Glaxo Wins Paxil Suicide Case Due To Preemption
88 CommentsBy Ed Silverman // February 2nd, 2008 // 5:21 pm
A federal judge in California dismissed a case brought by the family of a 13-year-old girl who committed suicide while taking the antidepressant, citing a controversial rule that FDA approval of a drug preempts state lawsuits challenging safety, efficacy, or labeling. At issue is whether patients can sue a drugmaker through state law when a product has already been approved by the FDA, a notion the US Supreme Court is expected to decide after agreeing to review a different case.
In the Paxil case, US District Court Judge Frank Damrell, Jr. dismissed the suit “on the grounds that, under state law, all of the claims required showing that Glaxo should have included a warning in Paxil’s labeling in 1997 that there was an increased risk of suicidality.” And so he decided the lawsuit created “a direct conflict with the federal labeling requirements for Paxil established” by the FDA, “preempting the plaintif’s claims, according to a statement issued by Glaxo’s attorneys.
The lawyers at King & Spalding argued that, at the time of the teenager’s suicide in 1997, “there was no reasonable scientific evidence to support” the warning proposed for Paxil, which the FDA had actually rejected. UPDATE: Ron Goldman, an attorney for the girl’s family, says the ruling was narrow, because Damrell focused on suidice data in adults prior to 1997, although he maintains “the science was there from the beginning that this drug could induce suicidality in some people.” He plans to file a motion to reconsider and, if necessary, an appeal.
UPDATE: For more comment from both sides, keep reading. And here is the ruling with Damrell’s explanation…
“A direct conflict of law exists in this case because (Glaxo) could not have been in compliance with federal law in February 1997 and have included the suicidality warning plaintiffs urge. In other words, had (Glaxo) included the warning that plaintiffs insist upon, (Glaxo) would have risked misbranding Paxil in violation of the Food, Drug & Cosmetic Act. Therein lies the actual and direct conflict presented in this case - comply with federal law and be held liable under state law tort claims, or, to avoid state tort liability, add a warning without reasonable evidence and violate federal law…
“…Absent reasonable evidence of a risk, (Glaxo) had no basis to petition FDA and simply did not have the option under federal law to include or secure a lawful warning for that risk in the drug’s labeling. Had it done so, (Glaxo) would have misbranded the drug in violation of the FDCA and subjected itself to a possible federal enforcement action against it or the withdrawal of its new drug application by the FDA. Stated otherwise, the obligation under state law on (Glaxo) that plaintiffs advance is flatly contrary to (Glaxo) obligations under federal law. As such, plaintiffs’ claims must be found preempted.”
Glaxo’s law firm goes on to argue that the judge’s decision “is significant and precedent setting because it is believed to be the first case in which a court has fully considered the legal issue of implied conflict preemption and rendered an opinion in a pediatric suicide case brought against an antidepressant manufacturer alleging a failure-to-warn of an increased risk of suicidality. This ruling could potentially lead to the dismissal of similar cases on preemption grounds.”
UPDATE: Goldman countered by reading one of Damrell’s remarks from the transcript of a hearing: “As a practical matter, if I see there was an association of suicide ideation with anybody and enough of it, the last person I want to see using it is a child. That may not be scientific, but I’m just talking as a grandfather and human being.”
Goldman himself adds: “It is difficult to reconcile Judge Damrell’s statement during oral argument with his ruling. Under the law, it is a drug manufacturer’s duty to warn of risks known or reasonably scientifically knowable. A drug company that fails or refuses to conduct necessary analyses in a scientifically acceptable manner, thereby shirks its legal, not to mention ethical and moral, duty to the medical profession and the public. The court’s ruling, if allowed to stand, will leave the Bratt family alone to absorb the entirety of this terrible loss, while GSK escapes accountability.
“When carefully analyzed, there is absolutely no evidence showing that it would have been “impossible” for GSK to warn of this very serious risk, an absolute requirement in cases where conflict preemption is raised. Under no circumstances, given the regulatory scheme, can a drug be considered “misbranded” if the science supports a truthful warning of the risk of suicidality. To the contrary, such a warning is in perfect harmony with the FDA regulations and the overarching purpose of the FDA: to promote health and safety in prescription drugs.”
Justice in Michigan
Speaking of the devil…
Obviously, everything depends on how one answers the question of whether GSK had “resonable evidence of a risk” in 1997. The “absence” of that is the premise of everything quoted that follows.
What follows is the usual melodramatic scenario that never happens. If there _were_ reasonable evidence, can anyone imagine “federal enforcement action” over “misbranding” or withdrawal of the NDA?
Right.
It would have been useful to have included some of the plaintiff’s perspective. I assume there was some attempt to show that GSK did, indeed, have “reasonable evidence of a risk.”
Ed Silverman
Hi Justice,
Yes, that would be nice. But unfortunately, we’ve just come across the statement issued by the Glaxo law firm and, since it’s Saturday evening back here in the nation’s medicine chest, I’ve chosen to post what I can, rather than wait however long for comment from the family’s attorneys.
ed
Justice in Michigan
I hear you, Ed - Undoubtedly, there will be no shortage of such comment, as there is from earlier, similar cases.
I read some of the decision itself and was interested to see that the Court used the older, more liberal definition of when a company can supplement a label without prior FDA authorization - that is where the “reasonable evidence of an association” language comes from.
In FDA’s most recent “rule,” the attempt is to stengthen that to evidence of causality - a much narrower standard, amounting, in practice, to a virtual shield on company-initiated new or strengthened warnings.
Is that the future we want? (This addressed to all)
Jaynesday
Justice in Michigan
Concerning reasonable evidence of a risk - See Antidepressant Studies Unpublished -http://www.nytimes.com/2008/01/17/health/17depress.html?_r=2&oref=slogin&oref=slogin
It sounds like Glaxo may have known more than they cared to share at the time of Paxil approval. If they are hidding under the skirt of preemption, I find that a bit hard to take and I can’t imagine what the parents of this child are feeling now.
