over the counter

Subscribe to over the counter via RSS
Photo of Eric Hudson

We’ve blogged a lot recently about preemption and the dismissal of complaints alleging that certain over the counter products, including acne medications, sunscreens, antiperspirants, expectorants, and shampoos contain benzene.  Almost a year ago we blogged about the dismissal of an OTC case involving medicated shampoo that allowed plaintiff leave to amend. Today’s decision, Pineda v. Lake Consumer Products, Inc., 2025 WL 2698991 (E.D. Pa. Sept. 22, 2025), is a mixed bag that addresses plaintiff’s amended complaint. It’s about coal-tar shampoos, which are known to include benzene and are subject to an FDA monograph that recognizes the naturally occurring presence of benzene in coal tar. Yet, shockingly, plaintiff filed a class action claiming she would not have purchased the shampoos had she known they contained benzene.Continue Reading OTC Preemption Letdown in the Eastern District of Pennsylvania

Photo of Eric Alexander

Not too long ago, we tried to extrapolate from a doctoral thesis on quantum dots to lessons for litigation.  That “[q]uantum dots are between one-billionth of a meter and one-hundred-millionth of a meter in size” emphasized that “appreciating the scope and scale of what is being discussed can be critical.”  In the spate of litigation…

Photo of Bexis

Plaintiffs (or more properly, their lawyers) across the country have been filing no-injury class actions against over-the-counter (“OTC”) drug manufacturers on a variety of cooked-up theories that have little or nothing to do with the safety or efficacy of these drugs.  One such theory, that we have discussed several times, is that drugs that the FDA allows to be labeled as “rapid release” should be penalized, under state law, for using that purportedly “misleading” description.  This litigation is based on one study, done years ago, that found that some “rapid release” products did not dissolve any more quickly (or less so) than other products not bearing that designation. Continue Reading “Rapid Release” Class Action Dissolved

Photo of Steven Boranian

A federal judge in California filed an important OTC preemption decision earlier this month, and it’s important because it applied federal preemption to shut down (for now) one of the many recent benzene-related consumer class actions.  The case is Daugherty v. Padagis US LLC, No. 24-cv-02066, 2025 WL 2243622 (N.D. Cal. Aug. 6, 2025)…

Photo of Bexis

Every week Bexis circulates an email with new, bloggable cases, but sometimes there are more new decisions than blogging days, and cases get passed over.

Here are three (relatively) recent examples

Gonzalez v. International Medical Devices, Inc., ___ F. Supp.3d ___, 2025 WL 2054361 (W.D. Tex. June 20, 2025), arose from the plaintiff’s apparent…

Today we address two more cooked-up—literally—Valisure cases, Bodunde v. Walgreens Boots Alliance, Inc., No. 1:24-CV-00985-JLT-SAB, 2025 WL 1411306 (E.D. Cal. May 15, 2025), and Navarro v. Walgreens Boots Alliance, Inc., No. 1:24-CV-00290-JLT-SAB, 2025 WL 1411406 (E.D. Cal. May 15, 2025).

These two cases involve legally identical magistrate recommendations that Defendant’s motions to dismiss…

Photo of Eric Alexander

In Hall v. Walgreens Boot Alliance, Inc., the Supreme Court of Washington considered a certified question from the Northern District of Illinois on an issue of Washington state law.  No. 102829-6, 2025 Wash. LEXIS 145 (Wash. Mar. 20, 2025).  The underlying case, a proposed consumer protection class action, involves the labeling of certain over-the-counter…

Photo of Eric Alexander

Like the radio stations of yore did with songs, we offer up two related posts back-to-back instead of the usual one.  We cannot offer a “favorite artist” as the source of consecutive songs, we offer two posts that relate to the legal implications of some of the typical things that FDA does and has been…

Drug & Device Resources

Bexis’ Book

FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
Learn more about this book