Zantac Lawsuit


Researching drug company and regulatory malfeasance for over 16 years
Humanist, humorist
Showing posts with label Mylan. Show all posts
Showing posts with label Mylan. Show all posts

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




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











Tuesday, April 11, 2017

Dolin Vs GSK: Suicide Prevention Warning "Futile", Claims GSK Exec





Futileserving no useful purpose : completely ineffective


Last Thursday GlaxoSmithKline vice-president, John Kraus, was called as a witness by defendants, GSK.

Kraus, when questioned by King & Spalding's jack-in-the-box, Andrew Bayman, was of the opinion that GlaxoSmithKline did everything in its power to warn of the FDA of the increased adult suicide risk posed by Paxil. Furthermore, Kraus stated it was the FDA's responsibility to determine that Paxil was safe and effective when used in accordance with the labeling.

On the subject of akathisia and whether or not it was a precursor to suicide, Kraus told the jury that GSK carried out its own study and found that akathisia was not associated with an increased risk of suicide or suicide-related adverse events.

This was basically all Kraus had to say. Bayman went over and over the same points. So, according to GSK's own vice president, the FDA were informed about the link between Paxil and adult suicides, but the FDA never acted on this information. Further, according to Kraus, akathisia is just a condition that "is some of the internal sense of feeling agitated, but it's accompanied by kind of a physical manifestation. This can include inability to sit still, moving up and down, things of this nature."

Kraus was not asked by Bayman whether or not he thinks Paxil caused Stewart Dolin to kill himself, neither was he asked his general opinion about adult Paxil-induced suicides. Hardly surprising given that Kraus testified in a previous adult Paxil suicide lawsuit that, "GSK could not definitively state that any increased risk would end at a particular age." (see Vanderwerf Vs SmithKline Beecham)

Yesterday Kraus was asked by Andrew Bayman why GSK never requested a meeting with the FDA to discuss possible Paxil label changes relating to the adult suicide link. Kraus somewhat flippantly, replied, "It would've been futile." He based this answer around GSK's supposed previous attempts to change the label specifically for Paxil. Kraus claimed the FDA preferred a class labeling, a system whereby the FDA prefer to group all SSRIs together. Kraus also stated GSK could not add an adult suicide warning to the black box on the Paxil labeling, citing this was up to the FDA. Kraus also asserts GSK could not add an adult suicide warning in the 'indication and usage section' of the label because it "wasn't appropriate" to add a warning to this particular section of the label. Kraus claims there was no place on the label that was appropriate to add an adult suicide warning.

In fact, claimed Kraus, there was nowhere on the label that was appropriate for an adult suicide warning.

Nice to see GSK have the consumer at heart, huh? So, according to Kraus and GSK, suicide prevention is "futile", correct?


Cross Examination

Brent Wisner was quick to point out to Kraus that the FDA does not prohibit GSK from adding warnings to Paxil labeling. When discussing GSK's refusal to meet with the FDA to address the specific Paxil labeling, Wisner asked who was it that made the decision not to meet with the FDA. Kraus admitted it was ultimately his decision.

On speaking of the two apparent placebo suicides that occurred during the Paxil clinical trials, Wisner asked Kraus if this was a lie. Kraus told the jury (under oath) that this was not a lie, suggesting instead that it was just "inaccurately written."

GSK and their witnesses do love this doublespeak, don't they?

Wisner also asked Kraus if GSK purposely withheld crucial adult suicide data from the FDA for 10 years because during those 10 years GSK had exclusive rights to sell Paxil. In other words, as long as GSK had the patent, nobody else could sell Paxil in its generic form. Kraus told the jury he didn't know because he was not a patent expert.

The subject of Paxil's promotion was raised, in particular how GSK reps used a published paper (Montgomery and Dunbar) that suggested Paxil reduced suicidality in adults. The paper was based on the two apparent placebo suicides. An internal memo to GSK's sales reps was read to the jury:

"In the analysis from controlled studies and open extension studies of Paxil calculated by patient year of exposure, there were 2.8 fewer suicides in the Paxil-treated group compared with active control and 5.6 times fewer compared with placebo. Clearly, very positive results."

The above was to be disseminated to doctors throughout the United States to alleviate concerns that Paxil did, indeed, induce suicidality in adults.

