TorteDeForm

Justinian Lane

Some positive news about preemption

I just got a copy of a decision from the Southern District of Indiana that held preemption did not prevent a failure to warn lawsuit over Paxil:

Defendant SmithKline Beecham Corp. (“GSK”) manufactures and sells pharmaceuticals, including Paxil, an antidepressant. Plaintiff Debra Tucker brought this wrongful death suit under Indiana state law against GSK, claiming that her older brother, Father Rick Tucker, committed suicide as a result of taking Paxil. She contends that GSK breached its duty to warn of an increased suicide risk in adults taking Paxil. Finding that the federal Food and Drug Administration (“FDA”) required GSK to include language in its drug label that conflicted directly with the warning that Tucker argues was required under Indiana law, this court dismissed Tucker’s state law claims as preempted by federal law. See Tucker v.SmithKline Beecham Corp., 2007 WL 2726259 (S. D. Ind. Sept. 19, 2007).

Tucker filed a motion under Rule 59 asking the court to reconsider its decision. As explained below, Tucker’s motion to reconsider is granted and the judgment is vacated. In finding conflict preemption, the court failed to appreciate the significance of the fact that the FDA regulations allow a manufacturer to modify pharmaceutical labels unilaterally and immediately, without prior FDA approval, when the manufacturer has reasonable evidence of a serious hazard.

Source: Case 1:04-cv-01748-DFH-WTL

If you don't have access to PACER and want a copy of the decision, shoot me an email.

Justinian Lane: Author Bio | Other Posts
Posted at 3:33 PM, Jul 18, 2008 in Civil Justice | FDA | Federal Preemption
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Comments

Paxil does not cause suicide. It prevents suicide. If this plaintiff prevails, it will hurt the care of depressed people, and increase the suicide rate. On policy grounds, this case should be dismissed.

Posted by: Supremacy Claus | July 18, 2008 7:44 PM

S.C. is right. The issue is depression. A major thing that happens is that depressed people tend to commit suicide. This is not the fault of paxil, rather the disease state. Many patients benefit from SSRIs and it keeps their depression undercontrol so that they do not commit suicide. I cant tell you how many of my patients decide to stop their medications when they look at the lawyer induced list of possible side effects. The most recent was a patient who came of her diabetes medication because she was afraid that it might increase her risk of heart attack. She did not consider that it was her diabetes that increased her risk and that stopping the medication raised her blood sugar to 450 which almost killed her.

Posted by: throckmorton | July 18, 2008 10:00 PM

To the above two,
Sounds like the typical pharma retort - don't blame the drug, blame the patient. Check the Adverse Events on the FDA sight. Oh wait those are all fabricated, right?

Posted by: Jaynesday | July 18, 2008 10:37 PM

Anyone who has the audacity to say that Paxil does not cause suicide should try a couple of years on the drug and then maybe they will understand what this drug does to peoples minds and bodies. I was prescribed it in 1998, way before any of these warnings, and like hundreds of thousands of others I suffered the infamous Paxil side effects and withdrawal syndrome. The truth about paxil is not difficult to find, there are a few blogs out there with all the information about this horrible, defective, dangerous and toxic anti-depressant. One is called "seroxat secrets". There are three main side effects of Paxil, which I believe not only contribute to suicidal thoughts and actions but actually can induce them. They are Akathisia, Depersonalization and de-realization. Paxil literally has the effect of driving people out of their minds. It should never have been licensed, and had the FDA been given all the clinical trials by GSK originally (as opposed to the doctored positive ones) it would not ever have been passed. It is possibly one of the most dangerous drugs ever made, and as an Ex-user and Paxil survivor, I don't say that lightly.

