Tagged: stewart dolin

Bob Fiddaman’s Latest Post From The Dolin Trial…


http://fiddaman.blogspot.ie/2017/03/dolin-vs-gsk-day-6-ass-kicking-semantics.html?spref=tw

Thursday, March 23, 2017

Dolin Vs GSK – Day 6 – Ass Kicking Semantics

ass kicking

To be beaten senseless because you definitely deserve it.

semantics
the branch of linguistics and logic concerned with meaning.


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

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

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

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

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

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

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

“Are you a pharmacologist?”, Bayman asked.

“No.” Dr. Cross replied.

“Are you an epidemiologist?” Bayman asked.

“No.” Dr. Cross replied.

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

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

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

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

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

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

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

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

Evidence here.

So, Bayman trying to convince the jury the suicide warning was down to the FDA contradicts what the top boss at GlaxoSmithKline says.
A strange defence, unless of course Bayman thinks JP Garnier was lying under oath?
Garnier lying? Surely not!
The trial continues tomorrow.
From this point I’ll be giving periodic updates and not daily ones.

The Dolin Trial..


Roy Strom, The Am Law Daily March 22, 2017    | 0 Comments

Photo: Diego M. Radzinschi/ALM

The bad blood between Dr. David Healy and GlaxoSmithKline plc brewed up long before the psychiatrist took the stand in a Chicago federal court last week to testify that the pharmaceutical giant hid the risk of suicide in its blockbuster antidepressant Paxil.

Healy’s testimony is the bedrock of a claim brought by the widow of a Reed Smith partner who committed suicide in 2010 while taking a generic version of Paxil. GSK argues that Stewart Dolin’s death was the result of stress from a diminished role at the firm following a 2007 merger. Dolin’s widow, who claims her husband died from an adverse reaction to Paxil, is seeking $12 million from GSK.

All GSK has wanted is for the fast-talking psychiatrist to stop testifying.

Healy, a professor at a British university and a practicing physician in Toronto, has been a thorn in the pharmaceutical giant’s side since about 1999, when he wrote “The Antidepressant Era” and first began raising concerns about GSK’s clinical trials related to antidepressants known as SSRIs, or selective serotonin reuptake inhibitors. In 2005, The New York Times profiled Healy, noting that he was “internationally known as both a scholar and a pariah.”

“You don’t really know who you can trust,” Healy told the paper.

Healy has been a longtime expert witness in cases against GSK. His all-day direct examination in Chicago last Thursday was followed by a six-hour cross-examination this week. Healy said he had testified in more than 10 cases against GSK, something the company’s lawyers at Dentons and King & Spalding made a spirited effort to prevent in the Dolin case.

Healy’s testimony, for instance, was admitted in a suit in the Southern District of Indiana involving the sister of a priest who committed suicide after taking paroxetine, the trade name for Paxil. That case appears to have settled in 2011. And in 2015, Healy was an author of a new review of clinical Paxil trials on teenagers, which led to headlines that the drug was unsafe for teens.

The heart of Healy’s testimony contends that GSK artificially inflated the number of suicides and suicide attempts committed by members of the placebo group during clinical trials for Paxil. That had the effect of minimizing the risk of suicide associated with the antidepressant, meaning there was no warning of suicide risks on the drug’s label.

In the Dolin case, GSK’s lawyers filed a motion to exclude Healy’s testimony in the Dolin case, writing a 46-page memorandum with 70 attached exhibits arguing that Healy was a financially biased witness with an axe to grind against GSK.

The filing asserts that the lead plaintiff lawyer in the Chicago case, Michael Baum, a senior managing partner of Los Angeles-based Baum, Hedlund, Aristei & Goldman, is an investor in a company founded by Healy. That company runs a website, RxISK.org, which GSK’s lawyers said helps promote suits against the pharmaceutical industry. The filing also said Healy’s personal blog showed his bias against GSK, including his purported belief that the company helped get him fired from a previous professor position and may have been behind an investigation that could have led to his medical license being revoked in the U.K.

U.S. District Judge James Zagel ruled that Healy (pictured right) could testify in the Dolin case. But at the trial, presided over by U.S. District Judge William Hart, lawyers could not ask Healy about his blog or his personal relationship with GSK.

King & Spalding life sciences and health care litigation co-chair Andrew Bayman asked Healy if his website was intended to make it easier for the public to file suits and to garner work for himself as an expert. Healy testified that he bills $750 an hour to testify and $400 an hour to review cases.

But as was the case with many of the points that Bayman tried to pin Healy down on, the psychiatrist was prepared with a response to that charge in court Monday.

The website “has nothing to do with supporting lawsuits. This is all about minimizing the problem so there won’t be lawsuits,” Healy said, adding that Baum’s investment in his company, “would probably put him out of business.”

Proceedings in the Dolin case are continuing this week in Chicago. Some of his former Reed Smith partners are expected to take the stand.

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

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?

Dolin Vs GSK – The Dunbar Tape


http://fiddaman.blogspot.ie/2017/03/dolin-vs-gsk-dunbar-tape.html

Sunday, March 19, 2017

Dolin Vs GSK – The Dunbar Tape

As promised, here’s more evidence that surfaced last week at the Dolin Vs GSK Paxil Induced Suicide trial.

This video features Dr. Geoffrey Dunbar, an executive at GlaxoSmithKline between 1987-97. His job was to oversee all the Paxil clinical trial results. He also helped author drafts regarding Paxil suicides, these drafts were later passed on to the FDA.

The data showed a 9-fold increase in suicidality with patients taking Paxil. Remarkably, the report sent to the FDA showed the complete opposite, in fact, the report showed the FDA that Paxil actually prevented suicide!

In the 2005 video deposition, Dunbar admits his reports included improperly counted suicidal behavior events and that publications in which he participated writing had incorrectly conveyed Paxil reduced suicidal behavior.

In essence, GlaxoSmithKline, along with the help of Dunbar, spun a 9-fold increase in suicide related events for patients taking Paxil to zero suicide related events.

For doctors and patients this meant that Paxil could hit the market with no concerns, and even if someone did kill themselves whilst taking Paxil, the event would be blamed on the person’s illness rather than the Paxil they were taking.

In the video below you will hear Dunbar say that it was “an error” that the suicide figures were wrong. That’s some error, right? On one hand the data shows a 9-fold increase in suicide related events for patients on Paxil, yet the complete opposite ended up in a draft to the FDA.

Furthermore, upon learning of his “error” he, to date (2005) had still not informed GlaxoSmithKline officials. He just ‘assumed’ that GSK had rectified a published article that he co-wrote, an article that he admitted, under oath, would have “presumably” influenced the people who read it.