Lisa Van S
Justice in Michigan,
Check out Paxilharmschildren.com you will see internal GSK documents. Paxil Study 329 was already in the works for a media blitz, until it was determined there were significant SAE’s. GSK may have won round 1. It could be another story on round 2.
Lisa Van S
Breaking News,.. GSK’s Attorney was former Counsel at FDA!!! Now that should bring about some Congressional Attention!!!
Laurie
And a 13 year old child becomes another statistic of Paxil use. GSK walks away happy that their drugs side effect profile for children wasn’t put to paper until 1998, and not made public until 2004. That caused this child her life.
Take heed doctors who prescribe this garbage….it’s all on your shoulders. Time to stop trying to prevent parental informed consent…it’s all that is going to save your malpractice insurance and license.
Take heed consumers…the FDA’s ability to actually ensure drug safety is a false security.
This disgusts me.
Lisa Van S
Laurie.
If Im not mistaken GSK was aware of this in 1997!! We know that Paxil Study 329 began in 1993. I smell another Congressional Hearing!!
Lisa Van S
Laurie.
You are right it was 1998
http://paxilharmschildren.com/13.html
And lets not forget that lovely Money Bag,… Ohhh, lets not forget the insulting cartoon of the screaming Lady.. With 37 out of 100 women beng prescribed an antidepressant, I guess they felt it was appropriate. If the Rutgers Woman’s Basketball team was offended by Imus, they should see what GSK thinks about Women in General…See Here:
http://paxilharmschildren.com/doc/paxil_wheresmy.pdf
Matt
Preemtion only has the drug makers interests at heart. The consumer is getting reemed by it. The FDA has failed time after time to protect the pubic; relying on the FDA’s word when it comes to the safety of drugs is pure stupidity.
Americans are in more danger now from their own government than they are from hostile foriegn countries and terrorists.
Lisa Van S
Laurie
Here we Go GSK Money Bag 1997 “Sales Exceed 1 “BILLION DOLLARS:
http://paxilharmschildren/doc/paxil_moneybag.pdf
Lisa Van S
I also smell a computer hack job coming!!!
Justice in Michigan
Just on the point of Glaxo’s attorney, Dan Troy (I don’t know that he was involved with this one) - FDA Chief Counsel from 2001-2004 and “godfather” of the current preemption doctrine - has been involved in numerous preemption cases since he left FDA, just as he had defended pharma and big tobacco before.
This is the revolving door. And if you wait out the relatively short amount of time between gigs, it’s not only legal but a la mode. See Congressinal staffers who also revolve through industry, FDA, back to Congress, etc.
So I don’t think this will trigger a Congressional investigation. This is Congressional everyday life.
Lisa Van S
Justice,
I know who Dan Troy is,..Unfortuntely. In 2004 I presented a petition to Energy & Commerce seeking Mr. Troy’s resiganation from FDA. WJLA out of DC did a story on him. He doesnt work for GSK. Reliable sources say that the lead counsel for GSK in this case, was a former counsel to FDA.
Bit of advice,..never,.. underestimate Congress!!!
Rita
I cannot imagine what the parents must be feeling! I’m totally disgusted.
I read three legal names that represented GSK in this suit, I’ll dig it up and post it when I find it.
pg
1997 GSK confidential internal memos:
1997 GSK internal memo
http://www.ssri-uksupport.com/files/GSKprFirmMemo.pdf
1997 GSK internal memo
http://www.ssri-uksupport.com/files/GSKwheresmypaxil.pdf
1997 GSK internal memo
http://www.ssri-uksupport.com/files/GSKmoneybagmemo.pdf
1997 GSK internal memo
http://www.ssri-uksupport.com/files/GSKbusinessplanguide.pdf
pg
Also, there’s a reference to as far back as 1993 in the Tobin -v- GSK (SmithKlineBeecham at the time)trial, transcript on this site:
http://www.healyprozac.com/Trials/Tobin/Depositions/rosello-depo.txt
Using file-edit and then ‘1993′, I found three references.
It’s almost daybreak here,tired and no chance of understanding what I’m reading with so little sleep and it may or may not be relevant. I don’t know.
pg
Sorry, I meant using EDIT then FIND and typing in ‘1993′ (because of vague recollection of that date coming up before).
pg
I suspect its relevant and why I remembered that date vaguely.
“…Q. Do you know whether or not any of those
0021
1 materials contain standard operating
2 procedures or Q&A’s for answering physician
3 inquiries about potential risks of suicide or
4 violence?
5 A. The sales training would train our sales
6 representatives, if a question was raised by a
7 physician about suicide, to refer to the
8 labeling, and if that didn’t adequately answer
9 the physician’s question, they would be
10 instructed then to contact the product
11 information department.
12 Q. So are you saying that the sales people
13 would never try to give a physician a
14 substantive answer themselves? In other
15 words, they would say, look at the label, and
16 if the label doesn’t do it, call somebody at
17 headquarters who can answer it?
18 A. That’s how they would be trained.
19 Whether or not we would have a sales rep
20 that’s done that, I don’t know. There is
21 3,000.
22 Q. If they follow their training?
23 A. If they follow their training, yes.
24 Q. Incidentally, do you call your sales
25 people detail men or –
0022…”
Mr. 1776
I guess that means ,in this sad families case they have
to re-institute the lawsuit against the FDA.
Glaxo Attorneys must be smiling.
Dose of Reality
I’m trying to decide whether this is a Scientology blog, one for belivers in conspiracy theories (Illuminati, Gnomes of Zurich, etc.), or plaintifs and trial lawyers.
What color is the sky in the world(s) where you reside?
Ed Silverman
Dear Dose,
For the record, this site is run by a professional journalist (please click on the ‘About us’ button) and is designed to report and discuss issues of importance and interest to people who work in the pharmaceutical world, those with a professional interest in the industry - advertising agencies, regulatory consultants, patent lawyers, plaintiffs lawyers, securities lawyers, consumer advocates, legislators, regulators, academics, physicians and nurses, among others - and consumers who want to follow events.
