Thursday, February 21, 2008

Much Is Given, Much Is Expected

Yeah, it was a hell of a party … but we’re sober now.

One of us even got almost hilariously misquoted in the press, when the reporter got the effect of the 2006 Preemption Preamble exactly backwards. As everyone reading this knows, in 2006 the FDA invigorated – not impeded – preemption.

But it’s time to face the cold, gray dawn.

The medical device industry, or at least the most innovative part of it, received major relief from product liability litigation yesterday in Riegel v. Medtronic (now online at 2008 WL 440744). As long as our clients with PMA-approved devices comply with federal law, they’re not going to be subject to much in the way of product liability. Not only that, as we pointed out only two weeks ago, so-called “parallel” (or “violation”) claims have their own conceptual problems, given the exclusive grant of enforcement authority to the FDA.

That’s not what we’re talking about right now, though. We’re stone, cold sober.

We won. What does that mean? At bottom, it means that, just as Riegel gives some of our clients the opportunity for a more litigation-free existence, that increased freedom carries with it a correspondingly increased responsibility.

Plaintiffs lawyers like to say (at least when they’re not piously denying the “regulatory effect” of tort law in briefs opposing preemption) that product liability litigation serves as an incentive to make safer products.

We defense lawyers retort that product liability litigation is horribly ineffective (given the influence of so many non-merits issues), inefficient (plaintiffs’ lawyers take 33% or more of most recoveries, and that’s not even counting defense costs), and downright counterproductive (deterring innovation, and punishing manufacturers for doing the right thing when they discover problems) compared to governmental regulation as a means of ensuring product safety.

Well, now we’re going to find out who’s really right.

In other words, the PMA medical device field is going to determine in practice whether a high regulation, low litigation environment is as effective a method of ensuring the safety of the public as we think it is – or if it’s as lousy a way of ensuring safe medical devices as the other side claims.

So, to the medical device industry – to the regulators at the FDA – and to our colleagues who practice FDCA regulatory law…. Don’t let us down, please.

We product liability defense lawyers are likely to be shuffling mostly off the PMA-approved stage – shooing our opponents along with us. That’s what we want. Good defense lawyers go out there every day trying to find ways to put ourselves out of a job. That’s what we’re supposed to do – find ways that our clients will have less need for our services. On the morning after, that looks like that’s finally happened with PMA medical devices. We wish those clients well, confident that there will always be a market for good lawyers.

But we know that this result will last only as long as the replacement system is effective at keeping the public safe.

That’s the bottom line. We expect even our opponents would agree with us on that.

Our clients are good, dedicated people. We know that, whether the other side wants to believe it or not. The medical devices that they’ve invented, well, some of them are little short of miraculous in what they can do. But they’re not perfect. Nothing and nobody is. Even when mistakes happen, we’ve seen our clients do the right thing over and over again, even though the prior system virtually guaranteed that they’d face major litigation as a result.

We fully expect them to continue doing the right thing, even with the threat of litigation substantially reduced. If they don’t – if they were to cut corners, fall down on their reporting and compliance, and so on – then the high regulation, low litigation model that Riegel is giving a chance to function isn’t going to work.

In this sense, Riegel presents a challenge to all of us who believe that free market capitalism – properly regulated – is the best economic system ever put into practice.

And this is not just a challenge for industry. Ditto the regulators. Riegel confers added responsibility on the FDA. The Agency has stated over and over again that it – not courts and lawyers – has primary responsibility for ensuring that the products it regulates are safe and effective. The FDA, like industry, now has to put up or shut up. With much of the litigation underbrush cleared away, the FDA will have to show that it is indeed the expert regulatory body that we believe it is. In short, it will have to exercise effective authority over PMA medical devices.

“Oops, we inspected the wrong facility,” isn’t going to cut it.

The FDA will have to display, day in and day out, the “rigor” that the Riegel majority found in its approval and post-approval processes. If the Agency doesn’t provide strong regulatory oversight, then inevitably unsafe medical devices will enter the market and people – real flesh and blood people – are going to get hurt. So we expect the FDA to reject such devices, even though in specific instances this will cost companies a lot of money. We expect the FDA to come down like a ton of bricks on anybody who cheats on safety-related issues after approval, such as not reporting adverse incidents, or not following good manufacturing practices.

