PREP Repeal Act Ends Legal Immunity for Drug Makers in Health Crises, Restoring Right to Sue

The “PREP Repeal Act” is straightforward: it completely scraps the legal immunity shields that pharmaceutical and medical device manufacturers currently enjoy during public health emergencies. Specifically, it repeals Section 319F-3 and Section 319F-4 of the Public Health Service Act, which previously protected companies from lawsuits related to countermeasures—like drugs, vaccines, or devices—developed and deployed during a crisis. The core purpose here, according to the bill’s findings, is to restore public trust and accountability by ensuring that individuals harmed by these products have their day in court, just like they would under normal circumstances.

Who’s Accountable Now: The End of the Liability Shield

Think of the liability shield as a giant insurance policy paid for by the government. When a health emergency hits, these sections basically told drug makers, “Go fast, make the product, and don’t worry about getting sued if something goes wrong.” This bill rips that policy up. Section 3 completely removes these liability protections for products defined as drugs, devices, biological products, or covered countermeasures, meaning manufacturers are now fully exposed to civil lawsuits if their products cause injury. This means if you are injured by a product related to a future public health emergency, you won’t be blocked from seeking compensation under federal or state law, a right explicitly preserved under Section 4.

The Trade-Off: Accountability vs. Speed

For the average person, this sounds like a win for consumer protection. If a vaccine or treatment causes harm, the company that made it can be held financially responsible. This is a huge shift, making manufacturers think twice about cutting corners during development. However, there’s a real-world tension here. The original immunity was put in place to incentivize companies to pivot quickly and produce necessary countermeasures during a crisis, knowing that the risk of mass litigation was mitigated. By removing this protection, the bill raises a crucial question: Will manufacturers be less willing to step up and produce emergency products quickly if they face massive liability risk? The bill is clear that any new legal actions filed after the law is signed will fall under these new rules (Section 5), but the long-term impact could be slower production or higher prices as companies factor in increased legal exposure.

Cleaning Up the Books

Beyond the liability changes, the bill also handles the financial side. Since Section 319F-4 is being repealed, the law also requires that any unspent money sitting in the “Covered Countermeasure Process Fund” be taken back by the government (Section 3(b)). This fund was designed to help manage the compensation process under the old system. Now that the liability process is shifting back to traditional civil courts, the fund is deemed unnecessary, and the remaining balances are rescinded. Finally, the bill includes a technical safeguard (Section 6) called “severability,” which means if a court decides one part of this law is invalid, the rest of the law—especially the parts restoring your right to sue—will remain in effect.