Tagged: Trial

Paxil (Seroxat) Implicated In Steven DeValle Trial..


http://www.uppermichiganssource.com/content/news/Steven-DeValles-second-day-sees-the-victim-on-the-stand-436603253.html

Steven DeValle’s second day sees the victim on the stand

MARQUETTE, Mich. (WLUC) – Opening statements started day two in the Steven DeValle attempted murder trial in Marquette, also on the stand today, the victim.

DeValle is charged with four counts, including strangulation and criminal sexual conduct against his ex-girlfriend last july.

Prosecuting attorney Matt Wiese calling his first witness, the victim herself, who we are not naming or showing.

In the prosecution’s opening statement, Prosecutor Matt Wiese told the jury to trust the evidence of those who were on the scene.

He also established for the jury DeValle was unstable and capable of attempting to kill the victim.

“He went from being enraged to being eerily calm and his mood she will tell you went in that way and when he became eerily calm is when she most feared for her life,” Prosecuting Attorney Matt Wiese said.

In the defense’s opening statement, attorney Ted fulsher told the jury DeValle and the victim were recently in a 15 month relationship, having only just days before gone on a family vacation together.

Fulsher told the jury about DeValle’s recent problems with mental issues, and of the recent switch in medication from Zoloft to Paxil.

“Paxil has numerous side-effects,” Defense Attorney Ted Fulsher said.

Those symptoms include, suicidal tendencies, erratic behavior and amnesia.

After opening statements, Wiese called the victim to the stand as his first witness.

The victim was asked when she saw a change in the defendant.

“I started noticing maybe some anger tendencies and maybe some anxiety tendencies about 1:30AM,” the victim said.

At that time, the victim says she messaged her police officer friend online to drive by and non-threateningly check in on them.

The victim claimed she then dialed in 911, to have it available if she needed to call, before the defendant knocked the phone out of her hand.

The defendant then became immediately concerned.

“He got angry and started making comments, you know, you’re calling the police on me and you know if you do that I’ll lose everything,” the victim said.

Wednesday, testimony from Forsyth Township Police and other medical personnel will be heard.


 

Steven DeValle trial enters day 4 as defendant takes the stand

MARQUETTE, Mich. (WLUC) – The Steven DeValle attempted murder trial entered its fourth day on Thursday July 27, with the defense calling a series of witnesses to the stand.

The first witness was Steven DeValle’s step mother. After that, his ex-wife in Illinois then delivered testimony via video conference. Both women claim that DeValle has never had a history of violence or abuse.

“As far as violence, that I know nothing of,” said Amy DeValle, ex-wife of the defendant.

The defense then heard from the officer who found Steven DeValle on the side of the road July 6, 2016, the morning after the incident. The deputy from Delta County said that DeValle seemed depressed and suicidal, it was then that he brought him to Escanaba’s St. Francis hospital.

The defense then submitted into evidence video of DeValle that morning when he was being arrested. In the video, DeValle appears manic, asking what he had done, claiming to have no memory of the incident.

Next, the defense called to the stand pharmacist Tyler Jenema, who said that while the medicine DeValle was taking, Paxil, could change his behavior, it was very unlikely that he would suffer from memory loss because of the medicine.

“The percentages are anywhere from half a percent or a little less, maybe up to one percent we think of patients maybe potentially experience amnesia,” said Jenema.

DeValle himself then took the stand, staying firm to his claim that he suffered from memory loss, even when his stories started to change. His original testimony to Forsyth Officer, Chief Warchock claimed that he had no recollection of the night of July 5, 2016 after 6pm but in court DeValle claimed he remembered events up to 9pm and even 10pm.

DeValle will continue to be examined and cross examined Friday, July 28 as the trial seems to be on track to that afternoon.

Reed Smith Widow Fires Back At GSK Bid For New Trial


https://www.law360.com/articles/945046/reed-smith-widow-fires-back-at-gsk-bid-for-new-trial

Law360, New York (July 17, 2017, 8:40 PM EDT) — The widow of a Reed Smith LLP attorney who died after taking a generic form of one of GlaxoSmithKline’s antidepressant drugs has blasted the company’s bid for a new trial, saying the company’s arguments for a do-over ignore evidence that does not fit its narrative.
A jury this spring awarded Wendy Dolin $3 million in her suit claiming her husband Stewart committed suicide after taking the generic version of GSK’s antidepressant Paxil and that the company failed to disclose the risk, and the company is now seeking a new trial, arguing Dolin didn’t prove her husband’s physician had been improperly warned about the drug’s side effects.

