Glaxo's Beef With David Healy Part II

Following on from Glaxo's Beef With David Healy, which I wrote about back in October 2015.

Back story.

In summary, Wendy Dolin has filed a suit against Paxil (Seroxat) manufacturers, GSK, alleging that Paxil caused the suicide of her husband, Stewart. Since filing Wendy has been subject to GSK's defence lawyers subpoenaing her cellphone and text message records, her home phone and her late husband's company phone. King & Spalding, GSK's defence team, have also asked Wendy about her love life and shown the private medical notes of her later husband to her children.

Not content with targeting a grieving wife, GSK have also singled out David Healy, an expert called by Dolin in the case against GSK.

In short, they have claimed that Healy should not be allowed to give evidence in the trial, he's not credible, he has a bias, he's telling people to go out and kill.

It's all hot air, much of which has been cherry-picked from Healy's blog and, in some instances misquoted and misguided - for example GSK's highly paid law team, who must have combed through Healy's blog by borrowing their client's rat-infested flea comb have claimed Healy has said things when in actual fact he hasn't, it's been comments left by others on Healy's blog - so much for crossing the T's and dotting the i's, huh?

Anyway, you get the gist, right?

GSK target the person filing the suit against them then, after failing, they then target that person's expert witness. You just have to love how King & Spalding operate at times.

Well, they failed in getting Healy's testimony thrown out. In fact, they wanted all four of Dolin's witnesses to not have their testimony's aired.

 They were denied these motions by Judge James B. Zagel who, in summary, said...

“I am denying all four of GSK’s motions to exclude. The Daubert criteria are satisfied when a well-credentialed expert provides well-supported opinions that are relevant and reliable.”

One would have thought that was that - but remember, we are dealing here with a pharmaceutical company (and their attorneys) who will try everything in the book when the defence of Paxil becomes so weak.


GMC BACKGROUND

In 2013 Healy found himself under the spotlight after a patient in his care suicided. This event spurned a review by Betsi Cadwaladr University Health Board (BCUHB) who, for reasons not known, hired an external consulting Psychiatrist, Dr. Robert Higgo to take a role in the review process.

The review, according to Healy, was meant to examine the circumstances surrounding the incident. Higgo, in his review, accused Healy of misconduct.and submitted his findings to the BCUHB.

In response to Higgo's allegations the BCUHB...

(1) initiated an internal investigation to examine the allegations

and

(2) sent a referral to the GMC to explore whether there was any misconduct that would raise concern about Dr. Healy’s fitness to practice medicine.

To cut a long story short, Healy was exonerated by the GMC. They concluded...

"As Dr. Healy had stated from the very beginning, that Dr. Higgo’s report was unfounded and that Dr. Healy did not engage in any conduct putting his fitness to practice medicine into question."

So, Healy was cleared. Here's where it gets interesting.

While in America, Healy was tracked down by attorneys who served him with a subpoena, the gist of which was that he should produce all documents concerning the BCUHB and GMC investigations.

No guessing who those attorneys were.

Healy refused, citing that it would jeopardise his employment as a physician and documents that were deemed privileged and confidential by BCUHB.

GSK then filed a motion to the court, basically demanding that Healy produce the documents.

The court asked to see the document in chambers (ie; just them and not GSK) so they could make a decision as to whether these documents were relevant to the Dolin case, moreover, relevant to GSK's argument that Healy's testimony in the Dolin case should be heard.

Healy handed over the documents to the court in July last year.

It was during the courts review of these documents that GSK filed motions for Healy to be dismissed as an expert witness - as previously mentioned, the court denied them this.

But, on and on they go. GSK now wish to conduct a hearing with Healy before the Dolin trial date of January 2017. Dolin, via her attorney, Brent Wisner of Baum, Hedlund, Aristei & Goldman, sent another letter to GSK indicating that...

“...in light of the recent ruling by the General Medical Council (“GMC”) clearing Dr. Healy of wrongdoing, this proceeding is no longer necessary or relevant.” 

