A (relatively) long time ago in a state not so far away, the Michigan Legislature enacted the Michigan Product Liability Act. It contained a provision providing the manufacturers of FDA-approved drugs with immunity from product liability absent the application of two narrow exceptions. A challenge to the constitutionality of the provision soon followed and the
This guest post is by Reed Smith‘s Matthew Jacobson. It discusses the FDA’s recent guidance on the hot topic of 3D printing as a manufacturing practice for regulated drugs and medical devices, but not biologics (at least not yet). As always with our guest posts the author is 100% responsible for the content.
This post is from the non-Reed Smith side of the blog.
Do as I say, not as I do. A crutch used by parents worldwide to justify their own bad habits while trying to ensure their children don’t repeat them. Technically, it’s being a hypocrite. Sure, parents should strive to set an example through behavior.
Implied Preemption. Off-label promotion. TwIqbal. They make up a core of our posts, yet we never seem to tire of them. Maybe our readers, especially interlopers from the other side of the v., tire of reading about them, but we can often find a wrinkle in a case that merits our huzzahs or inspires
Back in 2013, Ramirez v. Medtronic Inc., 961 F. Supp.2d 977 (D. Ariz. 2013), made it to #9 on our worst cases of the year list – which is pretty good (actually, pretty bad) for a trial court decision. Purporting to apply Stengel v. Medtronic Inc., 704 F.3d 1224, 1228-31 (9th Cir. 2013)
We were recently asked the question, “are failure to contraindicate claims preempted?” Our immediate response was, “How could they not be”? However, it’s not helpful to answer a question with a question, and as with all things preemption, matters are not as simple as they might seem. Therefore, we thought we’d explore this issue in
Parties often file motions in limine on fairly case-specific issues, building on the history of discovery and motions practice in the case. Applying a ruling on in limines from one case to another can be a dicey proposition as potentially significant differences in the facts, law, claims and defenses asserted, and other rulings can
Now that Dr. Scott Gottlieb is safely installed as FDA Commissioner, we at DDLaw can end our moratorium on blogposts about First Amendment issues. There was no way we wanted to give his opponents any ammunition by saying nice things about Dr. Gottlieb before his confirmation.
Not so now.
Given what Dr. Gottlieb has said
Executions by lethal injection are in the news. Arkansas recently executed four inmates in just eight days. One of the drugs that it uses for its three-drug lethal injection protocol was set to move beyond its expiration date. And, apparently, Arkansas wanted to use them before that happened. It seems that states are finding
‘Pointing to the empty chair’ is a well-known defense trial tactic. It allows the defendant to go on offense. Maybe the plaintiff deserves some compensation, so the narrative goes, but the plaintiffs sued the wrong party. If the jury believes that narrative, it might exonerate the defendant completely. Or it might at least assign some