Tagged: Bob Fiddaman

Mad In America: Wendy Dolin Takes on GlaxoSmithKline And Wins — For Now at Lea


Wendy Dolin Takes on GlaxoSmithKline And Wins — For Now at Least

Jim Gottstein, JD

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In July of 2010, Stewart Dolin, a partner at the mega law firm Reed Smith, jumped in front of a subway train in Chicago, killing himself. He was apparently suffering from akathisia caused by the so-called antidepressant drug paroxetine. The brand name for paroxetine is Paxil, but Stewart was given a generic version manufactured by Mylan.

Stewart’s widow, Wendy, sued GlaxoSmithKline (GSK), the manufacturer of Paxil, and Mylan, on the grounds that the paroxetine caused Stewart to commit suicide. The case came to trial on March 14th and ended on April 20th with a $3 million verdict for Wendy and their children. The trial itself was gripping, with excellent coverage by Bob Fiddamen:

Since Bob did such a great job, I am not going describe the trial except to say that it exposed GSK lies and the morally bankrupt conduct of GSK, its attorneys and expert witnesses. GSK knew Paxil caused adults to commit suicide and hid that from the Food and Drug Administration (FDA) and doctors. The trial transcripts can be found here and exhibits here.

This is one key to the case, because there is a legal principle shielding drug companies called the “Learned Intermediary Doctrine” which establishes that the doctor, with access to full information, recommended the prescription-only drug after carefully weighing the risks and benefits. The primary official way that doctors are told about the risks of a drug is through the FDA-approved “label.” The drug manufacturer can also issue what is called “Dear Doctor” letters alerting them to risks.

But if the drug manufacturer withholds information, then one can get over the Learned Intermediary hurdle. That is the crux of this case. The argument is that because the manufacturer did not tell the doctor about the substantial risk of suicide, the Learned Intermediary Doctrine does not apply. Ms. Dolin’s top-notch legal team from Baum Hedlund (well known for taking on drug companies, especially over antidepressants) and David Rappaport established that GSK did not inform the FDA or doctors that Paxil caused people to commit suicide, thus getting over the Learned Intermediary hurdle. In fact, GSK still denied it. Cases against drug companies for withholding important information are not unusual.

However, Wendy Dolin faced another really big problem, which was that Stewart took the generic version of Paxil, manufactured by Mylan. Wendy sued Mylan, but Mylan was prohibited from providing any information other than the approved FDA label. How can Mylan be liable for not telling doctors something that it is prohibited by law from telling them? For that reason, Mylan was held to not be liable and dismissed from the case. Wendy also sued GSK, but GSK argued, “Hey, we didn’t manufacture the drug Mr. Dolin took so we can’t be liable.”  This is a classic Catch-22. The generic drug manufacturer isn’t liable because it was prohibited from giving any additional information and the original manufacturer isn’t liable because it didn’t sell the drug.  And, indeed, the judge ruled that GSK could not be held for product liability since it wasn’t its pill that caused Stewart’s suicide.

This is where excellent lawyering came in. R Brent Wisner of Baum Hedlund and local counsel David Rappoport came up with what I think is a brilliant argument based on what is called common-law negligence. The elements needed to establish negligence in Illinois are:

  1. Duty of care owed by the defendant to the plaintiff;
  2. Breach of that duty; and
  3. The breach of duty proximately caused an injury.

See, Memorandum Opinion and Order (Order), page 8.

The judge held that GSK owed a duty to warn doctors (but not consumers) of the risks of which it knew, or should have known, satisfying the first requirement. This duty is not tied to the branded Paxil, manufactured by GSK, but is applicable to the generic versions as well. This allowed the case to go to the jury where the dishonesty of GSK was put on full view.

The jury was charged with determining whether GSK was negligent in failing to warn the doctors and then, if so, did that negligence cause Stewart to commit suicide. The judge instructed the jury as to what negligence and proximate cause mean, as follows:

“Negligence” as used in these instructions means the failure to do something which a reasonably careful person or corporation would do, or the doing of something which a reasonable careful person or corporation would not do under circumstances similar to those shown by the evidence. The law does not say how a reasonably careful person or corporation would act under those circumstances. That is for you to decide.

As used in these instructions, “proximate cause” means that cause in the natural or ordinary course of events produced the death of Stewart Dolin. It need not be the only cause, nor the nearest or last cause. It is sufficient if it combines with another cause resulting in Stewart Dolin’s death.

The entirety of the judge’s instructions to the jury can be found here.

Then, the jury indeed found GSK negligent in not informing doctors of the suicide risk and this negligence caused Stewart’s death. In order to get there, the jury had to believe Stewart’s doctor that he would not have prescribed the paroxetine if he had known about the risk, or would have monitored him.

Frankly, in the overall scheme of things, the $3 million verdict is not that large. Stewart was a successful partner in a big law firm, presumably making a lot of money. But Wendy Dolin’s lawsuit was never about the money. Bob Fiddaman published an interview with Wendy after the verdict that is quite worthwhile reading. I direct your attention to it especially for her description of the awful tactics of intimidation perpetrated by GSK’s lawyers. The other thing about Wendy’s interview that I would draw attention to is her description of the importance of the ruling on generics:

I knew from the moment this lawsuit was filed that GSK was always concerned that this was a generic drug. . . . It has been suggested that GSK wants to take this case to the Supreme Court because they are so afraid of what this guilty verdict means. As it stands, the legal ramifications for this verdict are so damaging for pharmaceutical companies that reaching the Supreme Court is very possible.

For sure, holding drug companies liable for failure to warn about risks with their drugs even after they have gone generic is a good thing. Actually, I think drug companies have an incentive to do this to depress generic sales in favor of new drugs that are still on patent and therefore subject to monopoly pricing. In fact, it has been a longstanding pattern that the real risks of drugs do not get revealed until they come off patent. This case, if sustained on appeal, gives even more incentive for the drug companies to diss their drugs after they come off patent.

We will have to see where this goes, but for sure it is a big victory for exposing the truth. Baum Hedlund and David Rappaport deserve kudos for taking this case and pursuing it so effectively.

Wendy Dolin: “…GSK would stop at nothing to intimidate me…”


Reading through Bob Fiddaman’s latest post (an interview with Wendy Dolin)- I can’t help but be struck by Wendy’s admirable bravery and courage in the face of a continual onslaught of  attempted character assassinations and intimidation towards her by GlaxoSmithKline.

To say that GSK (and the money hungry, blood thirsty lawyers, academics and doctors on their payroll) are abhorrent, reprehensible and sociopathic, would be putting it very mildly.

In my opinion, GSK behave in an utterly evil manner.

They hid the side effects of Paxil (Seroxat) through manipulation of their clinical trials and data. They failed to warn properly of the dangers of Paxil induced Akathisia and suicide. They were found responsible (and liable) for Stewart Dolin’s death in a US court of law. Furthermore, despite GSK’s lawyers relentless attempts to undermine Wendy (plus her family and friends), and the attacks on Stewart’s memory,  she maintained her dignity and resolve.

Her moral and ethical strength is remarkable.

GSK could learn a lot about humanity from Wendy Dolin.

Read Bob’s latest post (below) for a poignant and moving interview with Wendy.


http://fiddaman.blogspot.ie/2017/04/exclusive-interview-with-wendy-dolin.html

Tuesday, April 25, 2017

Exclusive: Interview With Wendy Dolin

Wendy Dolin

Wendy Dolin’s name has been cemented in history, as has that of her late husband, Stewart Dolin.

Her victory against pharmaceutical giant, GlaxoSmithKline, was never simply about Paxil causing the death of an adult. Many people in my circles already knew Paxil can and does cause akathisia and death among people of all ages. But GlaxoSmithKline and its paid experts have played down this truth for many years. Other pharmaceutical companies that manufacture SSRIs, (Pfizer-Zoloft, Eli Lilly-Prozac, etc.) have also actively concealed that akathisia is a serious adverse side effect of their products.

Wendy’s husband needlessly died as a result of GlaxoSmithKline failing to warn about akathisia. Furthermore, GSK failed to warn that akathisia can lead to suicide.