But Dolin on July 12 shot back at the pharmaceutical giant’s request for a new trial, saying that its claims are “patently untrue.”

For instance, GSK said that Stewart Dolin’s doctor testified he knew that suicidality was a common side effect of drugs like Paxil before he prescribed the drug and that he informed his patients, including Dolin, of the risks.

“These bold pronouncements of the record are, at best, misplaced and, at worst, outright false,” his widow said.

But the doctor testified that he relied on the 2010 Paxil label when he made his decision to prescribe the drug, which didn’t warn that Paxil could lead to suicidal behavior in adults over the age of 24. And he also testified that if GSK had warned of that risk, he wouldn’t have prescribed the drug to Dolin in 2010, Wendy Dolin said.

GSK argues the doctor knew that Paxil could induce suicidality in adults over age 24, since there was was language about suicide risks for all ages, according to Dolin.

But that’s a conflation of his testimony — the doctor knew that suicide was a risk associated with depression and anxiety, but not that Paxil could up that risk in adults over age 24, Dolin said.

GSK also argues that the U.S. Food and Drug Administration considered the label change Dolin said was necessary to fully warn doctors and rejected it, Dolin said.

But Dolin says GSK never proposed the warning that should have been included on the label, a short statement that taking Paxil is associated with suicidality in adults older than 24.

“Since GSK never attempted to insert that simple warning anywhere into the Paxil label, GSK cannot meet its burden of providing ‘clear evidence’ that the FDA would have rejected such a labeling change, especially when the only FDA expert to testify at trial rejected that notion,” Dolin said.

Dolin sued GSK in 2012, two years after her husband stepped in front of a train in downtown Chicago. Stewart Dolin had struggled with anxiety and depression off and on, and had begun taking generic Paxil just a few days earlier.

After the judge ruled that GSK is liable for the labeling on the generic versions of its drugs, Dolin argued the company had failed to alert the U.S. Food and Drug Administration to data that showed an increased risk of suicide in adults who take Paxil. With a short exception, the potential for suicide in adults was left off the drug’s label, the suit said, leaving doctors uninformed.

A jury agreed with Dolin, awarding her $2 million for Stewart’s wrongful death and $1 million for the pain he suffered in the days before he took his own life.

The FDA also invited GSK to discuss the inclusion of adult Paxil-specific language about suicidality in the label at a formal meeting in 2007, but the company didn’t take the agency up on its offer, Dolin said.

Representatives for the parties didn’t immediately respond to requests for comment on Monday.

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

GSK is represented by Andrew T. Bayman, Todd P. Davis, Ursula Henninger and Heather M. Howard of King & Spalding LLP and Alan S. Gilbert and Anders C. Wick of Dentons LLP.

The case is Dolin v. SmithKline Beecham Corp. et al., case number 1:12-cv-06403, in the U.S. District Court for the Northern District of Illinois.

13 Ways That GSK Hid The Seroxat/Paxil Suicide Signal…


Seroxat/Paxil/Aropax (Paroxetine) : The Anti-Depressant that makes you want to kill yourself!..

 


https://davidhealy.org/change-in-chicago-whose-problem/

Change in Chicago: Whose Problem?

May, 24, 2017 | Reply

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


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

Jim Gottstein, JD

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

BMJ: US drug regulators should consider adding adults to SSRI suicide warning, says campaigner


http://www.bmj.com/content/357/bmj.j2050
News

US drug regulators should consider adding adults to SSRI suicide warning, says campaigner

BMJ 2017; 357 doi: https://doi.org/10.1136/bmj.j2050 (Published 25 April 2017) Cite this as: BMJ 2017;357:j2050

  1. Ed Silverman

Author affiliations

A British doctor who campaigned for the public to be warned about increased suicide risk in young people taking antidepressants has said that US drug regulators should consider including adults in warnings.

David Healy, a psychiatry professor at Bangor University, called for the warnings after GlaxoSmithKline (GSK) was ordered to pay $3m (£2.34m; €2.75m) to the widow of a US man who killed himself shortly after starting generic paroxetine.

The jury in the case of Stewart Dolin, a 57 year old attorney, concluded that GSK had failed to properly warn the public about the increased risk of suicide when taking paroxetine. The jury reached its verdict after lawyers for Dolin’s widow, Wendy, presented evidence in the Chicago federal court suggesting that GSK knew that paroxetine posed a risk to adults but had concealed or manipulated data.

Dolin stepped in front of a train in July 2010 shortly after starting a generic version of paroxetine that was sold by Mylan Pharmaceuticals. Mylan was originally named in the lawsuit but was later dismissed because of regulations and a Supreme Court ruling that a generic company cannot be sued if the brand name company does not first change product labelling.

