Comments on: Former FDA Commish Argues Against Preemption http://www.pharmalot.com/2008/02/former-fda-commish-argues-against-preemption/ News, Comment and Conversation Sun, 21 Mar 2010 02:17:29 +0000 http://wordpress.org/?v=2.6.2 By: Justice in Michigan http://www.pharmalot.com/2008/02/former-fda-commish-argues-against-preemption/#comment-184965 Justice in Michigan Sat, 01 Mar 2008 15:03:43 +0000 http://www.pharmalot.com/2008/02/former-fda-commish-argues-against-preemption/#comment-184965 As things now stand, I don't think there is that "middle ground." The FDA/DOJ amicus in Kent went out of its way to say that FDA findings of fraud, and response to those findings, ought not serve as "gatekeeper" to private litigation in any context. (And, as noted here, FDA/DOJ virtually never make such findings, but my example premised that they did - most likely, pressured by whistleblower revelations, media, and Congress). That is why _some_ preemptors have tried to come up with some version of "no-fault" schemes in which proven victims could be compensated (there is no such viable model so far). The bottom line remains to rule-out civil actions in any contexts, under any circumstances, including fraud. As things now stand, I don’t think there is that “middle ground.” The FDA/DOJ amicus in Kent went out of its way to say that FDA findings of fraud, and response to those findings, ought not serve as “gatekeeper” to private litigation in any context. (And, as noted here, FDA/DOJ virtually never make such findings, but my example premised that they did - most likely, pressured by whistleblower revelations, media, and Congress).

That is why _some_ preemptors have tried to come up with some version of “no-fault” schemes in which proven victims could be compensated (there is no such viable model so far).

The bottom line remains to rule-out civil actions in any contexts, under any circumstances, including fraud.

]]> By: Nathan http://www.pharmalot.com/2008/02/former-fda-commish-argues-against-preemption/#comment-184679 Nathan Sat, 01 Mar 2008 11:19:41 +0000 http://www.pharmalot.com/2008/02/former-fda-commish-argues-against-preemption/#comment-184679 Justice says: "Let’s say there was definitively proved fraud perpetrated by a company. Would you then agree that should open the gate to civil liability (lawsuits by injured plantiffs)? That’s actually not the preemptors’ position. There would still be no tort remedy, even after proven fraud." Is there no "middle ground" on this issue? Why can't an individual sue in federal court on grounds that the company broke a federal law? (fraud) Justice says:
“Let’s say there was definitively proved fraud perpetrated by a company. Would you then agree that should open the gate to civil liability (lawsuits by injured plantiffs)?
That’s actually not the preemptors’ position. There would still be no tort remedy, even after proven fraud.”

Is there no “middle ground” on this issue? Why can’t an individual sue in federal court on grounds that the company broke a federal law? (fraud)

]]> By: Justice in Michigan http://www.pharmalot.com/2008/02/former-fda-commish-argues-against-preemption/#comment-184289 Justice in Michigan Sat, 01 Mar 2008 03:22:37 +0000 http://www.pharmalot.com/2008/02/former-fda-commish-argues-against-preemption/#comment-184289 I hear you, Nathan. That is apparently what happened in the case of Benedectin mentioned above. There may be other such instances, but I've never heard the preemption folk mention them. It's all Benedectin, all the time. (I should correct this. I know a few corp. lawyers who still think that Rezulin should, and would, still be on the market if it weren't for the other kind of lawyers. I don't know any docs who think this.) I hear you, Nathan. That is apparently what happened in the case of Benedectin mentioned above. There may be other such instances, but I’ve never heard the preemption folk mention them. It’s all Benedectin, all the time.

(I should correct this. I know a few corp. lawyers who still think that Rezulin should, and would, still be on the market if it weren’t for the other kind of lawyers. I don’t know any docs who think this.)