I started writing about Wendy’s case two years ago. I never knew back then the impact it would have on me as a writer, a consumer, and a human. It was inevitable that our paths would cross. Most of the stories on my blog feature real people harmed by drugs the pharmaceutical companies call “antidepressants.” These people are not fictional characters; their loved ones are not simply statistics. All are real people who, as a result of corporate greed and deceit,  lost a family member. I have personally met the majority of the families featured on my blogs, families who, through no fault of their own, have been left devastated by unimaginable, avoidable deaths. These courageous family members are left to pick up the pieces of a life obliterated by the pharmaceutical industry and its incestuous relationships with medicine regulators, such as the FDA and MHRA.

My own personal belief is that pharmaceutical CEO’s and executives should be imprisoned for withholding important safety information from consumers, particularly when withholding such critical information leads to suffering and/or death. This was surely the case in Dolin Vs GlaxoSmithKline. I also believe experts called to defend products in pharmaceutical litigation should be imprisoned if the evidence they produce at trial is shown to be false and if it is deemed perjury. One only has to look through the court transcripts in this case to see several statements by experts that were simply untrue.

Wendy, her family and close circle of friends, have remained dignified throughout the trial and pre-trial. On the other hand, the tactics of GlaxoSmithKline’s hired attorneys, King & Spalding, has been nothing short of repugnant. If their pre-trial tactics were legal, then the legal system needs a complete overhaul. Wendy’s interview today shares some of the shenanigans GSK pulled years ago before the trial began.

I have a particular disdain for King & Spalding, probably more so than GlaxoSmithKline. That disdain has been strengthened after interviewing Wendy and, of course, after being present during the first two weeks of this trial.

I think it’s safe to assume King & Spalding don’t like me either. I can live with that safe in the knowledge that I am, in essence, trying to do part of a job coroners should be doing. I try to give the dead voice. King & Spalding, it appears, not only try to stifle the voices of the living, but they also try to suppress and manipulate the voices of the dead.

I’m really proud of Wendy and her children, just as I am of others who take on the mighty pharmaceutical industry, be it through lawsuits, blogging or other advocacy work. It’s a dark, seedy world. I should know, I’ve been writing and researching about Big Pharma for more than ten years.

~ Bob Fiddaman

Here’s my interview with Wendy Dolin.

Congratulations on last week’s successful trial against GSK. You worked tenaciously since filing the case in 2014. I imagine today’s feelings of victory are bittersweet for you and your family.

Many people are unaware how traumatic the pre-trial process can be when challenging pharmaceutical companies and their attorneys. Can you share your experiences?

I knew when I filed this lawsuit, it was going to be a very difficult process. But I was unprepared for the sheer number of depositions and subpoenas GSK demanded. I was told this was a record number of requests. I understood the need for certain information, but it became very clear early on that GSK’s goal was to send a powerful message to me: That is, when you have the audacity to challenge GSK, all attempts will be made to harass everyone you care dearly about. GSK also repeatedly tried to humiliate me. For example, depositions that should have been a few hours became eight hours in an attempt to wear people down. GSK asked the same question over and over and over again hoping to manipulate, confuse and take people’s comments out of context.

Some of the irrelevant but personal questions GSK asked me included, “How many times do you go to temple? Are you dating anyone? Who are my partners at work?” They even requested Stewart’s high school transcripts. All were totally irrelevant and useless questions posed by attorneys from King and Spalding and Dentons. They were calling my friends, not identifying themselves and trying to get people to somehow say terrible things about my relationship with Stewart. There was nothing to say, of course, and GSK’s attorneys just embarrassed themselves. It became a joke amongst my friends as to who would be called next and who did GSK think they were dealing with that they thought their sweet talking female attorney was somehow going to get information?

All of these questions were offensive, but what is truly the most offensive and egregious act was showing my children Stewart’s therapy notes during depositions. As a therapist, as a mother and a compassionate human being, I am aware there was no purpose to have done such. I have talked to therapists, physicians and pharmaceutical lawyers and all agree there was nothing gained by this other than to show me that GSK would stop at nothing to intimidate me.

So, let me get this straight, attorneys for GSK telephoned your friends to try and dig up dirt on you? What sort of questions were they asking your circle of friends?

The good news regarding the phone calls is that most of my friends very shortly into the conversations realized something wasn’t quite right, and therefore they shortly ended the conversations. They asked “Do you know Wendy and Stewart Dolin?” or “What can you tell us about Wendy and Stewart Dolin’s relationship?” Most people said, “Whose side are you on?” To which, GSK attorneys replied, “You could be getting a subpoena, and that is not a very pleasant experience, so maybe you would like to tell us now what you know before the subpoenas arrived.” Several of the people GSK attorneys contacted were never, ever going to receive subpoenas but as part of my deposition, GSK wanted to know who were our closest friends and who were we with the weekend before Stewart died. What also was interesting is that GSK attorneys called my friends on their cellphones rather than their landlines. I never gave out any numbers. I don’t know for sure, but I think perhaps GSK’s attorneys naively thought they would somehow catch my friends off guard and get more info.

Interesting.

Thank you. The word akathisa is relatively unknown to many. Can you tell me when you first heard the word and how it related to Stewart’s death?

After Stewart, died nothing made sense. On Friday, August 13th a friend called me and said, “akathisia killed Stewart.” And of course, I replied, “What?” She suspected early on that she thought Stewart’s death was related to Paxil since that was the only thing that was different in his life that week. When I first heard the word, akathisia, I was walking my dog at the time. When I got home and wrote the word down, I decided to google “akathisia, Paxil, and suicide.” All of a sudden this wealth of information appeared.  One of the first articles that appeared was one by Dr. Peter Breggin titled “How GlaxoSmithKline Suppressed Data on Paxil-Induced Akathisia: Implications for Suicidality and Violence.” Then another article showed a connection between SSRIs and suicide and violence and included a definition of akathisia. It listed characteristics of akathisia. For the first time, what didn’t make sense now became perfectly clear. Stewart’s physical inner and outer restlessness, agitation and anxiety that I observed his last week of life now made sense. It was in this article that I first had the revelation that the drug I thought Stewart was ingesting to deal with his work related stress and anxiety instead created suicidal thoughts and actions, both of which he did not have previously.

The article went on to state that Akathisia is so terrible, “Death Can Be A Welcome Result.” This is an actual quote by Dr. Roger Lane, the chief medical officer for Pfizer. Pfizer makes Zoloft, which like Paxil, is also a SSRI. It was at that moment I knew I needed to do something to help protect others and improve public health. How can this devastating drug side effect not be unknown to most health care professionals or patients?

After learning about akathisia, did you research attorneys who might help you seek justice?

I was told that Baum Hedlund was the best law firm in the country regarding pharmaceutical litigation. I was told very early on by Baum Hedlund that the generic issue would be a large hurdle.

Moving on to MISSD. Can you tell me what MISSD is all about and why it was important to create this organisation?

When Stewart died, I wanted to start an organization to raise awareness regarding akathisia. It is incredible how the organization name came to me. So many people were saying to me how awful it is when someone dies so young and how much they will miss their loved one. I kept hearing the name “miss.” That’s how the name MISSD came to me. It stands for The Medication Induced Suicide Prevention and Education Foundation in Memory of Stewart Dolin.

After choosing the name, I gathered together close friends and family and was privileged to have the incredible Kim Witzcak as a board advisor. I have the best and most dedicated board. Since akathisia is what killed Stewart and very few people had ever heard of it, including health care providers, we decided our mission would be to educate the public regarding akathisia. The mission of MISSD is simple: To educate the public that when starting, stopping or changing a dosage of a medication like SSRI’s, the drug side effect akathisia can occur. MISSD highlights the symptoms of akathisia and what to do if you are experiencing akathisia. We are a non-profit organization and take no money from pharmaceutical companies. This is important to note because many nonprofits do take money from the pharmaceutical companies and I believe this can create an unethical relationship.

