It’s MLK day. It’s a firm holiday, we’re not supposed to be here, but we are. But since it’s a holiday, rather than write a substantive post (that’s work), we thought we’d take care of some other business.
First, our sharp-eyed readership has probably already noticed, but there’s been a minor site change. The
As long-time readers know, this blog was founded by a couple of guys who first got to know each other defending co-defendant manufacturers in the Orthopedic Bone Screw Mass Tort. That fact significantly colors what you read here. A lot of the issues that we harp on – off-label use, medical device preemption, fraud on the FDA, cross-jurisdictional class action tolling, broken device cases, expert testimony on issues of (FDA) law (that’s just off the tops or our heads) – we spent close to a decade litigating in Bone Screw land.
It wasn’t a bad living. 360 (requires subscription) recently named one of our old Bone Screw cases (Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001)) as the top product liability case of the last decade. (It also stole a post idea we’d kicked around but never gotten off our duff to write up). Even though we’ve moved on, our pet peeves haven’t.
But probably the most singularly “Bone Screw” issue was the theory that a surgeon could be liable under an “informed consent” rationale just because s/he didn’t tell a patient about the FDA regulatory status (that is to say, off-label use) of the drugs/medical devices used in the patient’s treatment. And we Bone Screwers killed that theory dead – maybe not as dead as we killed fraud on the FDA, but pretty darn close.Continue Reading Once More Into The Breach
We’ve previously written about Allergan’s First Amendment challenge to the FDA’s regulations relating to off-label promotion (here (last of four parts), here, and here), but in the grand tradition of the First Amendment, the war of words is escalating, mud is being slung, and court filings are name-dropping Trojan priests – but more on that later.
The past month has been busy, with the government filing its “Motion To Dismiss Or For Summary Judgment,” the public interest group Public Citizen filing an amicus brief supporting the government. As we discussed earlier, a consortium of public interest groups (some rare disease associations and the Washington Legal Foundation) already made an amicus filing in support of Allergan’s motion – we guess Public Citizen’s trying to even the score.
Anyway – the government’s motion. It is a 45-page whopper chock-full of pronouncements about the practical effect of numerous FDA regulations relating to promotion and labeling, so it is definitely worth a read for anyone interested in this area of the law. We’re only providing the highlights here.
The motion does exactly what you’d expect. It first tries to sidestep the grave constitutional issues raised by Allergan by claiming this whole shooting match isn’t ripe for adjudication. So how does the government do that? It argues that Allergan’s case relates to two proposed communications: (1) truthful warnings and safety information relating to the (off-label) use of Botox to treat a number of spasticities; and (2) promotional speech relating to an off-label use for which Allergan has an sBLA (that’s jargon for a supplemental application for approval, involving a biologic) pending. Because Allergan hasn’t actually said anything yet on these two topics, the FDA hasn’t had the opportunity to shut that speech down. Therefore, says the government, where’s the beef? (OK, those are our words, but that’s the gist of the argument).
Now, the government has a bit of a problem here, because the ripeness requirement is relaxed in the First Amendment context. The government acknowledges this, but then goes on to argue that there is no live dispute involving “actual or threatened application” of a regulation to bar particular speech. Mot. at 13 (quoting Renne v. Geary, 501 U.S. 312, 320 (1991)). We don’t think that makes a whole lot of sense (unless you’re the government). The government’s actually saying that Allergan has to expose itself to actual prosecution – at least in the FDA’s eyes – in order to tee up this arcane, convoluted regulatory scheme for scrutiny by a court? Hmm. But we get the strategy. Every lawyer remembers first-year Con Law; courts don’t reach constitutional issues unless they have to do so, and the government’s clearly hoping that it can play keepaway until at least April, when the FDA expects to issue a decision on the sBLA.Continue Reading Beware The FDA Bearing Regulations: An Allergan Update
We can’t say much about the Neurontin litigation because our firm has some involvement, but anybody who has to oppose a third-party payer action brought as a class action should read In re Neurontin Marketing and Sales Practices Litigation, ___ F. Supp.2d ___, 2010 WL 53568 (D. Mass. Jan. 8, 2010). The case decides various
We fight with plaintiff lawyers all the time. Some mornings we roll out of bed and immediately start swinging. So we love it when plaintiff lawyers decide to mix it up with us, grab a pen (or keyboard), and write rejoinders to our blog posts. Recently, Nuvaring plaintiff lawyers wrote an article in Product Liability
Remember the old SNL Weekend Update report: “This just in, Generalissimo Francisco Franco is still dead”? In that spirit, we bring you today’s post.
