Glaxo Settles Paxil Side Effects Lawsuits, Average Settlement $1.2 Million

Lawyersandsettlements.com is reporting that the average payout is in excess of $1.2 million for each family that brought a lawsuit against the manufacturer for alleged heart defects and other side effects suffered by their children.

You may recall that Glaxo initially contested that Paxil had anything to do with heart defects in children when they defended themselves in the Kilker v GSK trial - a trial that they lost, appealed against, and, it is believed, eventually settled.








$1.2 Million is a huge amount of money for these poor families - it is nowhere near what Glaxo should be liable for - no price can be put on any child being born with defects.

My thoughts go out to young Manie Edgington [6] - He was born with serious heart defects and is going through a pretty bad time at the moment. He's a fighter and sent me a lovely personal message some time ago.

Thinking of you little fella - you rock!

GlaxoSmithKline are back in the courts later this year in the UK.

The defining issues of this group action are thus:

Does Seroxat have a capacity to cause adverse effects consequent upon or following discontinuance (withdrawal) such as prevent or make more difficult the ability of users to discontinue, withdrawal from or remain free from taking Seroxat to a greater extent than all other Selective Serotonin Re-uptake Inhibitors (SSRIs)

Glaxo are contesting this.

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Medicate the Kids

Sometimes music can move you in such a way that you want to share in your experience.

During my long withdrawal from Seroxat I turned to music - it helped me more than anything, including family members who tried desperately hard to come to terms with what I was going through.

Imagine what that hell would have been like for a child.

There are still children being prescribed this junk.

I'll let Gavin DeGraw have the final say.



"Medicate The Kids"

Tell 'em, "Say no to drugs"
"Substances make you dumb"
Then you say, "give 'em some"
Are you the victim
Of this experience
Child experiment
Teacher's predicament?
You're in THE SYSTEM

And if you don't walk the line
You can walk the plank
Your older brother (government)
Wants to control your mind
You're more useful blank

[Pre-chorus]
Medicate the kids
Feathers turn to quills
Pump 'em full of training fluids
Powders and pills
There's nothing you can't flush out
And nothing you can't kill

[Chorus]
Why don't you just back off of us
Before we go crazy?
I'm gonna tell you,
"No way,
This ain't fair play,
Just don't medicate me"

Tell 'em, "Say no to drugs"
"Substances make you dumb"
Unless you get 'em from
Someone who loves you
One who knows best for you
Paid for those tests for you
Knows how to get you through
When it's above you
And you can't get on top
Cause it's high to climb,
You hear them saying,
"Don't make me call the cops"
Every other time

[Pre-chorus]
[Chorus]

[Bridge]
And there's a long line
Flowing from prescription aisles
Filed through legal means
So we can alter the child
For his protection
Tie him to extension cords,
This is the age of discipline

[Chorus]

Lyrics courtesy of azlyrics.com

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Blogs Hits On The Up

The traffic coming to this blog has been increasing as 2010 has rolled along. I'd just like to take this opportunity to thank all the regular readers and welcome all the new ones.

The month of June is significant as the traffic increased by a massive 186% compared to last year, this, in the main, down to the fact that I was writing about the inquest of Canadian teenager, Sara Carlin.

It was important for me to report on Sara's inquest as I believed the Canadian mainstream press were missing key points.

There are two other great Seroxat related blogs that are a wealth of information.

Seroxat Secrets & GSK : Licence To (K) ill

Seroxat Secrets has been running around four years and its author offers some great opinion. He also has a great timeline regarding Seroxat which stems from 1998 onwards. The author continues to pursue his search for the truth. He, like me, had a particularly difficult time withdrawing from Seroxat and he writes with a great passion.

GSK : Licence To (K) ill, authored by The Truthman, continues to press for answers too. The Truthman was also affected by Seroxat and his brilliantly named blog arrived on the scene a short while after mine and Seroxat Secrets. Another author who offers great opinion.

Both blogs have search boxes and both authors should be commended for their staying power and dedication to the cause.

Keep on keeping on guys.

I salute you both.