Posted by: ex paxil user | July 18, 2008 11:31 PM

Anyone who has the audacity to say that Paxil does not cause suicide should try a couple of years on the drug and then maybe they will understand what this drug does to peoples minds and bodies. I was prescribed it in 1998, way before any of these warnings, and like hundreds of thousands of others I suffered the infamous Paxil side effects and withdrawal syndrome. The truth about paxil is not difficult to find, there are a few blogs out there with all the information about this horrible, defective, dangerous and toxic anti-depressant. One is called "seroxat secrets". There are three main side effects of Paxil, which I believe not only contribute to suicidal thoughts and actions but actually can induce them. They are Akathisia, Depersonalization and de-realization. Paxil literally has the effect of driving people out of their minds. It should never have been licensed, and had the FDA been given all the clinical trials by GSK originally (as opposed to the doctored positive ones) it would not ever have been passed. It is possibly one of the most dangerous drugs ever made, and as an Ex-user and Paxil survivor, I don't say that lightly.

Posted by: ex paxil user | July 18, 2008 11:34 PM

Justinian points to one of the "hot" issues in the preemption debate, which is the degree to which comapanies not only can - but are obliged - to report risk data about which they become aware before waiting for an FDA label-change (which can easily take months). The moral and policy logic of that obligation need not be elaborated.

Along with its championing of preemption, the current FDA has also issued rules that make the criteria for such reporting (what are called "CBE" requirements) stricter than they had been. That is, the attempt has been to narrow the range of risk data about which companies are obliged to inform healthcare professionals, and the circumstances in which they are obliged to do so.

Obviously, this goes hand-in-hand with preemption - a correlary attempt to shield companies from potential liability.

What will the FDA think of next? Perhaps removing all brand names from rx drugs so that, even if there was a problem, no one would know which company might be responsible.

Posted by: Henry Greenspan | July 19, 2008 12:01 AM

Throckmorton, are you familiar with "Study 329" for Paxil?

Posted by: Justinian Lane | July 19, 2008 12:08 AM

SC Wrote:

"Paxil does not cause suicide. It prevents suicide."

Oh the uneducated. Check out the Glenmullen report. Paxil was tested on 'Healthy Volunteers', some of which had suicidal thoughts after taking Paxil.

Kind of blows your argument outta the water does it not?

I would love copy of the decision. Any chance you could email me one?

Fid

Posted by: BOB FIDDAMAN | July 19, 2008 1:12 AM

The above posters have the credibility of 9/11 conspiracy theorists, including Justinian. While 9/11 theorists are likely to have major psychiatric disorders, some above were formally diagnosed. One complained about withdrawal, when the case is about suicide.

All anti-depressants cause agitation in up to 5% of people. That includes the most sedative of all of them. Indeed, alcohol, a sedative, causes agitation in the same fraction, and some want to fight after drinking, and not got to sleep. If a medication causes adverse reactions, it should be stopped. Side effects are not a sign of a defective product. And infrequent ones do not require any special warning. They require ordinary common sense. If a drug causes new suicidal ideas, stop it slowly. That does not merit any payouts to land pirates.

As to any secret studies, those are just Spitzer gotchas. No one can withstand discovery. There is a rule against everything. For example, the SC has declared carbon dioxide a pollutant. That will permit the lawyer to charge money for carbon credits to anyone breathing out. Justinian, let's do electronic discovery on your personal computers.

The above, the FDA, and the left wing ideologues that bullied the FDA into these warnings are irresponsible. Their utterances reduced the rate of treatment, and they are responsible for a huge increase in the rate of suicide. The latter had been dropping rapidly until these lawyer predators and these left wing bullies were allowed to run roughshod by craven FDA functionaries.

This case merits an intervention claim on policy grounds. Where organized psychiatry is, I don't know, perhaps asleep.

Posted by: Supremacy Claus | July 19, 2008 9:26 AM

This is remarkable that Justinian and plaintiffs' lawyers have the chutzpah to sue over warning labels on Paxil -- the evidence is quite clear that the previous warning label was sufficient, and that the new warning label has reduced use of the drug and increased the suicide rate and was a counterproductive policy choice demanded by trial lawyers who care more about profits than people or drug safety. It's a poster child for overwarning, which is why we discuss it in the amicus brief in Wyeth v. Levine, which, one hopes, will throw this suit out.

