We’ve reported several times about Thorogood v. Sears, Roebuck & Co., the endless class action drama currently playing in the Seventh Circuit. In “There’ll Always Be Posner: Final Rinse,” we summarized Judge Posner’s opinion holding that the district court should have enjoined plaintiffs and plaintiff’s counsel from filing class actions concerning Sears stainless steel
TwIqbal & PMA Preemption, Perfect Together
We’ve blogged repeatedly about preemption in PMA medical device cases. We’ve also had a lot to say about using TwIqbal (that is Ashcroft v. Iqbal, 129 S.Ct. 1937 (2009), and Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007)) to police plaintiffs’ persistently poor pleading habits.
Today we’re synergizing the two, and looking at what defendants can do when they mix TwIqbal and PMA preemption together. We’ll tell you this up front – the result is quite to our liking – more like peppermint and egg nog, rather than, say, chocolate and ketchup.
What makes PMA preemption cases so amenable to TwIqbal treatment is that, after Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), PMA cases basically boil down to “parallel” violation claims. This limitation means that, to plead an unpreempted claim, a plaintiff has to allege something that’s: (1) a violation of the Food, Drug and Cosmetic Act (“FDCA”), and (2) also a violation of independent state law. This is also something we’ve discussed at length, for instance here, here, and here. But we’re not doing doctrine today, we’re doing pleading, so simply accept that legal framework for now.
There are a lot of plaintiffs out there who don’t do their homework. If they’re aware of the Riegel problem at all, they’ll try to fudge things by throwing in a warning letter if they’ve got one. But a lot of the time, we’ll get a standard, fill-in-the-blanks, form product liability complaint with a PMA device filled in. That’s not because plaintiffs’ lawyers are any lazier than the rest of us (we don’t think), but more a reflection on how contingent fees affect incentives to do legal spadework. When time isn’t money, time consuming (not to mention money consuming) things don’t get done.
The standard complaints don’t require very much TwIqbal. See Lemelle v. Stryker Orthopaedics, 698 F. Supp.2d 668, 678 (W.D. La. 2010) (TwIqballing claim that didn’t mention a violation at all); Yost v. Stryker Corp., 2010 WL 1141586, at *4-5 (M.D. Fla. Mar. 23, 2010) (complaint “only asserts a state law, without reference to a federal violation, [and] is preempted”); McQuiston v. Boston Scientific Corp., 2009 WL 4016120, at *7 (W.D. La. Nov. 19, 2009) (“[a] claim asserting that [defendant] did not comply with FDA specifications simply does not exist in the petition”). They’re pretty much sitting ducks for Riegel preemption motions because all they allege is garden variety negligence, strict liability, and warranty claims.Continue Reading TwIqbal & PMA Preemption, Perfect Together
Smoking the FDA
A while ago we posted about the FDA’s attempt to ban electronic cigarettes – essentially a way for smokers to get whatever they get from nicotine by flash vaporizing the stuff. Because there’s no smoke, these products were a way, after a fashion of “smoking everywhere” – hence the name.
As we mentioned in that post, the FDA’s nanny-state objectives were pretty well hosed in Smoking Everywhere, Inc. v. FDA, 680 F.Supp.2d 62 (D.D.C. 2010).
As a follow-up, we’re pleased to report that the opinion preventing the FDA from banning electronic cigarettes – basically because they don’t like them – has been affirmed. See Sottera, Inc. v. FDA, 2010 WL 4942132, (D.C. Cir. Dec. 7, 2010) – for the FDA, a date that will live in infamy.
These electronic cigarettes affected the FDA in a way resembling Pavlov’s dogs. The Agency hears “nicotine” and immediately starts salivating … “addiction.” That’s bad, so let’s ban it.
The FDA tried to carry out its ban by calling nicotine a “drug,” and/or an electronic cigarette a “medical device” – a means of dispensing nicotine. Sorry Charlie, this “product is marketed and labeled for ‘smoking pleasure,’ rather than as a therapeutic or smoking cessation product.” 2010 WL 4942132, at *1. That makes it tough to shoehorn electronic cigarettes into the category of “drug” or “medical device” – both of which have health claims as a prerequisite. See 21 U.S.C. §321(g)(1)(B) (drugs); 21 U.S.C. § 321(h)(2) (devices).
The FDA isn’t allowed to regulate pure hedonism. We think that’s a really good idea.
Now, it’s possible for the FDA to regulate tobacco products under a separate statute, the Tobacco Act, even where no health benefit is claimed. 2010 WL 4942132, at *3. But the FDA didn’t purport to do that, and the Act specifically doesn’t expand any other FDA authority – such as over “drugs” or “devices.” Id.Continue Reading Smoking the FDA
Should Drug And Device Lawyers Care About Global Warming?
