Glaxo Loses Bid To Preempt Paxil Lawsuit
34 CommentsBy Ed Silverman // February 26th, 2010 // 9:06 am
A lawsuit against GlaxoSmithKline over the suicide of 23-year-old Tricia Mason, who killed herself two days after taking its Paxil antidepressant, can proceed. The 7th Circuit appeals court ruled Glaxo didn’t meet its burden of showing with “clear evidence” the FDA would have rejected a labeling change to warn about enhanced suicide risk in young adults, The National Law Journal writes.
The “clear evidence” standard was set last year with the US Supreme Court decision in Wyeth vs. Levine, which decided Wyeth didn’t meet the burden of showing the FDA would have rejected a label change. The court let stand a Vermont Supreme Court ruling against Wyeth over deficient labeling related to the IV push injection of Phenergan, the Journal notes, adding both cases revolve around the issue of whether compliance with FDA regs preempts state court litigation (background).
Glaxo argued the Mason lawsuit was preempted because the FDA approved Paxil and reviewed available antidepressant data for years without requiring a suicide warning; the FDA took no action to force a warning during the time Mason took Paxil and so wouldn’t have approved a label change; and the methodology used to establish the suicide risk was not available until after Mason’s death.
In finding that Glaxo didn’t meet its burden of clear evidence, the 7th Circuit decision pointed to the “extensive showing” required in the Levine case, the Journal continues. “This is the first appellate court in the country to address the issue of preemption in the context of antidepressants,” says Bijan Esfandiari, the lawyer for Mason’s family. “We are disappointed and respectfully disagree with the decision,” Glaxo tells the Journal.
Justice in MI
Bad week for Glaxo. A better week for justice.
What’s interesting about this case is its further fleshing out what Levine will mean in practice.
This interpretation of Levine also suggests again (as if it needed to be suggested again) the extremity of Michigan’s absolute and unqualified preemption law.
Jaynesday
Good point Justice.
Inequality also exists in the difference btw drugs (preemption not allowed) and medical devices (preemption allowed).
If the Supreme Court says it’s wrong it should be wrong across the board. There is no difference due to where you live or the type of pharmaceutical product that is applied to your body.
M. Black
It seems as if they can’t make up their minds / stance.
~ MB
M. Black
Jayne,
But what about combination pharma / cosmetic products such as certain oral films applied to the teeth, gums, etc? It’s not one or the other. It’s both at once. Kinda paradoxey, but not.
And yes, I made up that word :-)
~ MB
Michael Kirsch, M.D.
It’s tough when a Pharm company becomes a defendant after some tragedy occurs. The press adopts a ‘presumed guilty’ posture, as if these guys are criminals. Wyeth, in my view, got a raw deal last year. See http://bit.ly/LPBYn
pharmavet
This case is a good example why Nurse Practioners should never be allowed to prescribe psychotropic medications. Any halfway competent psychiatrist would have had the expertise in history taking to elicit symptions of suicidal ideation and would have hospitalized this patient right away instead of sending her home with a prescription for Paxil or any drug. Would you or a loved one wish to receive a powerful psychotropic drug from someone who may have received an NP degree online? Not me. A life could have been saved here with competent history taking, diagnosis and a reasonably high index of suspicion that can only be obtained through rigorous medical education and psychiatric residency
Anon
Pharmavet,
I have to disagree with you. I have worked on drug studies with psychotropics that caused suicides. Active screening by competent psychiatrists for a risk of suicide prior to hospital discharge was ineffective in picking up the actual risks and preventing suicides. Possibly because the drug induced suicidal symptoms came on so quickly that pre-discharge and weekly f/u screening was inadequate to pick it up on and prevent actual suicides.
That is not to say that I don’t have concerns regarding prescribing by nurse practioners. However based on data I’ve seen I don’t believe that even trained and concientious physicians can prevent drug induced suicides.
Confucius
Can the legal eagles among us explain how a court expects a firm to prove what the FDA might have done? I’m not sure what “clear evidence” Glaxo would have to provide to meet its burden? What’s an example of what would pass the “extensive showing” standard? “Hamburg: Oh… and by the way, if anyone ever planned on asking about a label change regarding X, you’re barking up the wrong tree.”
Justice in MI
re: the Levine case, the Supreme Court decision was not about the merits of the Vermont award (already twice upheld), but about whether some version of FDA approval/compliance should _automatically_ preempt the right to bring suit. Wyeth initiated the suit, not Levine.
There are many who would have ruled differently in the original Levine case, but still rejected broad preemption, just as the Supreme Court did, 6-3. (Actually, 9-0 against the kind of preemption we have in Michigan.) Again, these are separate issues.
In the meantime, the stronger warning that Levine argued should have been on Phenergan is now there. This was an FDA (not Wyeth) initiative, based on the number of other gangrene/amputation cases associated with Phenergan.
So, from FDA’s own perpsective, the Vermont juries and Supreme Court probably got it right.
Lisa Van Syckel
Pharmavet,
How about a nurse practioner who prescribes antipsychotics for infants, got them in Jersey.