We know now, and even GSK has admitted, that the two suicides among the 544 placebo patients in Montgomery and Dunbar's 1995 publication actually occurred during single-blind placebo run-in. However, GSK has made no effort to retract the published paper by Dunbar and Montgomory, and neither have either of the authors. (Dunbar's video testimony can be seen here.) Once GSK realized they had a problem, an email was sent out by GSK's head of marketing, Barry Brand. The letter to GSK executives implied that anything submitted to the FDA regarding adult suicide would "be setting us up for potential problems." Furthermore, GSK's marketing head was named, once again, in another email shown to the jury. This email showed how GSK had concerns about raising the suicide issue with the FDA because, at the time, there was already litigation regarding SSRIs and suicide.

Wisner also showed the jury an email from GSK's Pamela Barrett who had raised this issue about adding GSK's Paxil studies into a pool. Barrett wrote that the inclusion of studies 057 and 106 in the suicidality analysis would have "skewed the data." Despite this, GSK still included studies 057 and 106 which watered down the actual number of suicides in the Paxil arm during GSK's clinical trials.

Cross-examination continues today.

Exclusive new 'In Da Paxil Club' video featuring...

John Kraus (GSK)
Andrew Bayman (King & Spalding)
Todd Davis (King & Spalding)
Andrew Witty (Former GSK CEO)
JP Garnier (Former GSK CEO)


CLICK HERE
(Opens in new browser)


Bob Fiddaman




Dolin Vs GSK - "Babes"

Dolin Vs GSK - Wendy's Cross and GSK's Petition

Dolin Vs GSK - Robert "Bling Bling" Gibbons














Friday, April 07, 2017

Dolin Vs GSK - Robert "Bling Bling" Gibbons




As noted in my last blog, Robert Gibbons is considered an "expert" only by GSK and other pharmaceutical companies who pay handsomely for his inventive numbers crunching. The phrase "figures lie, and liars figure" perfectly sums up Gibbons' "scholarly" junk science.

In the Netherlands, for example, Dr. Dick Bijl, who is the current Cheif Editor of Geneesmiddelenbulletin, a monthly bulletin for prescribing physicians, was less than complimentary toward Gibbons. Gibbons authored a research paper in which he claims higher rates of suicide are caused by the FDA Black Box warning. Gibbons states children are dying by suicide because they aren't taking SSRIs! But Bijl notes Gibbon's conclusions were “astonishing” and cannot be made from the data available. In an issue as important as childhood suicide, Bijl further states the authors were “reckless.” The Dutch investigative radio program, Argos, highlighted Bijl’s concerns, quoting experts in statistics, epidemiology, and child psychiatry, who warn of the “danger” in such “misleading” research.

With the above just being one example of Gibbons junk science, it came as no surprise that King & Spalding focused their day and a half examination on Gibbons' data. Of course, none of the well-documented criticisms of Gibbons by reputable scholars and scientists were mentioned by King & Spalding's Todd Davis. To back up his claims that Paxil and other SSRIs reduce the rate of suicides, Gibbons referred to other 'academic papers.' On cross-examination by Brent Wisner of Baum Hedlund, Gibbons motives became crystal clear. Wisner pointed out that every single research paper Gibbons quoted had authors who, collectively, had lucrative financial ties to the pharmaceutical industry. Gibbons admitted GSK is paying him $1,000 per hour to regurgitate his answers. On being asked if the two research papers Gibbons criticized had authors with direct conflict of interest ties to the pharmaceutical industry, Gibbons was, I imagine, left red-faced. It turns out his criticisms of papers that note there is a link between antidepressant use and suicide were authored by academics with no Big Pharma ties.

Nevertheless, Gibbons still maintains that antidepressants reduce suicides. He even told the jury that GlaxoSmithKline's own figure of a 6.7% increase for adults taking Paxil was incorrect. Gibbons seems to be in a bubble of delusion. Who wouldn't be when being paid $1,000 an hour by many pharmaceutical companies including Glaxo, Wyeth, and Pfizer?

It's difficult to accept the word of a millionaire who lacks morals and ethics. I say millionaire because between 2002 and 2013 Robert Gibbons pulled in a staggering $4,958,346 in National Institutes of Health (NIH) grants. This amount doesn't include the handsome sum he collects from pharmaceutical industries during litigation. Gibbons has been called a pharma whore and pharma shill, amongst other names. I'd say he's far worse than that:  His junk science is putting both adults and children at harm, and likely responsible for many avoidable SSRI-induced deaths.

It is nauseating to see the pharmaceutical attorneys and their witnesses continue to lie and deceive the unsuspecting public, jurors and consumers alike.

Gibbons finished his evidence yesterday and is now in line to give evidence for GSK in another lawsuit filed against them in the UK. That lawsuit alleges that patients taking Paxil struggled with horrific withdrawals whilst trying to taper off it. Buisness as usual then for Robert Gibbons.