So, there you go then. Paxil was promoted as being safe, when in actual fact GSK knew it was dangerous.

Nice company, huh?

Here’s the depo.

Bob Fiddaman
 
Dolin Vs GSK

More Damning Evidence About Seroxat/Paxil And Suicidality …


Brilliant reporting from Bob Fiddaman at the Stewart Dolin ‘Paxil Induced Suicide’ trial in the US.

More damning evidence that Paxil/Seroxat is a drug that simply should never have been on the market in the first place…


 

Friday, March 17, 2017

Dolin vs GSK – Healy ‘Rocks Da House’

This is complex, this is time consuming. Two days of evidence presented to the jury, judge and layperson (me included).

Cut through the endless amount of questions (they always lead to the truth where GSK are concerned) – and you will see, through Healy’s evidence, the reasons why this case is a “Slam Dunk” for Dolin et al and why GSK’s hot shot law team bounce up and down crying ‘objection’ at every given opportunity.

Objection! Because they don’t want the jury to know about their previous ghostwritten articles.

Objection! Because they don’t want the jury to know about GSK’s previous fine of $3billion (yes, that’s billion, fine for promoting Paxil off-label to kids.

Objection! Because they don’t want the jury to know about the Paxil withdrawal issue because, “it’s a case that is on-going against them in the UK) – Forget the case of Paxil withdrawal they’ve already settled with over 3,000 plaintiffs in the US, right?

Objection! Because they don’t want the jury to know they lied about the fact that Paxil was safe for kids.

They even objected to Wendy Dolin’s attorneys for wishing the jury had a great weekend, or words to that effect!

What I have witnessed here in Chicago is a law team representing an abhorrent company, the law team being made up of men and women (think about the birth defects Paxil has caused – I mean, their law team has a woman of child bearing years!)

Bayman (King & Spalding) also asked the Judge to reiterate to the jury that they should not “Google” about Paxil or the case in question. Yeah, right, Heaven forbid the jury stumble upon GSK’s abhorrent record and/or disregard for human life, right?

I honestly don’t know how a team with kids, siblings, wives, husbands or any other family members for that matter, can sit there and defend a drug (Paxil) that has caused so much heartache for families over the years. Are they devoid of any compassion, any empathy, any common sense?

My thoughts are, to some, irrelevant – Am I biased? Maybe? With a whole bunch of lawyers sitting on one side of a courtroom defending a drug that, probably, none of them have taken or, none of their loved ones have taken, I feel like I’m banging my head against a brick wall.

King & Spalding’s main two men, Andrew Baymen and Todd (snigger at a name that befits a child) Davis, seem devoid of any compassion and/or rationale – they don’t want to talk about ghostwritten articles, they don’t want to talk about the $3 billion dollar fine their defendant got for the illegal promotion of off-label practises of many drugs, including Paxil. They don’t want to talk about the withdrawal problems that Paxil can cause, and they don’t want to talk about how the company they are defending put children and adolescents at risk when they sent out their work force to promote the safety and efficacy of Paxil.

For these reasons, I am de-humanized from that table (in the courtroom) that represents this truly abhorrent company. A table of psychopaths or people who just want the right to pay their monthly bills? – Psychopaths is a pretty good description, given that they know, and have  known of Paxil’s severe side effects for many, many years.

Healy’s expert opinion leaves me wondering if the jury want/need to hear anything more. He told the jury how…

  • In 2006, the FDA knew about the increased suicidal risk on Paxil.
  • GSK reported that there was no risk f Paxil induced suicide in 1999.
  • GSK showed 6 suicide ttempts on placebo,when the actual figure was 1, in fact it was zero!
  • GSK claimed that Paxil did NOT cause suicide and this convinced prescribing Dr’s to prescribe Paxil.

Let’s just take a look at some evidence aired today…these are from GSK’s own internal documents. The public, or those who had or have been prescribed Paxil never got to hear about this…

– 50 year-old female patient who became suicidal on Paxil (GSK’s own admission, probable cause!)
– 55 year-old male patient who showed “unrest and agitation” – patient was put on Paxil for 3 days when problems began, Paxil was stopped – patient felt better.
– 59 year-old male – experienced ‘restlessness’, visual disturbances – Patient recovered one day after Paxil was removed!
– 32 year-old male, on day one of Paxil treatment, developed severe akathisia – patient was confused throughout study.

Healy reminded the jury that GSK’s stance was that Paxil, a drug that was used to treat anxiety and Major Depressive Disorder (MDD) actually made, some people develop symptoms that it was, originally, meant to treat!

Many exhibits were aired that further showed how GSK hid the suicide link with Paxil. In fact, it was learned, GSK’s own re-analysis of Paxil (2006) showed an increase of 6.7 patients in Paxil adult patents. (the increase 6.7 times the greater likelihood one who takes Paxil will develop suicidality)

Oh, by the way, Stewart Dolin was 57.

Healy told the court that, based on his own clinical experience, Paxil was the most potent and problematic of all the SSRIs on the market. He also informed the jury that, as a clinician himself, he does not prescribe Paxil and added that the hospital where he works does not have Paxil on their list as a possible medication to treat a psychiatric illness.

To back up the evidence, the jury was shown an email to GSK’s marketing guru, Barry Brand. The email focused on Paxil’s suicide problem.

King & Spalding’s, Andrew Bayman, played his ‘Jack-in-the Box’ routine throughout the day. His sidekick, from King & Spalding, Todd Davis, remained in the wings being as quiet as a mouse – strange because it is “Todd” who has targeted the kids of Wendy Dolin leading up to this litigation. Is Todd married? Does Todd have a regular girlfriend/boyfriend? Does he have children of his own? Is his blinking affliction down to the overuse of a psychotropic medication? Who knows?

That’s poor show from me, I shouldn’t mock the afflicted…then again, these schmucks have defended the indefensible for years – they’ve shown no remorse when people have gone on to kill themselves whilst on Paxil – why would they when they are earning vast amounts of money (by the hour) defending GSK?

GSK are King & Spalding’s cash cow. They tried, through objection, to hide the truth about Paxil to the jury. They failed on a grand-scale.

Most damning, for today at least, was Healy’s claim that he is one of the only people to have read the ‘raw data’ regarding Paxil and suicide, raw data that leaves him firmly believing Paxil can induce suicidality in adults, something that GSK have, for years, denied.

Healy also spoke how GSK used the term ’emotional lability’ when reporting suspected suicidality in clinical trials, a term that would have made, even him, think there was no problem with Paxil. A term that would have made most prescribing doctors think that there was no suicide problem with Paxil!

Churlish.

GSK’s table of attorneys look slick. One aging bald-headed guy even approached the judge at the end of today’s proceedings to complain that Wendy Dolin’s law team had wished the jury a “nice weekend” as they were dismissed.

