Thursday, January 31, 2008

Levine to Next Term?

We haven't seen any formal announcement, but the remainder of the Court's argument schedule for the current term has now been finalized, and Wyeth v. Levine isn't on it (neither is the other preemption case, PM v. Good). The two cases from the six granted on 1/18 that are on the list are MetLife v. Glenn and Meacham v. Knolls Atomic Power Laboratory. That says to us that Levine won't get decided this term.

We mentioned the politics over that in a previous post, so we won't repeat it here. Suffice it to say that we're disappointed.

Breaking News, Just In

Two new defense wins - links provided. First, today the Eighth Circuit affirms (now reported at 514 F.3d 815) a no-causation verdict in HRT litigation on the basis that the plaintiff herself (not the learned intermediary, so it's something of an odd situation) was warned but failed to read the warning. Thanks to Mike Scott, at Reed Smith.

Second, on everybody's favorite topic, preemption. Yesterday, a California federal district court finds preemption, (here for some reason this link keeps getting truncated; now reported at 551 F. Supp.2d 993) in yet another SSRI suicide case on the ground that the since the FDA said no to a suicide warning, state law cannot overrule that and say yes. Thanks to Mal Wheeler at Wheeler, Trigg, and Mark Brown of King & Spalding.

Keep those defense wins coming!

Preemption, Mass Torts and representing our clients

There’s a new case in our Drug Preemption Scorecard this week, and we don’t mean Herrmann’s brilliant win in Dobbs (although you can be sure that’s there as well). The new case is Gourdine v. Crews, 2006 WL 5277412 (Md. Cir. June 28, 2006), aff’d on other grounds, 935 A.2d 1146 (Md. App. 2007), out of Prince George’s County. Gourdine contains an excellent discussion of both the FDA’s Preemption Preamble and the relevance of the Buckman case.

But wait a minute. That’s a case from mid-2006. Whadda you guys mean, calling it “new.”

It’s “new” in the sense that nobody knew about this pro-preemption opinion until just recently – except maybe our friendly adversaries at the MarylandInjuryLawyerblog, and they weren’t telling. Nor would we expect them to.

OK, that kind of “new.” How did anybody find out about it, then?

Glad you asked, because that gets us to the point of this post, which is: in a mass tort world, where there’s so much interactive litigation involving the same issues – and particularly the same defenses – we think that the conscientious defense lawyer’s obligation to his or her pharmaceutical clients is broader than it used to be, and doesn’t (or at least, shouldn’t) stop with defending the cases one has to the best of one’s ability.

There are just too many interrelationships now to for us to leave the blinders on.

Yeah, yeah, so cue the Lion King “Circle of Life” music and everything. What does this have to do with Gourdine v. Crews?

While Gourdine’s probably not all that big of a deal now, with the Supreme Court having agreed to decide Wyeth v. Levine, but it could very well have been a big deal back when it was decided in June, 2006. Back then we were all scrambling for whatever favorable precedent there was to cite.

Regular readers of this blog surely remember the big-deal Colacicco decision. Colacicco was handed down only a month before Gourdine, and it cited only a handful of favorable preemption opinions, among them the Abramowitz state court slip opinion from New Jersey – twice. The point is that somebody had to bring both Abramowitz and now Gourdine out of obscurity.

Who’s that?

Umm ... Bexis-Herrmann, actually. Within a few days of Abramowitz being decided back in March, 2006 we somehow (we don't remember exactly how) found out about it and got a copy of it, presumably from defense counsel. We know whom to talk to at Westlaw, so in goes the opinion. Abramowitz thus gets a Westlaw citation, can be found by computer, gets found, and gets used in the Colacicco briefing. BANG! What was a little slip opinion gets cited in a major, published case.

And yup, the same thing happened a couple of weeks ago with Gourdine. An appellate court affirmed the dismissal on alternative state-law grounds, but there was a passing reference that, in the trial court, the defendant won on preemption too. “Preemption” makes our ears prick up, so a quick email to defense counsel produces a copy of the trial court opinion. Sure sure enough, it’s good. So in it goes to Westlaw.

Look at our Drug Preemption Scorecard a little more closely. There’s ten state-court trial opinions on it with Westlaw citations. Six of them are in favor of preemption. Well, five of those six got into Westlaw’s data banks through us, and only one of those five, the Ledbetter Vioxx case from Texas, would probably have found its way there anyway.

It’s not just preemption. There are lots of overlapping, interconnected issues in today’s mass tort environment. We’re happy to midwife getting slip opinions of all kinds onto the computerized reporters – where our defense colleagues can find and use them – from just about any court. This is something that makes us all better at what we do. Making sure that pro-defense decisions are as easily accessible as possible helps all of us on the defense side defend our clients better. If we all defend better, we all win more often, which is basically what our clients hire us to do.

The other side sure does it too. We’re sure not the ones who provided Westlaw with the four adverse state trial court preemption decisions that show up on the scorecard. Don’t expect altruism. As the scorecard says, “we’re not here to spread the word” about decisions that favor the other side. All this stuff (directly or indirectly) helps our clients win. We make no bones about this.

So if you’ve got an unpublished slip opinion that's favorable to the defense side – especially on something (which is most things) that could arise again in another case – send it to us. If we agree, we’ll try to get it online for you.

This is an example of what representing pharmaceutical and medical device defendants in 21st Century litigation is about. Indeed, that’s only the tip of the iceberg of what truly zealous representation now means in this area. To the extent possible, in accordance with the group’s rules, we bring our perspective on the law to groups like the American Law Institute and the American Bar Association. The other side sure does. There was an abortive attempt to pass an anti-preemption ABA resolution only last year.

Since we’re deluded enough to think that what we have to say might matter to a court in an important case where we’re not representing the defendant (yes, there are a few of those), we’ve written dozens of amicus (friend of the court briefs) in cases where we think there’s a dog in that hunt, but it isn’t ours.

There are law review articles – they get cited by appellate courts.

There’s books (they sometimes get cited too) so our defense colleagues can find at a glance what happened in, say, every learned intermediary, warning causation win that’s ever been decided – another area of special interest. Look, for example, at all the recent Pennsylvania computer-service-only citations on this topic. Yup, you now know how they got there.

There are white papers used to help pass legislative tort reform.

And then there’s this blog – although that only counts sometimes.

A lot – most – of this stuff goes on below our clients’ radar, since it doesn’t usually show up in their bills.

In a similar vein we got an interesting comment from “Ph.D” to the Levine playing field post last week. It poses some philosophical questions that are worth tackling:

Although I am against FDA preemption in general, I agree that the Levine case is not a strong one.

We’re four-square in favor of preemption, both from a legal and policy point of view. One of the reasons we think the Supreme Court took Levine is because the Vermont Supreme Court was not only wrong, but loud wrong. You’re right, it’s not a very good case on its facts for the anti-preemption position.

My question is this: If one honestly wants to put the preemption issue to the test - as sensible or nonsensical policy - wouldn't it be better to have a case in which there was, indeed, more ambiguity in the CBE issue, a company's compliance (not only in letter but in spirit), whether there were questions of suppressed studies or delayed reporting (which FDA/ORA chose to tolerate, as they normally do), and so on?
It depends upon what you’re trying to achieve. If you’re trying to get a clean shot at whether there’s going to be preemption in prescription drug product liability cases at all, Levine is a good case. If you’re going to concede that there’s some preemption and the question is how far it extends, then you’d probably want a case with some of the more complicated facts you mention. But Levine does leave plaintiffs the out of arguing “well we lost, but that case didn’t have X, Y, Z and this case does.” Then everyone spends the next decade litigating whether X, Y, or Z makes any difference. Plaintiff’s lawyers are pretty smart. Give them a case that’s bad for them, and they’ll figure out some way to distinguish it.

I understand that, from the perspective of defense attorneys, these "messier" questions do, indeed, make preemption harder to argue. And, indeed, swallow. Discovery might well reveal facts that show how limited assurance and accountability FDA compliance can actually provide.

So the question is really philosophical and ethical (not being a lawyer, I can ask it).

Does it matter to defense attorneys whether they contribute to rulings that may have broad policy implications that are a plus for their clients but a negative for public health in general?

Your question carries the implied premise that preemption is somehow a bad thing “for public health in general.” We don’t think it is. As imperfect as the FDA sometimes is, it remains the single entity that is most competent and with the express congressional authority to set nationwide standards for the drugs, devices, and other things it regulates. When it does that, and makes a decision that “this is what we think is best,” we believe the FDA’s judgment should be respected. It is simply impossible for a jury to consider “broad policy implications” in the context of facts relevant only to a single individual. That’s not a jury’s job. That’s the FDA’s job.

Take the SSRI suicide cases, for example, probably the biggest preemption battlefield at the moment. The FDA has looked at this time and time again and found no link. We think these cases are essentially bogus, demanding warnings that the FDA says aren’t medically justified. All this litigation not only raises the price of these drugs to the public (all litigation costs that a company incurs, from it’s own lawyer fees (that’s us) to settlements with the other side, is paid for by consumers in the form of higher prices), but discourages people who should be taking these drugs from doing so. And even if there were a causal link, do you really want doctors mentioning “suicide” to a clinically depressed person?

