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
Michigan Ct. App. Holds that PREP Act Preempts Claim against Tainted Remdesivir
Covid-19 is not over. Per doctor advice (namely, that geezers whose primary form of exercise consists of removing Meursault corks should do their best to avoid Covid) we recently received yet another Covid-19 jab. We’re not up to double digits yet, but cannot be far from it. For those of you who would gleefully castigate
E.D. Texas Invalidates FDA Effort to Regulate Lab Tests as Devices
These days there are two topics that dominate legal conferences, presentations, and CLEs: artificial intelligence (AI) and Loper Bright. You will doubtless see us frequently bloviate about the former, but today’s case – American Clinical Laboratory Ass’n v. Food and Drug Administration, 2025 U.S. Dist. LEXIS 59869, 2025 WL 964236 (E.D. Tex. March
N.C. Supreme Court Refuses to Extend PREP Act Preemption to Constitutional Claims
The recent case of Happel v. Guilford County Bd. of Educ., 2025 N.C. LEXIS 191, 2025 WL 879618 (N.C. March 21, 2005), will probably provoke a political debate, but that is not why your friendly neighborhood DDL blog has it up for discussion today. In Happel, the North Carolina Supreme Court created an
PA Supreme Court Holds that Off-Label Use of CBD is Reimbursable by Workers’ Comp
You can find useful legal precedents in surprising places. For example, Schmidt v. Schmidt, 2025 Pa. LEXIS 389 (Pa. March 20, 2025), is an interesting off-label use decision coming in a context that that most litigants of such cases will miss: a workers’ compensation case. But if you have been following this blog, Schmidt
Tubal Ligation Clip Claims Held to be Preempted
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
New York Appellate Court Reverses Denial of Summary Judgement and Holds No Duty to Warn of Someone Else’s Product
The Butler Snow contingent on the DDL blogging team had nothing to do with this post.
New York law is surprisingly good for defendants. Or maybe we’re jaded by bad experiences in other jurisdictions, and New York law manages to seem fair only by comparison. Certainly, we’d rather be in a courtroom in New York
Bair Hugger Rule 702 Disappointment Visits the Lehigh Valley
We’ve written many blogposts kvetching about rulings in the Bair Hugger Multidistrict Litigation (MDL) out in Minneapolis. See here, for example. The rulings on expert admissibility in the Bair Hugger MDL were particularly weak. But surely the rulings would be much better in our home district of the Eastern District of Pennsylvania, right? And
Fourth Circuit Affirms Conviction of Doctor for Off Label Use of Medical Device
United States v. Jackson, 2025 U.S. App. LEXIS 1261, 2025 WL 249109 (4th Cir. Jan. 21, 2025), is a criminal case involving off-label use of a medical device. The Fourth Circuit affirmed the conviction of a doctor for violating the Food, Drug, and Cosmetic Act, aggravated identity theft, and related offenses. The court sentenced
Court Dismisses Plaintiff’s Spinal Cord Stimulator Consumer Protection and Negligence Claims
In the litigation strategy class we teach at Penn Law, we always set aside a few minutes to go over the Aristotelian rhetoric trilogy of logos, pathos. and ethos. As you probably already know, logos is the persuasive value of an argument’s logic, pathos is the power of sympathy, and ethos refers to one’s character