Objection, objection, objection.

They seem like a stuck record. A team of misfits whose only mission is to blame everything but Paxil opting, instead, to blame the patients for having an ‘underlying illness’.

The questioning of Healy by Dolin’s attorney’s finished today. He will be cross examined by King & Spalding on Monday.

I’ll be there. Stewart Dolin will be there in spirit.

More on the past two days events tomorrow night, in particular evidence that shows how a witness called for GSK in this trial showed how another unrelated drug caused two patients akathisia and they ‘jumped’ to their death.

Stewart Dolin (57)  ‘jumped’ in front of a train because Paxil caused psychosis and akathisia, an adverse drug reaction that is so horrible, death can be seen as a welcome alternative.

Bob Fiddaman.

Dolin back stories.

Stewart Dolin’s Paroxetine Induced Suicide..


Despite tens of thousands of reports of SSRI induced suicidal thoughts, behaviours and completed acts over the decades, GSK are still trying to deny the reality of Seroxat/Paxil (Paroxetine) induced suicides..

Paroxetine is a killer drug….

I hope that Wendy Dolin wipes the floor with GSK (and their sociopathic lawyers) in court…


http://missd.co/wp-content/uploads/2016/07/DOLINLAW360Catch-22.topostpdf.pdf

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On a muggy evening, Wendy Dolin was walking her dog a month after the bewildering suicide of her husband, the former Reed Smith partner Stewart Dolin, when a friend accompanying her uttered a strange word suggesting an explanation: akathisia. Looking up the condition online that night in 2010, Dolin was stunned by how closely its symptoms of intense restlessness and anxiety seemed to match her husband’s puzzling behavior in the days before he took his life by jumping on the tracks of an O’Hare airport- bound Blue Line train in Chicago.

The name of the condition, more familiar to neuropsychiatry professionals and pharmaceutical injury lawyers than to Wendy Dolin, a licensed clinical social worker in Illinois, shone to her through the fog of an inexplicable act by a man she had known for 42 years. He had seemed his usual self until just days before the incident, she said, when he had begun taking paroxetine, the generic version of the antidepressant Paxil.

Stewart Dolin

He became so distressed soon after going on the medication that he pled to her one night that week in July: “I don’t get it, Wendy. I still feel so anxious,” she recalled.

After poring over internet search results about lawsuits that alleged that akathisia was a known side effect of Paxil, which belongs to a class of antidepressants called selective serotonin reuptake inhibitors, Dolin decided on a seemingly improbable course of action. She would sue the drugmakers responsible for the manufacturing and labeling of Paxil, a drug whose generic version her husband had taken for only six days before his death.

“I’d got home that night and Googled akathisia, Paxil, and suicide, and lo and behold, all this information pops up,” Dolin said, referring to search results of papers published in psychiatry journals and litigation summaries on law firm websites.

“It was completely clear — all of us were looking through our emails and notes from him and there was no clue, nothing, that it could have been something else,” she said.

Baum Hedlund Aristei & Goldman PC, a small personal injury firm based in Los Angeles, had been litigating wrongful death and injury suits involving suicides and suicide attempts related to antidepressants for about 20 years when Dolin contacted it in 2010 to take on her mission. Nearly two years later, the firm filed her negligence and wrongful death suit against Mylan Inc., the Netherlands- based generic-drug maker that manufactured the drug her husband was taking, and GlaxoSmithKline, which sold the drug’s branded versions and devised its labels, as the U.S. Food and Drug Administration requires.

The timing of her suit was inopportune for a plaintiff alleging an injury from a generic drug. The U.S. Supreme Court had just issued a landmark decision in 2011 in Pliva v. Mensing that shielded generic- drug makers from claims about their labeling of drug side effects and contraindications because FDA rules require them to follow the same warning language of their branded counterparts. Meanwhile, dozens of courts around the country were taking cues from a 1994 decision by the Fourth Circuit in Foster v. American Home Products Corp., which had found that although branded-drug makers are responsible for the labeling of their products, they don’t have a duty to warn patients taking generic versions of their drug.

The mountain of unfavorable case law had threatened to nip Dolin’s suit in its early pleading stages. Instead, she prevailed through multiple summary judgment motions by GSK — although the Mensing decision did jettison Mylan from her suit — as her lawyers strategized to counter the difficult precedent and found a willing ear in the Illinois federal judge overseeing the suit, James Zagel. Guided by the handful of courts before him to find branded-drug makers could be held liable under other tort theories besides strict product liability, he issued a surprising endorsement of Baum Hedlund’s arguments in the Dolin case, finding in February 2014 that GSK could be held liable for common law negligence claims.

Judge Zagel found that, unlike some other states, Illinois common law did not compel him to treat all claims stemming from a product injury as product liability claims.

“The injury here did indeed occur in connection with a product. And GSK manufactures products,” he wrote in his ruling. “Yet Plaintiff has not brought suit against GSK for tortious conduct committed strictly

The idea that in this country, so many people take generics and that they have no legal recourse, it’s just unthinkable.

— Wendy Dolin

as a manufacturer of products. And, though GSK implicitly urges to the contrary, I see no reason why all suits brought against GSK must be brought against GSK qua manufacturer.”

Under his watch, the case is set to proceed to a monthlong trial in January, and it will be the first to involve a suicide allegedly caused by a generic antidepressant, and the first to test whether a jury would actually hold a branded-drug maker liable for a generic-drug injury. Many of the earlier suits filed over suicides allegedly linked to generic antidepressants have either settled or been dismissed.

Wendy Dolin with her husband Stewart on a 2007 vacation in Aspen, Colorado.

If Dolin prevails, the stakes will be high for generic-drug patients across the country. Her attorneys believe it would likely set the stage for the Seventh Circuit to address the issue for the first time in the event of a GSK appeal. In that scenario, the question before the court would be whether branded-drug makers can be held liable for injuries caused by generic-equivalent drugs that they did not themselves make. If the Seventh Circuit were to answer the question differently from the few other federal appeals courts that have done so — the Fourth and Sixth circuits have ruled against the idea that a branded-drug maker could be liable for a generic-drug injury — the suit could very well wend its way up to the nation’s highest court.

“The idea that in this country, so many people take generics and that they have no legal recourse, it’s just unthinkable,” Dolin said. “I’d love this case to be the one that says, ‘This is no longer acceptable.’”

The Paradox of Litigating Over Generics

Generic drugs account for roughly 80 percent of all prescription drugs dispensed in the U.S., according to the FDA. Their prevalence is due in part to their cost, which can be as low as a tenth of the price of their branded equivalent. In 2010, the use of generic drugs saved the U.S. health care system roughly $158

billion, according to an estimate by the generic-drug trade group the Generic Pharmaceutical Association, which the FDA cites on its website.

