Covid Vaccine Injury Suit May Fuel Federal Overhaul, Litigation
A lawsuit by Covid-19 vaccine recipients claiming they were injured by their shots may usher in long-awaited changes to how the federal government handles immunization injuries.

Individuals frustrated by the HHS program designed to compensate them for their injuries are taking their grievances to court. In a lawsuit lodged with the US District Court for the Western District of Louisiana, they say the program is unconstitutional, depriving them of their rights to due process and a jury trial.

Lawyers say the move could spur Congress and the Department of Health and Human Services to reform how they handle vaccine injuries, as well as push more of the individuals alleging injuries to not just sue the government, but the drugmakers that the program is meant to shield from litigation.

“‘This is the first domino to fall,” said David Carney, a Green & Schafle LLC attorney representing people injured by vaccines. “We’re going to start to see a windfall.”

For years, attorneys and activists representing Americans injured by routine vaccinations have been pushing lawmakers to reform how the HHS reviews requests for compensation. They say that the process, dubbed the Vaccine Injury Compensation Program, is in desperate need for more special masters to review the backlog of nearly 4,000 injury claims.

Congress, they add, needs to expedite the process for adding new vaccines to the program, though lawmakers have yet to pull the trigger on legislation that’s been several years in the works.

Covid vaccine injuries are not among those currently under the VICP. Those are filed with the HHS’ Countermeasures Injury Compensation Program.

Created in 2010 to pay out damages for people injured in sudden health crises like Ebola and the Anthrax scare, critics say the CICP program is slow moving, opaque, and poorly equipped for handling the nearly 11,000 claims alleging Covid-related injuries awaiting or in review as of Oct. 1. And with a little more than 1,000 decisions reached, vaccine attorneys don’t expect the others to be resolved any time soon.

Vaccine law experts say the path forward is reforming the VICP and bringing Covid-19 immunization injuries under its umbrella. But doing so takes both the HHS and Congress, and attorneys say efforts from both appear lagging.

‘Best Interest’

Adding a vaccine to the VICP is no small feat. The HHS first has to recommend a jab for routine administration to children, and then the agency has two years to recommend that it be covered by the VICP.

In the case for Covid vaccines, the HHS has already recommended jabs for routine administration to children. Through informal conversations with HHS employees, Carney said he and others in the vaccine law space were led to believe Covid vaccines were going to be moved over to the VICP, though the agency has yet to take any action to make that happen.

Now, people suffering injuries allegedly from Covid vaccines “feel like the government is not acting in their best interest,” and are hiring attorneys, he said.

The burden, however, doesn’t entirely lie with the HHS. In order for the VICP to actually pay out for Covid injuries, Congress would have to sign off on taxing the doses for the program, a process that applies to any vaccine added to the program.

Over the past several years, lawmakers have put forth legislation to modernize the program. Earlier this year, Reps. Lloyd Doggett (D-Texas) and Lloyd Smucker (R-Pa.) introduced bills that would move pending Covid-19 vaccine injury claims to the VICP, bring on more special masters to review cases, and eliminate the need for Congress to sign off on a tax for every vaccine added to the table.

In October, React19—a group for people injured by Covid vaccines and a plaintiff in the lawsuit—briefed lawmakers about the need for changes.

Renee Gentry, director of George Washington University Law School’s Vaccine Injury Litigation Clinic, presented alongside React19 and has been urging lawmakers for reforms for a decade.

When it comes to getting Congress on board, she said “talking about vaccine on the Hill is a little bit like walking on the edge of a razorblade that’s on fire.”

“It’s a very, very subtle dance up there,” she said, adding it’s nearly impossible to have a “reasoned, calm, specific” conversation about vaccines.

Insufficient Remedy

An HHS spokesperson likewise called out Congress for not fully funding the HHS’s budget request for the CICP, though noted the agency has tried making “meaningful CICP process improvement,” such as bringing on more medical reviewers and improving communications with people requesting benefits from the program.

The spokesperson also said the Health Resources and Services Administration, the HHS entity that oversees the VICP and Countermeasures Program, is “working to establish” a table that would “list and explain injuries that, based on the statutory compelling, reliable, valid, medical, and scientific evidence standard, are presumed to be caused by covered COVID-19 countermeasures.”

Gentry, however, said there’s a growing frustration with the CICP’s handling of Covid claims, and that the program is “not appropriate for anything on this scale.”

In total, 12,233 Covid-19 claims have been filed with the CICP. More than 9,000 of those allege Covid-19 vaccines were involved in injuries or deaths. That’s the bulk of the 12,775 claims brought to the program over the past 13 years.

