Zantac Lawsuit


Researching drug company and regulatory malfeasance for over 16 years
Humanist, humorist

Tuesday, April 25, 2017

Explosive News!






I am going to take a rest for a week or so from blogging.

That's not the exposive news folks.

My next post will show correspondence between myself and the MHRA and will show confirmation that they knew about the 22 deaths that occured in Paxil clinical trials, 20 of which were suicides, 80% of which were carried out by patients over the age of 30. 100% of whom were taking Paxil (Seroxat).

In the meantime, all of this needs to sink in.


Plaintiff's Exhibit 347 - Dolin Vs GlaxoSmithKline


Bob Fiddaman.


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

--








Friday, April 21, 2017

For GSK. For King & Spalding




So, I hear you are claiming that you are going to appeal because you think a unanimous decision means that, um, the jury were wrong?

So, you intend to spend another $4 to $5million to, um, save $3 million?

No doubt your three experts, Gibbons, Kraus and Rothschild will be rubbing their hands. Collectively another half a million bucks coming their way!

This is for Andrew Bayman, for Todd Davis and for Glaxo's new CEO, Emma Walmsley.


CLICK HERE TO PLAY VIDEO



That is all.

For now ;-)

COMING SOON: Exclusive interview with Wendy Dolin.

Bob Fiddaman

Back stories

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

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





Thursday, April 20, 2017

Dolin Vs GSK - The Verdict





“Don’t you think if these medicines caused suicide someone would have spoken up?” ~ Andy Bayman - King & Spalding.

The jury have.


GlaxoSmithKline have been found guilty by a jury today in Chicago.

The jury found for plaintiff, Wendy Dolin, who filed suit against GlaxoSmithKline after her husband, Stewart, took his life 6 days after being started on a generic version of Glaxo's controversial antidepressant Paxil (known as Seroxat in Europe)

The jury found GlaxoSmithKline liable for the death of Reed Smith LLP partner Stewart Dolin and ordered the pharmaceutical giant to pay $3 million to his widow, Wendy Dolin, reaching the conclusion that a generic version of GSK’s Paxil caused Dolin to take his own life.

Officials from GSK said the verdict was disappointing and that they plan to appeal.

(Insert feelings of shock here)

A huge congratulations to Wendy and her legal team; Brent Wisner of Baum, Hedlund, Aristei & Goldman, PC, Los Angeles and David Rapoport of Rapoport Law Offices, Chicago.

Updates coming later. In the meantime, here's some of the reasons why the jury returned a guilty verdict. Click on images to enlarge. Images courtesy of Baum Hedlund. But first, read the press release from Baum Hedlund.

PRESS RELEASE - Baum Hedlund

$3M Jury Verdict Against GSK in Landmark Paxil Suicide Case

April 20, 2017, Chicago, Illinois - - A federal jury has sided with the widow of a deceased Chicago attorney in her generic Paxil suicide lawsuit against GlaxoSmithKline (GSK), ordering the pharmaceutical giant to pay $3 million.

The jury verdict resolves allegations in the trial of Dolin v. Smithkline Beecham Corp. (D/B/A GlaxoSmithKline-GSK) over the paroxetine-induced wrongful death of Wendy Dolin’s late husband, Stewart Dolin, who was a partner at the Chicago law firm Reed Smith when he took his own life in 2010. 

“We are very pleased with the jury’s verdict and are grateful for their diligent service,” said Brent Wisner, co-lead trial counsel for Ms. Dolin in the Paxil suicide case. “We feel justice has been served, and are hopeful this verdict will result in a labeling change to warn that people of all ages are at risk. This should send a clear message to GSK and other drug manufacturers that hiding data and manipulating science will not be tolerated. Brand drug manufacturers have the ability and responsibility to make their drug labels accurate. If you create a drug and know that it poses serious risks, regardless of whether consumers use the brand name or generic version of that drug, you have a duty to warn.”

