When a company brings a new product to market, who has the authority to approve the product’s label and associated warnings? In most instances involving pharmaceutical drugs or medical devices, it’s the federal Food and Drug Administration (FDA). Other products fall under different government agencies (i.e., Environmental Protection Agency (EPA) or Consumer Product Safety Commission (CPSC)) who have the final say. However, litigation prompts the question of whether such agencies have the power to determine the adequacy of warnings and labeling or whether a jury is better suited to do so. In considering proposed legislation that would limit failure-to-warn claims brought against product manufacturers, state legislatures appear to be increasingly ready to answer that question.
Where it started
On April 7, 2000, Diana Levine presented to her local healthcare clinic with complaints of nausea and a migraine headache.[1] As the healthcare providers at the clinic had done on several occasions in the past, they administered Phenergan, which was Wyeth’s (now Pfizer’s) brand name of promethazine hydrochloride, an antihistamine used to treat nausea. After the first dose failed to relieve Levine’s nausea, a physician assistant administered the drug again, this time by the “IV-push” method. Tragically, the Phenergan entered Levine’s artery causing her to develop gangrene and eventually lose her arm. Levine sued Wyeth, claiming that its label was defective because, although it warned of possible gangrene and amputation following an injection, it did not instruct physicians to administer the drug via “IV-drip” instead of “IV-push.”[2] Wyeth responded by pointing out that the FDA first approved the Phenergan label in 1955, and several times thereafter, most recently in 1998.[3] Wyeth argued that the FDA’s approval of the label preempted state law failure-to-warn claims, but the trial court held—and the United States Supreme Court later affirmed—that the FDA’s decision did not preempt recovery, and that state juries should be allowed to retroactively deem a product’s labeling defective in failing to provide adequate warnings.[4]
Wyeth v. Levine and several similar cases pose the question: why should companies be subject to litigation for failure-to-warn claims when they have followed the proper procedure and coordinated with the appropriate governing body to identify the relevant risks and develop an approved label? Recently, this question has been gaining traction in state legislatures across the country, often in the context of litigation involving pesticides.
State legislative trends
In the past decade, thousands of lawsuits have been filed across the country against pesticide manufacturers for allegedly failing to warn users of certain risks. These failure-to-warn claims arise out of state tort law and argue that the manufacturer did not adequately warn of the product’s risks or provide proper instructions for its safe use. To succeed, plaintiffs must show that the company failed to warn the user of a known risk, and as a result, the plaintiffs suffered harm. This inevitably raises the question: who should determine whether a product’s warning is adequate? Is it the agency tasked by Congress or is it a jury?[5]
To better understand this issue, it is important to outline the steps pesticide manufacturers must navigate to obtain product labeling approval. The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), which is managed by the EPA, governs the process. FIFRA directly regulates the distribution and sale of any labeled pesticides, and the EPA has express authority to decide whether a label adequately warns the end user of the potential harm.[6] FIFRA even prohibits any state from adopting “requirements for labeling or packaging in addition to or different from” those required under FIFRA.[7] When the EPA approves a pesticide label, including risk-related language that the manufacturer is not permitted to change, it is certifying that the manufacturer is providing adequate and appropriate warnings and information.
Courts across the country are divided on whether manufacturers should remain subject to failure-to-warn claims when they have complied with the relevant regulatory authority in developing their label. While the Ninth and Eleventh Circuits have ruled that such claims are not preempted, the Third Circuit held that failure-to-warn claims are preempted by FIFRA and the EPA.[8][9][10]. In the absence of Supreme Court guidance, state legislatures have taken action to address the issue.
For example, in 2024, bills were proposed in the state legislatures of Florida, Idaho, Iowa, and Missouri to codify the Third Circuit’s opinion and shield companies from failure-to-warn claims upon obtaining approval from the EPA. Though none were passed in 2024, twelve states brought similar bills in 2025.[11] Both North Dakota and Georgia passed their bills, while Florida, Mississippi, Wyoming, and Montana rejected the bills. Iowa, Missouri, Idaho, North Carolina, Tennessee, and Oklahoma have not yet reached a final decision. Within one year, the number of bills introduced on this issue has tripled, indicating growing legislative interest in shielding companies who comply with federal regulations from state failure to warn claims.
A detailed analysis of Georgia’s legislation suggests an intent to expand failure-to-warn preemption to other regulated industries as well. The bill states:
(3) Without reliable access to the most widely used crop protection products, costs to farmers could more than double; (4) A domestic supply chain for crop protection products is critical to ensuring farmers have access to all the tools they need to grow food and fiber; (5) Dependence on Chinese imports for critical ingredients in crop protection products creates supply chain vulnerabilities for the United States and opportunities for foreign adversaries to restrict access to crop protection products for American farmers; and (6) Every effort must be made to strengthen the United States domestic production of pesticides, including clarifying regulatory authority of pesticide labeling.[12]
The Georgia legislature’s rationale moves beyond agriculture. It reflects a more widespread concern about economic competitiveness, regulatory clarity, and supply chain security that could be equally applicable in other highly regulated sectors, such as pharmaceuticals and consumer products. The legislature recognizes the confusion concerning adequate labeling as a vulnerability to an industry, finding that failure to resolve the issue could cause added costs to citizens in the state. Additionally, Georgia aims to make American companies more competitive against foreign industries by clarifying regulatory authority. Given this rationale, it is reasonable to anticipate that Georgia could pursue similar legislative strategies in other regulated industries. It would enhance the state’s economic competitiveness, reduce costs, and improve regulatory clarity.
Could the trends expand?
