Imagine waking up one morning during the COVID-19 pandemic, eager to resume life as normal, and you decide to get the COVID-19 injection at your local pharmacy. In the name of “trusting the science,” you follow government guidelines and roll up your sleeve.
But what happens when the vaccine you were told would protect you instead results in life-altering harm? What happens if you are left struggling to walk, talk, or manage basic daily functions?
This isn’t just a hypothetical. For Donna Noto Diaz, it’s a grim reality. After receiving Moderna’s COVID-19 vaccine at a local Safeway pharmacy, she experienced a severe stroke caused by blood clots just five days later. Her once-normal life was shattered, leaving her reliant on her husband, who quit his job to become her full-time caregiver.
In the name of justice, the couple filed a lawsuit against Moderna, alleging strict liability, negligence, and breach of implied warranty. However, they soon found themselves up against an impenetrable barrier: the Public Readiness and Emergency Preparedness (PREP) Act.
A federal court ruled on Sep. 25 that Ms. Diaz could not sue Moderna for her injuries. The PREP Act bars claims against vaccine manufacturers for bodily harm arising from COVID-19 vaccines, Judge Kymberly K. Evanson said in a ruling dismissing the case.
This case is not unique. Thousands who have suffered adverse reactions after receiving a COVID-19 vaccine find themselves in a similar situation, blocked from seeking legal recourse due to the PREP Act. The scope and impact of this legal shield are far-reaching, raising a critical question: How did a law meant to protect public health turn into a tool for shielding pharmaceutical companies from accountability?
The PREP Act Shielded Vaccine Makers and Pushed Financially Driven Treatment Protocols
The PREP Act was passed in 2005 under President George W. Bush in response to concerns over potential bioterrorism and pandemics. The goal was simple: ensure a rapid, unencumbered response to public health emergencies by protecting those involved in developing, manufacturing, and administering medical countermeasures.
Under this law, the U.S. Department of Health and Human Services (HHS) could issue declarations granting sweeping immunity from lawsuits to pharmaceutical companies, hospitals, healthcare professionals, and other entities involved in distributing and administering these countermeasures.
Amid the global COVID-19 pandemic in March 2020, HHS quickly invoked the PREP Act to shield a wide range of COVID-19 countermeasures, including vaccines, treatments like Paxlovid, molnupiravir, and Remdesivir, face masks, diagnostic tests, and medical equipment like ventilators. This move protected pharmacies, hospitals, and healthcare providers, even when administering experimental or risky treatments, from lawsuits related to their use.
However, the PREP Act’s liability shield was only part of the equation. The U.S. government introduced federal financial incentives encouraging hospitals to use specific treatments, often over alternatives that might have been in patients’ best interests. With legal protection and the promise of higher reimbursements, hospitals and healthcare providers were placed in a position where following federally endorsed protocols became financially advantageous—regardless of the potential risks to patients.
Government Financially Incentivized Hospitals to Use Remdesivir
The immunity granted under the PREP Act was only part of the story. To understand how pharmaceutical companies and healthcare institutions were encouraged to adopt risky COVID-19 treatments, we need to look at the financial incentives put in place by the U.S. government.
Take the case of Remdesivir, one of the earliest treatments endorsed for COVID-19 patients. The government, through federal funding mechanisms and Medicare policies, incentivized hospitals to use this drug over potentially safer, less costly alternatives like hydroxychloroquine. Under the Coronavirus Aid, Relief, and Economic Security (CARES) Act, hospitals treating COVID-19 patients received a 20% add-on payment for Medicare patients diagnosed with the virus. This increase in reimbursement created an environment where hospitals were financially motivated to identify more patients as COVID-19 cases and adopt specific treatments, like Remdesivir, as recommended by federal guidelines.
The financial rewards for using Remdesivir didn’t stop there. Once it became one of the FDA-approved treatments for COVID-19, hospitals received increased Medicare payments when administering the drug, despite its known risks, which included kidney problems, liver toxicity, and cardiovascular issues. Legal immunity under the PREP Act ensured that healthcare providers could use this expensive and experimental treatment without fear of lawsuits, even in cases where it was not the most appropriate or safe choice for patients.
Government guidelines and hospital protocols further reinforced Remdesivir’s use, pushing it as the “go-to” treatment in healthcare settings across the country. Hospitals and healthcare providers found themselves in a position where adhering to these federally endorsed treatment plans was not just a matter of following guidelines—it was a lucrative decision. This situation created an alarming scenario where the priority shifted from patient care to financial gain, with patients often left to bear the consequences of these risky, incentivized treatments.
The combination of financial incentives and liability protections provided by the PREP Act encouraged hospitals to prioritize treatments like Remdesivir. This created a scenario where experimental or potentially harmful treatments were prioritized because they were more financially rewarding and legally safe rather than being in the best interest of patients.
Government Financially Incentivized COVID-19 Vaccination
The story of financial incentives didn’t end with treatments like Remdesivir. The U.S. government also introduced measures to encourage the mass administration of COVID-19 vaccines, setting the stage for profit-driven decision-making in healthcare.
Initially, healthcare providers were reimbursed around $28 per dose for administering COVID-19 vaccines. However, the Centers for Medicare & Medicaid Services later increased this rate to $40 per dose. Given that some vaccines, like Pfizer and Moderna, required two doses, providers stood to gain $80 per patient, with additional financial rewards available for administering booster shots. The higher reimbursement rates incentivized healthcare providers to prioritize vaccine administration, promoting a one-size-fits-all approach rather than individualized risk assessments.
Furthermore, the U.S. government purchased vaccines from manufacturers and distributed them to hospitals at no cost, allowing healthcare providers to bill insurance programs or federal agencies for the administration fee. This structure created a financially risk-free environment for promoting vaccines en masse. Hospitals and healthcare providers could, therefore, push for rapid and widespread vaccination efforts without worrying about potential legal consequences, thanks to the protections provided by the PREP Act.
