Dolin Vs GSK - JP Garnier Video Deposition

I was going to take a break this weekend as I'm in Washington DC taking time out from a hectic week of traveling to and from the Chicago courthouse where GSK are claiming Paxil does not cause suicide in adults. Furthermore, GSK claims Paxil did not cause 57-year-old Stewart Dolin to end his life by jumping in front of a train. GSK's argument is that Stewart Dolin had 'work-related' problems which caused him to jump. GSK claims the Paxil he was taking as prescribed had nothing to do with his akathisia-induced death.

Earlier this week three video depositions were aired to the jury, they featured former GSK CEO, JP Garnier, Former Glaxo Executive Jeffrey Dunbar and GSK biostatistician John Davies.

Much to my delight, the video depositions have now been released to the public - this is a unique move and one that makes me very happy indeed.

Today I'm going to focus on one of these three videos. It features former GSK CEO, JP Garnier. After watching the video you will hear audio that wasn't aired in court. It, once again, features former Glaxo CEO, JP Garnier. It is audio that has been public for many years and, in the context of his video deposition, shows how Garnier had an opportunity to inform the public about Paxil's suicide link but chose not to. He instead opted to hang-up the telephone live on air.

It's important that you watch the video first then listen to the audio.

In the video, we hear JP Garnier answer questions about GSK's responsibility to warn doctors and patients that Paxil can and does induce suicidality. In Dolin Vs GSK, King & Spalding (GSK's defence team) have already told the jury during opening arguments that Paxil does not cause suicide in adults. Furthermore, they have claimed they told the FDA that, after reviewing Paxil data, they wished to change the drug labeling.  According to GSK, the FDA chose to use its own wording rather than using GSK's. King & Spalding told the jury there was nothing else they could do regarding labeling. Garnier's testimony, however, suggests that was a bold-faced lie.

The video deposition was taken in 2006.

"You can change your label without even getting approval from the FDA, there's a law that allows you to do that, correct?"

Garnier answered, "Yes, but in practice, you don't want to do that."

He was then pressed, "Okay. But you can do it if you want, the law allows that to occur?"

Garnier replied, "Yes, but you do want the FDA to agree with the changes you are going to propose because they have the power to correct what you just said the day before. You know, let's say we decide to inform physicians of some new event affecting our drug, well, the next day the FDA might come back and say, well, we didn't like the way you did this, you have to redo it. So it's considerably disrupting, that's why most companies go through the FDA first, in practice, but you are right, there is a legal right for us to go directly to the public."

So, Glaxo's own CEO claimed in 2006 that there was a legal right to inform the public about any serious adverse event--including the most serious of them all, suicide.

Now, let's listen to an interview from Garnier taken in May 2008, some two years after he admitted (under oath) that he and his company had a legal obligation to inform the public about serious adverse events and that they did not have to go through the FDA to get this news out.

Garnier was being interviewed by BBC correspondent, James Naughtie, about a vaccine. However, Naughtie deviated from the subject of vaccines and chose to ask Garnier about Seroxat (known as Paxil in the US).  Garnier, when pressed, chose not to discuss. Now, didn't he have a legal right to do so, as he claimed in his 2006 video deposition? Instead, Garnier chose to hang up the phone and end the interview.

(Hmm, so much for having a legal duty to inform the public.)

I'll leave it up to you, the reader/listener, to decide whether or not you think Glaxo's former CEO had ample opportunity to inform the public about Paxil's serious adverse events.

Here's that classic audio... the discussion of Paxil starts at the 3.24 mark.

Garnier was given a public platform to inform consumers about Paxil's serious adverse events, remember, as a CEO, he had a legal right. Why then did he choose to end the conversation abruptly?

Just sayin'.

Over to you, Todd.

**COMING UP TOMORROW**

The video testimonies of former Glaxo Executive Jeffrey Dunbar and GSK Biostatistician John Davies.

Bob Fiddaman.

Related

Dolin v GSK - Opening Arguments

Dolin Vs GSK - Day Two - "Jack-In-The-Box"

Dolin vs GSK - Healy 'Rocks Da House'

Dolin vs GSK - Healy 'Rocks Da House'

This is complex, this is time consuming. Two days of evidence presented to the jury, judge and layperson (me included).

Cut through the endless amount of questions (they always lead to the truth where GSK are concerned) - and you will see, through Healy's evidence, the reasons why this case is a "Slam Dunk" for Dolin et al and why GSK's hot shot law team bounce up and down crying 'objection' at every given opportunity.

Objection! Because they don't want the jury to know about their previous ghostwritten articles.

Objection! Because they don't want the jury to know about GSK's previous fine of $3billion (yes, that's billion, fine for promoting Paxil off-label to kids.

Objection! Because they don't want the jury to know about the Paxil withdrawal issue because, "it's a case that is on-going against them in the UK) - Forget the case of Paxil withdrawal they've already settled with over 3,000 plaintiffs in the US, right?

Objection! Because they don't want the jury to know they lied about the fact that Paxil was safe for kids.

They even objected to Wendy Dolin's attorneys for wishing the jury had a great weekend, or words to that effect!

What I have witnessed here in Chicago is a law team representing an abhorrent company, the law team being made up of men and women (think about the birth defects Paxil has caused - I mean, their law team has a woman of child bearing years!)

Bayman (King & Spalding) also asked the Judge to reiterate to the jury that they should not "Google" about Paxil or the case in question. Yeah, right, Heaven forbid the jury stumble upon GSK's abhorrent record and/or disregard for human life, right?

I honestly don't know how a team with kids, siblings, wives, husbands or any other family members for that matter, can sit there and defend a drug (Paxil) that has caused so much heartache for families over the years. Are they devoid of any compassion, any empathy, any common sense?

My thoughts are, to some, irrelevant - Am I biased? Maybe? With a whole bunch of lawyers sitting on one side of a courtroom defending a drug that, probably, none of them have taken or, none of their loved ones have taken, I feel like I'm banging my head against a brick wall.

