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She Negotiates

She Negotiates

The 33 cent wage and income gap is unacceptable and unnecessary. So is the cliché glass ceiling. Bottom line, our...

Riegel v. Medtronic: An Opportunity for Industry and the Government to Do the Right Thing

What does the decision in Riegel v. Medtronic have to do with dispute resolution?  A lot if we collectively pause to commit ourselves to using this calamity/victory as an opportunity to benefit both industry and the public at the same time.  

Is that possible?  I'm a mediator for goodness sakes.  If I didn't believe that to be possible, I'd serve the world better by getting a real estate license.  

Re:  what follows:  I rarely see anyone representing a narrow set of industry interests respond to a victory of any magnitude with the humility and vision expressed by Mark Herrmann in his post from Drug and Device Law -- Much is Given, Much is Expected, excerpted below. 

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.

Comments (2)

Read through and enter the discussion by using the form at the end
anon - June 26, 2008 4:36 PM

You are right. Bravo to them and their vision. They profess that they only have one point of view: the pro industry view. Yet let's applaud they for their even handedness and ignore they are advocates. That will be fun.

To the man with a hammer, everything is a nail. To a mediator, everything is spun as some gesture of conciliation.

Let's say you are told by your state's high court: you can screw up however you want and you are immune for any lawsuits. If you said, I will be careful, judges, and I will not just negligent[ly] screw everything up even though I can if I want, would you expect some blog to praise you?

Vickie - June 26, 2008 5:10 PM

Whenever an attorney representing narrow interests wins one AND urges the industry he serves not to take advantage of the win, I'm on board with the attorney.

I may well disagree with the opinion addressed here -- which I have to admit I didn't read. I do not disagree with taking responsibility for the consequences of a court victory giving an unprecedented degree of freedom from liability to a particular industry.

I don't "know" Mark but I read him and he has always impressed me as a good guy; good lawyer; and a fine advocate. He obviously takes a different view from anon, who doesn't feel secure/free? enough to identify himself along with his opinion here.

Nevertheless, I want to encourage participation here. So I pretty much post all comments that aren't advertisements or clearly products of a disturbed mind (my editorial judgment alone).

So come on out, anon, and play in the field of opinion -- hammer, nail, or kum-by-ya around the fire -- none of it's as black and white as it seems.

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