Following on from a series of posts on this blog regarding GSK motions being denied by the Judge in charge of the Dolin v GSK case (Case: 1:12-cv-06403), comes news hot off the press that GSK have, once again, been denied further motions to get this and that pulled. Most notably is the evidence of expert witnesses for Dolin. In brief, GSK wanted to try and stop Dr Joseph Glenmullen and Dr David Healy from giving evidence. Their reasoning behind this motion bordered on desperation because GSK know that both Glenmullen and Healy have worked on Paxil litigation before, both have given evidence that has been damning for GSK.
GSK tried to exclude Healy's evidence based upon a General Medical Council (GMC) hearing that acquitted Healy. Not content with this, GSK wanted to hold their own hearing into the GMC matter, a kangaroo court, if you will. The Judge presiding over matters in the Dolin case has denied them this. GSK claimed that Healy has a "bias" against them (Insert tears here)
Other motions filed by GSK...
- To exclude any reference to GSK’s conduct and Paxil labeling prior to 2004 is DENIED.
- To exclude evidence with respect to FDA’s authority or GSK’s interactions with the FDA is DENIED.
- To exclude hearsay statements and opinions of Dr. Joseph Glenmullen is DENIED.
- To exclude evidence that GSK had a duty to directly warn patients of the risk of taking paroxetine is RESERVED.
- To exclude evidence of marketing and promotion is RESERVED.
- To exclude certain evidence is RESERVED.
Motions Granted,,,
- To exclude evidence of pediatric use of Paxil is GRANTED except as to the FDA’s review of the issue of suicide and the FDA’s review of GSK’s submission in 2003.
- To exclude references to other claims, lawsuits, investigations and reports is GRANTED.
- To exclude evidence of Any plea agreement and settlement is GRANTED.
- To exclude any reference to the “Lilly Protocol” is GRANTED.
- To exclude any reference to foreign labeling or warnings for Paxil is GRANTED.
For some, legal jargon is a turn off (not for me though, it's quite the opposite)
Let's break this down in laypersons terms...
GSK wanted to bar the testimony of Dolin's expert witnesses - they failed, in other words, the Judge, more or less, told them that despite filing reasons why experts testimony should not be heard - experts testimony shall be heard and there is nothing more that GSK can do about this. Furthermore, GSK wanted to see documents relating to an unrelated inquiry into Dr Healy. The inquiry was carried out by the GMC and exonerated Healy. Not, seemingly, happy with this, GSK wanted to be allowed to carry out their own interrogation of Healy relating to the GMC investigation - they, once again, failed, the Judge, more or less, told them that the GMC inquiry had nothing to do with the Dolin case, ergo, Healy shall be allowed to give his testimony without being badgered by GSK's attorneys regarding the GMC inquiry.
GSK wanted to exclude evidence relating to their interactions with the FDA, this would include emails, minutes etc. - They failed. The Judge has, more or less, told GSK that they will now have to show why they failed to sit down and discuss Paxil's propensity to induce akathisia and suicide with the American drugs regulator.
GSK wanted to exclude any evidence submitted by Dolin in relation to their conduct and Paxil labeling prior to 2004 - The evidence and conduct of GSK prior to 2004 is something they don't want the jury to see, nor, indeed, the public. In 2004 a black box warning was introduced regarding Paxil's propensity to induce suicide, they (GSK) feel that anything prior to that, ie; evidence that shows they knew long before 2004 that Paxil could induce suicide should not be submitted - they failed, in other words, the Judge, more or less, told them that evidence of them hiding the data and not warning the public about that danger shall be heard by the jury.
GSK wanted to exclude hearsay statements of Dolin's expert, Dr Joseph Glenmullen - Meaning that he would not have been able to offer an opinion based upon documents and clinical trials of Paxil - in a nutshell, GSK wished to gag him. - They failed. The Judge, more or less, told them that Glenmullen is a relevant expert in the field of Paxil inducing akathisia and suicide so they (GSK) cannot suppress his opinions.
Reserved Judgments
A reserved judgment is basically a decision that has not been made by the Judge, in other words, he may need more time and may, at a later date, deliver his judgement.
GSK asked the judge to exclude evidence that they had a duty to warn patients about the risks of taking Paxil. In essence, they don't want Dolin to show the jury that GSK had a moral and ethical duty to provide information regarding Paxil inducing akathisia and suicide. To use an analogy, it's akin to a chef preparing a meal with contaminated food. The chef knew he was using contaminated food but failed to warn the diners in the restaurant. The chef later argues that he had no duty to warn the diners. This motion has been RESERVED by the Judge.
