Sabtu, 31 Agustus 2013

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Minggu, 25 Agustus 2013

A View from the Bench on MDLs

Last week we attended ACI’s Annual Drug and Medical Device Litigation Conference. As always, it was nice to be in New York City during the holiday season (though the persistent drizzle was less than festive) and even nicer to see so many friends.

The presentations were quite good and up-to-date. The Mensing discussion was especially enlightening. As usual, we were most eager for the judicial panel, and it did not disappoint. In fact, it was so good, we’re calling it an early Christmas gift.

The topic for the judges was recent MDL litigation. Judges Cogen, Cote, Herndon, Montgomery, and Waxse were all engaging and thoughtful. Here are a few of the highlights:

• The judges realize that there is virtually no agreement as to how much a transferee judge must accomplish prior to remand. (Well, maybe we already knew that).

• There are also a variety of approaches to selecting bellwether trials. Permitting the parties to select their strongest cases, even with vetoes, does not ensure trials of representative cases. And if they’re not representative, where’s the value for settlement? One judge tells each party to proffer cases along with arguments for why they are truly representative. He then chooses the most representative case. Like baseball arbitration, it builds in an incentive for each party to be reasonable.

• As that old Barbie doll said, “Math is hard.” So is science. But all the judges believe that Daubert forces judges to act as real gatekeepers. Consequently, judges – with plenty of help from the parties, lawyers, and experts – must do the homework to keep junk science away from the jury. It was pretty clear that all of the judges on the panel were hard workers and quick studies, and that they would not be the least bit shy to police expert evidence.

• It’s no surprise that all the judges dislike discovery disputes. What is a surprise is the array of creative techniques the judges use to resolve or curtail these disputes. Our favorite? Ordering the parties to videotape a follow-up meet-and-confer session. If the dispute isn’t resolved, the parties must send the tape to the judge. Guess what? Not a single tape has yet arrived.

• Fed.R.Civ.P. 26 has a couple of subsections that lawyers might want to read again (or, maybe, read for the first time). Here is what Rule 26(b)(2)(C) provides:

On motion or on its own, the court must limit the frequency or extent of discovery otherwise allowed by these rules or by local rule if it determines that:

(i) the discovery sought is unreasonably cumulative or duplicative, or can be obtained from some other source that is more convenient, less burdensome, or less expensive;
(ii) the party seeking discovery has had ample opportunity to obtain the information by discovery in the action; or
(iii) the burden or expense of the proposed discovery outweighs its likely benefit, considering the needs of the case, the amount in controversy, the parties’ resources, the importance of the issues at stake in the action, and the importance of the discovery in resolving the issues.

Thus, either in considering a party’s motion, or on its own, a court must limit discovery that isn’t worth the effort or expense. Proportionality matters. Wow. That’s an issue with most of the discovery we see. And here’s the kicker: Rule 26(g)(1)(B) requires lawyers to sign discovery requests and responses certifying that either they are complying with the discovery rules (including 26(b)(2)(C), and that what they are doing is

(iii) neither unreasonable nor unduly burdensome or expensive, considering the needs of the case, prior discovery in the case, the amount in controversy, and the importance of the issues at stake in the action.

If a certification violates Rule 26, the court “must impose an appropriate sanction on the signer, the party on whose behalf the signer was acting, or both.” Fed.R.Civ.P. 26(g)(3). It’s like a Rule 11 for discovery. One judge said that pretty much every discovery request and response he’s seen violates 26(b)(2)(C) and could conceivably warrant sanctions.

Take a look at the Notes to these provisions. Maybe courts seldom invoke these provisions, halt disproportionate discovery, and impose sanctions, but it’s clear that active judicial involvement was contemplated. For our part, we’re happy to have a judge engage in that proportionality analysis. We’re even happier when it’s done by judges who are smart, fair, and conscientious. Based on what we saw last week, we’re optimistic.

• We’re not sure this last point is the most significant in terms of jurisprudence, but it produced the single most lasting image from the conference. One judge said that looking through the activities in an MDL can be like going through the refrigerator, opening up Tupperware containers, and gaping in puzzlement and/or horror at the goodies within. Yeah – we’ve been there, both actually and metaphorically.

Rabu, 21 Agustus 2013

New Stuff #2

Our continuing interest in removal/remand strategies for extricating our clients from state-court hellholes comes as no surprise to anyone who’s been following our blog for any length of time.  In particular, we’ve advocated and (we flatter ourselves) helped to popularize the technique of pre-service removal – see our most recent prior post here.

Basically, pre-service removal eliminates a loophole in the federal removal statute that allows plaintiffs to keep cases in which diversity of citizenship indisputably exists in state court through the device of suing an in-state defendant - if that defendant has been "properly joined and served."  Pre-service removal eliminates this “forum defendant” loophole by removing the action to federal court before the plaintiff has sued the in-state defendant (or, indeed, has served anybody at all).

