The advent of generic preemption in PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011) (“Mensing”), and Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013) (“Bartlett”), left plaintiffs who took generic drugs scrambling to invent bizarre, novel, and in some cases dangerous supposed causes of action. Before it went
On Promoting Off-Label Use
We’ve posted more times than we can count in support of the position that FDA-regulated manufacturers should be able to engage in truthful “promotion” of the off-label uses of their products. Well, on nationwide TV – and in the presence of the Commissioner of the FDA – on March 19, 2010 the President of the
Guest Post – The Supreme Court Addresses Purposes and Objectives Preemption in a Surprising New Context
Today’s guest post is by Tucker Ellis‘ Dick Dean, a longtime friend of the blog and our most prolific non-Reed Smith guest blogger. This post is a follow-on to the Blog’s discussions of purposes and objectives preemption in light of increasing skepticism about this aspect of preemption by some members of the Supreme
We Finally Have Something To Say About COVID-19
We haven’t had a word to say on the Blog about the biggest health story in the world. That was because, until now, there wasn’t a product liability angle to it. That’s now changed. On March 17, 2020, the U.S. Department of Health and Human Services (“HHS”) published in the Federal Register a “notice of
A Couple of Things
Here are a couple of things that happened recently (and no, we don’t mean a travel ban on Europe or the NBA cancelling the rest of its season). They’re not related, but separate posts would be too short.
First, last November we warned our colleagues that it was time to start thinking of alternative grounds
Territorial Limits to Pro-Plaintiff Member State Law Likely To Be OKed In EU
The DDL Blog has paid only sporadic attention to prescription medical product liability in the European Union, with a couple of posts, here and here. Today, however, we discuss an EU Court of Justice (“E.C.J.”) Advocate General’s opinion concerning medical device product liability, and specifically the extent to which a plaintiff from one of
Always Liability Increases? – Don’t Mess With Texas!
Not too long ago we criticized a proposed “restatement” from the American Law Institute that sought to absolve plaintiffs who acted intentionally from having their conduct (such as stealing drugs, deliberately taking someone else’s prescription), count as comparative fault in the lawsuits such plaintiffs frequently file against our clients. That particular proposal has been withdrawn
Is It Time To Reconsider Federal Officer Removal?
One way to remove a case to federal court that we haven’t discussed much is where the defendant is either a “federal officer” (not terribly relevant to our line of work), or else is a “person acting under that officer . . . for or relating to any act under color of such office.” 28
Adequate Warnings Should Be Enough
It seems so obvious as not to require a citation – but this is the Drug and Device Law Blog, so we’ll provide some anyway.
Furnishing an adequate warning satisfies a product manufacturer’s duty to warn.
Thus, in a prescription medical product case, “if the manufacturer provides complete, accurate, and appropriate warnings about the product
More on Genetic Testing Orders
We’ve discussed before how we expect genetic testing of plaintiffs to become routine in prescription medical product liability litigation. The cost of such testing is constantly plummeting, even more steeply than would be predicted by Moore’s Law. We even proposed a rule of federal procedure to govern the conditions under which such testing could