barre syndrome, also known as GBS, is a rare condition in which an individual’s own immune system attacks their nerve endings. While there are different subvariants of GBS, the hallmark symptoms of the condition include weakness, numbness, tingling and for some individuals, paralysis. Fatigue is also often reported. More information about GBS can be found here.
The association between GBS and vaccination was initially suspected after a large-scale influenza vaccination effort in 1976 revealed an increased signal of GBS among the vaccinated population. Subsequent studies confirmed an association between GBS and the 1976 flu vaccination efforts.
While vaccine induced GBS is still considered a rare event, the association with flu vaccines is well established. As a result of this association, GBS is listed as a Table injury in the Vaccine Injury Compensation Program (VICP). As a Table injury, if a person who receives the vaccine (referred to as the “petitioner”) can establish that they developed GBS within 3-42 days of receiving the vaccination, then the injured person is likely to receive compensation.
Covid-19 Vaccine Injuries and the Countermeasures Program
As more Americans undergo vaccination for Covid-19, it is inevitable that rare adverse events will occur.
While we represent individuals injured by vaccines covered under the Vaccine Injury Compensation Program (VICP), vaccine injuries stemming from a Covid-19 vaccination are, at present, not handled through the VICP.
Instead, Covid-19 vaccine injuries are litigated through the Countermeasures Injury Compensation Program (CICP).
During periods of national emergency, including medical emergencies such as during the Ebola and Zika epidemics, the Secretary of Health and Human Services (HHS) has the power to recommend a countermeasure, such as a vaccine or medication, with the aim of preventing or stopping those events. When HHS recommends such a countermeasure, any injury stemming from that covered countermeasure can be compensated through the CICP.
HHS Withdraws Rule Change Impacting Shoulder Injuries in the Vaccine Compensation Program
On April 22, 2021, Health and Human Services (HHS) published the final rule on the Federal Register withdrawing the proposed rule change previously published on January 21, 2021 which would have changed how cases involving shoulder injuries and vasovagal syncope were handled in the Vaccine Injury Compensation Program (VICP).
In explaining this action, HHS noted that members of the public had expressed concern that the agency’s process while pursuing the proposed rule removing shoulder injuries and vasovagal syndrome from the Vaccine Injury Table was irregular in its haste. HHS also observed that from a public health policy perspective, removing these injuries from the Vaccine Injury Table may dissuade individuals from undergoing vaccinations, which would be counter to the public’s interest in promoting vaccination. You can find HHS’s full rationale for withdrawing the rule here.
Proposed Vaccine Compensation Program Rule Change Impacting Shoulder Injuries Likely to be Withdrawn
On March 17, 2021, Health and Human Services (HHS) published a notice on the Federal Register alerting the public that the proposed rule change previously published on January 21, 2021 changing how cases involving shoulder injuries and vasovagal syncope are handled in the Vaccine Injury Compensation Program (VICP), is likely to be withdrawn following a thirty day comment period for public response ending on April 16, 2021.
The January 2021 rule by HHS would have removed shoulder and vasovagal injuries from the Vaccine Injury Table, requiring injured parties to pursue these injuries through “causation-in-fact” claims which often require the retention of medical experts and very often, an in-person hearing years down the line before a Special Master (Judge) in Washington, D.C. That rule change was initially due to go into effect on February 22, 2021, however, the effective date was pushed back two months until April 23, 2021 following a request by the Biden administration for time to review all administrative actions that occurred during the sunset of the previous administration.
Vaccine Program Rule Change Affecting Shoulder Injuries Delayed For Now
On February 23, 2021, Health and Human Services (HHS) published a rule on the Federal Register that effectively gives individuals that have experienced a shoulder injury or vasovagal syncope following vaccination, an additional two months, until April 23, 2021, to file a vaccine injury claim through the federal Vaccine Injury Compensation Program (VICP).
Originally, the rule which would change the way these injuries are handled within the VICP, making it more difficult for many vaccine injured individuals to pursue their claims, was due to take effect on February 22, 2021. The two month pause in the rule’s effective date was announced by HHS due to a request by the Biden administration for time to review all administrative actions that occurred during the sunset of the previous administration.
We have previously covered the rule changes, and the likely outcomes for vaccine injured individuals, in prior blog posts which you can find here and here.
Upcoming Changes To The Vaccine Injury Program Draws Attention Of National Press
On February 4, 2021, USA Today published an article about the upcoming removal of Shoulder Injury Related to Vaccine Administration (“SIRVA”) from the vaccine injury table. We discussed this rule change, which goes into effect on February 22, 2021, in a previous blog post. You can find our blog discussing that issue here.
The USA Today article discusses not only the rule change impacting SIRVA, but also touches on additional rule changes put in place by Health & Human Services (HHS) at the same time, all pushed through at the very end of the Trump administration with at best, minimal support, (chiefly from HHS). There was substantial pushback from players in the vaccine injury program, including the Advisory Commission on Childhood Vaccines (ACCV), the Vaccine Injured Petitioners Bar Association, members of the general public, physicians, pharmaceutical chains, etc., and individuals that have taken their SIRVA cases through the vaccine injury program.