There are a wide variety of posts about myriad topics and the ensuing discussions involve people from each corner of the universe mentioned above. Poke around and you may find there is a great deal to absorb, whether the topic is prizes instead of patents; the extent to which statins are useful; the need for making experimental meds available or the merits and shortcomings of preemption. No one post or series of comments reflects the larger wealth of material here. So dig in.
Regards
Ed at Pharmalot
Bob
Ed, you say this, yet the strong majority of articles are anti-pharma.
You also let people (it’s obvious who I’m referring to) run around with an agenda, and not be able to back up anything with substantiated facts. We in the business can see through it, but can the average person from the outside? Probably not.
The SL keeps getting more tabloid as the months go by…Sad and scary.
pligg.com
Pharmalot » Glaxo Wins Paxil Suicide Case Due To Preemption…
A federal judge in California dismissed a case brought by the family of a 13-year-old girl who committed suicide while taking the antidepressant, citing a controversial rule that FDA approval of a drug preempts state lawsuits challenging safety, effica…
Ed Silverman
Hi Bob,
At the risk of sounding like a broken digital download (not many listen to records anymore), the pharma industry is undergoing enormous change and challenge, which creates tension between various groups and individuals across a wide spectrum of society.
One of my jobs as a journalist is to follow the tension, and that’s why you see the items here that you do. I didn’t create those issues, however, I report on them. Or in this new blogging vernacular, I post about them.
However, if you were to look back at the posts over the past year, you would see a mix of items that cover a plethora of issues, from job outlooks, merger talk and exec changes to research findings and legislative proposals, which are unrelated to the running debates about the larger marekting or safety concerns. One very obvious and long-running example is the Provenge controversy, which could hardly be described as anti-pharma. (Do a search, Bob, and you’ll see what I mean).
As I’ve previously indicated, the comments are from a wide variety of people, as well. Many use anonymous sign-on names; many of them are from industry. They chat with consumers, who may not like pharma, and they chat amongst themselves here, along with people from other walks of life (in some cases, I’m aware of their occupations because I chat privately with some people who comment here). For instance, did you catch the running commentary two weeks ago about the merits of statins and NNT?
And as the moderator, I see my role as akin to hosting a welcoming living room where people can converse about issues of concern. I only intervene when someone is inappropriate in addressing others. This is a discussion - people are free to express opinions and those armed with facts are free to correct those who are off base, confused, or angry, for that matter. (As an aside, whether someone is anti-pharma or pro-pharma, they both have an agenda, do they not?)
Lastly, I’ll repeat another point - yes, The Star-Ledger of New Jersey owns Pharmalot, and I’m an employee. However, these are two separate editorial products. And I’m the editor at Pharmalot. The content of the newspaper and this site are distinct. If you have an issue with the newspaper, please write to one of the editors over there. If you want to discuss Pharmalot further, you’ve come to the right place.
Hope this helps,
ed
Lisa Van S
Well Hellooo Bob,..
GSK felt such Euphoria over the fact that they got away with death of this 13 year old child. This press release is just a stab in the back to this child and her family. Maybe they should change their cheeky behaviour. Its Industries callous behaviour that brings headlines, not someone’s religion.
GO GIANTS!!!!
Bob
Ed-Thanks. Sincerely.
Lisa-Still waiting for your credentials to be posted.
Lisa Van S
Dose of Reality,
I have posted several links here, if you notice, these are “GSK’s own documents”. I dont see L Ron Hubbards name on any of them. If Industry doesnt want bad headlines, then they should behave themselves. Gloting over a “dead child” is a pretty morbid thing to do.
The Scientolgy cry is getting quite old, so is blaming the child, when you cant defend your drug.
Lisa Van S
Hey Bob,
Got a last name and title?.. Im assuming you have something to hide.
BLD
Bob,
The rreason that the majority of posts appear to be anti-pharma is beciuse the industry had earned that place in the public’s heart. This once proud industry is now the subject of weekly news articles revealing significant wrongdoings. Almost every Big Pharma company has been involved. GSK, Lilly, Merck, Schering-Plough, BMS, JNJ and the rest have been caught. There is no more trust in the intentions of the companies. They are there to make lots and lots of money. The chief executives lie on a regular basis. Gone is the day when pharma really cared about patients. Now they just view them as dollar signs. I’ve worked in the industry for a long time and fail to understand how the big shots look at themselves in the mirror on a daily basis. Greed and corruption rule.
Justice in Michigan
Just want to thank Ed for his responses in this thread. Exactly to the point.
I would also say that the majority of folks her, even those often critical, are not “anti-pharma.” They _are_ anti what goes _avoidably_ wrong in the industry because of how serious the consequences can be. But they do not lose track of all the great things, and great people, associated with the industry.
BTW, the sky here is whitish grey. But a big blue…GO GIANTS!!!
Justice in Michigan
For Lisa re: Congress - check out editiorials in today’s NYT is you haven’t. Congress’s failure to provide the means for the FDA actually to fulfill its mandate is a pattern that goes back 100 years.
So, too, is the role of the Executive in appointing senior FDA officials whose primary loyalty is to regulated industry (with important exceptions). Long history there, too, as you know!
Bob
Lisa-
I sure do. Bob Davidson, graduated from Rutgers with a Ph.D. in Clinical Psychology.
It’s sad though that you don’t have more than a High School education, and you spout off.
I wonder who holds more weight?
pharma pr hack
Bob,
your comment to Lisa is indicative of why the industry is held in such low regard by the masses. It is an “i know more than you attitude” that is pervasive in pharma and medicine and it leads to a great deal of these court cases and low opinion polls. When the physicians and medical manufacturers cease to be partners in healthcare recognizing that it is a very different matter for the consumer and allowing them to be an active participant in choices and educating them then when the worst case scenario does happen there is a higher standard and a sense of blame that goes with it. Glaxo may have technically won the ruling making shareholders happy but the fallout in terms of respect and CSR will be felt for a long time. Most consumers on Paxil and their family members will see them as “hiding information” and shirking responsibility in the case as in hiding behind a bogus preemption defense. No one will ever be able to make these parents happy- their daughter isn’t coming back. Most consumers expect pharma companies to be a little more cognizant and much more sensitive of the stakes for them in medications. When it is right, it is great but when it is wrong- consumers pay in lives while companies only pay in dollars. it would behoove them all to remember that in their communications to news organizations and the general public.
