In every other corner of the law, the person who sells a product carries the burden of showing it is safe. A carmaker answers for its brakes. A builder answers for the cladding. A food company answers for what is in the tin.

During the pandemic, Australia reversed that burden for one product. Governments mandated it as a condition of work, the Commonwealth agreed to stand behind its makers, and the citizen who doubted it, refused it or was injured by it was left to prove the case against it.

That is an impossible task.

On 1 October 2026, the State of Florida tried to put the burden back where it belongs.

Florida’s case in plain English

Florida’s Attorney General, James Uthmeier, has sued Pfizer Inc. and its chief executive, Albert Bourla, in the Circuit Court for St. Lucie County. He sues under the Florida Deceptive and Unfair Trade Practices Act, the same law used against a dealer who winds back an odometer.

The allegation is simple. Florida says Pfizer told the public the vaccine was safe and would protect others, while holding information that pointed the other way. The complaint alleges Pfizer knew of a heart-inflammation signal in males under 18. It alleges the company’s own database held 158,893 adverse events from 42,086 case reports by 28 February 2021. It alleges Pfizer never tested whether the vaccine stopped transmission. In January 2023, Mr Bourla said Pfizer had seen ‘not a single [safety] signal’.

Florida seeks penalties of US$10,000 for each violation, the return of profits and an order stopping the conduct.

These are allegations. A court will decide.

What matters for Australians is not the outcome. It is the route Florida had to take to get there.

Who carried the burden?

Trace the burden through the pandemic and it lands, every time, on the citizen.

The worker. Public health orders made vaccination a condition of employment for health workers, teachers, aged care staff and others. The worker did not choose the product, could not read the supply contract, and could not know who would pay if it went wrong. The choice offered was the injection or the loss of a livelihood.

The challenger. Those who went to court carried the burden of proving the orders unlawful, and the Court would examine legality alone. In Kassam v Hazzard [2021] NSWSC 1320, Beech-Jones CJ at CL said at paragraph 7 that it was not the Court’s function to determine ‘the effectiveness of Covid vaccines’. That was a matter for the Minister. At paragraph 144 he went further: the fact there is ‘genuine scope for debate’ was ‘virtually determinative’ that the Minister had not acted unreasonably. Under that test, the State’s evidence need only be arguable. The citizen’s must be overwhelming.

Yet when the experts disagreed, the Court chose between them. It found the State’s vaccinologist, Professor Kristine Macartney, ‘an extremely impressive witness’ and accepted her evidence wherever the plaintiffs’ experts differed from it (paragraph 145). Her evidence on effectiveness then carried the finding that the orders were lawful (paragraphs 192 and 240). The inquiry the Court said it would not undertake decided the case, on the State’s evidence.

The asymmetry runs deeper. Professor Macartney had not treated Covid patients; the judgment records her explanation that her hospital split its infectious disease specialists into Covid and non-Covid teams (paragraph 145). Dr Brian Tyson, called by the plaintiffs, said he had treated almost 6,000 (paragraph 152). Part of his report was ruled inadmissible and the rest discounted (paragraphs 152 and 156). Professor Jay Bhattacharya of Stanford, whom the Court called a ‘well-regarded expert in his field’, was given little weight (paragraphs 174 to 179). None of the plaintiffs’ experts was cross-examined (paragraph 139).

The gaps were on the record at the time. The State’s own expert accepted that vaccination ‘does not provide absolute protection against infection or transmission to others’ (paragraph 185). Studies of transmission of the Delta variant itself were ‘not yet available’ (paragraph 184). Professor Bhattacharya’s evidence was that protection against infection was gone after five months (paragraph 173). The Court answered that the orders lasted only 90 days (paragraph 177).

Then there is consent. The Court accepted that the orders might have ‘even a coercive effect’ on vaccination (paragraph 59). It still held that consent given to avoid a general prohibition on movement is not vitiated (paragraph 63). In law, informed consent survived the mandates. In substance, it was a choice between the needle and the job.