MISSD presents at local, national and international conferences. We have created a booth and have exhibited in conference halls at too numerous to count. Last year our organization created an animated video about akathisia which has received almost 15,000 hits. In addition to the educational booth, pamphlets have been produced in English and Spanish that communicate the warning signs of akathisia, and we also have power point presentations. Two months ago my incredible board members and I presented at Loyola University Graduate School of Social Work.

MISSD is obviously near and dear to my heart. MISSD has saved lives and provided comfort to many people who have experienced such terrible loss.  We have a “Share” link on our MISSD website, and I keep seeing similar stories posted over and over again. They always start out “My loved one was fine, and then, gone, out of the blue, with no explanation.” In the middle of the trial, a woman texted me stating her husband ended his life after starting Paxil. I believe he was prescribed Paxil not for depression, but in an attempt to deal with side effects from chemotherapy. As I keep hearing these real stories, it makes me more determined to spread the word of MISSD.

We are particularly interested in working with military groups given that the military suicide rate is at a record high. MISSD believes there is a correlation between the number of drug cocktails our veterans are prescribed and the increases in suicide and suicidality. In March, MISSD helped sponsor an event called “K9’s for Veterans” where I talked to more than 400 military vets and their family and friends regarding akathisia.  After I had spoken, so many people came up to me and said thank you. They said, “that happened to me” or “It happened to someone I know.” MISSD is important to my board and me because it is helping prevent needless deaths. We are all so proud and thankful for our supporters who have helped us make a positive impact. I believe MISSD is the first organization in the world to raise awareness about akathisia. We are a safe patient advocacy group. When we all realized Stewart’s death could have been prevented, MISSD was our way to take action. Our knowledge of akathisia became a defining moment in all of our lives. We had to share this side effect so that the public can be better informed than we were.

What sort of response have you had from the launch of MISSD, have you come across any opposition from regulators or pharmaceutical companies?

No opposition from any regulators. At one point in my lawsuit, GSK wanted information on my board members, donators and GSK attorneys (either Andy Bayman or Todd Davis) presented print outs from our MISSD website. They wanted MISSD to be explored. Judge Zagel promptly stated MISSD was out of the lawsuit. The fact that GSK was worried about MISSD was gratifying because it confirmed we were shedding light on a subject they preferred to keep hidden.

The recently released MISSD video surely helps spotlight akathisia. What has been the overall response from the video?

Fantastic. We realized that if we were going to present to schools, hospitals, etc., we needed a powerful educational tool. We wanted a tool that was simple, short, and to the point. The video is creative and state of the art. Wherever we show the video, it is always very well received. It has been incredibly gratifying how well we have been received by the public. I think this is due in part because MISSD is not anti-drug, it is simply dedicated to raising awareness of akathsia and saving lives. Our mission resonates with so many people. Everything MISSD does is done very professionally, and we are viewed as a very important safe patient organization. Our initial fundraiser was primarily attended by friends, family members and associates of our board members. This is no longer the case. Today MISSD events are well attended, and I meet many new people for the first time at every event. They explain that they first found MISSD online as an important resource after their loved one died from prescription drug-induced akathisia. The families of akathisia victims who attend MISSD events come from all backgrounds and all parts of the country. We usually have more than 300 people at each event.

You’ve had many people visit Chicago from across the world, some of them also have tragic stories regarding the loss of loved ones due to prescription drug-induced akathisia. When did you realise the extent of this problem? 

When Kim Witczak presented the Selling Sickness conference in Washington, D.C. in 2013, I met many people, such as Mathy Downing and Sara Bostock, who lost loved ones to akathisia. This was important as I started to realize I was certainly not alone.

Later when I spoke in Copenhagen with Kim and Mathy and met Steffini Lynch and Leonie Donnelly, it further emphasized this was a universal problem. Recently as the MISSD presence has expanded, I realize that through our website many people have come to Chicago to MISSD events and found comfort and support from the mission of MISSD.

The jury unanimously agreed that GlaxoSmithKline is liable for not updating the Paxil label regarding the increased suicide risk created when adults take Paxil. In essence, the jury stated they believe, after hearing all the evidence presented by both sides, that Paxil caused Stewart’s suffering and death. Furthermore, the jury believes GlaxoSmithKline knew about these potential risks yet failed to warn consumers.

During the trial it came to light that 22 patients died in Paxil clinical trials, 20 of these died by suicide, and the other two deaths are suspected to be suicides. All 22 victims were taking Paxil at the time, and 80% of these patients were over the age of 30. GSK likes to argue that it was an “illness” that caused these deaths and not Paxil. What would you say to the surviving family members of these clinical trial victims if you had a chance to meet them?

That is a great question because it brings up so many issues. GSK talks at length about underlying illness. Yes, there are people that kill themselves because they have had a lifelong history of mental health issues. They struggle and medications have been life-saving in many situations. However, when you talk to love ones of people who died from akathisia you hear from many of them that the drugs were prescribed for issues such as insomnia, test anxiety, or situational stress. The drug companies seem to want to pathologize what it means just to be human.

During the trial, my sister sat through opening arguments and texted me, “I don’t know who they are talking about.” GSK tried to create a view of Stewart that quite frankly didn’t exist. But specifically, regarding prescription drug-induced suicides, I would tell the surviving family members to realize the death was not the fault of their loved one.  People sometimes say that when someone ends their life, it was their choice. I am not sure that that is a correct statement either. But death by akathisia is not a choice. It is not a suicide. It is a fatal drug reaction.

Additionally, I would tell surviving family members to get involved. There is a favorite quote of mine from the anthropologist Margaret Mead, “Never doubt that a small group of thoughtful, committed citizens can change the world; indeed, it’s the only thing that ever has.” Talk to others, spread the word regarding akathisia, contact government agencies. As we learned from this lawsuit, GSK blamed the FDA; We need to be proactive and contact our regulatory agencies to say inadequate warnings are just not acceptable. What this lawsuit has shown is that akathisia is a real, legitimate adverse drug reaction. The public needs to be aware of akathisia signs and symptoms.

Do you have any advice for consumers who are considering pharmaceutical industry litigation?

I think the person has to be aware that this process is emotionally and physically difficult. In addition to having the necessary courage and conviction, it is imperative to have top lawyers. My lawyers from Baum Hedlund and David Rapoport were incredible. They are professional and highly knowledgable. But they are also amazing human beings who understand the injustice that was done to Stewart. Our work together felt less like a lawsuit and more like a personal journey and commitment shared by all of us.

We know Glaxo is appealing the verdict. This means the funds the jury award for Stewart’s avoidable death and suffering will be held until the appeal process is finished. There have been a few online comments left on media articles in which a few posters have suggested this trial is just about money. How do you respond to people who suggest such?

I always want to respect people’s divergent opinions, and I can understand from the outside looking in one interpretation of the lawsuit might be that is about money. However, this notion is furthest from the truth. I would hope these individuals actually understood what critical information was highlighted in this trial because this information affects their lives as well as Stewart’s. I hope people would educate themselves regarding drug safety, drug studies, the role of the FDA, generics, etc. The vast majority of people have had very, very positive reactions to the verdict. There will always be people who disagree, and that is their prerogative.

I knew from the moment this lawsuit was filed that GSK was always concerned that this was a generic drug.  I was told before we even went to trial, that, if GSK lost, they would appeal. In fact, I believe there was a lawyer in the courtroom for GSK that was there for the sole purpose of  gathering information to start the appeal process. Appeals take several years and, of course, I could lose on appeal. It has been suggested that GSK wants to take this case to the Supreme Court because they are so afraid of what this guilty verdict means. As it stands, the legal ramifications for this verdict are so damaging for pharmaceutical companies that reaching the Supreme Court is very possible. That could take 5-7 years.

Clearly this case has never been about money. For me, it has always been about awareness, highlighting akathisia and ultimately changing the black box warning to include all ages. If those individuals who think this case is about money actually read the entire articles, they would learn about MISSD and all the work I do to increase akathisia awareness. While I am eternally grateful to the generosity of our supporters, I have also used my own resources to help educate the public about akathisia. I do this in honor of Stewart and to help others avoid similar tragedy.

