Reed Smith won two separate decisions in New Jersey yesterday. One of them, In re NuvaRing Litigation, No. Ber-L-3081-09, slip op. (N.J. Super. L.D. April 19, 2013), we’re not at liberty to discuss, but if you’re on our side, you won’t be disappointed reading it – in all its 91-page splendor.

The other, decision,

Three days ago, the United States Supreme Court unanimously upheld the federally-backed regime in Cafastan against the latest insurgent assault in Standard Fire Insurance Company v. Knowles, ___ S. Ct. ___, 2013 WL 1104735 (U.S. March 19, 2013).  The insurgents, in an attempt to avoid federal jurisdiction under CAFA, resorted to using the local populace (or at least, their purported absent class members’ claims) as a human shield.  The insurgents’ ultimatum?  Regardless of how much the would-be class’ claims might actually be worth, those claims will be decapitated, so that they cannot recover the minimum CAFA jurisdictional amount, which is $5 million.

The Supreme Court freed the hostages, holding, in accordance with Smith v. Bayer Corp., 131 S. Ct. 2368, 2380 (2011), that putative class representatives and their counsel were without power to bind the supposed class and decapitate their claims in this way:

The stipulation [plaintiff] proffered to the District Court, however, does not speak for those he purports to represent.  That is because a plaintiff who files a proposed class action cannot legally bind members of the proposed class before the class is certified.  Because his precertification stipulation does not bind anyone but himself, [plaintiff] has not reduced the value of the putative class members’ claims.

2013 WL 1104735, at *3-4 (citations omitted).  Because jurisdiction – and thus, the jurisdictional amount – is determined “as of the time [the action] was filed in state court,” id. at *4, the Court held that the insurgents were subject to extraordinary rendition to Cafastan, where their own claims might be subject to decapitation by stipulation, but not those of absent class members:

[T]he stipulation at issue here can tie [plaintiff’s] hands, but it does not resolve the amount-in-controversy question in light of his inability to bind the rest of the class.  For this reason, we believe the District Court, when following [CAFA] to aggregate the proposed class members’ claims, should have ignored that stipulation.

Id. at *6.Continue Reading Thirty Days In The Hole?

We’ve chronicled many times the largely unsuccessful attempts of third-party payers (in unholy alliance with plaintiffs’ lawyers) to sue derivatively over alleged off-label promotion of prescription drugs and medical devices.  Basically, these insurers, having already set their premiums and recovered for their expenses, take “free shots” at trying to get money back for what are

Our initial post about Bartlett v. Mutual Pharmaceutical Co., ___ F.3d ___, 2012 WL 1522004 (1st Cir. May 2, 2012), was more or less a crie de coeur over what we saw as an essentially absurd result:  that while a simple warning claim involving a generic drug is indisputably preempted under PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011), a claim much more fundamentally in conflict with FDA approval of generic drugs – that state tort law can impose liability for not removing an FDA-approved product off the market entirely – supposedly is not.
Plain and simple, the preemption result in Bartlett makes no sense.
Today we take a closer look at the Bartlett opinion and the reasoning, if it can be called that, that brought the court to its highly questionable result.
Two fundamental facts underlie Bartlett:  First, the plaintiff had (at least in theory) lost her warning-based claim for lack of causation – the prescribing physician did not read or otherwise rely on the allegedly inadequate warning, rendering the warning non-causal.  Second, for whatever reason, the defendant at trial made the strategic decision (which with the benefit of 20-20 hindsight now seems disastrous) not to offer any affirmative defense at all.
The plaintiff’s lack of a warning claim itself had two effects.  One, plaintiff was damn lucky, because warning claims against generic drugs were precisely what the Supreme Court held to be preempted in Mensing.  A verdict in Bartlett based upon a warning claim – the most common theory – would undoubtedly have been overturned before the First Circuit ever saw the case.  Two, since both Mensing and Wyeth v. Levine, 555 U.S. 555 (2009), involved warning claims (again, they’re the most common), neither case was 100% on point.
Bartlett initially demonstrates why “design defect” simply doesn’t fit prescription drugs (some medical devices are different).  As the First Circuit mentioned, you can’t change the “design” of something that “is a one-molecule drug; and the variations in [it] as sold consist of inactive ingredients that ordinarily do not have significant pharmacological effects.”  2012 WL 1522004, at *2.  The ordinary constraint on design defect claims – that there be an alternative design – does not exist where the product is a chemical molecule, let alone one that would require FDA re-approval if it were changed in any way that affected its safety or efficacy.Continue Reading More Thoughts On Bartlett