On July 10, 2010, 57-year-old Stewart Dolin began taking the prescription antidepressant medication paroxetine. The brand name version of this medication is called Paxil, which was researched, developed, manufactured and marketed by GSK. Paroxetine and Paxil are the same chemical compound and both use the same product information labeling. GSK created and was responsible for maintaining the accuracy of the Paxil label.

In the early afternoon on July 15, 2010, Stewart Dolin died when he was struck by a CTA Blue-Line train in the subway station near Washington Street in Chicago. Just before this, a nurse at the subway station who did not know Mr. Dolin noticed him pacing back and forth while looking in the direction of an approaching train that was not yet in sight. When the moving train appeared, the nurse observed Mr. Dolin leap in front of the train, where he was struck. Mr. Dolin was pronounced dead from the injuries he suffered due to the collision and his contact with the electrified track after the collision.

The lawsuit alleged GSK failed to adequately warn Mr. Dolin’s doctor about Paxil/paroxetine’s association with an increased risk of suicidal behavior in adults of all ages. The Court previously ruled that, although GSK did not manufacture the pills Mr. Dolin ingested, the company was responsible for the label and knew or should have known any failure to warn would result in harm to those taking generic versions of the drug.

“Glaxo has known for two decades that Paxil can cause people of all ages to commit suicide. The company not only hid the risk, but stuck its head in the sand and ignored countless suicides that occurred in its clinical trials,” said attorney Michael Baum, who also represented Ms. Dolin. He added that the drug’s Black Box warning – which states there is a suicide risk for children, adolescents and young adults, but the risk ends at age 24 – is “just wrong.”

During the five-week trial, GSK swore off its responsibility for ensuring the truthfulness of the label, arguing that, because the FDA never made GSK warn of a suicide risk, the company should be exonerated. According to Baum, this argument is “akin to a car speeding past a cop, the cop doesn’t stop the car, and the car crashes into another car and kills someone—the driver who killed someone cannot state it’s not his fault because the cop didn’t stop them.” 

In the end, the jury disagreed with GSK’s arguments, finding that the drug maker cannot sluff off its responsibility for its labeling just because the FDA let the company get away with it. 

Wendy Dolin was represented in her case by R. Brent Wisner and Michael Baum of Baum, Hedlund, Aristei & Goldman and David E. Rapoport and Matthew Sims of Rapoport Law Offices P.C.

For more information about the trial, visit baumhedlundlaw.com or MISSD.

Dolin v. GSK Trial Transcripts

Dolin v. GSK Trial Exhibits


Robin McCall
Media Relations & PR Manager
Baum, Hedlund, Aristei & Goldman, PC









Bob Fiddaman

Back stories

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

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




Tuesday, April 18, 2017

Dolin Vs GSK: Closing Arguments







I will keep it short and sweet, if I may.

Here's what King & Spalding's, Andrew Bayman, told the jury yesterday during closing arguments.

“Don’t you think if these medicines caused suicide someone would have spoken up?”

My response...


Now read the evidence...


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




Bob Fiddaman



Friday, April 14, 2017

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





The trial is almost over, and the jury has heard from many witnesses for both plaintiff, Wendy Dolin, and Defendant, GSK. GSK's last roll of the dice saw Anthony Rothschild (pictured above) take the stand. Up to 2009, and possibly to the present, Rothschild has taken money and related grants from the National Institute of Mental Health, Cyberonics, and Wyeth. He is a consultant for numerous pharmaceutical companies to include Pfizer, GlaxoSmithKline, Forest Laboratories, Eli Lilly, and Takeda.

First and foremost, Rothschild describes himself as an expert in psychological autopsies, a method, according to 'All About Forensic Psychology', that involves collecting all available information on the deceased via structured interviews of relatives, friends and healthcare personnel. Additionally, information is supposed to be collected from available health care records and related documents. We know Rothschild had access to Stewart Dolin's medical records and other documents but did he ever interview relatives or friends of Stewart Dolin? Did Rothschild ever interview Stewart's healthcare personnel? It appears he did not.

