Comments on: Senate To Hold Hearings On Preemption http://www.pharmalot.com/2007/09/senate-to-hold-hearings-on-preemption/ News, Comment and Conversation Fri, 10 Feb 2012 18:58:27 +0000 http://wordpress.org/?v=2.6.2 By: Theo http://www.pharmalot.com/2007/09/senate-to-hold-hearings-on-preemption/#comment-19148 Theo Wed, 12 Sep 2007 23:10:48 +0000 http://www.pharmalot.com/2007/09/senate-to-hold-hearings-on-preemption/#comment-19148 Preemption is a trick because it only absolves the guilty: The innocent would get off anyway, but with preemption the wrong-doer gets off too. Imagine you're crossing a street and a speeding drink driver runs a red light and runs you over; you've got pretty serious damages and a good cause of action, right? Preemption would let that driver off the hook because the criminal penalties are exclusive of any civil remedy the victim might have. Is that just? Hell no. Big companies want preemption for one reason - because it gets them off the hook when they've been negligent or engaged in misconduct and caused serious injuries and death. Preemption is a trick because it only absolves the guilty: The innocent would get off anyway, but with preemption the wrong-doer gets off too. Imagine you’re crossing a street and a speeding drink driver runs a red light and runs you over; you’ve got pretty serious damages and a good cause of action, right? Preemption would let that driver off the hook because the criminal penalties are exclusive of any civil remedy the victim might have. Is that just? Hell no. Big companies want preemption for one reason - because it gets them off the hook when they’ve been negligent or engaged in misconduct and caused serious injuries and death.

]]> By: Hank http://www.pharmalot.com/2007/09/senate-to-hold-hearings-on-preemption/#comment-19124 Hank Wed, 12 Sep 2007 20:27:41 +0000 http://www.pharmalot.com/2007/09/senate-to-hold-hearings-on-preemption/#comment-19124 As Ed know, this issue one of my obsessions, in part because I live in a state (Michigan) what has had an FDA-preemption law for twelve years. What that means is that _no_ Michigan citizens (none, nada, zilch) have been able to have a day in court related to Rezulin, fenphen, Vioxx, Baycol, or any of the other drugs withdrawn for safety reasons during this period. As intended by its proponents, FDA preemption would really grant _total_ immunity from civil liability to drug companies. They will claim there are some exceptions, but they are de facto meaningless (I won't bore you with the reasons why - at least not yet). In any case, that's what companies ask for when they file for "summary judgment" based on FDA preemption - the suit should be preemptively thrown out because the product was in compliance with FDA at that time. So here is what is at stake. Imagine a United States in which _no one_ could bring suit who believed a company inappropriately failed to warn, red flag, follow up, not camoflage, not intimidate researchers, not spin journal articles, miseleadingly advertise, etc. in connection with dangers of which they were aware. That is the country we could become when the current Supreme Court takes up the issue. And that is not far away. In my view, this is as serious as it gets. As Ed know, this issue one of my obsessions, in part because I live in a state (Michigan) what has had an FDA-preemption law for twelve years. What that means is that _no_ Michigan citizens (none, nada, zilch) have been able to have a day in court related to Rezulin, fenphen, Vioxx, Baycol, or any of the other drugs withdrawn for safety reasons during this period.

As intended by its proponents, FDA preemption would really grant _total_ immunity from civil liability to drug companies. They will claim there are some exceptions, but they are de facto meaningless (I won’t bore you with the reasons why - at least not yet). In any case, that’s what companies ask for when they file for “summary judgment” based on FDA preemption - the suit should be preemptively thrown out because the product was in compliance with FDA at that time.

So here is what is at stake. Imagine a United States in which _no one_ could bring suit who believed a company inappropriately failed to warn, red flag, follow up, not camoflage, not intimidate researchers, not spin journal articles, miseleadingly advertise, etc. in connection with dangers of which they were aware.

That is the country we could become when the current Supreme Court takes up the issue. And that is not far away.

In my view, this is as serious as it gets.

]]> By: Lisa Van Syckel http://www.pharmalot.com/2007/09/senate-to-hold-hearings-on-preemption/#comment-19032 Lisa Van Syckel Wed, 12 Sep 2007 00:57:39 +0000 http://www.pharmalot.com/2007/09/senate-to-hold-hearings-on-preemption/#comment-19032 This should be very interesting!!!..... This should be very interesting!!!…..

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