UK Seroxat Litigation Day 3 - More Silence and Discovery History

Day three of the UK Seroxat litigation sees more silence from the British media. I'm assuming they are waiting until the end of week 1 before they go to print. Opening statements can be repetitive and tiresome.

As I am not in a position to report on the trial given I'm a claimant, I want to highlight a previous case I worked on (for free). It involves Seroxat and just like the current litigation wasn't reported on in the media.

This old post of mine highlights how GSK's attorneys operate, at least in the States. It's important that I air this again as it shows readers who may be unfamiliar with GlaxoSmithKline exactly what kind of beast UK claimants are up against.

I worked on this case for almost three months before going public. Much of what went on behind the scenes has never been made public...until now. It's a long post as it takes some explaining. Imagine, if you will, a jigsaw, that you are told will reward you with a pot of gold upon completion. You get to the end only to find missing pieces. Some years later, after nobody has come forward to collect the prize, you are handed those missing pieces. There was no pot of gold for me but I took great satisfaction in helping a mother who had been harmed by one of the largest pharmaceutical companies in the world. My satisfaction came as a result of their forced u-turn.

First off, rules of discovery do apply to both sides to some extent. But the reality of the situation is that the defence does not end up having to play by the same strict rules. This doesn’t mean defendants can sit on their hands, though. Failure to respond to discovery in a timely manner can result in sanctions, including financial penalties.

Discovery
Discovery, in the law of common law jurisdictions, is a pre-trial procedure in a lawsuit in which each party, through the law of civil procedure, can obtain evidence from the other party or parties. Discovery is conducted in various ways such as interrogatories, requests for production of documents, requests for admissions and depositions. (Source)

Headlines Galore
In December 2013 a petition of allocatur was filed in the case of a woman who claimed that her use of  Paxil (Seroxat) during pregnancy caused birth defects necessitating an abortion. Allocatur basically means permission to be allowed to file an appeal.

The woman, Joanne Thomas from Pennsylvania, filed the allocatur to challenge a Nov. 27 Superior Court ruling that GlaxoSmithKline did not fraudulently conceal from her information about the U.S. Food and Drug Administration birth-defect risk classification of its drug Paxil. Given there was no fraudulent concealment to toll the statute of limitations, the Superior Court ruled the case was time-barred. Additionally, the court ruled that since Thomas' unborn baby did not reach the fetal gestational age of 23-24 weeks, it was not considered "viable" in terms of a wrongful death/survival claim.

In 2009, Glaxo lost a case that claimed it did not do enough to warn mothers of potential dangers when taking Seroxat during pregnancy. The next year, Glaxo paid more than $1 billion to settle 800 similar suits in the U.S.

The 'test case' Glaxo lost in 2009 involved Lyam Kilker.  Lyam was born in 2005 with multiple cardiac defects: a hole in his atrial septum, a hole in his ventricular septum, along with transposition of the great arteries. Shortly before conceiving, Michelle David, Lyam's mother, had been prescribed Seroxat for mild anxiety and occasional panic attacks, and she continued to take the drug throughout her pregnancy.

Lyam's mother filed a lawsuit against GlaxoSmithKline and on October 13, 2009, a jury in the Philadelphia Court of Common Pleas returned a verdict against GlaxoSmithKline. The jury ordered GSK to pay $2.5 million in damages to the family.

"Please don't forget about me"
During the Kilker trial, it came to light, via GlaxoSmithKline internal emails, that Glaxo had been contacted by a consumer in 2001. The name of the consumer was redacted.

Here are the emails that were sent to Glaxo in 2001

"I was diagnosed with panic disorder about four-and-a-half years ago. Since that time I've been taking Paxil, which is truly a miracle drug. I've been panic-free with this drug and have been able to go on with a normal life.

"I was married in October of 2000. My husband and I found out we were pregnant at Christmas time. I was so excited. I love children. The only problem is that I carried the baby to six months gestation and then had to have a termination.

"The doctors diagnosed my son with Truncus arteriosis. They said he would not lead a normal childhood and would most likely not make it through the open heart surgery that he would need as soon as he was delivered (if he was able to make it to that time).

"To say the least, I was absolutely distraught with this news. I thought this was something that I did [...] because I stayed on the Paxil for selfish reasons.

"I wanted to know if you could direct me to any information you might have of any woman that has taken Paxil and still had healthy babies.

"My husband and I are ready to try again to get pregnant in the next month or two. I am so nervous. I don't want to stop taking my miracle pill. But, then again, if there is a chance that this might hurt or affect the baby, I want to know upfront. And I will somehow stop taking it for the time being.

"Please contact me as soon as possible. I love everything this drug has done for me. I am so thankful that your company had this available for me. I just want to continue to have a normal life and have the child that I always wanted.