Thank you, Wendy.

Please, if there is anything you want to say to the readers of my blog, feel free to do so.

I am so grateful to the overwhelming support of many people from all over the world. A special thanks to you, Bob, for all you have done over the past years to raise awareness of drug side effects, specifically akathisia, and my lawsuit. You have devoted so much of your time and resources to this case, and I am eternally honored by your efforts. You are remarkable. Thank you so much.

Links

What is Akathisia? (Short Educational Video)

MISSD

Baum, Hedlund, Aristei & Goldman

Rapoport Law Offices, P.C

Dolin Vs GSK Paxil Trial Court Transcripts

Dolin v. GSK Paxil Trial Exhibits



Dolin Vs GSK Blog Coverage

Dolin v GSK – Opening Arguments

Dolin Vs GSK – Day Two – “Jack-In-The-Box”

Dolin vs GSK – Healy ‘Rocks Da House’

Dolin Vs GSK – JP Garnier Video Deposition

Dolin Vs GSK – The Dunbar Tape

Dolin Vs GSK – Day 4 – Slam Dunk

Dolin Vs GSK – 8.9 Suicide Increase For Adult Paxil Users

Dolin Vs GSK – Day 6 – Ass Kicking Semantics

Dolin Vs GSK – Day 7 – Abraham Lincoln

Dolin Vs GSK – Day 8 – Get to the Point, Todd!

Dolin Vs GSK – Glenmullen Nails It!

Dolin Vs GSK – “Babes”

Dolin Vs GSK – Wendy’s Cross and GSK’s Petition

Dolin Vs GSK – Robert “Bling Bling” Gibbons

Dolin Vs GSK: Suicide Prevention Warning “Futile”, Claims GSK Exec

Dolin Vs GSK : Jury shown List of the Dead in Paxil Clinical Trials

Dolin Vs GSK: Last Man Standing & The Return of Dr. Healy

Dolin Vs GSK: Closing Arguments

Dolin Vs GSK – The Verdict

Bob Fiddaman Reports On The Glaxo Criminals…


http://fiddaman.blogspot.ie/2017/03/dolin-vs-gsk-day-8-get-to-point-todd.html?spref=tw

Tuesday, March 28, 2017

Dolin Vs GSK – Day 8 – Get to the Point, Todd!

The Todd Stance
 
Oh Todd, oh Todd, oh Todd,
you make us feel so weary.
Your questioning of Stewart’s doctor
really is quite dreary.
So, GSK’s warning letter
is the crux of your defence?
It’s not logical or rational;
it simply makes no sense.
You say you warned the doctors
of Paxil’s suicide risk.
Yet Andy Bayman denies this claim,
like a repeating compact disc.
Adults are perfectly safe, he states:
It’s just kids who should be warned.
But your former CEO confirms
it’s your duty to inform.
You can keep your fancy haircut, Todd,
and expensive Armani suit.
You can keep your sense of what’s right and wrong
in this wrongful death lawsuit.
You can keep your lack of due care
and misleading words of warning.
We know Paxil causes death, you see,
and leaves families deep in mourning.
Bob Fiddaman ~ 2017
Day 8 of the Dolin Vs GSK Paxil-induced suicide trial saw Stewart Dolin’s physician and long-time friend, Dr. Marty Sachman, take the stand.
Sachman was first questioned by David Rappaport, one of the attorneys representing Wendy Dolin (Stewart’s widow).
The jury heard more about Stewart Dolin, the man, and less about the fact that GlaxoSmithKline concealed Paxil’s propensity to induce suicidality. Sachman told the jury, “Stew was a very reserved, quiet, intelligent, loving man. I never heard him raise his voice over our 25-year relationship. We were like brothers. We spent weekends together, travel together. He was my closest friend. A loving person and a loving family man.” 
Sachman was also questioned about Stewart Dolin’s anxiety, which, according to the doctor, was a result of work-related issues. He told the jury that he never thought Stewart was depressed and that Stewart always responded to the treatment he gave him from 2005-2010. On each occasion, after Sachman prescribed Stewart drugs, he would warn him of the side effects and, once Stewart felt better, would wean him off the prescription.
Two days before Stewart’s Paxil-induced death, Sachman and Stewart attended a memorial service for the father of their mutual friend. Later that evening Sachman, Stewart and Wendy went to dinner together. Sachman was asked to describe what he remembered about Stewart that night. He answered, “His demeanor was, as usual, our conversation was as usual. He was calm.”
Sachman then recounted his “absolute shock” upon hearing the news of Stewart’s death. He told the jury, “I just think that we depend on honesty in reporting research and data. How can we treat people effectively and safely if we can’t depend on that?”
Rappaport then asked Sachman about the communication between pharmaceutical companies and doctors regarding drug labeling. Sachman’s answer, which King & Spalding objected to and was struck by the judge, highlighted Dr. Sachman’s feelings about being deceived:
 
“Well, you know, physicians, myself and millions of other physicians, every day try to protect people, try to help people and protect them. We rely on truth and honesty from pharmaceutical companies and to falsify information or hold back information is totally criminal. It affects the lives of our patients.”
It’s appropriate Sachman used the word ‘criminal’ given that GlaxoSmithKline have previously pled guilty to criminal charges. Therefore, GlaxoSmithKline are criminals.
Concluding his examining of the witness, David Rappaport asked Sachman about the tie and belt he was wearing. Sachman started to weep, sharing that they belonged to Stewart. Dr. Sachman wore them to “remember him today.”
Cross-examination by King & Spalding’s Todd Davis.
The cross-examination by Davis centered around GlaxoSmithKline’s “Dear Doctor Letters” sent out whenever GSK decides to share a problem with their products. Davis went over and over a series of these letters sent to Sachman. Sachman told Davis that he had, indeed, received these letters. Once again, King & Spalding tried to catch a witness by asking the same questions that were asked years ago during deposition. GSK’s attorneys futilely tried this tactic with Dr. David Healy and Dr. David Cross earlier in the trial.
Davis droned on about the “Dear Doctor Letters” and whether Sachman read them. Finally, an understandably frustrated Judge Hart interjected and admonished Davis, “You’re covering the same ground…over and over again now, Mr. Davis…Let’s not go over the same thing over and over again.”
Davis, however, continued to go over the “Dear Doctor Letters,” and the judge again interjected, “Mr. Davis, the document speaks for itself, and the doctor has accepted it. I don’t see any reason to read the document to him and ask him whether he agrees or disagrees.” 
 
King & Spalding’s “finest” then switched gears, inquiring about Sachman’s prescription of Levaquin (an antibiotic) to Stewart Dolin. Davis asked Sachman if he had read the Levaquin warnings regarding the drug’s propensity to cause adverse effects including suicidal acts or thoughts.
It’s good to see Levaquin manufacturers use the appropriate suicidal acts in their warning label. This term is surely more understandable than the intentionally ambiguous “emotional lability” term GSK prefers. I can’t help but wonder whether Davis would be equally concerned if his spouse consumed a product that states it can cause “emotional labilty” as he would if the warning listed “suicidal acts?”
Bizarrely, Davis next asked Sachman if he was aware Stewart’s widow and children had taken trips in and out of the US since Stewart’s death? Davis likely knows this is irrelevant, but shamelessly asked anyway in a lame attempt to imply Stewart’s widow and children couldn’t possibly be mourning Stewart’s Paxil-induced death if the family has traveled in the last six years. An appropriate question on my mind is “Does Davis take trips in and outside the US after settling cases for GSK in which innocent consumers have died?”
Davis finished his cross-examination, and I presume the jury and judge were glad to have a break from Davis’ tedious repetition. Davis is largely ineffective; GSK might want to reexamine their legal fund investment in Davis when GSK is, no doubt, embroiled in future wrongful death lawsuits.
David Rappaport – Re-direct
I won’t go into too much detail regarding the re-direct because the following question and answer seemed to undue Davis’ performance:
Q. Have you seen in any of the labels that you’ve ever seen from GSK about Paxil any reference to the fact that they had a suicide signal from attempts and suicides in the initial clinical trials that was of the magnitude of 7 to 8 times greater risk than similarly-depressed people on placebo?
A. I certainly have not.
Before leaving the stand, Dr. Marty Sachman told the jury, “I’d like to say that in the midst of all of this attempted confusion of the real issue here, if it was clear that this drug had a higher risk of causing suicide in the age group Stewart Dolin was in, I would have never prescribed it.”
Three doctors have now taken the stand:  All have stated if they had known about the increase in suicidality and behavior in adults taking Paxil they would have never prescribed it.
Your move, Todd!
The trial continues today with a series of video depositions that, sadly, I won’t have access to unless they are made public.
Bob Fiddaman.