King & Spalding's main two men, Andrew Baymen and Todd (snigger at a name that befits a child) Davis, seem devoid of any compassion and/or rationale - they don't want to talk about ghostwritten articles, they don't want to talk about the $3 billion dollar fine their defendant got for the illegal promotion of off-label practises of many drugs, including Paxil. They don't want to talk about the withdrawal problems that Paxil can cause, and they don't want to talk about how the company they are defending put children and adolescents at risk when they sent out their work force to promote the safety and efficacy of Paxil.

For these reasons, I am de-humanized from that table (in the courtroom) that represents this truly abhorrent company. A table of psychopaths or people who just want the right to pay their monthly bills? - Psychopaths is a pretty good description, given that they know, and have  known of Paxil's severe side effects for many, many years.

Healy's expert opinion leaves me wondering if the jury want/need to hear anything more. He told the jury how...

• In 2006, the FDA knew about the increased suicidal risk on Paxil.
• GSK reported that there was no risk f Paxil induced suicide in 1999.
• GSK showed 6 suicide ttempts on placebo,when the actual figure was 1, in fact it was zero!
• GSK claimed that Paxil did NOT cause suicide and this convinced prescribing Dr's to prescribe Paxil.

Let's just take a look at some evidence aired today...these are from GSK's own internal documents. The public, or those who had or have been prescribed Paxil never got to hear about this...

 - 50 year-old female patient who became suicidal on Paxil (GSK's own admission, probable cause!)
 - 55 year-old male patient who showed "unrest and agitation" - patient was put on Paxil for 3 days when problems began, Paxil was stopped - patient felt better.
 - 59 year-old male - experienced 'restlessness', visual disturbances - Patient recovered one day after Paxil was removed!
 - 32 year-old male, on day one of Paxil treatment, developed severe akathisia - patient was confused throughout study.


Healy reminded the jury that GSK's stance was that Paxil, a drug that was used to treat anxiety and Major Depressive Disorder (MDD) could not cause adults suicidality yet it actually made, some people develop symptoms that it was, originally, meant to treat! Ergo, take Paxil to help anxiety MDD and suicidal thinking when, in actual fact, Paxil could cause these symptoms. Dr's would then increase the dose thinking that Paxil (at a lower dose) wasn't working.

Many exhibits were aired that further showed how GSK hid the suicide link with Paxil. In fact, it was learned, GSK's own re-analysis of Paxil (2006) showed an increase of 6.7 patients in Paxil adult patents. (the increase 6.7 times the greater likelihood one who takes Paxil will develop suicidality)

Oh, by the way, Stewart Dolin was 57.

Healy told the court that, based on his own clinical experience, Paxil was the most potent and problematic of all the SSRIs on the market. He also informed the jury that, as a clinician himself, he does not prescribe Paxil and added that the hospital where he works does not have Paxil on their list as a possible medication to treat a psychiatric illness.

To back up the evidence, the jury was shown an email to GSK's marketing guru, Barry Brand. The email focused on Paxil's suicide problem.

King & Spalding's, Andrew Bayman, played his 'Jack-in-the Box' routine throughout the day. His sidekick, from King & Spalding, Todd Davis, remained in the wings being as quiet as a mouse - strange because it is "Todd" who has targeted the kids of Wendy Dolin leading up to this litigation. Is Todd married? Does Todd have a regular girlfriend/boyfriend? Does he have children of his own? Is his blinking affliction down to the overuse of a psychotropic medication? Who knows?

That's poor show from me, I shouldn't mock the afflicted...then again, these schmucks have defended the indefensible for years - they've shown no remorse when people have gone on to kill themselves whilst on Paxil - why would they when they are earning vast amounts of money (by the hour) defending GSK?

GSK are King & Spalding's cash cow. They tried, through objection, to hide the truth about Paxil to the jury. They failed on a grand-scale.

Most damning, for today at least, was Healy's claim that he is one of the only people to have read the 'raw data' regarding Paxil and suicide, raw data that leaves him firmly believing Paxil can induce suicidality in adults, something that GSK have, for years, denied.

Healy also spoke how GSK used the term 'emotional lability' when reporting suspected suicidality in clinical trials, a term that would have made, even him, think there was no problem with Paxil. A term that would have made most prescribing doctors think that there was no suicide problem with Paxil!

Churlish.

GSK's table of attorneys look slick. One aging bald-headed guy even approached the judge at the end of today's proceedings to complain that Wendy Dolin's law team had wished the jury a "nice weekend" as they were dismissed.

Objection, objection, objection.

They seem like a stuck record. A team of misfits whose only mission is to blame everything but Paxil opting, instead, to blame the patients for having an 'underlying illness'.

The questioning of Healy by Dolin's attorney's finished today. He will be cross examined by King & Spalding on Monday.

I'll be there. Stewart Dolin will be there in spirit.

More on the past two days events tomorrow night, in particular evidence that shows how a witness called for GSK in this trial showed how another unrelated drug caused two patients akathisia and they 'jumped' to their death.

Stewart Dolin (57)  'jumped' in front of a train because Paxil caused psychosis and akathisia, an adverse drug reaction that is so horrible, death can be seen as a welcome alternative.

Bob Fiddaman.


Dolin back stories.

Dolin Vs GSK - Day Two - "Jack-In-The-Box"

Day two kicked off with King & Spalding's Andrew Bayman finalizing his points to the jury that he started yesterday. He told them that, in 2006, GSK told the FDA about Paxil's increased suicide risks, he also told them that 'Dear Doctor' letters were sent out across the United States and that Stewart Dolin's doctor was aware of this. According to Bayman, the FDA changed GSK's warnings for all SSRIs and not just Paxil. Bayman also claimed that the FDA had told them (GSK) 4 times that they could not use their own wording in the label warning. Bayman also told the jury that GSK's sales force (reps) have no influence in prescribing habits - at this point I had to hold in my laughter, given that they paid a $3 billion fine recently to the DOJ for doing just that! (See - "GlaxoSmithKline to Plead Guilty and Pay $3 Billion to Resolve Fraud.")

More on King & Spalding's Andrew Bayman later in this post.

Next up was Brent Wisner of Baum Hedlund who is representing Stewart Dolin's, widow, Wendy Dolin.