]]> By: Nathan http://www.pharmalot.com/2008/02/former-fda-commish-argues-against-preemption/#comment-184173 Nathan Sat, 01 Mar 2008 01:31:25 +0000 http://www.pharmalot.com/2008/02/former-fda-commish-argues-against-preemption/#comment-184173 Justice says: "I agree juries do not have the beneficiaries of the device/drug in front of them. But since their decion (if its negative) does nothing to take the device/drug away from those benficiaries, there is no issue here." That's true -- but huge liability lawsuits EFFECTIVELY take the product off the market by taking away the profit motive. For a medium or small sized market, it would only take a few major settlements for a company just to pull the product off the market and say "it's not worth the effort". Justice says:
“I agree juries do not have the beneficiaries of the device/drug in front of them. But since their decion (if its negative) does nothing to take the device/drug away from those benficiaries, there is no issue here.”

That’s true — but huge liability lawsuits EFFECTIVELY take the product off the market by taking away the profit motive. For a medium or small sized market, it would only take a few major settlements for a company just to pull the product off the market and say “it’s not worth the effort”.

]]> By: Justice in Michigan http://www.pharmalot.com/2008/02/former-fda-commish-argues-against-preemption/#comment-184025 Justice in Michigan Fri, 29 Feb 2008 22:35:49 +0000 http://www.pharmalot.com/2008/02/former-fda-commish-argues-against-preemption/#comment-184025 Nathan or others - Here is the real tough question, and I think closer to reality. Let's say there was definitively proved fraud perpetrated by a company. Would you then agree that should open the gate to civil liability (lawsuits by injured plantiffs)? That's actually not the preemptors' position. There would still be no tort remedy, even after proven fraud. Rather, the only consequence could be fines or other sanctions via the DOJ. Injured folks would still be out of luck unless - in a huge case - something was put together by the feds like the asbestos settlements. Good policy? Nathan or others - Here is the real tough question, and I think closer to reality.

Let’s say there was definitively proved fraud perpetrated by a company. Would you then agree that should open the gate to civil liability (lawsuits by injured plantiffs)?

That’s actually not the preemptors’ position. There would still be no tort remedy, even after proven fraud. Rather, the only consequence could be fines or other sanctions via the DOJ. Injured folks would still be out of luck unless - in a huge case - something was put together by the feds like the asbestos settlements.

Good policy?

]]> By: Justice in Michigan http://www.pharmalot.com/2008/02/former-fda-commish-argues-against-preemption/#comment-184018 Justice in Michigan Fri, 29 Feb 2008 22:26:50 +0000 http://www.pharmalot.com/2008/02/former-fda-commish-argues-against-preemption/#comment-184018 Nathan - In terms of your first post: - State tort liability has nothing to do with state statutes and regulation that conflict with FDA. No jury has ever decided a device should be taken off the market. Those decisions remain the province of the FDA. And FDA's views on those issues are virtually always part of the trial argument on manufacturers side. So it is not FDA _vs_ tort law; it is both together. Preemption flushes one side away. - Much the same applies to the second point. I agree juries do not have the beneficiaries of the device/drug in front of them. But since their decion (if its negative) does nothing to take the device/drug away from those benficiaries, there is no issue here. - As far as I know, there is only one case in which a class action settlement forced a drug off the market that turned out probably to not have the risks that were relevant. That was Benedictin. And that is why, if you read the arguments of the preemptors, it is all Benedectin, all the time. - Re: the second point, I agree that liability should depend on company malfeasance, not simply because of injury that could not have been forseen. As has been reiterated here, the likelihood that FDA will discover such malfeasance, let alone act on it, is very small compared either with the discovery process of civil trials or whistleblowers. (It's amazing how many actions that FDA/DOJ do end up taking essentially depended on either civil actions or whistleblowers.) Nathan - In terms of your first post:

- State tort liability has nothing to do with state statutes and regulation that conflict with FDA. No jury has ever decided a device should be taken off the market. Those decisions remain the province of the FDA. And FDA’s views on those issues are virtually always part of the trial argument on manufacturers side. So it is not FDA _vs_ tort law; it is both together. Preemption flushes one side away.

- Much the same applies to the second point. I agree juries do not have the beneficiaries of the device/drug in front of them. But since their decion (if its negative) does nothing to take the device/drug away from those benficiaries, there is no issue here.

- As far as I know, there is only one case in which a class action settlement forced a drug off the market that turned out probably to not have the risks that were relevant. That was Benedictin. And that is why, if you read the arguments of the preemptors, it is all Benedectin, all the time.