Prioritizing Profits Over Patient Safety
By coupling federal financial incentives with liability protections, the PREP Act created an environment where healthcare providers and hospitals were nudged to follow government-backed treatment protocols, often at the expense of patient care. In the case of Remdesivir, hospitals found themselves financially rewarded for using a drug with known severe side effects while simultaneously being shielded from legal repercussions if patients were harmed.
Similarly, the financial incentives for COVID-19 vaccine administration encouraged rapid and widespread vaccination efforts, regardless of individual patient risk factors—enabling a system where profit-driven healthcare decisions were safeguarded by law, leaving injured patients without recourse and pharmaceutical companies free from accountability.
This raises critical ethical and legal questions: What happens when the priority shifts from patient care to following government-backed protocols for financial gain? And why should companies like Pfizer and Moderna continue to benefit from these protections long after the initial emergency has ended?
A Compensation System That Fails Patients
While the PREP Act provides blanket legal immunity to pharmaceutical companies, hospitals, and healthcare providers, it also established a narrow pathway for compensation through the Countermeasures Injury Compensation Program (CICP). By creating a compensation system that is nearly impossible for most injured individuals to navigate, the federal government further reinforced an environment where pharmaceutical companies are insulated from accountability, and patients are left to fend for themselves.
The PREP Act, designed originally to promote swift responses to public health emergencies, has morphed into a protective shield for pharmaceutical giants like Pfizer and Moderna, enabling them to operate without the typical checks and balances of liability. Meanwhile, the CICP—the sole avenue for those harmed by these countermeasures—offers little hope for justice or support.
The CICP, unlike the National Vaccine Injury Compensation Program, is far less known and much more restrictive. It covers only countermeasures specifically designated under the PREP Act, including COVID-19 vaccines and treatments like Remdesivir. To be compensated by the CICP for a COVID-19 vaccine injury, it must be established, by “compelling, reliable, valid, medical and scientific evidence,” that the vaccine directly caused the injury or death.
Here’s where the imbalance becomes evident:
- Limited Compensation: The CICP only covers specific expenses related to a covered injury, such as unreimbursed medical expenses and lost wages. However, it does not compensate for pain, suffering, or long-term disability, leaving many victims without sufficient support.
- Strict Filing Requirements: Claimants must file their petitions within one year of receiving the countermeasure. Given the ongoing nature of many vaccine injuries, this short window significantly limits the number of individuals who can successfully apply for compensation.
- Lack of Due Process: Unlike traditional court proceedings where claimants have the right to present evidence, call witnesses, and cross-examine the opposing party, the CICP operates as a closed administrative process. Decisions are made solely by personnel within HHS. This raises serious concerns about impartiality and transparency, as the agency in charge of approving compensation is the very one that endorsed and promoted the countermeasures. There is no opportunity for judicial review or an appeals process, which strips injured individuals of the due process rights they would typically have in the court system.
- Low Payout Rate: Since its inception, the CICP has had a history of denying the vast majority of claims. As of Sep. 1, 2024, 13,392 claims have been filed with the CICP alleging injuries from COVID-19 countermeasures. Of those, only 3,260 have received decisions, while 10,132 are pending review. Of the 3,260 decisions, only 58 claims were deemed eligible for compensation. Of the 58 claims, only 16 have received compensation. This starkly contrasts with the PREP Act’s broad liability shields for manufacturers and healthcare providers, leaving injured patients with little recourse.
According to the most recent data from the Vaccine Adverse Reporting System, the primary government-funded system for reporting adverse vaccine reactions in the U.S., there have been 1,646,001 reported injuries following COVID-19 vaccination, including 37,390 deaths reported as of Aug. 30. The low number of applicants to the CICP fund for injuries or death from COVID-19 vaccines suggests people don’t know the program exists.
This situation paints a stark picture of the imbalance between corporate protections and patient rights. While companies benefit from federal immunity and financial incentives, patients bear the full brunt of potential adverse effects with virtually no recourse. The government’s dual strategy of protecting pharmaceutical companies while creating insurmountable hurdles for the injured has not only prioritized profits over safety but has also eroded public trust in healthcare systems and governmental oversight.
The Urgent Need for Reform
To restore balance, there needs to be an urgent reevaluation of the PREP Act’s scope and the circumstances under which its protections are granted. One potential approach is to completely remove liability protections for pharmaceutical companies, putting them on the same footing as manufacturers of other drugs and treatments. By holding vaccine makers and pharmaceutical companies accountable in the same way as other drug manufacturers, it would incentivize higher standards of safety, transparency, and ethical practices.
Patients injured by these products would then have access to the full range of safeguards offered by the U.S. legal system, including the courts, ensuring they receive a fair chance at justice and compensation.
If any protections are to remain, they must be accompanied by robust, accessible compensation mechanisms for those harmed. The CICP requires a complete overhaul—extending the filing period, expanding the types of compensation available, and providing an appeals process for rejected claims. Additionally, a transparent system that allows for independent review of adverse events would introduce the accountability currently missing in this equation.
Furthermore, since the emergency has officially ended, pharmaceutical companies should no longer enjoy carte blanche immunity under the PREP Act. Once the emergency is over, normal regulatory and legal standards should apply, ensuring companies can be held accountable for their products. This change would prevent pharmaceutical companies from operating without oversight or consequence long after the circumstances that initially warranted their protections have passed.
In the end, the priority must shift back to patient care and informed consent. Public health measures should not come at the expense of individual rights and well-being. Only with these changes can we begin to rebuild a healthcare system that places patients, not financial interests, at its core.