For a day and a half, under direct examination from defence attorneys, King & Spalding, Rothschild told the jury that  Stewart Dolin's state of mind caused his death and Paxil had nothing to do with Stewart's death. Rothschild further claimed there is no relationship between SSRIs, akathisia, and suicide. He went on to state that, even if there was such a relationship, Stewart Dolin was not suffering from akathisia.

Rothschild told the jury that he treats patients with akathisia, 99% of whom were on neuroleptic and/or antipsychotic medications. When asked if akathisia was difficult to treat, Rothschild answered, "...akathisia is not that complicated to treat. You just give another medication, and you can wipe out the akathisia quickly." Rothschild went on to tell the jury that he had read Stewart Dolin's medical notes and that, in his opinion, Stewart had suicidal thinking on July 6th before starting Paxil.

Oddly, Rothschild also informed the jury that he, Rothschild, walked from the Reed Smith offices to the train station where Stewart Dolin's life ended. Why Rothschild claimed this is unclear, as there is no way Rothschild could ascertain what route Stewart Dolin took from his Reed Smith office to the train station. Rothschild also claimed that he reviewed Stewart Dolin's credit card details and that Stewart had purchased a train ticket. This, too, has not been verified, but Rothschild claimed such a purchase was made in an attempt to convince the jury that, somehow, buying a train ticket, supported Rothschild's opinion that Stewart was of sound mind and body and planned his death.

"If someone has, again, an irresistible impulse, you know, I actually have trouble working that bloody machine. I mean, if you had akathisia, why would you buy a ticket. I mean, you just jump over the thing and run down." He added, "It's just, to me, this was deliberate and planned. I mean, he had, he had to think, "I need the card to get, to buy the ticket, buy the ticket and get on the platform." It took some, you know, it was premeditated. He had planned this out ahead of time."
When asked about the witness who saw Stewart Dolin pacing before he jumped, Rothschild dismissed the restlessness, telling the jury, "A lot of people pace when they're waiting for a train."

I don't know what types of train platforms Rothschild frequents, but I've taken trains many times in my life and have never seen a person pacing the platform. I'd think it rather odd if I saw someone pacing up and down a train platform, and I would be concerned.

Rothschild then claimed he had read the police report in this case. He falsely claimed, under oath, that Michael LoVallo, a managing partner at the law firm where he and Stewart worked, told the police "that these problems at work may have been part of the reason Mr. Dolin committed suicide." However, as you will learn in cross-examination, further on down this post, LoVallo did not state this to the police.

A case for perjury, perhaps? We shall see.

Throughout King & Spalding's direct examination many visuals were used in a futile attempt to convince the jury that Stewart Dolin was frequently criticized by his work colleagues and that this criticism added to Stewart's work-related stress. However, the reality is that Stewart Dolin received excellent reviews from the vast majority of his colleagues and this was later highlighted when Rothschild was cross-examined (below). Rothschild conveniently omitted the excellent appraisals Stewart received from his colleagues.

Cross-examination by David Rapoport 

Plaintiff attorney, David Rapoport started his cross-examination of Rothschild by asking about the supposed statement LoVallo made to the police. Rapoport asked Rothschild if it was a lie. Rothschild answered, "No, it was not." However, the fact is, there was no such statement made to the police by Michael LoVallo. LoVallo does not believe that work stresses caused or contributed to cause Stewart Dolin's suicide, and Rothschild was forced to concede this fact whilst under cross-examination.

Next came the issue of Rothschild's cozy relationship with GlaxoSmithKline. In the Dolin case alone, Rothschild has been paid approximately $165,000 for his testimony. Rapoport pressed Rothschild further and asked him about previous cases where GSK has called him as an "expert" witness. When asked how many times GSK has hired him as a witness in Paxil death cases, Rothschild couldn't seem to count that high. "Going back 15 years, I can't give you an exact number, but it's probably in the neighborhood of 20 or 30."

Thanks for that info, Mr. Rothschild. You've now informed the jury that Paxil has been implicated at least 20 to 30 times in drug-induced death cases.  Did Rothschild receive poor coaching from his attorneys or did he finally decide to tell the whole truth, given that he had previously been caught lying? Of course, in each of the "20 or 30" cases where Rothschild has been paid by GSK for testimony, Rothschild has always claimed Paxil does not cause suicide.

