Tagged: Dolin

Dr David Healy Recounts His Experiences Of The Dolin Paxil Trial..


Dr David Healy recounts his role in securing a victory against GlaxoSmithKline in the Stewart Dolin Paxil trial…

Compelling reading..

More on the Dolin trial in later posts..


https://davidhealy.org/change-in-chicago-playing-go/

Change in Chicago: Playing Go

May, 8, 2017 | 1 Comment

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

Seroxat/Paxil Lawsuit Shows That Seroxat Increases Suicide Risk Over 800 Percent…


http://www.naturalblaze.com/2017/03/pivotal-lawsuit-shows-widely-used-antidepressant-increases-suicide-risk-over-800-percent.html

Pivotal Lawsuit Shows Widely Used Antidepressant Increases Suicide Risk Over 800 Percent

suicideBy Annabelle Bamforth

A trial is currently underway in Illinois as a widow seeks to hold pharmaceutical manufacturer GlaxoSmithKline accountable for improper labeling and minimizing a potentially serious side effect of a well-known antidepressant.

Paroxetine is a widely prescribed antidepressant and anti-anxiety drug under the class of drugs known as selective serotonin reuptake inhibitors (SSRIs). Paroxetine is most commonly known as the brand name of Paxil, manufactured by GlaxoSmithKline (GSK). 

Since 2012, Wendy Dolin has been engaged in a legal battle against GSK following the suicide of her husband, Stewart Dolin. Wendy says that in the summer of 2010, Stewart was prescribed a generic version of Paxil for anxiety issues related to work. According to Wendy, Stewart Dolin complained of becoming increasingly anxious and restless and was unable to sleep while taking the drug. On July 15, 2010, less than one week after beginning this medication, Stewart committed suicide by walking in front of a train.

Wendy began searching for answers in the wake of her husband’s suicide and said she learned that he had been displaying signs of akathisia, a disorder characterized by an individual’s inability to relax or sit still. Psychiatrist Joseph Glenmullen said in 2006 that “Patients have described [akathisia] to me as listening to nails scratching on a black board 24/7, or your bones rattling like tuning forks. It is this inner agitation that is by far the most dangerous.” In 2012, Wendy filed a legal complaint against GSK seeking to hold the manufacturer liable for her husband’s death. The complaint noted that “a scientist working for another SSRI manufacturer, Pfizer, wrote in a 1998 medical journal article that the suicidal impulses resulting from akathisia may be explained as a feeling that ‘death is a welcome result’ when the ‘acutely discomforting symptoms of akathisia are experienced on top of already distressing disorders.’”

The critical issue in Wendy Dolin’s lawsuit is not simply paroxetine itself. It’s no secret that lawsuits against pharmaceutical companies are usually complicated under most circumstances, but this case is particularly notable as a tragic example of the gray area of liability when a patient is prescribed a generic drug, as well as the problems between the FDA and drugmakers that exist when it comes to publishing safety labels for patients and doctors.

It’s important to distinguish that Stewart Dolin was not prescribed the brand of Paxil, but a generic brand of paroxetine that was manufactured by another company, Mylan. Brent Wisner, Wendy Dolin’s attorney, described the issue as a “donut hole of liability” in which both the generic and the original manufacturer deny responsibility. “That’s where you have the generic maker on one hand saying, ‘We don’t know about these risks. We can’t be held responsible for them… plus, we can’t change the label,’” Wisner said according to an NBC investigative report. Winner added that “the brand name makers are saying, ‘Well, we didn’t make the pill.’”

Generic drugs are often prescribed in place of specific brands, mainly to save costs, as generic drugs cost far less than brand names on average. In Illinois, where the Dolin family resided, “state pharmaceutical laws actually require such a substitution unless a doctor has advised against it. Some of the few courts that have sided with plaintiffs in generic-drug injury cases have also highlighted this conundrum for generic-drug plaintiffs,” according to a Law360 report on Wendy’s case.