Warnings about the increased risk of suicidal thoughts and behaviour in children and young adults were added to the labels of antidepressants in the US and Europe more than a decade ago.1 In the US, however, labels do not warn of these risks for anyone over 24 years old.

Many consumers have tried to hold drug makers responsible for suicides in adults without success. But the legal team representing Wendy Dolin argued that GSK had artificially inflated the number of suicides and suicide attempts that occurred among people who were given a placebo during clinical trials of paroxetine. They said that this alleged move made the antidepressant look better by comparison, since it appeared to minimise the risk of suicide associated with the drug.

The lawyers also argued that GSK had used averages for all selective serotonin reuptake inhibitors (SSRIs) to demonstrate that paroxetine did not raise the risk of suicide in adults aged over 24. Court documents also indicated that paroxetine displayed a much higher risk than all but one of the SSRI drugs.

Wendy Dolin declared the verdict “a great day for consumers.” After the verdict she told the Chicago Tribune, “This for me has not just been about the money. This has always been about awareness [of] a health issue, and the public has to be aware of this.”

Healy, who spearheaded the campaign to upgrade suicide warnings on antidepressants and testified as an expert witness on behalf of Wendy Dolin, said that the findings in the case should prompt the US drug regulator to review the evidence on SSRIs and suicide risk in adults.

“When it becomes so clear cut that a jury finds there is a problem, it suggests the evidence is strong enough to look at the issue,” Healy told The BMJ. “If it’s that clear to the average man on the street, and the FDA [the US Food and Drug Administration] doesn’t do something about it, we have an odd situation.”

GSK, which markets paroxetine under the brand name Paxil in the US, has said that it will appeal the verdict. “GSK maintains that because it did not manufacture or market the medicine ingested by Mr Dolin, it should not be liable,” it said in a statement. “Additionally, the Paxil label provided complete and adequate warnings during the time period relevant to this lawsuit.”

GSK added, “The scientific evidence does not establish that paroxetine causes suicide, suicide attempts, self-harm, or suicidal thinking in adult patients. In 2007, FDA revised the labelling for the entire class of SSRI drugs (including generic paroxetine and Paxil). The label includes statements that studies did not show an increased risk of suicidality (attempts or ideation) in adults over the age of 24, and that there appeared to be a protective effect in adults over 64.”

References

The Dolin Trial… Glenmullen Enters The Fray..


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

Bob Fiddaman Reports On The Glaxo Criminals…


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

Tuesday, March 28, 2017

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

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

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


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

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

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


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

GSK… you evil bastards…

See Bob Fiddaman’s new post for more:

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


Wednesday, March 22, 2017

Dolin Vs GSK – 8.9 Suicide Increase For Adult Paxil Users

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Nice ethical company, huh?

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

Trial continues tomorrow.

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

Bob Fiddaman.
In Chicago.

Dolin Vs GSK

Dolin v GSK – Opening Arguments

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

Dolin vs GSK – Healy ‘Rocks Da House’

Dolin Vs GSK – JP Garnier Video Deposition

Dolin Vs GSK – The Dunbar Tape

Dolin Vs GSK – Day 4 – Slam Dunk

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


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

Tuesday, March 21, 2017

Dolin Vs GSK – Day 4 – Slam Dunk

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Andrew Bayman – King & Spalding’s finest

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

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

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

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

So, how does one defend the indefensible?

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

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

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

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

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

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

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

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

Healy, into his third day of questioning, smiled.

The answer he gave Bayman was simple.

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

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

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

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

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

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

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

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

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

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

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

Court resumes again tomorrow morning.

Bob Fiddaman.

Dolin Vs GSK

Dolin v GSK – Opening Arguments

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

Dolin vs GSK – Healy ‘Rocks Da House’

Dolin Vs GSK – JP Garnier Video Deposition

Dolin Vs GSK – The Dunbar Tape

Leonie Reports From The Stewart Dolin Paxil/Seroxat Suicide Trial..


https://leoniesblog.com/2017/03/19/dolin-v-smithkline-beecham-corp/

GSK’s Dirty Little Secret

Stewart
Dolin v SmithKline Beecham

So, myself and my friend Stephanie were in Chicago this week. We had traveled across the Atlantic to hear the opening arguments of Dolin v. Smithkline Beecham Corp (now GlaxoSmithKline – GSK). For more background to this case, see here.

