Florida Senate Advances Bill Allowing Vaccine Manufacturers to Be Sued in State Court

Florida lawmakers are moving legislation that would allow individuals injured by vaccines to sue manufacturers in Florida state courts. The bill passed a Senate committee with a 5-3 vote in January and is advancing through the legislative process.¹ If passed, this legislation would mark a departure from decades of product liability immunity that has largely shielded vaccine manufacturers from civil liability.

The bill, SB 408, allows individuals to bring a civil action against a vaccine manufacturer if the vaccine was publicly advertised in Florida and caused an injury or death.² The legislation defines advertising to include television, radio, print, online marketing, social media, and paid promotions. Communications between physicians and patients are excluded.³

Plaintiffs would be able to recover compensatory damages, attorney fees, and court costs. Claims must be brought within three years of the alleged vaccine injury.⁴

Federal Immunity Has Blocked Access to State Courts Since 1986

Since 1986, vaccine manufacturers marketing vaccines have had partial liability protection from civil lawsuits under the National Childhood Vaccine Injury Act of 1986 (“The Act”). The original Act did not protect doctors administering vaccines from medical malpractice and did not shield drug companies from design defect product liability.

However, in 1987, a congressional amendment was added to the Act removing medical malpractice liability from doctors whose negligence caused a vaccine injury. Then, in 2011, the U.S. Supreme Court majority ignored The Act’s legislative history and, with the encouragement of the pharmaceutical industry, medical trade groups and federal officials, removed design defect product liability from vaccine manufacturers—even when it could be proven the company could have made a vaccine less likely to cause harm.⁵

After 2011, the only option for Americans injured by vaccines was to file a claim in the federal no-fault Vaccine Injury Compensation Program (VICP) that was created under the 1986 Act as an alternative to a lawsuit against vaccine manufacturers. The federal compensation program diverts claims away from state courts and into a federally operated administrative process but limits discovery and restricts any compensation awarded by the U.S. Department of Health and Human Services (DHHS) or a special master in the U.S. Court of Federal Claims.⁶ The current Act’s compensation provisions apply only to federally licensed and recommended vaccines for children, and federally recommended vaccines are routinely mandated by states for children to attend school.⁷

When The Act was passed, it was the first time the government acknowledged that vaccine injuries were real and that the vaccine injured and their families should be entitled to financial support. It affirmed that the prevention of vaccine injuries and deaths should be made a national priority and the law included informing, recording, reporting and research provisions, while allowing children who were injured by federally recommended vaccines to bring their claims to what was promised to be an easier to access, no-fault, expedited, less expensive, less traumatic, more just and predictable federal vaccine injury compensation program. Parents were promised it would be a more predictable and just alternative to suing big drug companies in civil court where they could easily fall prey to legal tactics financed by big insurance companies and the deep pockets of the pharmaceutical industry.

The Act originally preserved the right to sue drug companies and doctors in a court room in the event that federal compensation was denied or insufficient. However, after lobbyists for the pharmaceutical industry and medical trade, together with federal agency officials, managed to remove civil liability and severely restrict vaccine injury compensation by way of congressional amendments, federal agency rule making and the help of the Supreme Court, federal vaccine injury compensation is almost impossible to get today.^{8 9}

State Law vs. Federal Law: Right to Access State Courts

Federal preemption is a legal doctrine that allows federal law to override state law when Congress has expressed an intent to occupy a field or when state law conflicts with federal objectives. Vaccine manufacturers have relied on preemption arguments to block state-law claims by asserting th9t federal vaccine policy, such as The Act, displaces state tort remedies.¹⁰

Courts have held that certain design-defect claims against vaccine manufacturers are preempted when vaccines are licensed and regulated by the federal government. SB 408 is structured to avoid direct conflict by tying liability to advertising conduct by drug companies rather than tying liability to vaccine design defects or federal government vaccine licensing and policy decisions. Relying on Texas as a model, Grall said that the bill won’t be preempted by federal law because it focuses on “advertising conduct that is leading people to have this distrust in the industry and leading to harmful results and causing injuries there is not compensation for.”¹¹

The Florida Constitution guarantees that courts remain open to individuals seeking redress for injury. This protection is known as the “right of access to courts.”¹² It effectively means that the government cannot eliminate a person’s ability to sue for harm without providing a reasonable alternative remedy. In addition, when access to courts is restricted, lawmakers must show that the restriction serves an important public purpose.

SB 408 is structured around this principle by restoring a pathway to civil litigation tied to advertising conduct by a pharmaceutical company. The legislation relies on the premise that individuals harmed by publicly promoted and marketed medical products that can cause harm are entitled to seek relief in state courts from the product’s manufacturer.

Florida Bill Responds to Vaccine Marketing Practices

SB 408 addresses vaccine advertising practices that did not exist when The Act was enacted and direct-to-consumer drug and medical product advertising was prohibited in the U.S. Florida lawmakers noted that vaccine manufacturers now engage in widespread direct to consumer advertising and public messaging campaigns because direct-to-consumer advertising of prescription drugs and other medical products, like vaccines, has been permitted by the U.S. Food and Drug Administration (FDA) since 1997.^{13 14}

During committee debate, Senator Erin Grall stated that the bill is intended to restore balance. Grall said, “We must build back public trust” explaining that Floridians currently lack meaningful legal recourse when vaccine injury occurs.¹⁵

The bill does not restrict physicians from recommending vaccines or discussing risks with patients and parents of minor children receiving vaccines. Vaccine manufacturers must continue to provide educational materials within clinical settings.¹⁶

Senate Regulated Industries Chairwoman Jennifer Bradley said the bill responds to a situation where “people hear ads from pharmaceutical companies claiming their vaccines are safe and incentivizing people to use them and they… have no redress, and they know that.”¹⁷

If enacted, the law would take effect July 1, 2026.¹⁸

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