Similar questions abound in just about every other area where the FDA has put its foot down and made a risk/benefit decision. That’s what Congress created it to do. If the Agency needs more power and resources to do its job right, then that’s what it should get – and preemption is necessary to make sure that the FDA stays relevant. If people can simply ignore what the FDA does and sue, then any incentive to fix problems within the FDA itself drops accordingly. The FDA becomes another toothless, mostly ignored agency like the FEC. We favor strong preemption together with strong FDA enforcement authority over drugs.

Or is it solely up to the Supreme Court to think through such wider implications in the way they frame a ruling in a particular case?

The Supreme Court picks which cases it hears. In addition to parties’ briefs, and to having probably the smartest bunch of clerks in the world, in an important case (aren’t they all?), the Supreme Court will receive a half dozen or more amicus briefs from interested persons who aren’t parties to the case dealing with precisely those sort of implications.

Hopelessly naive? Well, it is a genuine question. (I understand it will be argued that what is good for a client is good for public health in general. I would love to see a response premised at least on the _possibility_ that this was not the case.)

We represent clients. That’s what lawyers in private practice do. Our mindset is naturally going to equate what’s good for our client with what’s good for the public health. With respect to preemption we’re utterly convinced that this is so on any number of levels.

But let’s assume, in the abstract (not about preemption) that the position our client favors is in some sense detrimental to the “general” public health. What do we do?

The primary question is “is it legal”? We will not advise a client to break the law, no matter how beneficial to that client it might be. That’s unethical.

If it’s legal, however, then we’ll defend our client’s right to be able to do it. Society has made the judgment, either expressly or impliedly, through the democratic branches of government, that the conduct is to be allowed – even if it’s in some sense “unhealthy.” For example, we think bungee jumping’s pretty dumb, but if it’s legal, we’ll happily defend a bungee company being sued by somebody who claims it’s a “public nuisance” or some such just because people can get hurt. We think global warming’s a bad thing, but we’ll cheerfully defend a power company against a similar charge.

We don’t represent the public, we represent our clients in tort cases. At bottom, these are economic pieces of litigation – should our client have to pay money to somebody else? As we see it, the solution to the hypothetical “unhealthy” situation lies not in the courts, but with the democratic branches government. If something is harmful to “general health,” and thus to society, then the legislature, or the relevant administrative agency, has the power to prohibit it by law. Short of that, there’s a limit to what we think is proper in private tort litigation. We don’t think that activist courts prodded by activist lawyers should be in the business of banning “unhealthy” things that the democratic branches have not seen fit to prohibit. It’s not within the institutional competence of the court system.

In the final analysis, the point here is the same as the one that already made above. As defense lawyers in civil cases, our obligation is represent clients as best as possible within the boundaries of the law. Twenty-first century mass torts merely broaden the scope of what that kind representation now involves.

Fosamax As A Mass Tort

Bexis' firm represents Merck, so he was not involved in drafting this post. Pin the blame for what follows exclusively on Herrmann:

We were so busy ranting yesterday about that article on spine sugery in The New York Times that we nearly overlooked this little ditty from The Wall Street Journal. It reports that the Fosamax litigation "presents one of the bigger question marks to Merck's bottom line."

Fosamax is a drug indicated to strengthen bones that, according to the lawsuits, occasionally causes a bone-wasting condition called osteonecrosis of the jaw ("ONJ"). As of September 30, Merck had been named in 340 ONJ lawsuits, but it has recently been named in a "weakened bones in places other than the jaw" case, and plaintiffs are threatening to plead that Fosamax causes severe bone, joint, or muscle pain.

Is that really one of the bigger question marks to Merck's bottom line?

It depends.

To our jaded eyes, a set of just 340 cases is for rookies. Heck, at 340 you can still remember the name of each individual plaintiff and what state they sued you in. Our "very personal computers" don't go on the fritz until you approach 500 cases, and a true mass tort begins somewhere north of that. The two of us could defend 340 cases with one of us on vacation. (Who's heading to Aruba, Bexis, you or me?)

That's not to say that 340 cases aren't a menace. Just one "bad baby" or brain damage case can be as serious as a heart attack. (Heck, even a heart attack case can be serious.) But it's the quality of those cases, and the injuries involved -- not their sheer quantity -- that may induce a settlement. That's the way litigation is supposed to work. Mass torts coerce settlement because the logistics and cost of defending the cases threaten to overwhelm the defendant; a mere 340 cases doesn't meet that threshold.

So long as osteonecrosis of the jaw is a real disease -- one that exists and has objective criteria (that can't be faked) for diagnosing it -- Merck doesn't have to worry about an avalanche of ONJ cases overwhelming it. If ONJ is a real disease (and, according to Wikipedia, it sounds like one), then Merck will face only a limited number of cases. (One reason Breast Implants and Bone Screws became mass torts is because the alleged injury was "pain." Everyone can say they're feeling pain, and no one can refute it. Drugs that cause more objectively defined endpoints are less likely to become mass torts. We're unlikely, for example, to see thousands of "Accutane caused me to commit suicide" cases. To state that claim, you've gotta first blow yourself away, and even the greediest plaintiff is unlikely to go that far.)

If, however, the Fosamax litigation expands to pick up claims for "severe pain," then Katy bar the door.

Fosamax is prescribed in an older population -- people who are likely to suffer pain whether or not they ever took the drug. And there's no objective test to determine who's really suffering severe pain and who's just gaming the system for a payday.

From our defense perspective -- and even from a public policy perspective -- we're delighted that Merck's label on Fosamax has for years contained a precaution about the possibility of patients developing pain.

From a litigation perspective, we hope that the adequacy of that warning, or the general knowledge in the medical community about the risk that ingesting biophosphonates can be associated with pain, is sufficient to bar an influx of bogus "pain" cases.

Because even the two of us -- blogging Luddites that we are -- could handle 340 cases.

But we don't want to be in that number, if the pain comes marching in.

Wednesday, January 30, 2008

Congratulations! You're Our 100,000th Customer!

Well, not quite -- and we're not offering a prize.

But we've just passed a milestone: The Drug and Device Law Blog has just received its 100,000th pageview.

We're not throwing a party or anything.

But we sure do like the company. Thanks for visiting.

The More Things Change, The More They Remain The Same

We’re getting déjà vu all over again this morning, reading the story about spine surgery in this morning’s New York Times. It’s not just that it reminds us of Zyprexa – although it does – with a Times reporter talking to the plaintiff’s side and somehow gaining access to “confidential documents from a plaintiff’s lawsuit.” Query what confidentiality orders or arrangements may have been breached in the making of this article.

No, our reminiscences go back much further – back to Bone Screws, the litigation where Beck and Herrmann first met. That, too, was sparked by a questionable journalistic piece (a television program) featuring plaintiffs, plaintiffs’ experts, and plaintiffs’ counsel.

Not only that, but Bone Screws was as much about “conflicts of interest” as it was about anything else, and the refrain was the same: Isn’t it awful that spine surgeons are investing in (and otherwise making money from) companies that make the same new medical devices that they’re studying in clinical trials?

We have heard that all before, over a decade ago. Even the names bring back memories, with the article pitting the eminent spine surgeon Dr. Richard Balderston against long-time anti-technology guru Dr. Richard Deyo.

The litigation strategy seems familiar, too. Plaintiffs try to dig up all they can about “conflicts of interest” and get that information publicized by the press. If the publicity causes enough embarrassment for the surgeons with whom the defendant company works, then those surgeons will presumably pressure the defendant to settle suits regardless of merit.

Beyond history repeating itself, there remains an important unasked question – then and now: Who do you think invents new orthopedic medical devices? The surgeons, that’s who.

And who do you think has the best idea of whether somebody else’s invention is likely to work in spinal fusion surgery? The surgeons, that’s who.

In the spinal surgery area, as with a lot of other types of medical devices, the primary moving force behind technological improvement comes from the surgeons who use these products day in and day out.

Medical devices aren’t drugs. They’re mechanical things. You put a piece in here to hold something else in place over there. Well, nobody knows the benefits and drawbacks of these mechanical things better than the surgeons who spend hours and hours in complex operations assembling them in people’s spines. Having done all they can, the surgeons then have to hope that these devices will help their patients heal before the tremendous physical forces at work on the human spine (the curse of standing on two legs) inexorably tear their mechanical creations apart.

There’s a fundamental fact that the Times article glosses over, and that the plaintiffs (and their experts) who were the primary sources for this article want everyone to forget: Spinal fusion surgery has a pretty high failure rate. That’s inevitable. It’s a last resort sort of procedure. There’s no such thing as elective back surgery. The people forced to endure such surgery are in great pain and have really messed up backs. They’ve been through Hell. But more importantly, these patients have been through all sorts of more conservative treatments, from chiropractic to nerve block, to less invasive spinal surgery, without success. There’s no guarantee that surgery with innovative (and invasive) technologies such as artificial spinal discs will be any more successful.

Of course, for the plaintiffs quoted in the story – and evidently for New York Times reporters – all surgeries must be perfect and if not, somebody has to be blamed. It’s the usual scapegoats here, the spinal device companies and the surgeons themselves.