Being present in the courtroom during the early stages of this trial was, for me at least, a dream come true. I'm a bit of a geek when it comes to law, particularly pharmaceutical litigation. Though I was harmed by Paxil for years, my own adverse Paxil experiences pale into insignificance when I think about the trauma Wendy Dolin and her family have endured. Considering most families whose loved ones have died from Paxil never even have their day in court, the number of people adversely impacted by GSK's product is likely staggering. Another staggering number is GlaxoSmithKline's rules and regulations violations. GSK has settled out of court so many times with so many victims, I've lost count.

Some of the people who have been harmed by SSRIs have names and faces known to the general public because they have channeled their grief into advocacy so that others might live. I feel tremendous compassion and respect for these advocates, people like Neil and Rhonda Carlin, Kristina Gehrki, Leonie and Tony Donnelly, Stephanie and John Lynch, Stephanie Gatchell, Kim Witczak, and Elaine Billings. Behind them are thousands of nameless victims whose avoidable tragedies are not known by the general public.

Perhaps one day GSK and other pharmaceutical companies might publish all the data from their secret, sealed cases that were settled out of court? My, wouldn't that be a large document? GSK would need a dump truck to deliver all their binders.

King & Spalding could then advertise their data collection and legal services on national TV. I can almost see Todd and Andy now, standing next to sky-high boxes of binders.

"Hi I'm Todd, and this is Andrew. We here at King & Spalding like to polish a turd."

The trial continues next week with the continuation of evidence being given by John Kraus, who is a vice president with GSK. Kraus is a former psychiatrist. Seriously, a former psychiatrist who is now vice president of GSK?

This shit just writes itself!

Bob Fiddaman





Dolin Vs GSK - "Babes"

Dolin Vs GSK - Wendy's Cross and GSK's Petition






Wednesday, April 05, 2017

Dolin Vs GSK - Wendy's Cross and GSK's Petition






Continued from Dolin Vs GSK - "Babes"

Cross-examination of Wendy Dolin

Ursula Henninger continued her cross-examination in an attempt to dismiss the role Paxil played in Stewart Dolin's death. Henninger tried to shift focus from Paxil's adverse side effects to Stewart's work history and previous prescriptions. (Stewart was prescribed another SSRI, Zoloft, years earlier and it was discontinued because he experienced several adverse side effects.)

Henninger reviewed Stewart Dolin's employment history and raised questions about work-related tension and anxiety. She even asked questions about Stewart's experiences in law school and first professional job decades earlier.

I mean, C'mon! Doesn't everyone feel a little anxious when taking an important exam or starting a new job? Certainly, GSK and all pharmaceutical companies fully understand such situational anxiety considering all their sales pitches promote SSRIs as some sort of miracle pill to wash away anxiety and sadness. GSK and other SSRI makers use these scenarios to their advantage when advertising SSRIs. But in court, situational anxiety is touted by GSK attorneys as a cause of violent death!

To add insult to injury, Henninger then changed direction and asked Ms. Dolin about the time when her aging parents temporarily moved in with them. Henniger asked whether or not Stewart felt anxious about it. What loving son-in-law wouldn't feel concern about his aging in-laws?

Throughout the cross, Wendy Dolin explained that Stewart was dedicated to finding the right balance and that he viewed therapy as a personal investment to help maintain such balance. Henninger's repetitive questioning continued, and she even inquired about the dreadful night Wendy learned Stewart had died. Henninger reminded Wendy that in her original deposition Wendy had not reported any unusual behavior to the police officers the evening Stewart passed away. Wendy replied that she was "in a total state of shock."

Going down this line of questioning was unsavory and appeared unnecessary, but hey-ho, it is what we've come to expect from King & Spalding during this trial.

Re-direct

After Wendy's cross-examination, she was redirected by David Rappaport, and a video of Stewart's life was played for the jury. The jury saw Stewart high on life, active, fun, goofy, traveling, hiking, skiing but, most importantly, they saw the sheer joy and happiness on the face of a man who was devoted to the family and friends he dearly loved. When the video finished, David Rappaport turned to the jury and rested the case.

After the jury had recessed, King & Spalding petitioned the court to dismiss the case. The GSK lawyers claimed there was not sufficient evidence to support Wendy’s claim that Paxil’s adverse side effects and misleading, inadequate warning caused Stewart's death. I believe this is standard procedure for defence attorneys when faced with what seems to be impending defeat. It's also quite possible that the Bayman, Davis & Co. circus is suffering delusions.