The same regulatory logic underlying Georgia’s pesticide legislation applies to other regulated sectors in which federal agencies control labeling. For example, pharmaceutical and medical device labeling must follow the Federal Food, Drug, and Cosmetic Act (FDCA) and gain approval by the FDA. Warnings for children’s products must comply with the Consumer Product Safety Improvement Act (CPSIA) and be approved by the CPSC. Like pesticide manufacturers, companies in these sectors (and others) often face failure-to-warn claims despite full regulatory compliance in developing their warnings and labeling.
Pharmaceutical companies must provide “adequate tests by all methods reasonably applicable to show whether or not such drug is safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling thereof.”[13] Once that evidence is presented, the FDA implements a “structured risk-benefit assessment framework” in the approval process in order to achieve a balanced consideration.[14] After the drug is approved, the FDA retains the authority on the approval, including labeling that warns users of the risks.[15]
For children’s products, manufacturers must first determine the age of the intended user. Then, depending on the type of product, the manufacturer conducts testing through third parties to examine safety and durability. If the item passes these tests, the manufacturer applies for a Children’s Product Certificate (CPC). After approval, the products must follow the labeling requirements set forth by the CPSC, including warnings of small parts and choking hazards.[16] For items such as toys, games, marbles, or small balls, the CPSC requires manufacturers provide the exact labeling set forth in the Federal Hazardous Substances Act (FHSA).[17]
Manufacturers of medical devices, children’s products, and various other consumer products must adhere to a congressionally ordained process in developing labeling and warnings. Once regulatory approval is obtained, manufacturers no longer control the content of the label: it is dictated to them. Considering this, as well as state legislatures’ interest in shielding pesticide companies from failure-to-warn claims, it is foreseeable that similar protections could be coming for other products and industries to establish regulatory consistency and economic competitiveness.
Through their dissent in Wyeth v. Levine, Justice Alito, Chief Justice Roberts, and Justice Scalia expressly agreed with the view that state law failure-to-warn claims should be preempted by federal labeling regulations.[18] They highlighted the pitfalls of the current legal framework that allows juries (rather than the FDA) to be the arbiter of pharmaceutical drug labels.The reality in the case of Wyeth is that the FDA had deemed the “IV-push” method as “safe” and approved a label that reflected that determination.[19] Levine’s expert still stated to the jury “Thank God we don’t rely on the FDA to … make the safe[ty] decision. You will make the decision.”[20]But the FDA does make the safety decision, just like the EPA, CPSC, and other appointed agencies. The dissenters in Wyeth expressed the same logic that state legislatures are codifying: if government agencies have been entrusted with deciding if a product is safe and dictating labeling for it, a jury shouldn’t be allowed to retrospectively overrule those determinations.
Conclusion
As noted in the dissent in Wyeth, “tragic facts make bad law.”[21] That’s why many state legislatures are evaluating as a threshold matter whether companies should face failure-to-warn claims after obtaining regulatory approval for their labeling. There is a strong movement for legislation centered around the protection of companies that produce pesticides, and the same reasoning could be applied broadly. Given current legislative momentum, it is foreseeable that this rationale will extend into other industries, potentially limiting the viability of failure-to-warn claims like the one brought in Wyeth v. Levine.
[1] Wyeth v. Levine, 555 U.S. 555, 559 (2009).
[2] Id. at 560.
[3] Id. at 562.
[4] Id. at 581.
[5] See https://nationalaglawcenter.org/states-introduce-pesticide-liability-limitation-bills-in-2025-legislative-session/
[6] 7 U.S.C.A. § 136j(a)(1)(A) (West 2025)
[7] 7 U.S.C.A. § 136v (West 2025)
[8] Carson v. Monsanto Co., 92 F.4th 980, 999 (11th Cir. 2024)
[9] Hardeman v. Monsanto Co., 997 F.3d 941, 958 (9th Cir. 2021)
[10] Schaffner v. Monsanto Corp., 113 F.4th 364 (3d Cir. 2024)
[11] 2025 Bills:
North Dakota: H. 1318, 69th Leg. Assemb., Reg. Sess. (N.D. 2025)
Georgia: S. 144, 158th Gen. Assemb., Reg. Sess. (Ga. 2025)
Iowa: S. 394, 91st Gen. Assemb., Reg. Sess. (Iowa 2025)
Missouri: H.R. 544, 103rd Gen. Assemb., Reg. Sess. (Mo. 2025)
Idaho: H.R. 303, 68th Leg., Reg. Sess. (Idaho 2025)
Florida: H.R. 129, 92nd H., Reg. Sess. (Fla. 2025)
Tennessee: H.R. 809, 114th Gen. Assemb., Reg. Sess. (Tenn. 2025)
Oklahoma: H.R. 1755, 60th Leg., Reg. Sess. (Okla. 2025)
Mississippi: H. 1221, 2025 Leg., Reg. Sess. (Miss. 2025)
Wyoming: H.R. 285, 68th Leg., Reg. Sess. (Wyo. 2025)
Montana: H.R. 522, 69th Leg. Assemb., Reg. Sess. (Mont. 2025)
North Carolina: S. 639, 157th Gen. Assemb., Reg. Sess. (N.C. 2025)
[12] Georgia: S. 144, 158th Gen. Assemb., Reg. Sess. (Ga. 2025)
[13] 21 U.S.C.A. § 355(d)(West 2025)
[14] Id.
[15] 21 U.S.C.A. § 355(e)(West 2025)
[16] See https://www.cpsc.gov/Business–Manufacturing/Testing-Certification/Childrens-Product-Certificate
[17] 16 C.F.R. § 1500.19(h)(West 2025)
[18] Wyeth, 555 U.S. at 604.
[19] Id. at 605.
[20] Id. at 606.
[21] Wyeth, 555 U.S. at 604
Finis
