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Federal Label Approval as Potential Litigation Shield: What Monsanto v. Durnell Means for Regulated Manufacturers

21 Jul 2026

ABSTRACT: The United States Supreme Court ruled in Monsanto v. Durnell that EPA-approved pesticide labels preempt state failure-to-warn claims under FIFRA. Grounding its analysis in Riegel v. Medtronic, the Court sent a clear message to chemical, pharmaceutical, and medical device manufacturers: a federal label approval can be a litigation shield.

On June 25, 2026, the U.S. Supreme Court handed regulated manufacturers a significant litigation win. In Monsanto Co. v. Durnell, a 7-2 majority held that the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) expressly preempts state-law failure-to-warn claims where those claims would require a label warning beyond what EPA has approved. The decision has implications that reach well beyond pesticides — and manufacturers of pharmaceuticals, medical devices, and other federally regulated products should pay close attention.

What the Court Decided

John Durnell sued Monsanto in Missouri state court, claiming that two decades of Roundup use caused his non-Hodgkin's lymphoma and that Monsanto should have included a cancer warning on the product's label. EPA had registered Roundup without requiring a cancer warning — a conclusion the agency has maintained since 1991 and reaffirmed on multiple occasions despite challenges from international health bodies. A Missouri jury found for Durnell and awarded him $1.25million dollars.

The U.S. Supreme Court reversed and found that FIFRA's preemption clause bars any state requirement for pesticide labeling that is "in addition to or different from" federal requirements. The Court held that EPA's registration process — which requires the agency to affirmatively approve a pesticide's label and to determine that the label contains all warnings necessary to protect health — constitutes a binding federal requirement. Once EPA approves a label, a manufacturer is legally required to use it. A state tort verdict that demands a different or additional warning necessarily conflicts with that federal mandate and is preempted.

Why Riegel v. Medtronic Is Central to This Decision

The Court grounded its analysis heavily in Riegel v. Medtronic, the 2008 decision that established broad preemption for state-law claims targeting FDA-approved Class III medical devices. The majority in Durnell was explicit: FIFRA's preemption clause is "materially identical" to the Medical Device Amendments' preemption clause, and the two statutes operate the same way. Just as FDA's premarket approval process imposes specific device-level requirements that displace state tort standards, EPA's registration and label approval process imposes specific product-level requirements that do the same.

For medical device manufacturers, this is significant reinforcement of the Riegel preemption decision. Durnell reaffirms that Riegel's preemption framework is not an artifact of device-specific statutory language — it reflects a broader congressional judgment, expressed across multiple regulatory schemes, that uniform federal label determinations should not be second-guessed by juries. The Court also signaled that this logic extends to other federal statutes with similar preemption language, expressly listing provisions governing meat, poultry, eggs, cosmetics, OTC drugs, and certain food labeling requirements.

What This Means for Pharma, Device, and Chemical Manufacturers

Several practical consequences flow from this decision. First, where a federal agency has affirmatively reviewed and approved a product's label — including its warnings — a state failure-to-warn claim demanding something more is preempted. The specificity of the agency's determination matters: a general statutory misbranding standard is not enough, according to the Court in Durnell. What counts is whether the agency made a product-specific labeling judgment.

Durnell also flatly rejected the argument that state tort law parallels FIFRA merely because both require "adequate" warnings. That framing, the Court said, operates at too high a level of generality and would effectively nullify FIFRA's preemption clause. Manufacturers facing similar arguments under the FDCA's misbranding provisions should press this point aggressively.

The preemption defense applies even when new safety information emerges post-approval. The Court acknowledged that new data could prompt EPA to revise a label — but held that the theoretical possibility of future agency action does not strip the existing approval of its preemptive force. The appropriate remedy for new safety concerns is a petition to the agency, not a state tort suit.

Finally, parallel claims did not survive. The dissent argued that Durnell's claim merely paralleled FIFRA's misbranding prohibition and should therefore be allowed to proceed. The majority disagreed. EPA's product-specific registration determination — not the general statutory standard — is the relevant federal requirement, and a state claim that imposes anything beyond it is preempted.

Important Caveats

Durnell is a FIFRA decision, and its direct holding applies to pesticide labeling. Extension to pharmaceutical, device, and other regulated product contexts will require statute-specific analysis. The strength of the preemption defense will turn on whether the relevant agency affirmatively approves label content — as FDA does in the premarket approval process and, to a more limited extent, in the NDA and ANDA processes. Contexts where agency review is less comprehensive or where labeling authority is shared will present harder questions that will turn on the particular regulations and agency review for the label approval. Medical device manufacturers relying on Riegel are on the firmest ground; pharmaceutical and OTC manufacturers will need to assess their approval records carefully.