If the Agency doesn’t do this, the high regulation, low litigation model isn’t going to work.

The same holds true for our colleagues on the regulatory side. We expect them, as we expect ourselves, to represent the interests of their clients. But when they find, as they inevitably will, flaws in the system, they need – through organizations like the Food and Drug Law Institute – to work with the FDA to correct those flaws so that the Agency’s processes effectively protect the public. If our regulatory colleagues concentrate on gaming the system rather than ensuring its effectiveness, once again the high regulation, low litigation model won’t work.

And if this model doesn’t work, it won’t last.

Remember, it’s express preemption that was at issue in Riegel. That means that the protection from suit provided by the Riegel preemption holding is based upon the terms of the FDCA Act. The statute can be changed by Congress. Indeed, we fully expect the other side to try to strangle the high regulation, low litigation model in its crib. After all, they stand to lose their 30%+ cut.

However, we expect them to be unsuccessful – as long as the public health is properly protected.

We expect the other side to fail because we’re convinced that FDA regulation is a far superior means of ensuring the public health. We believe that the methodical and systematic decisions of an expert agency are far more likely to produce rational results conducive to product safety than the uncoordinated decisions of innumerable juries – which are influenced by every inflammatory trick that lawyers can play, apply a patchwork of inconsistent state law, and aren’t allowed to focus on anything more than the case in front of them.

If we didn’t believe this, we couldn’t do what we do.

But if we’re wrong (there’s only one guy on the planet who claims infallibility), and the high regulation, low litigation model results in a lot of substandard devices that hurt people, then Congress will change the law, and we’ll be back to litigation as usual.

Worse than that actually.

If the high regulation, low litigation model can’t deliver the goods, then its failure will discredit the medical device industry, discredit the FDA, and discredit us lawyers who represent the industry. If that happens, we’ll be worse off than we were before Riegel.

And that would be a very bad thing.


Anonymous said...

You wrote:

"The FDA will have to display, day in and day out, the “rigor” that the Riegel majority found in its approval and post-approval processes. If the Agency doesn’t provide strong regulatory oversight, then inevitably unsafe medical devices will enter the market and people ..."

The FDA is a joke. Udnerfunded, understaffed. IF you presume in the academic that the FDA does what it was supposed to do, I'd be fine with it.

As a panel just wrote:

The Food and Drug Administration is so underfunded and understaffed that it's putting U.S. consumers at risk in terms of food and drug safety, an advisory panel to the FDA says in a report to be discussed Monday.

gency responsibilities. Instead of being proactive, the agency is often in "fire-fighting" mode.

•A workforce with a "dearth" of scientists who understand emerging technologies. Turnover rates in some scientific positions at the FDA run twice that of other government agencies.

•An "obsolete" information-technology system.

The report says that the FDA's IT systems are so lacking that reports of product dangers are not rapidly compared and analyzed, and that inspectors' reports are handwritten and slow to move through the system.

Putting pruduct thorugh a broken system is ridiculous. Shame.

Beck/Herrmann said...

The FDA is no joke. Like it or not, it is the federal agency charged by Congress with overseeing the safety of drugs, medical devices, food, vaccines, and a lot of other stuff that keeps us alive and functioning.

The FDA only becomes a "joke" if congress refuses to adequately fund it and otherwise give it the tools it needs to do the job, and if the administration fails to provide the leadership and will for the Agency to do it's job.

There's no small measure of sour grapes here. We remember when, under Kessler, plaintiffs had a love-in with the FDA. Now the shoe's on the other foot and all we see are remarks like this.

Henry Greenspan, Ph.D. said...

I am including a somewhat revised version of a comment also provided on the Pharmalot blog in a thread responding precisely to this thread here. Not being a lawyer, there is no "30%" involved for me, of for anyone with whom I am associated. Thus, just as I agree that most people in the drug and device industry are people of integrity, I hope you will grant that most - if not all - profoundly opposed to preemption are also people of integrity. Please don't tar all of us if you ask not to be tarred yourself.