Those savings often interact with state laws in ways that ensure the widespread use of generics. A number of states have laws that encourage pharmacists to choose cheaper equivalents to a brand name prescription, unless a prescribing doctor includes explicit instructions not to do so. Such is the case in Illinois, where 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.

The Alabama Supreme Court, the highest state court in the country to address the issue of whether a branded-drug maker can be held liable for a generic-drug injury
— and one of the few to answer it in the affirmative —
emphasized those implications in a 2014 ruling.

“Additionally, many insurance plans are structured to promote the use of generic drugs,” the court wrote in the decision. Dolin’s own health insurance plan covers only generics, she said. The Alabama Supreme Court ruling, however, which came in the then-groundbreaking case Weeks v. Wyeth, has since been negated by a 2015 law by the state Legislature that rejects the notion that a branded-drug maker can be held liable for a generic drug.

The unique position of generics has a relatively recent history. The Federal Food Drug and Cosmetics Act once required all drugmakers to show that their drugs were safe and properly labeled before the agency would approve them. Then the 1984 Hatch-Waxman amendments to the FDCA sought to simplify the process for generic-drug makers, in order to expand affordable treatment options for patients. The amendments allowed generic-drug makers to sidestep requirements to conduct clinical trials to show the drugs’ safety and effectiveness, but it required them to show that they have followed the formulation and labeling of branded counterparts that have already undergone such trials.

Consumer advocates believe that such requirements have
created a significant gap in protecting patients for injuries they
may have sustained because of inadequate warnings, while protecting generic-drug makers from most liability claims involving their products. Public Citizen, the consumer advocacy group that petitioned the FDA in 2011 for the agency to allow generics to independently go about making changes to their labels, holds that view.

“A majority of prescriptions are filled with generic drugs because it makes health care more affordable, but when the drug doesn’t have adequate warnings on it, then physicians and patients can’t make proper decisions,” said Allison Zieve, the director of Public Citizen’s litigation group.

“Brand name manufacturers are required to update their labeling when they become aware of new information of drug risks, but once a generic is on the market, the market share for the branded version drops very quickly, and the brand name often stops selling the drug altogether,” she said. “There’s nobody under the current regime monitoring the drug to make sure that labels are updated.”

But the U.S. Supreme Court cited the Hatch-Waxman Act in cementing the protections for generic-drug makers in its 2011 Mensing decision. That case involved claims by Gladys Mensing and Julie Demahy, plaintiffs from Minnesota and Louisiana, respectively, that their long-term use of a generic version of the heartburn drug Reglan sold by drugmakers including Pliva caused them to develop tardive dyskinesia, a neurological condition that causes involuntary movements such as uncontrollable twitching or blinking.

The court found in its ruling that generic-drug makers cannot satisfy state law requirements to strengthen their warnings when they are already required by
federal law to match branded-drug labels.

In 2013, the Supreme Court expanded these protections further in Mutual Pharmaceutical Co. Inc. v. Karen Bartlett, largely blocking design defect claims by citing, among other factors, “Congress’ decision to regulate the manufacture and sale of generic drugs in a way that reduces their cost to patients but leaves generic-drug manufacturers incapable of modifying either the drugs’ compositions or their warnings.”

The Dolin Litigation

It was around the time of this flurry of major precedent against generic-drug plaintiffs in the courtroom that Brent Wisner of Baum Hedlund, then an associate at the firm in its San Francisco office, took on Dolin’s suit in 2012, his first case as a practicing attorney.

The suit faced hurdles not only because of the Mensing decision and the eventual Bartlett decision but also because of the sweeping influence of the Fourth Circuit’s Foster ruling, which had barred just the type of allegations that Dolin was making, he said.

Dolin’s suit claimed her husband had killed himself after exhibiting
uncharacteristically high anxiety within days of taking generic Paxil,
which had been prescribed to him by his family doctor and friend
of 20 years, Dr. Martin Sachman. GSK’s warning label, which the generic version’s maker, Mylan, was required to follow, had misled patients and doctors, she claimed. It did not sufficiently warn that akathisia, which according to her complaint is marked by “profound inner restlessness and agitation,” could give rise to suicidal tendencies, she said. GSK has argued that the 2010 labels for Paxil contained warnings about akathisia that said the condition was “most likely to occur during the first few weeks of treatment.” Dolin insists that GSK did not connect the dots clearly enough between akathisia and suicide or sufficiently note the incidence of such risks in adults.

Her suit also claimed that although GSK apparently knew of a statistically significant risk of suicidal behavior in adults taking the medication — roughly 6.7 times higher compared with patients on a placebo — the drug’s label concealed that risk by claiming that “the suicidality risk did not extend past the age of 24.” GSK has said that this language was ordered by the FDA as part of its warnings on all SSRIs that “short term studies” of antidepressants did not show such risks of suicidal behavior.

The Fourth Circuit’s ruling in the Foster case involved the death of a six-week-old infant who had been given a generic version of a colic medication called Promethazine Syrup Plain. The appeals court squarely rejected the notion that a brand-name pharmaceutical
could be held liable for negligent misrepresentation claims in that

instance. But in the pre-Mensing era of that ruling, the court had found that generic drugs were responsible for their own labeling, emphasizing the benefits they enjoyed because of the Hatch- Waxman amendments allowing them to circumvent expensive clinical trials.

“Name brand manufacturers undertake the expense of developing pioneer drugs, performing the studies necessary to obtain premarketing approval, and formulating labeling information,” the panel wrote. “Generic manufacturers avoid these expenses by duplicating successful pioneer drugs and their labels.”

At the time Wisner prepared to fight motions by Mylan and GSK challenging the viability of Dolin’s case, some 70 other courts had more or less adopted the Fourth Circuit’s view in Foster, according to court documents.

“Coming out of law school you want to deal with complicated legal issues,” said Wisner, who had just graduated with his law degree from the Georgetown University Law Center in 2010. “But I had a lot of people telling me I had no chance to prevail.”

I had a lot of people telling me I had no chance to prevail.

— Brent Wisner, Wendy Dolin’s attorney

So he hatched a plan. Anticipating that Mylan and GSK would seek to quickly dispose of his claims, he approached them in February 2013 with a calculated compromise. He would agree to put discovery on hold while the parties addressed questions of whether Dolin’s claims were preempted or not viable, but in exchange, Mylan and GSK would have to file their motions challenging her claims roughly at the same time.

