(Reuters) – A US government program that compensates people who say they are harmed by an emergency vaccine has paid out on less than 10% of claims, raising questions about whether the process should be used to deal with any side effects from a coronavirus shot to sue, according to some attorneys who have filed such claims.
FILE PHOTO: A woman holds a small bottle labeled “Vaccine COVID-19” and a medical syringe in this illustration April 10, 2020. REUTERS / Dado Ruvic / Illustration / file photo
The Countermeasures Injury Compensation Program (CICP), conducted by an agency under the U.S. Department of Health and Human Services (HHS), is designated to treat problems with a COVID-19 vaccine.
Lawyers say the program is inadequate to address rapid coronavirus vaccines bit.ly/bigpicturecovid.
They say any COVID-19 vaccine injury should be treated through another HHS program, known as the “vaccine court,” a more transparent process with a better record to compensate people for the rare injuries or serious side effects of routine inoculations , such as knife shots.
The National Fax Compensation Program (VICP) covers claims for 16 routine vaccines recommended by the Centers for Disease Control and Prevention (CDC).
When it comes to addressing potential damage from a COVID-19 vaccine, “there are major shortcomings that need to change” in the U.S. approach, said Peter Meyers, an emeritus professor at George Washington University School of Law and former director of the vaccine Injury Litigation Clinic.
Meyers described the CICP as a “black hole” process that is fully handled in HHS, instead of a court, with no fees for attorneys as expert witnesses, a short one-year window to file claims and limited participation by the plaintiff.
HHS declined to comment on criticism of using CICP to process potential COVID-19 claims.
Drug makers including Moderna (MRNA.O), Pfizer (PFE.N) and AstraZeneca (AZN.L) are already working to deliver a safe and effective vaccine against COVID-19 this year, compressing years of development into months.
The effort has raised concerns among many Americans that a vaccine could be introduced to tens of millions of people before the potential risks are fully known.
SHIELDS DRUGMAKERS
The U.S. system shifts responsibility for vaccines to the government, and protects drug makers, because widespread inoculation against disease is considered a benefit to society.
While billions of vaccines have been administered in the United States over the past 30 years, government data show that about 1 in a million people suffer a serious injury that guarantees compensation.
Congress this year set aside $ 30 billion for HHS to combat COVID-19, including funding for fax development and possibly any necessary compensation. To date, no claims regarding COVID-19 drugs have been submitted to CICP and the program has not requested specific funding, an HHS spokesman said.
Of 485 claims filed since CICP began claiming claims in 2010, only 39 people have been compensated for a total of $ 5.7 million, according to the Health Resources & Service Administration (HRSA), which runs the program for HHS .
Almost all claims involved H1N1 pandemic flu vaccines, according to information obtained by Meyers via a request for freedom of information. The CDC estimates that about 123 million people at the age of six months received the vaccine for H1N1, also called swine flu.
“It’s not fair to people up front, if they’re the first to get this vaccine and they have to go to the CICP and get too little to nothing,” said Renée Gentry, director of the Injury Clinic jury litigation.
U.S. officials have said the first people to receive a successful COVID-19 vaccine would include health care workers and people at high risk of complications from the virus.
An HRSA spokesman said the CICP denied claims for a variety of reasons, including the legal requirement that there be ‘compelling’ scientific evidence that a vaccine causes immediate injury. CICP only covers medical expenses and lost income that are not covered by others, such as private health insurance.
HELP OR HARM?
The programs are considered crucial by drugmakers, and protect them from liability in the U.S. market, where lawsuits over products have cost them billions of dollars.
Pfizer, working on a COVID-19 vaccine with German BioNTech (22UAy.F), expects the U.S. system to provide a blueprint for dealing with liability in other countries.
“We are pursuing similar protections for liability outside the United States through contractual and / or legislative efforts, and we believe this will be manageable,” Pfizer Attorney General Doug Lankler told investors last month.
AstraZeneca said it has obtained liability protection for its COVID-19 vaccine from most countries with its delivery agreements.
People who suffer serious injuries due to an emergency vaccine in the United States are required to first seek compensation through the CICP, and then, if they reject any distinction, they can bring a case to court. However, they have to prove that a drugmaker acted with “intentional abuse”, which lawyers said would make a case almost impossible.
Lawrence Karol, 70, of Encino, California, developed large fatty cysts after being vaccinated against H1N1 in 2009. It took him almost a year to find out where he could claim up to $ 10,000 in lost income and the cost of removing a baseball could contribute to large growth of his arm where he got his shot.
By the time he got a hearing, he was told that the time of one year for claims was over. The hearing judge said he had no appeal but one: “They told me to go to Congress to change the fax statute of restrictive laws,” he said.
Gentry of the Vaccine Injury Litigation Clinic said COVID-19 vaccines should fall under the VICP. The fund has paid out an average of $ 216 million annually to an average of 615 claimants since 2015, according to HRSA.
Police said the VICP pays on about 75% of claims. Cases include affidavits, public statements and appeals through the federal legal system.
The VICP is funded by an action tax on doses of vaccine, and pays fees to lawyers and experts, so reporters often have legal representation.
VICP cases can take years, but Gentry said it is still an improvement on the CICP program, which she described as “the right to save and lose.”
Report by Tom Hals in Wilmington, Delaware; Additional Report by Michael Erman in Maplewood, New Jersey; Edited by Michele Gershberg and Grant McCool
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