Wendy and Wisner claim that the warning label that was given to the generic brand was “factually incorrect and misleading.” In their lawsuit, they allege that “the paroxetine label in existence at the time of Stewart Dolin’s death did not warn of the drug’s association with an increased risk of suicidal behavior in adults despite GSK’s knowledge of a statistically significant 6.7 times greater risk in adults of all ages. In fact, the label stated the opposite – that the suicidality risk did not extend beyond the age of 24.” Stewart Dolin was close to 57 when taking paroxetine.

The lawsuit alleges that GSK whitewashed the suicide risks of Paxil in its data given to the FDA. The complaint explains that in 1989, GSK”s “Integrated Summary of Safety Information,” required to gain approval from the FDA, included a presentation identifying the number of suicide and suicide attempts during clinical trials. The suit alleges that GSK’s summary “skewed the statistical analysis of the data presented and obscured the true risk” by including suicide attempts “of placebo patients that had taken place in the placebo run-in (or wash-out) phase” before the clinical trials began. “Run-in” or “wash-out” refers to a time period of removing any other drugs in a trial participant’s system; any “adverse events” that take place during those periods are not appropriate or generally accepted for inclusion in calculations during clinical trials, the suit claims.

The Cook County Record reports that while those warning labels on Paxil and paroxetine were approved by the FDA, GSK said it was not allowed by the FDA to include an additional warning of a “statistically significant increase in the frequency of suicidal behavior in patients treated with paroxetine.” GSK claims that the FDA wanted to maintain homogeneous warnings among all antidepressants.

However, U.S. District Judge James Zagel noted that GSK “never asked for a formal meeting, nor did it seek additional labeling regarding Paxil-specific data” in a February 2016 ruling, and further wrote that “Moreover, GSK never sent a separate supplement and declined the FDA’s invitation for a meeting to discuss the inclusion of … the adult warnings.”

The trial against GSK is in progress and is expected to last a few weeks. Bob Fiddaman, a blogger and author who has written extensively about his own experiences with paroxetine, has been covering the developments of the trial. Fiddaman wrote that a “startling revelation” was unveiled on March 22nd:

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.

Fiddaman wrote that Dr. Ross, who worked for the FDA for ten years, offered lengthy testimony. Fiddaman points out that Dr. Ross discussed the problematic relationship between the FDA and drug manufacturers. The FDA relies heavily on the accuracy of the data that is provided by drug companies, which is problematic when the companies present arguable data.

GSK’s argument has summarily been that they do not bear liability because the drug that was prescribed to Stewart Dolin was not manufactured by Mylan, not GSK. The company has stated that “we remain consistent in our stance that since GSK did not manufacture or market the generic paroxetine ingested by Mr. Dolin, it should not be held liable in this trial.”

Annabelle Bamforth writes for TheFreeThoughtProject.com, where this article first appeared.

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

Bob Fiddaman Covers Day 2 Of The Dolin Paxil Induced Suicide Trial..


I don’t know  about you, but I have been fascinated by Bob Fiddaman’s coverage of the Stewart dolin Paxil induced suicide trial the last few days. His latest post uncovers some really damning material for GSK in regards to Paxil/Seroxat. It’s surprising that GSK chose to bring this case to court, surely even the dogs in the street know that GSK are nothing but an utterly reprehensible corrupt entity? and that close to NONE of their drugs can be trusted as efficacious or safe?

GSK are proven liars, felons, deceivers and fraudsters.

They lie about everything, particularly the data. They can’t be trusted. They have simply no credibility and they haven’t had a shred of it for years.

Paxil/Seroxat is particularly bad in terms of controversy because it’s utter poison.

The Seroxat Paxil scam has long been exposed, and the game has been up for a long time too.

These court cases reveal the carcass of a company- which has long been- rotten to the core.

Fair play to Fid for covering this compelling case.