We’re pleased to pass along a new win on this issue in New Jersey, which is pretty much the pre-service removal “ground zero,” given the number of pharmaceutical manufacturers with the misfortune of being headquartered in this notoriously pro-plaintiff jurisdiction.  The case is Poznanovich v. AstraZeneca Pharmaceuticals LP, No. 3:11-cv-04001-JAP-TJB, slip op. (D.N.J. Dec. 12, 2011).

Poznanovich is a Nexium case where the plaintiff – an Illinois resident attracted by New Jersey’s pro-plaintiff reputation – chose to sue in New Jersey state court.  Two named defendants, AstraZeneca LP and KBI Sub Inc., were allegedly New Jersey citizens, but the other defendants managed to remove the case before either of those defendants was served with process.

The recurring question on remand (before the Honorable Joel Pisano) was the usual – does the court follow the express language of the removal statute, 28 U.S.C. §1441(b), which predicates the forum defendant loophole on that defendant being “properly joined and served”?  Go with the plain meaning of the statutory text and the removal is proper.  Make up some speculation that the plain text leads to some “absurd” result (why isn’t the forum defendant rule itself “absurd” in the 21st Century?) and a court can find a way to remand.

Poznanovich fortunately was willing to give Congress credit for meaning what it said.  Finding (quite properly) that precedent on this issue was “split” (without any binding appellate authority), slip op. at 3, the court chose to adopt the majority view of the New Jersey federal courts and denied remand.

[T]he Court concludes that the weight of the authority and better reasoning supports denial of Plaintiff’s motion to remand.  The Court finds that the language of the statute is plain, and, thus, adherence to the plain language is required. . . .  Here, Congress expressly used the phrase “properly joined and served,” and this Court should not adopt an interpretation of the statute which renders the “and served” language superfluous.  Under the unambiguous language of the statute, the presence of an unserved forum defendant does not prohibit removal by a non-forum defendant in cases where complete diversity exists.
Slip op. at 8.

The court also disposed of some subsidiary red herring arguments.  The first – whether the forum defendant itself could remove before service – went by the boards because the moving party wasn’t, in fact, a forum defendant.  A partnership’s citizenship is determined solely by the citizenship of that partnership’s members, and is not affected by anyone with whom the partnership may later decide to form other partnerships.  Poznanovich, slip op. at 3-4.  Here, the plaintiff’s overpleading, suing a bunch of unnecessary peripheral entities, came back to bite him, since one of those peripheral entities was able to remove as a non-forum defendant.

Second, the plaintiff argued that removal simply could not occur in the absence of formal service.  The court correctly perceived that argument as garbage.  Need not does not equal must not.  Supreme Court precedent (Murphy Brothers, Inc. v. Michetti Pipe Stringing, Inc., 526 U.S. 344 (1999)), that defendants need not respond to unserved complaints, does not disable defendants from responding if they so choose:

That decision [Murphy], however, did not hold that formal service is a prerequisite for removal.  Indeed, a party is free to waive service of process. . . .  [C]ourts appear to routinely hold that formal service is not a prerequisite to removal.
Poznanovich, slip op. at 9-10 (citations omitted).

Third, plaintiff’s invoking the unanimity requirement was a smoke screen, because unserved defendants need not consent to removal.  Id. at 10.

Last and least, the subject matter jurisdiction of the court was not dependent upon prior service of process.  Since the state court had jurisdiction over the action from its inception, removal conferred the same jurisdiction on the federal court.  Id. at 10-11.

Anyway, Poznanovich confirms what we already thought – that the “plain meaning” approach has by far the better side of the argument.  The “absurdity” approach is just judicial nullification, pure and simple.  There’s no constitutional issue here, so if Congress thinks the law is being misapplied, it can always change the statute.  As Poznanovich points out, the majority rule commands majority support for good reason.

Congrats to Amy Fisher at Ice Miller for emerging victorious, and further thanks for passing the decision along to us.

Jumat, 16 Agustus 2013

No Trout in the Milk

Yet once more, O ye laurels, and once more. Another splendid Viagra opinion sprang forth recently. This time we aim to avoid any silly double-entendres, even accidentally. (What's that? We already failed?!).

The case of Ridgeway v Pfizer, Inc., No. 09-2794 (E.D. La. April 27, 2010), involves the application of that old law school chestnut, res ipsa loquitur. More specifically, the case analyzes why res ipsa loquitur does NOT apply.

Where to start? Case or law? We'll start with the case. Plaintiff claimed he took a Viagra pill, enjoyed its benefits soon after, and soon after that he suffered a stroke. That's pretty much all the evidence plaintiff brought to bear. Plaintiff's doctors did not think Viagra caused the stroke. One doctor said there was "no way" Viagra caused the stroke, adding that "there's no cardiologist, urologist, neurosurgeon with credentials and any integrity that would blame Viagra for him having a stroke." Slip op. at 7. That doctor also threw around words like "totally ridiculous" and "nonsense." Id. at 8. Other treaters agreed, disavowing knowledge of any potential mechanism for Viagra to have caused the stroke, or of "any medical literature that would establish a causal link between the two". Id.

None of this rather helpful (for the defense) testimony was disputed. In fact, plaintiff offered precisely no evidence in response. For example, plaintiff offered no expert who opined that Viagra caused the stroke.