More Dolin Trial Bombshells: Former FDA Offical Testifies That Paxil Is Not Safe And Doesn’t Work!…


“…David Ross. The former FDA Medical Advisor was asked if he prescribed Paxil to his patients.

Amid the objections from King & Spalding’s Andrew Bayman, he answered,

“No. I don’t believe that it works and I don’t believe that it’s safe.”….


Well, well, it seems that as the days go by more and more shocking revelations come out from the Stewart Dolin ‘Paxil Induced Suicide’ Trial in the US…

GSK… you evil bastards…

See Bob Fiddaman’s new post for more:

http://fiddaman.blogspot.ie/2017/03/dolin-vs-gsk-89-suicide-increase-for.html


Wednesday, March 22, 2017

Dolin Vs GSK – 8.9 Suicide Increase For Adult Paxil Users

Day 5 – Dolin Vs GSK Paxil Induced Adult Suicide – Chicago.

There was a startling revelation today in the Dolin Vs. GSK trial: Attorneys representing widow Wendy Dolin showed the ratio of Paxil-induced suicidality in adults is a staggering 8.9.  It is not 6.7, as previously claimed and reported by Glaxo. The 6.7 figure is astoundingly high in itself, but the 8.9 ratio is flabbergasting!

Plaintiff witness, Dr. David Ross, said this figure is ‘astounding.’ What you should remember here is that GSK’s 1989 drug application for Paxil said the suicidality odds ratio was 2.6.

Over the years as GSK’s lies were uncovered and more bodies were buried because of Paxil, GSK later changed the Paxil-induced suicide rate to 6.7. But today the world knows the actual Paxil-induced suicidality figure for adults is 8.9. This number is almost a nine-fold increase in adult Paxil patients experiencing suicidal thoughts, suicidal thinking and completed suicide–thoughts that are created by akathisia and other adverse reactions to Paxil and not by any underlying pre-existing condition.

Today at the trial, expert witness, Dr. David Ross, who worked for the FDA for ten years, testified extensively. While working at the FDA, Dr. Ross was responsible for reviewing new drug applications (NDA’s), i.e., he oversaw the statistics.

His evidence started with 6 points about GSK’s responsibilities (or lack of…)

1. Paxil is associated with an increased risk of suicidal behavior in adults beyond the age of 24.

2. GSK was not upfront about Paxil’s suicidal behavior risk.

3. In 2010, GSK had the ultimate responsibility for the Paxil label. GSK was responsible for ensuring the Paxil label did not contain any false, misleading, or inaccurate information about safety.

4. Federal regulations required GSK to warn doctors that Paxil induces adult suicidal behavior, starting in 1992.

5. GSK could have warned doctors by changing the Paxil label. There is no evidence the FDA would have stopped GSK from issuing a Paxil-specific warning in the non-class labeling sections. In fact, the FDA specifically invited GSK to discuss such changes.

6. GSK did not warn doctors of the true Paxil-induced suicidal behavior risks for adults beyond the age of 24.

Dr. Ross further reiterated to the jury what David Healy previously stated: that the responsibility for accurate drug labeling lies with the product manufacturer and not with the FDA. Dr. Ross added, “…the FDA does not do drug trials, we only know what we are shown.” He added, “You have to rely on the drug company.” He also informed the jury that the FDA’s annual budget is $1.3 billion, most of which comes from drug companies.

Another striking statement Ross shared with the jury was, “The FDA is in charge of enforcing the law, and GSK is in charge of following the law.”

Today’s evidence clearly shows that GSK has not followed the letter of the law enforced by the FDA.

Attorney Brent Wisner from Baum Hedlund asked Dr. Ross if he thought GSK’s label regarding adult suicide was adequate. Dr. Ross answered, “No.” and further added, “It was false and misleading and remains so today.”

Ross also told the jury that if he saw a nearly 9-fold increase in suicide in a drug (any drug) that he “Would not prescribe the drug.” In fact, Ross would categorize a 9-fold increase of any drug as a “frequent adverse event on labeling.”

He also told the jury that the term “Emotional lability” that GSK used instead of suicidality, “conceals what is really going on.”

Remarkably, two GSK employees, along with a third author who received funding and/or similar perks from GSK, published a medical journal paper stating Paxil actually reduced suicide in adults. Ross told the jury that he believed this published paper which contains obvious statistical errors should be retracted. The published article, “Reduction of suicidal thoughts with paroxetine in comparison with reference antidepressants and placebo”, by Montgomery, Dunner, and Dunbar was then used by GSK reps to promote the safety of Paxil in adult patients to prescribing doctors, even though GSK knew it was the complete opposite!

Indeed, it was a very bad day for GSK. The standard “Objection!” was lamely shouted out by King & Spalding’s resident Jack-in-the-box, Andrew Bayman, more times than I care to recall. The majority of his objections were overruled by the Honorable Judge Hart.

I’ve long been a critic of both the British and American drug regulators (the MHRA and FDA). Despite ten years of successful blogging, I’m never too old to learn something new, even when the new information is quite tragic: Today I, and the jury learned that drug companies such as GSK hold medical regulators by the balls. Drug companies provide information (to include false data from faulty clinical trials) and medical regulators have to accept drug company information as the truth. GSK should expect ramifications from global regulators after today’s evidence. An almost 9-fold increase in suicidal behavior in adults taking Paxil is appalling, particularly when we know that, for years, GSK continues to claim there is no causal association between suicide and adults taking Paxil.

This lopsided relationship has terrible ramifications for mental health authorities and suicide nonprofits who unconcernedly take drug company hush money. For years both have claimed antidepressants are a safe and effective treatment for a variety of possible ailments (anxiety, OCD, adult depression, e.tc.) A nearly 9-fold increase in suicidality strongly suggests that both mental health and mental health nonprofits have been duped by the pharmaceutical industry, along with prescribing doctors, medical regulators, and an unsuspecting public.

Just think folks: GSK even tried to get a license for Paxil to be prescribed to children after they knew of the Paxil-induced suicide increases in adults!

Nice ethical company, huh?

I’ll leave the last words to today’s witness, David Ross. The former FDA Medical Advisor was asked if he prescribed Paxil to his patients. Amid the objections from King & Spalding’s Andrew Bayman, he answered, “No. I don’t believe that it works and I don’t believe that it’s safe.”

Trial continues tomorrow.

For now, it’s time for a Guinness, in honour of Stewart Dolin.

Bob Fiddaman.
In Chicago.

Dolin Vs GSK

Dolin v GSK – Opening Arguments

Dolin Vs GSK – Day Two – “Jack-In-The-Box”

Dolin vs GSK – Healy ‘Rocks Da House’

Dolin Vs GSK – JP Garnier Video Deposition

Dolin Vs GSK – The Dunbar Tape

Dolin Vs GSK – Day 4 – Slam Dunk

GSK’s Lawyers Grasp At Straws At The Stewart Dolin ‘Paxil Induced Suicide’ Trial…


http://fiddaman.blogspot.ie/2017/03/dolin-vs-gsk-day-4-slam-dunk.html

Tuesday, March 21, 2017

Dolin Vs GSK – Day 4 – Slam Dunk

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Andrew Bayman – King & Spalding’s finest

Imagine, if you will, a schoolyard bully who tries to impress his fellow bullies. Imagine, if you will, the kind of person who wants to be popular among his peers yet every time he tries to impress them he gets things wrong, so wrong.

