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:
(c) NO EFFECT ON LIABILITY UNDER STATE LAW
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.
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.