So at this point we're wondering whether this is a laydown. (Darn it!). What's the issue?
According to plaintiff, he don't need no stinkin' evidence because it's a case of res ipsa loquitur. That Latin phrase is usually translated as "the thing speaks for itself.". There are some Classics scholars who quibble and say it means "the thing itself speaks". We won't get into that fight. After all, in high school we thought "Cogito ergo sum" meant "I think my name is Ergo".
Why was Ridgeway asserting res ipsa loquitur? Simple: (1) He was a-okay, (2) then he took a Viagra pill, and (3) then he had a stroke. QED.

Well, no. As the court explains, res ipsa loquitur applies when something quite unusual happens and it almost certainly could not have happened unless someone breached a duty of care. "The doctrine allows an inference of negligence to arise [the court's words, not ours] from the common experience of the factfinder that such accidents normally do not occur in the absence of negligence." Slip op. at 10.

Think of a surgical instrument residing in someone's innards after an operation. That won't happen unless somebody was negligent. The Ridgeway court cites the seminal res ipsa loquitur case of Byrne v Boadle, (1863) 2 H & C. 722, 159 Eng. Rep. 299 (Ct. Exch), where a barrel of flour fell out of a warehouse window and clobbered some poor unfortunate. That barrel stays in the warehouse and that head stays unconked if everybody did their job correctly. The source of injury was in the exclusive control of the defendant and there's no chance of contributory or comparative negligence.

Our own personal favorite example of res ipsa is Thoreau talking about finding a "trout in the milk." Some 19th Century Massachusetts dairymen driving milkwagons to market apparently would water the product down by dipping buckets in the canal and pouring the water into the milk. It's like a Transcendalist New England version of the mouse in the Coke bottle. (We once saw a criminal defense lawyer try to use the "trout in the milk" image to argue why there was inadequate evidence that his client was running a mail fraud scheme. But while there was no trout in the milk, there were tape recordings and a cooperating witness, so Thoreau could not acquit the accused.)

The doctrine of res ipsa loquitur is said to go back to Cicero (in a case where, like Ridgeway, he came in second place). But it didn't apply to the Ridgeway case. The plaintiff had a history of hypertension. For such a man, strokes are, sadly, not all that unusual. Strokes can happen (usually do happen) sans Viagra. Put simply, plaintiff had not managed to exclude other serious risk factors. It also didn't help plaintiff that he had been taking Viagra for a decade without incident. (Well, maybe that's not exactly the right way to put it, but you get the point). Even worse, plaintiff's opposition brief stated that medical evidence was unavailable "due to the fact that Plaintiff's injury is one that is so new in nature and mechanism of action there has [sic] not been studies completed". Slip op. at 14. So this is not a case of res ipsa loquitur. No barrel fell out of a window. There's no trout in the milk. Rather, as the court concluded, it "is simply a case in which plaintiffs have no evidence of causation". Id. at 14.

Thanks to Lori Leskin of Kaye Scholer for sending along this win.

Kamis, 15 Agustus 2013

People Who Live In Glass Houses....

There's already been lots posted about the FDA's "Transparency Initiative" elsewhere, so we won't go into any depth at this point - we're litigators, not regulatory types.  We'd just like our viewers to note that many of the FDA's 21 proposals could have significant litigation effects.

For example, number 1 could result in a searchable database of anecdotal adverse event reports that would allow plaintiffs' experts to generate "summary reports" - seemingly bearing the FDA's imprimatur - with the push of a few buttons (with no mention of segregating out litigation generated AERs).  There's supposed to be some sort of "disclaimer," but we question if it will be as strong as what the FDA said back in 1996:  "Accumulated ADE cases may not be used to calculate incidences or estimates of drug risk."

Nos. 8 & 10 would provide public information of all pending investigational and marketing applications, including "intended uses."  This includes ANDAs.  Everyone's competitors would then know what's in the pipeline and would be able to throw spanners in the works.  If you think the pioneer/generic wars are bad now, imagine how they'll be when everyone knows exactly what applications are pending for what.

With every FDA regulatory letter (No. 21), inspection report (No. 6), and adverse application decision (Nos. 13-15) becoming instantly public, imagine the new litigation solicitation opportunities available to the other side (expanding to anything that goes wrong during clinical trials, for one thing).

The FDA also wants to create broad "public health" and "correct misleading information" exceptions to the confidentiality of summary safety and effectiveness data in pending applications (No. 16).  So if the FDA thinks regulated person has said something "misleading," it will now be in a position to impose the punishment of releasing that person's confidential data.  Great chilling effect, that.  FDA even wants to talk about releasing "non-summary" data - that's right, raw research data - from pending applications (No. 17).

Fortunately, there's a 60-day comment period before any of this can move ahead.  Anybody who has comments - and we can't imagine any FDA regulated manufacturer, importer, or participant in clinical trials who isn't threatened in some way by this - be sure to get them in by July 20, 2010.

Senin, 12 Agustus 2013

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Rabu, 07 Agustus 2013

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