Let me introduce you to King & Spalding’s, Andrew Bayman.

Bayman, who on day one of Dolin Vs GSK, claimed that Paxil does not induce suicide, today got to cross-examine Dolin’s first expert, Dr. David Healy.

This was something I was really looking forward to. On one hand, I wanted to see how good King & Spalding were, let’s face it, they’ve made a lot of money defending large corporate companies over the years. As Glaxo’s first choice of defence attorney’s one would assume that they would try and throw the kitchen sink at any expert witness who speaks out against their client, moreover, their client’s product, as is in this case, GlaxoSmithKline’s Paxil.

So, how does one defend the indefensible?

Step forward Andrew Bayman, a guy who struts his stuff by flicking out his arms suggesting that he is ready to spar with any opponent who dares cross the might of King & Spalding or, indeed, GlaxoSmithKline.

It’s fair to say that Bayman failed to deliver today, in fact, if I was GSK’s CEO I’d be deeply disappointed in the performance of King & Spalding’s finest.

So, how does one go about disputing evidence put forward by the world’s leading SSRI expert, David Healy? Does one dispute the science behind the evidence?

As you’d expect from GSK, their attorneys do everything but discuss the science.

I’ve seen excuses made by Glaxo over the years but one today almost had me biting the arm of the front pew where I was seated.

Bayman, in efforts to discredit Healy, asked him about his popular website, Rxisk.org, moreover about the donations to the said website.

Bayman, upon learning that Healy’s Rxisk website received a small donation from an American attorney, went down a road that was laughable, nae embarrassing. In the words of Del Boy, a popular British fictional wheeler and dealer, he made himself look like a right ‘plonker’ (Google it, Todd, you’ll see I’m right)

Bayman, flicking out his arms like a gunslinger from a John Wayne movie, made the assumption that Healy’s Rxisk was merely a platform to attract patients with stories of SSRI side effects so he and his attorney friend, who made the small donation, could, in future, litigate on behalf of any of the patients who leave comments on Healy’s website.

Healy, into his third day of questioning, smiled.

The answer he gave Bayman was simple.

Healy told Bayman, and the jury, that any attorney who donated money to Rxisk.org would possibly be in an awkward position. In fact, upon receiving this small donation Healy told the donator that Rxisk was all about seeking the truth about SSRI’s and any such truth outed would possibly lessen lawsuits filed against the makers of SSRI’s.

Bayman seemed to be at a loss for words with this reply.

Next, faux pas was Bayman showing the jury, via the various screens dotted around the court, a selection of text taken from a book Healy wrote back in 2013. Also various published papers by Healy.

Upon asking Healy if he had written the text highlighted, Healy responded by telling Bayman to scroll down the page to see the reference. There he would see that the highlighted text Bayman had chosen to show the jury was actually a quote by, um…wait for it…someone else.

All day, Bayman was cherry-picking selective text from various articles written by Healy. All day long Healy told him that if the sentence was read in full context then he (Bayman) would see what it actually meant.

You see, Bayman’s job was to try and make David Healy slip up. He wanted the jury to see that Healy contradicts himself. He failed on a grand scale.

“No further questions” came at around 3.40pm and, I must admit, I was surprised that Bayman was severely lacking in the questioning skills that I have become accustomed to reading John Grisham novels.

It was a good day for Dolin and her law team of David Rappaport and Brent Wisner, they made few objections, preferring instead to let Bayman dig himself a hole and look rather incompetent to the watching jury.

I felt embarrassed for Bayman, it was one of those moments one gets when watching David Brent in The Office (UK version) (Google it, Todd)

He tried to serve aces all day long – he just kept hitting the net.

It’s enlightening to know that this is GSK’s defence. Target whoever stands in their way and forget about the 10 years or so that they failed to tell the FDA about Paxil’s suicide risk. A point that Healy also picked up on when he told the jury that if GSK had told the FDA all those years ago about Paxil’s propensity to induce suicide, then many lives could have been saved.

Court resumes again tomorrow morning.

Bob Fiddaman.

Dolin Vs GSK

Dolin v GSK – Opening Arguments

Dolin Vs GSK – Day Two – “Jack-In-The-Box”

Dolin vs GSK – Healy ‘Rocks Da House’

Dolin Vs GSK – JP Garnier Video Deposition

Dolin Vs GSK – The Dunbar Tape

Incredible Footage Of Former GSK CEO – JP Garnier- Surfaces- On Fiddaman’s New Post -From The Stewart Dolin ‘Paxil Induced Suicide” Trial In The US…


Bob Fiddaman has been doing stellar reporting/blogging about the Stewart Dolin, “Paxil Induced Suicide” Trial in Chicago. He has just posted incredible footage of JP Garnier (the former GSK CEO – before Andrew Witty) discussing Paxil/Seroxat in a video deposition (May 2006). Garnier is his usual arrogant, creepy self, however, the deposition itself is incredible. It seems that GSK had a legal duty to warn about serious adverse affects, so why were they passing the buck to the FDA?

Paxil/Seroxat caused much harm, death and destruction to tens of thousands of people, however judging by Garnier’s attitude in this video deposition, he comes across like he couldn’t care less…

In fact, he looks bored..

I guess dead Paxil/Seroxat people are just boring issues to some pharma CEO’s..

What is the point in having a CEO, if they are never held accountable?

Disturbing…


Saturday, March 18, 2017

Dolin Vs GSK – JP Garnier Video Deposition

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

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

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

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

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

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

The video deposition was taken in 2006.

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

Garnier answered, “Yes, but in practice, you don’t want to do that.”

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

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

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

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

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

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

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

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

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

Just sayin’.

Over to you, Todd.

**COMING UP TOMORROW**

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

Bob Fiddaman.
 
Related
 

 

More Damning Evidence About Seroxat/Paxil And Suicidality …


Brilliant reporting from Bob Fiddaman at the Stewart Dolin ‘Paxil Induced Suicide’ trial in the US.

More damning evidence that Paxil/Seroxat is a drug that simply should never have been on the market in the first place…


 

Friday, March 17, 2017

Dolin vs GSK – Healy ‘Rocks Da House’

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Healy reminded the jury that GSK’s stance was that Paxil, a drug that was used to treat anxiety and Major Depressive Disorder (MDD) actually made, some people develop symptoms that it was, originally, meant to treat!

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

Oh, by the way, Stewart Dolin was 57.

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

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

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

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

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

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

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

Churlish.

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

Objection, objection, objection.

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

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

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

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

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

Bob Fiddaman.

Dolin back stories.

Part 2 Of Bob Fiddaman’s Posts On Peter Humphrey’s Recently Filed Lawsuit Against GlaxoSmithKline…


http://fiddaman.blogspot.ie/2016/11/chinawhys-vs-gsk-claims-part-2.html

Sunday, November 20, 2016

ChinaWhys Vs GSK – The Claims – Part 2

Following on from the first parter, Lawsuit Alleges GSK’s Witty Lied to the Media – Part I, today sees part 2 (The claims of ChinaWhys against GSK) – Part 3 (Coming later this week) will focus on the incarceration of Peter Humphrey and his wife, Yu Yinzeng and also the rehiring of accused whistleblower, Vivian Shi)

Here is what Peter Humphrey and his wife, Yu Yinzeng, of ChinaWhys, are alleging…

 – Between 2010-2013 GSK spent nearly $225 million on planning and travel services. Approx 44% of the sampled invoices were inflated and approximately 12% were for events that did not occur.

 – GSK set up a special “crisis management” team in order to bribe a Chinese regulators with money and gifts. A GSK executive attempted to bribe a Chinese investigator with an IPad and a lavish dinner. All bribes were approved by the head of Chinese operations, Mark Reilly.

 – GSK planned to suppress evidence of its illegal bribery activities.

 – As far back as 2008, GSK China deliberately falsified its books and records in order to conceal its illegal practices in China. These included, bribery and promotion of drugs for purposes that have not been approved by the Chinese authorities.

