Primary jurisdiction

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Same Rule, Different Setting: Litigants Cannot Usurp the FDA’s Authority

By Susanna Moldoveanu on April 25, 2025

Today’s opinion, In re SoClean, Inc., Mktg., Sales Pracs., & Prods. Liab. Litig., No. 22-MC-00152-JFC, 2025 WL 974258 (Sp. Mstr. W.D. Pa. Mar. 20, 2025), involves a lot of case-specific discussion with little applicability to the broader readership of the Blog. But it also contains some general observations regarding invading the province of the FDA that are “so fresh and so clean” (if this litigation name takes you back, as it does us, to circa 2000 Outkast).Continue Reading Same Rule, Different Setting: Litigants Cannot Usurp the FDA’s Authority

First Circuit Revival of Action Against Compounder

By Stephen McConnell on March 15, 2023

In our first appellate oral argument we found ourselves in front of a very hot Ninth Circuit panel (that means lots of questions). We danced our hardest to affirm the district court’s denial of a criminal defendant’s motion to suppress. The problem was that the lower court had wandered onto shaky ground. We knew it.

Georgia Dismisses Supplement Case on Primary Jurisdiction Grounds

By Michelle Yeary on July 5, 2022

Today’s case – Smith v. Hi-Tech Pharmaceuticals, Inc., — S.E.2d –, 2022 WL 2285920 (Ga. Ct. App. Jun. 24, 2022 — does not break new ground. But it is a published decision by a state appellate court and for that reason, it deserves some attention.

Plaintiff, a resident of Washington, DC, brought a single…

Minnesota Court Holds that Dispute with Compounder is Preempted

By Stephen McConnell on June 29, 2022

We are always delighted to find a case that bars a claim based on FDA preemption, but Nexus Pharms., Inc. v. IntegraDose Compounding Servs., LLC, 2022 Minn. Dist. LEXIS 1734 (Minn. 4th Dist. May 24, 2022), is unusual. It is not a product liability case. Rather, a pharmaceutical company sued a compounder for fraudulently…

Pain Doctor Challenge to Pharmacy Refusal to Fill Prescriptions is Subject to Board of Pharmacy Primary Jurisdiction

By Stephen McConnell on July 21, 2021

Today’s case, Bradley v. CVS Pharmacy, Inc., 2021 Cal. App. LEXIS 451, 2021 WL 2176797 (Cal. Ct. App. May 28, 2021), is not about drug or device product liability, but its discussion of deference to administrative agencies is interesting. There are several different but closely related doctrines that either require or permit judicial deference…

Another Supplement Class Action Runs Into Primary Jurisdiction

By Eric Alexander on September 18, 2020

Stop us if you have heard this before. A group of plaintiffs bring a purported class action under a range of California consumer protection laws seeking damages related to the purchase of a medical product (or collection of somewhat related medical products) that they claimed failed to comply with FDA requirements. The defendants raise preemption…

The Primary Jurisdiction Hits Keep on Coming

By Stephen McConnell on June 3, 2020

Last Thursday, Richard Dean gave us yet another excellent guest-post on primary jurisdiction. That under-appreciated doctrine is to Richard what preemption is to Bexis, or what dog shows are to Rachel, or what Ian Fleming and Dashiell Hammett (whose birthdays coincided with Richard’s May 28 post) are to us.

We had selected primary jurisdiction with…

Guest Post – Primary Jurisdiction- More About That 16th Draft Pick

By Bexis on May 28, 2020

Here’s another guest post by friend-of-the-blog, Dick Dean of Tucker Ellis. Dick is a big fan of primary jurisdiction (if only more courts shared his enthusiasm), and this post deals with some recent Supreme Court precedent that is helpful to such arguments, and that might otherwise have been missed. As always our guest bloggers…

Court Rolls Up CBD Class Action (at least for now)

By Stephen McConnell on January 15, 2020

We keep reading in Law360 and other publications about defense law firms that are ramping up cannabis practice groups. Our own firm is one of them. These developments sparked an interest. After all, won’t many of the principles we’ve worked with over the years for prescription and OTC medications apply to pot and its…

Primary Jurisdiction Forecloses Lanham Act Challenging Medical Device Classification

By Stephen McConnell on October 30, 2019

The focus of this blog is on product liability cases, but every once in a while a case from another subject matter area tugs at our elbow, begging for attention. Today’s case, Kurin, Inc. v. Magnolia Medical Technologies, Inc., 2019 U.S. Dist. LEXIS 184382 (S.D. Cal. Oct. 23, 2019), is an interesting – albeit…

Drug & Device Law