- Re: the second point, I agree that liability should depend on company malfeasance, not simply because of injury that could not have been forseen. As has been reiterated here, the likelihood that FDA will discover such malfeasance, let alone act on it, is very small compared either with the discovery process of civil trials or whistleblowers. (It’s amazing how many actions that FDA/DOJ do end up taking essentially depended on either civil actions or whistleblowers.)

]]> By: Nathan http://www.pharmalot.com/2008/02/former-fda-commish-argues-against-preemption/#comment-183827 Nathan Fri, 29 Feb 2008 19:04:31 +0000 http://www.pharmalot.com/2008/02/former-fda-commish-argues-against-preemption/#comment-183827 David, What should the "injured patient" get compenasted for? For side effects? There should be NO compensation for anything unless a law was broken! (ie unless fraud was committed) Drugs have side effects -- everyone knows that. You shouldn't be able to sue unless you can show that the company knew about the ailment you were aflicted with and purposely withheld the info from the public and/or FDA. David,
What should the “injured patient” get compenasted for? For side effects? There should be NO compensation for anything unless a law was broken! (ie unless fraud was committed) Drugs have side effects — everyone knows that. You shouldn’t be able to sue unless you can show that the company knew about the ailment you were aflicted with and purposely withheld the info from the public and/or FDA.

]]> By: david egilman http://www.pharmalot.com/2008/02/former-fda-commish-argues-against-preemption/#comment-183810 david egilman Fri, 29 Feb 2008 18:46:16 +0000 http://www.pharmalot.com/2008/02/former-fda-commish-argues-against-preemption/#comment-183810 The injured patients get compensated for the injuries that occur in torts only. The FDA knows the injuries will occur. The compensation costs (externalities) are built into the price of the drug. This is how capitalism is kept honest. None of this has anything to do with the FDA. If the FDA wants to compensate fairly then pre-emption is justified. The injured patients get compensated for the injuries that occur in torts only. The FDA knows the injuries will occur. The compensation costs (externalities) are built into the price of the drug. This is how capitalism is kept honest.

None of this has anything to do with the FDA. If the FDA wants to compensate fairly then pre-emption is justified.

]]> By: harpy http://www.pharmalot.com/2008/02/former-fda-commish-argues-against-preemption/#comment-183785 harpy Fri, 29 Feb 2008 18:15:52 +0000 http://www.pharmalot.com/2008/02/former-fda-commish-argues-against-preemption/#comment-183785 Nathan, there is a world of difference between devices and drugs. What's right for the goose isn't always right for the gander. Nathan, there is a world of difference between devices and drugs. What’s right for the goose isn’t always right for the gander.

]]> By: Nathan http://www.pharmalot.com/2008/02/former-fda-commish-argues-against-preemption/#comment-183772 Nathan Fri, 29 Feb 2008 18:00:20 +0000 http://www.pharmalot.com/2008/02/former-fda-commish-argues-against-preemption/#comment-183772 Justice, Here's a quote I found to be a very elegant summary of the "pro-preemption" reasoning: "A state statute, or a regulation adopted by a state agency, could at least be expected to apply cost-benefit analysis similar to that applied by the experts at the FDA: How many more lives will be saved by a device which, along with its greater effectiveness, brings a greater risk of harm? A jury, on the other hand, sees only the cost of a more dangerous design, and is not concerned with its benefits; the patients who reaped those benefits are not represented in court." This statement speaks for itself, I believe. Here's the link: http://blog.pharmexec.com/2008/02/25/pre-emption-watch-legal-eagle-explains-riegel/ Justice,
Here’s a quote I found to be a very elegant summary of the “pro-preemption” reasoning:

“A state statute, or a regulation adopted by a state agency, could at least be expected to apply cost-benefit analysis similar to that applied by the experts at the FDA: How many more lives will be saved by a device which, along with its greater effectiveness, brings a greater risk of harm? A jury, on the other hand, sees only the cost of a more dangerous design, and is not concerned with its benefits; the patients who reaped those benefits are not represented in court.”

This statement speaks for itself, I believe.
Here’s the link:
http://blog.pharmexec.com/2008/02/25/pre-emption-watch-legal-eagle-explains-riegel/

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