Bob
PR hack-I wonder who I will trust in the future. People who have Doctorates and MD’s, or hacks who don’t even have a college degree.
Dr. Stahl who is a genius in this field, or Lisa Van Syckle.
Continue to believe the Lisa’s of the world. I’m sure she also has some refreshing Kool-Aid for you as well…
Jaynesday
Bob,
Keep it up, your getting lighter with each word you write.
pharma pr hack
Bob,
You entirely missed the point, whether you or a practicing physician or the ceo of Novartis knows best- the worst case scenario are consequences born unto the consumer- the MD who prescribed the Paxil is still practicing but that little girl is dead. What I am trying to point out is that pharma’s rep is in the toilet because instead of viewing the consumer relationship as a partnership where the consumer trust is earned by actions and the distribution of information — it is viewed as i know best and only I deserve to decide because of my intelligence and my station.
Insurance research has shown that consumers are less likely to sue physicians for malpractice despite their ability to win the case when they have a strong relationship with their patient. I can assure that condescension is not an attractive bedside manner for a physician or a pharmaceutical manufacturer.
Laurie
Pr hack….I couldn’t say it any better. Bob, and other pharma folks on here don’t even see the damage they do to the reputation of the industry they represent. It doesn’t take a Phd to know your child hung herself days after starting a drug for test taking anxiety. The “unsubstantiated” claims he speaks of were just that….UNTIL the FDA substantiated them with the Black Box Warnings. The “I’m better than you” never enters my practice as a nurse. If it ever does, it’s time for me to leave the profession.
Most can see clearly how adverse reactions are ignored and downplayed with the attitude that Pharma has towards those not as “educated” as them…the public is just the ones who are swallowing the pill and as long as they do that and not make a sound, Pharma is happy.
Lisa Van S
Bob,
“I wonder who holds more weight”
My Mother’s Intuition, and my unconditional love for my children. Wouldnt trade that for anything in this world.
I have come to know and respect many Psychologists and Psychiatrists, not one of them speaks in the manner that you do.
Big Pharma Employee
Based upon recent decisions with the Paxil suicide lawsuit and the Ortho-Biotech qui tam decision, it appears that pharmaceutical companies are protected and the public is at their mercy. Even honest employees can not have any impact through sarbanes-oxley to protect the patients. The lid is off and the genie is out of the bottle to do his will.
Only nationalized healthcare can reign in the runaway train of pharma.
Lisa Van S
Bob
By the way, its spelled “Van Syckel”
Nathan
Bob,
Welcome back. Typically there are more positive pharma comments than are appearing in this thread. You can usually count on myself, Altex, and Brian defending the industry. However, you probably haven’t heard from us in this particular conversation because we are too busy basking in the good feelings that accompany an important victory for us.
Let the rest of the crowd commiserate and complain together in this thread. God knows we (pro-pharma folks) do enough commiserating and complaining about all the anti-pharma decisions and media reports that have been coming as of late.
pharma pr hack
Nathan… I don’t really think anyone at Glaxo should take any victory in the death of a child on their med. This is an opportunity for them to go the extra mile while they are in the public eye and lead instead of hiding behind preemption and a black-box warning. With the number of individuals in the US currently on Paxil- they could be using this media storm to educate consumers on signs to watch for i.e. suicidial ideations and direct them to discuss it with their doctors, look at a comprehensive national database to track Paxil users and ensure regular mental health screenings..
There are many positive actions they can take to assure the public that they are a responsible healthcare partner and “basking in the good feelings that accompany an important victory for us” may be acceptable for McDonalds, a political campaign or even people who make widgets but I can assure you the bar is a little higher for people who play such an important role in the healthcare system and whose actions truly can mean life or death for consumers.
I’m not by any means anti-pharma and am a very strong proponent of the good done by pharmaceutical products both economically and medically - however, I do believe the callousness of many posters on this website and many others under the guise of being “pro-pharma” actually do the industry much more harm than good.
Laurie
pr hack, you are a breath of fresh air.
If more had your insight and attitude, there wouldn’t be the mistrust of pharma like their currently is. As I have told Nathan, Atlex, and Bob many times, I’m not antipharma. I’m pro fully informed health decisions. If it wasn’t for pharma my husband would be dead, but that doesn’t stop me from speaking out about those drugs that carry undisclosed risks.
Nathan
PR Hack - no one is feeling victorious because of the death of a child. We’re feeling victorious here because it (potentially) heralds a new era where liability will be limited to times when actual criminal wrongdoing has occured. I can’t speak for this case — for all I know there was criminal activity involved. If that were the case, then I hope that the case is overturned and GSK has to pay. However, state courts seem to hand out civil and punitive liabilities in many, many cases where no criminal conduct has been proven to have occured. That’s wrong in my mind.
pg
The following site gives added information on suicidality in clinical trials. It covers GSK and Paxil alongside other drug makers and their SSRIs with the same problems.
http://www.socialaudit.org.uk/58090-DH.htm
“ANTIDEPRESSANTS AND SUICIDE
BRIEFING PAPER, 20 JUNE 2003…”
A link at the bottom of the page takes you to correspondence with British regulators and that in turn gives even more insight into the problems of suicidality on antidepressants - and not a speck of scientology in sight!
The number of times over the years that people who are interested in debate, transparency and scientific integrity generally are called ’scientologists’ makes me begin to doubt if there IS actually such a movement or whether it was invented by nervous representatives of various drug companies for the sole purpose of diverting attention away from unethical practices when they occur. Because THAT is exactly when it happens - anywhere that examination and discussion of unethical practices is underway.