Furthermore, plaintiff added that if GSK wish to pursue this matter then  she (Dolin) would like to conduct targeted discovery related to GSK’s interactions, if any, with GMC and Betsi Cadwaladr University Health Board (“BCUHB”)

Has the penny dropped yet?

The GMC exonerated Healy but now, it seems, GSK want their own kangaroo court to attack him even further.

In a quite genius twist Dolin's legal team have now asked the court that if GSK are granted a special hearing with Healy before trial then they request that plaintiff should be permitted to conduct targeted discovery relating to any influence GSK may have had in BCUHB’s or the GMC’s investigation of Dr. Healy.

In short, Dolin is asking for...

All documents reflecting communications between GSK or its agents, including counsel representing GSK, and Robert Poole, Robert Higgo, Giles Harborne, Matt Makin, Alberto Salmoiraghi, Peter Higson, or anyone at Betsi Cadwaladr University Health Board that mention or discuss Dr. David Healy.

All documents reflecting any payments or monies by GSK or its agents, including counsel representing GSK, to the aforementioned.

They've requested the same documents between GSK and the GMC too.

I wouldn't put it past anyone connected with GSK to find ways to sling mud at one of their biggest critics - I've heard the 'bullet left on a car story' but thought it was just folklore - I'm seriously beginning to think there was merit in that claim from a plaintiff who went up against GSK many years ago... apparently they wouldn't accept GSK's offer, next thing they know, there's an empty bullet casing left on their car...but that's another story.

Who needs John Grisham, huh?

The whole sordid affair, or rather matter of affairs, has me wondering if GSK's UK legal team will go down the same road when defending Paxil in a UK lawsuit next year. Just over a hundred people have filed a group action claiming they suffered as a consequence of withdrawing from Paxil. In 2002 GSK settled over 3,000 similar cases in the United States but, for one reason or another, GSK won't settle with those who make the same claims against them in the UK.

Will they be mud slinging Healy et al again, or bloggers for that matter?

The motion to vacate the 'special hearing' was filed by R. Brent Wisner on August 1.


Author's note.

Researching pharmaceutical companies, in particular GlaxoSmithKline, over the past ten years or so has taught me a few things when it comes to litigation.

1. The pharmaceutical company will defend cases in antidepressant related suicide, homicide, birth defects and withdrawal - even though the drug in question has been proven to cause such adverse reactions - they will, under oath, admit their drug can cause all of the above but will refute that (in the case they are defending) it did not cause x,y, or z to kill themselves or cause induced homicide, birth defects or horrific withdrawal problems.

2. They will drag litigation out for as long as they can, throwing subpoenas left, right and centre - they will object to this and that and will file motions in the hope that plaintiffs attorney's will spend more - thus settle at a later date for a meagre offer - See the Paxil birth defect case - Joanne Thomas v GlaxoSmithKline here and here.

3. They like to show their teeth. It's a way to stop further litigation against them. The actions in the case of Dolin v GlaxoSmithKline is basically a stark warning being sent out to anyone who may have ideas of going up against GSK in the future. It doesn't matter if you lost your child to suicide or had to abort your child due to birth defects caused by Paxil - or if you lost your job and marriage due to horrific Paxil withdrawal - you are dealing with a company that shows no empathy - it's an entity that is psychopathic - it cares not a jot about personal feelings - Grinding its teeth and digging its heels in is just an advertisement by proxy. The message being, Oppose us and we will make your life a complete misery. They not only do this with people who bring claims against them, they do it with expert witnesses who go up against them. One only has to look at the way they have targeted David Healy - it's not just about targeting Healy, it's about sending a message out to other future expert witnesses.

That's my take on things anyway.

Anyone know how the ruckus between David and Goliath finally ended up?

Answers on a postcard to King & Spalding.



Bob Fiddaman


Related

Court document shows how a jury, in 2001, found GSK's Paxil responsible for inducing suicide and/or homicide.

