Politico Pro: Covid shots energize lawmakers’ plan to change vaccine injury claims system
A bipartisan pair of House lawmakers is backing an update to the nation's system for compensating people injured by vaccines, with an eye on making it easier for those experiencing rare but serious side effects from Covid-19 shots to eventually seek payment for their claims.
A new proposal from Reps. Lloyd Doggett (D-Texas) and Fred Upton (R-Mich.), which got a hearing in the House Energy and Commerce Committee on Tuesday, could help address concerns from some legal and vaccine experts who say the existing compensation system for claims related to the new Covid-19 shots is opaque and may exacerbate hesitancy among some people worried about side effects.
"Having a vaccine injury compensation that's robust, that's clear to patients, that actually quickly takes them through the injury compensation process, is extremely important to reinforcing our very strong safety system in the United States," Phyllis Arthur, vice president at the Biotechnology Innovation Organization, told lawmakers Tuesday.
For over three decades, people claiming injury from FDA-approved vaccines could seek compensation through the National Vaccine Injury Compensation Program, an industry-funded system meant to reinforce confidence in vaccine safety while shielding vaccine makers from lawsuits. But the compensation process for Covid vaccines is more complicated — they're not yet eligible for that program because they have been authorized for emergency use, a standard short of full FDA approval.
Injury claims for Covid vaccines are now covered by an obscure HHS agency's program that typically has a higher bar for claims. Even after Covid shots earn full FDA approval, experts well-versed in vaccination laws and regulators aren't sure how the injury compensation system will work for those already vaccinated.
The legislation from Doggett and Upton has been in the works since last fall — before the coronavirus vaccines hit the market — with input from HHS and the backing of vested interests as diverse as trial lawyers and drugmakers. The lawmakers are hoping to include the bill in a broader legislative package encouraging vaccine development.
"To assure the best protections for the one-in-a-million who may receive a Covid-19 vaccine-related injury, reasonable compensation should be available promptly through the much stronger and more consumer-friendly Vaccine Injury Compensation Program," Doggett, the chair of the Ways and Means Health Subcommittee, said in a statement.
His bill with Upton would expedite the process for adding Covid vaccines to VICP once they've received full regulatory approval. It would also extend the program's statute of limitations for injury claims from three years to five years, which could give people more time to file injury complaints for Covid shots. Separate legislation from Doggett would speed up the timeline for Covid vaccine makers to contribute to VICP their mandated 75-cent per dose excise tax.
Some of the changes lawmakers are considering to VICP have been under discussion for years. There hasn't been a meaningful update to the system since it was established in 1988.
Arthur said the Doggett and Upton legislation "would update and strengthen" the system so the few people who experience adverse events from vaccines can be better compensated.
It's unclear, however, whether people who've already filed complaints over Covid vaccine injuries would be allowed to shift those claims to VICP. A spokesperson for the HHS agency now overseeing Covid-related injury claims said it would depend on "numerous variables."
The proposal from Doggett and Upton doesn't go far enough for some legal experts who say Congress must provide a more convenient path for people claiming injury from Covid vaccines.
"The bill is a good step forward, and I laud them," said Katharine Van Tassel, a visiting professor at the Case Western Reserve School of Law who has called for more aggressive reforms. "But all they're doing is putting a Band-Aid on a huge, huge problem."
The system for addressing Covid vaccine complaints stems from the Prep Act, a 2005 law that provides liability protections to frontline industries fighting health crises. The law tasks HHS' Health Resources and Services Administration with adjudicating claims filed against drugs, vaccines and other measures authorized under emergency powers.
Critics call that process murky at best. Compared to VICP, plaintiffs must meet a higher burden of proof. Their medical damages are limited to direct costs their insurance won't cover, and benefits paid out for loss of income due to injury are capped at $50,000 per year.
Before the coronavirus pandemic, the fund had paid out just 29 claims, or less than 10 percent of all those filed. Most of these claims stemmed from the nerve disorder Guillain Barrè Syndrome, linked in rare cases to the vaccines authorized against the 2009 swine flu pandemic. One involved a death allegedly related to a small pox vaccine, according to agency data viewed by POLITICO.
But Covid is a much bigger test of the system. Some 175 million Americans have received at least their first dose six months into the nation's vaccination campaign.
As of June 1, there were nearly 870 coronavirus-related claims seeking compensation from HRSA's Countermeasures Injury Compensation Program. It's unclear how many of those claims are linked to Covid shots. The rest are related to other countermeasures receiving Prep Act liability protections, including ventilators.
But earlier HRSA data reviewed by POLITICO showed vaccines made up almost one-quarter of claims. As of April 26, there were 455 claims pending at HRSA, with over 100 stemming from Covid vaccines, citing side effects such as heart inflammation, blood clots, seizures, abnormal swelling, Guillain Barre Syndrome and sore arms.
HRSA doesn't disclose much about how it processes these complaints. An agency spokesperson said the program "retains medical experts to review the claims" and that the time it takes to resolve them is "highly variable." Most come without the necessary medical records, which is often the biggest source of delay in resolving complaints, the spokesperson said. Plaintiffs have one year to file a complaint from the time of alleged injury.
Peter Meyers, a professor emeritus at George Washington University's law school, where he previously headed a vaccine injury litigation clinic, said he believed Congress should be "bolder" and "immediately transfer" pending Covid-19 vaccine claims to VICP.
However, Heidi Li Feldman, a professor of tort law at Georgetown University, said the legislation from Doggett and Upton ultimately took a measured approach that could build public confidence in the safety of Covid vaccines.
"It's normalizing the Covid vaccine, which makes sense to do because it is likely to become a regular feature of our health care environment," she said.