Regarding the value of a science degree - it is how the person uses it that counts, not the letters after the name. If a scientist does NOT WELCOME debate and FIGHTS AGAINST transparency and debate on important issues that have been kept hidden beneath confidentiality orders, then the degree gained is simply being MISused by a’Junk Scientist’ to forward his own ends in one way or another and therefore has less genuine worth than the word of those who have more integrity.
Like Dan Akins said in ‘Junk Science; How Politicians, Corporations, and Other Hucksters Betray Us ‘
“So where is the junk science? The answer is that it’s in the hiding of what you need to know.”
Justice in Michigan
Nathan - FYI, if FDA preemption becomes the law of the land there will, de facto, be no accountability whatsoever. While there will probably be some version of a “fraud exception” - as we’ve had in our Michigan preemption law - it is meaningless because companies settle when they know DOJ has the goods on them. Thus, no prosecution, no proven fraud, no liability.
If you or anyone was counting on the FDA/DOJ to bring charges, keep waiting. While hear about some of the high profile cases, it virtually never happens. When it does, it typically depends on a whistleblower.
If you believe what you wrote, I hope you will be that whistleblower when the time comes.
Justice in Michigan
This also.
Nathan wrote: “state courts seem to hand out civil and punitive liabilities in many, many cases where no criminal conduct has been proven to have occured. That’s wrong in my mind.”
I would entirely agree with you if that were true. But it is not.
pg
While I admit to not understanding law particularly well, I am surprised that GSK won this case given the the outcome of their being sued successfuly for drug claim fraud regarding Paxil in 2004.
http://news.bbc.co.uk/1/hi/business/3771429.stm
Perhaps the problem is that GSK (and other drug companies indulging in similar criminal activity) DO get to settle out of court and presumably, each time they do so, they have no official and historical record against them ?
Jaynesday
pg
That’s not all…
See the article in the New York Times (1/17/08)siting a study by the New England Journal of Medicine about antidepressent drugs including Glaxo’s Paxil.
Antidepressant Studies Unpublished
“In published trials, about 60 percent of people taking the drugs report significant relief from depression, compared with roughly 40 percent of those on placebo pills. But when the less positive, unpublished trials are included, the advantage shrinks: the drugs outperform placebos, but by a modest margin, concludes the new report, which appears Thursday in The New England Journal of Medicine.”
It certainly underlines the - catch me if you can - mentality of some drug companies and the unfortunate blindness of preemption, doesn’t it?
pg
If what is exposed makes GSK (or any other drug company) nervous enough to show up to fight what has been exposed, then one handy tip is to Link, Link, LINK to more of the very evidence that they’re afraid of.
Lisa Van S
And the Giants Win!!!!!!
Paul
I am simply shocked at the amount of cynicism and poisoned thinking that is floating around and also ends up in these comments.
I don’t work for a pharma company so don’t have any interest in defending them, but at some point we all have to grow up and realize that there are three sides to every story. There is the plaintiff lawyers on one side who exaggerate things and drag innocent patients for pure financial gain; then there is pharma companies defending their businesses and reputations. No one is trying to reconcile all this. I think this judgement does that to some extent. If there had been proof, it would have been presented; if it was not presented it probably means that it was not there.
We have to stop blaming every ill of society and every negative health outcome on one industry. Accountability goes to many places, not just there: doctirs, patients, parents of patients, hospitals, politicians, managed care companies, and sheer luck and genetics.
pg
LOL Paul, we believe you. By the way: What is the THIRD SIDE? You mention THREE sides to every story but only manage to discuss 2 of those and it just so happens that neither of those 2 out of 3 address why a drug company would hide evidence and cause the death of children, nor does it address why people like you would not bother to consider it.
Out of three sides, you just discuss two.
1. Plaintiff lawyers who exaggerate things ….
2. Pharma defending their businesses…
Please enlighten us on your third point?
ie: if your child died because of scientific fraud, see http://pn.psychiatryonline.org/cgi/content/full/39/13/1 (GSK paid a settlement on this one, seem my last post above)
would you take your own advice and say…
’stop blaming every ill of society… on industry’?
Would you say, thats OK, the drug company lied, my child’s died. I believed you, I trusted my child to take your drug, it’s not your fault, I musn’t blame scientific misconduct for the death of my child, its my fault, MY BAD?
Actually it might not be suicide. It might be that your wife was on paxil and your baby is born with BIRTH DEFECTS - whichever. YOU are responsible for things that you didn’t know about because it was hidden. Is that right? Drug makers and doctors are trained to know this and you’re not but.. hey in YOUR words “Accountability goes to… patients, parents of patients…”
Come off it! How stupid do you and your conflict of interest think the public are?
Justice in Michigan
Paul - If you followed my posts I think you’d find I agree with you. The civil liability system is far from perfect. The FDA is far from perfect. The industry is far from perfect. And we are all of us far from perfect.
The issue of preemption comes down to whether FDA compliance _alone_ should shield companies for civil liability. No need to rehearse the arguments for and against. Perhaps just worth saying that, until the current administration, FDA’s own position (as articulated by its Chief Counsel) was that FDA regulations and state civil liability provide what are generally “two complementary systems of consumer protection.” Recent editorials in both NEJM and JAMA agree. And docs are no strangers to those trial lawyers!
So the one-sided position is to take one of those systems - civil liability - and throw it away. _That_ is FDA preemption.
As far as particular cases, that’s a different question. There are deserving cases and entirely undeserving one.
Again, the point that is hard to grasp is that, if FDA preemption prevails (via one of the current Supreme Court decisions), there will be _no_ such cases - deserving, undeserving, or anything in between. Once again, FDA compliance will mean dismissal across the board.
Does that sound like a policy that rightly balances the variety of rights, claims, and situations that may develop? That’s the question.
pg
Poisoned thinking Paul? Could you explain that?
My idea of poisoned thinking is the type of thinking that sees serious adverse drug effects and hides it from the public, get their DRUGS approved and spend fantastic amounts of money in out of court settlements to ensure they don’t get a criminal record. Thats what you’d expect from cocaine dealers pushing drugs outside the schoolyard - though that type of dealer would end up in jail anyway - they wouldn’t be able to buy their way into a settlement.