Everything we have learned about industry, FDA, and their relationship over the past decade (and much longer) tells us that they will not step up to the plate. On the FDA side, they simply do not have the means to do the kind of job you describe.

I believe it a certainty, therefore, that disaster will occur, and it will be on a scale much larger and more devastating than anything we have seen because most of it will happen in the dark. When the levee breaks, it will entail more than burying the bodies and hoping for a Congressional fix. Trust in the FDA and the industry will be shattered for a very, very long time. And that itself will result in both economic and public health disaster. We will have a lot of dead people. And a lot of dead companies. So I agree - the situation will be profoundly worse for the industry, and all of us, than it is now.

That is one reason I have been arguing for several years that preemption has never been in industry’s interest. Entirely, the opposite. And the disapproval rates one sees now will be looked back upon as very good days compared to what is to come.

I am sorry to be so negative. Trust me, this is not a political statement. And it is precisely the opposite of anti-industry. It is looking a policy in the face - the policy of preemption - and simply saying what cannot be blinked away: it is logically, practically, and ethically bankrupt. It is a preemptive strike that will cost more, in both lives and treasure, than the preemptive strike on Iraq. It is an avoidable disaster (in the drug arena), but one that will almost certainly not be avoided.

And, sad to say, those who are on the inside of the industry know this best of all. And many of them have told me this, just as I am sure, in one way or another, they have told you.

Anonymous said...

The FDA is a complete joke and you know it. Stop pretending like there's some kind of rational basis for total preemption beyond your clients spending a bunch money to limit their liability. Money talks and B.S. walks.

Just be honest about guys have engaged in some great lawyering and have managed to get lucky with a pro-business supreme court that, fortunately for you, happens to have a profound dislike for plaintiffs' lawyers. Seriously, Scalia could barely contain himself in Riegel. When reading his opinion, I thought he was going to just come out and say that plaintiffs' lawyers are spawn of the devil and that stupid state court juries just aren't smart enough to decide ANY complex cases.

Well, if Scalia is correct, I guess that means we ought to just get rid of the whole jury system. If a jury can decide a benzene lymphoma case then why can't it also decide a drug or device case. This is completely absurd.

I guess in the future when we handle voie dire, we need to find a bunch of smart, learned, folks like scalia who really know what's good for the country and can think broadly in a more "utilitarian" fashion. Maybe then we'd get some "fair" verdicts, right?

Wow...eight years of Bush certainly has its consequences.

Beck/Herrmann said...

Plaintiffs' lawyers need to consider their own excesses. The Riegel case involved a product used for a contraindicated use (calcified arteries) and them misused (overinflated) on top of that. Yet it was the manufacture that got sued.

And then there's the whole mass tort industry. Any recall, and almost any warning letter or other adverse information of any sort about a prescription drug or medical device becomes within a week there are ten class actions filed and massive solicitation.

The plaintiff's side never had Scalia. But five justices voted against preemption as recently as Lohr - indeed, as recently as Bates. The plaintiffs' side lost four of those five. That should say something.

The tort system has gotten out of control. It's tried to usurp the role of the FDA. It's not surprising to see courts looking for ways to rein it in.

GraniteKey said...

You nailed it on the head with this post. If medical device manufacturers do the right thing, then we end up with safe devices, and not having to spend untold resources on litigation allows more resources to make them safer. Litigation can and often does unfairly cripple progress.

Steve0h said...

Score one for the Supreme Court. It should be agreed that everyone in any industry does their best to produce a product supreme quality regardless of the industry. This holds true for any medical device industry. With the regulations put in place by the FDA, consistent audits to ensure compliance, there have been huge strides in product safety and oversight. By any means there is no possibility for negligence. There is only possibility for research, development and progress. For the nay Sayers who disagree on the concept that a life may be lost, the ultimate goal is still in place that there will be a greater number of lives saved.