Dolin presented the jury with three video depositions, the first being a May 2006 testimony from former GlaxoSmithKline CEO, JP Garnier. The depo was used in a previous case against GSK where Debra L. Tucker filed suit against them for the wrongful death of her brother, Rick, who, she alleged, killed himself after taking GSK's Paxil.

In the 2006 testimony Garnier was asked...

"Would you agree that a reasonable and prudent pharmaceutical manufacturer has a duty to warn prescribers of serious adverse events?"

Garnier answered, "Yes, I would agree."

It was also learned from Garnier's deposition that there is a law in place to help pharmaceutical companies should they wish to change the labelling because of new evidence that may arise regarding serious adverse reactions. He was asked...

"You can change your label without even getting approval from the FDA, there's a law that allows you to do that, correct?"

Garnier answered, "Yes, but in practice you don't want to do that."

He was then pressed, "Okay. But you can do it, if you want, the law allows that to occur?"

Garnier replied, "Yes, but you do want the FDA to agree with the changes you are going to propose because they have the power to correct what you just said the day before. You know, let's say we decide to inform physicians of some new event affecting our drug, well, the next day the FDA might come back and say, well, we didn't like the way you did this, you have to redo it. So it's considerably disrupting, that's why most companies go through the FDA first, in practice, but you are right, there is a legal right for us to go directly to the public."

The above 2006 statement from Garnier kind of contradicts what King & Spalding's attorney, Andrew Bayman, told the jury earlier in the day.

The next video deposition aired in court today was from John Christian Davies, a statistician from GSK. He confirmed that 8 of the 11 suicide attempts that have been previously mentioned in this trial were aged 30 or below, leaving 3 that were over the age of 30. GSK, in the Dolin trial, are denying that Paxil can cause suicide in adults. Hard to believe that a bunch of highly paid attorneys would think that anyone over the age of 30 are children or adolescents.

The final video deposition to be aired today was that of Geoffrey Charles Dunbar. Dunbar gave his testimony in September 2005, again it was in relation to another Paxil wrongful death lawsuit.

In 1987 Dunbar joined GSK, who were then known in the UK as Beecham Pharmaceuticals. He was given the role of director of CNS, a role whereby he oversaw Paxil clinical trials. Paxil, at this stage, was still in its infancy and hadn't yet come to market.

In the 2005 video deposition Dunbar was asked about the contentious two placebo suicides that were wash-out and run-in suicides (Back story). He said that he was not aware of them, he added that he had only recently become aware of them (bear in mind that the video deposition was taken in 2005).

Dunbar was then pressed further...

"Whether it was through oversight or negligence or intent or whatever the reason, that publication of published data was invalid, wasn't it?" 

and

"Well, regardless of intent here, isn't it true that public health on SSRIs for paroxetine was greatly misserved by your publications of this data in '91 and '92 and up through '95 as being valid paroxetine figures not designated with an asterisk for wash-out and run-in? That was a misservice to public health, wasn't it?"

Dunbar answered, "It was an error."

Dunbar was then asked, "Okay. Are you inclined to do anything to correct the record, such as notifying GlaxoSmithKline that your authorship was incorrect?"

Dunbar answered that it wasn't his intention to do so, on being asked why this was so? He answered...

"Because I think GlaxoSmithKline are very well aware of the issues we're discussing now."

Once the video depostions were played to those in attendance today, David Healy was then called to the witness stand...it was not without incident as King & Spalding made objections before Healy entered the courtroom, objections that saw King & Spalding attorney, Andrew Bayman, almost bursting a blood vessel as he tried to persuade the Judge not to allow certain lines of questioning from Baum Hedlund's Brent Wisner.

The questions thrown at David Healy today, and his subsequent answers, will be covered in a blog post tomorrow. Suffice to say King & Spalding's Andrew Bayman spent most of the day impersonating a Jack-In-The-Box as he stood from his seated position pleading objections to the Judge more times than I can count.

I personally think Bayman had an adverse reaction to the presence of Healy.

More on this tomorrow.

Bob Fiddaman.

Dolin back stories.

Dolin v GSK - Opening Arguments

Day one of Dolin v GSK is over and, as expected, GSK are, it appears, trying to muddy the name of the victim, Stewart Dolin.

David E. Rapoport opened the arguments on behalf of Stewart Dolin's widow, Wendy. He explained to them how, in 1989, GSK submitted  its “Integrated Summary of Safety Information” to seek approval of Paxil for adult depression. He also explained to the jury how the submission conveniently hid the link to Paxil being responsible for inducing suicide and suicidal thinking in patients during the clinical trials. (Back story) Rapoport also told the jury about Stewart's life and how he had, in the past, been prescribed Paxil and Sertraline (Zoloft).

GSK made several objections, one of which was the objection to Rapoport's use of the word "Paxil" - Part of GSK's defence is that Stewart took a generic version of Paxil made by Mylan, ergo they are not responsible for his Paxil induced suicide - I say "Paxil" because whoever manufactured it after the patent ran out did so using GSK's brand, a brand that became a household name. Stewart's prescribing doctor even referred to it as Paxil. It was a churlish objection from GSK and one that, I think, will have little or no bearing on the outcome of this trial.

All in all, Rapoport spoke for around two hours, after which the Judge called for a 15 minute recess.

Next up was GSK, represented, in part by Andrew Bayman of King & Spalding, and, as expected, they were slick and focused on Stewart Dolin's mental state at the time of his death. They tried to state that Stewart Dolin had work related problems which caused his "suicide". Interestingly, they also claimed that Paxil does not cause suicide. So, effectively, every single person that has died by suicide whilst on Paxil did not die by suicide because of Paxil. Hard to believe given the amount of men, women and children that have died by violent suicide whilst taking Paxil.

**Correction**
GSK was represented by Andrew Bayman of King & Spalding and not Dentons as previously stated.

The fact that Paxil has a black-box warning was brushed over by GSK who claimed that the black box warning was put in place for all SSRIs and was meant as a red flag for prescribing physicians to monitor their patients.

GSK's lawyer told the jury that he intended to speak for just an hour, an attempt at point-scoring exercise if ever I've seen one. However, approaching the hour the Judge intervened and told him his hour was almost up. He responded by saying he just needed to summarize which he plans to do do tomorrow morning.