Without internal spinal fusion devices, recovery from back surgery would take six months and the patient would have to be totally immobilized in one of those cartoonish full body casts – stuck in a hospital bed and unable to do anything at all for him or herself. Even then, the success rate was well south of 50%. Ever since the first spinal fixation devices came on the market decades ago – Harrington rods (straight metal pieces with a couple of hooks here and there) and the like – almost all of the progress in making spinal fusion surgery safer and more effective has been driven by spine surgeons with bright ideas that a hook here, a screw there, a new kind of cage somewhere else, would help solve some of the problems that they saw in their practices.

And it’s unrealistic to expect these surgeons – especially the best and brightest ones who think up most of these things – to work for free. It takes money to turn a sketch on a notepad into something that the FDA will approve for marketing and sale. Like any other inventor, spinal surgeons take out patents, receive royalties, sell their intellectual property, and (gasp) even form companies themselves. Not only that, they talk to their friends and colleagues, and when they see somebody else’s promising idea, they have the money to invest in that.

So it’s always going be the same in spinal fixation devices – twenty years ago and twenty years from now. The surgeons who come up with the ideas are going to be making money from the technology that they in large part helped create. The Times may view this as a “conflict of interest,” but in reality, it’s how bottom-up capitalism works in an innovative field.

But the article’s real beef seems to be that the same spine surgeons who invent the devices also participate in the clinical trials that lead to FDA approval. As our kids would say, “Well … duh.”

Remember, we’re not even talking about ordinary spinal surgeons here (all of whom have to have obscene amounts of training just to get into this specialized field). We’re talking about the best of the best, like Drs. Ziegler and Balderston in the article, who have the prestige to be in a position to run a clinical trial, the inclination (and institutional resources) to perform cutting edge research, and, yes, the financial incentive to carry it through.

The NYT article makes some allegations of failure to report “conflicts of interest,” and we don’t have anything good to say about anybody who deliberately conceals something that either the government or professional ethics require be disclosed. We think FDA disclosure is a good thing (whether doctors should have to tell patients is a lot iffier). But from what we can tell, most of the financial ties mentioned were either properly disclosed, or didn’t need to be disclosed. The disclosure issue is for atmospherics; the thesis of the article seems to be that the very existence of these sorts of financial incentives, in and of itself, is a bad thing.

That’s where we disagree. In a perfect world, everybody acts altruistically, but that’s not the world we live in. Who else is supposed to develop the technology if there’s no financial incentive to do so? The government’s not about to do it, and would probably impede technological advance more than assist it if it tried to assert a research monopoly. How about the big universities and teaching hospitals? Surprise, they already do, but they also do it for money, too, and thus have many of the same financial issues that the article considers problematic.

Technology doesn’t grow on trees – it takes inventiveness to create it, and then it takes $$$ to develop. There has to be a source for these funds, and if it’s the doctors using the devices who put their own money on the line, well, we see that (defense lawyers that we are) as a sincere endorsement of the technology. And if you want the best docs to conduct the research, well those are precisely the docs most likely to have invented the technology to start with.

If one removes the profit motive from the development of technology, the result will be less technology. That may be fine with some of the Times’ commentators (academics and insurers who would have to pay for it), but it’s a bad thing for the thousands of non-plaintiffs who have been helped by this particular device, and for the millions helped by similarly developed medical devices.

But do the financial “conflicts of interest” actually cause the clinical studies themselves to be conducted less than ethically? The article – even using “confidential” documents spoon-fed to the reporter by somebody on the plaintiff’s side – doesn’t provide any indication that it did. We’d call that all bun and no beef.

So what can be said about the validity of the studies themselves?

First, the article says that the studies were peer-reviewed. That means that disinterested scientists had the opportunity to look at these studies, critique them, and if they had found serious problems, veto publication. It’s time-honored scientific practice. It means, if there were serious statistical funny business going on, it would be ferreted out according to accepted scientific method, just as happened with the Korean stem cell scandal.

Second, as the article states, the FDA “subjects research to a higher level of scrutiny” if there’s financial involvement among the researchers. That’s as it should be, too. It’s yet another argument against second guessing by private plaintiffs looking for a buck when unfortunately they end up in that seemingly irreducible segment of the population for whom nothing – not even the most state of the art, cutting edge medical procedures – works to stop their back pain. There’s no indication here (and, believe us, if there were, it would be in the article) that, even under increased scrutiny, the FDA found any problems with how these studies were conducted.

Third, the proof, as they say, is in the pudding. The article mentions that the device in question, something called a “Prodisc,” has been “used on thousands of patients, has been shown to benefit many people with back pain.” How a device performs in clinical practice is ultimately the test that matters. The article, however, didn’t interview anyone in the (it seems anyway) vast majority of the patient population with successful outcomes – just a few plaintiffs. The squeaky wheel gets the grease. One doctor mentioned a patient who “had trouble standing before her Prodisc but was able to go hiking afterward.” Why not let us hear from her, too?

Fourth, the article doesn’t even address the structure of FDA-approved clinical trials, which involve hospitals and independent review boards of various types, all of which act as checks on the freedom of financially-interested surgeons (were they so inclined) to manipulate protocols to generate unrealistically favorable results.

Thus, while the article is long on reciting various investments and other financial ties, it’s notably short on any concrete allegations that any research was ever affected. Why? Because that sort of thing is quite rare. Again, these are eminent doctors. They aren’t the sort to risk their professional reputations (not to mention being sued) with funny business that might bring them a few more hundreds of thousands of dollars atop the millions they already have. Sure, there is an occasional bad apple, but this article seeks to indict the system. It needs to show more than a couple of plaintiffs giving anecdotal impressions about how, in litigation hindsight, their doctors seemed to them to be acting.

As far as we’re concerned, anybody who’s going to cast aspersions on the scientific ethics of medical device development needs to be able to show that the science itself has actually been adversely affected. This article provides zero evidence that it has.

The only criticism of the science, if it can be called that, is at the tail end of the article from a Medicare official (with his own financial incentive to avoid paying for surgeries that use innovative devices) suggesting that a 10% exclusion rate (reasons for exclusion not given) from one study “was unusually high.” There’s not even an allegation that financially interested surgeons serving as investigators in the study excluded patients at a higher rate than those without such financial interests. So even if the exclusion rate was high, which we can’t comment about one way or the other, there’s nothing indicating that these exclusions were affected by any financial ties.

So we just don’t find any “there” there. To us it’s another example of plaintiffs’ lawyers playing the media, something we’ve commented on before. And the media loves to be played. Here, unnamed counsel have supplied a friendly reporter with plaintiffs, experts, and confidential documents. Just add innuendo.

All the news that’s fit to print? We don’t think so.

Tuesday, January 29, 2008

A Thought On Jury Questionnaires

Like Rick Stuhan, who guest-posted here yesterday, we often like jury questionnaires.

Asking potential jurors to complete written questionnaires serves several purposes.

First, written questionnaires can shorten the time needed for voir dire, because questions that would otherwise be asked orally during voir dire will already have been answered in writing. There's no need to ask those questions again.

Second, a written questionnaire gives a juror more time to think about the questions and to answer them accurately. Instead of answering an oral question with no time to reflect, the juror can gather his or her thoughts before answering a written question.

Third, questionnaires often permit counsel to learn more information about potential jurors than is allowed during oral voir dire.

Fourth, a written questionnaire, approved by the judge, will pose neutral questions in a non-prejudicial way, avoiding some of the gamesmanship that can occur when lawyers conduct oral voir dire.

Fifth, if the questionnaire can be completed and provided to counsel before the morning of jury selection, then counsel can have a decent amount of time to think about the answers before exercising their strikes, rather than having to select the jury on the fly, with no time for thought.

Sixth, written questionnaires, with a promise that they'll be held in confidence, can ask personal questions (about the potential juror's medical history, for example, which might be relevant in a drug or device case) that can't appropriately be asked in open court. Rather than spending the significant time needed to conduct individual voir dire in private, one juror at a time, the court can have jurors answer the personal questions in writing.

We could go on.

But we won't.

Suffice it to say that we often like jury questionnaires.

The issue is how to persuade courts to use them.

More and more courts are permitting juror questionnaires these days, and we approve of that trend.

If you're in a court that doesn't typically use questionnaires, here's a thought: Make the questionnaire look as simple as humanly possible.

We've seen folks submit proposed jury questionnaires that are 20 and 30 typed pages in length, asking a series of (double-spaced) questions and providing an inch or two of space between questions for the jurors to write in answers.

The judge predictably looks at the 30-page monstrosity and declines to use it. Why should the court inflict a 30-page test on jurors?

Thoughtful counsel, however, will craft questionnaires that elicit essentially the same amount of information, but don't appear to be as burdensome.

Here's what we suggest: Aim for a questionnaire that consists of just a single sheet of paper,
printed on two sides.

To make this work, you must forget about creating anything that looks like a traditional document: portrait-style layout on the page; standard size fonts; lots of room for answers.

Instead, think short. Real short.

Turn the page landscape-style, so you can fit three columns of questions across the page.

Shrink the font. It can't be illegible, but it sure doesn't have to be pica, either.