In the wake of the Chinese heparin scandal, the FDA has promised stepped-up enforcement of CGMP (see one report on the FDA Law Blog, here). And where there is
Just before the new year Medtronic’s litigation team brought home yet another preemption win that bears discussion. In Ilarraza v. Medtronic, Inc., slip op. (E.D.N.Y. Dec. 28, 2009), the plaintiff took one look at the law of preemption (but only after filing suit); filed an amended complaint that dropped all his prior claims (the
Remember Gresham’s law? If you ever suffered through Econ 101 in college, chances are you do. That’s the proposition that “bad money drives out good.” More generally, what Gresham’s law is all about is that if there’s a choice between doing something the “good” way and doing the same thing by way of some “bad” shortcut, if the shortcut is allowed, everybody will go that way. “Good” can be enforced through everything from legal sanctions (don’t commit fraud) to moral suasion (signs in the wilderness stating that “cutting switchbacks damages the trail”).
But if “bad” is not only allowed, but rewarded, then “bad” will definitely replace the corresponding “good.”
Well, Tom Gresham, meet mass torts.
The Eighth Circuit handed down a stinker of a ruling yesterday in In re Prempro Products Liability Litigation, No. 09-1205, slip op. (8th Cir. Jan. 6, 2010) (hereafter “PPLL”). As the name indicates, it arose from the Prempro MDL. But the identity of the drug hardly matters – or even whether the product was a drug. It could be any mass tort, as far as we’re concerned.
That’s also convenient because Dechert is now involved in the litigation involving these products, so we have to steer away from anything concerning the merits of that litigation.
So what happened in PPLL? It’s the latest round in the endless tactical tug of war between plaintiffs who prefer to litigate in state court (elected judges, more home cooking, less strict rules on everything from pleading to class actions to experts) and defendants who prefer to litigate in federal courts (lifetime tenured judges, more resources = more opinions, stricter rules, etc.). It involves something called “fraudulent misjoinder.”
What’s that? Well, under the rules, every plaintiff is supposed to file his/her/its lawsuit individually. That means pay the court’s filing fee (one way the judicial branch supports itself), and have jurisdiction – importantly, diversity jurisdiction – determined by who the parties are. (Aside for non-lawyers: “diverse” = plaintiff and defendants are citizens of different states; “non-diverse” = citizens of same state on both sides of the “v.”).
There are exceptions. Federal Rule 20 governs “permissive joinder.” It provides that plaintiffs or defendants may be “joined” in the same lawsuit if there’s a claim (called a “right to relief”) asserted either by more than one plaintiff or against more than one defendant: (1) that involves (called “arising out of”) “the same transaction, occurrence, of series of transactions or occurrences” and (2) “any question of law or fact common to” all plaintiffs or defendants “will arise in the action.”
“Misjoinder” is any joinder of parties that’s in violation of Rule 20 (or an equivalent state court rule).Continue Reading Gresham’s Lawyers
We’ve been critical of the non-management of pleading issues in the Nuvaring MDL (see here).
We’re not going there again today. Rather, we’re discussing how these issues can be handled – even if there’s not technically an MDL.
Kudos to New Jersey District Court Judge Freda Wolfson, who is handling consolidated (non-MDL) litigation concerning the drug Plavix. She had 24 individual actions from sixteen states all alleging injury from the same drug. Taking this dilemma by the horns, Judge Wolfson refused to allow plaintiffs to get away with vaguely pleaded claims by obscuring them in a legal thicket of multiple different jurisdictions’ consumer fraud and negligent misrepresentation causes of action.