Opening arguments is basically two parties setting out their stall. It was pretty obvious that GSK would go down this route (blame the victim). During the lead-up to this trial they have targeted Stewart's widow, children, friends and expert witnesses.

Tomorrow morning they will no doubt reiterate their "blame-the-victim mantra" they tried to sell today. It's the only defence they seem to have.

Bob Fiddaman.

Dolin Back Stories

Paxil Suicide - The Way GSK Hid the Link

It's the morning of the trial. The jury will shortly be sworn in.

The crux of the matter in Dolin Vs GSK is whether or not Paxil caused Stewart Dolin to kill himself whilst under Paxil's influence.

Dolin's widow, Wendy, intends to show the jury details of GSK's prior knowledge of the Paxil suicide link. Furthermore, how GSK hid this link with skullduggery; ie; they carried out underhanded and unscrupulous behavior to keep the truth from healthcare professionals, regulators and, more importantly, patients.

In 1989, GSK submitted its “Integrated Summary of Safety Information” to obtain approval of Paxil to treat adult depression. Amongst other adverse event statistics, the Safety Summary reported the number of suicides and suicide attempts experienced by patients who took Paxil, a placebo or a comparator drug during GSK’s initial clinical trials.

In GSK's presentation they compared the suicide attempts with patients in the Paxil group and those patients in the placebo group; and here's how they hid the fact that more patients in the Paxil group had a far higher (significant number) of suicides and suicide attempts.

During the run-in period (which is also called wash-out), patients taking part in a clinical trial are taken off of any medications they may be taking and given a placebo (commonly known as a dummy or sugar pill) instead. In this way, a person’s system is “washed out” of other drugs and all patients start the trial on a drug-free basis at “baseline,” i.e. at the actual beginning of the clinical trial.

Because people who are stopping medications during this wash-out period may experience adverse events associated with withdrawing from the medication they were on, adverse events experienced during this period are not properly counted as occurring during the clinical trial. Adverse events that occur during run-in periods cannot be included when calculating adverse event ratios for clinical trials. This is standard practise for clinical trials.

The FDA's Dr. Martin Brecher had mentioned in testimony that it is “scientifically illegitimate” to count placebo run-in/washout events. Furthermore, Michael Seika, another FDA medical reviewer, explained why run-in adverse events should not be counted. According to a December 8, 1999 GSK memo of a conversation with the FDA:

Specifically, I [Thomas Kline, Assistant Director of Regulatory Affairs at GSK] asked [Michael Seika] if a patient were to die during placebo run-in, i.e. prior to randomization, should that patient be included in the calculation for placebo deaths. He clearly stated that such a patient should not be counted in our analyses, since such a patient would not comprise the “controlled” portion of a trial.

Despite GSK knowing that counting adverse events during placebo run-in was improper they included them in their 1989  “Integrated Summary of Safety Information”

When the 1989  “Integrated Summary of Safety Information” is properly dissected we see that patients taking Paxil were at an 8.9 times greater risk of experiencing a suicide event than those on placebo.

GSK knew this but, by including the count for the placebo run-in/washout events, they were able to hide the risk of suicide from the FDA and, subsequently, prescribing doctors and patients.

By increasing the number of suicide attempts of patients taking placebo and reducing the number of Paxil patients attempting suicide, the percentages between Paxil and placebo became approximately the same - ergo Paxil patients had an equal chance of feeling suicidal if they had taken placebo. Because of this, the percentage of Paxil patients attempting suicide went down from the original submission because GSK reduced the number of Paxil suicide attempts from 42 to 40.

So, by removing the run-in suicide attempt events, Glaxo hid the fact that the correct number was 40 suicide attempts while on Paxil versus 1 attempt on placebo, an approximately 7.5 fold increase of suicide attempt risk for Paxil patients.

Paxil was approved by the FDA in 1992. The approval was based on GSK's false placebo numbers and the incorrect conclusions based on them.

Additionally, once Paxil was approved by the FDA, GSK then went out en masse via a massive promotional campaign touting Paxil as safe and effective, they did this by using the false placebo numbers.

A year prior to Paxil's official launch GSK's (then SmithKline Beecham)  Dr. Geoffrey Dunbar and Sarah Mewett presented a paper entitled 'Evaluation of Suicidal Thoughts and Acts with Paroxetine' at a medical conference, in order to address the then-recent concerns linking suicidality to SSRI antidepressants. In their presentations they claimed that “Suicides and suicide attempts occurred less frequently with Paxil than with either placebo or active controls - they made this claim using the false placebo numbers.

Furthermore, in 1995 GSK's Dunbar, along with two psychiatrists, submitted an article in the Medical Journal of European Neuropsychopharmacology. The article was published and claimed that Paxil actually reduced suicides and suicides attempts.

With this peer reviewed article in place GSK then instructed its saleforce team (reps) to play down the suicide risk associated with Paxil - (at the time reports via the media were suggesting there was a connection between Paxil and suicide)

GSK made billions of dollars from Paxil knowing that the data they submitted was false, meantime, patients on Paxil were feeling suicidal, many were completing suicide.

However, this wasn't enough for GSK.

On April 11, 2002, GSK submitted a Supplemental New Drug Application (“sNDA”) to FDA proposing the use of Paxil to treat children and adolescents with major depressive disorder and obsessive compulsive disorder. During its review of GSK's application the FDA's  Dr. Andrew Mosholder  noted that the most prominent adverse reactions in the Paxil clinical trials were “behavioral effects,” but he stated “these events were coded with terms such as hostility and emotional lability.

In other words, GSK, once again, strove to hide the suicide link in Paxil - remember, this application was for children! The actual figures showed that Paxil demonstrated a relative risk 3.0 times greater than placebo.