The Takeaway for Manufacturers and Their Counsel

Durnell is an important decision, but it does not render manufacturers litigation-proof. Its preemptive force depends on the rigor and specificity of the underlying federal approval. Manufacturers and their counsel should audit existing agency approvals to assess how affirmatively and specifically the relevant agency addressed the warning at issue in any pending or anticipated litigation. Where the approval record is robust, Durnell supports early preemption arguments — ideally at the motion to dismiss or summary judgment stage — before costly discovery and trial. Companies with products regulated under federal labeling schemes should work with defense counsel now to map their regulatory history and develop a coordinated preemption strategy across their approved products.

Katherine Cortesy Examines Recorded Medical and Vocational Examinations in WDC Journal

20 Jul 2026

Baker Sterchi attorney Katherine Cortesy authored “Privacy Please: The Case Against Recorded Medical and Vocational Examinations,” published in the spring edition of Wisconsin Civil Trial Journal, a publication of the Wisconsin Defense Counsel (WDC). The article argues that courts should generally deny requests to record independent medical, vocational and psychological examinations because recordings can compromise the validity of the evaluations, while existing litigation safeguards protect the parties’ interests.

Based in the firm’s Madison office, Cortesy handles insurance defense litigation with an emphasis on personal injury, products liability and medical malpractice. She is a member of the WDC’s Women in the Law Committee and Young Lawyer Committee. Cortesy earned her law degree from the University of Wisconsin Law School and is licensed to practice in Wisconsin.

Published three times a year, Wisconsin Civil Trial Journal is a scholarly journal that provides detailed information on tort law and other matters of interest to the defense bar.

Clay Crawford to Present on Time-Limited Demands at FDCC Annual Meeting

17 Jul 2026

On July 31, Baker Sterchi Member Clay Crawford will co-present at the Federation of Defense & Corporate Counsel (FDCC) Annual Meeting being held in Lisbon, Portugal. The session, “Looking to the Future: Addressing Time-Limited Demands in the Age of Nuclear Verdicts and AI,” will explore strategies for addressing time-limited demands while avoiding bad faith and legal malpractice liability.

Crawford focuses his practice on insurance coverage, bad faith and catastrophic injury defense. He is a member of the American Board of Trial Advocates, Claims and Litigation Management Alliance and FDCC. He also serves as co-chair of Baker Sterchi’s Insurance Coverage & Bad Faith Practice Group and frequently speaks on insurance coverage topics.

Crawford has been recognized for his insurance work in Missouri by legal industry ranking and peer-review organizations for several years. He earned his law degree from the University of Missouri-Kansas City School of Law and is admitted to practice in Missouri.

For more information or to register for the meeting, click here.

Wisconsin Court Grants Summary Judgment for Nonprofit and Insurer Clients in Third-Party Assault Case

16 Jul 2026

On June 10, Baker Sterchi secured summary judgment for a nonprofit recreational organization and its insurer in a personal injury case pending in the Circuit Court for La Crosse County, Wisconsin.

The plaintiff alleged that, while a member of the nonprofit and using its facility, he was threatened and assaulted by another patron after facility staff allegedly failed to provide assistance or safe passage despite being notified of the confrontation. The plaintiff asserted negligence claims against the nonprofit and its insurer, alleging they failed to protect him from the criminal acts of a third party.

The defense argued that, under Wisconsin law, the nonprofit had no duty to prevent the assault because the third party’s criminal conduct was not reasonably foreseeable under the circumstances. The court agreed and granted summary judgment in favor of the nonprofit and its insurer, dismissing all claims against them with prejudice.

The ruling resolved the premises liability and related insurance claims before trial. The plaintiff’s intentional battery claim against the individual assailant remains pending.

Washington Court of Appeals Affirms Summary Judgment for Supermarket Chain Client

13 Jul 2026

On June 8, 2026, Baker Sterchi secured affirmance of summary judgment in favor of a supermarket chain client in a premises liability case arising from a customer’s fall over electrical cords.

The plaintiff encountered two extension cords crossing the floor while shopping at one of the client’s stores. Although she saw the cords, she attempted to step over them, caught her trailing foot and fell. She subsequently filed a negligence action, alleging the store should have anticipated the potential harm despite the open and obvious nature of the condition.

Summary judgment was filed, arguing that the plaintiff saw the cords, appreciated the risk associated with stepping over them and voluntarily chose to encounter that risk. The trial court granted the motion and dismissed the plaintiff’s claims.

In affirming summary judgment, the Court of Appeals held that the cords presented an open and obvious condition and that the plaintiff’s testimony established she understood and assumed the risk of stepping over them. The court also rejected her argument that the client should have anticipated the harm, concluding that the cords were not an extreme danger and that she could have asked an employee for assistance or avoided the section altogether.

Two Baker Sterchi Professionals Named 2026 MLM Unsung Legal Heroes

10 Jul 2026

Baker Sterchi professionals Anita Driscoll and Charniece Rollie have been named 2026 Unsung Legal Heroes by Missouri Lawyers Media. The award honors law firm staff who consistently go above and beyond the call of duty, often behind the scenes.