GSK attorneys cited points of law and case points, but the Honorable Judge Hart wasn't buying their bull. Judge Hart ruled that the evidence Dolin has presented is to be viewed in a light most favorable to Dolin. The trial will proceed.



Counter Evidence

GSK is now starting to present its counter-evidence and yesterday called its first "expert" witness, Robert Gibbons. To call Gibbons an "expert" is laughable considering Gibbons has been labeled a "Shill"* by members of his own profession.

Gibbons, a biostatistician, has infamously lobbied for the removal of the black box warnings for children. He appears to believe children are not harmed by SSRIs and that some kids are actually dying because they are not prescribed SSRIs. Further, Gibbons has also made outlandish claims stating SSRI drugs, such as Paxil, actually reduce suicide.

More on Gibbons tomorrow, although not too much. I feel it improper to give Gibbons a platform to spout his ignorance and junk science on my blog.


Bob Fiddaman

*A shill, also called a plant or a stooge, is a person who publicly helps or gives credibility to a person or organization without disclosing that they have a close relationship with the person or organization.





Dolin Vs GSK - "Babes"





Tuesday, April 04, 2017

Dolin Vs GSK - "Babes"





Yesterday several witnesses gave evidence in the Dolin Vs. GSK trial. Stewart Dolin's co-worker, Mike LoVallo was first examined by plaintiff's attorney, David Rappaport. Rappaport asked LoVallo a few questions about Stewart's day-to-day role at their firm. The same can't be said for King & Spalding's resident jack-in-the-box, Andrew Bayman, whose cross-examination gave a whole new meaning to the word "boring."

Bayman seemed to gain nothing with his tiresome line of questioning. Rather, he unwittingly highlighted for the jury the lame ways GSK tries to defend its drug and product labels. Thus far, GSK has blamed the FDA, the prescribing physician, and the now deceased Paxil victim, Stewart Dolin. GSK's repetitious cross-examination never focuses on the company's duty to inform doctors and patients of the real risks posed by its product.  Had GSK done everything it could have and should have done decades ago when Paxil hit the market, there would be no Dolin Vs. GSK trial.

As we've seen before, Bayman's cross-examination of LoVallo lasted longer than plaintiffs' direct examination. King & Spalding plays the 'you-didn't-say-that-two-years-ago' game. They frequently ask the witness or expert questions that were already answered years ago in depositions.  Perhaps King & Spalding believe it is ground-breaking to discover that a witness might use slightly different words when explaining the same sentiment and thoughts the witness shared years before? Their tactics are akin to a team of schoolyard bullies goading their victim, trying to put words into their mouths. More often than not, witnesses and experts called thus far have had to tell King & Spalding to read the whole of the depositions. But King & Spalding want to take lines out of context and read, what they deem, might be damning evidence against the witness or expert. GSK's attorneys know full well there is no "caught you" there, but they hope some of their misleading questions will be heard by the jury to cast doubt on Paxil's starring role in Stewart Dolin's death.

Apparently, pharmaceutical company attorneys like to "cherry pick" data and stretch the truth in court just as pharmaceutical companies do in clinical trials. But today GSK's legal tactics didn't amount to much when questioning the Dolin family.


King & Spalding's Cross-Examination




King & Spalding chose a new player for their circus performance. No jack-in-the-box Bayman, no clown antics from Todd Davis. Instead, King & Spalding opted to cross-examine the Dolin family by using a female attorney from their firm. Ursula Henninger (pictured above) has, according to her online profile, more than 20 years of experience trying personal injury claims in courts throughout the United States. She has defended a variety of product liability claims, including those against tobacco manufacturers and pharmaceutical companies. Seems a bit odd that she was relegated as a mere courtroom sidekick, sitting quiet as a mouse with seemingly no active role in the trial until today when the Dolin family took the witness stand.

You can draw your own conclusions as to why King & Spalding decided to use Henninger to cross-examine the Dolin family. Is it a stereotypical, sexist tactic? You know, choose a female attorney to question the widow and her children? Is GSK hoping the jury will see a female lawyer as a "softer, kinder" interrogator? Perhaps. But if playing the gender card was part of GSK's strategy, it didn't seem effective. Henninger offered no condolences to any member of the Dolin family and instead jumped straight into her questions. She lacked sympathy and empathy, and I suspect this deficit will be noticed by the jury.

Stewart's children, Bari and Zach, gave evidence first and spoke of the love they had for their father and how empty they have felt since his passing. It was then the turn of their mom, and Stewart's widow, Wendy.


Enter Wendy Dolin.

I am going to be brief here as the court was recessed part-way through Wendy's evidence at the time of this writing. I'll update when Wendy Dolin finishes her testimony. With that said, it's important to report on Wendy's evidence thus far.

