The law has an essential role in health. Patients injured by defective products deserve compensation. Companies that conceal adverse events, manipulate clinical trials or mislead regulators should face serious consequences. Litigation helped expose the tobacco industry’s deception over smoking and has uncovered genuine misconduct by pharmaceutical and medical-device companies.
But accountability is not the same as lawfare.
Lawfare begins when legal and regulatory procedures are used not primarily to establish the truth or compensate injury, but to impose costs, intimidate researchers, discredit inconvenient evidence or prevent controversial products from reaching the market. The lawsuit does not have to succeed. The process itself—legal fees, discovery demands, reputational attacks and years of uncertainty—can accomplish the objective.
This is becoming a threat to public health. It affects which medical questions are studied, which results are published, which products companies develop and which treatments doctors are willing to recommend. The public sees the lawsuit that was filed. It does not see the medicine, medical device or safer consumer product that was abandoned because the legal and political risks became too great.
From scientific review to litigation strategy
A recent investigation by The Firebreak provides an instructive example. The National Academy of Sciences has removed a climate-science chapter written for the Reference Manual on Scientific Evidence, which helps judges assess expert testimony. The Academy has promised an independent review but has not yet identified the reviewers, explained how they will be chosen or said how much of the underlying record will be released.
The controversy concerns climate science, but the institutional problem applies directly to health. Judges are not epidemiologists, toxicologists or clinical-trial specialists. They understandably rely on reports carrying the authority of institutions such as the National Academies. That authority is valuable precisely because courts assume that authors were selected fairly, conflicts were disclosed, dissenting evidence was considered and peer review was genuinely independent.
The problem became more apparent when the National Academies published its 2026 report on attributing individual extreme-weather events to climate change. According to The Firebreak, a contributor connected with climate litigation discussed the relationship between attribution research and legal action, while his law-firm affiliation was not disclosed in the report. The report was subsequently cited repeatedly in an amicus brief supporting one of those climate cases.
None of this proves that its scientific conclusions are false. Climate change is real, human activity contributes to it, and attribution science has advanced. The point is that when scientific assessments are created in proximity to litigation, the interests of contributors, funders and outside advisers must be disclosed.
If reports intended to influence courts are shaped by people connected to litigation campaigns, their conclusions may acquire legal authority before their assumptions have received adequate scientific challenge.
Health science is especially vulnerable because research findings can produce enormous legal and commercial consequences. A small change in an estimated relative risk can generate thousands of claims. A disputed observational study can be presented to a jury as proof of causation. An institutional consensus report can be treated as though it settled a question that remains contested among specialists.
Litigation-generated medical evidence
Courts require scientific evidence, and there is nothing inherently improper about conducting research that may be used in litigation. Nor is industry-funded research automatically unreliable. Most new medicines and devices could not be developed without commercial funding.
The appropriate questions are whether the methods are sound, the data complete, the conflicts disclosed and contrary findings treated fairly. Yet these standards are increasingly applied asymmetrically.
A researcher who has advised a pharmaceutical or nicotine company may be dismissed as “industry funded,” even when the relationship is openly declared. A researcher supported by a foundation campaigning for litigation or regulation may still be presented as independent. The result is not the removal of interested science from public health. It is the elevation of politically approved interests over commercially disfavored ones.
Litigation then magnifies the distortion. Science asks whether a finding is reproducible across different studies, populations and methods. Courts decide whether a particular party has met a legal standard in an individual dispute. A sympathetic patient, a severe disease and a confident expert witness can be more persuasive to a jury than an explanation of baseline risk, statistical power, confounding and confidence intervals.
Glyphosate illustrates the problem. The US Environmental Protection Agency has concluded that glyphosate is “not likely to be carcinogenic to humans” and that its approved uses do not present human-health risks of concern. The International Agency for Research on Cancer reached a different hazard classification. That disagreement deserves scrutiny, but enormous jury awards can transform an unresolved scientific question into a litigation industry.
A verdict may be justified under the rules of a particular case without establishing a reliable general scientific conclusion. Yet once large awards are available, there are powerful incentives to produce experts, studies and narratives capable of sustaining further claims.
Research risks becoming part of the litigation supply chain.
The consequences for patients
The most damaging effects are often invisible.
Researchers learn which subjects can bring subpoenas, hostile complaints, demands for correspondence or accusations of serving industry. Universities become reluctant to defend scholars working in controversial areas. Doctors become wary of departing from institutional protocols, even when an individual patient might benefit. Manufacturers concentrate on products with sufficient prospective revenues to withstand years of litigation and regulatory delay.
The effect on clinical practice is already recognizable as defensive medicine. In one widely cited survey of high-risk specialists, 93 percent reported practicing defensive medicine. A national survey later found that 91 percent of physicians believed doctors ordered more tests and procedures than necessary to protect themselves against litigation. Estimates of the total cost are disputed, but the behavioral distortion is difficult to deny.
The patient may therefore undergo a test not because the doctor considers it clinically necessary, but because the doctor wants evidence that every possible precaution was taken. This increases costs, exposes patients to unnecessary procedures and shifts medicine away from individual judgment.
The same environment favors large incumbent companies over smaller innovators. A multinational pharmaceutical company can maintain legal and regulatory departments. A start-up developing a new diagnostic tool, drug-delivery system or smoking alternative may be destroyed by the cost of defending even an unsuccessful claim.