Getting back to the issue of Stewart Dolin's train ticket, Rapoport showed Rothschild a Ventra card. The card is a pre-paid travel pass. Rothschild couldn't say for certain if Stewart used a Ventra card on the day of his death. Strange, because under direct examination Rothschild had claimed that a person with akathisia would not buy a ticket. He presumed that Stewart bought a ticket when in fact Stewart may not have had to buy a ticket at all.

Psychological autopsies

Under cross-examination, Rothschild was asked whether or not he was board certified to conduct psychological autopsies. He answered, "There is no such thing."

It's a crying shame that GSK's expert doesn't know much about the profession in which he claims to be an expert. The Psychological Autopsy Certification Training (PACT) disputes Rothschild's claim. Since 2011, The American Association of Suicidology (AAS) has offered the Psychological Autopsy Investigator Certification Program. I'm amused and aghast that GSK calls an "expert" who has no credentials in his field.

Visuals

During Rothschild direct examination by King & Spalding, many visuals were shown to the jury, visuals that lamely attempted to paint a bad picture of Stewart Dolin. Rapoport picked up on this. One such visual was a 2009 PGL evaluation where comments were left by  Stewart's employees. Rothschild didn't tell the jury about the glowing appraisals Stewart Dolin received. He didn't mention that Stewart's colleagues described Stewart as "honest, hardworking, and one who leads by example." He left out that Stewart "Seems to be decisive and takes what he does very seriously and cares about the group, seems to be a good administrator." He forgot to tell the jury that "Stew is honest and direct in his dealings with the C & S group."  "Stew is approachable and willing to listen. He sincerely wants to do his best. He's able to balance different constituencies" and so on. There were many more compliments of Stewart Dolin that Rothschild left out.

Rapoport then showed how Rothschild, in a previous testimony, claimed there is no evidence that there's a higher rate of death by suicide in children and adolescents who take Paxil versus placebo.

Finally, Rapoport asked Rothschild the following:

"So you've treated thousands of patients, some of them have committed suicide and never once have you found that a drug contributed to suicide in the patients, have you?"

Rothschild answered "No."

Rothschild was then asked further questions by King & Spalding on re-direct examination. It was basically them repeating themselves over and over until finally King & Spalding rested their defence.

David Healy returns to the stand.

In an unusual move, plaintiff's expert witness called Dr. David Healy back to the witness stand. Healy rebutted claims made by GSK's previous witnesses. GSK's "experts" previously criticized Healy's evidence, in particular, Healy's professional knowledge about akathisia.

Healy's evidence was, once again, damning to GSK.

Plaintiff's Exhibit 347
(Fig 1)

Of the 22 deaths that occurred during the Paxil clinical trials, many were violent. GSK's expert, Dr. Kraus, had previously testified that Paxil-related suicides were not violent. Healy was asked, "...of these 22 people who killed themselves while taking Paxil in GSK's clinical trials, how many of them were violent?" Healy answered, "16." He added, "There were a range of acts from hanging to gunshot wounds to throwing themselves in front of trains."

Healy was also asked if  GSK accurately reported suicide events in their Paxil clinical trials?

He answered, "No, they haven't." Furthermore, Healy told the jury, "I have been able to analyze the data from one of GSK's major depressive disorder trials and, in particular, to look at the suicidal events that happened in that trial."


On the subject of akathisia, GSK's "expert" witness, Anthony Rothschild, had earlier told the jury that there was no scientific or peer-reviewed literature supporting an association between akathisia and suicide. Asked whether or not this was true, Healy told the jury this was not true and he further referenced a book about akathisia authored by Dr. Sachdev. Healy informed the jury that this text is viewed as an authoritative work in the field. Healy also stated that GSK's "expert," Anthony Rothschild, had written about akathisia. In Chapter 2 of Rothschild's book, he wrote, "Akathisia, a syndrome marked by distinctly unpleasant symptoms of motor restlessness and anxiety may increase the risk of suicide."

