Photo of Stephen McConnell

Medical device preemption should be straightforward.  The statute could not be clearer.  Federal regulation supplants state laws that would impose requirements that are different from or in addition to the federal requirements.  But the law has evolved into a bit of a mess, with misreadings of certain approval/clearance pathways and inventions of exceptions, such as

Photo of Bexis

Late last year, we discussed the dismissal of three purported California no-injury class actions alleging that certain over the counter (“OTC”) acne medicines were contaminated with carcinogenic benzene.  That post also commented:

By the way, guess who says they found the benzene in the products?  It was that good, old “independent” lab, Valisure −  which proceeded to file a citizen’s petition with the FDA seeking action against [these] products.  Sound familiar?

Last month, the FDA responded to the petition.  The agency was not impressed.  Its own testing – contrary to Valisure’s overblown claims in its petition (“detected high levels of benzene . . . in many specific batches”) found practically nothing to be concerned about.  It tested “95 acne products containing benzoyl peroxide for possible benzene contamination,” and “more than 90% of tested products had undetectable or extremely low levels of benzene.”  FDA, Statement ¶1 (March 11, 2025). THe FDA initiated a “limited number of voluntary recalls” due to “findings show[ing] a small number of products with elevated levels of benzene contamination.” Id.  Only six of 95 products were recalled, and even then, only specified lot numbers.  FDA Statement ¶7.Continue Reading It’s About Time – FDA Calls Foul on Valisure

Photo of Stephen McConnell

Bergdoll v. Coopersurgical, Inc., 2025 U.S. Dist. LEXIS 38300 (W.D. Mo. March 4, 2025), is a good Class III medical device preemption decision. The device was a Filshie clip, which is used to perform tubal ligations.  The claim in Bergdoll is the typical one that the clip migrated and caused adverse symptoms. Bergdoll is

Photo of Lisa Baird

Last summer, we gleaned the bitter fields of Davidson v. Sprout Foods, Inc., an opinion in which the Ninth Circuit allowed direct private enforcement of Food, Drug, and Cosmetic Act (FDCA) food labeling requirements because the class plaintiff used the fig leaf of California’s Sherman Act to do so.  Our post about the Ninth

Photo of Michelle Yeary

Defendant in Beavan v. Allergan U.S.A., Inc., 2014 N.J. Super. Unpub. LEXIS 2898 (N.J. App. Nov. 21, 2024) made two solid arguments for summary judgment – preemption based on the FDCA’s recall regulations and plaintiff’s lack of admissible expert testimony.  The trial court rejected both.  The appellate court, however, saw the merit in the

Photo of Steven Boranian

Every time we read an order about “pre-approval” defects in prescription drugs, we stop to scratch our heads.  It is not because we are easily confused, at least not on most days.  No, we pause to ponder what exactly a “pre-approval” defect is and how a company can be held to answer for an alleged