YOU appear to be saying that “poisoned thinking” is from the people who have researched, noted the evidence and want transparency and ethics put back into science, particulary when a negative LACK of transparency and an negative inbalance of ethics in science results in the deaths of children.
Donna
Another child is dead. know that, many more to follow……….
Paul
pg
Your posts are exactly that, poisoned thinking. You see things one way and one way only. If a person gets hurt then it can only be the fault of a pharma company - never the fault of anyone else and never an unfortunate result of the risk benefit ratio. You expect 100% certainty in everything.
As for the third side of the argiment, it is the one in-between. It is the one that is well articulated by others such as justice-in-michigan:
- The system is broken, there needs to be more scrutiny by the FDA before something gets approved
- There has to be more surveillance along the way.
- There have to be more constraints put on the plaintiff system. My personal opinion is that plaintiff lawyers and the so called “expert witnesses” they buy are worse than the pharma companies they go after.
- There has to be better education and accountability by doctors.
- Managed care needs to do something to allow doctors to spend more time with patients explaining benefits as well as risks. Doctors are incented to see as many patients as quickly as possible.
- Parents and patients need to ask more quuestions before they get treated
All these things are part of the third side to the solution.
pg
Lets just go back to THINKING (thats logical, investigative thinking) re safeguarding our children. DO ANTIDEPRESSANTS CAUSE SUICIDE?
Or should we just forget SCIENCE and do as Paul says - forget ethics in science and take a wild guess - blaming it all on “doctirs, patients, parents of patients, hospitals, politicians, managed care companies, and sheer luck and genetics.” and “stop blaming every ill of society and every negative health outcome on one industry” -which he must mean to be the ones we, not being experts, TRUST to employ EDUCATED & QUALIFED scientists to MAKE THE “MEDICINE”
pg
PAUL, there is no excuse. If you hide negative clinical trial data, and fly false results under the banner of science - how can you even TRY to blame it on others?
SCIENTIFIC MISCONDUCT kills people. I’m not anti-medicines. I’m against FRAUD AND MISCONDUCT in medicine. Where are you exactly?
pg
Well, its daybreak for me and I guess you had better go back and confer with your peers and I’ll be back to answer you next time I’m online.
Justice in Michigan
OK. One more pass from here, with the hope that there is a Tyree out there somewhere….
Nathan’s comment that I took issue with was: ““state courts seem to hand out civil and punitive liabilities in many, many cases where no criminal conduct has been proven to have occured.””
To me, that is more or less equivalent to saying: “Drug companies seem to knowingly look on as people are killed by their products in many, many cases which could have been prevented.”
Needless to say, there are people who will fully agree with either one of these demonic portrayals. I do not.
There are, indeed, instances of corrupt lawyers and run-away juries. And there are, indeed, instances of corrupt companies and criminal malfeasance.
I believe that neither characterization is normative for either trial lawyers or drug companies, and certainly not for the people who work in both professions.
More broadly, I do think we live in a system in which a race to the moral bottom - on all sides - is generally rewarded. And so each side justifies their own deliquencies by evoking the others’ - of which there are always titillating examples.
So, for me, it’s about taking a deep breath and asking: What is the best policy, overall, taking the range of human frailties into consideration.
As far as the civil justice system, the very fact that we see different decisions by different juries - whether in cases involving Paxil, Vioxx, or whichever - suggests the complexity. I think we’re better off living with some version of that complexity than moving all the chips to one side or the other.
That’s why I’m against FDA preemption: FDA compliance being the single, all-encompassing standard that trumps everything. The messier system we have now isn’t pretty, but it’s closer to the realities of who, what, and where we are.
Truthman
Bob,
Welcome back. Typically there are more positive pharma comments than are appearing in this thread. You can usually count on myself, Altex, and Brian defending the industry. However, you probably haven’t heard from us in this particular conversation because we are too busy basking in the good feelings that accompany an important victory for us”
A thirteen year old is murdered by GSK. GSK get off on a loophole and Nathan suggests that the pro-pharma brigade should “BASK IN THE GOOD FEELINGS THAT ACCOMPANY AN IMPORTANT VICTORY”…
WOW… With people like that working in the pharmaceutical industry is it no wonder it has such a bad name?
Nathan
Justice,
Thank you for your well thought out and respectful responces. Even though I disagree with you in large part, you make some good points and remain very rational rather than just ranting like so many others on this site.
That said, here’s a comment about one of your statements. You say:
” the FDA’s own position… was that FDA regulations and state civil liability provide what are generally ‘two complementary systems of consumer protection.’ … So the one-sided position is to take one of those systems - civil liability - and throw it away. _That_ is FDA preemption.”
The standards for FDA approval (ie the FDA regulations) have been getting tighter and tighter. (ie one of the two legs is much stronger than it used to be) So te overall balance has shifted towards the consumer over the last decade. Couple that with the stereotypical “I’ll sue” attitude of most Americans when something doesn’t go their way, and you have a justice system that is now much more willing to hand out civil liabilities than it used to be. Cutting back on leg of the current system (civil liability) is one way to restore the system to the way it once was and to keep a balance between industry and the consumer. Another way is some sort of tort-reform that would more easily toss out frivolous lawsuits. But this doesn’t seem to be making much headway…
Another facet to consider is that runaway lawsuits (and the associated liability insurance that we all need) are driving the medical industry towards socialized medicine. Once the government takes over the health care industry, who are we going to sue when things go wrong?
Lisa Van S
To All,
Civil Liability or Criminal Responsibilty? Ask any parent who has had a child harmed, or, has had a child die, due to Industry misconduct, what, their choice would be. Money doesnt heal the physical and emotional scars, Money wont bring a child back, and money will not deter misconduct. Place those who harm and kill our children for financial gain in a 6 by 8 jail cell, among the general prison population, and let it be known that they harmed or killed a child. Then, and, only then, will Parents receive Justice.
