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Massie Proposes to Make COVID Vaccine Makers Liable for Injuries, Opening Door for Thousands of Lawsuits

By Michael Nevradakis, Ph.D. | The Defender | July 16, 2025

Rep. Thomas Massie (R-Ky.) on Tuesday introduced legislation to repeal the “sweeping” liability shield that exempts COVID-19 vaccine manufacturers from responsibility for serious injuries or death caused by their products.

The liability protection amounts to “medical malpractice martial law,” Massie said in a press release.

The PREP Repeal Act (H.R.4388) would revoke the Public Readiness and Emergency Preparedness (PREP) Act of 2005, a law that provides legal immunity to “covered persons” who manufacture or administer countermeasures during a public health emergency.

“Covered persons” under the PREP Act include vaccine makers, manufacturers of masks and other personal protective equipment, and physicians, nurses and pharmacists who administer vaccines.

The Biden administration ended the COVID-19 public health emergency in May 2023. However, the public health emergency, declared in January 2020 by the U.S. Department of Health and Human Services (HHS) under the PREP Act, remains in effect.

In December 2024, HHS extended the liability protections through 2029. It was the 12th extension since 2020.

Massie’s bill would strip away these protections, repealing the PREP Act’s liability shield and restoring civil remedy rights for people harmed by products covered under the act.

“Τhe ability of citizens to seek redress for injury or harm is a fundamental principle of justice and due process,” the bill states, adding that the PREP Act’s liability shield has “undermined public trust and accountability” and “enabled regulatory capture.”

“The 2005 PREP Act prevents people from holding corporations accountable for the pain and suffering they cause during Presidentially declared emergencies. Americans deserve the right to seek justice when injured by government-mandated products. The PREP Repeal Act will restore that right,” Massie said in the press release.

In an interview today on the “Brian Thomas Morning Show,” Massie said the bill would apply to all COVID-19-related countermeasures, not just vaccines.

“If somebody made a mask that had cancer particles on it, and you inhaled those … too bad, they’re covered by the PREP Act,” Massie said. “I don’t like lawsuits, but they do keep corporations sort of in check. There’s this incentive not to harm people if you’re going to have to pay for it, if it becomes unprofitable.”

Attorney Ray Flores, senior outside counsel for Children’s Health Defense and an expert on the PREP Act, said:

“The ‘sweeping liability protections’ extend far beyond manufacturer shields to condone every conceivable medical atrocity. If Massie’s bill passes, the pandemic assembly line would be dismantled. It would be goodbye liability protections, goodbye mandates and goodbye mass-human experimentation.”

According to Flores, repeal of the PREP Act would also end other current public health emergencies, including mpox (monkeypox), pandemic influenza, anthrax and Zika.

Dr. Meryl Nass, founder of Door to Freedom, said the bill “will stop another COVID vaccine fiasco and also stop the widespread use of unproven tests such as the COVID-19 PCR tests, which were also issued under emergency use authorizations (EUA).”

Wayne Rohde, author of “The Vaccine Court: The Dark Truth of America’s Vaccine Injury Compensation Program” and “The Vaccine Court 2.0,” said the bill contains “nonspecific language” and gaps that require attention. Rohde said this includes:

“How to wind down the Act, address all of the amendments added to the Act over the last 4 years, covered persons, how to handle the covered countermeasures such as medical devices, medications, drugs and personal protective equipment, and, of course, the elephant in the room, the vaccines used and their future legal liability.”

Legislation would open the door to thousands of lawsuits previously blocked by PREP Act

Massie’s proposed legislation would apply to all current and future lawsuits challenging the PREP Act, including pending appeals.

Attorney Rick Jaffe said the proposed legislation is retroactive to March 10, 2020, “reopening the courthouse doors to thousands of injured individuals whose claims were previously blocked by PREP’s sweeping liability shield.”

The legislation would allow claimants to sue COVID-19 vaccine makers directly, Jaffe said:

“The bill, if passed, allows people injured by the COVID shots to sue, presumably, the manufacturers as well as those who administered the shots, and that would be a big and much unwanted thing from the perspective of the manufacturers and pharmacy chains which administered the shots.”

Massie told Brian Thomas he believes the PREP Act is unconstitutional, as it preempts state medical malpractice laws.

“Here’s why I call the PREP Act medical malpractice martial law,” Massie said. “It’s a federal law that says none of the state laws apply, and I think it’s a violation of the 10th Amendment. There’s nowhere in the Constitution that lets the federal government say that all state laws dealing with liability are null and void.”

Most, but not all, courts have so far sided against vaccine injury lawsuits challenging the PREP Act’s liability shield.

In March, the Maine Supreme Judicial Court upheld a lower court ruling that school medical staff who gave a COVID-19 vaccine to a minor without obtaining parental consent cannot be held liable under the PREP Act.

The Maine ruling came one week after the U.S. Supreme Court refused to review a lower court’s ruling in a similar lawsuit in Vermont. In that case, a school administered a COVID-19 vaccine to a 6-year-old boy despite his and his parents’ objections. Last year, the Vermont Supreme Court ruled that the PREP Act shielded school officials from liability.

At least two recent lawsuits challenging the PREP Act have cleared initial judicial hurdles but remain pending.