That way, Wisner reasoned, he could address both defendants’ motions in a single opposition, creating a path for the judge to issue a cohesive response addressing the arguments of both defendants in the same opinion. Mylan filed its motion to dismiss in August 2012, citing the Mensing ruling. GSK followed suit with its summary judgment motion in January 2013, arguing that there was “virtual unanimity” among the numerous courts to consider this question and that they had rejected the kind of misrepresentation theories that Dolin was advancing. The drugmaker also argued that Illinois product liability laws require claims related to injuries caused by a product be brought against the company that actually manufactured it.

“Regardless of how plaintiff couches her claims, they are all barred under Illinois law because GSK did not manufacture, distribute or sell the immediate-release paroxetine that allegedly caused Mr. Dolin’s death,” it argued. “Without this fundamental predicate, Plaintiff cannot establish the necessary elements of her claims.”

Wisner believed his approach could nudge Judge Zagel to make a more comprehensive analysis about whether case and state laws truly end up leaving most generics plaintiffs with no legal recourse for alleged injuries.

“I wanted him to be ruling on the ability of my client to get any sort of justice,” Wisner said. “My thinking was, when you consider both of these issues together — innovator and generic immunity — it is easy to see how unfair the law has become.”

Judge Zagel took the cue and found in his now-renowned ruling in February 2014 that Illinois law doesn’t call for common law negligence claims to be treated like product liability claims just because the suit involves a product and an alleged injury it caused.

“GSK vigorously contends that the design and warning label are not in themselves ‘products,’” Judge Zagel wrote. “[But] GSK has not shown why Plaintiff should be precluded from claiming at common law that GSK, independent of its capacity as a manufacturer of one particular iteration of paroxetine, was negligent in connection with its responsibility for these ‘non-products,’ and that this negligence contributed to her injury.”

The ruling was a breakthrough for Dolin, too. “The phone rings [that day], and Brent [Wisner] says, ‘I think you just sorta made history here,’” she said.

The Trial

The Dolin trial is set to boil down to a few crucial questions for the jury, foremost of which is whether the drug Paxil, which the FDA first approved in 1992, causes suicidal tendencies in adults. Dolin’s experts, who are expected to testify on this issue of general causation, have so far withstood GSK’s challenges.

 

Among them is Dr. Joseph Glenmullen, a psychiatry professor at the Harvard Medical School who has written two books about antidepressant side effects. In a 2007 report to Baum Hedlund, unsealed in a different case over Paxil in Kansas state court, Glenmullen argued that GSK’s own data to the FDA in 1989 showed a substantial increase in risk of suicidal tendencies in patients on Paxil compared to those on placebo pills but that the drugmaker underreported or downplayed such risks to regulators.

It was only in 2006 that the company acknowledged in a so-called Dear Health Care Provider letter, which is meant to inform doctors of updated safety information, that Paxil could increase the risk of suicidal tendencies in certain patients by about six times as compared with a placebo, according to his report. That year, GSK modified its label to warn that it had found Paxil posed a “statistically significant” increase in the frequency of suicidal behavior in adult patients with major depressive disorder. This language made way for the FDA’s classwide labeling for all SSRIs the following year that would update all black box warnings — the agency’s most serious safety warnings — on the drug. The classwide label would warn patients and consumers only about increased suicidal tendencies among young patients aged 18 to 24.

In 2011, Wendy Dolin founded a nonprofit dedicated to spreading awareness of akathisia titled MISSD, shorthand for “the Medication-Induced Suicide Prevention and Education Foundation in Memory of Stewart Dolin.”

Glenmullen’s report, along with a similar one that followed the same year by the British drug safety regulator finding GSK knew of such risks in adolescent patients since 1998, prompted Iowa Republican Senator Chuck Grassley to urge the FDA in June 2008 to determine if the drugmaker had suppressed any safety information when it sought approval for the drug.

Glenmullen has maintained his position in the Dolin case, in which he has testified that taking paroxetine was a “proximate cause” in Stewart Dolin’s suicide. GSK sought to exclude his testimony in September, arguing that Glenmullen had not shown any idea linking Paxil to suicides, only to suicide attempts, which the drugmaker argued was not an adequate substitute.

Judge Zagel denied such motions in November, finding that Dolin’s experts had offered “reliable” testimony.

Dolin’s experts also include Dr. David Healy, a psychiatry professor at the University of Wales in England. Healy, who has worked as an expert witness for Baum Hedlund for years in lawsuits involving antidepressants, has stated in the case so far that GSK’s own labeling documents from 2006, including letters to physicians, had acknowledged that “the frequency of suicidal behavior was higher in patients treated with paroxetine compared with placebo … this difference is statistically significant.”

If the jury agrees on that question of general causation, it would then have to decide whether GSK adequately warned of the risk. If it decides the warnings were insufficient, the jury would then have to consider whether the failure to warn led to the suicide — that is, whether better warnings would have led Dr. Martin Sachman to prescribe a different treatment.

Baum Hedlund has also enlisted former FDA physician David Ross to testify on the regulatory history between GSK and the FDA and what data the drugmaker shared with the agency.

One of the key points of contention is whether GSK did its thorough due diligence to make sure its labels contained warnings specific to Paxil’s potentially increased risk for suicidal tendencies — the FDA’s own analysis found a 2.76 times higher risk for patients taking paroxetine.

Although GSK had asked the FDA about adding Paxil-specific warnings to the agency’s classwide warnings in 2007 in order to alert doctors and patients about the drug’s potential to cause suicidal tendencies in adults, it did not follow through with the agency’s invitation to ask for a formal meeting to discuss that change, Dolin has argued.

GSK has dismissed this argument as mere “conjecture about a meeting that did not take place,” countering that it had submitted two different sets of documents to the FDA under its Changes Being Effected program, which allows branded-drug makers to update their labels based on new information. Each time, GSK said, it sought to retain warnings specific to Paxil on its label, but it received a rejection by the agency, according to its filings.

Defense attorneys believe GSK’s argument could offer an important window for the drugmaker to persuade the jury that even if it had actually called for such a meeting, the FDA would likely not have approved it.

“Both Judge Zagel and Dolin have said here, ‘You could have had that meeting, so you haven’t exhausted all your options to show that the FDA couldn’t be convinced otherwise,” said Henninger Bullock of Mayer Brown LLP, who has represented branded-drug makers in similar suits. “But GSK can say: ‘Well, we tried, and the FDA told me twice already that I couldn’t modify the classwide label, so to request a meeting would be futile.’”

A spokeswoman for the FDA declined to comment on pending litigation.

Besides experts, Dolin and her two adult children with Stewart are expected to testify, along with Sachman, who said at deposition last year that he didn’t know of the drug’s risks and if he had he would never have prescribed it to his best friend, Wisner said.

Wendy Dolin may be questioned at trial over the circumstances surrounding her husband’s death. “I knew my husband, and I don’t even consider it a suicide anymore,” she said.