Wendy told the jury how she met Stewart at the age of 16 in Miami, Florida. She noted that they were married on June 15th, 1974. She recalled Stewart had a strong work ethic from a very young age. "He was delivering prescriptions for the Belmont Pharmacy.  And or those of you I know are from Chicago, the pink hotel on Bryn Mawr used to have a soda shop.  And he was a short-order cook there.  And this was at 15 years old.  So he was an extraordinarily hard worker and really smart."

Regarding Stewart's work-related anxiety problems, she told the jury, "Stewart was someone who was really proactive. I think that's the best way to put it. He took care of it. I mean, he thought about it, you know. You know, I just thought he was a normal human being who periodically had stress and anxiety like probably most of us."

Being asked about her typical weekends with Stewart, Wendy told the jury how much she and Stewart enjoyed each other's company. "Our weekends consisted of something that's really special.  On Fridays and Saturday nights, he'd say, "Well, what time do you want to get up, Babes?"  He used to call me Babes. And I'd tell him the time. And he'd usually bring up a cup of coffee, and then the dog would follow. And he would wake me up, and we'd come downstairs, and we'd sit on the couch in the living room, talk for a long time.

"Our friends used to say to me, "What the heck do you talk about?" And I'd say, "Well, we manage to talk." And that became known as couch time. And what's really special about couch time is my friends know how special that is, so when my friends sleep over, everybody has to have couch time. But that was really, you know, it's really funny, not funny ha ha.  It's that, you know, we worked so hard to get to a place where we had no debt, and our house was paid off.  You know, you saw these two beautifully high-functioning connected kids settled in their jobs, and you're able to do things like go to dinner or go on a trip.  But when it's all taken away, that's what I just ache for, that special time, which is just brings you back to what it was really like to just be Wendy and Stewart."

Explaining her grief, Wendy told the jury, "I love writing to him.  It's like cathartic. It's like couch time, you know, through a letter.  And then the cemetery is still something that -- I don't know.  Grief, it's, you know, everyone in this room, I'm sure, has had a loss of someone dear; and it's just really hard, you know. And I try to be whole as much as I can.  I try to put on a happy face, but it's hard. There's always something there to remind me of him."

Cross-examination

Tomorrow I will report on Wendy Dolin's cross-examination.

Bob Fiddaman


MISSD
Since Stewart's drug induced death, Wendy has set up a non-profit organization dedicated to honoring the memory of Stewart and other victims of akathisia by raising awareness and educating the public about the dangers of akathisia.

Akathisia is a disorder, induced by SSRI medications, which can cause a person to experience such intense inner restlessness that the sufferer is driven to violence and/or suicide. It has been said, "Death can be a welcome result." 








Thursday, March 30, 2017

Dolin Vs GSK - Glenmullen Nails It!





On Tuesday a series of video depositions were aired to the jury. Sadly, I have no access to the videos and cannot directly report on them. Thankfully, GSK's lawyer, Todd Davis, has provided fabulous entertainment akin to a desperately sad clown. Yesterday Davis ineffectively cross-examined the plaintiff's next expert witness, Dr. Joseph Glenmullen.

Dr. Glenmullen is yet another thorn in the side of GSK. He has previously served as expert witness in many Paxil lawsuits, and, just like Dr. David Healy, is disliked by GSK and their King &  Spalding attorneys. Both Glenmullen and Healy were subjected to GSK's pre-trial circus in which GSK filed motion after motion arguing that these renowned doctors should not give evidence at this trial. GSK's attempts were denied.

After yesterday, I can vividly see why GSK opposed Glenmullen as an expert. In short, Glenmullen ran circles around Davis. More on this further on down this blog post.

Glenmullen detailed Stewart Dolin's medical notes and told the jury the akathisia Stewart experienced occurred the last time he was prescribed Paxil. This was six days before Stewart's Paxil-induced death. During these six days, Stewart showed increased signs of agitation, just as he did when he was previously prescribed Zoloft years ago. In fact, when the Zoloft dose was increased, Stewart's adverse drug reaction (akathisia) worsened. When Stewart stopped taking Zoloft, his agitation subsided. Sadly for Stewart and his survivors, when he last took Paxil his adverse drug reaction ended in death. Akathisia, as Glenmullen stated yesterday, is "a drug-induced reaction, a compulsion to kill yourself." Glenmullen added that a death such as this is referred to "as a paroxetine-induced accident, not a suicide. It's paroxetine. It's the label that didn't warn that is the cause."