See: Hall v. Bristol-Myers Squibb Co., 2009 U.S. Dist. Lexis 121057 (D.N.J. Dec. 30, 2009) (applying Florida law); Begley v. Bristol-Myers Squibb Co., 2009 U.S. Dist. Lexis 121058 (D.N.J. Dec. 30, 2009) (applying Illinois law); Bunting v. Bristol-Myers Squibb Co., 2009 U.S. Dist. Lexis 121059 (D.N.J. Dec. 30, 2009) (applying Colorado law); Smith v. Bristol-Myers Squibb Co., 2009 U.S. Dist. Lexis 121062 (D.N.J. Dec. 30, 2009) (applying Pennsylvania law); Barge v. Bristol-Myers Squibb Co., 2009 U.S. Dist. Lexis 121080 (D.N.J. Dec. 30, 2009) (applying Georgia law); Robinson v. Bristol-Myers Squibb Co., 2009 U.S. Dist. Lexis 121082 (D.N.J. Dec. 30, 2009) (applying Maryland law); Moscinski v. Bristol-Myers Squibb Co., 2009 U.S. Dist. Lexis 121084 (D.N.J. Dec. 30, 2009) (applying Wisconsin law); Solomon v. Bristol-Myers Squibb Co., 2009 U.S. Dist. Lexis 121092 (D.N.J. Dec. 30, 2009) (applying Texas law); Gonzalez v. Bristol-Myers Squibb Co., 2009 U.S. Dist. Lexis 121093 (D.N.J. Dec. 30, 2009) (applying New York law); Money v. Bristol-Myers Squibb Co., 2009 U.S. Dist. Lexis 121094 (D.N.J. Dec. 30, 2009) (applying Oklahoma law); Cooper v. Bristol-Myers Squibb Co., 2009 U.S. Dist. Lexis 121095 (D.N.J. Dec. 30, 2009) (applying Alabama law); Adkins v. Bristol-Myers Squibb Co., 2009 U.S. Dist. Lexis 121096 (D.N.J. Dec. 30, 2009) (applying Tennessee law); Mattson v. Bristol-Myers Squibb Co., 2009 U.S. Dist. Lexis 121114 (D.N.J. Dec. 30, 2009) (applying California law); Mayberry v. Bristol-Myers Squibb Co., 2009 U.S. Dist. Lexis 121115 (D.N.J. Dec. 30, 2009) (applying Mississippi law); Street v. Bristol-Myers Squibb Co., 2009 U.S. Dist. Lexis 121120 (D.N.J. Dec. 30, 2009) (applying Ohio law); Carr-Davis v. Bristol-Myers Squibb Co., 2009 U.S. Dist. Lexis 121155 (D.N.J. Dec. 30, 2009) (applying Missouri law).
As you might think, a lot of water went under the bridge to reach this point. Between October 2006 and March 2007, 24 individual cases were filed against Bristol-Myers Squibb and Sanofi-Aventis about the drug Plavix. The plaintiffs, who were from all over the United States (but not from New Jersey), invoked diversity and asserted claims under, of all things, New Jersey law.Continue Reading Mopping it up
This just in: The Eighth Circuit has affirmed the Baycol MDL judge’s authority to enjoin the plaintiffs, after losing a class certification motion in the MDL, from running to a (presumably) friendly state-court judge to get the same class certified. Here’s a link to the opinion.
What happened is that one West Virginia law based consumer fraud (that is, economic losses only) class action was removed to federal court and became part of the Baycol MDL. Class certification was denied. In re Baycol Products Litigation, 218 F.R.D. 197, 202 (D. Minn. 2003) (omnibus complaint); In re Baycol Products Litigation (McCollins), No. 02-0199, slip op. (D. Minn. Aug. 25, 2008) (West Virginia specific order).
While all this was going on, a second, substantively identical class remained in West Virginia state court because there was no diversity of citizenship. After none of the federal decisions, the West Virginia plaintiffs pressed for certification in the parallel state court suit. Slip op. at 4-5.
The defendant sought to enjoin prosecution of the West Virginia do-over in state court, and the MDL judge granted the injunction.
As the Eighth Circuit observed, these kinds of forum-shopping shenanigans by plaintiffs looking for a do-over can’t happen any more, thanks to CAFA. Slip op. at 3.Continue Reading Baycol Class Action End Run Stuffed