GSK, which has taken a whopping 30 depositions in the case over a one-and-a-half-year period, has designated more than two dozen witnesses, including company witnesses and about nine experts.

“GSK is not responsible for Mr. Dolin’s death and we’ve submitted our position in filings to the court,” spokeswoman Jenni Ligday told Law360 in a statement.

Dolin herself may be grilled on the specifics of her husband’s mental state and activities leading up to his death. Some salient details of his final hours stand out to her as especially convincing evidence that he did not plan his suicide in a state of anxiety over long-simmering work-related problems, as GSK has argued.

The drugmaker had argued that Stewart Dolin had experienced work-related anxiety and depression for years, according to a heavily redacted segment of its summary judgment motion in October.

Shortly before his bizarre and tragic visit to the subway station, he had had lunch with an accountant at the Rivers Restaurant near his office in the Chicago Loop. There, he had ordered a chicken salad, requesting the dressing on the side, Wendy recalled, remarking ruefully, “You had the dressing on the side an hour before you [supposedly] planned to die?”

“I knew my husband, and I don’t even consider it a suicide anymore,” Dolin said. “I consider it a fatal drug reaction.”

Sindhu Sundar is a feature writer at Law360. Follow her on Twitter.

King And Spalding And Their Criminal Clients GlaxoSmithKrime


http://articles.mercola.com/sites/articles/archive/2011/01/18/sixty-minutes-exposes-why-you-cant-trust-drug-companies.aspx

You may remember this story from last November when it first hit the news. But in the 60 Minutes interview above, whistleblower Cheryl Eckard opens up to reveal even more disturbing details about the gross negligence at the Cidra pharmaceutical plant, run by one of GlaxoSmithKline’s subsidiaries.

They eventually pleaded guilty to the felony crime of distributing adulterated drugs, yet not one single person in charge of the debacle went to jail!

Why Should We Trust Felons?

Once you’ve been exposed to the seedy underbelly of the drug business—the LEGAL drug business—you can’t but realize that we’re dealing with a very large group of criminals and felons. There’s really no nicer way to put it.

After all, companies are run by human beings. Company logos don’t make decisions by themselves.

http://engineeringevil.com/2013/09/03/gsk-china-bribery-co-ordinated-at-company-level-says-xinhua/

(January 18, 2011 Mercola)

A Chinese police investigation into drug maker GlaxoSmithKline has discovered that alleged bribery of doctors in China was co-ordinated by the British company and was not the work of individual employees, state media reported on Tuesday.

Police in July detained four senior Chinese executives at GSK over allegations the company funnelled up to 3 billion yuan (HK$3.8 billion) to travel agencies to facilitate bribes to doctors and officials to boost the sale of its medicines.

“It is becoming clear that it is organised by GSK China rather than … sales people’s individual behaviour,” the official Xinhua news agency reported.

(September 3, 2013)


GSK have paid billions in fines for fraud, bribery and general criminality which led (in some cases) to deaths of men, women, children and babies. One of their lead lawyers, Todd P Davis, seems to think nothing of defending companies like GSK against birth defects liabilities, anything for a quick buck eh Todd?

Todd P

Todd works for the King and Spalding law firm. Nice job role Todd- defending convicted felons who think nothing of concealing side effects that kill babies and kids… you must sleep well at night?

King And Spalding are desperately trying to discredit Dr David Healy because David has been speaking out against GSK’s atrocious behavior for almost two decades now (see Fiddaman’s blog and my post).

Leonie Fennell has written a blog about all this too- it’s well worth checking out-

https://leoniefennell.wordpress.com/2015/10/14/glaxosmithkline-david-healy-paxil-stewart-dolin/

David and Goliath Glaxo..

David and Goliath/GSK

GlaxoSmithKline is a UK based pharmaceutical company with a very evil history. This has shown itself time and again in a litany of dubious actions and the pushing of equally dubious medications. In one instance, an FDA Scientist, David Graham, estimated that GSK’s diabetes drug, Avandia, may have caused as many as 100,000 heart attacks, strokes and deaths. Finally in 2011, the European Medicines Agency banned Avandia, ordering it to be taken completely off the market. GSK were found to have been aware of the risks, but hid the real ‘data’, publishing their own version – hiding the deaths.

In 2012 GSK came to the attention of the world’s media once again, this time for paying the largest fine in the history of Big Pharma – a whopping 3 Billion Dollars. Besides hiding Avandia data, GSK also admitted to bribing doctors and encouraging them to prescribe their antidepressant Paxil/Seroxat to children, all the while knowing that it caused suicidality in all ages; many children and adults died.

David Healy et al have recently brought Glaxo back into the spotlight – kicking and screaming ‘foul’ I might add. Last month’s revelation in the British Medical Journal Restoring Study 329: efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence proved once again that GSK hid data which showed that Paxil caused suicide in children. The re-analysis of ‘Study 329’ once again found huge discrepancies; another attempt by GSK to hide bodies, this time little children.

Don’t shoot the messenger:

So what have GSK decided to do? Hold their hands up? Come clean? Apologise for the deception? Grovel to the parents and families left behind? Nope! GSK is now attempting to discredit the messenger, Dr David Healy, who just happens to be an Irishman and a genius to boot (I’ve seen him in action). It’s perhaps not a coincidence that he’s one of the few phychopharmacology experts in the world with the credibility and knowledge to challenge any pharmaceutical company, particularly on antidepressant drugs.

Dolin v. SmithKline Beecham:

David Healy is the expert witness in an on-going trial against GSK (Dolin v. SmithKline Beecham), a case concerning the death of Steward Dolin, a corporate lawyer in Chicago. Stewart jumped in front of a train 6 days after starting Paxil/Seroxat. We had the pleasure of meeting Stewart’s lovely wife Wendy (who is taking the case) last month in Copenhagen. What she said about GSK’s carry-on would make your hair stand on end; as if she hasn’t been through enough hell, but hey, never say GSK  couldn’t sink any lower. They usually do!

According to Bob Fiddaman, GSK put forward a motion that David 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”. Seriously? Toys and pram spring to mind.

Grown men actually put their heads together and came up with the latter. It’s probably why women should rule the world, but I suppose that’s a story for another day. Other fairly nefarious allegations by GSK include – Healy has implied that people who have lost loved ones due to alleged drug side effects would take violent revenge against pharmaceutical executives. Japers, better make sure we don’t all go on a collective rampage. Idiots!

As Fiddaman said “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.” The distracting hand was at it again eh?

For more comprehensive reading – see Bob Fiddaman’s Blog and Mr Antidepaware.