"Please contact me as soon as possible ... Please don't forget about me."

--

The woman sent a second email, on 1 June 2001.

"This response is in regards to an e-mail that I had sent you previously. I was asking to see if you have any or are in the process of any clinical trials for women who are currently on Paxil and pregnant. I wanted to find out information to see how many women were on Paxil during pregnancy and if they were able to successfully have healthy babies.

"I am in no way insinuating your product did this to my child. I love the product, and I don't think I could have gotten through my panic attacks without the wonderful help of this miracle drug.

"I just want to start to try and get pregnant again soon. I do not want to put my unborn child through anything that would hurt him/her.

"Please, if you do not have this information, where is this information held? Does anyone do studies like this? Please, any information you may give me would be great. Thanks again for your help."

--

The following GSK internal memo from June 2001 refers to her emails.

"Report 2001014040-1 describes the occurrence of a terminated pregnancy in a female of unknown age prescribed paroxetine (Paxil) for panic disorder.

"This report was received from the patient and has not been confirmed by a physician or other health care professional. Concurrent medications and medical conditions were not known.

"Four-and-a-half years ago, the patient started Paxil (dose unknown). Since taking Paxil, the patient noted she has been panic-free and has been able to go on with a normal life.

"Patient discovered she was pregnant in December 2000 while being treated with Paxil. However, she reported that at six months gestation the pregnancy had to be terminated because the fetus was diagnosed as having Truncus arteriosis.

"Her physician told her that the child would not lead a normal childhood and would most likely not make it through the open heart surgery that he would need as soon as he was delivered, if he was able to make it to that time."

--

Eventually, GSK emailed the following response to the woman on 6 June 2001.

"Thank you for your inquiry. We are attaching a copy of our current product information for Paxil. Please review the section on use during pregnancy.

"Further questions about your treatment should be directed to the physician, pharmacist or healthcare provider who has the most complete information about your medical condition.

"Because patient care is individualised, we encourage patients to direct questions about their medical condition and treatment to their physician.

"We believe that because your physician knows your medical history, he or she is best suited to answer your questions.

"Our drug information department is available to answer any questions your physician or pharmacist may have about our products. Your healthcare professional can call our drug information department ..."

--

These emails were produced at the Kilker trial as was a GSK admittance, albeit via an internal document.

An internal GSK document relating to the correspondence, headed "re-investigation of case number A0348482B", dated 13 June 2001, states: "Relatedness assessment to medication – almost certain."

So, GSK knew as far back as 2001 that it was almost certain that Paxil caused the birth defects. They never, however, gave this information to the female consumer who wrote to them. This despite the woman asking for information regarding Paxil as she and her husband wished to try for another baby, "I just want to start to try and get pregnant again soon. I do not want to put my unborn child through anything that would hurt him/her."

---

Contacting a Blogger
In 2014, I was contacted by Joanne Thomas who, if you remember, had lost her case against GSK due to a statute of limitations defence being used.

Joanne was unaware that she had been the subject of many blog posts and had been sought by attorneys, some even hired private detectives to try and track her down. Dr. David Healy had also previously wrote about her, here and here, but she was unaware of this.

Her email to me obviously struck a chord and I asked her to view a video I had uploaded to YouTube. The video, a deposition from GSK's Jane Nieman, had been used as evidence in the Kilker trial.

Within minutes of watching the video Joanne emailed me back saying, "Omg...Bob that's me!!!!
"Jesus Christ 31:07 ... I believe its my call!!
"I am a mess...."

I spoke at length with Joanne and her father and pieced together her case, in all it took around three months to put an article together. I also contacted her attorneys to basically let them know they had "missed a trick."

Within the space of a few weeks after publishing my findings, GSK and Joanne's attorneys agreed on a settlement. Disappointingly, Joanne's attorneys told her not to contact me anymore this after I handed them victory against GSK. A nice 40% of Joanne's award for them for others doing their work. 

Joanne sent me emails which showed GSK in a tizz over the evidence they had previously kept from her attorneys. We spoke again on the phone and she asked my advice about the paltry sum GSK was offering her. Her lawyers, in my opinion, a two-bit bottom-feeding law firm, put pressure on Joanne to accept GSK's measly compensation. What price for killing a child, huh? Sadly, Joanne was to be gagged once she accepted the settlement.

I don't know how Joanne is getting on these days and don't really blame her for ceasing contact with me. I do, however, know that GSK knew exactly who she was but told a judge that her case was barred by the Statute of Limitations when the reality is they had already admitted back in 2001 that they were certain Seroxat caused her child's birth defects. GSK knew but didn't tell her and put her and any future babies at risk. Don't you find this conduct inconceivable?

Keeping evidence 'in-house' that may point to a fault causing death is one thing, but to keep it 'in-house' knowing that it may happen again to the same person is unforgivable.