Sometimes good ideas don’t prevail the first time – or even the first few times – they make their appearance.  With that in mind we bring to your attention Windle v. Synthes USA Products, Inc., 2012 U.S. Dist. Lexis 52397 (N.D. Tex. April 13, 2012).  Windle was a removal attempt – an unsuccessful one

There hasn’t been a lot of talk about this, but Congress just passed, and the President signed, something called the” Federal Courts Jurisdiction and Venue Clarification Act of 2011,” H. R. 394, P.L 112-63, copy here.  As far as we’re concerned, this new act (we’ll call it, creatively, “the Act”) is as significant for what it didn’t do as for what it did.
The Act completely rewrote 28 U.S.C. §1441(b).  Why’s that important?  Because the literal language of §1441(b) – “removable only if none of the parties in interest properly joined and served is a citizen of the State in which such action is brought” – is what allows removal prior to service to trump the so-called “forum defendant” loophole.  As we’ve pointed out in many posts (most of which you can access from here), the “and served” qualifier to the forum defendant loophole means that, if an otherwise diverse action is removed before an in-state defendant is served, then that defendant’s citizenship, according to the statute, must be ignored and the action is properly in federal court.
That’s the express language of the statute.  The plaintiffs have responded with a mushy, result-oriented counter-argument that surely Congress didn’t mean what it said; that result would be absurd. As we’ve mentioned, some benighted courts have bought that rationale.
Well, that argument just went out the window.  Why?  Because in the Act (the 2011 one mentioned above), Congress had the opportunity to change §1441(b) if it was uncomfortable with the result dictated by that section’s express terms.  It didn’t.  Quite the contrary, while Congress completely rewrote §1441(b) in the Act, it retained (and arguably improved, see this law review article, pp. 162-63) the “properly filed and served” language verbatim in the new version.  After the Act, here’s how §1441(b) now reads:

(b) REMOVAL BASED ON DIVERSITY OF CITIZENSHIP. – (1) In determining whether a civil action is removable on the basis of the jurisdiction under section 1332(a) of this title, the citizenship of defendants sued under fictitious names shall be disregarded.
(2) A civil action otherwise removable solely on the basis of the jurisdiction under section 1332(a) of this title may not be removed if any of the parties in interest properly joined and served as defendants is a citizen of the State in which such action is brought.

Act §103(a)(3) (emphasis added).Continue Reading Removal News

We’ve decided that, since PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), product liability preemption in the context of generic drugs has come into its own and should no longer be lumped in with the overall topic of drug/vaccine preemption.  Thus we’re bestowing a new scorecard on post-Mensing generic drug preemption decisions. We’ll

Like everybody else we took a look at the Supreme Court’s decision in AT&T Mobility LLC v. Concepcion, slip op., 131 S. Ct. 1740 (U.S. 2011), on the Federal Arbitration Act’s preemption of state law limiting the enforceability of class action waivers.  However, just as the Capitol Steps’ first reaction to a political scandal is “what rhymes with it?” our first reaction to major new precedent is “is it useful in drug/device litigation.”
Our reaction to AT&T Mobility is “maybe.”  Reading the case, we don’t think that it’s possible to restrict it’s scope just to class-action-based arbitrations, which is it’s precise factual context.  Rather, since the motivating force behind FAA preemption is the “liberal federal policy favoring arbitration,” 131 S. Ct. at 1745, we’d have to say that state law purporting to invalidate limitations on non-arbitration class actions is a fortiori preempted.  By that we mean that, if contractual limits on class actions in arbitration are enforceable under the FAA, given its arbitration-friendly policy, then contractual limits on class actions outside of arbitration are even more favored, since litigated class actions are even more invasive of arbitration rights.
So we think that AT&T Mobility invalidates all state law attempts to obstruct arbitration waivers involving class actions, whether the state is attempting to preserve class action in or out of arbitration.Continue Reading AT&T v. Concepcion in Drug/Device Cases?

Our post the other day on Wolicki-Gables v. Arrow International, Inc., 2011 WL 780684, slip op. (11th Cir. March 8, 2011) (“W-G”), generated a fair amount of attention from some of the more sophisticated reporters who cover our field, because we discussed how the decision contributed to a growing circuit split concerning

We confess that we read McAdams v. Medtronic, Inc., 2010 WL 3909958 (S.D. Tex. Sept. 29, 2010), a while ago, but we weren’t sure what to make of it.  On the one hand, there’s an interesting idea in there.  On the other hand, it didn’t win in McAdams. We still don’t know if