Regarding GSK's supposed adult suicide warning on the Paxil labeling, Glenmullen clearly nailed it. Referring to the 2010 Black Box warning displayed in court, Glenmullen told the jury how there was explicit language that short-term studies did not show an increase in the risk of suicidality with antidepressants compared to sugar pills in adults beyond age 24. He also pointed out the sentence, "Depression and certain other psychiatric disorders are themselves associated with increases in risk of suicide." He explained to the jury, "...What that tells me as a practicing psychiatrist is that if I'm treating a 57-year old patient and I put them on Paxil, Paxil couldn't make them worse. Paxil couldn't make them suicidal. It would be, and it says explicitly, their depression or other psychiatric condition."

Glenmullen further noted the black box warning is "really bad" because it implies the suicide warning is just for children, ergo a doctor treating an adult could not warn about a potential risk of suicide because the labeling suggests there is only a suicidality risk among children taking Paxil.

The jury was informed that the labeling was written in such a way so that doctors would not only NOT know about the adult suicide risk, doctors would actually increase the dose because they would assume worsening of depression and/or new disturbing behaviors had nothing to do with Paxil.

Glenmullen added, "And here's another dimension to it. If the patient gets worse and it might be the drug, what do you do? You take them off the drug to see. If they get worse and it couldn't be the drug but it's the depression, what do you do? You increase the drug, which is going to worsen the risk. So it's very dangerous. And that's why, in my opinion, it's really this lack of a warning that's responsible for his (Stewart Dolin's) death."

Glenmullen told the jury he is "100% certain" that "Mr. Dolin's was a "paroxetine-induced, Paxil-label-induced death."



Cross-examination by King & Spalding's Resident Clown

As per his norm, Davis repeatedly tried but failed to discredit the witness. He attempted to catch out Glenmullen with answers Glenmullen provided in various testimonies, including testimony that was more than 11 years ago!

A spectator in the court told me, "You should have seen the spectacle created by GSK when it came time to do their cross.  They were so unorganized with their multiple binders that the jury started to laugh."

Davis also went down the route of asking Glenmullen how much he was paid to give expert opinions in previous Paxil litigation. Leaves me wondering how much Todd Davis has been paid to defend one of the most controversial drugs in history. Further, I wonder whether he and his law team view their thousands of "settlements"as victory.

In what world is it viewed as a success to place gagging orders on families of Paxil victims so that the truth about the dangerous product is hidden?

Thus far, Davis has done a fine job of entertaining both spectators and jurors alike. Today's Davis looks more like a sad clown than the smug clown who skipped into court three weeks ago. So, there you have it: King & Spalding attorneys seem to work well together if one considers their joint performance mere entertainment. Sad clown Davis and his jack-in-the-box sidekick, Andrew Bayman, will continue their lame cross-examination of Glenmullen today.

Bob Fiddaman




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.










Friday, March 24, 2017

Dolin Vs GSK - Day 7 - Abraham Lincoln




Day 7 in Dolin Vs GSK began with the continued cross-examination of former FDA official, Dr. David Ross, by GSK's King & Spalding attorneys.

GSK is desperately trying to convince the jury that the company repeatedly sought to change the Paxil labeling but, supposedly, the FDA wouldn't allow it. GSK's attorney, Andrew Bayman, futilely tried to put words into the mouth of the witness, attempting to trick Dr. Ross into agreeing he said things he has never actually said.

It's still a head scratcher for me - on the one hand, GSK is claiming that Paxil is safe for adults, on the other they claim they told the FDA there was an increase in suicidality in adults on Paxil. How could both be true?

It appears Glaxo concedes Paxil can increase suicidality in adult consumers but that this suicidality increase does not lead to completing suicide.  However, if you die by "suicide" when consuming  GSK's product, Paxil, GSK's drug didn't cause it.

Yesterday, former FDA official, Dr. Ross, was asked by Bayman:

"Other than the 6.7 finding with respect to the secondary analysis of definitive suicidal behavior, you're not aware of anything in GSK's 2006 adult suicidality analysis that would meet the definition of reasonable evidence of an association between the use of Paxil and suicidality that would warrant a label change, correct?"

Dr. Ross, who remained unphased, replied:

"Well, the answer to that is yes, I am, but more importantly, as I said to your colleague two years ago, that's a little bit like saying, 'aside from that, Mrs. Lincoln, how did you enjoy the play?'"

This was a great response considering the excuses GSK regurgitates when faced with claims that Paxil induces adult suicidality, and severe withdrawal effects or birth defects, etc. It is the standard corporate response to repeat, "Paxil has helped millions of people worldwide."