In March, the Supreme Court of North Carolina ruled that a lawsuit filed by the mother of a 14-year-old boy given a COVID-19 vaccine at school without consent can proceed. The court ruled the PREP Act does not preempt state law requiring parental consent for vaccination.

In November 2024, a federal court ruled that a lawsuit filed by a woman injured by AstraZeneca’s COVID-19 vaccine during a U.S. clinical trial can continue.

According to the complaint, AstraZeneca’s consent form for trial participants promised enrollees medical treatment in the event of illness or injury suffered during the study. The court rejected the drugmaker’s claim that a federal liability shield protects it from breach-of-contract claims.

Bill would end ‘dismal’ PREP Act vaccine injury compensation program

Massie’s proposed bill also rescinds unused federal funds earmarked for injury claims under the PREP Act.

Such claims are heard by the Countermeasures Injury Compensation Program (CICP), a government-run COVID-19 vaccine injury compensation program established under the PREP Act.

CICP has faced criticism for its slow pace of resolving claims and the limited compensation it offers.

Jaffe said:

“The PREP Act created a legal black hole where traditional tort rights and due process protections disappeared, replaced by a virtually unreviewable administrative compensation program — the CICP — that has denied nearly every COVID-related claim. In effect, Americans injured by federally endorsed products were stripped of their constitutional right to seek redress. This bill restores that right.”

According to the most recent CICP data, of the 13,836 claims related to COVID-19 countermeasures filed to date, 75 were found eligible for compensation. As of June 1, 39 of those have been compensated. The overwhelming majority of claims were denied (4,338) or are “pending review or in review” (9,423).

Dr. Joel Wallskog, an orthopedic surgeon injured by COVID-19 vaccines and co-chair of React19, an organization advocating on behalf of vaccine-injury victims, said CICP strips claimants of their constitutional rights to due process and a jury trial.

“The CICP program was intended to be the safety net for those Americans injured by the emergency countermeasures, such as the COVID-19 shots. However, the program is a dismal failure with over a 98% denial rate,” Wallskog said.

If the proposed legislation passes, Flores said, the most likely outcome would be attempting to move COVID-19 injuries into the National Vaccine Injury Compensation Program (VICP), which covers injuries from vaccines routinely administered to children and pregnant women.

However, such a move may face obstacles, including complications regarding how to handle claims pending before the CICP.

Rohde said:

“Money obligated for current operations would not be affected [but] how do you determine the monetary need for pending CICP petitions? How to handle the CICP petitions already received and what about the future claims? Do you move all the CICP vaccine petitions into the VICP? That creates all sorts of new problems.”

In May, the Centers for Disease Control and Prevention (CDC) changed its recommendations on COVID-19 vaccines for healthy children. The CDC now recommends that parents of healthy children consult their pediatricians and together make decide whether to vaccinate against the virus.

According to Flores, “Now that these injections are not on the routine recommended schedule for healthy children and pregnant women, they wouldn’t qualify” for compensation from the VICP.

‘It will probably only pass if Americans get behind it in a big way’

Massie’s proposed legislation is similar to a bill introduced last year that would allow Americans to sue the manufacturers of COVID-19 vaccines for vaccine-related adverse events, including deaths, by removing the vaccine makers’ liability shield.

The Let Injured Americans Be Legally Empowered Act, or the LIABLE Act (H.R.7551), has since languished in the U.S. House of Representatives.

Wallskog said Massie’s bill faces “an uphill battle to make it to the Congressional floor and get to a vote.”

Flores was less optimistic about the bill’s future because it would allow claimants to sue COVID-19 vaccine manufacturers directly.

“The bill, in theory, is just what we need. However, implementing it would cause utter chaos,” Flores said. “Absent a miracle, the prospects [of passage] are slim to none.”

Nass said public awareness and support are crucial for the bill’s success.

“It will probably only pass if Americans get behind it in a big way,” Nass said.

Wallskog said if the legislation is passed, it would be more far-reaching than a declaration by Health Secretary Robert F. Kennedy Jr. removing COVID-19 countermeasures from the PREP Act.

“Executive orders can simply be reversed by the next HHS secretary. Legislative change is much more powerful with more staying power,” Wallskog said.

This has not occurred to date, which Flores said is “the greatest indication of the forces that Kennedy and Rep. Massie are up against.”

Related articles in The Defender

• COVID Vaccine Makers Get Another Free Pass as Biden Administration Extends Liability Shield Through 2029
• Exclusive: Public Health Emergency in U.S. Set to Expire May 11 — But EUA Vaccines, Liability Shields Aren’t Going Away Anytime Soon
• Nearly 10,000 Claims Pending as COVID Vaccine Injury Compensation Program Faces Possible Budget Cut
• New Law Would Make COVID Vaccine Makers Liable for Injuries, Deaths
• Liability-Free COVID Vaccine Makers Seek Additional ‘Free Pass’ From FDA

This article was originally published by The Defender — Children’s Health Defense’s News & Views Website under Creative Commons license CC BY-NC-ND 4.0. Please consider subscribing to The Defender or donating to Children’s Health Defense.

July 16, 2025 - Posted by aletho | Civil Liberties | COVID-19 Vaccine, Human rights, PREP Act