I certainly can't imagine that the Seventh Circuit will let the S.D. Ind. ruling stand, as it conflicts with the correct decision of the Third Circuit. I hope GSK stands its ground.

That's aside from the ludicrousness of the underlying suit. No one alleges Paxil removes free will from adults, yet the plaintiff seeks to blame a drug manufacturer for an adult's suicide--which coincidentally came right before an audit that would have revealed he was embezzling from the Catholic Church.

Posted by: Ted | July 19, 2008 10:12 AM

Ted, are you familiar with study 329?

And to be clear, I am not suing over anything.

Posted by: Justinian Lane | July 19, 2008 11:17 AM

To "Supremacy Claus" and "Ted"

You obviously have not researched this drug, nor have you experienced the "side effects" , nor have you experienced the pain of witnessing a family member in agony from the effects of Paxil..
This drug is notorious for causing personality changes, aggression, irritation, akathisia, suicidal impulses and actions, birth defects and a host of hundreds of other side effects. These "warnings" were added reluctantly by GSK to the patient info leaflet over the years due to public pressure and as more and more people began to complain of the same effects, the mainstream media reported teh dangers widely. People have died because of this medication, people have lost their lives, people have lost family, people have lost their quality of life, some people have lost everything. I took the damn drug, and I know what it does to people. It is the most infamous drug of the past decade because it is highly dangerous . Denying the reality of what this drug does to people is futile, the truth about it is documented in tens of thousands of web pages all over the internet, from 10, 000 signatures on the paxil petition , to tens of thousands of members of online paxil withdrawal support groups , from the "seroxat users group" UK to "Paxil progress". There are countless news articles, blogs , documentaries and videos from mental health groups, the BBC and others. The facts are, Paxil is dangerous and defective and it should never have been licensed!!! Period...
Do some research on the drug, and you will be horrified at what you will find..

Posted by: Ex paxil user | July 19, 2008 11:31 AM

Ex: Those are all Brit twit left wing hate speech spewers. They are devoid of credibility.

Aspirin is a 1000 time more dangerous than Paxil. You should avoid aspirin too.

Posted by: Supremacy Claus | July 19, 2008 7:19 PM

Supremacy Claus ..

I would hardly call the BBC a left wing brit twit hate speech spewers..
The BBC has more integrity in a nano second of broadcasting than you obviously have in your entire existence.. get a life man..

Posted by: ex paxil user | July 20, 2008 8:17 AM

The BBC has the credibility of Pravda, and far more hatred for our way of life than Pravda. They are internal collaborators with anything that will destroy Anglo civilization. After the next terror attack in the US, they should get banned as a terrorist front organization. If the elite of the BBC step foot in the US, they should be arrested, tried briefly and hanged. That is whose propaganda garbage you are peddling. Sell it to the Marines that just got off the bus.

Posted by: Supremacy Claus | July 20, 2008 3:22 PM

Ex: I have no desire to pick on you. However, we have a Supremacy Clause in the US Constitution. It makes the FDA Preamble explicit language of preemption rule out local claims.

If Paxil caused you side effects, it should have been stopped, as quickly as prudent, but slowly enough to prevent withdrawal. Usually, agitation takes place in the first week, and no withdrawal will result if stopped immediately.

You could be helped by another medication. Paxil can help others, including some who respond only to Paxil.

Any payouts by local, bought off courts to the US land pirates means the research budget for the next, superior medication has been wasted buying more business jets for these cult criminals, and their running dogs on the bench.

Posted by: Supremacy Claus | July 21, 2008 7:17 AM

All I will say to you Mr Claus (e) is , I sincerely hope you or a member of your family is never harmed by a defective and dangerous medication like Paxil..
It is only when it affects you or someone you care about that you will realize just how much the pharmaceutical industry gets away with. I have been researching Paxil for 6 years , I was on it for 4, I speak from personal experience and a wealth of knowledge which I have researched.

