How Biden’s Freeze May Affect HHS’s SIRVA Rule Change

UPDATE AS OF 04/05/2021: The Department of Health and Human Services is in the processing of withdrawing the SIRVA rule change. Read this blog to learn more: https://shannonlawgroup.com/hhs-rescinds-proposal-to-remove-sirva-from-vaccine-injury-table/.

If you believe you have a shoulder injury as a result of a vaccine, contact us today for more details. 

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Last year, the Department of Health and Human Services’ pushed to remove the most commonly alleged vaccine injury called SIRVA (shoulder injury related to vaccine administration) from the Vaccine Injury Table. We encouraged our readers to comment on the proposed rule that was open to public comment. Over 750 people submitted comments mostly in opposition to the proposed rule change, including many of our own clients. Despite strong opposition to the proposal, HHS went through with the new rule after reviewing and responding to the statements.

The SIRVA rule change is scheduled to be published in the federal register on January 21, 2020. It will become effective on February 21, 2020. Any petitions filed after February 21, 2020, alleging a SIRVA injury will not have the benefit of it being listed on the Vaccine Injury Table. They will not be given a “presumption” that the vaccine caused the injury.

Without that presumption, Petitioners may be required to prove their shoulder injury like a rotator cuff tear was caused by the vaccine. This process typically requires expert testimony and a hearing before a Special Master. This rule change would effectively prevent thousands of people who experience SIRVA from obtaining full and fair compensation for their injuries.

SIRVA injuries don’t happen only due to the negligence of a “misplaced needle.” In fact, many SIRVA injuries occur absent any negligence at all. According to medical literature and case studies, it is both the intramuscular administration of the needle and components of the vaccine that combined cause shoulder injuries from vaccines.

The impact of the SIRVA rule change will contradict the very purpose of the Vaccine Injury Compensation Program.  The Program’s goal is to ensure that the public has continued access to vaccinations. Removing SIRVA cases from the Vaccine Injury Table will force injured patients to sue their doctors, nurses, or pharmacists. This chain of events will inevitably lead to a reluctance by those providers to administer vaccines at all. Vaccine distribution is especially important during a pandemic.

President Biden’s Administration Freezes All Pending Rules—Including the SIRVA Rule Change?

There may be one last opportunity to reverse HHS’ proposal from becoming effective law. On January 20, 2021, President Joe Biden was sworn in as the 46^th President of the United States. On his first day as president, Biden’s Chief of Staff, Ronald A. Klain, instructed all agency and department heads to put a “freeze” on all pending rules.

The freeze applies to both “rules that have been sent to the OFR but not published in the federal register” as well as “rules that have been published in the federal register, . . . but have not taken effect.” You can read the Chief of Staff’s memo here.

While we wait for confirmation, it appears that the freeze would apply to HHS’s SIRVA rule change. Although the proposed rule has been reviewed, it was not scheduled to be published in the federal register until January 21, 2020. In that event, the memo instructs all agencies and departments to “immediately withdraw them from the OFR for review and approval” by a department or agency head appointed by President Biden.

We will know more in the coming days, and we’ll continue to monitor the situation. We are still hopeful that SIRVA remains on the Vaccine Injury Table so that those unfortunate enough to experience this injury have a path to compensation.

Are you experiencing symptoms of SIRVA? Contact us today for a free consultation

If you have questions about SIRVA, the VICP, or HHS’s proposed rule change, please do not hesitate to contact us. At the time of posting this article, we are still conducting consultations for SIRVA injuries. If you believe you have experienced a shoulder vaccine injury or any other vaccine injury, please contact us at the bottom of this page or call us at (312) 578-9501 to set up a free consultation.