Why would GSK attempt to place an adult suicide warning on the Paxil label if it is the company's position that Paxil does not induce suicidality in adult patients?

King & Spalding's Bayman has been trying to catch Dr. Ross in non-existent contradictions for two days. Dr. Ross, who often quite brilliantly turns the questions back onto Bayman, remains steadfast that the Paxil suicidality data created by GSK is false and misleading.

Thus far GSK has claimed it wasn't their fault they didn't warn the public, it was the FDA's failure. It wasn't Paxil that precipitated the death of Stewart Dolin; it was his underlying illness. It is GSK's position that Paxil causes suicidality in adult consumers; it's also their position that it doesn't.

Akathisia is the Paxil-induced medical condition that often precipitates suicidal thoughts and suicide itself. GSK continues to point out that there is an FDA class warning for all SSRIs stating the drugs can cause akathisia. However, what GSK attorneys don't want to mention is that their product, Paxil, is more likely to cause suicidality than other SSRI offenders. Specifically, when the clinical trial data is correctly interpreted, it shows Paxil causes an 8.9 increase in adult suicidality.

All SSRIs can and often do cause akathisia and suicide. Unfortunately, drug companies and the FDA continue, to this day, to inadeqautely define akathisia. This collective failure continues to harm patients and ill-informed prescribers.

Today's Paxil label describes akathisia simply as "psychomotor restlessness." Further, it states:

"The use of paroxetine or other SSRIs has been associated with the development of akathisia, which is characterized by an inner sense of restlessness and psychomotor agitation such as an inability to sit or stand still usually associated with subjective distress. This is most likely to occur within the first few weeks of treatment."

Once again, there is no mention that akathisia is a precursor to suicide. Of course, GSK's Andrew Bayman doesn't tell the jury this fact, either. However, GSK's BigPharma colleague, former Pfizer Medical Director Dr. Roger Lane, confirmed this fact way back in the 1980's.  Lane wrote two peer-reviewed articles about SSRI-induced akathisia. About akathisia-induced suicide, he stated, "It may be less of a question of patients experiencing fluoxetine-induced suicidal ideation, than patients feeling that ‘death is a welcome result’ when the acutely discomforting symptoms of akathisia are experienced on top of already distressing disorders."

Lane was referring to fluoxetine, which is the drug, Prozac, just as paroxetine is the drug Paxil. An expert witness for Prozac manufacturers, Eli Lilly and Company, conceded under oath that SSRIs cause akathisia. At the Forsyth v. Eli Lilly and Company murder/suicide trial, Lilly’s expert witness, Dr. Victor Reus testified that both Paxil and Prozac can cause akathisia in patients.

King & Spalding's Andrew Bayman frequently concedes in the Dolin Vs GSK trial that SSRIs can cause akathisia. Further, Bayman continues to point out that akathisia is listed on the drug class label. However, what Bayman doesn't want to emphasize is what drug company scientists have known and confirmed for years: As Pfizer's Dr. Roger Lane stated decades ago: "death is a welcome result’ when the acutely discomforting symptoms of akathisia are experienced."

GSK has downplayed the suicide risk in adults taking Paxil for nearly 25 years. It's absurd and misleading to claim that calling akathisia "psychomotor restlessness" would ever lead consumers and prescribers to interpret this intentionally vague definition as an increase in suicidality.

GSK and all SSRI manufacturers should be shouting from the rooftops the exact definition of akathisia, as should medicine regulators. Instead, yesterday the Dolin Vs. GSK jury was treated to some loud entertainment by Bayman. He tried to drown out the facts by shouting at the expert witness. It was so unprofessional that the Honorable Judge Hart had to tell Bayman to "stop shouting."

Further witnesses will be called next week as this case unfolds. Meanwhile, here's a short video produced by MISSD that helps everyone better understand akathisia.






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

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


Thursday, March 23, 2017

Dolin Vs GSK - Day 6 - Ass Kicking Semantics






ass kicking

To be beaten senseless because you definitely deserve it.

semantics
the branch of linguistics and logic concerned with meaning.


The plaintiff examination of former FDA Medical Advisor, Dr. David Ross, finished today. Ross, who was examined by Brent Wisner of Baum Hedlund, read from a document shown on the screen to the jury. The paper was published in J Clin Psychiatry and authored by, amongst others, John E. Kraus, an employee of GlaxoSmithKline. The published article, 'Meta-analysis of efficacy and treatment-emergent suicidality in adults by psychiatric indication and age subgroup following initiation of paroxetine,' tries to play down the risk of Paxil-induced adult suicide. Further, the paper claimed that there was no difference in suicidality among patients who took paroxetine and those who took a placebo.

