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Tuesday, July 22, 2025

Thomas Massie’s new invoice would let folks sue pharma for COVID vaccine accidents


A number of years after the COVID-19 vaccine’s rollout, the one federal program that gives compensation for COVID vaccine accidents continues to course of claims at a snail’s tempo whereas rejecting most of these claims that it does resolve.

As of June 1, solely 39 folks have acquired compensation from the Countermeasures Damage Compensation Program (CICP) for a COVID-19 vaccine damage. It has rejected one other 4,338 claims. Some 9,423 individuals are nonetheless ready for the federal authorities to even assessment their case.

The lengthy wait occasions and excessive rejection charges have prompted some lawmakers to suggest repealing the legal responsibility protections created by the Public Readiness and Emergency Preparedness (PREP) Act, which prevents folks from suing COVID vaccine makers in state courts and leaves them depending on the CICP as the one doable supply of compensation.

That features Rep. Thomas Massie (R–Ky.), who launched a invoice final week to repeal the legal responsibility shields within the PREP Act.

“The PREP Act is medical malpractice martial regulation,” mentioned Massie in a press launch. “Individuals deserve the appropriate to hunt justice when injured by government-mandated merchandise.”

Handed as a part of a protection spending invoice in 2005, the PREP Act was supposed to shore up firms’ willingness to provide novel “countermeasures” within the wake of a public well being emergency like a pandemic or bioterror assault by shielding them from civil fits.

The regulation permits the Well being and Human Companies Secretary (HHS) to challenge blanket legal responsibility waivers to countermeasures produced in response to a public well being emergency. Individuals injured from a coated countermeasure can pursue compensation by the CICP, however they can not sue in state court docket.

In February 2020, then-HHS Secretary Alex Azar invoked the PREP Act’s legal responsibility defend for COVID-19 countermeasures, which coated then-yet-to-be-invented vaccines, masks, exams, and extra.

Massie’s PREP Repeal Act would finish these legal responsibility protections, thus opening up vaccine makers to non-public damage lawsuits in state courts.

Advocates for the vaccine injured say any consideration to their plight is welcome.

“Any time a lawmaker has the braveness to not solely acknowledge this constitutional injustice, but in addition to proactively try to proper the mistaken is a vital step for our injured group,” says Christopher Dreisbach, the authorized affairs director for React19, a bunch representing the COVID vaccine injured.

However, Dreisbach says that Massie’s invoice would provide little aid to many individuals who suffered a COVID-vaccine damage throughout the primary vaccination drive in 2021 as a result of state statutes of limitations on private damage lawsuits are sometimes two to a few years.

Had been federal legal responsibility protections on COVID vaccine makers lifted, individuals who’d suffered a vaccine damage in 2021 seemingly can be prevented from suing in 2025.

Even when they weren’t, state civil litigation is a protracted, unsure course of, says Renée Gentry, director of the Vaccine Damage Litigation Clinic at George Washington College.

“It isn’t straightforward to sue producers. In the event you assume the federal authorities is difficult to go up in opposition to, attempt going up in opposition to Merck,” she says.

It is inherently troublesome to show causation in medical settings, says Gentry, notably in civil litigation the place it’s important to present fault. Underneath the Supreme Court docket’s Daubert check, vaccine-injured people may very well be prevented from introducing sure sorts of scientific proof in any civil trial, she provides.

Gentry predicts that vaccine makers would additionally file their very own lawsuits in opposition to any regulation that permits folks to sue over vaccine accidents that occurred whereas vaccines had been coated by federal legal responsibility protections.

For these causes, Gentry and different vaccine damage advocates have proposed shifting COVID vaccine accidents into the opposite federal vaccine damage program that covers most non-COVID vaccines.

This program, the Nationwide Vaccine Damage Compensation Program (VICP), permits folks to file petitions in federal claims court docket in search of compensation from the federal government for a vaccine damage.

To obtain compensation, the petitioner want solely present “that it’s extra seemingly than not” {that a} vaccine triggered their damage.

Ought to the federal government problem their petition, a particular grasp, performing as decide, oversees the case and decides if compensation is due. Petitioners have a proper to an legal professional in these proceedings. If their declare is rejected, they will enchantment to the next court docket and even petition the U.S. Supreme Court docket to listen to their case.

Compensation is in the end paid for by vaccine makers through an excise tax on particular person vaccine doses.

This quasi-judicial course of is way totally different, and way more favorable to the vaccine damage claimants, than the CICP.

Underneath CICP, claimants file a declare with the Well being Sources and Companies Administration (HRSA) inside HHS, which decides whether or not or to not grant compensation.

As a result of this can be a purely administrative course of, claimants haven’t any proper to an legal professional and no proper to have their declare reviewed by a impartial third social gathering. Whereas they will request a reconsideration of a denied declare, they haven’t any proper to file a authorized enchantment.

The usual of proof for a CICP declare can also be far larger. Claimants have to point out “compelling, dependable, legitimate, medical, and scientific proof” that their damage was the results of a coated countermeasure.

The VICP compensates about 70 p.c of claims and has paid out $778 million from fiscal 12 months 2021 by right this moment.

That compares to the CICP, which has paid out solely $3 million in compensation to simply 39 folks—$2.5 million of which went to a single claimant. The everyday CICP compensation award is a number of thousand {dollars}. About 98 p.c of CICP claims which have been determined have been rejected.

HHS Secretary Robert F. Kennedy Jr. has proposed shifting COVID-19 damage claimants into the VICP program, however doing so would seemingly require Congress to approve an excise tax on COVID vaccine doses.

A number of payments have been launched in Congress to widen the VICP to incorporate COVID-19 damage claims or in any other case reform the CICP to perform extra just like the VICP. None have gone anyplace.

Within the difficult world of vaccine damage advocacy, most of the critics of the CICP are additionally essential of the VICP, which additionally supplies pharmaceutical firms with legal responsibility protections.

A invoice launched by Rep. Paul Gosar (R–Ariz.) within the final Congress would have repealed the legal responsibility protections in each the VICP and the CICP.

“Sadly, the 2 divergent approaches have come to characterize not only a strategic distinction, but in addition a political stalemate, leaving the sick and struggling with worn partisan speaking factors, fairly than outcomes,” wrote Dreisbach in an essay for the Brownstone Institute in January.

The vaccine-injured have additionally filed a number of federal lawsuits difficult the constitutionality of the CICP. Each allege that this system violates the vaccine-injured’s proper to a trial by jury by eliminating their capability to sue with out providing an inexpensive various to litigation.

Within the waning days of the Biden administration, then-HHS Secretary Xavier Becerra prolonged PREP Act legal responsibility protections for COVID vaccine accidents by December 2029.

As long as that declaration is in impact, folks claiming a COVID vaccine damage are caught with the CICP as their solely technique of compensation. Absent reform, that successfully means they haven’t any technique of compensation in any respect.

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