Sometimes we read a decision in favor of the defense that makes it seem like getting the good result was easy. The court summarily disposes of plaintiff’s arguments, adopts the defendant’s reasoning, and might throw in a comment or two about things the plaintiff could have done—but didn’t. But getting those good results is almost
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Off-Label Prescribing Is Not A Crime
By Lisa Baird
Today’s post is about one of our favorite topics, off-label use. This time, it isn’t about what manufacturers can say about unapproved uses. It’s about whether the DOJ can wield the FDCA’s misbranding provisions to criminally investigate hospitals whose physicians prescribe FDA-approved drugs for off-label purposes.
In In re Administrative Subpoena 25-1431-032 to Rhode…
It Is Indeed Time To Reconsider Federal Officer Removal
By Bexis
Back in 2020, we published a post, “Is It Time To Reconsider Federal Officer Removal?” It discussed a Fifth Circuit asbestos case, Latiolais v. Huntington Ingalls, Inc., 951 F.3d 286 (5th Cir. 2020), overruled prior precedent in light of a congressional amendment to the federal officer removal statute, 28 U.S.C. §1442(a), that broadened…
“Shall Not Be Used” Means Shall Not Be Used
The court in In re Acetaminophen—ASD-ADHD Products Liability Litigation confronted a problem that should not have existed in the first place–plaintiffs’ co-lead counsel violating confidentiality and coordination orders that he had helped negotiate.
The underlying orders were straightforward. The MDL confidentiality order protected confidential and highly confidential information produced in the litigation and prohibited the…
One Headcount To Learned Intermediary Rule Them All – Part 1
By Bexis
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.,…
California Supreme Court Hears Argument On The “Duty to Innovate”
We observed arguments last week in the California Supreme Court in Gilead Tenofovir Cases, and quality advocates on both sides put on a great performance. As we previewed last week, the case presents a question with potentially sweeping consequences for product liability law: Does a pharmaceutical manufacturer owe a duty of reasonable care to…
A Device That Uses Magnetic Levitation Sounds Pretty Innovative To Us
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…
CGMPs: Changing Good Manufacturing Practices (and Preemption)
By Lisa Baird
In the drug and device product liability world, we love our acronyms and our short-hand phrases. The MDAs to the FDCA. Class III. PMA. 510(k).
Today’s acronym is CGMP, which sometimes you will see written as “cGMP”. The GMP stands for Good Manufacturing Practices, and the “C” (or “c”) has, since a 1996 Final Rule…
Preemption Round Two in the Eastern District of New York
By Eric Hudson
About a year ago we blogged about a strong preemption decision from the Eastern District of New York, Gallego v. Tandem Diabetes Care, Inc., 2025 WL 948282 (E.D.N.Y. March 28, 2025). Gallego involved a Class III insulin injection pump that sent a warning alarm to its user that insulin was no longer being delivered.…
An Expert Weighs in on Privilege and TPLF Discovery
By Bexis
Bexis has been working with Lawyers for Civil Justice on a number of projects, including the currently pending initiative to enact a federal rules amendment that requires meaningful disclosure of third-party litigation funding (“TPLF”) on essentially the same rationale that insurance policies are routinely disclosed under Fed. R. Civ. P. 26 (a)(1)(A)(iv). As part of…