Justice in Michigan
If we’re going to talk about FDA complaince - both approval and post-marketing = than every study of the past ten years comes to the same conclusion - IOM, GA0, FDA’s own commissioned studies, etc. We’ve all heard those conclusions. The idea the FDA is getting stronger is the opposite of what they say. Even Peter Barton Hutt, conservative FDA Chief Counsel under Nixon, said the other day that regulatory scheme is “barely hanging on by its fingertips.”
That is partly why NEJM, JAMA, and other observers have stressed the importance - now more than ever - of that “other leg.”
The other point would be the large area of delinquencies that FDA compliance just doesn’t cover but are within the sphere of civil liability. I won’t repeat those here except to say that, even if we had a perfect FDA, the issue wouldn’t be resolved.
Justice in Michigan
Should have added this. For folks with a genuine interest in FDA preemption, and want a perspective that is neither that industry nor trial law (corporate or plaintiff), I recommend Kesselheim and Avorn, “The Role of Litigation in Defining Drug Risks,” JAMA, Jan. 16, 2007. It is short, accessible, specific, and clear.
Pharmacist in IA
The fact that, in America, a jury of individuals with absolutely no scientific or medical training can decide that a drug did or didn’t cause a suicide, heart attack or anything at all should be all we need to know that the whole justice system is fatally flawed. Look at the overwhelming scientific blood evidence in the O.J. Simpson case and an acquitting juror’s statement that “all that means is he’s got blood and we’s all got blood” as the knowledge base of the jurors who are allowed to decide cause and effect of a prescription drug on an individual.
We let thousands of people sue drug companies because they perceive that a drug was the cause of an event. Then we let ignorant jurors decide these cases based on evidence and conjecture delivered by attorneys. This doesn’t prove the drug was at fault. But it makes people feel better. And it’s all about feeling better, not science, truth or true justice.
Justice in Michigan
“Phamacist”
The editors of the New England Journal of Medicine fully disagree with you. So, if you honestly believe “scentific and medical training” count for something, you will have to deal with the fact that the issue that seems so clear to you is viewed oppositely by them.
To take one juror’s sentence from the OJ trial - assuming it is even quoted correctly - would not qualify for credible evidence of any larger point. Is that what you call rational argument?
But your using the example is a pretty good indication that rationality is not the issue for you. Juries decide cases. In general, they are about as smart, or dumb, as you and I. And about as fair. And about as dedicated to doing the right thing. If your message is an example of “objectivity” as you view it, I would trust them over you in a heartbeat.
Lisa Van S
Pharmacist in IA,
“A jury of individuals with absoluteley no scientific or medical training can decide that a drug did or didnt cause suicide”
Four years ago I was approached by a NJ Pharmacist, whose father committed suicide by dousing himself, then drank gasoline, before lighting a match and setting himself on fire. He had been prescibed an antidepressant less than three weeks earlier. He didnt need a jury; he was a pharmacist, and he knew that the antidepressant was the cause of his father’s suicide.
As a pharmacist, do your job,… and provide patients with a medication guide. Pharmacists are now in the line of fire for civil liability, Im sure you are aware of that, and If I were you I wouldnt belittle attorneys; you may find yourself needing one in the future…
Lisa Van S
Hey Justice,
Touche…
Bob
Lisa-Why are you so sue happy?
I would laugh at you if I were on the jury, and tell you to pay attention to your child.
ol cranky
Lisa:
Do you realize you’re implying that a pharmacist should in some way be held liable for filling a valid prescription if a patient has what he/she (or family members are sure is) an adverse drug experience and the pharmacist didn’t counsel the patient against the drug’s use? Sorry, while there are legitimate reasons for the pharmacist to contact the prescribing physician to question a prescription and pharmacist’s do have an obligation to counsel the patient about a drug’s use (consistent with the labeling), it is not the pharmacist’s place to interfere with or undermine a patient’s treatment.
While your friend the pharmacist “knew” it was the anti-depressant that caused his father to commit suicide, his gut feeling is not empirical evidence and doesn’t mean that the drug was, in fact, the cause of the suicidal ideation. Just because psychotropic drugs are over-prescribed and are often prescribed w/o the necessary supporting therapy and follow-up, doesn’t mean all use of these agents is wrong by default or that negative outcomes are necessarily due to an ADR or even lack of efficacy.
pg
To Justice
Thanks for posting “The Role of Litigation in Defining Drug Risks”. I didn’t get in the official way(needed to register on one so carried on down google) but found a number of sites anyway that led me either to the article itself or to parts of the article and added information. Very helpful, thank you.
Lisa Van S
Ol cranky,
You may not like it, but many of us rely on a gut feeling,.. including law inforcement!! I suggest you stick to your pharma industry cushy job. unless of course you have something of value to say!!!
Lisa Van S
Bob,
Actually my children are now adults,..But ohhh boy,.. I will take great pleasure in inilating you. Go ahead,.. attack me,… make sure its your best shot!!!
pg
Justice, there were a few sites I found particulary helpful, probably the easiest to understand being:
http://ahrp.blogspot.com/2007/01/role-of-litigation-in-defining-drug.html
On the other hand, one of the sites that I found most intriguing - but sadly I can’t follow too well so only got a taste of it all before losing the plot was the following:
http://www.sillscummis.com/downloads/events/305/Drug%20&%20Medical%20Device%20Litigation.pdf
It seems to be the ultimate CorporateLawfest - a feast of mostly recognisable pharmaceutical industry lawyers working together to develop strategies to evade/avoid litigation.
Here’s just a few of many interesting quotes from the site:
“Corporations can gain many advantages by understanding how to effectively harness the preemption doctrine”,
“Best practices for protecting your company: successful strategies for using the preemption defense to your advantage”,
“Medical monitoring is being required by courts for people who have been exposed to DEFECTIVE [emphasis added] drug and medical device products”,
and lots more.
Any help on the latter link would be very much appreciated.
ol cranky
Lisa:
You can feel free to have your own opinion and follow your gut, but I don’t agree with holding someone liable without a legitimate reason and evidence to support doing so. A cop and DA can investigate a criminal based on their gut but expecting a judgment against someone based solely on those opinions isn’t justice. It is unconscionable for a pharmacist to interfere in a patient’s medical care by refusing to fill/dispense a legitimate and valid prescription or to counsel the patient against use of any medication because of his/her personal opinions or feelings.