We’ve posted about one of the big certiorari grants from yesterday – Wal-Mart Stores v. Dukes – so today, we’re taking a look at the other one – American Elec. Power Co. v. Connecticut, aka the “global warming” case. Here’s the link to the SCOTUSblog collection of case resources. Just as with Dukes,
Foreign Discovery Targets Beware
Any litigant (usually a foreign company, but not necessarily) who produces, in litigation in the United States, documents from a foreign source is exposing those documents to any and all federal criminal prosecutions. So sayeth the Ninth Circuit in In re: Grand Jury Subpoenas Served on White & Case LLP, Lieff, Cabraser, Heinemann, K&L Gates
The Dukes Cert. Grant – What It Is; What It Isn’t
The Supreme Court granted certiorari in the Dukes v. WalMart (now called WalMart v. Dukes) class action today. By blogging standards, that fact is probably old news. For example, here’s a New York Times story about the grant. The law profs’ blogs have also been all over this.
We weren’t even going to blog about this, except we’ve already had two people contact us and ask what we thought. Since we figure there’s some confusion about what Dukes is all about, we thought we’d better say something.
First, the text of the Court’s order is:
Petition GRANTED limited to Question I presented by the petition. In addition to Question I, the parties are directed to brief and argue the following question: “Whether the class certification ordered under Rule 23(b)(2) was consistent with Rule 23(a).”
That means, to know what’s going on, we have to go to the cert. petition – filed by WalMart as the petitioner, since it lost in the 9th Circuit below. That’s also why WalMart’s name goes first in the Supreme Court. The Court’s practice is always to list the petitioner first, even if it was the defendant in the lower courts (and thus went after the “v.” in those courts).
OK, we’ve dug out the petition. That first question is: “(1) Can claims for monetary relief be certified under Fed. R. Civ. P. 23(b)(2) – which by its terms is limited to injunctive or corresponding declaratory relief – and, if so, under what circumstances?”
So what is Dukes about? The briefest description we can give is that it’s about the scope of Rule 23(b)(2). We’ll get back to that.Continue Reading The Dukes Cert. Grant – What It Is; What It Isn’t
No, er, Kidding, Sherlock
Sometimes courts come out with rulings that surprise us, either pleasantly or unpleasantly. Sometimes courts are utterly predictable. There’s a little of both in the most recent chapter of the Iacangelo saga, which we’ve covered before here. Iacangelo v. Georgetown University, 2010 WL 4807082 (D.D.C Nov. 19, 2010). Plaintiffs brought suit on behalf of their daughter, who had been treated for arteriovenous malformation (AVM), an abnormal tangle of veins and arteries in her brain through which blood could not flow properly. The treating doctor used a method known as embolization, which involves using adhesives and other mechanisms to seal off the blood vessels feeding the AVM in the brain. In this case, the doctor used Histoacryl, a glue, and Lipiodol, a poppy seed-oil compound visible in X-rays. The FDA had not approved Histoacryl and Lipiodol for this treatment, either in combination or separately. Moreover, those substances could not be purchased from suppliers inside the United States. You might ask, “So what?” And you’d be pretty smart.
The treating doctor was named Watson, which accounts for the silly title of this post. In the old (1940s) Sherlock Holmes movies, Nigel Bruce played Dr. Watson as a dough-eye doofus, but in the original stories by Sir Arthur Conan Doyle, Watson was smart even if he lacked his buddy’s superhuman deductive powers. Dr. Watson was also something of a tough guy. He had been wounded in Afghanistan, and could handle a gun rather well. Perhaps most interestingly, in the first story, A Study in Scarlet, Conan Doyle wrote of Dr. Watson’s “experience of women which extends over many nations and three continents.” Hmmm. Maybe Jude Law’s recent portrayal of the good doctor wasn’t so far off the mark. And the words “good doctor” bring us back to the Iacangelo case.
The parties offered “wildly divergent accounts of what Dr. Watson told Ms. Kerris, her patients, and her husband.” 2010 WL 4807082 at *1. Since we’re at the summary judgment stage — for you non-lawyers, that means we don’t evaluate who’s telling the truth (although we have our suspicions) — we’ll go with plaintiffs’ allegations, including that Dr. Watson said that embolizations “had a 95% chance of success,” and that Dr. Watson never revealed that neither Histoacryl nor Lipiodol had been FDA approved.Continue Reading No, er, Kidding, Sherlock
Another Decision recognizing Preemption in an IDE Device Case
In Burgos v. Satiety, Inc., 2010 U.S. Dist. Lexis 125924 (E.D.N.Y. Nov. 30, 2010), the court held earlier in the week that all claims (negligence, strict liability, warranty) were preempted where plaintiff received the device in question (some sort of gastric stapling system) as part of an investigational device clinical trial. The entire discussion
On the Letter of the Law
First of all, yeah, we know about Wyeth v. Rowatt, ___ P.3d ___, 2010 WL 4812919 (Nev. 2010). We’re just extremely limited in what we can say, since here on the East Coast, Dechert handles similar hormone therapy litigation for the same client. Rowatt is one of those times when we most miss Herrmann.
Summary judgment in West Virginia even without the learned intermediary doctrine
West Virginia has rejected the learned intermediary doctrine, a bad decision we sliced and diced here and here. This left us wondering if a defendant has a shot of winning summary judgment on proximate causation in a West Virginia failure to warn claim. Many failure to warn claims can be defended by taking the