The Big Pharma Business Model: Deception And Bribery

It’s déjà vu all over again. Remember how, three years ago, Pfizer paid $2.3 billion to the Department of Justice to settle off-label claims relating to Bextra and other drugs, and Eli Lilly paid $1.4 billion for Zyprexa marketing?

If so, then last week was no surprise: GlaxoSmithKline agreed to pay a whopping $3 billion to settle criminal and civil charges brought against it by the Department of Justice. Quoting from the DOJ press release, GlaxoSmithKline was accused of:

  • distributing a misleading medical journal article that misreported that a clinical trial of Paxil demonstrated efficacy in the treatment of depression in patients under age 18,
  • GSK did not make available data from two other studies in which Paxil also failed to demonstrate efficacy in treating depression in patients under 18.
  • GSK sponsored dinner programs, lunch programs, spa programs and similar activities to promote the use of Paxil in children and adolescents.
  • GSK paid millions of dollars to doctors to speak at and attend meetings, sometimes at lavish resorts, at which the off-label uses of Wellbutrin were routinely promoted and also used sales representatives, sham advisory boards, and supposedly independent Continuing Medical Education (CME) programs to promote Wellbutrin for these unapproved uses.
  • GSK failed to include certain safety data about Avandia, a diabetes drug, in reports to the FDA that are meant to allow the FDA to determine if a drug continues to be safe for its approved indications and to spot drug safety trends.   The missing information included data regarding certain post-marketing studies, as well as data regarding two studies undertaken in response to European regulators’ concerns about the cardiovascular safety of Avandia.
  • GSK promoted Avandia to physicians and other health care providers with false and misleading representations about Avandia’s safety profile … GSK stated that Avandia had a positive cholesterol profile despite having no well-controlled studies to support that message. The United States also alleges that the company sponsored programs suggesting cardiovascular benefits from Avandia therapy despite warnings on the FDA-approved label regarding cardiovascular risks.
  • GSK paid kickbacks to health care professionals to induce them to promote and prescribe these drugs [Paxil, Wellbutrin, Avandia, Advair, Lamictal, and Zofran] as well as the drugs Imitrex, Lotronex, Flovent and Valtrex.

Let’s call GlaxoSmithKline what it is: a criminal enterprise. GSK didn’t miss the finer points of a couple red-tape regulations: the DOJ alleged they tampered with scientific studies, concealed safety data, then lied to doctors and patients and, if that didn’t work, outright bribed the doctors. Why?  For Wellbutrin, the purpose was to sell psychoactive drugs to kids that were known to be useless in treating depression, but which had a plethora of side effects, including, quoting the label:

headache, insomnia, dizziness, tremor, somnolence, thinking abnormality, abnormal dreams, sleep abnormalities, … depersonalization, emotional lability, hostility, suicidal ideation, aggression, delusions, euphoria, hallucinations, manic reaction, nightmares, paranoid ideation, delirium, psychosis, organic mental disorders, catatonia, restlessness, and completed suicide, … palpitation, cardiac arrhythmias, hypertension (in some cases severe), hypotension, syncope, tachycardia.

For Avandia, the point was to trick diabetics into taking a drug — a drug for which a number of safer alternatives were available, including lifestyle changes and no medicine at all — that “causes or exacerbate congestive heart failure in some patient” and creates a “statistically significant increased risk of myocardial infarction.” That’s on the warning label now, but it wasn’t when most of the marketing was going on, even though GSK knew about the problems.

These aren’t placebos. The side effects aren’t just an upset stomach or nausea. You know what happens when you sue a drug company over a prescription medication? They claim that all prescription drugs are “unavoidably dangerous,” so dangerous that plaintiffs shouldn’t even be allowed to file strict liability or defective design, or failure-to-test lawsuits, because the courts should presume these drugs necessarily kill people. Yet, while it was arguing in court that its drugs were “unavoidably dangerous,” GSK thought it was just fine to prey upon parents’ anxieties about their children’s mental health and diabetics’ fears of crashing or going into shock if they could make a couple billion dollars out of it.

So people are going to jail, right? This is, after all, America, the county with the highest per capita prison population in the world, where the Supreme Court has said you can get strip-searched for riding your bicycle without a bell, where the federal government can send you to jail for growing marijuana in your backyard for your own medicinal use even if your state permits it, where you can be tasered for back-talking to a cop in a traffic stop as long as they don’t taser you “excessively,” where a judge can send you to jail for six months for smiling in court. If we can find some reason to throw you in jail, we’ll take it.

Unless, of course, the defendant did the deed in service of a big corporation. No one at GlaxoSmithKline is under any threat of prosecution. The Department of Justice brought obstruction of justice charges against GlaxoSmithKline’s in-house lawyer for allegedly concealing information in the Wellbutrin investigation, but the prosecution was a failure, resulting in the judge dismissing it before even submitting it to a jury. If that specific information was so important that concealing it was a crime, then why weren’t the initial concealers prosecuted for hiding it from the FDA and the medical community?

So actual prison time, even just the threat of prosecution, for selling people deadly snake oil is out the window. Even the $3 billion is less than it seems, too; calling it a “slap on the wrist” isn’t quite right, but it is by no means real punishment, perhaps more a whisternefet. The money is all being paid by GlaxoSmithKline, not by the employers, officers or directors involved, so it does nothing to deter future drug company employees from doing exactly the same thing — which we know they will, given that this settlement is just the latest in a long string of massive settlements involving all of the big names in pharmaceuticals, including Pfizer, Eli Lilly, Merck, you name it. This headline from the Guardian says it all: “Pharma overtakes arms industry to top the league of misbehaviour.”

We could complain that the wrongdoers at GSK are walking free as a result of paying other people’s money (i.e., the shareholders’ money), but, as the Guardian article points out:

Despite the large fine, $3bn is far less than the profits made from the drugs. Avandia has made $10.4bn in sales, Paxil took $11.6bn, and Wellbutrin sales were $5.9bn during the years covered by the settlement …

The shareholders thus aren’t going to complain at all; GSK is doing exactly what they asked them to do: it’s making money. As Robert Reich points out, “the penalty could almost be considered a cost of doing business.” There’s a reason you can walk down any urban street in the middle of the day and see UPS and FedEx trucks illegally stopped in the middle of the road doing deliveries: delivery companies just consider the tickets a cost of doing business.

That’s the new pharmaceutical company business model: lie, cheat, and bribe your way into billions of dollars. Play upon the fact that doctors are clueless about “off-label prescriptions,” so that, every year, more than 100 million off-label prescriptions with “little or no scientific support” are written. All a pharmaceutical company has to do is set up some baloney expenses-paid conference in Vail or St. Croix or dispatch some sales representative to the doctor’s office — or, if all that fails, just write a check — and, voilà, millions of patients will be prescribed an expensive, useless and dangerous drug for an “off label” purpose unapproved by the FDA.