Leave room for written answers only where written answers are essential, such as, "Your current occupation and employer." For everything else, ask a short question followed by tiny boxes that invite the juror to check "yes" or "no" (or where, appropriate, "agree," "disagree," or "no opinion," or "yes, myself," "yes, family or friend," or "no"). You get the idea.

When you leave room for written answers, force the jurors to write in tiny letters. Maybe give 'em a couple of lines, an eighth of an inch of apart (vertically) to print their kids' occupations, for example.

And, as we said, print the thing on two-sided paper.

You can then hand the judge a single sheet of paper (with three columns on each side, and printed on both sides of the page), and ask the court to distribute it several days before jury selection begins. If both parties favor using the questionnaire, and it appears to (and, in reality, does) pose so little burden on the jurors, the court is likely to distribute the questionnaire.

Moreover, if it's logistically possible, and if the judge is willing, have the jurors return the questionnaire a day or two before jury selection begins. This will give you a night (or perhaps even a weekend) to evaluate the information before making your strikes.

To our eye, this is often sensible and helpful to both parties, and it's an idea well worth considering.

But don't be silly about it: Do not submit a 25-page, double-spaced questionnnaire and expect a court to use it.

You wouldn't use it, either; it's just too intimidating.

Collapse the thing to a single, two-sided page, and savor the opportunity to think intelligently about potential jurors before being asked to exercise your strikes.

First U.K. Class Action Recovery

The Time Online reports the first settlement of an aggregate lawsuit in the United Kingdom.

A retailer agreed to reimburse 1000 purchasers who overpaid for replica soccer jerseys 20 pounds each.

This is the first settlement announced under the Enterprise Act of 2002, which authorizes proceedings similar in some ways to American-style class actions.

We're not too worried about the 20,000 pounds being paid in the settlement.

But we're awfully worried about this settlement as a harbinger of things to come.

Hat tip to Point of Law.

Monday, January 28, 2008

The Same Old Story, Part II

On Friday, we wrote of Vytorin, that "we haven't yet seen the 10b-5 securities fraud class actions."

Well, that wasn't a very long wait. Some things are just all too predictable.

Written Juror Questionnaires In Civil Cases

This guest post was written by Richard G. Stuhan. Mr. Stuhan is a partner resident in the Cleveland office of Jones Day. This post is entirely his work. It, of course, represents only his views, and not the views of his clients or firm:

Attitudes toward the use of written juror questionnaires are changing rapidly. Long favored by the defense bar, written questionnaires are becoming increasingly popular among plaintiffs’ lawyers and among judges in both state and federal court.

To lawyers who regularly administer written questionnaires, resistance to their utilization is puzzling. There are several possible explanations for resistance from the plaintiffs’ bar. First, successful plaintiffs’ lawyers traditionally have taken an intuitive approach to jury selection – i.e., they have relied on their instincts and experience to form a judgment as to whether a particular juror should be seated. The data-driven approach that written questionnaires represent is starkly at odds with the traditional approach. Second, the plaintiffs’ bar concluded that the use of written questionnaires would confer a competitive advantage on defense lawyers more accustomed to using that technique. Third, there were doubtless some plaintiffs’ lawyers who concluded that, if the defense bar was in favor of juror questionnaires, that was reason enough to oppose them.

The principal reason courts have resisted the use of written questionnaires is that they were not familiar with them. Judges tend to be set in their ways, and any suggestion that the court should conduct its proceedings any differently than it has always done so is not likely to be well received. Moreover, it cannot be denied that the use of written questionnaires entails a certain administrative burden. There have to be enough pens and pencils for all of the jurors. Each of them needs to have a writing surface. Once completed, the questionnaires need to be copied for all interested counsel. The lawyers need to have time to review the responses before jury selection begins. These can be cumbersome and time-consuming procedures, and some jurors might find the process burdensome. What the courts did not see was that these burdens were more than offset by the efficiencies written questionnaires generate.

But all of that is changing. Working with trial consultants, plaintiffs’ lawyers have discovered that written questionnaires can augment their tried and true techniques. Meanwhile, courts are finding written questionnaires far less exotic than they once did. Virtually every court has had some experience with written questionnaires, and the topic has generated considerable discussion in the legal literature.


Courts in different parts of the country employ different terminology in describing the questionnaire which is the subject of this article. Particularly confusing is the oft-used phrase “supplemental juror questionnaire.” This terminology derives from the fact that many courts require jurors, at the time they report for service, to complete a basic questionnaire. Typically, these questionnaires elicit the kind of information that prisoners of war supply in World War II movies – i.e., name, rank, and serial number. In a few jurisdictions, the information requested on the basic questionnaire goes further. It might, for example, capture the juror’s marital status, the type of work he does, and/or what his spouse does for a living. The questionnaires discussed in this article are deemed “supplemental” because they seek information in addition to the basic information that the court collects as a matter of routine.

Devising An Effective Written Questionnaire

A written questionnaire will assist in jury selection only if it poses questions that are known to be correlated with verdict orientation. There is, for example, no reason to inquire about the juror’s military service, television viewing habits, or use of the Internet unless you have some reason to believe that the answers to those questions will be useful in predicting how the juror is likely to vote in your case. Usually, the connection between specific questions and verdict orientation is established through well-conducted jury research. In repetitive litigation (e.g., a succession of suits brought against the manufacturer of an allegedly defective medical device), however, the connections might also be established through post-verdict juror interviews.

Lawyers traditionally have picked juries on the basis of demographic characteristics – age, gender, marital status, occupation, income, education, etc. The conventional wisdom was that plaintiffs’ counsel wanted young, single or divorced, low income women of color, while the juror of choice for the defense was an older, married or widowed, higher income white male. There is, however, mounting evidence that demographics are not a reliable predictor of verdict-orientation. Far more dependable in determining how a juror will vote are questions about the jurors’ experiences (e.g., Is the juror exposed to toxic chemicals in the work place? Is he active in his union? What, if any, newspapers does he read on a regular basis?) and attitudes (e.g., Does he believe that large corporations put profits over safety? Does he believe that jury verdicts are too large? Does he think that the government is responsible for insuring consumer safety?).

The “trick” in designing an effective questionnaire is not just to pose questions that correlate with verdict orientation, but to propound questions in which the correlation is not obvious. For example, if you represented a pedestrian who was hit while in a crosswalk by a drunken driver, you would probably want to seat jurors who themselves have had bad experiences with drunken drivers. If, however, you asked questions that explicitly identify such individuals, that information would also become known to defense counsel, who would then seek to excuse those jurors – if possible, for cause, or through the exercise of a peremptory challenge. It would be far better for you if you posed questions based on research showing that, say, a person who regularly reads the Washington Post is more sympathetic than the population at large. In that scenario, you would know that there is a connection, but your opponent (unless he had done the same research) would not.

Why Are Written Questionnaires Valuable?

It is not by happenstance that written questionnaires have become increasingly popular. Lawyers on both sides of the aisle recognize that a written questionnaire, if used properly, can play a major role in jury selection – not as a substitute for counsel’s instincts or oral voir dire, but, rather, as a supplement to those tools. Courts increasingly recognize that, at least in complex litigation, written questionnaires can save time. Moreover, in high-profile cases, written questionnaires may be essential to the defendant’s ability to get a fair trial.

Many jusifications have been advanced for the use of written questionnaires. The ones that appear to be the most persuasive are as follows:

First, written questionnaires enable the court to efficiently obtain information from prospective jurors. Absent a written questionnaire, the court and counsel have no choice but to go through the box and ask each juror the same questions. While one juror is being questioned, the other jurors must sit and watch. When a written questionnaire is administered, all of the jurors are answering the questions at the same time. This could generate substantial time savings in a case in which a pool of 50, 100, or even more jurors has been summoned.

Second, written questionnaires elicit more candid responses from jurors than can be obtained though oral voir dire. Most people do not engage in a lot of public speaking as part of their daily lives, and that is essentially what participation in voir dire involves. It is very difficult for most people to stand up in front of a room full of strangers and answer questions – particularly questions that they did not know were coming and that are sometimes highly personal. Add to the mix the apprehension that any outsider feels when forced to participate in the legal system and it is easy to see why jurors would say as little as possible during oral voir dire in order to get through it as quickly as they can. The odds of getting candid, thorough, and carefully considered information increases exponentially when jurors are afforded an opportunity to answer questions privately and without the time pressure that normally attends oral voir dire.

Third, written questionnaires lead to more thorough examinations of the jurors. The information provided on a written questionnaire can become a springboard for follow up questioning during oral voir dire. Of course, examination of the jurors will be more thorough only if counsel have had a fair opportunity to review and synthesize the information obtained through the written questionnaires. In some instances, courts will ask counsel to commence oral voir dire immediately after the questionnaires have been completed. Such an approach completely undermines the utility of the written questionnaire. In order for the process to be effective, counsel should have at least overnight or – depending on the size of the pool – a few nights to digest the information obtained through the questionnaires and prepare appropriate follow-up questions.