 – GSK paid a patient RMB 50,000, who nearly died after being given Lamictal off-label. Despite having knowledge of Lamictal caussing near death in this patient, GSK still told its reps to promote the use of Lamictal for off-label purposes.

 – GSK targeted ‘persuasive doctors’ in attempts to influence purchasing descions at their hospitals. GSK are to said to have forged a connection with these doctors by taking them to expensive lunches and dinners and also giving them gifts and cash.

 – GSK paid between 500 and 1,000 doctors to go on an all-expenses paid holiday to locations such as Brazil, India, Israel, Greece, Japan and Hungary. GSK covered all costs, including cash to cover meals and sight-seeing excursions. These were disgusied by GSK as “Conference trips.”

 – Head of Chinese operations, Mark Reilly, reeived a bribe in the form of ‘sexual relations’ in return for passing business on to China Comfort Travel, a travel agency who organised ‘conference sevices’ for GSK.

 – GSK paid doctors based on their prescription numbers.

 – GSK’s senior legal counsel, Jennifer Huang, asked private investigator, Peter Humphrey, to investigate the Public Security Bureau and to prepare an analysis of the Chinese political regime. Huang told Humphrey that she wanted to find out who’s who regarding the team who were investigating GSK.

 – Humphrey became concerned that GSK were trying to obstruct the investigation and declined to investigate state secrets.

 – Humphrey was also asked, by GSK, to look into the Ministry of Public Security, the Economic Crimes Investigation Department regarding the relationship between them and  the Public Security Bureau. Humphrey, once again, declined.

 – Head of Chinese operations, Mark Reilly, told Humphrey that the alleged whistleblower, Vivian Shi was “coming after him.” (Humphrey).  Reilly then fled China the following day.

 – GSK China told its employees to “destroy all non-compliant promtional maeterials and gifts.” They also implemented a new email system and deleted emails that were more than a year old. They claimed this was to “reduce unnecessarily legal costs.”



Bob Fiddaman.

Back Stories from the Fiddaman Blog

Glaxo – The Sex Tape Scandal

GSK’s Mark Reilly Accused of Running a “massive bribery network”

I’m Just a Blogger – Here’s GSK Served on Prawn Crackers

GSK Hiked Product Prices to Fund Bribery Scam

GSK’s Sales Reps Want Their Money Back

GSK’s Private Investigator [The Video]

Peter Humphrey’s 2012 Presentation – Pharma Bribery

GSK’s Chinese Whispers and David Cameron

“GSK were really cagey”, Claims Whitehall Official.

Glaxo Hire Ropes & Gray to Delve Into its Chinese Operations.

GSK CHINA – Bribery was Rife 13 Years Ago

Witty Plays Down China Scandal

Witty Witty Bang Wang. The Glaxo Gangbang…Allegedly

Book Your Holidays With GSK Travel

Andrew Witty… I know narrrrrrrrthing

The Penny Drops for GSK’s Private Investigator.

GSK China Bought Patient’s Silence for $9,000

Lawsuit Alleges GSK’s Witty Lied to the Media – Part I

Bob Fiddaman’s New Post : ” Lawsuit Alleges GSK’s Witty Lied to the Media – Part I “…


http://fiddaman.blogspot.ie/2016/11/lawsuit-alleges-gsks-witty-lied-to.html

Thursday, November 17, 2016

Lawsuit Alleges GSK’s Witty Lied to the Media – Part I

Lawsuit Alleges GSK’s Witty Lied to the Media – Part I  
~ Bob Fiddaman
 

A 42 page complaint was filed on November 15, 2016, by Peter Humphrey and his wife, Yu Yingzeng, in relation to GSK’s nefarious activities in China which saw the pair incarcerated for around 2 years in Chinese slum-like conditions prison cells.

The complaint delves deep into the whole sordid affair and alleges bribery on a huge scale, more importantly, the complaint alleges that GSK hired the services of Humphrey and Yu in efforts to smokescreen the corruption in China, corruption, according to the complaint, that they had known about for many years. Furthermore, the 42 page document alleges that GSK’s CEO, Andrew Witty, lied to the media when he was asked about the corruption in China.

Humphrey and Yingzeng were the founders of ChinaWhys, a professional-services consultancy that specializes in discreet risk mitigation solutions, consulting and investigation services to corporate clients in matters of high sensitivity across Greater China and the Asia Pacific.

On April 15, 2013, Humphrey met with GSK’s Head of Chinese operations, Mark Reilly, April Zhao, GSK China legal counsel and Brian Cahill, also GSK legal counsel. It was at this meeting that Humphrey was told that GSK had been sent a series of emails from a whistleblower alleging widespread corruption – GSK told Humphrey that they believed they knew who the whistleblower was.

Vivian Shi had previously worked for GSK as a government affairs director, GSK had terminated her services with them in December 2012. According to the complaint GSK claimed that Shi had orchestrated a “smear campaign” against GSK involving a total of 23 emails that had been sent to Chinese officials throughout the country, a letter had also been sent to GSK’s ‘top management’ alleging widespread corruption in GSK’s pharmaceutical and vaccine business that had been approved by GSK China’s senior management.

These were allegations brought to Humphreys attention just months after GSK had been fined a record breaking $3 billion by the Department of Justice in America – the fine was handed down after a guilty plea by GSK who, after the settlement, entered into a five-year Corporate Integrity Agreement with the Office of Inspector General of the Department of Health and Human Services. The agreement requires enhanced accountability, increased transparency and wide- ranging monitoring activities conducted by both internal and independent external reviewers.

One month after meeting with GSK officials Humphrey was told that GSK’s global CEO, Andrew Witty, had been made aware that GSK had been using a travel agent to channel kickback to customers and doctors throughout China. Days after Witty had been made aware, the whistleblower also sent a video to him and other senior management that showed GSK China’s Mark Reilly engaged in sexual activity – Reilly later claimed that the woman in the video was his “regular girlfriend”.

GSK officials told Humphrey that they had launched their own internal inquiry regarding the whistleblower allegation and that they were false. They told Humphrey, “There is nothing there”. This, according to the complaint, was a lie.

Humphrey and his wife offered to investigate the whistleblower allegations but GSK declined the offer, opting instead for Humphrey to investigate Vivian Shi, the woman they believed was the whistleblower.

Two months after Humphrey and Yu started their background search of Vivian Shi, GSK received another letter from the whistleblower alleging that GSK China continues to engage in systematic bribery of doctors, this email focused on GSK China’s botox business whereby the whistleblower claimed that…

GSK had a ‘pay to prescribe’ scheme that funneled money through a central source at Beijing Medical College whereby ‘lecture fee payments’ were made to doctors who could “…incentivize and reward doctors for prescribing Botox.”

At no point did GSK show either Humphrey or Yu this letter.

On June 12, 2013, the Wall Street Journal (WSJ) ran an article highlighting GSK China’s massive bribery network. In July of that year 4 senior GSK China executives were arrested and, according to Humphrey’s filed complaint, GSK CEO, Andrew Witty told the worlds media that “…it appears that certain senior executives in the Chinese business have acted outside of our processes and our controls to both defraud the company and Chinese healthcare system.” Witty also claimed that GSK’s Head office in London lacked knowledge of the whistleblower allegations and “had no sense of this issue.”

According to the complaint, this made no sense as since the previous month GSK did, indeed, “have a sense” of the issue since it announced its 4 month internal investigation into allegations of bribery and corruption in China and found “No evidence of corruption or bribery.”

The complaint states…

Witty argued, nonsensically, that the previous whistleblower allegations were “quite different” from the more recent charges, saying, “they are two completely different sets of issues, we fully investigated the first and, of course, this has now surfaced in the last couple of weeks.”

This was a lie, since “what surfaced” in the PSB investigation and raids of GSK offices in July was precisely the illegal activity that the whistleblower had documented and threatened to reveal in January.

The complaint was filed in The United States District Court for the Eastern District of Pennsylvania.

