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In a move that experts said raises legal and constitutional questions, California lawmakers are making an end run around the Centers for Disease Control and Prevention (CDC) by empowering the state to make its own vaccine recommendations.
In September, California Gov. Gavin Newsom signed a law that grants the California Department of Public Health (CDPH) the power to make its own vaccine recommendations.
The new law, Assembly Bill No. 144 (AB 144), also protects healthcare workers and other vaccine providers from being held legally liable if someone is injured by a vaccine recommended by California’s health department, but not universally recommended by the CDC.
In an analysis for the California Globe, attorney Rita Barnett-Rose called California’s liability shield for vaccine providers a “serious problem.”
She pointed out that people injured by vaccines recommended by the CDC can apply for compensation through the National Vaccine Injury Compensation Program (VICP). However, according to Barnett-Rose, the VICP wouldn’t apply in the case of someone injured by a vaccine recommended by California’s health department, but not universally recommended by the CDC.
That would leave the vaccine-injured without a pathway to compensation — because California’s law doesn’t create an alternative avenue for injured families to seek compensation.
“The result is a system in which those who administer state-preferred vaccines are protected from liability, while children injured by those recommendations may be left without access to either federal compensation or traditional state tort remedies,” Barnett-Rose wrote.
California’s law also differs from federal law in that vaccine manufacturers could be held liable for injuries caused by vaccines recommended in California, but not by the CDC.
That’s not the case for CDC-recommended vaccines. The National Childhood Vaccine Injury Act of 1986 granted vaccine makers immunity from liability for most injuries caused by vaccines included on the CDC’s childhood immunization schedule.
VICP and the 1986 act also don’t cover vaccines that are authorized during a public health emergency. The Public Readiness and Emergency Preparedness Act of 2005 (PREP Act) protects the manufacturers of those vaccines, including COVID-19 vaccines, from lawsuits.
Vaccine injury claims under the PREP Act are covered under the Countermeasures Injury Compensation Program (CICP), which is widely regarded as being a more cumbersome program to navigate compared to VICP.
The PREP Act affords a broad liability shield to those administering vaccines, while the 1986 act provides a partial liability shield.
Does AB 144 conflict with federal law?
Lawyers and vaccine injury experts are debating the potential implications of California’s AB 144 and the extent to which it broadens existing federal liability protections.
California attorney Ray Flores, senior outside counsel for Children’s Health Defense, said, “AB 144 doesn’t cover manufacturers. AB 144 only protects vaccine providers. Except for vaccine provider protection, there is no contradiction with VICP.”
Citing the COVID-19 vaccine as an example, Flores said that although federal guidelines no longer recommend the shot for children, California continues to do so. However, since COVID-19 vaccines are still covered under the PREP Act, AB 144 doesn’t confer any additional protections to anyone administering them.
Wayne Rohde, author of “The Vaccine Court: The Dark Truth of America’s Vaccine Injury Compensation Program” and “The Vaccine Court 2.0,” said, “If the vaccines recommended by the state are approved by the U.S. Food and Drug Administration and the CDC recommends the vaccine to children and/or pregnant mothers, there is no conflict with the VICP.”
Barnett-Rose suggested that AB 144 was likely drafted to address concerns by vaccine administrators that they would not be protected from liability for administering vaccines recommended by the CDPH but not by the CDC.
“AB 144 responds to that reluctance not by strengthening the evidence base, but by insulating providers from liability,” Barnett-Rose wrote.
According to Barnett-Rose, this raises “serious” constitutional concerns.
“States may recommend or promote medical interventions, but they may not simultaneously immunize providers from liability and deny injured individuals any realistic opportunity to seek compensation — particularly when state recommendations diverge from evolving federal guidance,” Barnett-Rose wrote.
Barnett-Rose noted that routine adult vaccines, including “travel vaccines, adult-only products like shingles, and vaccines recommended only for limited or special-risk populations,” are not covered under federal liability protections — so people injured by those vaccines still have the right to sue under state law.
