The Shield

Families of paralyzed children sued. At the 1958 trial the jury found that Cutter had not been negligent and found it liable for breach of implied warranty. In Gottsdanker v. Cutter Laboratories (1960) the California Court of Appeal affirmed. It extended to vaccines the rule that allowed a consumer to recover for defective food without a contract with the maker. The California Supreme Court cited the vaccine warranty cases in 1963 in Greenman v. Yuba Power Products, the decision that established strict products liability.

The rule placed the cost of a defective dose on the manufacturer, whether or not the manufacturer was at fault. Paul Offit, in his 2005 history of the incident, argues that this liability without fault later drove manufacturers out of vaccine production.

The lawsuits that preceded the Act were brought chiefly over the DTP vaccine. Congress moved vaccine injury claims out of the ordinary courts and into a federal program that pays without proof of fault. The program leaves a route to court open and controls when a claim can reach a manufacturer there.

Courts dismiss suits that bypass the program. In September 2025 the Fourth Circuit affirmed the dismissal of a Gardasil suit, Needham v. Merck, on grounds of timeliness and failure to exhaust the program. The same panel rejected a constitutional challenge to the addition of HPV vaccine to the Vaccine Injury Table.

The Act that limited manufacturers' liability also directed the Secretary of Health and Human Services to promote safer childhood vaccines and to report to Congress periodically on that work. Chapter 3 documents the record of those reports and of the statutory task force on safer vaccines (Finding 3.8).

Claims under the Act have gone through the compensation program since 1988. In 2018 a court order in a private group's lawsuit recorded that HHS had no such reports.

The Robi case in Los Angeles had gone to trial in January 2025, was paused at the plaintiff's request, and ended in a confidential settlement without a verdict. Merck's filing states that the March 2025 ruling covered 16 bellwether cases and that the plaintiffs appealed to the Fourth Circuit. No appellate court has ruled on Gardasil preemption, and no jury has decided whether Gardasil caused the injuries alleged.

The Court's reasoning ran through the label. EPA approves a pesticide's label at registration, and the manufacturer must use that label until EPA approves a change. EPA has not required a cancer warning on glyphosate. A state jury verdict demanding one therefore imposed a labeling requirement "in addition to or different from" the federal one, which FIFRA forbids. The Court relied on Riegel v. Medtronic, which applied the same reasoning to medical devices.

The holding reaches failure-to-warn claims. Design-defect and negligence claims survive it. A St. Louis trial on design-defect claims began on 29 September 2026, and the jury returned a unanimous verdict for Bayer at the end of October. Calley Means, a former White House adviser, called glyphosate the second product after vaccines that cannot be sued over, which overstates both cases: Roundup design-defect suits continue, and a vaccine claimant may sue after the compensation program rules.

The December 2025 brief gave two reasons for the change: a Third Circuit decision, Schaffner v. Monsanto, that had created a conflict among the courts of appeals, and "the change in Administration." The Court granted review, heard argument on 27 April 2026, and decided the case for Monsanto on the position the government had urged.

The Court's account is accurate on the narrow point that EPA reached the same conclusion in 1991, 1993, 2017 and 2019. The preemptive force of the label in Durnell rests on that series of conclusions. The most recent of them did not survive judicial review, and EPA has issued no replacement. In the interval, the Supreme Court has made the label a bar to cancer-warning claims nationwide.

Section 707 of the Defense Production Act protects persons from liability for acts taken in compliance with orders issued under the Act. Executive Order 14387 requires domestic producers to comply with it and directs that no order under it place the corporate viability of any domestic producer of glyphosate-based herbicides at risk. Bayer, through Monsanto, is the only domestic producer. The order's findings concern defense supply and agriculture. It contains no finding on the health effects of glyphosate.

Two states had already acted. North Dakota enacted HB 1318 on pesticide labeling in April 2025, the first such law. Georgia followed in May 2025 with SB 144, which shields pesticide makers from some cancer failure-to-warn claims and does not apply to existing cases. Both are label-shield laws: they tie a manufacturer's protection to the EPA-approved label, the instrument on which Durnell later turned.

The Cutter case set the baseline: a manufacturer whose product injured children paid, whether or not it had been careless. Each later protection moved part of that cost away from the manufacturer on the strength of a government act. The 1986 Act paired its protection with a compensation program and a duty to report on safer vaccines. FIFRA preemption depends on EPA's evaluation of the label, and Executive Order 14387 rests on findings about defense supply.

Each protection remains in effect. In 2018 HHS had no record of any vaccine safety report under the Act. EPA's most recent glyphosate cancer evaluation was vacated in 2022, four years before the Supreme Court gave the label preemptive force. The executive order that extended immunity to glyphosate production made no finding on its safety. In 2026 the House voted 280–142 to strip a statutory pesticide shield from the farm bill, and in the same year the President conferred Defense Production Act immunity on glyphosate production and the Supreme Court held Roundup cancer-warning claims preempted.