I had more shares on the following two posts than any other of my blog posts I've ever written. GSK, King & Spalding (GSK Attorneys) all visited my blog, hence the reason, they settled with her.

Here are the two posts that forced the hand of GSK to settle.

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

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

Enjoy.

Bob Fiddaman

Coming soon. GSK's defence in the UK Seroxat litigation - Playing the media blame game and why it doesn't hold water.

UK Seroxat Litigation - Day 2 - Deathly Media Silence

The mainstream media still seem disinterested in the on-going UK Seroxat litigation in London. Perhaps, they are waiting for some internal documents to surface, you know, something meaty they've never seen before?

Perhaps they are waiting to see if anything pertaining to GSK's Yugoslavia trials are aired?

GSK's Yugoslavia Seroxat Trials

Back in 1988, SmithKline Beecham (SKB) initiated a trial [called the relapse trial]

At this time, SKB was seeking approval of Seroxat and the Yugoslavia trial was to show the FDA (the US drug regulator) how effective Seroxat was in treating depression – they would also try to show the FDA how it was important to keep taking Seroxat and not to stop… because if you did stop then you would go into relapse, in other words, SKB was trying to prove that stopping Seroxat meant the patient’s original illness would return.

The following two posts may be a helpful resource for media outlets, should they ever take an interest in the current Seroxat litigation. Here and here.

Should the media wish to see the data from these trials, they could always contact the MHRA. They may be surprised by the MHRA's answer.

At the very least, it should prompt some serious questions regarding the Yugoslavia Seroxat trials and the way GSK, then SKB, seemingly spun withdrawal into relapse.

Back story - MHRA Missing Key Seroxat/Paxil Withdrawal Information

Because of my involvement with the current trial, I am restricted in writing about it. I can, however, write about GSK's history. That said, tomorrow I will be writing about a case involving Seroxat and birth defects. My previous blogs surrounding this particular case saw an insight into how GSK's attorneys operate, moreover, how they quickly settled out-of-court with a Pennsylvanian woman who had contacted me. An in-depth research of her case showed that GSK had clearly not handed over all items of disclosure to her attorneys, once I went public with this, they offered the woman in question a settlement, despite GSK previously persuading judges to strike her case.

More on that tomorrow.

Bob Fiddaman

FCUK GSK

UK Seroxat (Paxil) Litigation against GSK starts Monday, April 29, 2019

#KeepTheDate

#0429

For back stories regarding Seroxat (Paxil) please visit the website that GSK paid to have removed...but which was later resurrected by Seroxat activists. The original author of Paxil Protest was Rob Robinson, he's a legend around my way and was also part of a class action lawsuit in the US whereby GSK settled with over 3,000 plaintiffs regarding Seroxat withdrawal problems. GSK, who remember is a British company, have refused to settle similar claims brought by UK consumers.

PAXIL PROTEST (Rob Robinson)

More on the Seroxat litigation here.


Bob Fiddaman

The Anecdotes

If the benefits of SSRIs are loosely based around anecdotes then why are the MHRA ignoring the 'anecdotal' risks?

In December 1996, Stevie unexpectedly received a diagnosis of clinical depression and a prescription for Seroxat, an SSRI antidepressant.

Now, listen.

Stevie's story is one of many featured on 'Let's Talk Withdrawal'. An innovative series of podcasts from James Moore.

Bob Fiddaman

.

Revisiting Seroxat Withdrawal

One has to ask why manufacturers of products choose to ignore negative news and fail to warn the public about possible side effects of a product they manufacture.

I've been writing and researching GlaxoSmithKline for over ten years now, some would suggest that I have a bias when writing about them, in as much that I only ever write about their dirty deeds and not the 'good' side of Glaxo.

Thing is, I don't really see anything positive coming out of GlaxoSmithKline, even when it does one will find there's usually something underhand hidden in the good news that they preach. They team up with children's charities and that, to an outsider, makes them look really caring - the same outsider will quickly forget about the potential millions of children Glaxo put at risk when promoting Seroxat off-label to this vulnerable population. Yeh, we have to forgive at times, maybe just move on and forget but it's hard to do where Glaxo are concerned.

My time on Seroxat and subsequent withdrawal from it is well documented both on this blog and in my book (The evidence, however, is clear, the Seroxat scandal) I'm one of many thousands that struggled to wean off Seroxat - many of those thousands have been compensated by GlaxoSmithKline, in fact over 3,000 consumers in America were paid by Glaxo in an out-of-court settlement - in other words, they were paid and had to sign confidentiality agreements whereby they couldn't tell anyone exactly how much Glaxo paid them. Glaxo also admitted no liability, which basically means they can say that Seroxat did not cause addiction in those 3,000+ consumers - they can stick to the line that it takes roughly two weeks to safely withdraw from Seroxat. Glaxo can and will always claim that "We believe the product is not defective and that there is therefore no merit in this litigation." - I am refering to the on-going UK litigation here.