You say "Usually, agitation takes place in the first week, and no withdrawal will result if stopped immediately" .. Agitation can and does happen any time on Paxil, people who were prescribed it long term were in essence , human guinea pigs, this drug is absolutely horrible. Physicians were not properly warned of the signs and were told that withdrawal was a relapse and side effects were from the original condition. GSK doctored the original trial results by changing end points in the trials to make paxil look favorable. The information against paxil which is out there now is literally huge. You should research it , because until you actually know the subject matter , there is really no point in me taking any of your remarks seriously..

Posted by: ex paxil user | July 21, 2008 9:57 AM

All I will say to you Mr Claus (e) is , I sincerely hope you or a member of your family is never harmed by a defective and dangerous medication like Paxil..
It is only when it affects you or someone you care about that you will realize just how much the pharmaceutical industry gets away with. I have been researching Paxil for 6 years , I was on it for 4, I speak from personal experience and a wealth of knowledge which I have researched.

You say "Usually, agitation takes place in the first week, and no withdrawal will result if stopped immediately" .. Agitation can and does happen any time on Paxil, people who were prescribed it long term were in essence , human guinea pigs, this drug is absolutely horrible. Physicians were not properly warned of the signs and were told that withdrawal was a relapse and side effects were from the original condition. GSK doctored the original trial results by changing end points in the trials to make paxil look favorable. The information against paxil which is out there now is literally huge. You should research it , because until you actually know the subject matter , there is really no point in me taking any of your remarks seriously..

Posted by: ex paxil user | July 21, 2008 9:59 AM

All I will say to you Mr Claus (e) is , I sincerely hope you or a member of your family is never harmed by a defective and dangerous medication like Paxil..
It is only when it affects you or someone you care about that you will realize just how much the pharmaceutical industry gets away with. I have been researching Paxil for 6 years , I was on it for 4, I speak from personal experience and a wealth of knowledge which I have researched.

You say "Usually, agitation takes place in the first week, and no withdrawal will result if stopped immediately" .. Agitation can and does happen any time on Paxil, people who were prescribed it long term were in essence , human guinea pigs, this drug is absolutely horrible. Physicians were not properly warned of the signs and were told that withdrawal was a relapse and side effects were from the original condition. GSK doctored the original trial results by changing end points in the trials to make paxil look favorable. The information against paxil which is out there now is literally huge. You should research it , because until you actually know the subject matter , there is really no point in me taking any of your remarks seriously..

Posted by: ex paxil user | July 21, 2008 10:01 AM

Ex: You seem to have so much knowledge of Paxil, legally, you may be a "sophisticated user." That means, you cannot make any legal claim against the makers for failure to warn about some potential harm.

Justinian: The FDA Preamable asserts field preemption. An adjoining appellate court held against an excess of warnings, in a car case. This ruling seems anomalous.

Posted by: Supremacy Claus | July 22, 2008 6:53 AM

Supremacy Clause...


"Ex: You seem to have so much knowledge of Paxil, legally, you may be a "sophisticated user." That means, you cannot make any legal claim against the makers for failure to warn about some potential harm"

I think that is quite a ridiculous assumption ...
And anyway, No one was warned about all the side effects and dangers of Paxil until the last 2 years or so..
Prior to that people were told it was safe and effective, non habit forming etc etc..
There is still many dangers just being discovered , birth defects , long term neurological damage etc etc..
So as for "sophisticated user" , the only sophisticated thing about that loop hole is the people who try to use it as a defense..

Posted by: ex paxil user | July 24, 2008 5:56 PM

I just have to say that Paxil saved my life during an excruciating bout with severe anxiety and clinical depression. It does not work for everyone; nothing does. But, there are many people for whom this has been a lifesaver, and I don't think taking it off the market is a proper reaction to the known problems that there are with it.

Posted by: paxil saved me | August 27, 2008 5:24 PM

Also ... I have gone off of Paxil twice, and back on it. I did not have any huge problems with "withdrawal." There were some uncomfortable effects, but they were mild. I worked with my doctor to taper off of it slowly (and taper onto it when I needed it again), and it was not a problem. I do know that some people do have problems, but many don't. Again, I don't think it should be taken off of the market.

Posted by: paxil saved me | August 27, 2008 5:27 PM