Comments on: Congress Has A Bill To Reverse Device Preemption

By: laura

laura — Fri, 27 Jun 2008 15:04:16 +0000

AV Block,
I agree with you when you state that trial lawyers make a lot of money. But is that a reason to remove accountability from medical device companies? That is what preemption does. Doctors make a lot of money, should we not allow them to practice? Architects make a lot of money, should we stop them from designing buildings? Corporate executives make a lot of money, should we remove them from their jobs? The reason these people make a lot of money is because they provide valued services. If you’re upset that trial lawyers make a lot of money, please don’t use that as a reason to take away my right to hold a medical device company accountable for the product that killed my mother.

By: AV Block

AV Block — Fri, 27 Jun 2008 13:22:37 +0000

The major beneficiaries of this law will not be consumers, but trial lawyers. Think of the fees generated for these lawyers. And they get to participate in the upside.

What a great way to drive up healthcare costs, guys!

By: Jaynesday

Jaynesday — Fri, 27 Jun 2008 10:40:49 +0000

I second what Laura said about making a phone call to your Congress person. My experience is that the aids that take the calls are more than helpful. They may not know a lot about the issue of preemption but they are a direct contact with the person in charge. In my case I even received a phone call back about the issue.

By: Justice in MI

Justice in MI — Fri, 27 Jun 2008 04:32:38 +0000

Obviously agree, Laura. I will say that, personally, it took me several attempts before I could get a direct statement from my own Rep. But I eventually did. It can take persistence.

I would also take the liberty of saying this:

The most compelling stories re: preemption will come from people inside industry who have experiences which convey directly what FDA regulation does and does not mean. Or they may have firsthand experience with the role that anticipated litigation does play in decision-making.

If there are such people who read this, and they are willing to contact me (with confidentiality guaranteed), I hope they will. Email: justiceinmich@gmail.com

A number of you have already been in touch, and that is enormously appreciated.

I frankly believe that the only way to stop preemption at this point will be testimony that comes from the experiences of people who know what it will mean from the “inside.”

By: laura

laura — Fri, 27 Jun 2008 02:36:34 +0000

That said, wherever you stand, I would make sure you know where your own representatives stand. And I would push in every usual way that they make their views public and explicit. This issue deserves full, transparent public debate

Justice,
You are absolutely right on target with your comment. It is imperative that our elected officials know how we feel on this issue. Most people would be surprised to see how accessible their representatives and senators are. I hope that anyone who has strong feelings on this issue picks up their phone and calls their representative and senators’ offices tomorrow. Ask to talk to the elected official or an aid. Most likely, you will be put through to an aid but, I can assure you, they will appreciate your input. If you have had a personal experience regarding medical device preemption, let them know. They are looking for examples to illustrate flaws in preemption. Right now, it is entirely in their hands. If they feel that their constituents are behind them, they will act. They just need to hear from you.

By: Just A Thought

Just A Thought — Fri, 27 Jun 2008 02:11:17 +0000

So the government feels they have the right to tell the population that they can be damaged without recourse.
Only we ARE the government. Our elected officials are supposed to be representing us. The Supreme Court will be approached against preemption on a case by case basis. This is going to bring all the heat down on the ‘we approved it without properly reviewing it’ FED and muck up the courts. It isn’t going to be pretty and it isn’t going to stick.

People will medicate less and Goliath is going to fall for lack of trust. Because the one sure way to make someone act irresponsibly is to not hold them responsible.

Should be interesting to watch.

By: Lisa Van S

Lisa Van S — Fri, 27 Jun 2008 00:56:46 +0000

You Go Frank!!!,.. Thanks Bobby, NJ Luvs Ya!!

By: Justice in MI

Justice in MI — Thu, 26 Jun 2008 21:08:30 +0000

No secret where I stand on this issue. But I cannot say I am hopeful. There is some division within the Dem leadership on this issue. While a majority in the House is quite likely, the Senate will be a squeaker at best. And, if history is any guide, Bush will veto. There is almost certainly not enough votes in Senate to override. So the preemptors out there can probably relax.

For reasons that are mainly accidents of history, the part of the FDCA that concerns drugs does not have an express preemption provision, as Ed notes. Thus the issue in the drug arena will be more complicated for several reasons.

BTW, if it’s not clear, the original MDA (Medical Device Act) express preemption was intended to prevent indidual states from setting up directly competing _regulatory_ regime. (i.e., California creates a state-level FDA and decides a particular pacemaker is not approved for use there.)

The argument of the preemptors is that civil liability consititutes a similarl competing regulatory regime. The argument against is that it simply does not. All issues of warning, etc., remain exclusively with FDA and - as you’ve heard a zillion times - FDA itself (until current administration) - has almsot always viewed civil liability as complementing, not competing with, its regulations.

Exceptions (and here the Levine case may get tricky) are when it can be shown that a company has explicitly requested a label change and FDA has explicitly rejected it. Under those circumstances, it would make sense to most folks not to hold company accountable for not adding a warning what FDA did not agree with. But such circumstances are rare at best.

My own favored ruling would be a narrow one - support FDA preemption in circumstances as specific as that, but not otherwise. But the odds of that happening … are also not good.