The word ‘precautionary’ appears nowhere in the 297 paragraphs of the judgment. Precaution was applied to the virus. It was never applied to the product.

The plaintiffs’ expert put Israeli data before the Court. A cohort study found that vaccinated people were 13 times more likely to catch the Delta variant than people with natural immunity. The State’s expert answered that it ‘had not been peer reviewed’ [187]. It has been since. Clinical Infectious Diseases published it in 2022 with the same 13-fold figure. The Court said peer review would not have mattered, because the study compared the vaccinated with the previously infected, not with the unvaccinated [188]. Yet for a worker who had already recovered from Covid and was told to vaccinate or lose the job, that comparison was the whole question. In a pandemic, real-time data is never peer reviewed when it matters. It is peer reviewed when it is too late to act on it.

The British data cut the same way. A large UK household study, put to the State’s expert in cross-examination, found that vaccinated people who caught Delta carried a similar peak viral burden to the unvaccinated [186]. The Court read the study as undermining the plaintiffs’ expert, because the same research found vaccination protected about as well as prior infection [187]. But the viral-burden finding was the one the mandate could not answer: a vaccinated worker who caught Delta could carry as much virus as an unvaccinated one.

The State never had to prove its orders necessary. The citizen had to prove that no reasonable Minister could have made them, before a court that declined the scientific contest and then resolved it for the State. I acted in those cases.

The injured. A person harmed by the vaccine had to prove, on the balance of probabilities, that this injection caused this injury. Causation of that kind is hard in any medical case. It is harder still when the adverse-event data sits in a company’s files, the supply contracts are confidential and the regulator is the agency that approved the product, an agency that recovers about 92 per cent of its costs from the industry it regulates.

At no point was the maker required to prove anything to the person it was mandated upon. The proof ran one way: from the citizen, upwards.

What the record shows

The government’s own records show what the injured are up against.

By 31 December 2025, the Therapeutic Goods Administration held 1,052 adverse event reports with a fatal outcome after Covid vaccination in Australia. Nine of those reports concerned children under 18. The TGA has assessed 14 deaths as linked to vaccination, 13 after AstraZeneca, and one from myocarditis after a Moderna booster. It has not found a causal link in any of the children’s cases. Those figures come from the TGA’s own Senate Estimates brief.

A report is not proof. The TGA is right to say so, and so must we. But a report is also not the whole picture, because most adverse reactions are never reported at all. A systematic review in Drug Safety, drawing on 37 studies across 12 countries, put the median rate of under-reporting to spontaneous reporting systems at 94 per cent. Even for serious reactions to specific drugs, the median was 85 per cent.

Under-reported data still told the truth early. Myocarditis after mRNA vaccination first surfaced as a signal in passive reports: Israel’s adverse-event monitoring and the American VAERS system. Peer review confirmed it within months, in the New England Journal of Medicine in late 2021 and in JAMA in January 2022. By the time of Kassam, the State’s own expert accepted the risk, most common in young males after the second dose [167]. A single VAERS report proves nothing, and the CDC says so. A pattern of reports is how every safety signal begins.

So the citizen who must prove injury starts from a database that captures a fraction of events, assessed by the regulator that approved the product, under contracts no one may read.

The official advice has moved since the mandates. On 7 September 2026, the Australian Technical Advisory Group on Immunisation published its recommendations for the vaccine’s move to the National Immunisation Program from 1 October 2026. For healthy children aged six months to 17 years, the advice is two words: ‘Not recommended’. Free doses now go to older Australians and to people at higher risk.

The product once pressed on whole workforces is no longer recommended for healthy children. The people injured under the old advice are still waiting for a remedy.

The one product

No other product in Australian history carried this combination at once: a mandate imposed by the State, provisional approval granted at speed, and the Commonwealth standing behind the maker.

The Commonwealth granted indemnities to Covid vaccine manufacturers under ss60 and 110 of the Public Governance, Performance and Accountability Act 2013 (Cth). In plain terms, if a claim succeeds against the maker, the taxpayer can end up paying it. The contracts that set the terms have never been released. Australians were required to take a product whose maker’s liability had been shifted, on terms they are still not allowed to read.