GSK: Motions Denied in Paxil Suicide Case

Earlier this year I reported on how GSK, via their team of highly-paid lawyers, had targeted four expert witnesses that were due to give evidence in (Dolin v. SmithKline Beecham Corp. et al., case number 1:12-cv-06403)

For those that don't know, Wendy Dolin had filed suit against GSK claiming that their antidepressant, Paxil, had induced the suicide of her husband, Stewart. Since filing, Wendy has, just like the four expert witnesses due to give expert opinion supporting her claim, has come under fire from GSK. In fact, Wendy Dolin has been sent more than 30 subpoenas from GSK, they have also made over 70 record requests and have shown the Dolin children their father's private medical notes. To top it all, GSK's lawyers have been asking (goading) Wendy about her love life since her husband killed himself.

Not satisfied with targeting a bereaved wife, GSK then turned their attention to four expert witnesses. One of those witnesses, Dr. David Healy, came under heavy fire from Glaxo's gunslingers, King & Spalding. They had accused Healy of being a radical activist who held an extreme bias against GSK (insert tears here). Furthermore, GSK had probed into Healy's private life and had, during a 10 hour deposition, talked more about his finances than the actual science behind Paxil and induced suicide.

The decision is in folks and.... (drum roll)..

GSK have been roundly trounced.

Judge James B. Zagel, in summary, said...

"I am denying all four of GSK’s motions to exclude. The Daubert criteria are satisfied when a well-credentialed expert provides well-supported opinions that are relevant and reliable. My decision does not, however, mean that the reliable opinions of all four of these expert witnesses are correct—reliability is a measure of consistency of opinions, not necessarily a measure of correctness. Such a determination will be the job of a fact-finder at trial."

Healy, along with three other experts, namely; Dr. David Ross, Dr. Joseph Glenmullen, and Dr. Roger Grimson, will now be allowed to offer their expert opinions in the Dolin case, something that GSK have fought desperately hard to suppress and, as I suspect, may now be the factor in some sort of settlement being agreed upon.

This isn't the first time GSK have faced claims that Paxil induces suicides in adults. In 2001 a jury returned a verdict that Paxil was responsible for inducing homicide and suicide in Don Schell, who had, some years previous, shot to death his wife, daughter and granddaughter before turning the gun on himself.

Glaxo were ordered to pay $6.4 million to the remaining family members.To the layman, it beggars belief why Glaxo would oppose the claims of Wendy Dolin given that they have already lost one Paxil induced suicide case. The mud-slinging and goading of plaintiff and expert witnesses doesn't surprise me in the least, it's what I have come to expect of Glaxo and their defence lawyers. Wendy Dolin isn't the first plaintiff to have pressure put on her by Glaxo, she won't be the last. Healy et al aren't the first expert witnesses to have mud thrown at them, again, they won't be the last.

If anything, this ruling has shown Glaxo that no matter how hard they try to suppress those who wish to seek the truth, they will always fail.

I hope the Dolin case goes the whole hog and isn't settled. To put Paxil in the public eye (yet again) is something that needs to be done. The message that this antidepressant can cause homicidal and suicidal acts needs to be repeated. It is, in my opinion, a menace to society just as, I believe, GlaxoSmithKline are. Yeh, okay, we will have those that say Glaxo have saved millions of lives with vaccines and have helped millions of people with various respiratory diseases, fair enough, I guess, but that does not give them the right to market and manufacture drugs that can induce homicide and suicide - it's akin to the defence of a serial killer, 'He donated to charities every week your honour, so what if he killed a dozen or so adults, he's a decent man, at heart."