While only a small fraction of Countermeasure Program’s Covid claims have been addressed, the overwhelming majority of those—1,235—have been denied. Most missed a filing deadline.

The program has deemed 32 claims eligible for compensation; only 6 have resulted in compensation, all of which involved Covid-19 vaccines.

“An unsatisfactory remedy has now shown itself to be unsatisfactory,” said Christina Ciampolillo, past president of the Vaccine Injured Petitioners Bar Association. “There’s not a lot of promise that you can point to for changes to the CICP in the future.”

Nevertheless, in May, the HHS extended liability protections under the CICP until the end of 2024. After that, Ciampolillo said, it becomes an open question as to whether Covid vaccine manufacturers would be open to lawsuits from people alleging injury.

“There’s a deadline there,” said Ciampolillo, an attorney at Conway Homer PC. “That’s kind of the no man’s land that everybody is wondering about.”

More Lawsuits

The lawsuit against the HHS may serve as the catalyst for ushering in change.

“If case does move forward, I would suspect HHS would work more closely in concert to finally get these important bills that will streamline compensation moving,” said Brianne Dressen, co-chair of React19 who experienced blurred vision, severe paresthesia, and other afflictions after a shot of AstraZeneca’s Covid vaccine during a clinical trial.

However, should the case fail, Dressen said her group would “continue to seek other avenues through the legal system,” including “other types of lawsuits” and applying more “pressure in the halls of Washington.”

Likewise, vaccine injury attorneys said more lawsuits could follow.

“There’s probably a large number of injured people, and the more negative outcomes that are realized through the CICP, I think you’ll have more frustrated individuals,” Ciampolillo said.

The CICP essentially shields drugmakers from lawsuits. But Carney said that given there’s “not a sufficient legal forum to adjudicate” Covid-19 injury claims and that the CICP isn’t “a suitable alternative to civil tort litigation,” it is arguable that pharmaceutical companies could be next in line to be sued.

“Very soon, we’re going to see people sue the vaccine manufacturers,” Carney said.