Lawfare therefore does not necessarily remove the most dangerous products. It can protect them by making safer alternatives commercially impossible.
Antibiotics and vaccines
Antibiotics demonstrate what happens when weak commercial incentives collide with high development costs. New antibiotics must be used sparingly to preserve their effectiveness, which necessarily limits sales. The World Health Organization has warned that declining investment and insufficient innovation are undermining efforts to combat antimicrobial resistance. It estimates that developing an antibiotic can take 10 to 15 years, with only a small proportion of preclinical candidates ever reaching patients.
Expansive liability is not the principal cause of the broken antibiotic market, but it adds another layer of risk to a field already offering poor prospective returns. Society cannot complain about the absence of new treatments while continually increasing the costs and liabilities associated with producing them.
Vaccines present a related problem. Manufacturers should be accountable for poor production, concealed evidence and demonstrable injury. But if every alleged adverse event can generate open-ended litigation regardless of causal evidence, companies may retreat from vaccine development or demand government protection against liability.
This is not theoretical. The federal government says the National Vaccine Injury Compensation Program was established after lawsuits against manufacturers and health-care providers threatened vaccine shortages and declining vaccination rates. It provides a no-fault alternative to ordinary litigation while retaining compensation for people who suffer qualifying injuries. The associated liability protections are substantial but, as the government explains, not absolute.
That is the sort of balance public health requires: compensation without making production commercially irrational.
Yet accountability must run in both directions. Legal or institutional threats against researchers who identify genuine safety signals can also suppress necessary scrutiny. Lawfare can be used to attack a product, but it can also be used to protect an official position from challenge.
The objective must be accurate benefit-risk assessment—not the unquestioning defense of vaccines and not their destruction through indiscriminate claims.
Harm reduction is particularly exposed
The threat is greatest when a new product is substantially safer than what it replaces but not completely safe.
Public health depends heavily on such improvements. New medicines often have fewer side effects rather than none. Safer surgical techniques still carry risks. Vaccines prevent disease but can cause uncommon adverse reactions. Nicotine products can greatly reduce the danger of smoking without being harmless.
Litigation tends to collapse these relative-risk questions into binary ones: did the product cause an injury, was every conceivable risk disclosed, or could it have been safer?
Nicotine policy demonstrates the consequences. Cigarettes are extraordinarily dangerous because burning tobacco produces smoke containing thousands of chemicals. Nicotine pouches and regulated vaping products avoid combustion and are consequently far less dangerous than smoking. The UK government’s comprehensive evidence review concluded that, in the short and medium term, vaping poses “a small fraction of the risks of smoking”.
Sweden’s experience shows what substitution can achieve. The country combines widespread use of snus with exceptionally low smoking prevalence. According to the Public Health Agency of Sweden, daily snus use remains common, particularly among men, while daily smoking has fallen dramatically.
Yet a manufacturer wishing to introduce a lower-risk nicotine product in the United States must negotiate an expensive FDA application, unpredictable delays, political opposition and potential litigation. Before any new tobacco product can legally be marketed, the manufacturer must obtain a written FDA marketing order.
In January 2025, following extensive scientific review, FDA authorized 20 ZYN nicotine-pouch products after finding that they met the statutory public-health standard. FDA concluded that, because they contain substantially lower levels of harmful constituents than cigarettes and most smokeless tobacco products, they pose lower risks of cancer and other serious conditions.
That did not end the campaign against them. Regulatory authorization does not prevent activists from attacking the evidence, pressuring politicians or attempting to remove products through additional legal action.
Large tobacco companies may survive this system. Independent innovators frequently will not. Meanwhile, cigarettes—the most lethal nicotine product—remain widely available.
A legal and regulatory system supposedly designed to protect health can therefore entrench the product causing the greatest harm.
Who reviews the health reviewers?
Health institutions should face the same accountability they demand from manufacturers. That means disclosing not only commercial relationships but also funding and professional connections involving advocacy groups, foundations, plaintiffs’ lawyers and litigation campaigns.
Assessments likely to influence courts or regulators should reveal:
- How authors, advisers and peer reviewers were selected.
- All relevant financial and professional affiliations.
- Whether funders or campaign organizations helped define the research question.
- What dissenting evidence was considered.
- How substantive objections were answered.
- Whether participants or their institutions could benefit from the report’s use in litigation.
- Whether the underlying data and analytical methods are available for independent examination.
Government authorization should not provide absolute immunity from legitimate claims. Regulators make mistakes, and companies sometimes withhold information from them. But neither should careful regulatory findings be disregarded whenever a litigant can find a competing expert.
Above all, policymakers must recognize that excessive legal exposure has public-health costs. It encourages defensive medicine, concentrates development among the largest companies, deters research into contested subjects and delays lower-risk products.
A health system that punishes every adverse outcome will not produce risk-free medicine. It will produce less medicine, less candor and less innovation.
The question raised by The Firebreak—who will review the reviewers?—is therefore fundamental to global health. Who examines the experts whose findings drive litigation? Who discloses the interests of foundations and advocacy organizations? Who measures the patients harmed when a useful product never reaches the market?
We need courts to hold medical companies and health institutions accountable when they mislead the public. But we also need rigorous scientific standards to discipline litigation. Otherwise, lawsuits will increasingly determine which health claims are accepted, which research is undertaken and which products survive.
That is not evidence-based public health. It is health policy by legal intimidation.