Below is a document I found online, I've posted it before on here and even tweeted it to GSK and their lawyers. The document is a series of emails regarding a clinical trial, better known as "Project 1059."

Project 1059 saw James Ballenger, MD carrying out a long-term panic disorder study in 2000, Seroxat was the choice of drug. The study was cancelled by GlaxoSmithKline (then SmithKline Beecham) after they learned that Ballenger's findings had found something that they wanted to keep quiet.

As with most clinical trials, the finding are written up by ghostwriters. The series of emails below shows how they (the ghostwriters) couldn't turn bad news in to good news. This is quite rare, particularly with Seroxat, as some years previous Glaxo had managed to turn bad news in to good regarding Study 329  - In a nutshell, that study showed Seroxat was no more effective than placebo in kids and, more importantly caused a significantly high amount of kids to have suicidal thinking.

Anyway, back to Project 1059. James Ballenger, MD had found that many people in his study were suffering when trying to stop Seroxat. This was bad news for Glaxo, so bad that they actually pulled the study. The emails below are from Daniel Burnham of SmithKline Beecham to ghostwriter Sally K. Laden who, ironically, was also at the forefront of turning the bad news of Study 329 in to good news.

 Daniel Burnham of SmithKline Beecham writes...

"The issue of discontinuation sx [side effects] vs. relapse is obviously a concern of the J Clinical Psychiatry reviewers... Thus we have decided to terminate further work on this manuscript."

The industry prefer to call withdrawal issues "discontinuation problems".

What is striking about this correspondence is Laden's response to Burnham...

“We understand your reasons for cancelling this project. There are some data that no amount of spin will fix, and these certainly fall into this category.”

So, after learning that a number of people in Project 1059 were having trouble withdrawing from Seroxat, Glaxo, knowing that this could affect potential sales, decided to pull the plug on the study, in other words they would bury the data and thus keep Seroxat in the public eye as the best antidepressant on the market that had only 'minimal' side effects.

It's important that these emails are spread far and wide - they have been publicly available for a few years now and will more than likely be used as evidence in the UK Seroxat litigation. I mean, what Judge could say that the emails below don't really prove that Glaxo knew about the withdrawal problems with Seroxat?

Here's the internal emails.

Judgement was given on Feb 4, 2016 with regard to the on-going Seroxat (paroxetine) litigation in the UK. Glaxo, as you would imagine, wanted the Judge to throw out the claims that Seroxat caused withdrawal effects in UK consumers.

In his judgment (1), Mr. Justice Foskett said...

"Overall, it would seem that in the USA between 2000 and 2005 over 3500 claimants alleged that they suffered discontinuation symptoms when they attempted to reduce or discontinue the use of Paroxetine and in 2005 a confidential settlement agreement with a total of 3,294 eligible claimants (whose claims would otherwise have gone to a jury trial) was reached with no admission of liability. From 2003 a cohort of claimants filed a "putative class action" consisting of all California residents who paid for prescriptions of Paroxetine in California in which it was alleged that they sustained economic damage and were entitled to reimbursement or other relief due to alleged "discontinuation symptoms." In January 2012 a class-wide settlement with no admission of liability was achieved. Again, the claims would have gone to a jury trial in the absence of settlement."

I'm almost certain GlaxoSmithKline will try to defend Seroxat and make claims that they have evidence that Seroxat does not cause severe withdrawal problems - I'm really looking forward to seeing that evidence because after 10 years of writing and researching GlaxoSmithKline I have not once been able to find any such evidence, in fact the only evidence I've found publicly is internal emails produced in US litigation regarding Seroxat and birth defects, suicide and withdrawal problems. If Glaxo can produce evidence that shows there really is no problem when discontinuing Seroxat then I will, as a show of good will, stop blogging and move on to something else.

Your move, Glaxo!

Bob Fiddaman.

Glaxo Blew It!

"You had your chance and you blew it." ~ Robert De Niro

I don't suppose for one minute that the likes of Andrew Witty (GlaxoSmithKline) would ever take advice from a 51 year-old blogger from Birmingham - to be honest I don't care if he takes it - I'm offering this for free, it's not just for Witty, it's for other pharmaceutical company CEO's who, for whatever reason, think that problems raised can easily be swept under the carpet.

I've been writing this blog for almost ten years now, the research that goes into many of the blog posts I write can be, at times, very time consuming, none more so when it comes to GlaxoSmithKline who, for one reason or another, always seem to be grabbing the headlines in the international press. If they aren't paying out settlements for fraud, they are being accused of fraud - it's a never-ending trail of cancerous cells that just can't be obliterated.