The United States went further. The federal PREP Act bars claims ‘for loss’ against makers of covered pandemic countermeasures, with one narrow exception for wilful misconduct that must be proved by clear and convincing evidence in a single federal court. That shield is the reason Florida did not sue for injury at all.

Florida sued as a consumer regulator instead. Texas tried the same route in 2023. A federal judge dismissed that case on PREP Act immunity.

Think about what that means. To ask a manufacturer whether it told the truth, an American State must first fight its way around a statutory immunity. Then ask which other industry enjoys that protection when its product must be injected into a worker as the price of keeping a job.

The answer is none.

Australia has no door

Florida at least has a door to knock on. Australia does not.

Our consumer law has the same core rule. Section 18 of the Australian Consumer Law prohibits misleading or deceptive conduct in trade. But the manufacturers could not lawfully advertise a prescription-only medicine to the public. Section 42DL of the Therapeutic Goods Act 1989 (Cth) makes that an offence. Subsection (10) carves out any reference ‘authorised or required by a government or government authority’. The rule that bound the maker did not bind the government’s own vaccine advertising, and every message Australians heard about safety and protecting others came from governments.

Governments are hard to reach under that law. It binds the Commonwealth only ‘in so far as it carries on a business’ (s2A of the Competition and Consumer Act 2010 (Cth)), and the courts have held that carrying out a function of government in the community’s interest is not carrying on a business. A public health campaign is unlikely to be actionable under the consumer law.

So the accountability question moves from the boardroom to the Cabinet room, and there the door is locked.

In December 2021, the Senate Select Committee on Covid reported on the Health Minister’s claims of public interest immunity over pandemic documents, including material on the CSL contract and a briefing to National Cabinet. Since 1973 the Senate has required a response within three months. The government answered in September 2026, almost five years later, and said a substantive response ‘is no longer considered appropriate’.

The injured were shown a different door, then watched it close. The Covid Vaccine Claims Scheme demanded a listed condition, a hospital admission and at least $1,000 in losses, and excluded pain, suffering and psychological harm. It stopped taking claims on 30 September 2024. By then, on Services Australia’s own figures, it had received 4,735 claims and paid 396. When I wrote to the Health Minister in July seeking a statutory scheme, the Department replied that the scheme was ‘time-limited’ and ‘ex-gratia’, and that a feasibility study for a future scheme had been ‘progressed’. It has not been published.

A mandate without a remedy is not public health policy. It is risk transferred, by law, from the seller to the citizen.

Put the burden back

The fix does not require anyone to take a side on vaccination. It requires the law to treat this product like every other.

First, any product the State makes compulsory should carry a statutory duty on its maker to disclose its safety data, and on the government to publish the contract terms that shift the maker’s risk to the public. In March 2024, a Senate committee examined a bill to end vaccine-maker indemnities. The majority recommended it not pass, even as its own report recorded that many manufacturers required indemnities as a condition of supply.

Second, a mandate must come with a permanent, no-fault injury scheme funded by those who profit, with no hospital-admission gate and no closing date. A 2026 peer-reviewed review counts 28 national or provincial no-fault schemes. Japan’s, under a 1948 statute, has certified 1,078 Covid vaccine deaths for compensation. Australia closed its scheme to new claims two years ago and has not replaced it.

Third, the burden of proof must follow the mandate. Where the State compels a medical intervention, the State and the maker should bear the onus of showing it was safe for the person compelled, not the reverse.

Florida found a way to ask what Pfizer knew and when. Australians are entitled to ask the same of their own government, and to an answer before the next emergency arrives.

What this shows is that truth is knowledge held back by power.

Hold-the-line!

Tony Nikolic is the Director and Principal Solicitor of Ashley, Francina, Leonard & Associates, Sydney. In his mandate cases, the expert evidence included Professor Jay Bhattacharya, now Director of the US National Institutes of Health.