Glaxo need to step up to the plate. They need to compensate Wendy Dolin for her loss, they need to stop pussy-footing around and acknowledge that defending Paxil in suicide cases is a fruitless exercise, they know it, their shareholders know it and the general public know it. Paxil is a nasty drug that causes more harm than good. Glaxo claim Paxil has helped millions of people worldwide but just like the fictitious serial killer above, they throw a blanket over the darker side of Paxil, the induced homicide and suicide, the birth defects, the horrific withdrawal suffered by those trying to stop Paxil.

It will be interesting to see what Glaxo's next step is regarding the Dolin case. They've thrown pretty much everything at the grieving widow but she has stood firm and remained strong because she knows that the truth will, eventually, out.


Bob Fiddaman

Glaxo's Beef With David Healy

I've been watching the proceedings of a current trial in the US. It involves the wife of a man who killed himself shortly after being prescribed Paxil.

If you are like me, a bit of a geek when it comes to reading court documents, then you will just love this.

It plays out like a John Grisham novel. Here we get to see the mechanics of defence lawyers, particularly when it comes to allowing expert witnesses to offer evidence against the company they are representing, in this instance, GlaxoSmithKline.

Background:

In June 2010 Stewart Dolin visited his family doctor who wrote him a prescription for Paxil for "work-related anxiety and depression".

Dolin's prescription was dispensed but he received the generic form, manufactured by Mylan.

Six days after beginning his course of the generic Paxil, Dolin left his office shortly after having returned from lunch with a business associate. He walked to a nearby Chicago Transit Authority Blue Line station at Washington and Dearborn in downtown Chicago. As a northbound train approached the station, Mr. Dolin leaped in front of it to his death. Blood tests taken with Mr. Dolin’s autopsy were positive for paroxetine.

Stewart's wife, Wendy, filed suit against GSK. (Dolin v. SmithKline Beecham Corp. et al., case number 1:12-cv-06403)

Motions:

GSK have filed so many motions in this case. Basically, they write to a judge asking him to make a decision on claims they make. In the case of Dolin they first claimed that, although Stewart Dolin had taken paroxetine, it wasn't their brand. In fact, the brand that Dolin had taken was a generic form, manufactured by Mylan and not GlaxoSmithKline.

On March 4, 2014, an Illinois federal judge determined that GlaxoSmithKline PLC can be held liable for a suicide even though the consumer took a generic version of the antidepressant Paxil, (Source)

Next form of defence for Glaxo's highly paid law team, King & Spalding, was to target the person bringing the claim against them. In this instance, the wife of the deceased, Wendy Dolin.

GSK's defence lawyers subpoenaed Wendy Dolin's cellphone and text message records, her home phone and her late husband's company phone.

Wendy then filed her own motion stating that she had already complied with what she characterized as GSK's intrusive discovery requests, and accused GSK of excessive prying that would not end without the court's intervention.

Furthermore, Wendy claimed in her motion that GSK had sent more than 30 subpoenas and over 70 records requests, and shown the Dolin children Stewart Dolin's confidential therapy notes despite Wendy Dolin's objections.

GSK has also taken hours of deposition testimony from her and grilled her about her personal medical information and her romantic life since her husband's death, according to her motion.

On September 12, 2014, Dolin and GSK came to a "resolution" regarding Glaxo's contentious subpoena. The resolution has, to date, remained confidential.

So, in attempts to, what can be seen as dragging the case out, King & Spalding have now turned their attentions on experts called by Dolin. One such expert witness is Dr. David Healy.

Healy and colleagues, earlier this month, published a damning report on Glaxo's handling of Study 329, a clinical trial involving adolescents and the use of Paxil. Glaxo had, back in 2001, claimed Paxil was safe and efficacious in this patient population. Turns out, they were lying and just spun the results, putting thousands of teens at risk - See (Restoring Study 329)

Fair to say then that Healy is not on Glaxo's Christmas card list.

Muddy the waters:

So, what does one do with criticism, what does one do to suppress the truth?

We've seen the above tactics of GSK's highly paid law team.

