Arbitration & Mediation

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

By Victoria Pynchon

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.

Full post as published by Settle It Now Negotiation Blog on February 21, 2008 (boomark / email).