What happened next was another twist in this case. More evidence, it appears, that GSK has been less than honest with the truth. In the Major Depressive Disorder (MDD) trials, GSK claimed 11 subjects attempted suicide. But Healy pointed out that this was incorrect, in reality, 12 people attempted suicide in GSK's MDD trials. When asked if GSK calculated this 12th suicide attempt in any of their analysis, Healy replied, "Apparently not."

This means that the 6.7% increased risk of suicidal behavior among adults who consume Paxil, "should be something more like 7.3," noted Healy.

The combined figure, as reported earlier in this trial, is actually a staggering 8.9%.

After Healy's rebuttal, a defeated Todd Davis from King & Spalding asked the judge to strike the testimony of Healy. The Honorable Judge Hart replied, "the motion to strike is denied."

Closing arguments from both plaintiff and defendant start next week.

Wednesday, April 12, 2017

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








The cross examination of John Kraus continued yesterday and saw plaintiff attorney, Brent Wisner, (Baum Hedlund) highlight the deaths that occurred during GSK's clinical trials of Paxil. For the benefit of the readers, and those who have been following this trial, I feel it is worthy of going through the individuals, if only to show them a mark of respect. Kraus maintains that these 'subjects' may have died as a result of their 'underlying illness.'

The jury heard about the following suicides during Paxil clinical trials. All the subjects were taking Paxil at the time of their death.

Female, 56 - Suicide.
Unknown gender - 50 - Suicide by hanging.
Female, 42 - Suicide by overdose of doxepin.
Female, 18 -  Suicide.
Female, 58 - Suicide by hanging.
Male, 24 - Unknown if it was suicide - Patient was hit by a train and killed
Male, 34 - Suicide
Female, 48 - Suicide
Female, 46 - Suicide by hanging.
Male, 54 - Suicide, jumped under a train.
Female, 67 - Suicide - on the fourth day of the study she threw herself out of a window.
Female, 32 - Suffocation due to vomiting.
Female, 33 - Suicide, jumped from 4th floor balcony.
Male, 65 - Suicide by an unknown method.
Male, 23 - Suicide.
Female, 31 - Suicide.
Unknown gender , 86 - Suicide by hanging.
Male, 46 - Suicide/Homicide - on December 14, 1998, the patient went to the home he shared with his estranged wife and shot her, he then turned the gun on himself.
Male, 40 - Suicide.
Male, 35 - Suicide (Shot himself)
Male, 19 - Suicide (Shot himself)
Female, 58 - Suicide by hanging.

My condolences to all their families.

There were also 40 suicide attempts during the Paxil clinical trials. Kraus was asked whether he ever sat down with any of those who tried to kill themselves while taking Paxil to ask them what they actually personally experienced?

Kraus answered, "No."

On the deaths, Kraus was asked whether or not the majority were over the age of 30. He answered that "80% of them" (were over the age of 30)

Brent Wisner then looked at the judge, "No further questions, Your Honor." He said.


Bob Fiddaman

**Update**

There's been some confusion about the way clinical trials are undertaken. A reader asked if subjects in clinical trials should all be fit and healthy with no underlying illness. Although some trials are run like this, most aren't.

Pharmaceutical companies much prefer clinical trials where the subjects are suffering an underlying "disorder." They can then claim, if the trial is a success, their product can treat that disorder and any suicides or attempts can be blamed on the "illness" rather than the treatment. Remember, clinical trials are ongoing, even when the drug gets to market. This is called the 'Post Marketing Phase.'

When a patient contacts the company because of an adverse reaction, the company request all medical files from the patients doctors. They do this, they claim, to rule out any other possible cause. In reality, they do this to blame underlying illness, other medication that may have been being used at the time, and/or the prescribing doctor.

This is clearly evident in the on-going Dolin Vs GSK Paxil induced suicide lawsuit.

It's called having your cake and eating it, too.


~ Bob Fiddaman




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