If you don't know the answer to why they hid the suicide information in both adult and children's Paxil clinical trials, then you probably don't know how business works. GSK hid the risks in both; they made lots of money from Paxil by getting it prescribed to adults, they wanted to do the same in the children's market - but the FDA and British drug regulatory agency never granted it a license for use in children. It was, however, still prescribed to children - once again on the back of GSK's salesforce team convincing doctors that it was safe and effective - they did this by showing prescribing doctors articles by prominent pediatric psychiatrists. What they didn't show the prescribing doctors was that the published material they were showing them was ghost-written by a PR company hired by GSK - prominent child psychiatrists merely put their names to the published material.

This, ladies and gentlemen, is how GSK operate. This is how they were able to hide the suicide link. This is how they have made billions of dollars off the back of Paxil. This is why Stewart Dolin killed himself.

I'm off to the courthouse. Will blog about days events later.

Dolin Back Stories.

Bob Fiddaman.

Stewart Dolin: The Force is With You

Well, I landed in Chicago on Friday ahead of the eagerly awaited Paxil induced suicide trial, a trial that has seen legal wrangling (stalling) from the defendent, GlaxoSmithKline. They've been targeting the children of Stewart Dolin, they've been targeting his widow, Wendy, with endless subpeonas. They've been targeting Wendy's expert withnesses, they have filed endless motions, they have, and continue to, denied that Paxil caused Stewart Dolin, a mild-mannered, loving man, to jump in front of a train and take his own life. They are, it appears, adamant that they can defend the allegations that Paxil caused Stewart to jump - Let's see shall we.

I'm here with some familiar faces, all of whom have suffered their own loss through antidepressant induced deaths. Kristina Gehrki, whose daughter, Natalie, ended her life due to antidepressants inducing akathisia. Leonie Fennell is also here with me. Leonie's son, Shane, became so psychotic on the antidepressant he was taking that he carried out an act of homicide before ending his own life. Along with Leonie, Stephany Lynch, whose son, Jake, ended his life after enduring the horrific side effects of his prescription antidepressant. Kim Witczak is also here, her husband, Woody, was prescribed an antidepressant for 'insomnia' - the side effects proving to be too much for him, or rather the akathisia. Woody also ended his own life.

What companies like GlaxoSmithKline want the public to know is that all of the above succumbed because they were mentally ill, or, they had underlying issues. The defence of Glaxo in the Dolin v GSK trial will, more than likely, centre around their claims that Stewart was having problems at work, when in fact, he was highly regarded by both his employees and employers.

This has been a long journey for Stewart's wife and children - GSK's attorneys, King & Spalding, have shown their true colours in the lead up to this case, all of which has been documented on this blog.

It's going to be very interesting to see King & Spalding's Todd Davis perform - it's something that I am very much looking forward to. It's going to be a surreal experience to watch someone defend a company who have knowingly sat on the Paxil suicide information for years, furthermore, for me at least, it's going to be the first time I see a human with zero empathy, providing, of course, that Davis shows a lack of empathy in the courtroom. - Anything uttered in court is a matter for the public record and it's my intention to blog about the events, be they the depositions of the Dolin children who were, it appears, grilled by Davis and his highly paid collegues at King & Spalding, even if video depositions aren't played throughout the trial there will be mention of them from both sides.

Glaxo, as per the norm, are defending the indefensible, in doing so they have hired the services of King & Spalding who have tried desperately hard to throw mud at Plaintiff/s and her experts.

Tomorrow sees the jury being sworn in and then the opening arguments. Glaxo will, no doubt, try and call for a mistrial, they will utter the word "Objection" time and time again. You see, Glaxo don't want the jury to know that Paxil can cause adults to kill themselves, they don't want the jury to know how seemingly normal people can go bat-shit crazy when taking Paxil - they won't want the jury to know how they have hounded Stewart Dolin's widow, family and friends since Wendy first filed.

From me, Bob Fiddaman, Kristina, Leonie, Steph and Kim, we hope justice prevails. We hope Glaxo's internal documents that they want to keep away from the public because these documents will show GlaxoSmithKline in a bad light.

Glaxo's CEO, Andrew Witty, leaves GSK next month - he beleives he has left the compny in good shape - I believe Andrew Witty is completely deluded.

Trial starts tomorrow - First blog about it will appear on here shortly after day one finishes. This will continue daily.

As I said, anything uttered in court will be shared.

Bring it on Glaxo!


Bob Fiddaman.

Attorneys For Dolin Deliver GSK A Can Of Whoop-Ass!

Regular readers of this blog will know that I have, for a lengthy period, been covering the Dolin Vs GSK Paxil induced suicide trial, a trial that will commence next Tuesday in Chicago.

For a number of years now GSK have defended the allegations that Paxil (paroxetine) induced the death of Stewart Dolin. They have cited that Dolin was taking a generic version of their drug, ergo they were not responsible. They have cited that they wanted to change the labelling of Paxil but the FDA wouldn't let them (although evidence shows that they did everything to avoid changing the labelling) - They have blamed Stewart's work problems on his death, even though he was held in high regard by his employers and work colleagues. They have asked his widow about her love life, showed personal medical notes to his surviving children, subpoenaed phone records, attacked expert witnesses, objected to almost every single shred of evidence that goes against them and, as reported yesterday on this blog, don't want the jury in this trial to see how a former FDA official, Martin Brecher, once said, during a deposition how illegitimate their Paxil suicide figures were.

On the latter, Dolin's attorneys have responded in spectacular fashion. You see, by objecting to Brecher's testimony they have stupidly opened a huge can of worms that actually looks more embarrassing for them than the Brecher's actual testimony!

GSK claimed that they never cross-examined the FDA's Martin Brecher but a recent filing by Dolin's attorney's reads...

In fact, GSK had three attorneys sitting at Dr. Brecher’s deposition, presumably all well-qualified to ask questions of Dr. Brecher, and indeed willing to participate and make objections throughout the course of the deposition. 

Furthermore, Dolin's attorneys argue...

The final question under Rule 804(b)(1) is whether GSK had the ‘motive’ to develop Dr. Brecher’s testimony. Of course they did, as will be explained momentarily. First, however, as a Case: 1:12-cv 06403 Document #: 498 Filed: 03/08/17 Page 7 of 13 PageID #:372958 preliminary matter, Plaintiff takes issue with GSK’s broad-sweeping and overly general characterization of the In re Paxil Litigation as solely being “Discontinuation Litigation” that did not have overlap with suicidality related to Paxil use. This is simply false.

