Here’s a pop quiz. You’re a nurse. You’ve just used an insulin pen on Patient A. Do you: (a) use the same pen on Patient B or (b) grab Patient B’s own pen? If you picked (a), please put down the syringe, because you have apparently never heard of a little thing called the germ
Learned Intermediary
Claims Can Still Be Preempted If The Drug Is Later Withdrawn
Long ago, it seemed that large-scale drug or device litigation was usually spurred on by a recall, market withdrawal, or major labeling change describing a new risk or limiting the scope of product use. The plaintiff lawyers these days seem to be more willing to put their energy into attacking currently marketed products without triggering…
Pedicle Screw Robots (and some World Cup)
You’ve probably noticed there’s been a lot of soccer going on recently. We don’t purport to be experts on the “beautiful game,” but every four years we find ourselves riveted by a sport we don’t always watch and sometimes don’t understand. The expanded field of 48 teams generated lots of unexpected excitement, and we thoroughly…
Prescription in All But Name: Illinois Reverses Multi-Million Dollar Baby Formula Verdict Under the Learned Intermediary Doctrine
Baby formula is not a prescription drug. No doctor hands you a slip of paper for it. The FDA does not regulate it that way. And yet — when a premature newborn receives cow-milk-based preterm formula through a tube in a neonatal intensive care unit, administered by hospital staff, ordered by neonatologists, selected after individualized…
Evidence of Retention Is Not Evidence of Causation: Oklahoma Affirms Summary Judgment in Gadolinium Case
Gadolinium is a heavy metal. Sounds ominous. But it is also the active component in contrast agents used in more than 100 million MRI procedures — and its accumulated safety record is, in the words of plaintiff’s own literature, “extraordinarily positive.” Combs v. Bayer AG, 2026 WL 1693470, at *11 n.19 (Okla. App. Ct.
One Headcount To Learned Intermediary Rule Them All – Part 3
Here at the Blog, we love the learned intermediary rule. We’ve chronicled the rule’s steady expansion as it now has precedential support in all fifty states. “Every state in the country, along with the District of Columbia and Puerto Rico, has adopted the learned intermediary doctrine in some iteration.” Dearinger v. Eli Lilly & Co.…
One Headcount To Learned Intermediary Rule Them All – Part 2
Here at the Blog, we love the learned intermediary rule. We’ve chronicled the rule’s steady expansion as it now has precedential support in all fifty states. “Every state in the country, along with the District of Columbia and Puerto Rico, has adopted the learned intermediary doctrine in some iteration.” Dearinger v. Eli Lilly & Co.…
One Headcount To Learned Intermediary Rule Them All – Complete 50-State Survey
Here at the Blog, we love the learned intermediary rule. We’ve chronicled the rule’s steady expansion as it now has precedential support in all fifty states. “Every state in the country, along with the District of Columbia and Puerto Rico, has adopted the learned intermediary doctrine in some iteration.” Dearinger v. Eli Lilly &…
The Learned Intermediary Rule & Preserving the Physician/Patient Relationship
The learned intermediary rule – that prescription medical product warnings are directed to (and written to be understood by) the professional medical personnel who prescribe them – is as close to unanimous as any tort doctrine that we know of. We keep a running tab on the 50 states, and the rule has support in…
The Narrow Gap Is Not Wide Enough For Wieder
The latest medical device express preemption decision, Wieder v. Advanced Bionics LLC, 2026 U.S. Dist. LEXIS 70645, 2026 WL 880370 (S.D.N.Y. Mar. 31, 2026), comes out of the Southern District of New York and involves a Class III, PMA‑approved cochlear implant.
Fluid allegedly worked its way into the device and caused a short‑circuit and device…