Humphrey and Yu are represented by Boies, Schiller & Flexner LLP

**Coming in Part 2**
– A full and comprehensive list of the allegations made by Peter Humphrey and Yu.
– GSK ask Humphrey to ‘overtly’ obstruct the Chinese government investigation.
– Evidence, including emails, to be destroyed as not to implicate any wrong-doing by the company.



Bob Fiddaman


Back stories.

Glaxo – The Sex Tape Scandal

GSK’s Mark Reilly Accused of Running a “massive bribery network”

I’m Just a Blogger – Here’s GSK Served on Prawn Crackers

GSK Hiked Product Prices to Fund Bribery Scam

GSK’s Sales Reps Want Their Money Back

GSK’s Private Investigator [The Video]

Peter Humphrey’s 2012 Presentation – Pharma Bribery

GSK’s Chinese Whispers and David Cameron

“GSK were really cagey”, Claims Whitehall Official.

Glaxo Hire Ropes & Gray to Delve Into its Chinese Operations.

GSK CHINA – Bribery was Rife 13 Years Ago

Witty Plays Down China Scandal

Witty Witty Bang Wang. The Glaxo Gangbang…Allegedly

Book Your Holidays With GSK Travel

Andrew Witty… I know narrrrrrrrthing

The Penny Drops for GSK’s Private Investigator.

GSK China Bought Patient’s Silence for $9,000

Brilliant New Post From Bob Fiddaman: “GSK China Bought Patient’s Silence for $9,000″…


As usual, Mr. Fiddaman hits the nail on the head…


 

http://fiddaman.blogspot.ie/2016/11/gsk-china-bought-patients-silence-for.html

Wednesday, November 09, 2016

GSK China Bought Patient’s Silence for $9,000

A truly fascinating read regarding the corruption in China, all committed by the hand of British based pharmaceutical giant, GlaxoSmithKline.

The New York Times (NYT) recently ran a superb article regarding GSK’s nefarious activities in China, activities that saw them plead guilty, a result of which saw them being handed down a $500 million dollar fine.

The article by David Barboza, although brilliant, is tantalizing, in as much that The Times claims to have in its possession emails and documents, none of which they have provided, at least in their entirety.

The China scandal is a story of greed, corruption, cover-ups, bribery and pay-offs, all combined with a sex scandal video and a company burying it’s head in the sand over its China practices – preferring instead to go after the person who blew the whistle on the whole sordid affair.

It’s a subject I covered many times on this blog (Links at the foot of this post) and one that seems to be rehashed with additions on a regular basis.

The Times article throws out some very interesting facts about the case that were previously kept under wraps – one such fact being that they (The Times) have evidence that “Glaxo “almost killed one patient by illegally marketing its drug Lamictal,” said the email, which was obtained by The Times. “GSK China bought the patient’s silence for $9,000.””

Glaxo buying a patient’s silence? Surely not?

There was me thinking they only did that in litigation, Paxil withdrawal (Over 3,000 patients ‘paid off’) – Paxil Birth defects (Over 800 patients ‘paid off’)

So, who was the patient in receipt of Glaxo’s $9,000, moreover, what did this patient have that GSK didn’t want others to see?

According to the NYT…

The email was one of nearly two dozen that the whistle-blower sent over the course of 17 months to Chinese regulators, Glaxo executives and the company’s auditor, PricewaterhouseCoopers.

In 2012 Glaxo plead guilty to a whole host of violations throughout America, the guilty plea resulted in a record breaking fine of $3 billion. At the time, Glaxo Chief, Andrew Witty, pledged, “We’re determined this is never going to happen again.”

Witty, who had been made aware of the unfolding stench in China shortly after the 2012 guilty plea in the US, is stepping down from his CEO position in April next year – It’s quite a legacy he has left behind, one which he took over from former Chief, JP Garnier who, in essence, oversaw the corruption in America and left Witty to suck up the fallout.

What an abhorrent company this is. Corruption, bribery (of officials and patients) and the manufacturer of prescription meds that have either killed people or disfigured them in such a way that they need to continue having surgery for the rest of their lives. Let’s not forget those that have suffered as a result of becoming addicted to GSK’s medications either.

The Times article also digs deeper into the involvement of Mark Reilly, who, at the time, was Head of GSK’s China operations. They claim…

An email alleged that Mr. Reilly, a British national who had helped manage the company’s China operation for four years, was complicit in a bribery scheme tied to a travel agency called China Comfort Travel, or C.C.T. According to the email, Glaxo funneled money through the travel agency to pay off doctors. The travel agency also supplied Mr. Reilly with women, as a way to secure that business.

“In order to acquire more business, C.C.T. bribed Mark Reilly, the general manager of GSK (China) with sex,” the email said. “Mark Reilly accepted this bribery and made C.C.T. get the maximized benefits in return.”

That’s some perk to have!  China Comfort Travel bring a whole new meaning to the word ‘comfort’.

Any jobs going whereby the employer offers a bonus of playing hide the salami?

I’m sure red-blooded males would have been first in-line for such a job working for a company complicit in fraudulent activities. Sadly, for those red-blooded males at least, Reilly was offered (and took) the perk – I wonder if he claimed for the 15 minutes of overtime too? (Assuming that Reilly could last that long in the sack)

When faced with over 17 months of emails from the whistleblower Glaxo decided to seek help, they did so by hiring a private investigator, Peter Humphrey and his wife, Yu Yingzeng.

Humphrey did some digging and, at the time, provided information to Glaxo that pointed to the possible whistleblower. Vivian Shi, was a 47-year-old executive handling government affairs in Glaxo’s Shanghai office, I say former because she was previously fired by GSK for their belief (Before Humphrey was hired) that she was behind the whistleblowing allegations. The ‘official’ line of her dismissal was that she had been falsifying travel expenses.

Humphrey, it appears, was merely suggesting that Shi may have been involved – he, at no time, ever provided GSK with any evidence that their former executive was the one who was whistleblowing. Shi, who remember had already left GSK, denied any part in the whole Chinagate scandal.

During his investigations Humphrey obtained information that was deemed to be by false means according to Chinese officials. Both he and his wife were later arrested, charged then sent to prison. Meantime, Reilly, who was the mastermind of the whole scam, was sent back home to the UK – No jail time. It’s unknown what Reilly is doing today, presumably he doesn’t work for GSK in any capacity, although I wouldn’t put it past them to re-hire him, just as they did with Vivian Shi, the very person they had fired because they thought she was the one blowing the whistle on its Chinese operations.

Remarkably, GSK re-hired Shi last year, although it is unclear in what capacity. (See Glaxo and Former Whistleblower Suspect Reunite)

GSK must be a truly great company to work for, not only do they offer, by proxy, free blowjobs to heads of operations but they re-hire you after previously sacking you for, ahem, “falsifying travel expenses.”

The Times article is a must read and once again highlights how GSK prefer to target people who bring the company’s misdemeanors to their attention rather than target the person carrying out the misdemeanors.

GSK Corporate motto claims, “We are dedicated to improving the quality of human life by enabling people to do more, feel better, live longer.” – I just never knew this included blowjobs via complicit bribery deals – the re-hiring after breaking rules – and buying patients silence.

Nice job (blow) Glaxo!

Bob Fiddaman

Back Stories

Glaxo – The Sex Tape Scandal

GSK’s Mark Reilly Accused of Running a “massive bribery network”

I’m Just a Blogger – Here’s GSK Served on Prawn Crackers

GSK Hiked Product Prices to Fund Bribery Scam

GSK’s Sales Reps Want Their Money Back

GSK’s Private Investigator [The Video]

Peter Humphrey’s 2012 Presentation – Pharma Bribery

GSK’s Chinese Whispers and David Cameron

“GSK were really cagey”, Claims Whitehall Official.

Glaxo Hire Ropes & Gray to Delve Into its Chinese Operations.

GSK CHINA – Bribery was Rife 13 Years Ago

Witty Plays Down China Scandal

Witty Witty Bang Wang. The Glaxo Gangbang…Allegedly

Book Your Holidays With GSK Travel

Andrew Witty… I know narrrrrrrrthing

The Penny Drops for GSK’s Private Investigator.