In fact, one of GSK’s attorneys at the Brecher deposition, who is also one of GSK’s attorneys in this case, explicitly noted the broad scope of the deposition, applying to many GSK and Paxil cases throughout the country:

In addition, this case has not only been noticed in the In Re: Paxil case, it's also been cross-noticed in several other cases that are pending throughout the country that Mr. Farber and his co-counsel have brought. And it's also -- I advised Mr. Farber that GSK intends to also use this deposition in cases in which discovery is currently being stayed because of various pending motions.  ~ GSK Attorney Todd Davis, DE 497, Ex. 9, p. 10.

Dolin's attorney's ask the question, How then, is it possible that GSK could have overlooked all these “other cases” and mistakenly omitted from its submissions to this Court the real details about those “other cases?”

They also ask, Why would GSK not attack the subject testimony, if it believed it to be untrue or invalid?

Fair enough questions and ones that, seemingly Todd and co seemed to have avoided.

I mean, why didn't they dispute what Brecher had to say, why didn't they attack Brecher as they have attacked Stewart Dolin's widow, children and expert witnesses? It seems this is the norm for GSK's attorneys so why let Brecher off lightly?

If the truth is known GSK knew that Brecher's testimony was damaging - anything that damages GSK is best left buried, be that scientific evidence that Paxil causes severe and debilitating adverse reactions or induces suicidal thinking and completion in some patients.

Bury the data is the norm for GSK, we've seen it time and time again regarding Paxil.

Bury the victims - well, that's left to the likes of Wendy Dolin and Neil and Rhonda Carlin whose daughter, Sara, died by Paxil induced suicide. Also the parents of Sharise Gatchell, another victim who died by Paxil induced suicide. - There have been many more who have fallen foul to Paxil, many more who have taken Paxil on trust because GSK told the scientific and medical world that it was not only safe but effective.

Stewart Dolin will have his voice heard next Tuesday as the opening arguments begin in this trial - unless, of course, GSK do what they do best and settle as his widow climbs the steps of the court house on day one.

Almost every objection they have thrown in this case are peices of turd thrown onto the tracks of the Chicago Transit Authority Blue Line station northbound line in downtown Chicago where Stewart, under the influence of akathisia caused by Paxil, leaped to his death.

GSK are, as I've said many times before, a corporation run by narcissists and psychopaths, this narcissism and psychopathic tendencies spread throughout their workforce where the only thing that seems to matter is how much bonus they will make annually on the back of promoting drugs that are, for want of a better word, shit.

Wendy Dolin is represented by the national law firm of Baum, Hedlund, Aristei & Goldman, based in Los Angeles and the Chicago law firm, Rapoport Law Offices.

Bob Fiddaman.

Dolin Back Stories.

Glaxo Don't Want Jury To See Paxil's "illegitimate" Suicide Figures

Yet another objection by GlaxoSmithKline in the eagerly awaited Dolin Vs GlaxoSmithKline Paxil induced suicide trial, set to begin next Tuesday in Chicago.

GSK, it appears, are now bitchin' about evidence submitted by Wendy Dolin, the widow of Stewart Dolin, that shows how (in a previous trial) the testimony of former FDA employee Dr. Martin Brecher showed that stopping or discontinuing Paxil led to undesirable side effects. (In re Paxil, Case No. CV-01 07937 MRP (C.D. Cal.))

GSK's objection states...

"Permitting Plaintiff Wendy Dolin to introduce Dr. Brecher’s testimony would be highly and unfairly prejudicial because the jury would be left with the incorrect impression that FDA determined that GSK’s reporting of suicides and suicide attempts in the Paxil NDA was “scientifically illegitimate.”

During Brecher's original deposition, taken almost 14 years ago, it was learned that Brecher, whilst employed at the FDA, told Glaxo (then SmithKline Beecham) officials that "Paxil was dangerously addictive." (1)

Glaxo are also objecting to this evidence being submitted in the Dolin trial because, "...the prior case involved a different subject matter than this case."

Brecher, whilst under oath was also questioned about the suicide figures relating to patients taking Paxil. Here's part of that deposition. Keyword here is "illegitimate."

You'll note that GSK's attorney's cite the same thing when Brecher is being asked questions that forms part of their objection in the Dolin case, ergo "It has absolutely nothing to do with this litigation."


Q (by Mr. Farber): Now, you had the NDA that was submitted in November of ’89 and you took over the job in January of ’90, correct. So you had had – this is prior to the Teicher article now in January by month at least and the NDA had been submitted two months earlier. That NDA had suicide tables and data; did it not?

A: Yes.

Q: And did you through a matter of course in your regular routine review that suicide data?

A: I believe I did.

[Objection and colloquy omitted]

Q: So the data on suicide that you had when the NDA – let’s basically -- That will be Exhibit 15.
[Colloquy omitted]

Q: Take a look at that for a minute. Ready?

A: Uh-humm.

Q: Now this table Roman numeral 11.21 talks about attempted suicides and overdoses, Worldwide Data. And at the bottom it indicates the Par safety summary of 10 November of 1989. And you’ll notice up in the right-hand corner of the Worldwide Data that it has all the population that we talked about earlier that you believed I was telling you the truth and I am, the one that says 2,963 under Paroxetine, 1,151 and 554 respectively for placebo; do you see that?

A: Uh-humm.

Q: Okay. Now, here we have attempted suicides on the top line that are further broken down into drug overdose and I’ll save you the time by figuring this out and it’s to their benefit anyway, so the drug overdose category is within the top category, it’s not – it’s not in addition to, it’s a subset of attempted suicides. And my question is the asterisk of two overdoses during the placebo run-in, you see the asterisk on the side, and of the overdoses, attempted suicide, two were – occurred during the run-in period. Let me ask you this: Based on your procedures at FDA – first of all, let – let me back up a minute. Based on your procedures at the FDA, what is a run-in period?

A: Prior to randomization subjects are discontinued from their old medication and given placebo usually for about a week, sometimes shorter.

Q: And how about wash-out, same?