Lisa Van Syckel
Anon,… I agree with you 100%, from personal experience, one minute they are fine, the next minute they are in a suicidal rage. Children and adolescents have to be watched 24/7, even then, it is quite difficult, all it takes is stepping out of the room for amoment.
pharmavet
Lisa, I agree with you. I really can’t think of a drug class that I would trust an NP to prescribe and have the expertise to monitor. I was about to say antibiotics, but even some of them can be dangerous if misprescribed, and we all know about antibiotic resistance. The more we know about advanced topics such as pharmacogenomics, etc. the more I am inclined to restrict prescribing to physicians.
This is somewhat getting off topic, but why do we need NP’s in the first place? Part of the reason is that they fill the gap left by the decline in PCP’s. This needs to be rectified in any health care reform legislation.
Justice in MI
Confuc’d–I’m not a lawyer, or even an eagle, but the point here is that Glaxo lawyers were arguing that they could not have unilaterally changed the Paxil label to include suicidality because they would have been “out of compliance” with FDA. All of this is based on Dan Troy’s (now Glaxo’s top lawyer) CBE redefinitions that were rejected by the Supreme Court.
Your Hamburg example puts the burden of responsibility on the wrong side. For Glaxo to say they could not have changed the warning would require evidence that Glaxo actually made any peeps in that direction and was stopped by FDA from following through. Since Glaxo (as far as I know) did not so peep, their own argument about what FDA “would have done” does, indeed, lack any factual foundation.
Justice in MI
Once again, the argument above specifically concerns preemption as a basis for dismissal or summary judgment; not the merits of a particular case.
So it remains entirely possible for judges and juries in particular cases to decide that there was no relevant evidence of unfulfilled obligation on Glaxo’s part, and no reason to hold Glaxo liable.
Lisa Van Syckel
Justice, Baum Hedlund has sent out a press release in regards to this case. They have done a wonderful job in explaining this case
Jaynesday
M. Black,
Agree to your statement -
“But what about combination pharma / cosmetic products such as certain oral films applied to the teeth, gums, etc? It’s not one or the other. It’s both at once. Kinda paradoxey, but not.”
To which I would say -
Or what about membranes (medical devices) and related items that are applied to the inside of the body, sometimes then absorbed by the body and too many times cause infections with drastic damaging results including death?
Too bad that the current Medical Device Act bill pending in Congress, which intends to cancel preemption rights, has been remade into a health care bill poker chip. Even though preemption is not tort reform…. well maybe the lazy man’s (defense lawyer’s) tort reform.
Justice in MI
Hi Lisa,
Do you have a link for the Baum, Hedlund release? Thanks.
I just quickly read through the decision, and it is fascinating and even a bit curmudgeonly. Recommend for Confucius and others who may have serious questions about the basis of the ruling.
harpy
FDA has analyzed this proposed rule in accordance with the principles set forth in Executive Order 13132. Section 4(a) of the Executive order requires agencies to “construe * * * a Federal statute to preempt State law only where the statute contains an express preemption provision or there is some other clear evidence that the Congress intended preemption of State law, or where the exercise of State authority conflicts with the exercise of Federal authority under the Federal statute.” The sole statutory provision giving preemptive effect to the proposed rule is section 751 of the act (21 U.S.C. 379r), which would apply only with respect to OTC drug components of combination.\7\
\7\ The proposed rule seeks to clarify which cGMP requirements apply when drugs, devices, and biological products are used to create combination products. The agency notes that there are no express preemption provisions of the act applicable to prescription drugs or biological products. Section 521 of the act (21 U.S.C. 360k) contains an express preemption provision that applies to devices; nonetheless, the Supreme Court concluded in Medtronic, Inc. v. Lohr, 581 U.S. 470, 50001 (1996), that requirements not applicable to a particular device (such as the device good manufacturing practice requirements at issue in this proposed rule) do not preempt State law under section 521 of the act.
VII. Analysis of Impacts
Federal Register September 23, 2009 Proposed rule
google be a wondrous thing. the law has yet to catch up to technology, in so many ways.
harpy
d’oh - it ate my link. here ya go:
http://www.thefederalregister.com/d.p/2009-09-23-E9-22850
Robert
From experience from a former spouse, I can say that Paxil is a mean, mean drug. The withdrawals are fierce and the side effects are ridiculously severe.
J.D.
It appears that the preemption dam (damn preemption?) has a small crack. May the flood gates open.
Justice in MI
I guess the Levine case opened the floodgates.
But we’ll see what 2010 brings. The preemptors are a patient, enormously well funded (Chamber of Commerce), and disciplined group. If their friends win Congress, it is predictable that they will attempt to amend the FDCA along the lines of the MDA, and recussitate preemption in the drug arena via legislation.
Michael
Hopefully not, Justice, because if that happens we will lose our democracy.