Fourth, a written questionnaire greatly reduces the risk that a maverick juror will taint the entire panel. This is particularly important in high-profile cases, where feelings among the jurors might run high. After such a juror has made an inflammatory remark – e.g., announcing that her spouse was injured by the same product in precisely the same way that the plaintiff alleges – excusing that juror and instructing the rest of the panel to disregard the statement is not a meaningful solution. The alternative – dismissing the entire panel – is one that most judges would be extremely reluctant to embrace. The written questionnaire addresses this problem by giving jurors with strong feelings an opportunity to vent on paper. Ideally, such jurors can be identified on the basis of their questionnaire responses, questioned in chambers, and (if necessary) excused before they poison the entire pool.

Securing Judicial Approval

Once you become convinced that the written questionnaire is appropriate in your case, how do you persuade the court to allow you to use it? By far the most effective way to obtain judicial approval of a questionnaire is to persuade your adversary to join in requesting one. Courts are much more reluctant to deny use of a questionnaire if both sides want it than if only one party seeks permission. Of course, getting your opponent to join in requesting a questionnaire may necessitate compromises. You may not be able to ask some questions that you would like to pose to the venire or you might have to live with questions that you would rather not ask. In most situations, however, a compromise questionnaire is better than no questionnaire at all.

If your adversary will not join in seeking a questionnaire or if the court is reluctant to approve a questionnaire even though both sides endorse it, you will have to file a motion. What you argue will depend on the source of the resistance that you are getting. If, for example, the court is resisting because it fears that the questionnaire will waste time, your job is to explain how and why a written questionnaire actually saves time. In a high-profile case, you might have to make a Constitutional argument in order to get your way. Your argument would be that your client’s right to a fair trial cannot be guaranteed unless you have had a full and fair opportunity to explore whether jurors come into the courtroom with disqualifying biases.


Written juror questionnaires have become an accepted part of the legal landscape. Used appropriately, they become a valuable part of the jury selection process. Both plaintiffs and defense counsel can profit from the use of juror questionnaires as part of an overall jury selection strategy, and their odds of persuading the court to allow the questionnaire are greatly enhanced if they join in seeking court approval.

Saturday, January 26, 2008

The Same Old Story

Just yesterday, we said of Vytorin: "We haven't yet seen . . . lawsuits by state attorneys general, but that's what usually happens next."

Today, the New York State Attorney General subpoenaed Merck and Schering Plough.

Why are we not surprised?

Friday, January 25, 2008

More Zyprexa Settlements

The Indianapolis Star (via Pharmalot) reports that Eli Lilly has agreed to settle another 900 Zyprexa personal injury cases.

25,000 down; 1100 to go.

Anatomy lesson

We told you this story last June.

We'll tell you again today.

First, something happens in the press. This time, it was a front page story in The New York Times.

Immediately, the usual cast of characters starts trolling for business.

The class action lawsuits roll in.

The Congressional inquiries begin.

Plaintiffs file a motion to consolidate with the MDL Panel.

We haven't yet seen the 10b-5 securities fraud class actions, the third party payor claims, and lawsuits by states' attorneys general, but that's what usually happens next. Stay tuned.

With the grant of cert in Wyeth v. Levine, we were afraid that our little blog might soon be obsolete.

Like that would ever happen.

Thursday, January 24, 2008

Political Backlash to the New CBE Regulation

We told you when we posted about it last week (here and here) that the FDA's new proposed CBE regulation would create a firestorm.

The organization formerly known as ATLA was the first to react, but the Democrats in Congress were not far behind.

Here's a link to today's Star-Ledger reporting on a letter several leading Democrats have sent to the FDA objecting to the proposed rule.

We haven't heard the last of this, we promise you, and if you want to read more, there's a brand new synopsis of the FDA's proposal at the FDA Law Blog.

Levine - Assessing The Playing Field

The Wyeth v. Levine case is such a big deal that you can bet we’ll be discussing it a lot. For one thing, it has the potential to obliterate entire mass tort litigations at a stroke. Since we’re mass tort kind of guys, we’re keeping a mental hit list of where we’d strike first after a favorable outcome – but that’s not something we’d give away here - not now, anyway.

On the other hand, it’s not the millennium either. Levine won’t end modern prescription drug product liability litigation as we know it. But a favorable preemption ruling in Levine could well bring about a good, and long overdue, pruning. We see it – at a minimum – as eliminating a host of claims involving situations where the FDA has authoritatively spoken on a particular risk involving a particular drug. Several MDLs could well go bye-bye as a result.

Then again, we could lose. The Court could go the other way and restore the pre-Buckman world where guys like us, defending pharmaceutical companies, would gaze wistfully at the medical device folks (which also includes guys like us) and wish that we had a preemption defense, too.

Big issues raised in the Levine briefing to date, which means in the briefing on the certiorari (typically abbreviated “cert.” – referring to an obsolescent name for discretionary appellate review) petition – include:

  • Are FDA-approved labels a “minimum standard” or something more than that? We’ve already had plenty to say on this, here specifically in connection with Levine, and here more generally.
  • Is the defendant free to use a CBE (“changes being effected”) supplement to make a unilateral change that strengthens or adds a warning without prior FDA approval where the FDA already addressed that particular labeling issue? We’ve already had plenty to say on this issue, here.
  • Does the presumption against preemption apply in a conflict preemption case? We’ve already had plenty to say on this issue, here.
  • Does “direct and positive conflict” language in an uncodified part of the 1962 amendments to the FDCA oust implied “obstacle” preemption? We’ve touched on this issue here, here, and here, but haven’t devoted a lot of time to it yet. We will, but not today.
  • What degree of deference should be given to the FDA’s recent statements about preemption? We’ve already had plenty to say on this issue here.
And if you don’t want to take our word for it, all of the briefs on the cert. petition in Levine are available through the auspices of the really excellent SCOTUSblog – which is probably the legal blog we use more than any other in our actual, paying work. You can find links to all the Levine briefs right here (Levine is the second case on the list).

One other thing before we get to the point of this post. Contrary to the impression we had when the Supreme Court granted cert. last week, it’s not yet 100% sure that the Court will hear the Levine case this term. There were 6 cert. grants on the 1/18/08 order, and there are only two open slots for oral argument. For details, see the ever-informative SCOTUSblog. We think it’s likely that Levine will be one of those two because: (1) it is one of the two longest-pending cases on the Supreme Court’s docket (there’s no mystery to figuring that out; just look at the order for the lowest docket numbers after the “06-“); and (2) the Court already has two other FDCA-related preemption cases on its docket (if you don’t already know that, why are you reading this blog?), and they’ll probably want to decide them as a package. If the Court had wanted to wait, it would have followed the SG’s recommendation and simply held the Levine petition.

Getting Levine heard this term is – like everything else about the case – a big deal. Why? Politics. The legal positions taken by the SG and the FDA reflect the broader views of the administration that’s in office. We’d have to say that preemption in prescription drug and medical device tort litigation has fared pretty well with the current crew. But we read the same polls everybody else does, and we know that, for any case that gets held over for the next Supreme Court term, there’s a pretty good chance that a new administration’s political appointees will have a different take on the preemption issue.

So we’ll see what happens.

Now to the point – and yes, we do have one. There’s an old saying that “hard cases make bad law.” We don’t know who said it (somebody named “Maxim”?), but we think it’s true. So a logical first place to start when approaching something as controversial as the Levine case is with the facts. Specifically, how good are the facts for implied conflict preemption?

Well, first of all, Levine doesn’t involve any of the real preemption battleground drugs – it’s not an SSRI suicide case, nor does it involve Elidel, Prempro, Vioxx, Nexium, or any other drug that has produced multiple preemption decisions. See our Prescription Drug Preemption Scorecard for a complete list. That means Levine presents a playing field that’s relatively unimpeded by prior precedent.

That’s not to say that the facts are particularly recent – they’re anything but that. The drug in Levine is Phenergan, something that’s been on the market since 1955, and which has several uses. You may even have taken it as the active ingredient in some cough syrups. We have. It tastes rather revolting (at least it used to), but it will knock out a cough.

But that’s not the only use for Phenergan. It’s also used to treat really, really bad nausea of the sort that can land somebody in the hospital with dehydration. In these severe cases, it’s not enough just to take the stuff orally like we did with cough syrup. For faster relief, Phenergan can be given intravenously.

Beyond that, there are a couple of ways to administer a drug intravenously. There’s the “drip” method, where the fluid goes into your body at whatever rate your body wants to absorb it, and there’s the “push” method, which is used in the more serious cases when it’s necessary to get more of the stuff into you faster. No rocket science there.

Levine involves a medical decision to administer Phenergan by IV push, so this particular prescriber must have thought that the plaintiff-patient absolutely, positively needed the stuff.

Why do we say that? Well, like any prescription drug, Phenergan has inherent risks. In Levine, that risk was quite severe indeed. We don’t know why, and for purposes of Levine we don’t have to know, but if Phenergan gets into an artery – as opposed to a vein – it can cause gangrene.

That’s some risk – and that’s apparently what happened to the plaintiff in Levine. Somehow (and the briefs aren’t saying), the IV needle for the plaintiff’s Phenergan ended up poked into her artery rather than into the intended vein. As a result (we’re assuming medical causation for purposes of this discussion; we don’t know how much it’s disputed), the plaintiff lost her forearm to gangrene. That’s big damages, if there’s liability.