**In other related news, GlaxoSmithKline's second- quarter profit slumped by a massive 92%, hurt by costs to settle lawsuits over the Avandia diabetes medicine and the Paxil antidepressant.



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Glaxo, Children and Lucozade...Not made from Girders!

Image: topnews.in



Oh how I remember as a kid I used to get the old sniffle. My dear old mother would make sure I was comfortable in bed, hot water bottle, a supply on tissues to wipe the running nose.

There was something else too.

A big bottle wrapped in an orange cellophane wrapping. It was apparently good for me, would build my strength back up.

Today sees many different varieties, all different flavours, each one individually telling us all how good it is for us.

I'm talking about Lucozade. Here's how I remember it:

It was almost like a kids Champagne back then in the 1970's - only time it was ever seen, in my street at least, was when someone was ill.
















So many to choose from today though and such pretty packaging:

Original, Lemon, Orange and Tropical.

Mmmm, yummilicious.

Thank you Glaxo for making such a wonderful soft drink.











Sadly, Lucozade isn't all it's cracked up to be.

The Independent are running with the story that GlaxoSmithKline have been forced to warn parents that the drinks may cause hyperactivity.

Glaxo aren't the only culprits to mislead.

The makers of Irn Bru, a soft drink popular with the Scottish public, is also said to make children hyperactive.

Irn Bru is made by A.G. Barr plc. For those folk who read this blog that are from overseas, Irn Bru tastes like pink bubblegum... and it's made from girders!

As for Lucozade, well I seem to recall it tasting like normal fizzy pop with aspirin.

Here's what the Independent has to say:

A newly introduced EU law compels both drinks to display a warning that they contain artificial colours linked to behavioural problems in young children.

Manufacturers were asked to remove the colours two years ago by the Food Standards Agency (FSA) following a study which found they worsened the behaviour of young children. Lucozade Original's lurid yellow appearance comes from sunset yellow, or E110, while Irn-Bru's distinctive orange glow comes from sunset yellow and a red colouring, ponceau 4R (E124).

The article continues with:

Both also contain sodium benzoate (E211), a preservative that was found to cause hyperactivity by Southampton University, but which is not covered by the EU rule. Lucozade's owner GlaxoSmithKline warned shoppers about sunset yellow voluntarily, but it and Irn-Bru's maker AG Barr have to state that the additives "may have effects on activity and attention in children".

Glaxo keeping information back with regard to the safety of children?

Surely not?

Déjà vu anyone?


Question: Any child been prescribed an SSRi because they were deemed hyperactive?



Thank goodness the Food Standards Agency [FSA] are on the ball. Can you imagine if Lucozade was deemed to be a medicine and it was left to the MHRA to make a decision?

Ah, I can see it now. MHRA writing to Glaxo to tell them to go and sit in the naughty corner.


As for Irn Bru, I'll let some Scottish blogger have a rant.

GlaxoSmithKline: Do more, feel better and live longer... but struggle along that journey!


Fid

SEROXAT PROMOTIONAL VIDEO - BBC PANORAMA

Just came across this promotional video for the BBC Panorama programme, 'The Secrets of the Drug Trials.

It was created by Mark Chaudoir who is a D&AD Gold award-winning director of Commercials, Corporates, Promotional films and TV Graphics.

This 30 second promo really sums up the message regarding the way GSK buried the evidence that linked Seroxat to suicidal tendencies in teenagers.

Panorama Seroxat from Mark Chaudoir Films on Vimeo.

The complete 30 minute documentary can be viewed here

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Glaxo's Profits Hit New Depth

**Drum roll please

Bloomberg are reporting that GlaxoSmithKline's second- quarter profit slumped by a massive 92%, hurt by costs to settle lawsuits over the Avandia diabetes medicine and the Paxil antidepressant.

That's one hell of a drop for Glaxo's shareholders, earnings dropped to £130 million pounds or 2.6 pence a share, from £1.57 billion pounds, or 31 pence, in the same period a year ago.

Full report on Glaxo's website

Bloomberg article is HERE











and let's not forget...