I look forward to more revelations in the coming days ahead.


http://fiddaman.blogspot.ie/2017/03/dolin-vs-gsk-day-two-jack-in-box.html

Thursday, March 16, 2017

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

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Day two kicked off with King & Spalding’s Andrew Bayman finalizing his points to the jury that he started yesterday. He told them that, in 2006, GSK told the FDA about Paxil’s increased suicide risks, he also told them that ‘Dear Doctor’ letters were sent out across the United States and that Stewart Dolin’s doctor was aware of this. According to Bayman, the FDA changed GSK’s warnings for all SSRIs and not just Paxil. Bayman also claimed that the FDA had told them (GSK) 4 times that they could not use their own wording in the label warning. Bayman also told the jury that GSK’s sales force (reps) have no influence in prescribing habits – at this point I had to hold in my laughter, given that they paid a $3 billion fine recently to the DOJ for doing just that! (See – “GlaxoSmithKline to Plead Guilty and Pay $3 Billion to Resolve Fraud.”)

More on King & Spalding’s Andrew Bayman later in this post.

Next up was Brent Wisner of Baum Hedlund who is representing Stewart Dolin’s, widow, Wendy Dolin.

Dolin presented the jury with three video depositions, the first being a May 2006 testimony from former GlaxoSmithKline CEO, JP Garnier. The depo was used in a previous case against GSK where Debra L. Tucker filed suit against them for the wrongful death of her brother, Rick, who, she alleged, killed himself after taking GSK’s Paxil.

In the 2006 testimony Garnier was asked…

“Would you agree that a reasonable and prudent pharmaceutical manufacturer has a duty to warn prescribers of serious adverse events?”

Garnier answered, “Yes, I would agree.”

It was also learned from Garnier’s deposition that there is a law in place to help pharmaceutical companies should they wish to change the labelling because of new evidence that may arise regarding serious adverse reactions. He was asked…

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

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

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

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

The above 2006 statement from Garnier kind of contradicts what King & Spalding’s attorney, Andrew Bayman, told the jury earlier in the day.

The next video deposition aired in court today was from John Christian Davies, a statistician from GSK. He confirmed that 8 of the 11 suicide attempts that have been previously mentioned in this trial were aged 30 or below, leaving 3 that were over the age of 30. GSK, in the Dolin trial, are denying that Paxil can cause suicide in adults. Hard to believe that a bunch of highly paid attorneys would think that anyone over the age of 30 are children or adolescents.

The final video deposition to be aired today was that of Geoffrey Charles Dunbar. Dunbar gave his testimony in September 2005, again it was in relation to another Paxil wrongful death lawsuit.

In 1987 Dunbar joined GSK, who were then known in the UK as Beecham Pharmaceuticals. He was given the role of director of CNS, a role whereby he oversaw Paxil clinical trials. Paxil, at this stage, was still in its infancy and hadn’t yet come to market.

In the 2005 video deposition Dunbar was asked about the contentious two placebo suicides that were wash-out and run-in suicides (Back story). He said that he was not aware of them, he added that he had only recently become aware of them (bear in mind that the video deposition was taken in 2005).

Dunbar was then pressed further…

“Whether it was through oversight or negligence or intent or whatever the reason, that publication of published data was invalid, wasn’t it?” 

and

“Well, regardless of intent here, isn’t it true that public health on SSRIs for paroxetine was greatly misserved by your publications of this data in ’91 and ’92 and up through ’95 as being valid paroxetine figures not designated with an asterisk for wash-out and run-in? That was a misservice to public health, wasn’t it?”

Dunbar answered, “It was an error.”

Dunbar was then asked, “Okay. Are you inclined to do anything to correct the record, such as notifying GlaxoSmithKline that your authorship was incorrect?”

Dunbar answered that it wasn’t his intention to do so, on being asked why this was so? He answered…

“Because I think GlaxoSmithKline are very well aware of the issues we’re discussing now.”

Once the video depostions were played to those in attendance today, David Healy was then called to the witness stand…it was not without incident as King & Spalding made objections before Healy entered the courtroom, objections that saw King & Spalding attorney, Andrew Bayman, almost bursting a blood vessel as he tried to persuade the Judge not to allow certain lines of questioning from Baum Hedlund’s Brent Wisner.

The questions thrown at David Healy today, and his subsequent answers, will be covered in a blog post tomorrow. Suffice to say King & Spalding’s Andrew Bayman spent most of the day impersonating a Jack-In-The-Box as he stood from his seated position pleading objections to the Judge more times than I can count.

I personally think Bayman had an adverse reaction to the presence of Healy.