Finalizing his questions to Dr. Ross, Brent Wisner informed the jury that the article was actually written in 2008. Bayman, King & Spalding's resident jack-in-the-box retorted that it was 2011, a year after Stewart Dolin died. Bayman seemed confident and had a smug look on his face at the thought of getting one over a prosecuting attorney. The smug look was wiped from his face by Wisner when Wisner informed Bayman--and the jury--that the paper was submitted to the journal in 2008 and published in 2011. This was two years before Stewart Dolin's Paxil-induced death. Bayman's jack-in-the-box spring lost its bounce as he slumped back down in his chair licking his wounds like a scolded schoolboy.

I do love to see Brent Wisner in action, and it is even more fun to see Wisner kicking GSK's ass.

King & Spalding's cross-examination of Wendy Dolin's expert witness, Dr. David Ross, commenced today. It was merely a game of semantics, blame shifting and one person (Bayman) trying futilely to catch another in contradiction.

Andrew Bayman once again was in charge of the calvary, his sole mission being to undo all the data Dr. Ross previously shared with the jury.

Did Bayman succeed?

Hardly. It seemed a junior-league attempt to try and trip up Dr. Ross regarding a deposition he gave more than two years ago. It was also an effort to try to show the jury that, despite all the evidence showing Paxil has a 9-fold increase in inducing suicidality in adults, GSK is not responsible for clearly communicating this life-threatening information to healthcare professionals and the public.

Bayman kicked off by trying to discredit the credentials of Dr. Ross.

"Are you a pharmacologist?", Bayman asked.

"No." Dr. Ross replied.

"Are you an epidemiologist?" Bayman asked.

"No." Dr. Ross replied.

Bayman, whose team can't seem to defend the statistics previously shown at trial regarding the number of adults endangered by Paxil, was trying to convince the jury that Dr. Ross wasn't qualified to provide evidence regarding FDA rules and label regulations.

It left me wondering if Glaxo's former CEO, JP Garnier, would ever be asked if he were a criminologist. To my knowledge, the Monty Burns look-a-like holds no Ph.D. in criminology, yet, under his guidance, GSK committed various crimes which they have already plead guilty to committing.

Indeed, Bayman himself has defended GSK's nefarious activities on countless occasions, as have the law firm for whom he works. Does this make Bayman and his fellow co-workers qualified experts in septal heart defects, homicide, and addiction, all of which have previously been the subject of King & Spalding trials regarding Paxil use?

Bayman also went down the tired road of 'It wasn't Paxil, it was the underlying condition.' A line we hear on a daily basis from pharmaceutical companies defending the latest prescription drug-induced lawsuits.

Yesterday the jury were shown that Paxil labeling does not mention the suicide risk in adults. They were also shown that there is little or no explanation of the word 'Akathisia' that accompanies the patient information leaflet for Paxil.

Bayman argued that the word 'Akathisia' is in the labeling. Maybe so, but who, exactly, knows what akathisia means, particularly when the medical term remains ambiguously undefined, as GSK wants it. There is no mention on the label that Akathisia often creates suicidal thoughts and actions. Instead, the SSRI class labeling states akathisia is 'motor restlessness' - a vague description for a prescription-drug induced condition that often causes suicide!

Despite there being a 9-fold increase of suicidality in adults taking Paxil, and that GSK has known this for 25 years, there is no mention of this in today's Paxil label. Bayman glossed over this by deflecting the blame to the FDA. He claimed the FDA have responsibility for the language on the labeling, ergo, it's not GSK's fault, it's the FDA's fault. In any event, Bayman claims that GSK tried to change the labeling. Perhaps this might be true, yet, oddly Bayman has shown the jury no proof that GSK ever attempted to petition the FDA to communicate the real suicidality risks Paxil causes. Even if GSK did petition the FDA to correct the Paxil label, GSK apparently then sat back and did nothing after the FDA did not amend the label despite having a legal, moral and ethical duty warn consumers of the real Paxil-created risks. Even GSK's former CEO, JP Garnier, admitted this moral responsibility in a video deposition shown the jury last week.

Garnier said under oath, and I quote, "...there is a legal right for us to go directly to the public."

Evidence here.



So, Bayman trying to convince the jury the suicide warning was down to the FDA contradicts what the top boss at GlaxoSmithKline says.

A strange defence, unless of course Bayman thinks JP Garnier was lying under oath?

Garnier lying? Surely not!

The trial continues tomorrow.

From this point I'll be giving periodic updates and not daily ones.







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