A: That -- that period also washes out their previous medication.

Q: So the terms are effectively synonymous for the purposes of …

A: (No verbal response.)

Q: Okay, now, based on FDA procedure and I’ll even elevate that to scientific procedure that you understood scientific procedure to be when you were at the FDA, is it scientifically legitimate to count a suicidal act occurring during wash-out and run-in to the placebo count?

[GSK COUNSEL]: Object to the form of the question. It has absolutely nothing to do with this litigation.

MR. FARBER: You’re going to see a connection if you’re patient here.

A: No, because everybody got placebo.

Q: So it’s scientifically illegitimate way to count, correct?

A: Yeah.

--

So, it appears that the current crop of Glaxo attorneys involved in defending Paxil in a suicide trial don't want this evidence seen by a jury, just as the old crop of Glaxo attorneys didn't want the jury in a Paxil addiction case to see evidence of Paxil induced suicide.

Begs the question; what exactly do Glaxo want the jury to see, just their evidence? A case of having their cake and eating it, perhaps?

The Paxil addiction lawsuit was settled out of court, over 3,000 plaintiffs received a compensatory award (figure unknown)

In the UK, consumers of Paxil (known as Seroxat) have been waiting almost 10 years to find out if they can press ahead and sue GlaxoSmithKline with regard to severe adverse reactions caused by Seroxat. In a recent pre-trial judgment the UK Plaintiffs were told that the outcome of the class action in the USA has no relevance to the UK cases. Glaxo had previously objected that the UK Courts did not need to know this. (2)

A strange judgment given that the relevance is in the word 'Withdrawal'. Nonetheless, the UK consumers still battle on.

Opening arguments in the Dolin trial commence Tues, March 14 in Chicago. I'll be writing daily reports on the events.

Bob Fiddaman.


(1) "Paxil was dangerously addictive."
(2) SANDRA BAILEY & OTHERS Vs GLAXOSMITHKLINE (UK) LIMITED 01/03/2017


Doin v GSK back stories.

Glaxo Settle Paxil Birth Defects

Once again GlaxoSmithKline have settled out of court with a mother who claimed that she and other mothers had not been properly warned about the risks of taking Paxil during pregnancy.

The lawsuit, which was filed 9 years ago, has recently seen both parties come to an agreement - ergo the plaintiffs (50 in all) will probably receive around $150,000 each.

Faith Gibson, who was the lead case in the litigation, used Paxil during her pregnancy and her daughter, Leah, (pictured above) was born with a hole in the heart in 2005. Meah, now aged 11, remains particularly susceptible to whichever cold or flu is going around.

Her mother said...

"In general, Meah, now 11, seems to be doing better physically. But the ordeal has affected her mentally as well.

"Any kind of pain she has in her heart or any sort of discomfort she feels in her chest, she feels like it’s something bad going on and that she might have to have surgery again.

"That side of things hasn’t subsided at all. She’s got a nasty scar on her chest to remember it by, so it’s always there."

GlaxoSmithKline said that despite the settlement in principle, it does not admit to any liability or wrongdoing but has agreed to resolve the class action case to avoid the time and expense associated with a trial and subsequent steps in the proceedings.

“We continue to be of the view that the scientific evidence does not establish that exposure to Paxil during pregnancy causes cardiovascular birth defects."

--

We all know different.

See the evidence in links below, evidence that caused a huge embarrasment to both Glaxo and their attorneys, King & Spalding.

Bob Fiddaman.

Ryan, Glaxo's Non-Viable Fetus - Part I

Ryan, Glaxo's Non-Viable Fetus - Part II - The Twists

Truth

Daily reports from the trial on the Fiddaman blog.

DOLIN Vs GSK - "D-DAY"Countdown

Back Stories

Bob Fiddaman.

GSK: "No time to prepare a defense"

The latest in the on-going Paxil induced suicide trial from Chicago.

Despite being told by the Judge to not overwhelm the jury with evidence, GSK have submitted page after page of evidence that it wishes to present to the jury, much of which is hearsay and irrelevant. One document is almost 600 pages in length!

Despite being told by the Judge that the jury don't need to know that Stewart Dolin took a generic version of Paxil, GSK have thrown their toys out of the pram and made demands that the jury should know (Boo-hoo)

GSK have, in Dolin vs GSK, filed endless amounts of motions, 90% of which have been denied by the Judge.

GSK have also targeted the experts for Dolin, in particular, David Healy, who they depositioned for almost ten hours, nine of which were questions about his private and personal life and not about the science (data), of which he has been called to provide evidence.

GSK have also filed countless subpoenas requesting that the widow of Stewart Dolin provide them with cell phone records from her personal phone and that of her late husband's, Stewart.

GSK have also shown private medical notes of Stewart to his children.

The latest?

Well, now it seems GSK are crying that they don't have enough time to prepare to defend the allegations brought against them by Stewart's widow, Wendy. Law360 are reporting that GSK, via their highly paid attorneys, are now, in a last ditch attempt, trying to make claim that they are not prepared for trial ~ Hey, it's only been, um, like, almost five years since she first filed.

Law 360 writes...

An amended complaint filed by Wendy Dolin, the wife of late Reed Smith partner Stewart Dolin, last week brings new allegations to the fore that GSK intentionally did not warn consumers of Paxil that the antidepressant could increase suicidal thoughts and behavior — at least according to GSK's motion Thursday to do away with the claims.

GSK said that it is unprepared to defend against accusations of willful and wanton conduct at a trial set to begin March 14 and that Wendy Dolin's attorneys should not be allowed to press the claims.

“Specifically, GSK has had no opportunity to investigate or tailor its defense to these late claims which plaintiff filed, without any explanation for the undue delay; nearly five years after this case commenced; almost two years after the close of discovery; and after the court considered and ruled on multiple dispositive motions and motions in limine,” the company argued.

The amended complaint charges GSK of "wanton and willful conduct" with regard to them intentionally not warning consumers of Paxil that the antidepressant could increase suicidal thoughts and behavior.

GSK are claiming that Stewart Dolin contributed to his own death - they have previously tried every trick in the book to make it appear as if Paxil had nothing to do with his Paxil induced akathisia (which is a precursor to suicide thoughts and completion)

This from Law360...