1. Claim it's not our drug, ergo not our responsibility

2. Throw endless subpoenas at the person bringing the claim, including delving into her late husband's phone records in the small hope they can find a crumb of evidence that will help them suppress the truth about the Paxil suicide link in adults.

3. Show the children of the deceased personal confidential therapy notes from their father.

4. Grill the widow about her medical background and romantic interests since the death of her husband.

Way to go King & Spalding, you're basically a mirror image of the clients you represent (my opinion "Todd" - see disclaimer at foot of blog - it's been there for years)

Not satisfied with raping the memory of Stewart Dolin, King & Spalding have now turned their attention to David Healy.

Now, I'm not going to blow smoke up Healy's ass, he's one of the good guys, that's all you need to know. He raises awareness because he cannot just stand by and watch bad drugs do harm. That alone should be applauded. Healy has a lot more to lose than your average blogger (myself included). He puts his career on the line by speaking out, it's one hell of a sacrifice. He could have quite easily closed his eyes but he has something that we all have, something that only those with blackened hearts suppress.

Conscience.

King & Spalding nefarious, nae rabid, attack on Healy is not too dissimilar to the raping of Stewart Dolin's memory.

So, what's this motion about?

Well, according to King & Spalding, Healy should not be allowed to give evidence in the trial, he's not credible, he has a bias, he's telling people to go out and kill.

Yup, you read that last bit correctly.

GSK's motion to exclude Healy is a work of art, the kind of art many of us don't understand. It's a huge pile of excrement carefully sculptured by the expert hands of King & Spalding's finest. Ironic that this huge pile of steaming cak is called a motion!

Here's some of the reasons why they don't want Healy to give evidence.

1. Dr Healy is not qualified to testify because of his radical advocacy and extreme bias against GSK.

Oh, boo hoo. Naughty Dr. Healy having an opinion on GSK. Since when did someone with an opinion become a radical activist?

Would this actually have something to do with the fact that Healy has, in the past, given his expert opinion in the cases of Kilker vs GSK and Tobin v GSK. In both cases jury's found GSK guilty. The Kilker case saw GSK's Paxil ruled as the cause of Lyam Kilker being born with birth defects. In the Tobin case a jury found that Paxil was the proximate cause of Donald Schell taking a gun to family members, killing them, then killing himself.

GSK, don't, it appears, think so. They claim Healy, via the medium of his blog, has, in the past, claimed that “the pharmaceutical industry ‘rapes’ patients,” that he “compares GSK’s insistence on  statistically-significant findings to sexual abuse by Catholic priests,” and that GSK’s “widespread cover-up of adverse events dwarfs the Nazis’ cover-up of the Holocaust.” 

Here's the rebuttal of Dolin's attorneys.

Dr. Healy never stated that pharmaceutical companies “rape” patients, but specifically defined a concept that he calls “pharmaceutical rape culture” which he defines as a “concept that examines a culture in which harm from pharmaceutical products is pervasive and normalized due to societal attitudes about  medicine and health care.” Dr. Healy specifically distinguishes pharmaceutical rape culture from actual rape, but draws cultural parallels to the way society reacts to the problem, i.e., blaming the victim. 

Similarly, Dr. Healy never compared GSK’s insistence on statistical significance to “sexual child abuse.”  Dr. Healy’s blog entry simply discusses how the Church’s use of Canon Law to disregard state and federal law parallels how pharmaceutical companies “actively attempt to over-ride the legal systems of the United States and other countries with claims that unless findings are demonstrated in controlled trials to a statistically significant extent that they simply aren’t happening.” 

Finally, GSK’s reference to the Holocaust is not only inaccurate, it is offensive.  Dr. Healy made a passing reference to the Nazis in his blog entry to illustrate the fact that pharmaceutical companies have actively sought to hide risks from patients and authorities using a myriad of methods.  The specific quote is: 

[Pharmaceutical companies] have taken astonishing steps to prevent decent reporting, or to denigrate reporting when it happens, and to manage the perception of risk rather than risks themselves.  If the Nazis had access to [their] bag of tricks, there would be real and widespread doubt that the Holocaust ever happened.  