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Covid Vaccine Injury Suit May Fuel Federal Overhaul, Litigation A lawsuit by Covid-19 vaccine recipients claiming they were injured by their shots may usher in long-awaited changes to how the federal government handles immunization injuries. Individuals frustrated by the HHS program designed to compensate them for their injuries are taking their grievances to court. In a lawsuit lodged with the US District Court for the Western District of Louisiana, they say the program is unconstitutional, depriving them of their rights to due process and a jury trial. Lawyers say the move could spur Congress and the Department of Health and Human Services to reform how they handle vaccine injuries, as well as push more of the individuals alleging injuries to not just sue the government, but the drugmakers that the program is meant to shield from litigation. “‘This is the first domino to fall,” said David Carney, a Green & Schafle LLC attorney representing people injured by vaccines. “We’re going to start to see a windfall.” For years, attorneys and activists representing Americans injured by routine vaccinations have been pushing lawmakers to reform how the HHS reviews requests for compensation. They say that the process, dubbed the Vaccine Injury Compensation Program, is in desperate need for more special masters to review the backlog of nearly 4,000 injury claims. Congress, they add, needs to expedite the process for adding new vaccines to the program, though lawmakers have yet to pull the trigger on legislation that’s been several years in the works. Covid vaccine injuries are not among those currently under the VICP. Those are filed with the HHS’ Countermeasures Injury Compensation Program. Created in 2010 to pay out damages for people injured in sudden health crises like Ebola and the Anthrax scare, critics say the CICP program is slow moving, opaque, and poorly equipped for handling the nearly 11,000 claims alleging Covid-related injuries awaiting or in review as of Oct. 1. And with a little more than 1,000 decisions reached, vaccine attorneys don’t expect the others to be resolved any time soon. Vaccine law experts say the path forward is reforming the VICP and bringing Covid-19 immunization injuries under its umbrella. But doing so takes both the HHS and Congress, and attorneys say efforts from both appear lagging. ‘Best Interest’ Adding a vaccine to the VICP is no small feat. The HHS first has to recommend a jab for routine administration to children, and then the agency has two years to recommend that it be covered by the VICP. In the case for Covid vaccines, the HHS has already recommended jabs for routine administration to children. Through informal conversations with HHS employees, Carney said he and others in the vaccine law space were led to believe Covid vaccines were going to be moved over to the VICP, though the agency has yet to take any action to make that happen. Now, people suffering injuries allegedly from Covid vaccines “feel like the government is not acting in their best interest,” and are hiring attorneys, he said. The burden, however, doesn’t entirely lie with the HHS. In order for the VICP to actually pay out for Covid injuries, Congress would have to sign off on taxing the doses for the program, a process that applies to any vaccine added to the program. Over the past several years, lawmakers have put forth legislation to modernize the program. Earlier this year, Reps. Lloyd Doggett (D-Texas) and Lloyd Smucker (R-Pa.) introduced bills that would move pending Covid-19 vaccine injury claims to the VICP, bring on more special masters to review cases, and eliminate the need for Congress to sign off on a tax for every vaccine added to the table. In October, React19—a group for people injured by Covid vaccines and a plaintiff in the lawsuit—briefed lawmakers about the need for changes. Renee Gentry, director of George Washington University Law School’s Vaccine Injury Litigation Clinic, presented alongside React19 and has been urging lawmakers for reforms for a decade. When it comes to getting Congress on board, she said “talking about vaccine on the Hill is a little bit like walking on the edge of a razorblade that’s on fire.” “It’s a very, very subtle dance up there,” she said, adding it’s nearly impossible to have a “reasoned, calm, specific” conversation about vaccines. Insufficient Remedy An HHS spokesperson likewise called out Congress for not fully funding the HHS’s budget request for the CICP, though noted the agency has tried making “meaningful CICP process improvement,” such as bringing on more medical reviewers and improving communications with people requesting benefits from the program. The spokesperson also said the Health Resources and Services Administration, the HHS entity that oversees the VICP and Countermeasures Program, is “working to establish” a table that would “list and explain injuries that, based on the statutory compelling, reliable, valid, medical, and scientific evidence standard, are presumed to be caused by covered COVID-19 countermeasures.” Gentry, however, said there’s a growing frustration with the CICP’s handling of Covid claims, and that the program is “not appropriate for anything on this scale.” In total, 12,233 Covid-19 claims have been filed with the CICP. More than 9,000 of those allege Covid-19 vaccines were involved in injuries or deaths. That’s the bulk of the 12,775 claims brought to the program over the past 13 years. While only a small fraction of Countermeasure Program’s Covid claims have been addressed, the overwhelming majority of those—1,235—have been denied. Most missed a filing deadline. The program has deemed 32 claims eligible for compensation; only 6 have resulted in compensation, all of which involved Covid-19 vaccines. “An unsatisfactory remedy has now shown itself to be unsatisfactory,” said Christina Ciampolillo, past president of the Vaccine Injured Petitioners Bar Association. “There’s not a lot of promise that you can point to for changes to the CICP in the future.” Nevertheless, in May, the HHS extended liability protections under the CICP until the end of 2024. After that, Ciampolillo said, it becomes an open question as to whether Covid vaccine manufacturers would be open to lawsuits from people alleging injury. “There’s a deadline there,” said Ciampolillo, an attorney at Conway Homer PC. “That’s kind of the no man’s land that everybody is wondering about.” More Lawsuits The lawsuit against the HHS may serve as the catalyst for ushering in change. “If case does move forward, I would suspect HHS would work more closely in concert to finally get these important bills that will streamline compensation moving,” said Brianne Dressen, co-chair of React19 who experienced blurred vision, severe paresthesia, and other afflictions after a shot of AstraZeneca’s Covid vaccine during a clinical trial. However, should the case fail, Dressen said her group would “continue to seek other avenues through the legal system,” including “other types of lawsuits” and applying more “pressure in the halls of Washington.” Likewise, vaccine injury attorneys said more lawsuits could follow. “There’s probably a large number of injured people, and the more negative outcomes that are realized through the CICP, I think you’ll have more frustrated individuals,” Ciampolillo said. The CICP essentially shields drugmakers from lawsuits. But Carney said that given there’s “not a sufficient legal forum to adjudicate” Covid-19 injury claims and that the CICP isn’t “a suitable alternative to civil tort litigation,” it is arguable that pharmaceutical companies could be next in line to be sued. “Very soon, we’re going to see people sue the vaccine manufacturers,” Carney said. PM can grace bloomberg forum but bloomberg might get POFMA? https://news.bloomberglaw.com/health-law-and-business/covid-vaccine-injury-suit-may-fuel-federal-overhaul-litigation No paywall site https://archive.is/1qIga
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Covid Vaccine Injury Suit May Fuel Federal Overhaul, Litigation
A lawsuit by Covid-19 vaccine recipients claiming they were injured by their shots may usher in long-awaited changes to how the federal government handles immunization injuries.
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