Ensuring the Viability of the National Vaccine Injury Compensation Program

On March 30, 2023, Attorney Gentry was invited to provide public comment to the National Academies of Sciences, Engineering, and Medicine's ad hoc committee to review the epidemiological, clinical, and biological evidence regarding Adverse Events Associated with Vaccines. Her comments are below.

Good afternoon. I am Prof. Renée Gentry. I am the Director of the Vaccine Injury Litigation Clinic at The George Washington University Law School and a lawyer who has represented vaccine injured clients in the VICP for more than two decades.

I want to thank the Committee for the opportunity to comment today. In reviewing the questions from your meeting last month, I was heartened to hear several members address the way this committee’s reports are used in the Vaccine Program, and how that evidence is viewed by HHS.

In my 20+ years practicing in the Vaccine Court I have seen many positive changes related to this Committee’s work, including new vaccines and injuries being added to the Table. However, one change over the past ten years has had a devastating impact on the effectiveness of the VICP to uphold Congress’ intent for this Program.

That change has been the aggressive delegitimization of all non-Table vaccine injuries by HHS. The hard line drawn by HHS in contesting these cases, I believe, contravenes Congressional intent as well as the intent of this Committee and pushed the Vaccine Court further into the protracted litigation of the civil arena Congress hoped to avoid. The stakeholders who created the program, including Vaccine Manufacturers, parents of vaccine injured children and the lawyers who represented them, intended for the VICP to be Petitioner friendly, informal, non-adversarial and generous. The Congressional record at the time recorded Congress’ admonition that it was better to compensate someone who was not injured by the vaccine than to fail to compensate someone who was. This Committee’s comments on how its reports are to be used and not used reflects this same goal.

I believe, the VICP as it exists today would be unrecognizable to those original stakeholders.

In some circumstances, HHS’ unrelenting opposition to vaccine injuries using epidemiology discussed by this committee, has resulted in the elimination of entire categories of injuries, in others the virtual elimination of an entire covered vaccine, (the HPV vaccine) where few if any injuries have been compensated since it was added. This is particularly dangerous when everyone fully expects new vaccines to be added in the future.

What has been the result? The HPV vaccine cases are now opting out of the VICP after the 240-day mark - to pursue civil suits against the manufacturer. There’s at least one MDL on HPV cases that is moving forward. This is the exact thing Congress wanted to avoid – but HHS’s unreasonably hard line on injuries has the effect of delegitimizing all vaccine injuries into a zero-sum game. This is primarily being done through the use of epidemiology this Committee has reviewed, but I believe, not in the way this Committee intended.

I will end with this. Vaccines are critically important to our national health policy. In order to guarantee a strong and successful universal immunization program you must have a vibrant safety net for those rare individuals who were injured. A Compensation program must be a reasonable and meaningful alternative to civil litigation or it has failed. I ask the Committee to take these comments into consideration in their work.

Thank you for your time.

For more information contact The Law Office of Renée J. Gentry, Esq.