Thomas Massie's New Bill Would Let People Sue Pharma for COVID Vaccine Injuries
Federal liability protections currently prevent people suing COVID-19 vaccine makers, and instead require them to request compensation from a program that's covered only 39 COVID vaccine injury claims.
Several years after the COVID-19 vaccine's rollout, the only federal program that provides compensation for COVID vaccine injuries continues to process claims at a snail's pace while rejecting most of those claims that it does decide.
As of June 1, only 39 people have received compensation from the Countermeasures Injury Compensation Program (CICP) for a COVID-19 vaccine injury. It has rejected another 4,338 claims. Some 9,423 people are still waiting for the federal government to even review their case.
The long wait times and high rejection rates have prompted some lawmakers to propose repealing the liability protections created by the Public Readiness and Emergency Preparedness (PREP) Act, which prevents people from suing COVID vaccine makers in state courts and leaves them dependent on the CICP as the only possible source of compensation.
That includes Rep. Thomas Massie (R–Ky.), who introduced a bill last week to repeal the liability shields in the PREP Act.
"The PREP Act is medical malpractice martial law," said Massie in a press release. "Americans deserve the right to seek justice when injured by government-mandated products."
Passed as part of a defense spending bill in 2005, the PREP Act was intended to shore up companies' willingness to produce novel "countermeasures" in the wake of a public health emergency like a pandemic or bioterror attack by shielding them from civil suits.
The law allows the Health and Human Services Secretary (HHS) to issue blanket liability waivers to countermeasures produced in response to a public health emergency. People injured from a covered countermeasure can pursue compensation through the CICP, but they can't sue in state court.
In February 2020, then-HHS Secretary Alex Azar invoked the PREP Act's liability shield for COVID-19 countermeasures, which covered then-yet-to-be-invented vaccines, masks, tests, and more.
Massie's PREP Repeal Act would end those liability protections, thus opening up vaccine makers to personal injury lawsuits in state courts.
Advocates for the vaccine injured say any attention to their plight is welcome.
"Any time a lawmaker has the courage to not only acknowledge this constitutional injustice, but also to proactively attempt to right the wrong is an important step for our injured community," says Christopher Dreisbach, the legal affairs director for React19, a group representing the COVID vaccine injured.
Nevertheless, Dreisbach says that Massie's bill would offer little relief to many people who suffered a COVID-vaccine injury during the main vaccination drive in 2021 because state statutes of limitations on personal injury lawsuits are typically two to three years.
Were federal liability protections on COVID vaccine makers lifted, people who'd suffered a vaccine injury in 2021 likely would be prevented from suing in 2025.
Even if they weren't, state civil litigation is a long, uncertain process, says Renée Gentry, director of the Vaccine Injury Litigation Clinic at George Washington University.
"It's not easy to sue manufacturers. If you think the federal government is hard to go up against, try going up against Merck," she says.
It's inherently difficult to prove causation in medical settings, says Gentry, particularly in civil litigation where you have to show fault. Under the Supreme Court's Daubert test, vaccine-injured individuals could be prevented from introducing certain types of scientific evidence in any civil trial, she adds.
Gentry predicts that vaccine makers would also file their own lawsuits against any law that allows people to sue over vaccine injuries that occurred while vaccines were covered by federal liability protections.
For these reasons, Gentry and other vaccine injury advocates have proposed shifting COVID vaccine injuries into the other federal vaccine injury program that covers most non-COVID vaccines.
This program, the National Vaccine Injury Compensation Program (VICP), allows people to file petitions in federal claims court seeking compensation from the government for a vaccine injury.
To receive compensation, the petitioner need only show "that it is more likely than not" that a vaccine caused their injury.
Should the government challenge their petition, a special master, acting as judge, oversees the case and decides if compensation is due. Petitioners have a right to an attorney in these proceedings. If their claim is rejected, they can appeal to a higher court and even petition the U.S. Supreme Court to hear their case.
Compensation is ultimately paid for by vaccine makers via an excise tax on individual vaccine doses.
This quasi-judicial process is much different, and much more favorable to the vaccine injury claimants, than the CICP.
Under CICP, claimants file a claim with the Health Resources and Services Administration (HRSA) within HHS, which decides whether or not to grant compensation.
Because this is a purely administrative process, claimants have no right to an attorney and no right to have their claim reviewed by a neutral third party. While they can request a reconsideration of a denied claim, they have no right to file a legal appeal.
The standard of proof for a CICP claim is also far higher. Claimants have to show "compelling, reliable, valid, medical, and scientific evidence" that their injury was the result of a covered countermeasure.
The VICP compensates about 70 percent of claims and has paid out $778 million from fiscal year 2021 through today.
That compares to the CICP, which has paid out only $3 million in compensation to just 39 people—$2.5 million of which went to a single claimant. The typical CICP compensation award is a few thousand dollars. About 98 percent of CICP claims that have been decided have been rejected.
HHS Secretary Robert F. Kennedy Jr. has proposed shifting COVID-19 injury claimants into the VICP program, but doing so would likely require Congress to approve an excise tax on COVID vaccine doses.
Several bills have been introduced in Congress to widen the VICP to include COVID-19 injury claims or otherwise reform the CICP to function more like the VICP. None have gone anywhere.
In the complicated world of vaccine injury advocacy, many of the critics of the CICP are also critical of the VICP, which also provides pharmaceutical companies with liability protections.
A bill introduced by Rep. Paul Gosar (R–Ariz.) in the last Congress would have repealed the liability protections in both the VICP and the CICP.
"Unfortunately, the two divergent approaches have come to represent not just a strategic difference, but also a political stalemate, leaving the sick and suffering with worn partisan talking points, rather than results," wrote Dreisbach in an essay for the Brownstone Institute in January.
The vaccine-injured have also filed several federal lawsuits challenging the constitutionality of the CICP. Both allege that the program violates the vaccine-injured's right to a trial by jury by eliminating their ability to sue without offering a reasonable alternative to litigation.
In the waning days of the Biden administration, then-HHS Secretary Xavier Becerra extended PREP Act liability protections for COVID vaccine injuries through December 2029.
So long as that declaration is in effect, people claiming a COVID vaccine injury are stuck with the CICP as their only means of compensation. Absent reform, that effectively means they have no means of compensation at all.