Gangrene is not only a serious risk of Phenergan but – more importantly for preemption purposes – it is also a known one. There was an FDA-approved warning about gangrene on the Phenergan that the plaintiff took. Naturally, the plaintiff claims that this label wasn’t enough, since that’s what plaintiffs have to do. If the drug’s label is adequate, the plaintiff loses. Plaintiffs don’t like to lose any more than we do.

First good fact for the defendant: The warning in this case was anything but wishy-washy. It mentioned the risks of “arterial” exposure in several places – including in boldface, all caps type: “INADVERTENT INTRA-ARTERIAL INJECTION CAN RESULT IN GANGRENE OF THE AFFECTED EXTREMITY.” It expressly told the treating doctor (under the learned intermediary rule all prescription drug warnings are addressed to MDs, not to patients) to consider whether an IV push method of injection was appropriate at all, given the risk. The warning advised “extreme care” not to get any Phenergan into the patient’s arteries. It stated that if anything went wrong and that did happen, it was “likely” that serious injury, specifically, “gangrene requiring amputation,” would result:

Due to the close proximity of arteries and veins in the areas most commonly used for intravenous injection, extreme care should be exercised to avoid perivascular extravasation [that’s “missing the vein and putting the drug in the surrounding tissue” for you non-doctors] or inadvertent intra-arterial [that’s “into the artery”] injection. Reports compatible with [that means “that could involve”] inadvertent intra-arterial injection of Phenergan Injection, usually in conjunction with other drugs intended for intravenous use, suggest that pain, severe chemical irritation, severe spasm of distal [that means “relatively far away”] vessels, and resultant gangrene requiring amputation are likely under such circumstances.

The label in question mentioned “gangrene” no less than four times.

In short, the defendant gave a warning that: (1) expressly mentioned the particular risk (gangrene), (2) described how serious it was (“likely” if the drug is introduced into the artery), (3) told doctors how to avoid the risk (use IV-drip in preference and be very careful), and (4) used a satisfactory format (all caps and bold). There are a lot of places – but apparently not the Peoples’ Republic of Vermont – where the Levine case would have ended with a summary judgment ruling that this warning was adequate as a matter of state law. You can find a complete list of those cases on pages 2.04-31 to -35 (there are a lot of them) in Bexis’ book.

We’ll tell you right up front that all this description comes from the defendant’s opening papers that sought (now, successfully) to get the Supreme Court to take the case. Come on, we’re defense lawyers. Do you think we’d take the facts from the plaintiff’s point of view? If you want a plaintiff-side slant, maybe you’ll find it here or here. Or maybe not. You’re not likely to hear about facts from a lawyer (us included), unless they help his/her side.

Anyway, we’d have to say that the Phenergan warning is pretty darn good – adequate as a matter of law in a lot of jurisdictions. So how does the plaintiff claim it’s inadequate if it specifically mentions the risk and tells the prescriber how to avoid it?

Good question.

The answer to that question is where preemption comes in. The plaintiff doesn’t really find fault with what the label says about the risks of IV-push administration of Phenergan. What she claims is that the defendant must go further and say don’t use IV-push at all – that the risks are so awful (and gangrene is surely that) that the added benefit of getting more of the drug into the body faster just isn’t worth it – ever. In medical/legal/regulatory jargon, that kind of a “don’t do it at all” warning is called a “contraindication.”

As you can tell, a contraindication is a very serious kind of warning. For that reason, the FDA has strict standards that have to be met before a contraindication can be approved. They’re found in 21 C.F.R. §201.57(d). That regulation requires that a contraindication must relate to a “known hazard” (the risk in Levine seems to meet that) and due to that hazard “the risk of use clearly outweighs any possible benefit.” (There’s where a contraindication doesn’t cut the regulatory mustard, in the opinion of the FDA, if not the plaintiff.)

The reason for preemption is that, in the case of Phenergan, the FDA had looked at all this itself. Gangrene was a known risk, first seen in 1967. The risk was reported to the FDA, and the resultant warning about that risk went through several versions over the years. By 1981 it said that, due to various risks, the IV-drip method was “usually preferable.” During that 14 year period before 1987, the FDA never once sought a contraindication, despite the severe nature of the risk.

There was a general reformatting of prescription drug labeling in the late 1980s, and Phenergan was part of that. In particular, the FDA sought a number of label changes relating to “recognition and management of unintended intra-arterial injection.” One of these was to enhance what the label said about IV-drip. The FDA wanted the label changed to state that the drip (as opposed to the push) method “may enhance the possibility of detecting arterial placement” – that is, the doctor could tell more easily if there was a potentially dangerous screw up. The approved label change also pointed out that the drip method “results in delivery of a lower concentration of any arteriolar irritant” (it’s words like “arteriolar” – and “perivascular extravasation” – that show why we have a learned intermediary rule). Thus doctors (who know these big words) understood that, if there actually is a screw up, and only drip is used, less Phenergan (the “arteriolar irratant”) gets where it doesn’t belong.

Again, that’s as far as the FDA ever went. It never suggested that IV-push was so risky that it should be contraindicated.

Second good fact for the defendant. The defendant manufacturer then attempted to make more changes to the Phenergan label that the FDA rejected. It made submissions in 1988 and 1989. Their exact nature isn’t particularly important, since they were rejected, but they included both inadvertent intra-arterial injection and other stuff not involved in the Levine case. This time, however, the FDA said “no.” That “no” occurred in 1997, about three years before the incident that involved this plaintiff and nearly a decade after the revised labeling was submitted.

We expect somebody to ask why the FDA took so long – the entire term of Bush I and the first Clinton term. It’s a good question, but we have no idea what the answer is. Maybe Dr. David Kessler, who ran the FDA for most of that time, does.

All we know is that, when the FDA did act, it said “no.”

Anyway, by letter dated February 21, 1997, the FDA told the manufacturer to ditch the new (or by that point, not so new) labeling changes – at least the part about intra-arterial injection: “f. Inadvertent Intra-arterial Injection – Retain verbiage in current label.” (This is in the appendix to the defendant’s papers, 160-163a for those of you keeping score at home.)

Well, when the FDA says “no,” that’s what a manufacturer does - if it likes to keep being able to sell its product. Thus, the new labeling was withdrawn and the old label apparently resubmitted (we’re not FDA regulatory experts, and we’re not sure why it was necessary to do that (perhaps other changes went through), but that seems to be what happened). The result was a second letter from the FDA dated September 18, 1998, reiterating that the manufacturer was not to change the label: “The final printed labeling (FPL) for the package insert must be identical to the draft package insert submitted May 8, 1998.” (Again, see the defendant’s appendix at 164-166a.)

Looking at those facts, we’d have to say that Levine presents a preemption case that we’re quite comfortable with. The issue of gangrene and intravenous administration is plainly not anything “new” that would justify use of a “change being effected” supplement – either under the FDA’s understanding of the CBE exception at the time that process was created, or under the Agency’s currently proposed revision to the CBE regulation.

Not only that, but Levine is a case where you can argue that the FDA said “no,” but the plaintiff is trying to get the common law to say “yes.” We like that kind of case because it’s a simple, powerful argument. The plaintiffs will undoubtedly try to nitpick exactly what label changes were before the FDA, but “retain” and “identical” are rather difficult words to get around. It’s like we tell our kids – “what part of ‘no’ don’t you understand?”

And there’s more. The plaintiff’s proposition in Levine is that the common law should essentially prohibit a medical procedure – by declaring that IV-push should be contraindicated. This is not just a matter of telling doctors to do something differently, but of telling them not to do it at all. What the plaintiff makes is a risk/benefit claim, not the usual inadequate warning claim. This sort of claim is considerably more extreme than those seen in most prescription drug product liability cases, and it plays right into the FDA’s greatest strength – it’s always been the Agency’s job to make risk/benefit decisions of this sort. Accordingly we think (hope?) it will prove more difficult for the Supreme Court to endorse such a claim than might be the case if a run-of-the-mill inadequate warning (e.g., “you should have stated the risk more clearly”) claim were at issue.

Finally, in 2006 the FDA set out six categories of failure to warn claims that it thought were preempted by the FDCA. We think that at least two of them are potentially relevant:

  • claims that a manufacturer failed to warn not including contraindications or warnings that are not supported by evidence that meets the FDA’s scientific standards; and
  • claims that a manufacturer failed to warn by not including a statement in its labeling or in advertising that the FDA had prohibited the manufacturer from stating.
71 Fed. Reg. 3922, 3936 (FDA Jan. 24, 2006) (emphasis added).

Whether the first exception applies depends upon facts that we don’t have, but it certainly doesn’t appear from what the FDA concluded that the “risk clearly outweigh benefit” standard of §201.57(d) is met. The second category of FDA-recognized preemption clearly applies, since the FDA stated explicitly that the manufacturer was to continue using the label at issue without any changes.

Another thing we like about the Levine facts is what they apparently don’t contain. For that, we do look at the plaintiff’s papers.

Reading the plaintiff’s brief against certiorari, we find no claim that the defendant misstated or understated the risk in its label. That’s rare in a drug labeling case, and quite good for the defendant. While that’s not really surprising, given the plaintiff’s contraindication argument, it’s one less bunch of adverse facts to have to deal with. Going further, there’s no suggestion that the defendant ever hid anything from the FDA – and plaintiffs absolutely love to call defendants criminals any time they possibly can. While we don’t think misrepresentations to the FDA should matter under Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), as a matter of atmospherics they usually do.

