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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 FD
A/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.