Driscoll, a legal administrative assistant, was recognized in the legal secretary category. Based in the firm’s Kansas City office, she has supported attorneys and colleagues for more than 39 years, working alongside Member Tom Seigfreid for her entire tenure at the firm. Over nearly four decades, Driscoll has taken on a wide range of responsibilities with professionalism, precision and dedication. Her commitment to the legal administrative assistant role and steady support of the firm have made her a valued part of Baker Sterchi’s history and culture.

Rollie, Director of Administration, was recognized in the firm administrator category. With nearly 25 years of legal industry experience, including 10 years at Baker Sterchi, she is responsible for several key operational areas. Like Driscoll, Rollie has worn many hats at the firm, rising from legal administrative assistant to assistant to the executive director and now director of administration. In her current role, she oversees firmwide conflicts and resolution, along with records management, facilities, reception and office services for the firm’s Kansas City office.

Rollie also has held leadership roles in legal industry organizations, including serving as president and vice president of the Heart of America Legal Professionals Association and as a member of the NALS Next Generation Leadership Committee. She holds a Certificate of Mastery in Inclusive Leadership from Authentico and the Greater Kansas City Chamber of Commerce and was recently appointed to the Professional Development Committee of the International Facility Management Association’s Kansas City Chapter.

Driscoll, Rollie and the other 2026 honorees are featured in a special section of Missouri Lawyers Weekly published July 9.

Baker Sterchi Welcomes Attorney Kerry Keefe

10 Jul 2026

Baker Sterchi welcomes Kerry Keefe as senior counsel in the firm’s Seattle office. Keefe brings more than three decades of high-stakes litigation and public-sector leadership experience to a practice focused on civil litigation, constitutional and tort matters, civil rights enforcement and complex government investigations. She has tried more than 80 criminal and civil cases to verdict.

Keefe’s public-sector leadership experience includes senior roles with the Seattle Police Department, the Office of the Mayor of Seattle, the U.S. Attorney’s Office and the King County Prosecuting Attorney’s Office. As Civil Chief of the U.S. Attorney’s Office for the Western District of Washington, she led a division handling Federal Tort Claims Act matters, False Claims Act and whistleblower actions, civil rights enforcement, employment and immigration matters and litigation involving tribal treaty rights.

Keefe earned her law degree from Seattle University School of Law and her undergraduate degree from Georgetown University. She is licensed to practice in Washington.

Baker Sterchi Welcomes Attorney Kalina Spasovska

09 Jul 2026

Baker Sterchi welcomes Kalina Spasovska as an associate in the firm’s Seattle office. Spasovska is a civil defense litigator who focuses her practice on defense work for local government entities and clients facing personal injury and premises liability claims.

During law school, Kalina served as a legal intern and extern with the Seattle City Attorney’s Office, where she assisted with civil and criminal matters and gained courtroom experience.

Spasovska earned her law degree cum laude from the Seattle University School of Law, an M.A. from the University of Roehampton London, University of Gothenburg, University of Tromsø and her undergraduate degree from the University of Washington. She is licensed to practice in Washington.

Christie to Present at IDC AI Symposium; Odom Serves on Planning Team

08 Jul 2026

Baker Sterchi Member Bob Christie will present at the Illinois Defense Counsel Artificial Intelligence Symposium on July 17 in Edwardsville, Illinois. Baker Sterchi Member Greg Odom served on the planning team for the event, which will provide defense attorneys with practical strategies for integrating AI into their practices while addressing client expectations, ethical considerations and perspectives from claims professionals, expert witnesses and the judiciary.

Christie’s session, “AI Best Practices In and Out of the Courtroom,” will explore the use of AI in attorney practices, both in and out of the courtroom, including demonstrations of various types of AI software and the benefits they offer to defense counsel.

Based in the firm’s Seattle office, Christie co-chairs the firm’s Trial & Appellate Practice Group and is a member of the Public-Sector Risk Management & Consulting group. He defends professionals, businesses, governmental entities, law enforcement officers and individuals in high-exposure matters. Christie is active in several peer-selected legal organizations, including serving as chair of the International Association of Defense Counsel Trial Techniques and Tactics Committee and as secretary of Lawyers for Civil Justice. He is admitted to practice in Washington, Oregon, Idaho and before the U.S. Supreme Court.

Based in the firm’s Belleville office and an active IDC member since 2013, Odom currently serves as the organization’s second vice president. He also serves on its Board of Directors and Toxic Torts Committee and writes and edits for IDC’s annual Survey of Law. Odom is a trial attorney focusing on mass toxic tort and commercial litigation in Illinois and Missouri state and federal courts. He co-chairs Baker Sterchi’s Toxic Tort Practice Group.

The IDC is a statewide organization of civil defense attorneys dedicated to supporting the defense bar and improving the civil justice system in Illinois.

For more information or to register for the event click here.

Legal Administrative Assistant, Seattle

01 Jul 2026

Our Seattle office is seeking a highly motivated and skilled Legal Administrative Assistant. View the job description here.