More on this tomorrow.

Bob Fiddaman.

Dolin back stories.

Christmas Cheer GSK Style! : Just The Usual Sociopathic Skullduggery and Devious Under-handedness, From The Felons Glaxo, And Their Dark Hearted Lawyers..


http://fiddaman.blogspot.ie/2016/12/glaxo-has-dolins-bells-ringing.html

From Fiddaman Blog:

Saturday, December 24, 2016

Glaxo Has Dolin’s Bells Ringing

GlaxoSmithKline – The company that keeps on giving.

Glaxo have been dealth yet another blow in the Paxil suicide case filed by Wendy Dolin over 5 years ago.

To date Glaxo have made endless requests that have been denied by the Judge, they have tried to get expert witnesses barred from giving evidence and even wanted to hold their own kangaroo court for one of Dolin’s witnesses, David Healy – once again they were denied.

Their latest attempt is, or was, a wonderful attempt at skullduggery. It defies belief that they would try to even go down this particular route but, I guess, they have exhausted every possible line of trickery and manipulation so one final attempt before trial commences shouldn’t really come as a surprise to those who know exactly how Glaxo and their highly paid law team, King & Spalding, like to operate.

Some time ago Glaxo were informed by the Judge that they should not try to blind the jury in this case with irrelevant documents. The jury just need to know the facts and endless documents would just confuse them. So, what did Glaxo do on the back of this request from the Judge? Well, they submitted a 170 ­page exhibit list with roughly 1,500 proposed defense trial exhibits – so, no attempt at burying the jury in paper, right? (See Judge Backs Widow’s Objection To GSK Trial Documents)

The documents are hundreds of pages long and, according to Dolin, if printed out would fill more than 20 bankers’boxes.

Wendy Dolin, through her law team, Baum Hedlund Aristei & Goldman PC, objected to the mountain of paperwork and the Judge, U.S. District Judge William T. Hart, has sustained her objections, leaving Glaxo and  King & Spalding with their tails between their legs and having to spend Christmas with the knowledge that they cannot dupe the Judge or jury in this case.

Better luck next time folks (I’m sure there will be another Paxil related suicide case to defend)

Furthermore, GSK objected to evidence being presented to the jury by Dolin, namely, correspondence between Glaxo and the FDA. The Judge denied them this and many other objections they had filed regarding Dolin’s evidence to be presented – (Boo-hoo)

The antics of Glaxo and their crispy white shirts has prompted yet another ditty from  yours truly. I hope Glaxo and King & Spalding enjoy this latest offering.



DOLIN’S JINGLE BELLS
The Judge has dealt a blow
On the mighty GSK
He has told them ‘No’
You cannot have your way.
He has barred their lists
Not let them have their way
The jury in the Paxil case
Who they’ve tried to lead astray
Oh, Dolin bells, Glaxo smells,
the Judge has blown away
Glaxo’s endless motions,
exhibit lists, horseplay.
Oh, Dolin bells, Glaxo smells,
they’ve been denied again
Let’s all laugh at their expense
and pull their lawyers chain.
Paxil is not safe
It makes you lose your mind
Suicide and birth defects
For which they have been fined.
They’ve settled out of court
With Paxil addicts too
They claim its safe and effective
But we all know that’s untrue.
Oh, Dolin bells, Glaxo smells,
the Judge has blown away
Glaxo’s endless motions,
exhibit lists, horseplay.
Oh, Dolin bells, Glaxo smells,
they’ve been denied again
Let’s all laugh at their expense
and pull their lawyers chain.
Now Dolin awaits her day
That she will have in court
Where documents presented
Will show they failed to report
the Paxil suicide link,
which they kept at bay
To me, at least, they’ve lost this case
So, let’s jingle all the way.
Oh, Jingle bells, Glaxo smells,
the Judge has blown away
Glaxo’s endless motions,
exhibit lists, horseplay.
Oh, Jingle bells, Glaxo smells,
they’ve been denied again
Let’s all laugh at their expense
and pull their lawyers chain.
Lyrics by Dee Nide and the Motions.

