Friday, March 14, 2008

That Didn't Take Long

Just after Riegel was decided, we mentioned that there would undoubtedly be attempts made in Congress to strangle the new legal regime that the Court wrought in its cradle. It didn’t take long, either. A couple of days ago, we saw a bill introduced in Congress that would eliminate express preemption under the Medical Device Amendments (“MDA”) altogether.

It’s very simple. The plaintiffs’ lawyers’ bill proposes to amend the MDA’s preemption provision, 21 U.S.C. §360k, to add a new, third, subsection:


Nothing in this section shall be construed to modify or otherwise affect any action for damages or the liability of any person under the law of any State.

That’s all. The legislation has no purpose except to reverse the express preemption decision in Riegel. Not only that, check out the “effective date” language. The plaintiffs’ bill is intended to be retroactive to 1976 when the MDA was enacted.

Never let it be said that the plaintiffs’ lawyers’ lobby in Washington doesn’t know how to write legislation.

With this bill, it can also said that the myth of “big bad Pharma” (including medical devices) should definitively be put to rest forever. Whatever lobbying power “Pharma” might supposedly have, that power pales in comparison to the plaintiffs’ lawyers’ lobby. This bill proves it.

Yeah, we know, the “big bad Pharma” myth dies hard (since the other side does so much to perpetuate it), so we’re going to have to give you better reasons than that.

We will.

Remember Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996)? We sure do. We Bone Screwers had just gotten a preemption ruling only a couple of months before that would have shut down about 85% of that mass tort. In re Orthopedic Bone Screw Products Liability Litigation, 1996 WL 221784 (E.D. Pa. April 8, 1996).

Same old, same old…. Yup, we’ve been fighting these preemption battles for that long. You see, we’ve always tried to find ways to win mass torts, not just position them for settlement.

Well, Lohr comes down and, as everybody who reads this blog knows, the industry – big bad Pharma – got its head handed to it. Lohr was such a disaster that it’s one of those events that we still remember exactly where we were when we first heard about it.

Lohr involved medical devices cleared for marketing as “substantially equivalent” to some device that existed before the MDA was passed. How big was that? That type of marketing clearance is how well over 90% (we’ve seen stats indicating more like 99%) of all medical devices make it to market. Lohr meant, and means, essentially that 90-99% of all medical devices have no preemption protection at all.

That’s a lot of devices and a lot of device manufacturers.

So what did “big bad Pharma” do after Lohr?

Not much. The preemption landscape for the vast majority of medical devices has pretty much stayed the same ever since – for more than a decade now.

Unlike the plaintiffs’ lawyers’ lobby now, our side never tried to ram a bill through Congress (then controlled by Republicans, remember) that would have overturned Lohr and expanded preemption to the 90%+ of devices that had just had preemption ripped away from them.

Too hard, was the word. The votes just weren’t there.

Supposedly big bad pharma didn’t have the political muscle even to think about protecting 90%+ of all medical devices with a pro-preemption amendment.

But let the other side lose the preemption war with respect to even 1% of all medical devices?

Boom! The ink’s hardly dry on Riegel and here they come with legislation designed to make sure there’s no preemption anywhere, ever again - express preemption, anyway. They can’t take implied preemption away unless they repeal the FDCA and abolish the FDA

The plaintiffs’ lawyers’ side sure is convinced that they can put the political arm on Congress in ways that big bad Pharma would never even dream of. Even though they like to vilify our clients for purported political influence, they know the truth as well as we do. Our side wouldn’t even attempt such a thing.

That’s a good definition of chutzpah.


Eric Turkewitz said...
This comment has been removed by the author.
Eric Turkewitz said...

With this bill, it can also said that the myth of “big bad Pharma” (including medical devices) should definitively be put to rest forever. Whatever lobbying power “Pharma” might supposedly have, that power pales in comparison to the plaintiffs’ lawyers’ lobby. This bill proves it.

Just because it was introduced doesn't mean it will get passed. And if it gets passed, it doesn't mean it will get signed.

Anonymous said...

OK. So we're back to the Constant Gardner versus the King of Torts. And neither demonology will get us anywhere.

Any consideration to the possibility that it is _not_ all about those greedy trial lawyers? Any consideration to the possibility that Pallone and Waxman also hear from those demonic doctors, like the editors of the New England Journal of Medicine, who wrote that FDA preemption would be a disaster for patient rights, industry accountability, and public health?

Indeed, in a moment of clarity, you guys raised the possibility yourself in your "big responsibility" post, as much as you predicted the disaster forseen by many would not happen.

Any of us could be wrong (as you also wrote there). I agree with exactly what you wrote there - let's hope it's not you. Not for your sake; for all of ours, including the industry.

Henry Greenspan, Ph.D. said...

"They can’t take implied preemption away unless they repeal the FDCA and abolish the FDA."

Can you explain this? As I recall, precisely the same language as the Pallone/Waxman bill had been proposed as part of the FDAAA. (You were less than pleased then too.) Of course, it was removed in compromise.

FDAAA obviously covers both drugs and devices. Why couldn't that happen again?

Beck/Herrmann said...

Whether or not there's a statute, there's implied preemption (in very general terms)whenever state law would make it difficult or impossible to comply with federal law. (When federal and state law conflict, state law must yield, according to the Constitution.) Even if a statute says that there is no preemption, if the FDA, for example, requires a manufacturer to include certain statements on product labeling, state law could not prohibit the manufacturer from making those statements.

That "implied preemption" is a matter of constitutional, not statutory law.

Henry Greenspan said...

Thank you for your clarification.

When the issue came up in FDAAA, you commented here:

"Regular visitors to this blog will remember that, once upon a time, during the history of the FDAAA, the plaintiffs’ crowd actually did try to slip an anti-preemption poison pill into the bill. We blogged about that a couple of times here and here. That provision read:

Nothing in this act or the amendments made by this act may be construed as having any legal effect on any cause of action for damages under the law of any state (including statutes, regulations, and common law).

Well, the effect of that ploy was immediate and far-reaching. Industry – our clients – threatened to withdraw its support from what became the FDAAA, and within days the offending provision was promptly removed."

Back then, indeed, we had language essentially identical to the Pallone/Waxman bill.

I would have guessed (and am prepared to be wrong) that if such statutory language was irrelevant - and the issue were purely constitutional - your clients would have been less determined to withdraw their support for FDAAA as a result of it.

Time will tell.

Beck/Herrmann said...

Thanks for your interest.

We didn't mean to say that the statutory language was irrelevant.

Of course, from the defense perspective, you'd like to have both express statutory plus implied Constitutional preemption.

Congress can theoretically eliminate the former, which does indeed hurt industry. But it cannot eliminate the latter, so some form of Constitutional implied preemption will always be available.

Anonymous said...

Bill Introduced in Congress = Parties That Might Like the Bill Have More Power Than Their Zillion Dollar Foes

It is at all possible that this equation is just a wee bit of a leap of logic?

Ron Miller

Anonymous said...

Thank God that Pallone and Waxmann are attempting to protect the American comsumer. I would much prefer Bill in bed with Monica than George in bed with Pharma, Dan Troy, and Ted Olsen. At least the former didn't kill anybody, which is a lot more than can be said of the latter.