We reported a couple of months ago on important decisions in the Fourth Circuit that invalidated state laws in West Virginia and Maryland purporting to compel pharmaceutical manufacturers to deliver steeply discounted prescription medicines to unlimited numbers of pharmacies under the federal 340B drug discount program. Because the opinions created a circuit split on a
The now well-known requirement from the TwIqbal cases that a complaint contains factual allegations that establish that relief is plausible derives from Rule 8(a)(2) requirement that each pleading contain “a short and plain statement of the claim showing that the pleader is entitled to relief.” One recurring point of contention in drug and device litigation
This post is from the non-RS side of the Blog.
Consider the following scenario. A fifty-two-year-old woman has end-stage left ventricular heart failure despite medical care and the latest medications. Her prospects for a heart transplant or the implantation of a left-ventricular assist device to prolong her life are limited, including by financial considerations. She
That title might be overblown, because we are discussing only two cases. But one of them is the Roundup case, and we could not resist the cheesy wordplay.
Roundup is neither a drug nor device. It is regulated by the Environmental Protection Agency (EPA), not the Food and Drug Administration (FDA). Nevertheless, the Federal Insecticide
Can states compel prescription drug manufacturers to deliver steeply discounted medicines to unlimited numbers of pharmacies? That is the issue that has been kicking around federal courts for a few years now, and the Fourth Circuit has now weighed in by answering “no.”
We are talking here about drugs purchased under the federal government’s 340B
This post comes from the non-RS side of the Blog.
Prescription medications for psychiatric conditions fill an important role in modern healthcare. They tend to have labels with lots of information about the risks of various emotional, psychological, and neuroreceptor-mediated conditions, including worsening of the underlying conditions being treated, interactions with other medications or substances
This post is from the non-Reed Smith side of the blog.
They say it’s better to be lucky than good. But in Luckey v. Abbott Laboratories, Inc., 2026 WL 836122 (E.D. Ky. Mar. 26, 2026), plaintiff was neither.
This is a straightforward—and satisfying—PMA preemption decision involving a heart valve allegedly marketed to last at
Today’s case, Kouyate v. L. Perrigo Company, 2026 WL 591874 (W.D. Mich. Mar. 3, 2026), is the latest entry in the ever-growing pile of meritless benzene OTC class actions. This time, the target is acne treatments containing benzoyl peroxide (BPO), with the now-familiar allegation that BPO degrades into benzene during storage and shipping. If
Five months ago, we posted on a decision from an Ohio intermediate appellate court finding that a state AG action against sellers of vaping products was impliedly preempted under Buckman. Part of what got our attention about the decision in State ex rel. Yost v. Cent. Tobacco & Stuff, Inc., No. 24 CAE
If ever there were a case that reads like a checklist for how not to plead around preemption, it’s Dunham v. Boston Scientific Corp., — F.Supp.3d–, 2026 WL 539533 (W.D. Mich. Feb. 24, 2026). Plaintiff alleged that his spinal cord stimulator—a Class III, premarket approved device—implanted to treat his chronic back pain caused him