 

Paxil/Seroxat/Aropax (Paroxetine) : “Question Of Drug’s Label Goes To Trial…”


http://www.chicagolawbulletin.com/paxil-2-16-16.aspx

Question on drug’s label goes to trial

paxil-2-16-16,ph02

James B. Zagel
Law Bulletin staff writer

A federal judge has again declined to throw out a lawsuit accusing the maker of the anti-depressant Paxil of liability in the suicide of a Chicago lawyer who took a generic version of the drug.

In a written opinion last week, U.S. District Judge James B. Zagel rejected the argument that the negligence claims brought under Illinois law by Stewart Dolin’s wife are pre-empted by federal law.

Wendy Dolin filed the suit in Cook County Circuit Court, and GlaxoSmithKline (GSK) removed it to federal court under diversity jurisdiction.

The suit maintains the labels on Paxil and its generic version are false and misleading because they failed to warn of an increased risk of suicide in adults over the age of 24.

In a motion for summary judgment, GSK argued such a warning is pre-empted by the Federal Food, Drug and Cosmetic Act.

Zagel didn’t see it that way.

A failure-to-warn claim is preempted by federal law, he wrote, citing Wyeth v. Levine, 555 U.S. 555 (2009), only if there is “clear evidence” the U.S. Food and Drug Administration would not have approved the warning the plaintiff alleges is required by state law.

GSK presented no such evidence, Zagel wrote.

In 2007, he wrote, the FDA invited GSK to discuss the option of keeping language on Paxil’s label warning of the possibility of an increased risk of suicide or suicidal thoughts in adults.

GSK didn’t take the FDA up on that invitation, Zagel wrote.

GSK, he wrote, did not ask for a formal meeting with the FDA and did not ask to include additional language on the label concerning Paxil’s possible effect on adults.

Under those circumstances, GSK failed to meet the “demanding burden” of showing it would have been futile to seek permission from the FDA to add an adult suicide warning on Paxil’s label, Zagel held.

Wendy Dolin is represented by attorneys who include R. Brent Wisner of Baum, Hedlund, Aristei & Goldman P.C. in Los Angeles.

The lead attorney for GSK is Alan S. Gilbert of Dentons U.S. LLP.

Neither attorney could be reached for comment.

In 2010, Stewart Dolin killed himself by leaping in front of a Chicago Transit Authority train at the Blue Line station at Washington and Dearborn streets in the Loop.

Dolin, 57, was a partner in Reed, Smith LLP.

He had started taking a generic version of Paxil, the brand-name version of paroxetine hydrochloride, six days before he committed suicide.

In addition to alleging the warning on the paroxentine label was inadequate, Wendy Dolin contends GSK concealed and manipulated data concerning the drug.

GSK wanted to obscure the fact that paroxetine carries a 6.7 times higher risk of suicide in adults who take the drug compared to those who take a placebo, Dolin contends.

In 2014, Zagel dismissed all claims against Mylan Inc., which made the paroxetine taken by Dolin.

But he held GSK must face claims under Illinois law of common-law negligence, negligent misrepresentation and product liability based on a negligence theory.

In the 2014 opinion, Zagel conceded GSK did not manufacture the paroxetine taken by Dolin.

But the federal Hatch-Waxman Act requires that a generic drug’s design and warning label must match those of the name-brand drug, Zagel wrote.

Therefore, he held, the brand-name maker must in some circumstances face claims based on the warnings on the generic version’s label.

In last week’s opinion, Zagel declined to reverse his 2014 ruling.

Noting that GSK and Wendy Dolin plan to call expert witnesses to the stand during the trial, Zagel also declined to hold that the Paxil’s label is adequate as a matter of law.

And Zagel rejected arguments that the doctor who prescribed Paxil for Stewart Dolin knew of the drug’s risk and, therefore, GSK could not be liable in Dolin’s suicide.

The doctor’s testimony suggests he didn’t know of the increased risk of suicide in adults over 24, Zagel wrote, and he relied on the 2010 Paxil label before prescribing the drug.

The suit is to go to trial on Sept. 19.

Zagel issued the opinion Thursday in Wendy B. Dolin v. SmithKline Beecham Corp., No. 12 C 6403.