Fid

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'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
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THE GLAXO/MHRA/PAXIL FILES

SPECIAL THANKS TO DOUG BREMNER, CHRISTOPHER LANE AND HEALTHY SKEPTICISM FOR MAKING SOME OF THESE DOCUMENTS AVAILABLE

PAXIL/SEROXAT - GREATEST NUMBER OF SUICIDE ATTEMPTS


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GSK PAXIL CASPPER DOCUMENT

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GLAXOSMITHKLINE PROGRAM CALLED “PSYCHNET”

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FOREWORD BY PAUL N. JENNER, DIRECTOR AND VICE PRESIDENT OF NEUROSCIENCE AND STRATEGIC PRODUCT DEVELOPMENT


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SECTION 1: TOWARDS THE SECTION BILLION -- ALL SSRI'S ARE NOT THE SAME


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SECTION 2: NEW INDICATIONS: SOCIAL ANXIETY DISORDER / SOCIAL PHOBIA


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SECTION 3: ISSUES MANAGEMENT: MANAGING THE DISCONTINUATION ISSUE

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"DURATION OF TREATMENT AND DEPRESSION: RELAPSE AND RECURRENCE RATES"

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"PAXIL CR" PRODUCT MONOGRAPH


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PAXIL LITIGATION DOCUMENTS


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GSK's PAXIL.COM...STILL A WEALTH OF [DIS] INFORMATION


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DOCUMENT RETENTION, LETTERS TO MINISTERS, LETTERS AND EMAILS ABOUT SEROXAT AND LIST OF FOI REQUESTS


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MINUTES OF MEETING BETWEEN MHRA AND BOB FIDDAMAN


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PRESS RELEASE: GSK INVESTIGATION CONCLUDES


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MHRA INVESTIGATION INTO GLAXOSMITHKLINE/SEROXAT


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GSK SEROXAT - LETTER TO GSK FROM MHRA


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GSK SEROXAT - LETTER TO TRADE ASSOCIATIONS


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SUMMARY OF REGULATORY ACTION


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LETTER FROM GSK CHIEF MEDICAL OFFICER TO MHRA


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MHRA RESPONSE TO LETTER FROM GSK CHIEF MEDICAL OFFICER


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PAXIL STUDY 329 ALL OVER AGAIN?
Article By Bob Fiddaman


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MARKET SENTINEL'S STAKEHOLDER ANALYSIS COMMISSIONED BY THE UK MHRA TO ASSESS PUBLIC DISCUSSION OF THE SEROXAT CONTROVERSY


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KILKER V GLAXOSMITHKLINE COURT TRANSCRIPTS

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PAXIL STUDY 329: PAROXETINE vs IMIPRAMINE vs PLACEBO IN ADOLESCENTS

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Glaxo Quietly Settling Paxil [Seroxat] Lawsuits

No admission of liability but lots of money being thrown in the direction of claimants.

Bloomberg has the latest update regarding the huge settlements GlaxoSmithKline are making with regard to the Paxil lawsuits in America. They are reporting that GSK has agreed to pay more than $1 billion to resolve more than 800 cases alleging its Paxil antidepressant caused birth defects in some users’ children.


Furthermore they add:

The birth-defect settlements bring to more than $2 billion the amount Glaxo has agreed to pay to resolve a variety of Paxil-related suits, including claims it caused suicides or attempted suicides and addiction problems.

GlaxoSmithKline's Sarah Alspach chipped in with the obligatory...

“GSK believes it acted properly and responsibly in conducting its clinical trial program, in marketing the medicine, in monitoring its safety once it was approved for use and in updating pregnancy information in the medicine’s label as new information became available.”

GlaxoSmithKline are the subject of a UK Group Action. The case goes to trial later this year.

The Seroxat Group Action claims are being pursued under the Consumer Protection Act [CPA] 1987.

The CPA provides for a non-fault based liability if the product is found to be defective and to have caused injury as a result. The Claimants allege difficulties in withdrawing from the drug.

The action is due for trial in the High Court in London later this year.

As yet, GlaxoSmithKline, have made no approach to settle this particular case despite settling with US litigants in similar withdrawal cases.