GSK wanted to exclude evidence of the marketing and promotion of Paxil. This includes internal documents and (probably) pharmaceutical rep notes showing how they played down the risk of Paxil inducing suicide. Marketing could be anything from running an advert on television to bribing doctors to prescribe more Paxil, something that they have already been found guilty of in the US. This motion has been RESERVED by the Judge.
Granted Judgments
GSK have been granted a total of five judgments, all of which are common knowledge to the layperson. You'd have to be from the planet Zog to not know about the Paxil pediatric evidence they manipulated (Paxil 329)
They were also granted their motion to not have references to other claims, lawsuits, investigations and reports aired in the Dolin case. Again, Planet Zog inhabitants would be oblivious to GSK's dark history of Paxil causing severe withdrawal (Over 3,000 cases 'resolved' in the US) - Paxil being found responsible for a homicide and suicide - a jury arriving at this decision (See Tobin Vs SmithKline Beecham - Fig 1) - Paxil causing birth defects (Over 800 cases 'resolved' in the US)
Fig 1
More recently, we can see how they handled the widespread bribery and corruption in China, and how, it's alleged, their CEO, Sir Andrew Witty, lied to the media regarding his knowledge of the violations - here and here.
GSK were also granted motions to exclude any reference to the 'Lilly protocol' and also to exclude any reference to foreign labeling or warnings for Paxil.
**Updated**
The "Lilly Protocol" involved using suicidal people in Prozac clinical trials to make it so there were a lot of placebo suicidal behavior events to offset and “hide” the elevated on drug events in meta-analyses of suicidal behavior. Wheadon, the Lilly employee that came up with this idea, transferred to GSK and implemented the same idea which became Paxil MD-057 and 106 which for years were used to undermine the suicidal behavior rates.
As for the exclusion of evidence pertaining to foreign labeling or warnings for Paxil, GSK probably don't want the jury to see how the labeling differs from country to country, or, at the very least, how it used to differ.
Since the claim was filed in 2012 GSK have sent Wendy Dolin more than 30 subpoenas, they have also made over 70 record requests and have shown the Dolin children their father’s private medical notes. To top it all, GSK’s lawyers have been asking (goading) Wendy about her love life since her husband killed himself.
In 2010, Stewart Dolin (pictured) killed himself by leaping in front of a Chicago Transit Authority train at the Blue Line station at Washington and Dearborn streets in the Loop. Dolin was just 57.
He had started taking a generic version of Paxil six days before he leaped to his death.
Dolin is represented by Baum Hedlund Aristei & Goldman, P.c.
GSK is represented by King & Spalding.
It seems quite apt to rehash this reworking of a classic soul track. (New lyrics beneath the video)
Enjoy.
Go Ahead And File A Motion - The Paxil Remix
Maybe to win this trial you'll cheat
But there's no denying your rap sheet.
And maybe you have reasons to stall
Your drug has killed many, after all.
In that case I don't want no part
I do believe that, your lawyers have blackened hearts.
Oh, but if you feel stalling me
If you got the notion
Go ahead, and file a motion.
Oh, but if you feel stalling me
If you got the notion
Go ahead, and file a motion.
Ooh
Maybe you think that stalling will bring me down
And maybe you think you can run me into the ground.
Maybe you think that I'm just a fool
Knowing all along it was you who broke the rules.
In that case I don't want no part
I do believe that, your lawyers have blackened hearts.
Oh, but if you feel stalling me
If you got the notion
Go ahead, and file a motion.
Oh, but if you feel stalling me
If you got the notion
Go ahead, and file a motion.
Ooh, ooh
Ooh, ooh
Oh GSK, in that case I don't want no part
I do believe that, your lawyers have blackened hearts.
Oh, but if you feel stalling me
If you got the notion
Go ahead, and file a motion.
Oh, but if you feel stalling me
If you got the notion
Go ahead, and file a motion.
Oh, GSK
Go ahead, and file a motion.
[FADES] - Ooh GSK, go ahead, and file a motion.
Pokey Fiddaman & The Satiricals - 2016
Music by Smokey Robinson & The Miracles
Bob Fiddaman.
Back Stories
Dolin v GSK
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