At no time did Dr. Healy suggest or even insinuate pharmaceutical cover-up of adverse events “dwarfs the Nazi’s cover-up of the Holocaust.”  This sort of inflammatory and misleading...

--

Personally, and this is just my opinion, I think that King & Spalding paralegals and other staff have, seemingly, trawled through Healy's blog as a reporter for the National Enquirer would. The sole purpose is to dismiss his beliefs whilst trying to find cherry-picked sentences that they feel may incriminate him, and, furthermore, persuade a judge that Healy is some sort of crank.

For the record, the "pharmaceutical rape culture" reference was actually a blog post by another blogger.

Is it me, or does anyone else think these highly paid attorneys can't do their job properly?

Dolin's attorneys added that Healy "...discusses topical and controversial issues and he does so with poetic license."

GSK then, quite remarkably, decided to look into the phrase, "poetic license."

Weeks after the rebuttal of Dolin's legal team GSK then attached as an exhibit  a "true and correct copy of the online Oxford Dictionary definition of poetic-license."

Since when did GSK start using the Oxford Dictionary?

Here's part of a transcript from BBC Panorama. Journalist, Shelley Jofre was interviewing Glaxo spokesperson, Alistair Benbow. Ironically, the subject of definition came up.

BENBOW: Addiction is characterized by a number of different criteria which includes craving, which includes increasing the dose of drugs to get the same effect, and a number of other features and these are not exhibited by Seroxat.

JOFRE: That's not, with respect, what the Oxford English Dictionary says. It says addiction is having a compulsion to take a drug, the stopping of which produces withdrawal symptoms.

BENBOW: If you use that limited description of addictive then most prescription medicines could be defined as addictive.


So, on one hand the Oxford English Dictionary gives a true and correct definition, yet on the other hand the Oxford English Dictionary only gives a limited description!

Come on Glaxo, you can't have it both ways. If, as they claim, the dictionary (provided as an exhibit) gives a true and correct definition then Benbow telling Jofre that the same dictionary only gives limited descriptions was an actual lie... or was it just an opinion of Benbow, one that was radical and, dare I say it, biased.

GUN-TOTTING HEALY

One of the most ludicrous claims of GSK was that Healy, once again through the medium of his blog, suggested that "it would be reasonable for people who have lost loved ones due to alleged drug side effects to take violent revenge against pharmaceutical executives or editors of the New England Journal of Medicine."

Based on this one paragraph GSK accused Healy of inciting violence against GSK’s executives and medical journal editors.

(Insert laughter here)

(Change your underwear here)

As Dolin's attorneys put it, "Healy is expressing concern that discord is “brewing” and that absent action, there could be violence.  Dr. Healy expressly condemns such violence. "

As I said a the top of this post, I'm a bit of a geek when it comes to reading court documents. Whilst reading through GSK's motions I've had Nescafe shoot down my nostrils, reached the point of apoplexy, so much so that I had to bite the arm of my chair, and, been to the bathroom to avoid any embarrassment of urinating myself.

Healy's deposition was supposed to be about science, in actual fact GSK's attorneys chose, for at least 90% of the 10 hours, to talk about Healy's blog, his financial accounts, and every other avenue that they could think of - rather than deal with the science.

If anything, these motions merely highlight the lengths GSK and their legal representation, King & Spalding, will go to as to avoid the Paxil/suicide link being, once again, publicly aired.

Other experts for Dolin have also come under fire from GSK. More mud-slinging, more cleverly crafted piles of poo.

Those King & Spalding offices, I believe, need fumigating.



Bob Fiddaman. (Using Benbow's poetic licence)



Source: Public Access to Court Documents (Pacer) 

Wendy Dolin is represented by Bijan Esfandiari, Michael Baum, Frances Phares and R. Brent Wisner of Baum Hedlund Aristei & Goldman PC