We arrived straight into an unprecedented weather event, Storm Stella – described in the media as a weather bomb, having undergone bombogenesis (haven’t a clue either). Thus, while we were a little worried that the trial might be postponed, we were more concerned with the liklihood of two Irish females freezing to death. However, despite hitting a cool minus-8, with some pretty bizarre white-out conditions, we survived and the trial went ahead as planned (with the Hon. William T. Hart presiding).

This case centers on Wendy Dolin, the plaintiff, alleging that her husband’s death in 2010 was drug-induced and that GSK failed to warn of the increased risk of suicide in older adults taking the antidepressant Paroxetine. Her lawyers, Baum Hedlund, contend that GSK hid a ‘dirty little secret’ – that the drug can cause akathisia, often coded under the innocuously-sounding ‘inner turmoil’. However, this drug-induced condition is far from harmless and injury to oneself and/or others, can quickly follow. Furthermore, as alleged in this case, it can often prove fatal; see here.

At the time of his death, Stewart Dolin was 57 and was a corporate lawyer with ReidSmith. While suffering from work-related stress, he was prescribed Paroxetine by his physician, Dr. Martin Sachman – a family friend. Paroxetine is perhaps more widely recognised by its trade name Paxil, or Seroxat in Europe. Six days after being prescribed a generic form of the drug, Stewart died by jumping in front of a Chicago train. He was affluent, well-liked by colleagues and well-loved by his family. Per one of his colleagues “Stu Dolin was a close personal friend, valued colleague and a great leader in our firm. His energy and spirit benefited everyone around him. The lawsuit claims that GSK failed to adequately warn doctors (including Dr. Sachman) of the increased risk of suicidal behavior in adults. Indeed, GSK’s opening argument proclaimed that ‘Paxil does not cause suicide’. That was then contradicted by GSK’s very own literature, where a 2006 analysis showed a 6.7 times greater risk of suicidal behaviour in adults (of all ages) taking Paxil, over placebo.

Doctor David Healy was on the stand for 2 full-days, as an expert witness for the plaintiff. His testimony included an account of how GSK had hidden suicide events from the Food and Drug Administration (FDA), thus manipulating the suicide-ratio and effectively hiding the bodies. Explaining drug-induced suicides to the jury, his world-leading expert status in psychopharmacology was unquestionable. No doubt, GSK ‘s legal team will attempt to annihilate that particular status before he exposes any more ‘dirty little secrets’. Like how 100% of Paxil consumers will experience sexual dysfunction – another life changing adverse-effect he mentioned in court, and another one not precisely admitted to by the manufacturers.

Not surprisingly, GSK’s lawyers (King and Spalding), became increasingly apoplectic, interjecting every few minutes with their objections, which proved fascinating in itself. The last hour before the court adjourned for the week-end proved to be very enlightening indeed, with their team looking increasingly agitated. Doctor Healy was then asked some questions by the plaintiff’s legal team:

(1) Do you have any doubt that Paxil can cause suicide? He answered ‘No’.

(2) In your opinion, did GSK warn doctors of the increased risk of suicide in adults? Again he answered ‘No’.

There seemed little doubt to anyone listening that Paxil could cause Akathisia and/or a drug-induced suicide. However, no doubt GSK will have many experts to refute that, whatever the evidence has shown. Having listened to this week’s testimonies, there is absolutely no doubt in my mind that Steward Dolin’s death was induced by the Paxil he was taking in the final 6 days of his life. However, the trial will most-likely go on for another few weeks when the jury will ultimately decide. Sadly, as is normal in these legal cases, every aspect of Wendy and Stewart’s private life will be publicly torn to shreds, with their every move dissected to try and put doubt into the jury’s mind. Whatever the outcome, Stewart’s wife Wendy, is one very, very brave lady.

Clearly, GSK’s lawyers are particularly polished and well used to court proceedings. That said, following the jurys’ retirement for the weekend, there was a last minute crucial objection from their legal team. One of their lawyers raised a final grievance – that a lawyer for the plaintiff’s side had the cheek to say ‘have a good weekend’ to the jury. Seriously? Drug induced suicide was the issue here and this farewell gesture caused offence to GSK’s legal team?

Anyway, if you would like to see the three video depositions that were shown to the court; they were uploaded yesterday. You really don’t need to be a body language expert to determine how truthful these GSK experts are being – or not.

GSK Biostatistician John Davies Deposition in Paxil Suicide Case:
https://www.youtube.com/watch?v=C9_WvgqYkag
Former Glaxo Executive Jeffrey Dunbar Deposition in Paxil Suicide Case:  https://www.youtube.com/watch?v=K5OL0DC4xQE
Damning Testimony from Former GlaxoSmithKline CEO Jean-Pierre Garnier in Paxil Suicide Case: https://www.youtube.com/watch?