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
No one can sell a new drug without prior approval from the FDA. That rule is codified in the federal Food, Drug, and Cosmetic Act and is not controversial (or at least should not be controversial). Less clear is whether a seller of an FDA-approved drug can sue a competitor under state unfair competition laws
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
Taking pot shots at “Big Pharma” is easy. Crack a joke about Big Pharma and you are sure to get a laugh. Amirite?
That is not to say there is never a fair point or two to be made about pharmaceutical development or marketing, or health care and the delivery of same in this country.
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
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
The Supreme Court elucidated
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
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
Happy New Year. We are doing that usual January/Janus thing of looking both backwards and forwards. We are gearing up for a massive litigation in 2025, for a couple of trials, and for the January 16 Drug and Device Law webinar on the best and worst cases of 2024. And we’re still finding some 2024