The latest in Glaxo's long history of popping in and out of court rooms is the alleged claim that Seroxat causes severe withdrawal problems - surely not?

One only has to enter the search terms 'Seroxat + withdrawal+addiction' into Google to find out how Glaxo, who monitor what is said about their products, actually do nothing when faced with a barrage of criticism from patients (nae consumers) - ie; they don't address a problem when it arises, they ignore it because they know to engage with patients can be detrimental to the business, ergo can damage sales.

That's where they are going wrong.

Glaxo have had ten years to sort out the problem British patients have been facing with their (once) best-selling antidepressant Seroxat - truth is, they have done nothing about the reported adverse reactions or rather they, just like the British drug regulator, the MHRA, shrugged their shoulders at them. What's a couple of hundred people suffering on a product compared to those who say nothing, anyway?

There's the old 'ignore them and they will go away' factor that comes into play here too. The MHRA and GlaxoSmithKline take this approach, again, this is where they go wrong.

Do you think I would have dedicated almost ten years of my life to researching and writing about pharmaceutical companies and medicine regulators if they had opened their doors to me and shown me how I was wrong and they were right? Of course to do so would mean they would have to summon the evidence that I was wrong - they haven't and they can't.

This isn't me being obstinate or, as the MHRA like to call me, vexatious. This is plain and simple - they refuse to engage with me and people like me because we are question-askers, we ask the right questions and we are not guided by lawyers or editors who tell us that we can't ask this or that.

It's about transparency and I've yet to see any transparency from GlaxoSmithKline or from any other pharmaceutical company come to that.

Now, all that is about to change. News early last month that the UK Seroxat litigation can proceed to trial must have come as a blow to GlaxoSmithKline because those very same questions that they have been avoiding will be asked in an open court, complete with a public gallery. Glaxo, via their lawyers, had previously asked the Judge to halt the trial, citing various reasons. The Honorable Mr Justice Foskett denied them this (Full 31 page ruling here)

Documents will be, for the first time, aired to the British public. All and sundry (including health care professionals) will be able to read about the severity of Seroxat withdrawal. Those same people will learn that, for years, Glaxo denied this even though they knew about it. (See Seroxat - Project 1059 Laden With Withdrawal Problems)

It's vindication for those who have suffered severe withdrawal effects of Seroxat, worse still for those that still are. How many of these people have had to try and tell their husbands or wives that they just don't know why they are suffering these crazy symptoms? How many of those that have suffered have endured the opinions of their health care professionals telling them, "It's the illness and not the drug"? How many have had to explain to their children why they are suffering electric zap sensations and that their brains feel like they are frying? Perhaps those who have suffered have had to explain to their kids why 'mommy and daddy' can no longer live together or why they can't have the Christmas presents they asked for because the crazy withdrawal from the medicine keeps them in bed or doubled up in the fetal position for hours on end, "That's the reason why I lost my job, son." Maybe they've had to apologise to their children for losing their temper on them (aggression being yet another side-effect of withdrawing from Seroxat) - If only Glaxo would have been truthful, huh?

GlaxoSmithKline, as I said, have had almost ten years to hold up their hands and admit that they got it wrong - they chose not too because they thought the problem would go away. Back in 2011 Witty was approached and asked if he would meet the Seroxat Users Group to discuss the very same thing they now find themselves defending in court - the Seroxat withdrawal issue - he declined (See GSK's Andrew Witty in Patient Aftercare Snub)

Truth is, bloggers tend to get the bit between their teeth because they sense a great injustice has been done - then, as they plod along, year after year, they find that this is not just an individual problem, there are more people out there suffering, not just the horrific withdrawals either - suicide, self-harming, birth defects are just three of the many reported adverse events associated with Seroxat.

In the early 2000's Glaxo settled out of court with over 3,500 American consumers who claimed Seroxat had caused serious withdrawal problems. They did so with confidentiality agreements, also known as "gagging orders". Pharmaceutical companies do this to suppress the truth, it's also what litigation is all about - it keeps those documents (previously unseen) away from the public, press and healthcare professionals.

It very much looks like those documents may just see the light of day in the UK as 105 consumers of Seroxat head to court later this year. I, for one, can't wait to finally see that I have been correct all along and that Glaxo have not only being keeping the secrets of Seroxat away from me but from others too, including my doctor and your doctor.

I'm echoing here what a fellow blogger has wrote over at Seroxat Secrets. He pretty much hits the nail on the head with, "...And all those once-secret documents and the information they hold will be available the world over for future claimants to use. I think a whole new raft of claims will be kick-started in the USA alone. I wonder what GSK’s share price will look like after all this? And how institutional investors will view a company that breaks the law and lies & cheats its way to profit?"

