Three members of the firm’s Medical and Life Sciences Practice Group recently wrote a column examining the scope of OTC preemption and a shift toward defense-favorable decisions that was published in a magazine targeting defense, insurance and corporate counsel.
Kelly Jones Howell, Marina Plotkin and Jesse C. Wang discussed federal preemption as a defense against state-law claims involving over-the-counter drugs, particularly lawsuits alleging misleading labeling or undisclosed trace contaminants. “Where Federal Regulation Stops and Tort Law Begins” appeared on pages 22 to 27 in DRI’s For the Defense Magazine.
The three looked at recent decisions, such as Monsanto Co. v. Durnell, involving Roundup weed killer and concluded federal law provides broad protection, prior enforcement of the FCDA is restricted, the type of damages claimed are critical, scientific detection does not automatically establish liability, courts have applied the statute inconsistently and recent decisions favor a more textual approach.
“For defense counsel, Durnell and the recent OTC decisions serve as a reminder to press § 379r’s text at every stage, anchor arguments in monograph compliance, and criticize repackaged labeling challenges directly, rather than assuming courts will apply the statute correctly on their own. For plaintiffs’ counsel, the same decisions narrow the available paths forward, but do not close them off entirely. Personal-injury claims grounded in genuine product liability theories, like Rutledge, remain viable at the motion to dismiss stage. Ultimately, Section 379r reflects that OTC drug labeling should be governed by uniform federal standards rather than a patchwork of state requirements. While courts have not always applied that principle consistently, an increasing number of decisions are enforcing the statute as written.”
Kelly had previously written a legal alert on Monsanto Co. v. Durnell, and a legal alert on a similar preemption case, L’Oréal USA Benzoyl Peroxide Products Litigation.
Read the entire column in For the Defense Magazine for complete details.