You know full well I am no shill for the pharmaceutical industry and your insinuation that I have nothing of value to say because I work in clinical drug development is juvenile, patently offensive and, frankly, beneath you.
There have been many times when I have been absolutely sure that a remarkable improvement or an adverse event was related to a study drug (based on a temporal relationship and expected effects based on the investigator’s brochure/package insert/other publication) only to be unblinded and find out the subject was on placebo. Gut instinct, even with what appears to be some corroborating evidence, is not always correct. One of the first things I learned in stats was not to jump to the conclusion that even a tightly linked positive relationship between variables was, by default, proof of a causal relationship and that you must consider the impact of potential confounders: The amount of crime increases with number of churches there are in a geographic area. Bad priest jokes notwithstanding, churches do not cause crime (and crime doesn’t increase the number of congregations); the number of churches per square mile increases as the population increases, the crime rate also goes up as population density increases. This is a much more simple example of the impact of confounders when not considered during analysis; mental health issues are much more complex.
Let’s drop the personal attacks so we can have a more productive discourse.
pg
I think I messed up, hit the wrong key or something, cant see the post. Trying again, sorry if its a repeat:
Justice, there were a few sites I found particulary helpful, probably the easiest to understand being:
http://ahrp.blogspot.com/2007/01/role-of-litigation-in-defining-drug.html
On the other hand, one of the sites that I found most intriguing - but sadly I can’t follow too well so only got a taste of it all before losing the plot was the following:
http://www.sillscummis.com/downloads/events/305/Drug%20&%20Medical%20Device%20Litigation.pdf
It seems to be the ultimate CorporateLawfest - a feast of mostly recognisable pharmaceutical industry lawyers working together to develop strategies to evade/avoid litigation.
Here’s just a few of many interesting quotes from the site:
“Corporations can gain many advantages by understanding how to effectively harness the preemption doctrine”,
“Best practices for protecting your company: successful strategies for using the preemption defense to your advantage”,
“Medical monitoring is being required by courts for people who have been exposed to DEFECTIVE [emphasis added] drug and medical device products”,
and lots more.
Any help on the latter link would be very much appreciated.
Lisa Van S
Ol Cranky,
that will never happen!!! Its a shame that protecting adolescents is not your priority,…but it is mine..Adolescents have a constitutional right to make informed decisions. Its a shame that you dont share the same belief.
pg
The bits I DID understand in the CorporateLawyerfest link above (if it lands on pharmalot - I can’t see it yet - remind me of “THE FIRM”, a wicked movie, loved it. That of course was fictional. But in reality NOBODY NEEDS a film to bring the real world into focus - just go here, (can’t see my other posts yet, glitch maybe? Do just in case they don’t show up here is The Firm/Real Life CorporateLawFest records :
http://www.sillscummis.com/downloads/events/305/Drug%20&%20Medical%20Device%20Litigation.pdf
Chris2
pg -
Your post should show up immediately.
You linked to a very common type of industry seminar. These happen all the time.
> Any help on the latter link would be very much appreciated.
What kind of help are you looking for?
pg
Oh I still can’t see any post, but I’m sure Ed will sort it out somehow. If not/he cant, I’ll post it again an a day or two when next online.
Lisa Van S
Hey Guys,
Its not you,.. Its me!! Ed is screening our comments!,.. Again,… It appears that men have more rights than woman!!
So its a free for all!!
Lisa Van S
Ed,
Im quite capable of anything thrown my way. This NJ Mom needs no protection from the media.. Thanks Anyway
ol cranky
Lisa:
Where the heck do you get off saying “Its a shame that protecting adolescents is not your priority”? Protecting patients (regardless of age) has always been a top priority of mine and I’ve never summarily dismissed the rights or well being of adolescents. In no way does my statement that it is unconscionable for a pharmacist to interfere in a physician’s treatment of a patient by refusing to fill/dispense a prescription and/or dissuading a patient from following physician’s instructions indicate a disregard for the safety of adolescents. You are free to think that adolescents should not ever get any sort of psychoactive medication under any circumstances and believe that any and all adverse events experienced by someone exposed to those drugs is caused by them (regardless of the actual circumstances). I, personally, think those sort of blanket beliefs are short-sighted and that the imposition and insinuation of your personal beliefs on the medical care of people not in your care is misguided at best. It is not a pharmacist’s place to prevent me (or my teen) from filling a valid and legitimate prescription for prozac or percocet any more than it would be for that pharmacist to refuse to fill an equally valid and legitimate prescription for a hormonal contraceptive.
I know your personal experiences with mental health professionals and clinical trials have been horrific. I agree that additional objective review of these compounds, especially with regard to their use in children, is warranted, but I think it is irresponsible to allow personal/emotional decisions prevent any and all use of these medications regardless of the circumstances.
Justice in Michigan
PG - Re: your second link, I have nothing against companies getting together to learn how to protect themselves from liability if that means (a) being in FDA compliance, (b) doing the right things in general (not using delay, obfuscation, etc. in reporting); not attempting to bribe or intimidate academic researchers; etc..
There are conferences like these all the time. It is an industry in itself. If I could afford it, I would go myself. It would be a great education, and I’m certain the food and trinkets would be fantastic!
Short of that, the Drug and Device Law Blog, which is linked to this one, is run by two lawyers who defend drug and device companies. If you want to know how that side thinks about all this, I fully recommend it.
Of course, you have to keep in mind that the goal is to coach other corporate lawyers on arguments and strategies that are most likely to win in court (i.e., protect their client-companies). Whether the arguments are the truest or fairest or wisest are entirely different questions.
But they are among the best lawyers money can by, and I mean that in no cynical sense. In terms of lawyering skills, they are.
Justice Seekers
I’ve been reading everyone’s comments and just wanted to drop in and say that this was an overall horrible situation. I find myself torn between the multiple point of views that everyone shares.