Of course it could go either way, not, as I suspect, on evidence provided though. Glaxo's representative lawyers, Addleshaw Goddard LLP, will have already tactically planned how they wish to defend these allegations be it by dragging out the case for as long as they can in the hope that the claimants will have their funding dry up. Sadly, for Addleshaw Goddard that is, this isn't an option. Funding is in place and, according to The Honorable Mr Justice Foskett, assurances have been given that the claimants have more funding should the need arise. A tactic of big corporations is to drag out cases for as long as possible, it's a great tactic because it means eventually the small man will have to back down. All the time the fat-cat lawyers are getting paid by those they represent, a win-win situation. It appears the latest judgment by The Honorable Mr Justice Foskett will not allow this to happen. Round One, it appears, to the claimants.

Then, of course, Addleshaw would have been going through precedents to see if they can get the case thrown out because a ruling made by Judge X in the year XXXX. That's their job, to defend the indefensible...by any means.

Glaxo defence lawyers may or may not throw a curve-ball, they may plead with the Judge that the documents presented in court are sensitive therefore should not be made public - it appears as though it's a gamble they are prepared to take which means correspondence between themselves and the MHRA will be "outed" as they say. If they are going to go down then why not drag the limp-wristed medicines regulator with them, huh?

It's been almost 10 years in the making.

Eat your heart out John Grisham.

Bring it on.

Claimants are represented by Jacqueline A. Perry QC, Niazi Fetto and Timothy Killen (instructed by Fortitude Law)


Defendants are represented by Malcolm Sheehan QC and Andrew Kinnier (instructed by Addleshaw Goddard LLP)


Bob Fiddaman.

Exclusive: UK Seroxat Litigation to Press Ahead

FOR IMMEDIATE RELEASE

Judgement was given on Feb 4, 2016 with regard to the on-going Seroxat (paroxetine) litigation in the UK. (1)

Defendants, GlaxoSmithKline, sought an order that would have had the effect of bringing these proceedings to a permanent halt.

In arriving at his conclusion to not grant GlaxoSmithKline their order, Mr. Justice Foskett said...

"The Defendant is anxious (it might be said, over-anxious) to stop this litigation in its tracks. The motivation may simply be a total conviction that there is, in effect, no case to answer and that it is wrong to be harassed with unmeritorious claims. Alternatively, it may derive simply from a desire not to have to face in this jurisdiction the kind of claims brought in the USA and elsewhere. It may, of course, be a combination of both."

Mr. Justice Foskett had previously asked both parties to supply him with a summary of other litigation throughout the world concerning Paroxetine. In his Judgement Mr. Justice Foskett said...

"Although the list of actions provided to me on behalf of the Claimants is longer than that provided by the Defendant, a cursory comparison suggests that they largely cover the same material. Overall, it would seem that in the USA between 2000 and 2005 over 3500 claimants alleged that they suffered discontinuation symptoms when they attempted to reduce or discontinue the use of Paroxetine and in 2005 a confidential settlement agreement with a total of 3,294 eligible claimants (whose claims would otherwise have gone to a jury trial) was reached with no admission of liability. From 2003 a cohort of claimants filed a "putative class action" consisting of all California residents who paid for prescriptions of Paroxetine in California in which it was alleged that they sustained economic damage and were entitled to reimbursement or other relief due to alleged "discontinuation symptoms." In January 2012 a class-wide settlement with no admission of liability was achieved. Again, the claims would have gone to a jury trial in the absence of settlement."

It's good to see this on-going litigation finally get the thumbs-up to move forward to trial, and in my view the Honorable Mr Justice Foskett has to be applauded here for meticulously combing through arguments from both parties.

Mr Justice Foskett's Judgment seems to have paved the way for both parties to, at the very least, now plan where they are going with this.


The case between: SANDRA BAILEY AND OTHERS (Claimants) and  GLAXOSMITHKLINE (UK) LIMITED (Defendant) will now proceed to trial.

Claimants are represented by Jacqueline A. Perry QC, Niazi Fetto and Timothy Killen (instructed by Fortitude Law)

Defendants are represented by Malcolm Sheehan QC and Andrew Kinnier (instructed by Addleshaw Goddard LLP)


Bob Fiddaman.



Declaration of Interests: I am one of the claimants.

(1) Bailey & Ors v Glaxosmithkline (UK) Ltd [2016] EWHC 178 (QB) (04 February 2016) 

Consumers Vs Pharmaceutical Companies - The UK System

It's kind of set in stone these days that Seroxat, the antidepressant manufactured and marketed by British pharmaceutical giant, GlaxoSmithKline, is a faulty product. It's been through the American court system in various types of litigation.

1. Suicide - GUILTY - APPEALED - SETTLED - Compensation paid
2. Birth Defects - GUILTY - APPEALED - SETTLED - Compensation paid
3. Withdrawal problems - RESOLVED - Victims compensated

To date, GlaxoSmithKline have not settled any cases that relate to Seroxat use and suicide, birth defects and withdrawal problems in the UK.

They are a British company yet, it appears, will only settle with American consumers of Seroxat (Known as Paxil in the US)

To go up against a pharmaceutical company in the UK is notoriously difficult. Many law firms prefer not to touch cases against pharmaceutical companies because they can drag on for many years, the risk is too high, they can either 'make' or 'break' the claimant's legal representation.

The UK Seroxat litigation is fast approaching 10 years since it was first filed. Glaxo, represented by Addleshaw Goddard, have not, at any point, expressed an interest in resolving the litigation. They, it appears, wish for the cases, involving just over one hundred claims, to go to trial... at least they do at this point in the proceedings.

The litigation has been laboriously slow - claimants have been dropped by law firms, despite those law firms attesting that their cases against GSK were strong. Public funding has been given, then put on hold, then taken away.

In America, the Seroxat withdrawal problems lawsuit involved over 3,000 claims against GSK. The whole process of filing and agreeing to resolve took as little as two years. Each of the 3,000 were awarded compensation. Each of the 3,000 had to sign confidentiality agreements - ergo, they could not tell anyone how much they were awarded by GSK.

Meantime, UK consumers who suffered Seroxat withdrawal problems, some who still do, continue to wait for their cases to be heard in trial. The date of which has yet to be determined.

Almost 10 years.

It's a showing of the iron fist by GlaxoSmithKline and it sends out a strong message to consumers of pharmaceutical products. That message being, "We won't bend over for British consumers, even though we are a British company."

Glaxo are denying that they knew there was a withdrawal problem with Seroxat, this despite settling the 3,000 or so case in America. This, despite public documents that have shown that hey did indeed know about the withdrawal problem in adults but 'hushed up' these findings.

Project 1059 revealed a series of emails between  Daniel Burnham of SmithKline Beecham and a ghostwriting company. In those emails, below, the Seroxat withdrawal issue was raised. Burnham became concerned and decided to pull the plug on Project 1059. There was no way that they could have this Seroxat withdrawal issue made public.

You can view the series of emails here.

Meantime, Glaxo CEO, Andrew Witty, continues to cover his company in garlands, he continues to refuse to meet with anyone who has suffered as a result if ingesting Seroxat. Irish blogger, the Truthman, who, like me, has been writing about GSK for almost a decade, perfectly dissects a recent interview between journalist Evan Davis and Glaxo's Witty here.

It's well worth the read, an edited version of the interview between Evans and Witty is also shared on the Truthman's post.

Glaxo, in my opinion, are psychopathic, it's hard to pinpoint who is the person behind the dodgy marketing and hiding of negative results, so, as a whole, Glaxo, to me at least are not only psychopathic but delusional too.

As for Witty, once again my opinion of him, is that he lacks compassion and empathy for those harmed by his company. He continues to harp on about how Glaxo (these days) are more transparent than any other pharmaceutical company. He fails to mention that they were forced to be more transparent by the recent $3 billion they paid the American Department of Justice for, amongst other things, a lack of transparency in sharing negative trial results.

Who knows if the UK litigation will ever see the light of day. I would love nothing more than a judge who sees through Glaxo's arguments and allows documents produced at trial to be made public and not sealed away.

The criticism of GlaxoSmithKline is warranted. As long as they continue to treat their consumers like lab rats then they will always fall under the spotlight.

We, as humans, have a desire to see more when something teasing is revealed, be that a woman in a sexy low-cut dress or a pharmaceutical company not disposing of emails that highlight how they ignored links of severe Seroxat withdrawal.

Glaxo are not sexy, in fact, the more that they reveal, the more sickened I become.

I'll eventually walk away from this blog, a change of direction and finding peace is, I feel, what I've earned over these past ten years or so. Until I feel that time is right I'll continue to cross swords with GSK - I guess that the Truthman will too.

Perfer et obdura; dolor hic tibi proderit olim. (Google it)


Bob Fiddaman.

Two Facebook Statuses That Say It All

Seroxat (Paxil) withdrawal...

If you, like many thousands, find difficulty when trying to wean yourself off Seroxat (known as Paxil in the US and Aropax in Australia) then you'll know that there is no guidance.

The manufacturers, GlaxoSmithKline, refuse to help - Any correspondence sent to them during your horrific withdrawal will be met with the bog standard replies of "We are not allowed to discuss individual cases blah, blah..."

Your prescribing healthcare professional will, more than likely, refer to the product monograph which really tells them that there isn't a huge problem when patients taper from Seroxat - the product monograph, if you didn't know, is crafted by the drug company.

The medicines regulator, be they the British MHRA, the American FDA or the Australian TGA, will shrug their shoulders then scurry back to their various rat holes in the hope that you don't disturb them again.

Internet forums will offer various tidbits of information, you'll show your prescribing physician and he/she will probably tell you that these types of forums are run by conspiracy theorists.

~Bob Fiddaman


--

As I was getting nowhere debating back and forth with the MHRA and Pharmaceutical company Lundbeck I decided to write to the Minister for Public Health, Jeremy Hunt, about my daughters death which I believe was caused by the SSRI Citalopram. She was fatally malformed, incompatible with life. I had been given a "prescribed overdose" (according to lundbeck) by my GP unwittingly throughout the pregnancy and thoroughly reassured that it was not a teratogen. I was on a prescribed dose of 60mg, this dosage was the maximum back in 2004, but was lowered a few years ago to 40mg by the manufacturer and the MHRA as it was known to cause the heart condition "Long QT syndrome" and sudden death in adults. Today I was very surprised to have received a response -

Dear Miss Buchanan,

Thank you for your correspondence of 5 October to Jeremy Hunt about citalopram. I have been asked to reply.

I was very sorry to read about the death of your daughter and the circumstances surrounding her cremation.

However, the Department of Health is unable to comment on individual cases.

The Medicines and Healthcare products Regulatory Agency (MHRA) has provided the following information.

Citalopram is a member of the class of antidepressants known as selective serotonin reuptake inhibitors (SSRIs). SSRIs are used to treat depression in pregnant women in cases where there are no safer alternative effective treatments. The decision to prescribe SSRIs requires a careful evaluation of the need for treatment and any known risk of harm to the mother and/or foetus. Untreated depression during pregnancy is known to be harmful to the mother and foetus.

Some studies have suggested a small increased risk of birth defects with some SSRIs. Data has shown that paroxetine and fluoxetine are associated with an increase in risk of birth defects in the baby if the mother takes them in the first trimester. The background rate for birth defects is two to three per cent of all pregnancies. Current available data is insufficient to prove birth defects occur more commonly after taking citalopram than this background rate.

It is known that all the SSRIs can be associated with an increased risk of persistent pulmonary hypertension, a heart condition in the newborn, when taken later in pregnancy. Neonatal withdrawal and toxicity reactions have also been reported when SSRIs are taken in later pregnancy.

Several important changes to the citalopram prescribing information were introduced by the MHRA in 2011, including maximum dose restriction in adults after a detailed review of data showed citalopram was associated with a dose-dependent increased risk of abnormal heart rhythm.

The MHRA continues to monitor the safety of use of SSRIs in all patient populations very closely and all new data are rigorously assessed to evaluate the need for further regulatory action.

I am sorry I cannot be more helpful, but I hope this reply helps to clarify the situation.

Yours sincerely,

Malcolm Jones
Ministerial Correspondence and Public Enquiries
Department of Health

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I'm sorry to see that, once again, I have been given the usual spiel about the MHRA monitoring medications such as these, but what use is monitoring them if, when issues are flagged up, they chose to do absolutely nothing about it? I have never had once single invitation from the MHRA to converse with them or provide them with further information on my daughters death, this is despite me contacting them fairly regularly for over the past two years.

What else can I do? Is there anywhere else I can turn, anything I can try? I'm not giving up on this. I won't ever give up.


Cheryl Buchanan


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Says it all really...



Bob Fiddaman

Paxil [Seroxat] Withdrawal

Anger, aggression belligerent, irrational, self-harm, suicidal, weight gain, personality change, strange behaviour.

All of the above became apparent during Paxil increase and withdrawal.

Paxil is the US brand name for paroxetine.

It is known as Seroxat in the UK and Europe.

Seroxat is marketed and sold by GlaxoSmithKline.

GlaxoSmithKline deny allegations that Seroxat has caused a significant amount of litigants withdrawal problems.

Now...

...watch and learn...

Related


GlaxoSmithKline/MHRA - When Ignorance Turns To Bliss - Part I of IV

GlaxoSmithKline/MHRA - When Ignorance Turns To Bliss - Part II of IV - Witness For The Defence

GlaxoSmithKline/MHRA - When Ignorance Turns To Bliss - Part III of IV - Expert Statistician

GlaxoSmithKline/MHRA - When Ignorance Turns To Bliss - Part IV - The Colour of Money


MHRA To 'Re-educate' UK Doctor's on SSRi's Part I

MHRA To 'Re-educate' UK Doctor's on SSRi's Part II "Keeping A Stiff Upper Lip"
 
MHRA To 'Re-educate' UK Doctor's on SSRi's Part III - MHRA's Ghosts In The Machine

MHRA In Buck-Passing Specialist Cahoots

SEROXAT/PAXIL WITHDRAWAL GUIDANCE - FIDDAMAN 2011



Fid

ORDER THE PAPERBACK 'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman US and CANADA HERE OR UK HERE

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