In all honesty, I would just love it if GlaxoSmithKline stood in the High Court and presented evidence that suggested there *wasn't* a problem regarding Paxil withdrawal. The items of disclosure obtained by the claimant's lawyers would then become public and I would love nothing more than to upload them for the whole world to see on here.

The full Bloomberg article can be read HERE

Last year Glaxo were ordered to pay $2.5million over claims that its Paxil antidepressant caused birth defects. Jurors in state court in Philadelphia deliberated about seven hours over two days before finding Glaxo failed to properly warn doctors and pregnant users of Paxil’s risk. The panel awarded $2.5 million in compensatory damages to the family of Lyam Kilker. The 3-year-old was born with heart defects his mother blamed on the drug.

Glaxo appealed the decision but have since settled.

The court transcripts from the GSK V Kilker trial can be viewed here:

All documents from the Tracey Law Firm

Court Transcripts

9/15/09 AM: Opening Statements
9/15/09 PM: David Healy, M.D. -- Direct Examination
9/16/09 AM: David Healy, M.D. -- Direct (continued)
9/17/09 AM: David Healy, M.D. -- Cross Examination
9/17/09 PM: David Healy, M.D. -- Recross; Redirect
9/18/09 AM: Suzanne Parisian, M.D. -- Direct Examination
9/18/09 PM: Suzanne Parisian, M.D. -- Direct (continued)
9/22/09 AM: Suzanne Parisian, M.D. -- Cross Examination
9/22/09 PM: Suzanne Parisian, M.D. -- Redirect; Recross
9/21/09 AM: Shira Kramer, Ph.D. -- Direct Examination
9/21/09 PM: Shira Kramer, Ph.D. -- Direct (continued); Cross Examination; Redirect
9/23/09 AM: Ra-id Abdulla, M.D. -- Direct Examination
9/23/09 PM: Ra-id Abdulla, M.D. -- Cross Examination; Redirect
9/29/09 AM: Anthony Scialli, M.D. -- Direct Examination
9/29/09 PM: Anthony Scialli, M.D. -- Cross Examination
9/30/09 AM: Anthony Scialli, M.D. -- Redirect; Recross
9/30/09 AM: Stephen Hobbiger, BSC -- Direct Examination
9/30/09 PM: Stephen Hobbiger, BSC -- Cross Examination; Redirect
10/1/09 AM: H. Scott Baldwin, M.D. -- Direct Examination
10/1/09 PM: H. Scott Baldwin, M.D. -- Cross; Redirect; Recross
10/2/09 AM: Judith Jones, M.D., PhD -- Direct Examination
10/2/09 AM: Judith Jones, M.D., PhD -- Cross Examination; Redirect
10/6/09 AM: Gary Shaw, PhD -- Direct Examination
10/6/09 PM: Gary Shaw, PhD -- Cross Examination; Redirect
10/8/09 AM: Closing Arguments -- Plaintiff & Defendant
10/8/09 PM: Closing Arguments -- Plaintiff Rebuttle & Jury Charge

Plaintiff's Experts

Ra-id Abdulla, M.D., Pediatric Cardiologist, Professor of Pediatrics, Rush University in Chicago

David Healy, M.D., FRCPsych, Neuropyschopharmacologist, Professor of Psychiatry, Cardiff University, University Hospital Wales North Wales Department of Psychological Medicine

Valerie Parisi, RN, Lifecare Planner

Suzanne Parisian, M.D., former FDA employee

Shira Kramer, Ph.D., Epidemiologist


Defendant's Experts

H. Scott Baldwin, M.D., Pediatric Cardiologist, Children's Hospital at Vanderbilt

Stephen Hobbiger, BSC, Vice President of Neuroscience, Global Clinical Safety & Pharmaco Vigilance

Judit Jones, M.D., Ph.D., FDA expert, Clinical Pharmacologist, Pharmacoepidemiologist

Anthony Sciali, M.D., OB/GYN, Reproductive Toxicologist, George Washington University

Gary Shaw, Ph.D., Epidemiologist


Fid

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'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING