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.

Glaxo's Beef With David Healy Part II

Following on from Glaxo's Beef With David Healy, which I wrote about back in October 2015.

Back story.

In summary, Wendy Dolin has filed a suit against Paxil (Seroxat) manufacturers, GSK, alleging that Paxil caused the suicide of her husband, Stewart. Since filing Wendy has been subject to GSK's defence lawyers subpoenaing her cellphone and text message records, her home phone and her late husband's company phone. King & Spalding, GSK's defence team, have also asked Wendy about her love life and shown the private medical notes of her later husband to her children.

Not content with targeting a grieving wife, GSK have also singled out David Healy, an expert called by Dolin in the case against GSK.

In short, they have claimed that Healy should not be allowed to give evidence in the trial, he's not credible, he has a bias, he's telling people to go out and kill.

It's all hot air, much of which has been cherry-picked from Healy's blog and, in some instances misquoted and misguided - for example GSK's highly paid law team, who must have combed through Healy's blog by borrowing their client's rat-infested flea comb have claimed Healy has said things when in actual fact he hasn't, it's been comments left by others on Healy's blog - so much for crossing the T's and dotting the i's, huh?

Anyway, you get the gist, right?

GSK target the person filing the suit against them then, after failing, they then target that person's expert witness. You just have to love how King & Spalding operate at times.

Well, they failed in getting Healy's testimony thrown out. In fact, they wanted all four of Dolin's witnesses to not have their testimony's aired.

 They were denied these motions by Judge James B. Zagel who, in summary, said...

“I am denying all four of GSK’s motions to exclude. The Daubert criteria are satisfied when a well-credentialed expert provides well-supported opinions that are relevant and reliable.”

One would have thought that was that - but remember, we are dealing here with a pharmaceutical company (and their attorneys) who will try everything in the book when the defence of Paxil becomes so weak.


GMC BACKGROUND

In 2013 Healy found himself under the spotlight after a patient in his care suicided. This event spurned a review by Betsi Cadwaladr University Health Board (BCUHB) who, for reasons not known, hired an external consulting Psychiatrist, Dr. Robert Higgo to take a role in the review process.

The review, according to Healy, was meant to examine the circumstances surrounding the incident. Higgo, in his review, accused Healy of misconduct.and submitted his findings to the BCUHB.

In response to Higgo's allegations the BCUHB...

(1) initiated an internal investigation to examine the allegations

and

(2) sent a referral to the GMC to explore whether there was any misconduct that would raise concern about Dr. Healy’s fitness to practice medicine.

To cut a long story short, Healy was exonerated by the GMC. They concluded...

"As Dr. Healy had stated from the very beginning, that Dr. Higgo’s report was unfounded and that Dr. Healy did not engage in any conduct putting his fitness to practice medicine into question."

So, Healy was cleared. Here's where it gets interesting.

While in America, Healy was tracked down by attorneys who served him with a subpoena, the gist of which was that he should produce all documents concerning the BCUHB and GMC investigations.

No guessing who those attorneys were.

Healy refused, citing that it would jeopardise his employment as a physician and documents that were deemed privileged and confidential by BCUHB.

GSK then filed a motion to the court, basically demanding that Healy produce the documents.

The court asked to see the document in chambers (ie; just them and not GSK) so they could make a decision as to whether these documents were relevant to the Dolin case, moreover, relevant to GSK's argument that Healy's testimony in the Dolin case should be heard.

Healy handed over the documents to the court in July last year.

It was during the courts review of these documents that GSK filed motions for Healy to be dismissed as an expert witness - as previously mentioned, the court denied them this.

But, on and on they go. GSK now wish to conduct a hearing with Healy before the Dolin trial date of January 2017. Dolin, via her attorney, Brent Wisner of Baum, Hedlund, Aristei & Goldman, sent another letter to GSK indicating that...

“...in light of the recent ruling by the General Medical Council (“GMC”) clearing Dr. Healy of wrongdoing, this proceeding is no longer necessary or relevant.” 

Furthermore, plaintiff added that if GSK wish to pursue this matter then  she (Dolin) would like to conduct targeted discovery related to GSK’s interactions, if any, with GMC and Betsi Cadwaladr University Health Board (“BCUHB”)

Has the penny dropped yet?

The GMC exonerated Healy but now, it seems, GSK want their own kangaroo court to attack him even further.

In a quite genius twist Dolin's legal team have now asked the court that if GSK are granted a special hearing with Healy before trial then they request that plaintiff should be permitted to conduct targeted discovery relating to any influence GSK may have had in BCUHB’s or the GMC’s investigation of Dr. Healy.

In short, Dolin is asking for...

All documents reflecting communications between GSK or its agents, including counsel representing GSK, and Robert Poole, Robert Higgo, Giles Harborne, Matt Makin, Alberto Salmoiraghi, Peter Higson, or anyone at Betsi Cadwaladr University Health Board that mention or discuss Dr. David Healy.

All documents reflecting any payments or monies by GSK or its agents, including counsel representing GSK, to the aforementioned.

They've requested the same documents between GSK and the GMC too.

I wouldn't put it past anyone connected with GSK to find ways to sling mud at one of their biggest critics - I've heard the 'bullet left on a car story' but thought it was just folklore - I'm seriously beginning to think there was merit in that claim from a plaintiff who went up against GSK many years ago... apparently they wouldn't accept GSK's offer, next thing they know, there's an empty bullet casing left on their car...but that's another story.

Who needs John Grisham, huh?

The whole sordid affair, or rather matter of affairs, has me wondering if GSK's UK legal team will go down the same road when defending Paxil in a UK lawsuit next year. Just over a hundred people have filed a group action claiming they suffered as a consequence of withdrawing from Paxil. In 2002 GSK settled over 3,000 similar cases in the United States but, for one reason or another, GSK won't settle with those who make the same claims against them in the UK.

Will they be mud slinging Healy et al again, or bloggers for that matter?

The motion to vacate the 'special hearing' was filed by R. Brent Wisner on August 1.


Author's note.

Researching pharmaceutical companies, in particular GlaxoSmithKline, over the past ten years or so has taught me a few things when it comes to litigation.

1. The pharmaceutical company will defend cases in antidepressant related suicide, homicide, birth defects and withdrawal - even though the drug in question has been proven to cause such adverse reactions - they will, under oath, admit their drug can cause all of the above but will refute that (in the case they are defending) it did not cause x,y, or z to kill themselves or cause induced homicide, birth defects or horrific withdrawal problems.

2. They will drag litigation out for as long as they can, throwing subpoenas left, right and centre - they will object to this and that and will file motions in the hope that plaintiffs attorney's will spend more - thus settle at a later date for a meagre offer - See the Paxil birth defect case - Joanne Thomas v GlaxoSmithKline here and here.

3. They like to show their teeth. It's a way to stop further litigation against them. The actions in the case of Dolin v GlaxoSmithKline is basically a stark warning being sent out to anyone who may have ideas of going up against GSK in the future. It doesn't matter if you lost your child to suicide or had to abort your child due to birth defects caused by Paxil - or if you lost your job and marriage due to horrific Paxil withdrawal - you are dealing with a company that shows no empathy - it's an entity that is psychopathic - it cares not a jot about personal feelings - Grinding its teeth and digging its heels in is just an advertisement by proxy. The message being, Oppose us and we will make your life a complete misery. They not only do this with people who bring claims against them, they do it with expert witnesses who go up against them. One only has to look at the way they have targeted David Healy - it's not just about targeting Healy, it's about sending a message out to other future expert witnesses.

That's my take on things anyway.

Anyone know how the ruckus between David and Goliath finally ended up?

Answers on a postcard to King & Spalding.



Bob Fiddaman


Related

Court document shows how a jury, in 2001, found GSK's Paxil responsible for inducing suicide and/or homicide.

Paxil Pregnancies in Philidelphia

Imagine the scenario, if you will.

You're in court because you lost your leg in a coach accident. The coach company are defending allegations that they are responsible. Evidence surfaces that the coach you were travelling on had faulty brakes, moreover, the driver of the coach didn't know about the faulty brakes but the coach company did.

Testimony is taken from the driver prior to the trial. He states that if he had known about the faulty brakes on the coach he would not have driven it.

On the day of the trial your legal team wish to present the testimony of the driver. The defence team object and the Judge sides with them.

Days later, as the trial nears completion, the Judge announces that you cannot proceed with your claim against the company because you have no proof that the driver would have taken the bus out that day if he had been warned that it had faulty brakes.

You, your legal team, and all those present in court are stunned into silence at the Judges' rationale because you do have the proof but he won't allow you to present it.

You following?

If the above scenario seems absurd then welcome to the world of Philadelphia.

Back in April  Judge Kenneth Powell halted not one but nine Paxil birth defect cases. The lead case in question involved Braden Rader, who was born with tetralogy of fallot (a combination of several congenital heart defects) that his mother claimed was caused by the use of Paxil during the early stages of her pregnancy in 2003. (Rader et al. v. SmithKlineBeecham Corp. et al.)

Powell ruled that the prescribing physician, Robert Kiehn, had not testified that he would have altered his decision to prescribe Paxil to Rader’s mother, plaintiff Elisabeth Balser, if he had of known about its link to birth defects.

However, Kiehn had already testified in a videotaped deposition that he would not have prescribed Paxil if he had known about the birth defect links but Judge Powell had previously prevented this testimony from being played to the jury.

Obviously, his decision to halt the trial is being appealed and, at present, this trial and 9 others is on "stay" - basically put on hold until a decision is made on the appeal.

GSK's attorneys, as one would expect, have requested to lift the stay, in other words, they have tried to get all of them thrown out by the Judge before a result of the appeal.

In this instance we have a different Judge making the decision. Philadelphia County Court of Common Pleas Judge Arnold New has denied Glaxo's bids to lift a stay on litigation.

The state of Philadelphia is no stranger to cases of Paxil birth defects.

Back in 2014 I wrote about one such case regarding Pennsylvanian mother, Joanne Thomas. (Links at foot of this post) Her case was tossed by the Judge because, according to Glaxo's lawyers, she was too late in filing. In any event, Glaxo argued, her fetus was non-viable (Non viable means not capable of living, growing, or developing and functioning successfully. It is antithesis of viable, which is defined as having attained such form and development of organs as to be normally capable of living outside the uterus.)

Thomas lost her case then, later, lost the appeal. However, all was not lost. Thomas approached me and after many hours, days weeks and months, I contacted her attorneys with evidence to present to the Judge who had denied her appeal.

You see Glaxo's attorneys should have provided Thomas' attorneys with discovery - that discovery would have shown that Glaxo had already admitted (via internal emails) that Thomas' use of Paxil during her pregnancy was probably the cause of her having to abort her fetus due to it developing a whole heap of birth defects.

Thomas eventually made an out of court settlement with GSK and was told by her own attorneys to have no more contact with me. Shucks, hand them a winnable case on a plate and that's the thanks I get!

It's since been suggested that I should have billed the attorneys for the months of hard slog I put in (for free) - Ah well, you live and learn.


In the case of Braden Rader, I guess we'll just have to wait and see how the appeal goes.

(Source) - GlaxoSmithKline Denied Bid To Unpause Philly Paxil Litigation



Bob Fiddaman.


Related

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

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

GSK ~ A Class Act

Courtesy of Google Images

I had one of those Nescafe down the nostrils moments earlier. Snot accompanied the Nescafe as it projected down my left nostril, much of it spraying the screen of my laptop.

GSK, it appears, have been implementing ethics into the way they give incentives to sales staff by rolling out new sales training, performance review and bonus structure.

In an interview with HR Magazine, GSK's Dannii Portsmouth, (Pictured top of post) said, “We don’t think we've done anything inappropriate in the past, but we think the expectations of society have changed.”

(Insert laughter here)

Portsmouth is GSK's Director, HR Business Lead, UK & Ireland Pharmaceuticals - to suggest that; a) the company who employ her have done nothing inappropriate in the past and b) it's down to the expectations of society, is classic GSK spin.

Here we have a company spokesperson trying to put right many wrongs but she fails at the first hurdle with a statement of denial. "We don’t think we've done anything inappropriate in the past."

Really?

So, why plead guilty then?

One word: Incredulous!

GLAXOSMITHKLINE SETTLEMENT FACT SHEET 

GSK has agreed to plead guilty and pay $3 billion as part of this criminal and civil resolution.

GSK has agreed to plead guilty to three misdemeanor violations of the Food, Drug and

Cosmetic Act:

Regarding Paxil, GSK will plead guilty to distribution of a misbranded drug due to false and misleading labeling, in violation of 21 U.S.C.

Regarding Wellbutrin, GSK will plead guilty to distribution of a misbranded drug due to inadequate directions for use, in violation of 21 U.S.C.

Regarding Avandia, GSK will plead guilty to failure to report data to the FDA, in violation of 21 U.S.C.

So, nothing "inappropriate " huh, Dannii?

Oh, and what about the statement of apology to the Chinese government and its people?

You remember that, right Dannii?

The fine of  $490m (£297m) after a court found your company guilty of bribery after having made an estimated $150m in illegal profits.

Still,  nothing "inappropriate. " 

What about the out-of-court settlements made to over 3,000 claimants who were addicted to your company's antidepressant, Seroxat?

Or the countless settlements made with mothers who, as a result of ingesting Seroxat during pregnancy, gave birth to children with birth defects or had to abort their foetuses because the chances of survival after birth were slim, to say the least. Case in point, Joanne Thomas from Pennsylvania. You, or rather your company, gave her the run-around, she lost her case against you, appealed, lost that too - then, miraculously your company settled with her after your law team messed up by not disclosing everything to her attorneys - naughty Glaxo - (see here and here)

Still, nothing "inappropriate. " - I mean, what's 800 or so kids being born with severe heart or cranial defects? Just part of the business, huh Dannii?

Don't even get me started on Study 329, Dannii!

I could go on and on to show you exactly where GSK have been inappropriate but what's the point?

Glaxo employees, Portsmouth included, have a knack of burying their heads in the sand when it comes to Glaxo's dark history - Maybe that's the only way they get to sleep at night, who knows?

First rule of ethics, admit to your inappropriateness then seek to make sure it doesn't happen again.

The expectations of society have always been the same, we expect you to be honest and truthful, we expect to live and not suffer at the hands of your drugs.

End of rant.

Dannii Portsmouth's musings can be read, in full, here.


Bob Fiddaman.


*Disclaimer*

This blog post was not sponsored or endorsed by Nescafe.

How to Polish a Turd, the GSK Way

A recent interview with Glaxo's Andrew Witty saw BBC journalist, Evan Davis, more or less told how to phrase questions. Davis had broached the subject of Glaxo's murky past - Witty, using the art of deflection, told Davis, "I think the bigger question is, where do you want to go forward?"

So, how do you polish a turd?

Well, you talk about what you have in the pipeline, (excuse the pun) thus eliminating tricky questions about the following...



6/4/2015 - India Meningitis Vaccine Market Collusion - GlaxoSmithKline, Sanofi-Aventis - $9,442,587

9/15/2014 - Clean Air Act Violation at Hamilton, MT Facility - GlaxoSmithKline - $172,900

8/11/2014 - Hazardous Waste Violations in King of Prussia - GlaxoSmithKline - $317,550

6/4/2014 - Multistate Illegal Marketing Settlement - GlaxoSmithKline - $105,000,000

5/13/2014 - China Bribery and Fraud - GlaxoSmithKline - $487,000,000

3/25/2014 - Mylan v. GlaxoSmithKline (Breach of Generic Paxil Agreements) - GlaxoSmithKline - $106,700,000

3/18/2014 - Contaminated Drug Ingredients at Ireland Plant - GlaxoSmithKline - FDA Warning Letter

12/17/2013 - Maryland Diabetes Drug Improper Marketing Lawsuit - GlaxoSmithKline - $15,000,000

7/24/2013 - Multistate Avandia Settlement (July 2013) - GlaxoSmithKline  - $184,000,000

6/14/2013 - Cappellino v. GlaxoSmithKline (Gender Discrimination) - GlaxoSmithKline - Complaint

4/19/2013 - OFT Paroxetine Antitrust Investigation - GlaxoSmithKline - U.K. Office of Fair Trading Press Release

2/5/2013 - Louisiana Off-Label Marketing Lawsuit - GlaxoSmithKline - $45,000,000

11/15/2012 - Multistate Avandia Settlement (November 2012) - GlaxoSmithKline - $90,000,000

11/15/2012 - Flonase Antitrust Litigation - GlaxoSmithKline - $150,000,000

7/9/2012 - Dolin v. GlaxoSmithKline (Paxil Wrongful Death) - GlaxoSmithKline - Complaint

4/17/2012 - Idaho Average Wholesale Price Lawsuit - GlaxoSmithKline - $2,600,000

2/7/2012 - Defrauding Louisiana’s Medicaid Program - GlaxoSmithKline - $10,000,000

1/11/2012 - Argentina Vaccine Trials Fine - GlaxoSmithKline - $93,000

11/3/2011 - Criminal and Civil Investigations Settlement - GlaxoSmithKline - $3,000,000,000

10/27/2011 - South Korea Antitrust Fine - GlaxoSmithKline - $2,651,737

10/7/2011 - Current Good Manufacturing Practice Violations at Worthing, UK Facility - GlaxoSmithKline - FDA Warning Letter

6/27/2011 - Nigeria Trademark Infringement - GlaxoSmithKline - $7,873,706

6/23/2011 - Puerto Rico Drug Manufacturing Facility Settlement - GlaxoSmithKline - $40,750,000

5/17/2011 - South Carolina Attorney General Avandia Lawsuit - GlaxoSmithKline - Complaint

2/15/2011 - Louisiana Attorney General Avandia Lawsuit - GlaxoSmithKline - Complaint

11/17/2010 - Humana v. GlaxoSmithKline (Reimbursement for Avandia-Related Injuries) - GlaxoSmithKline - Complaint

11/9/2010 - Utah Attorney General Avandia Lawsuit - GlaxoSmithKline - $8,500,000

10/26/2010 - Puerto Rico Drug Manufacturing Facility Settlement - GlaxoSmithKline - $750,000,000

10/6/2010 - Hawaii Average Wholesale Price Litigation - GlaxoSmithKline - $10,000,000

8/30/2010 - Kentucky Kytril and Zofran Average Wholesale Price Lawsuit - GlaxoSmithKline - $3,750,000

7/12/2010 - U.S. Senate Investigation of Avandia - GlaxoSmithKline - Senate Finance Committee Letter to FDA

6/23/2010 - Paxil Birth Defect Litigation - GlaxoSmithKline - Confidential settlement with 190 families 

4/19/2010 - FDA Review of Altabax Promotional Material - GlaxoSmithKline - FDA Warning Letter

10/13/2009 - Kilker v. SmithKline Beecham (Paxil Birth Defects) - GlaxoSmithKline - $2,500,000

10/1/2009 - Denture Cream Product Liability Litigation - GlaxoSmithKline - Complaint

12/23/2008 - Santa Clara County Drug Pricing Lawsuit - GlaxoSmithKline, Wyeth - Complaint

9/30/2008 - Paxil Class Action (National) - GlaxoSmithKline - $40,000,000

7/26/2008 - Medicines Australia Code of Conduct Violations - GlaxoSmithKline - $310,000

7/21/2008 - Relenza Litigation Settlement - GlaxoSmithKline - $19,500,000

5/19/2008 - Release of TCE in Scottsdale, AZ - GlaxoSmithKline - EPA Press Release

5/2/2008 - Wellbutrin Direct Purchaser Antitrust Litigation - GlaxoSmithKline - $49,500,000

2/27/2008 - Bartram v. GlaxoSmithKline (Paxil Birth Defects) - GlaxoSmithKline - Complaint

12/17/2007 - Avandia Marketing, Sales Practices and Products Liability Litigation - GlaxoSmithKline - $770,000,000

10/6/2006 - Paxil Class Action Litigation (Madison County, IL) GlaxoSmithKline - $63,833,148

9/11/2006 - Under-reporting Profits - GlaxoSmithKline - $3,400,000,000

7/10/2006 - Cunningham v. GSK (Paxil Wrongful Death) - GlaxoSmithKline - Complaint

3/28/2006 - Paxil Multistate Litigation - NY Attorney General Settlement - GlaxoSmithKline - $14,000,000

9/20/2005 - Zofran and Kytril False Claims Act Violations - GlaxoSmithKline - $150,000,000

4/1/2005 - Relafen Multistate Litigation - NY Attorney General Settlement - GlaxoSmithKline - $10,000,000

11/24/2004 - Relafen Consumer Litigation - GlaxoSmithKline - $75,000,000

8/26/2004 - Paxil New York Litigation - GlaxoSmithKline - $2,500,000

7/8/2004 - Augmentin Antitrust Litigation - GlaxoSmithKline - $92,000,000

2/6/2004 - Relafen Antitrust Litigation - GlaxoSmithKline - $175,000,000

4/16/2003 - Overcharging Medicaid - GlaxoSmithKline - $87,600,000

9/6/2002 - Average Wholesale Price (AWP) Drug Litigation - GlaxoSmithKline - $70,000,000

6/6/2001 - Tobin v. SmithKline Beecham (Paxil Wrongful Death) - GlaxoSmithKline - $6,400,000


**TOTAL - $10,057,614,485 (That's 10 billion, folks!)


**Federal Contractor Misconduct Database


There are many more missing from the Federal Contractor Misconduct Database, most notably the settlement (resolution) GSK made with over 3,000 Paxil plaintiffs who alleged the drug had caused them addiction problems, Also missing is the individual payment made to Pennsylvania mother Joanne Thomas who settled with GSK after losing her original case against them, see here and here.
The UK Seroxat Group Action is also missing from the list. The claim alleges that UK consumers become dependent upon the antidepressant, Seroxat. (Paxil)

Then, of course, we have the on-gong investigations of bribery and corruption in the following countries, United Kingdom, Iraq, Poland, Bahrain, Jordan, Kuwait, Lebanon, Syria, Oman, Qatar, and United Arab Emirates.

The mission of GSK, according to their website, is to improve the quality of human life by enabling people to do more, feel better and live longer.

(Insert laughter here)



Bob Fiddaman

GSK Use Delay Tactics on Grieving Widow

Doncha just love this company?

Fined $3 billion for committing fraud in the USA, basically promoting drugs to physicians for uses in patients that should never have been prescribed those drugs in the first place.

Fined $490 million in China for bribing doctors to prescribe drugs to patients that should never have been prescribed those drugs in the first place.

Had lawyers representing them (when there really was no need to) at the inquest of 18 year-old Sara Carlin, who took her own life whilst on Paxil.

Ordered to pay compensation to the family of Lyam Kilker after a jury found that Paxil was the cause of his birth defects.

Ordered to pay compensation to the family of Donald Schell, a 60 year old man, living in Gillette, Wyoming, after a jury had found that Paxil had induced Schell's hypomania to such an extent that he killed his wife Rita, his daughter Deb and baby Alyssa and then turned the gun on himself.

Initially refused to pay Joanne Thomas, a mother from Pennsylvania, any form of compensation after she accused GSK of manufacturing a pill (Paxil) that caused birth defects in her fetus (Ryan) - they later went on to settle (Undisclosed fee) after Joanne's attorneys 'renegotiated' after two stories that broke exclusively on this blog (here and here)

Agree to pay over 800 birth defect cases where Paxil was blamed for causing a multitude of birth defects in babies and fetuses.

Agree to settle with over 3,000 claimants in the US who filed a class action lawsuit claiming that they became addicted to Paxil (source) yet refuse to settle a similar 'class action' case in the UK.

One would think that all of the above would be a major embarrassment for the British pharmaceutical giant and their American attorneys, King & Spalding. Think again.

Stewart Dolin killed himself in 2010 by jumping in front of a train in Chicago. His wife, Wendy, filed suit alleging that Paxil had caused her husband to develop akathisia, a condition that causes psychological agitation.

GSK argued that Dolin was taking the generic version of Paxil marketed and manufactured by Mylan, ergo they were not responsible for the drug inducing suicide. However, a  U.S. District Judge told Mylan that they would not have to face any trial but said Glaxo was responsible for the generic drug's design and warning label and would have to face negligence claims.

Bitter, Glaxo then went on to subpoena Wendy Dolin's cellphone and text message records, her home phone and her late husband's company phone. So far, GSK have sent more than 30 subpoenas and over 70 records requests, and shown the Dolin children their father's confidential therapy notes despite Wendy Dolin's objections. According to Wendy Dolin's motion GSK have also questioned her about romantic life since her husband's death. Quite why they have questioned her about her life after her husband's death is beyond me. It does, however, show how low GSK, and their multi-million dollar law firm that represent them, will stoop to defend yet another Paxil suicide.

If all this wasn't enough, GSK have now, it appears, twisted the knife further into the stomach of Wendy Dolin by attempting to push the trial’s start date into 2016.

Law 360 (Subscription) are reporting that GSK's attorneys, King & Spalding, have told an Illinois federal judge that they don't have time to prepare, this, despite the case being filed over four years ago. King & Spalding are claiming that they are working on two other cases and don't have time to prepare themselves for the Dolin case.

I can't quite get to grips with GSK's apparent disdain for Wendy Dolin nor the lack of respect they are clearly not showing regarding the memory of Stewart Dolin.

I've gone on record many times stating that I do not like GSK or their attorneys, King & Spalding. I do not like the way they operate nor do I like what they each try to suppress regarding items of discovery (You really do need to read the Joanne Thomas articles to see exactly what they try to suppress)

As for GSK trying to blame Mylan, well, that doesn't really surprise me. Mylan sold Paxil under a generic name and Glaxo conveniently forgot to tell them about warning potential patients that Paxil may cause suicide. It's akin to a car salesperson selling you a car and failing to mention that the brakes don't work!

A pretty decent analogy given that earlier this year it was revealed that General Motors Co.'s emails with King & Spalding LLP and other outside counsel show the automaker engaged in a "massive cover-up" to hide its deadly ignition switch defect. (Source)

Wendy Dolin is represented by Michael L. Baum, Bijan Esfandiari, Frances M. Phares and R. Brent Wisner of Baum Hedlund Aristei & Goldman PC and Joshua Weisberg and Lindsey Epstein of Rapoport Law Offices PC.

GSK is represented by Alan S. Gilbert and Melissa A. Economy of Dentons and Andrew T. Bayman, Todd P. Davis and Christopher R. Benson of King & Spalding LLP.

Bob Fiddaman.

Apathetic Attitudes and Antidepressants

 The Creation

By determining where Abraham fits into history chronologically and adding up the ages provided in Genesis 5 and 11, it becomes apparent that the Bible teaches the earth to be about 6000 years old, give or take a few hundred years. [Source]

This has NEVER been proven.


Cave Drawings

The artworks are in a rural area on the Indonesian Island of Sulawesi.

Until now, paintings this old had been confirmed in caves only in Western Europe.

Researchers tell the journal Nature that the Indonesian discovery transforms ideas about how humans first developed the ability to produce art.

Early artists made them by carefully blowing paint around hands that were pressed tightly against the cave walls and ceilings. The oldest is at least 40,000 years old. [Source]

Below we can see evidence that substantiates these claims [Fig 1]

Fig 1

People, despite this obvious flaw in the Bible and its teachings, still purchase copies of the Bible and live by its teachings. The Bible has reached millions of people the world over. In fact, we now know that the earth is millions of years old, at least 4.5 billion years.

The Chemical Imbalance and Depression

During the 1990's Americans were submitted to heavy marketing by the pharmaceutical industry by the means of  television commercials for antidepressants that claimed that depression was caused by a “chemical imbalance” of low levels of serotonin and which could be treated with “chemically balancing” antidepressants such as Prozac, Zoloft, Paxil, and other selective serotonin reuptake inhibitors (SSRIs). [To source this one only has to read a patient information leaflet that accompanies the various SSRI's on the market today]

The Myth

"No biological etiology has been proven for any psychiatric disorder in spite of decades of research. Don't accept the myth that we can make an 'accurate diagnosis.' Neither should you believe that your problems are due solely to a 'chemical imbalance.'" - Edward Drummond, M.D. Associate Medical Director, Seacoast Mental Health Center, Portsmouth, NH

"After a half-century of research, the chemical-imbalance hypothesis as promulgated by the drug companies that manufacture SSRIs and other antidepressants is not only with clear and consistent support, but has been disproved by experimental evidence."  ― Irving Kirsch, The Emperor's New Drugs: Exploding the Antidepressant Myth

"There is no chemical imbalance to begin with, but when treating mental illness with drugs, we create a chemical imbalance, an artificial condition that the brain tries to counteract." - Dr. David Healy, Psychiatrist, psychopharmacologist, scientist, and author

"The actual truth about a chemical imbalance is that it’s an actual lie. Nobody has yet measured, demonstrated, or created a test to show that somebody has a chemical imbalance in their brain. Period." - Thomas Stephen Szasz - Psychiatrist and academic, a Fellow of the American Psychiatric Association, a member of the American Psychoanalytic Association, a professor of psychiatry at the State University of New York and starting in 1990, he was professor emeritus of psychiatry at the State University of New York Upstate Medical University in Syracuse.

People, despite these findings, still continue to take antidepressants because they are told by doctors and psychiatrists, and the pharmaceutical companies that their depression is caused by a chemical imbalance. Moreover, healthcare professionals, including family doctors and  adult and pediatric psychiatrists continue to prescribe antidepressants to millions of people the world over.


The Apathy

When the teachings of the Bible were proven to have flaws we saw little interest. People world-wide shrugged their shoulders and said "So what, we will never fully understand God's way, after all, he is mysterious. I still believe in his work."

Can you imagine the headlines 2,000 years ago?

How would the people of those times reacted?

Well, I guess with apathy, the same apathy that is shown by millions of people when they read the same thing about the mythical marketing of antidepressants and depression. "So what, we will never fully understand how the brain works, after all, it's complex. I still believe antidepressants work."

I've often wondered why churches, whatever their domination, refuse to speak out about the harm antidepressants cause - One church does, for that they are ridiculed and labelled as 'nutters' or 'brain washers" - This being the Church of Scientology.

For the record, I'm neither a Scientologist or attached to any other religious denomination. Point I'm making is one party speaks out and the other parties ridicule.

Coroner's Inquests

AntiDepAware is a website created by a friend of mine. 'Brian' collates newspaper archives of coroner inquests, he has amassed quite a database.

What Brian tries to do is create awareness where the coroner fails.

Here's just one recent example of Brian's...

15-year-old schoolboy George Werb died near his home in Colyton, South Devon, on Friday June 28 2013, when he was struck by a train.

George’s father Justin told the inquest held this week that George first started to become withdrawn about 18 months before his death. He began to have delusions that he was suffering from ailments and diseases, but had to wait 10 months until his first appointment with a Child and Adolescent Mental Health Services (CAMHS) team member. He was diagnosed as suffering from psychosis involving persistent delusion disorder with depression.

George was initially prescribed the anti-psychotic drug Olanzapine, but Justin explained that they noticed a “massive change” in their son from the point he started taking the medication. George became extremely distressed, and the medication was discontinued.

George’s parents were subsequently advised that he needed hospitalisation to ensure his safety and for ongoing assessment and treatment. The closest hospital with availability was 220 km away at Huntercombe Hospital in Berkshire, where George was prescribed the antidepressant Fluoxetine (Prozac), after which he became suicidal and withdrew from the drug.

George’s parents were dissatisfied with the hospital and with George’s treatment there, and removed him after three weeks.

After returning home for a short period, George was sectioned and, in the month before his death, was admitted to the Priory, Southampton, 140 km from home.

Here he was treated by psychiatrist Dr Carlos Hoyos. He was once more prescribed Olanzapine and, at first, placed on one-to-one observations. Over the course of the following weeks his observations were reduced and his medication regime increased.

George’s mother Joanne told the inquest that, days before he died, she read a note by George expressing his worry about the effect that his medications were having on him. She said that she told Dr Hoyos about the note and of George’s desperation to come off Olanzapine.

She said: “We did tell him that George was suicidal. But he did not want to discuss it. He was just adamant George stay on the dosage he was on and start with the Fluoxetine. We felt he had not listened to what we had tried to say to him.”

George, at the tender age of just 15, walked in front of a train after being released from the Priory.

Antidepressants and Suicide... and Apathy

The issue of suicidality on SSRIs became one of public concern with reports in 1990 that Prozac could lead to suicidality in patients.

Fourteen years later, warning labels were put on antidepressants.

We still have those same shoulders shrugging today then those of fourteen years ago. We still have doctors and psychiatrists prescribing these medications, ignoring the findings.

Ironically, Psychiatry does not see religion as a mental disorder. If a Christian, or any other religious follower, told a psychiatrist that he believed the earth was just over 6,000 years old then his treating psychiatrist could not diagnose him/her with any delusional mental disorder.. yet a 15 year-old child, who had a slight case of hypochondria, is prescribed mind altering drugs that are known to induce suicide.

And we, the general public still shrug our shoulders.


Something is radically wrong with the human belief system.

Bob Fiddaman.

Paxil: The Statute of Limitations Defence

The Article

Paxil Birth Defect Action Time-Barred, Fla. Federal Judge Rules

MIAMI — A Paxil birth defect action is time-barred under Florida law because the plaintiffs knew of a possible connection between their injuries and the drug more than four years ago, a federal magistrate judge has ruled.

On Aug. 12, Magistrate Judge Jonathan Goodman of the U.S. District Court for the Southern District of Miami found the mother had notice of the possible invasion of her legal rights by Dec. 20, 1997, when her doctor noted in her medical records that her son’s condition was “apparently due” to Paxil.

The Background 

On January 27, 2012, Iolany Ferez, filed, on behalf of her minor son, Andrew Plascencia,(AP) a product liability action against GSK in Pennsylvania state court. Ferez alleged that Paxil caused A.P. to be born with Tricuspid Atresia, Right Ventricular Hypertrophy, and a heart murmur.

Ferez gave birth to A.P. in 1996. Doctors noted at birth that A.P. had a heart murmur, and diagnosed him with a heart defect the next day.  A.P.’s heart defect was classified as a tricuspid atresia type II‐B, a condition that has required two corrective procedures and regular cardiology visits throughout his life.

According to court documents, Ferez suspected Paxil caused A.P.’s heart defect almost immediately because she had taken it throughout the first six weeks of her pregnancy with A.P.She had not taken anything during her first two pregnancies and both children were born without defects.

Ferez asked A.P.’s cardiologist and her gynecologist whether Paxil may have caused A.P.’s heart condition. Both responded that they did not know.

On December 20, 1997, Dr. Marcio Ferez, Ferez’s father, employer, and primary care physician, noted in Ferez’s medical records that A.P.’s heart defect was “apparently due to” Paxil. In September 2005, GSK mailed a letter to Dr. Ferez and other healthcare professionals advising them of a recent study that showed Paxil was associated with an increased risk of congenital malformations, most commonly cardiovascular. A second letter was sent in December 2005, advising of an additional study showing an increased risk for cardiovascular malformations in infants born to women who had first trimester Paxil exposure.

The GSK Defence

GSK argued that the statute of limitations bars the claim of Ferez because she had actual and constructive knowledge that A.P.’s heart defect may have been caused by Paxil.

Conclusion

Although the Court was sympathetic to A.P.’s condition and injuries and recognizes that Paxil may well be responsible for his birth defect, “liability cannot rest on sympathy alone.”

GSK’s summary judgment motion was granted. (granting summary judgment to defendant in products liability case based on statute of limitations).

Commentary

Iolany Ferez took Paxil during her pregnancy. Her  son was born some time later and it was found that he had a number of birth defects. Ferez put two and two together and came to the conclusion that Paxil may have caused these defects because she had given birth on two previous occasions to healthy babies where, during these pregnancies, she was not taking Paxil.

GSK have claimed that because Ferez made an assumption that it could have been their product that caused her son's defects and didn't file a lawsuit against them straight away, she is out of time to make any such claim for compensation.

Can you imagine if victims of Jimmy Saville, or any other pedophile for that matter, were told that they, or the prosecuting team, couldn't bring any charges against him because they never came forward at the time of the alleged assault?

The Judge ruled in favour of Glaxo, "Although the Court is sympathetic to A.P.’s condition and injuries and recognizes that Paxil may well be responsible for his birth defect, liability cannot rest on sympathy alone."

So, an acknowledgement by the man with the gavel that Paxil may well be responsible for this particular child being born with a birth defect...but, um, tough shit, his mom  should have joined the dots and filed earlier.

What kind of system is this?

Sadly, Judges are bound by statute instead of common sense. Knowing the statute of limitations inside out is a must for any attorney representing the pharmaceutical industry. They cannot defend the drug because physical evidence shows the harm the drug causes - instead they rely on a statute that was, in my opinion, designed to help the mighty to continue being mighty and for the lowly to know their place.

In the meantime, the son of Ferez, who has Tricuspid Atresia, Right Ventricular Hypertrophy, and a heart murmur, has to go through a life of uncertainty. His mom has to pick up all the medical bills which can run into many thousands of dollars.

GSK have once again shown that their corporate motto that GSK is a  "global healthcare company that is committed to helping people to do more, feel better and live longer", is misleading and should be altered accordingly.

How have they helped the son of Iolany Ferez to do more?

How have they helped the son of Iolany Ferez to feel better?

How have they helped the son of Iolany Ferez to live longer?

This isn't the first time GSK have used a statute of limitations defence. They did so in the case of Joanne Thomas.

Thomas had to abort her fetus due to a number of defects caused by Paxil.

GSK argued she was out of time filing a lawsuit, the Judge agreed.

Research, carried out by myself and Thomas, showed that she wasn't out of time and that GSK knew that she wasn't. Attorney's involved in the case drew up a settlement between Thomas and GSK. There was no media coverage, apart from my own, about Glaxo knowing that Thomas had contacted them via email many years before she filed suit.

It's unknown if Thomas agreed to settle. Good luck to her if she did.

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

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

Bob Fiddaman.