“I think judicial elections are really the untold story of Citizens United, the untold implication. When the decision happened, a lot of people said ‘OK, this means that Exxon will spend millions of dollars to defeat Barack Obama when he runs for reelection.’ See, I don’t think there’s any chance of that at all. That’s too high-profile – there’s too much money available from other sources in a presidential race. But judicial elections are really a national scandal that few people really know about, because corporations in particular, and labor unions to a lesser extent, have such tremendous interest in who’s on state Supreme Courts and even lower state courts that that’s where they’re going to put their money and their energy because they’ll get better bang for their buck there.” – Jeffrey Toobin, Bill Moyers Journal: Justice For Sale?, 2/19/2010
Lisa Van Syckel
Justice, Here it is
http://www.expertclick.com/NewsReleaseWire/ReleaseDetails.aspx?ID=3086
Lisa Van Syckel
Justice, That last link is no good, try this one
http://www.baumhedlundlaw.com/drug2_press/mason_preemption.php
Justice in MI
Thanks, Lisa. Their lawyer in the case is quoted: “”Pre-emption in prescription drugs is a relic of the past.”
Certainly nowhere near being true in Michigan!
JaT
I have to disagree with you, Lisa and Pharmavet, unless I am missing something.
As with doctors offices- pharma reps peddle their wares to nurse practitioners. So if we are relying on sales reps to further the educations of doctors, there is no reason to think that a nurse practitioner has any less product information.
It is the drug, not the prescriber, at issue, I think. Nobody giving the class of drugs enough consideration.
Hmmm?
annonymous
From what I’ve read, Paxil has certain characteristics that explain some of the nasty clinical side effects seen from it. IIRC, it has very short half life.
That explains why it is perhaps among the most addictive of the SSRIs, with something like 25% of those who take it developing physical dependence. (That when they discontinue, they experience serious withdrawal side effects).
Additionally, it has among the higher rates of sexual dysfunction and other side effects.
Not to mention a variety of other troublesome pharamcokinetics, like including the ability to make Tamoxifen, a breast cancer treatment, not work as well.
That said, it has become extremely popular. Why? Cynics might point towards the rise of generalized anxiety disorder, a recent and suddenly very popular condition that - perhaps by cosmic coincidence - Paxil was shown to be a solid treatment for.
I decided to go anonymous for this because it is my heartfelt belief that Paxil is a seriously flawed medication that highlights the serious shortcomings of the SSRIs - and is used when there are significantly safer options.
Chalk another victory for the power of Big Pharma, to make an extremely questionable medication extremely popular.
The only people who suffer are those who, say, start taking it and commit suicide several days later (stories of which I have encountered in my research.)
Pharmadev
Ok, time for a dose of reality.
As a developer you invest many years and many, millions on development with FDA overseeing every step. You spend 1-2 years negotiating labels and then more years and millions on watching for side effects (and yes FDA was intensely studying suicide issues in these drug to decide if changing the label would do more harm than good).
Now if you do everything right as a company by FDA you still can be destroyed by any jury of folks with no undersanding of medicine of phamaceutils/decides and an elected judge with a different opinion in the hundreds of counties accross the country.
Good luck to anyone that expects companies to take on innovative products in complex disease like depression. Look at what the companies are doing now … Movng to generics; OTC; anmal health and other lower risk areas.
truthman30
Why is Paxil still on the market? ..
GSK has paid over 1 Billion in lawsuits claiming damage from the drug, yet it’s still on the market and it’s still being prescribed!
What does it take to have a drug banned? If causing suicides, homicides and birth defects can all be attributed to one drug, then surely this is enough negatives to get it pulled!! Can anyone explain to me why Paxil is still on the market as a product? Surely, any product that causes this much damage to people should not be offered as an option for anything!
Check out Seroxat (Paxil) secrets for the whole story of this horrible drug ..
http://seroxatsecrets.wordpress.com/
Lisa Van Syckel
Truthman, Check out today’s Miami Herald. A psychiatrist over medicated fostercare children with psychtropic drugs in clinical trials. Will definitely make you sick to your stomach
Jeff
Paxil is an evil drug, and if everyone weren’t addicted to this hell spawn drug, it should be taken off the market.
And after they PROVED that evidence was originally suppressed for its approval, why do they keep approving it for more things???
Kelly
Paxil is not an “evil drug.” It’s very true that it can have bad side effects and dependency, but if you do your research, so do many other antidepressants of its type. There’s really no magical antidepressant that works for everyone and is totally safe. There are terrible cases with loads of them. I have panic disorder and did a lot of research before going on any medication because I was very worried about side effects and dependency, and what I found is that I’m not really safe no matter what drug I’m on. And for those of you who would respond that I shouldn’t be taking one, I’ll just say now that I was unable to be reasoned with without it.
Elaine
This reaction to SSRI’s is the scariest reaction. The words “jittery” or “akathisia” or “restless” don’t properly describe what happens. Maybe the words, “someone jumping out from behind a door a thousands times,” more properly describes it. Imagine all of your feelings of despair suddenly turn into feelings of happiness at the thought of your own death. Terrifying. Mental paralysis. I was lucky–I was able to call a suicide hotline. Some people are not so lucky.
Paxil is not alone. Zoloft does it too. Why not restrict prescribing to psychiatrists? They restricted accutane to the dermatologists.
To be fair to the drug companies, the whackos on the bus (public) also elicit mental paralysis (over time), but that’s another story.
May God bless Tricia Mason.