If the CDPH recommends any of these vaccines in the future, or recommends vaccines not protected by the PREP Act or included in VICP’s Vaccine Injury Table or the CDC’s childhood immunization schedule, legal questions would arise over what legal recourse, if any, would be available to anyone injured by those vaccines.
“VICP applies only to vaccines listed on the Vaccine Injury Table, which in practice has tracked vaccines recommended by ACIP for routine childhood use and subject to the excise tax,” Barnett-Rose wrote. ACIP — the Advisory Committee on Immunization Practices — advises the CDC on vaccine policy.
According to Barnett-Rose, while California officials “may argue that families could still turn to Vaccine Court” — referring to VICP — such claims are “legally fragile.”
“VICP is not an automatic compensation system; it is an adversarial forum litigated by the Department of Justice,” Barnett-Rose wrote. “Federal attorneys routinely contest eligibility and jurisdiction, particularly when a vaccine is administered outside ACIP’s routine recommendations or intended population.”
“California cannot guarantee continued access to federal compensation,” she wrote. “Due process principles prohibit the state from abolishing long-recognized rights of recovery without preserving some meaningful avenue through which injured individuals may seek compensation,” Barnett-Rose wrote.
A ‘new era of states determining the vaccine schedule for their own state’
Barnett-Rose cited the Hep B (hepatitis B) vaccine as an example. Earlier this month, ACIP voted to stop recommending the Hep B shot for healthy newborns. Last week, the CDC adopted ACIP’s recommendation.
As a result, the newborn dose of the Hep B vaccine “will likely fall outside” VICP, Barnett-Rose wrote.
California announced it will continue recommending the shot to newborns. But federal government attorneys may seek to block vaccine injury claims stemming from Hep B shots administered under California’s recommendations, Barnett-Rose suggested. In this case, those victims and their families would not have any similar recourse under state law.
Other attorneys and experts questioned this interpretation. According to Flores, “AB 144 is essentially symbolic” and makes a political statement that the CDC “is no longer science-based.”
“AB 144 allows a wider range of recommendations in its immunization guidance — but that’s something they’ve always been able to do,” Flores said. “The CDC only recommends. The CDC never mandates. There is no law that says that CDC’s recommendations have any authority. States are free to diverge — just look at Florida.”
According to Rohde, the VICP’s Vaccine Injury Table “is not age specific.” This means that “a Hep B [vaccine] injury that occurs at 1 week of life is no different than an injury that occurred at 4 months of age or 3 years of age.”
“The states have traditionally determined the vaccine schedule based upon the recommendations of the CDC,” Rohde said. “Now, we are entering into a new era of states determining the vaccine schedule for their own state based upon their own recommendations, not the CDC’s.”
AB 144 may face judicial challenges in the future
Barnett-Rose suggested that if the current administration continues to make changes to vaccine recommendations and removes vaccines from the childhood immunization schedule, or begins stripping liability protections from some vaccines, “the legal and constitutional gap created by AB 144 will only widen.”
In September, California and a coalition of other western U.S. states formed the West Coast Health Alliance, which issues its own vaccination recommendations.
Attorney Rick Jaffe stated that this would lead to a situation where courts would have to intervene and resolve the legal questions that would arise.
“Assuming the federal government were to get rid of immunity, I don’t think the law is going to be that a vaccine-injured person’s right to sue the manufacturer — or injector — will depend on which state the person lives in,” Jaffe said.
California attorney Greg Glaser said AB 144 “is absolutely challengeable in both state and federal courts.”
“Potential grounds include constitutional challenges under the Supremacy Clause, and due process violations for denying access to remedies and equal protection issues, since the law creates different classes of vaccine-injured individuals based on state boundaries,” Glaser said.
According to Jaffe, the U.S. Constitution’s Supremacy Clause, under which federal laws preempt state laws, may be implicated in the legal challenges that may follow. Still, this issue is “largely not ripe until the federal government gets rid of immunity.”
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