We’ll go through the legal arguments in Levine soon enough – probably after the top-side merits briefs are filed – but looking at the case purely from a factual perspective, we have to say that we’re encouraged by what we see.

Wednesday, January 23, 2008

Antitrust Objection To Vioxx Settlement

As readers of this blog know, Bexis' firm is involved in the Vioxx litigation. This post, like all of the others about the Vioxx litigation, represents Herrmann's work alone:

Many folks interpreted the Vioxx settlement agreement to require participating plaintiffs' counsel to (1) recommend to all of their clients that they participate in the settlement, (2) withdraw from representing any plaintiff who chose not to participate, and (3) refuse to represent any new client who was not participating in the settlement. (At this blog, we've remained completely agnostic on the ethics issue; we express no opinion one way or the other.)

The ethical charges created the predictable firestorm. Ethicists howled; pundits pontificated; and groups of plaintiffs' lawyers filed motions in assorted courts challenging certain aspects of the settlement.

Professor George Cohen of Virginia is a particularly vocal critic of the settlement. At a panel at the American Enterprise Institute earlier this month (which was then broadcast on C-SPAN and C-SPAN2), Cohen leveled criticisms of the settlement on grounds including alleged violations of Model Rule of Professional Conduct 1.2(a) (failure to abide by the client's decisions), 1.16(b) (withdrawing from representation for an improper reason), 2.1 (failing to exercise independent judgment), and 5.6 (improperly restricting the lawyer's right to practice). Cohen also suggested that the settlement might violate the antitrust laws, because all of the participating lawyers were "conspiring" to refuse to represent clients who opted out of the settlement.

If you thought Cohen was kidding, you were wrong. He has now filed a letter with the Federal Trade Commission requesting an antitrust review of the Vioxx settlement because of his concern about an illegal group boycott.

Hat tip to Point of Law, and plainly much more to come.

"Comments" Are Now Unrestricted and Unmoderated

A few folks have contacted us complaining about either (1) the need to provide a Google password to post a comment on this blog or (2) the delay in seeing a comment posted, because the comments are "moderated" and your two hosts don't check sufficiently frequently to moderate (and post) the comments soon after they're written.

We've now changed the settings, so this blog will (at least temporarily; we'll see how the experiment goes) permit comments without the need to provide a password, and we will no longer be moderating the comments. We assume this means that we'll draw more spam and crazy stuff in the comments, but we're willing to live with that for the sake of permitting a more open dialogue among our visitors.

So it's now open season.

Feel free to chime in as you like -- but please go easy on the spam and crazy stuff.

Tuesday, January 22, 2008

Tulane Law Review MDL Symposium

The first national symposium on multidistrict litigation will be held at Tulane Law School in New Orleans on February 15th and 16th, 2008.

With one exception, the speakers are an extraordinary bunch, including: Judge John Heyburn (W.D. Ky. and Chairman) and Judge Kathryn Vratil (D. Kan.) from the MDL panel; Judge Mark Davidson (Chair of Texas MDL committee), Judge Stanwood Duval (E.D. La.), Judge Eldon Fallon (E.D. La.), Judge Carol Higbee (N.J. Sup. Ct.), Judge Janis Jack (S.D. Tx.), Judge Lee Rosenthal (S.D. Tex.), and Judge Sarah Vance (E.D. La.), distinguished state and federal judges with extensive MDL experience; academic commentators Alexandra Lahav (Connecticut), Robin Effron (Chicago), Richard Marcus (Hastings), Francis McGovern (Duke), and Edward Sherman (Tulane); and practitioners intimately involved with multidistrict litigation on both sides of the bar today, such as Richard Arsenault (Neblett, Beard), Judy Barrasso (Barrasso, Usdin), Dawn Barrios (Barrios, Kingsdorf), Russ Herman (Herman, Herman), Mark Herrmann (Jones Day) (yes, yes -- he's the exception) , Todd Hilsee (Hilsoft Notifications), and Phillip Wittman (Stone Pigman).

The symposium will cover a wide range of issues across the national landscape of multidistrict litigation, from the actual workings of the United States Judicial Panel on Multidistrict Litigation and the selection of the transferee court, to the question of coordination between simultaneous MDLs in both state and federal courts.

You can view the symposium schedule and speakers, as well as register online at:

Questions? Please contact the Symposium Editor, Mary Kathryn Nagle at

Minnesota - Still On The Road To Recovery

This guest post was written by Sean Costello. Mr. Costello is an associate resident in the Atlanta office of Jones Day. This post is entirely his work. It, of course, represents only his views, and not the views of his clients or firm:

A few weeks ago, this blog posted a short piece on an ABA Journal article discussing Minnesota’s allure to out-of-state products liability plaintiffs. The ABA Journal article, entitled “Lawsuits Travel Up North,” identified three things that, combined, attract out-of-state products liability plaintiffs: (1) a generous statute of limitations for products liability claims; (2) a choice-of-law rule that treats statutes of limitation as “procedural” rather than “substantive,” which means that Minnesota’s statutes of limitations almost always apply; and (3) liberal forum rules that allow non-resident plaintiffs with zero connection to Minnesota to sue out-of-state defendants who have minimum contacts with Minnesota (e.g., their products are sold there).

That post caught my eye, because I had guest posted a few months ago about some positive signs in the North Star state, suggesting there that Minnesota was “on the road to recovery.” My guest post discussed recent state-court decisions that had rejected the notion that Minnesota’s statute of limitations applies to any case brought in its courts, no matter how attenuated the Minnesota connection. These decisions, adopting the modern approach, analyzed the statute of limitations under modern choice-of-law rules instead of treating it as Minnesota’s courts traditionally had—i.e., as a “procedural” matter governed automatically by Minnesota law. In addition, in 2004, Minnesota’s lawmakers passed Minn. Stat. § 541.31 to give the judges a little help. (Well, actually, the Minnesota legislature didn’t come up with it. The National Conference of Commissioners on Uniform State Laws drafted it back in 1983. Minnesota’s statute is basically the Conference’s Uniform Conflict of Laws—Limitations Act, with a few tweaks. The Uniform Act, along with comments, can be found here.)

The gist of the “new” rule is this. If an out-of-state plaintiff brings a claim based on the substantive law of another state, the other state’s statute of limitations applies, not Minnesota’s. If the plaintiff asserts claims under more than one state’s law, then the court performs a conflict-of-laws analysis to figure out which state’s statute of limitations applies. In other words, Minnesota’s statute of limitations no longer has a monopoly on the claims of out-of-state plaintiffs. There’s a catch: the statute applies only to “claims arising from incidents occurring on or after August 1, 2004.” Minn. Stat. § 541.34. And there’s an exception: “If the court determines that the limitation period of another state . . . is substantially different from the limitations period of this state and has not afforded a fair opportunity to sue upon, or imposes an unfair burden in defendant against, the claim, the limitations period of this state applies.” Minn. Stat. § 541.33. Some fear that the exception may swallow the rule, but that fear is probably overblown. The comments to the Uniform Conflict of Laws—Limitations Act explain that this “escape clause” “should rarely be employed.” Uniform Conflict of Laws-Limitations Act, Comment to §4. Let’s hope the Minnesota courts heed the comments.

With all of these positive developments, it looked like Minnesota was on the road to recovery with a full tank of gas. Hence the title of my guest post. But along comes this ABA Journal article suggesting that Minnesota has gotten underway. Since 2004, Minnesota has become to out-of-state plaintiffs what a light bulb is to flying bugs. Like all good articles, the ABA Journal piece combined anecdotal stories with hard facts. On the anecdotal side, the article discussed a case where the plaintiff pleaded in the complaint (!) that she was filing in Minnesota because she was too late to file anywhere else.

That a plaintiff would cop to filing in Minnesota because she couldn’t file anywhere else certainly suggests a dysfunction in Minnesota’s system. But the numbers expose the real extent of the problem. According to the author, “out-of-state plaintiffs make up about 93 percent of drug and medical device cases filed in Minnesota’s state and federal courts,” at least since May 2004. The numbers flabbergast. In 2004, there were just 500 such filings. By 2005, that number had nearly doubled, reaching 951. And in 2006, there were nearly 7,000 filings. Minnesota’s light shone bright.

I scoured the publicly available statistics but couldn’t find anything that approached these numbers. In fact, everything I came across seemed to tell a different story. According to the statistical charts on the federal judiciary’s website, both “other personal injury” (i.e., something other than marine or motor vehicle) and “other tort actions” declined precipitously between March 31, 2004 and March 31, 2006. Between 2004 and 2006, “other personal injury” cases free fell from 2,894 to 1,409; and the number of “other tort” cases skidded from 466 to 208. That’s just the Minnesota federal court; these figures don’t include Minnesota’s state courts. Still, this was a far cry from the ABA Journal article’s numbers. Besides, if we’re talking out-of-state plaintiffs and out-of-state defendants, you’d expect that most of those cases would wind up in federal court.