Dolin's attorney R. Brent Wisner of Baum Hedlund Aristei & Goldman PC told Law360 on Friday that it was untrue that GSK is not prepared to defend against the accusations. He said the latest complaint was a standard pretrial effort, approved of by the judge, to “clean up” the complaint by clarifying allegations that had already been submitted to the court.

He added that Illinois law allows plaintiffs to allege two kinds of negligence, both standard failure to fulfill a duty and willful and wanton conduct. If the court finds that GSK intentionally hid negative side effects from Stewart Dolin and other Paxil patients, then the company cannot mitigate damages by alleging that the late Dolin contributed to his own death.

So, it appears that Dolin's allegations were initially approved of by the Judge and that GSK are, once again, stalling the wheels of justice - I wrote my thoughts on this here.

The eagerly awaited trial commences next month (March 14) in Chicago. It will be interesting to see if GSK decide to make an offer of a settlement in this case. In 2001, after defending it's drug Paxil in the implcation that it induced the homicide and suicide of Donald Schell, the jury were asked one simple question, to which they replied "Yes". (See Fig 1)

Fig 1.

If that isn't wanton and willful conduct then I don't know what is, do you?

This is for GSK and their suits. It's a 'looped' version as it seems GSK are in the habit of wishing to extend time, when their own seems to be running out.

Enjoy, Todd.

Dolin is represented by BAUM HEDLUND ARISTEI & GOLDMAN, P.C. and RAPOPORT LAW OFFICES, P.C.

GSK is represented by KING & SPALDING LLP and  DENTONS LLP.



Bob Fiddaman.

Dolin back stories.

Paxil Induced Suicide Trial - GSK Opposing the Judge

I've mulled over this for a week or so. I've been doing some travelling and taking a break from all things GSK - It's always a good idea to try and wipe the stench of GSK from oneself, particularly after many years of writing about their abhorrent behaviour.

The following is a case that I'm familiar with as I have wrote about it numerous times on this blog. This particular Paxil induced suicide trial has been dragging on for a number of years. GSK have argued that Stewart Dolin took a generic version of Paxil made by a different company, therefore they are not responsible/liable for any injuries caused by the said drug. The judge told them that the generic version side effects, marketed by Mylan, was, indeed, still their (GSK's) drug (in essence) because evidence provided shows that they knew about the adult suicide link in taking Paxil and failed to warn the generic manufacturers about this link. In turn, the judge told the widow of Stewart Dolin, Wendy, that if she was to file a lawsuit then it should be against GSK and not Mylan.

After many years of targeting the Dolin family, GSK's attorneys then targeted the expert witnesses for Dolin. Now, it appears that the initial ruling (Mylan are not responsible) which was ruled over two years ago, is the basis for GSK's latest argument.

According to the legal subscription based website, Law 360, GSK now want the jury to know that Stewart Dolin took a product marketed by another pharmaceutical company and that they (GSK) made no profit from the sale of this particular generic version.

Okay,

Here's my take.

GSK want the jury to know that Stewart didn't take their drug, he took Mylan's.

The Judge has previously ruled that they (GSK) are still responsible for any updates on the labelling and that that information be relayed to all the generic labels too.

So, he basically told them, your drug, your responsibility to inform the generic manufacturers.

These are my thoughts - I have no legal background.

GSK want the jury to know that Stewart took a product that was not manufactured by them, ergo, they made no profit from it.

This will, supposedly, put an element of doubt in some of the jury members.

Secondly, if the Judge does a u-turn and allows GSK to inform the jury that Stewart took a Mylan product then they (GSK) could possibly make Stewart's widow (Wendy) a settlement offer...but a much lower one because they will argue, it wasn't our drug. They want this evidence submitted to the jury for these two reaons.

1. To put doubt in the jurors minds.
2. To offer a settlement much lower than a settlement would be had Stewart had taken their own brand.

It's kind of like a last ditch attempt at saving money.

They also want to blindside the jury with documents that are either irrelevant or hearsay, some of these documents will see that evidence supporting Dolin's claim (incriminating evidence) will have been omitted - so, they wish to provide cherry-picked documents to the jury in pretty much in the same way that they cherry-pick clinical trials regarding Paxil.

Some of the documents they wish to provide to the jury are excessively large - the judge has already ruled that they can't do this but they still wish to ignore this ruling. One of the documents, for example, is almost 600 pages in length! - This is not because they feel the apparent evidence contained within is strong enough for the jury to rule in their favour, it's simply page after page of nonsense designed to confuse the jury. When you get a confused jury, you get certain members of that jury who will get pissed off, bored and will just want an end to it all - ergo, the debating of jury members (deliberation) will see certain jury members not willing to speak up or offer opinion because, well, because they will just be totally confused by it all. So, being confused, bored and pissed off, jurors are more than likely to "go with the flow" - GSK will be hoping that the "flow" is running their way.

They know they are pissing off the judge but, as I say, it's a last ditch attempt at saving a couple or so million dollars. It's incredible when you think that GSK have already paid millions of dollars to their legal team that they are trying to penny-pinch here. They really have nothing to lose by opposing any ruling by the judge in this case - they know, pretty much, that they cannot win so they are trying desperately to reduce the amount they will have to pay - it's a huge risk because every attorney should know that you never piss off a judge - it is, seemingly, a risk that GSK are willing to take. When all else fails, throw in the kitchen sink.

Anyway, these are my thoughts and, as I said, I am not an attorney. I have, however, read a lot of John Grisham :-) - I could be way off the mark - it could just boil down to the fact that GSK are a walking, talking sociopath and it would be a fruitless exercise to try and get inside the mind of one of those, right? Let's face it, they've never once apologised for putting children and adolescents at risk of suicide with Paxil so why would they be overly concerned about an adult?

Dolin is represented by BAUM HEDLUND ARISTEI & GOLDMAN, P.C. and RAPOPORT LAW OFFICES, P.C.

GSK is represented by KING & SPALDING LLP and  DENTONS LLP.

Bob Fiddaman.

Dolin back stories.