Unable to makes sense of the numbers on my own, I went straight to the horse’s mouth and contacted the author of the ABA Journal article. He promptly contacted the lawyer, Scott Smith, who had supplied the figures. They were more than happy to indulge my oddball questions and got back to me almost immediately. It turns out that the numbers are based on Mr. Smith’s personal research – everyone has a hobby – and represent numbers of plaintiffs, not numbers of cases. The numbers in the article, then, weren’t typos or the result of some other mistake. In just a little over two years – 2004 to 2006 – the number of products liability plaintiffs asserting claims against pharmaceutical and medical device makers had multiplied several times over!

Obviously, Minnesota is an attractive place for those plaintiffs who may have statute-of-limitations problems, thanks to it triple threat of a generous statute of limitations, anachronistic choice-of-law rule, and lax forum requirements. The state also has a fairly high lawyer-per-capita rate. There are more than 11 lawyers per 10,000 residents, which puts it just outside the top ten states in that respect. Yes, there’s a website that puts that sort of information at your fingertips. (For a Midwest City, that’s pretty high, but doesn’t seem so bad compared with Washington, D.C., which ranks number 1 with 276 lawyers per 10,000 residents.) And many of those lawyers are plaintiffs’ personal injury lawyers who must work to eat.

But those facts merely help to explain why out-of-state plaintiffs who have timeliness concerns might want to file in Minnesota. They don’t explain why there were so darn many of these plaintiffs in 2006 compared with 2004. After all, Minnesota’s been an attractive place for procrastinating plaintiffs for decades. It’s old news. Something else must explain why the number of out-of-state products liability plaintiffs spiked in 2006.

Maybe the reason is that there were a lot of MDL’s in Minnesota in 2006. That’s the theory offered by a plaintiffs’ lawyer in the ABA Journal article, and it certainly makes sense. Minnesota has become a real hot spot for MDL’s, particularly pharmaceutical and medical device MDL’s. The Baycol, Viagra, and Guidant and Medtronic Implantable Defibrillator MDL’s are (or were) all pending in the District of Minnesota. These MDL’s account for thousands of actions – the Baycol MDL alone consists of over 9,000 – so if they are responsible for the out-of-state plaintiffs, we might have our answer. We’ve all heard Herrmann’s joke that an MDL is like the ball field in Field of Dreams, because, if you build it, they will come. And “they” are certainly coming to Minnesota. By the thousands.

Moreover, if MDL’s are responsible, that would at least mean that the increase in plaintiffs can’t fairly be attributed to plaintiffs seeking to take advantage of Minnesota’s peculiar approach to the statute of limitations, choice of law and forum. It would mean, instead, that thousands of plaintiffs were swept up in an MDL that happened to be located in the state’s federal courts. After all, the transferee court applies the choice-of-law rules of the jurisdiction in which the transferor court sits. Van Dusen v. Barrack, 376 U.S. 612 (1964), basically says so. And, though parties might be able to stipulate otherwise, this generally is the rule even if a consolidated complaint is filed in the MDL proceeding. See Brown v. Hearst Corp., 54 F.3d 21, 24 (1st Cir.1995). In fact, the court handling the Guidant Implantable Defibrillator MDL made this very point just last year:

The transfer under § 1407 , even after the filing of an amended complaint, is only a change in courtrooms. Consolidation of a master complaint is merely a procedural device designed to promote judicial economy, and, as such, it does not affect the rights of the parties in separate suits. Just as transfers pursuant to §§ 1404 and 1407 do not affect the applicable choice-of-law rules, the Court concludes that the filing of a Master Complaint or an amended complaint-by-adoption or waiving Lexecon requirements do not impact the applicable choice-of-laws rules.

In re Guidant Corp. Implantable Defibrillators Products Liability Litigation, 489 F.Supp.2d 932, 935 (D. Minn. 2007). This is something for any defendant facing an MDL anywhere to keep in mind, lest it wind up unwittingly agreeing to Minnesota’s liberal choice of law and statute of limitations rules.) Problem is, Mr. Smith said his numbers don’t include MDL’s. So much for that hypothesis.

Maybe there was some other pro-plaintiff change in Minnesota law that beckoned out-of-state plaintiffs. That’s not it, either. The American Tort Reform Association’s list of 2007’s “Judicial Hellholes” came out at around the same time as the ABA Journal article. Minnesota wasn’t on the list, and, given the outrageous numbers of out-of-state plaintiffs, you’d expect it to make an appearance, or at least be flagged as a place to watch. Minnesota’s never made the list. Not in 2006. Not in 2005. Never. Defendants in particular cases – or particular industries – might have reason to disagree, but Minnesota’s courts have not generally been held in low esteem by corporate defendants in recent years, in contrast to some of the courts that regularly make ATRA’s list. In fact, a couple of months ago, this blog posted about a favorable Minnesota state court decision in a Wyeth case (Zandi), half-joking that results like that might be a reason to reconsider removal to federal court. And a review of 2006 decisions reveals no bombshell case that would explain why out-of-state plaintiffs began to grow on Minnesota’s courts like Kudzu on Georgia pines. Thus, to wrest a positive out of what’s happened in Minnesota, plaintiffs might be able to file in Minnesota without having their claims bounced for being late, but they won’t necessarily get a good result once there.

What explains the proliferation of out-of-state products plaintiffs, then? Here’s a hypothesis: The reason 2006 saw a spike in out-of-state products liability plaintiffs is due, at least in part, to the very 2004 “borrowing statute” intended to reduce their number.

Ironic? Not really. Not even in a loose Alanis Morissette sense. It’s a matter of timing. Minnesota’s borrowing statute applies only to “claims arising from incidents occurring on or after August 1, 2004.” Minn. Stat. § 541.34. The statute was a kick in the rear to some plaintiffs’ lawyers. Many probably found themselves with portfolios of aging claims by out-of-state plaintiffs that they hadn’t filed yet. They were staring down the barrel of a statute-of-limitations defense unless they filed quickly. Many probably didn’t even know that the statute had been passed until shortly before they filed. Imagine thinking that you had until 2010 to file until you attended a CLE and found out your time was running out at the end of the day. Yikes! More than a few lawyers probably found themselves in that position. Moreover, some of the pre-borrowing statute claims were probably coming due. Those, for instance, that had accrued in 2000 or 2002, depending on the nature of the claim, would have been approaching their expiration dates. The increase would certainly explain why things got so busy in 2006 compared with 2004. These cases would have been filed at some point; they were just filed sooner than they might otherwise have been filed.

This wouldn’t be the first time a legal reform intended to reduce litigation had the opposite effect, at least temporarily. The 2005 Class Action Fairness Act provides a good recent example. As reported at the time, the week before CAFA was passed, class action filings in state court shot up. Way up. In Madison County, Illinois, for example, lawyers filed 34 class actions the week before CAFA became law. And in neighboring St. Clair County, Illinois, lawyers filed 51 class actions. In the years since CAFA, of course, the number of state court class action filings took a nosedive. Indeed, according to some widely circulated reports, only nine putative class actions were filed in Madison County, Illinois in the year after CAFA took effect.

The effect, then, is only temporary. That’s cold comfort to the defendants facing these sorts of cases. But let’s not forget that the statute is not the only salvation. Cases like Hernandez, discussed in my guest post, suggest that courts may be willing to find some of these claims time-barred, even those that arose before the statute’s August 1, 2004 date. (Minnesota’s state courts seem more willing to do so than the federal courts, moreover, another reason to contemplate carefully whether federal court would be an improvement.) While plaintiffs’ lawyers might argue that the statute’s August 1, 2004 date controls, there are plenty of good arguments why it does not preclude a court from applying a substantive choice-of-law analysis and finding even pre-August 1, 2004 claims time-barred now. After all, according to the ABA Journal article, the Minnesota legislature apparently repealed the earlier borrowing statute because it thought that doing so would “free the courts to apply” a substantive choice-of-law analysis. Since most of Minnesota’s courts seemed oblivious to this, the legislature in 2004 passed the current statute to make that intent clear. Like almost all statutes, it has an effective date. But since the precedential basis for applying a substantive choice-of-law analysis predate even that statute, and is a judicial doctrine, rather than a legislative one, there’s no reason the courts should be hamstrung by the statute’s effective date. Indeed, maybe a further reason so many plaintiffs filed suit in 2006 is that they (or their lawyers) didn’t want to take that chance.

Just as there was a leap in state court class actions in the year before CAFA because of CAFA, there’s been a big jump in out-of-state personal injury plaintiffs in Minnesota because of the borrowing statute. Minnesota has hit some bumps on the road to recovery, but its destination remains the same.

Still, one can’t help but do some backseat driving here. Minnesota could have taken a much shorter and more direct route to recovery. It could have changed its forum rules to make it harder for out-of-state plaintiffs to sue non-Minnesota defendants in the state. If you can’t sue in the state, then you can’t take advantage of its obscenely long statute of limitations or anachronistic choice-of-law approach. (That would be a positive regardless of the statute-of-limitations issue, as there’s no good reason residents of other states should be able to sue in Minnesota for injuries they suffered in places other than Minnesota.) Problem solved. Now. Not years later. Maybe the legislature should put reforming the state’s forum rules on its agenda.