What’s the worst that could happen to the company? They pay a toll, sign on for a meaningless “Corporate Integrity Agreement” that will do more to shield future perpetrators than to deter them, and then get back to the business of loading people up with dangerous drugs they don’t need.

[Update: Coincidentally, today USA Today has an editorial saying the same thing, while Avvo VP & General Counsel Josh King has a rebuttal. King’s article is at best naive: saying we shouldn’t have criminal prosecutions of corporate executives because “the vast majority of executives want to do the right thing” is like saying we shouldn’t prosecute homicide because “the vast majority of people aren’t murderers.” Update II: Scott Greenfield chimes in as well. Regular readers will be shocked to learn he disagrees with me.]

You Think GSK Are Unscrupulous Sociopaths?… You Haven’t Met Their Lawyers…


“…Cecily’s doctor was hardly alone in prescribing Paxil that year. A year before, in 2001, a much-publicized paper described a clinical trial that showed Paxil to be safe and effective in teenagers as well as adults. Study 329, as it became known, helped spur a huge increase in Paxil prescriptions. In 2002 alone, over 2 million prescriptions were written for children and teens, and many more for adults. (As a 25-year-old, Cecily Bostock was, from a neurophysiological perspective, on the cusp between adolescence and adulthood.) Did Cecily’s psychiatrist choose Paxil because of Study 329? It’s hard to believe the answer is not at least partly yes..”

“…As Carey notes in his Times story, thousands of children, teens, and young adults attempted or committed suicide while on Paxil—but it’s impossible to know how many, if any, did so because of Paxil. This new BMJ paper makes it seem more likely than ever than some did. And of her daughter, Sara Bostock has no doubt…”

(The Atlantic 2015)

Bob Fiddaman has just done an excellent post on the Stuart Dolin Paxil Suicide trial and the various shenanigans of GSK’s (one of many) law firms- King And Spalding.

You can read the post here

Personally, I don’t know how any lawyers or firms can justify working for a company like GSK. I understand that everyone has to do a job, but seriously, defending a drug company with a record of widespread corruption and fraud spanning decades (see here) is paramount to endorsing this behavior is it not?

Not to mention working for a company which actively encourages promoting their (proven to be) dangerous medications (Paxil, Pandemrix) for children. If any of these lawyers have kids, then I don’t know how they sleep at night?

Does King and Spalding endorse the corporate manslaughter of kids by pharmaceutical companies?

Because that’s what GSK did with Paxil study 329 (read about it here). Supporting this drug company- or taking pay checks from it- is supporting the corporate killing of kids for profit and endorsing GSK’s bribery and fraud networks. King and Spalding should be ashamed of themselves, as should every other law firm who works for this abhorrent company.

King and Spalding- your GSK paychecks are blood money, gained from the blood of Paxil suicides, how do you justify this to your conscience?

Not content with working for one of the most corrupted and fraudulent sociopathic corporations on the planet, it seems that now King and Spalding have decided to out-do their masters GSK in the sociopath stakes…

King And Spalding have tried every trick in the book in order to try to discredit the Dolin family, Stewart’s memory, and in particular his widow, Wendy.

Law360, New York (August 14, 2014, 3:32 PM ET) — A deceased Reed Smith LLP partner’s wife, who claims her husband’s suicide can be traced to GlaxoSmithKline PLC’s antidepressant Paxil, on Wednesday challenged the drugmaker’s subpoena for cellphone and text message records, accusing GSK of using aggressive discovery tactics that invade her privacy.

King And Spalding’s behavior seems to imitate that of their bosses, it’s totally unethical and morally repugnant.

These lawyers are nothing but bullies…

Dr David Healy is the expert witness in this trial, and King And Spalding are also trying to intimidate Healy in the same way that they did with the grieving widow, Wendy Dolin.

GSK hate critics like Healy because Healy was one of the first to speak out against them. GSK have been killing kids for decades with their anti-depressant Paxil (Seroxat) and they don’t like it when people try to get access to their internal documents through the courts. It seems that for GSK, and their sociopathic lawyers- money, legal fees and company profits- are more important than human lives, even the lives of children are disposable and immaterial to these deplorable, amoral individuals…

Healy is a patient activist, he fights for patient rights, access to data, and highlights side effects of medications like Paxil.

GSK are patient killers, they have nothing but contempt for those harmed by their medicines- that’s why they seek to discredit people like Healy..

Law360, New York (April 30, 2015, 4:14 PM ET) — GlaxoSmithKline PLC told an Illinois federal judge Wednesday that the widow of a former Reed Smith LLP partner claiming a generic version of GSK’s antidepressant Paxil caused his suicide must provide more information on an expert who said the company is out to get him.

GSK said Dr. David Healy, a Welsh psychiatrist whose report linking paroxetine hydrochloride to suicidal behavior was submitted as evidence by plaintiff Wendy Dolin, was referred to the U.K.’s General Medical Council following an investigation for which Healy believes GSK is responsible, and said Dolin’s counsel instructed Healy not to discuss the GMC’s probe and refused to provide some documents relevant to Healy’s qualifications.

The documents are relevant to the potential bias Dr. Healy may have against GSK based on his claims that GSK specifically, or the pharmaceutical industry generally, may be behind his referral to the GMC,” GSK said.

According to GSK, Healy has blogged about his “conspiracy theories” concerning pharmaceutical companies including GSK, and that during his deposition in another case, Healy said the Royal College of Psychiatrists had written the council to say that Healy should be suspended.

Healy reportedly obtained that information through the U.K.’s Freedom of Information Act and GSK said it wants access to the documents he received.

The day before GSK’s April 2 deposition of Healy in London, Dolin’s attorneys stepped in with a “laundry list” of objections on the basis of relevance and confidentiality, and instructed Healy not to answer any questions about the investigation, GSK said.

The drug maker then requested that Dolin provide a privilege log to identify what documents were being withheld, but the plaintiff’s counsel refused, according to GSK.

GSK said Wednesday that Dolin’s argument that documents and testimony regarding the investigation are privileged are too vague to even be addressed.

However, the pharmaceutical company said that if the plaintiff’s objections relate to concerns over the release of patient information, those details could simply be redacted.

In 2012, Wendy Dolin sued GSK and Mylan Inc., which produced the generic medication her husband and former Reed Smith partner Stewart Dolin took before jumping in front of a Chicago “L” train.

Dolin’s complaint said her husband killed himself six days after he began treating his anxiety and depression with paroxetine hydrochloride.

Michael Baum, an attorney for Dolin, told Law360 on Thursday that he is in the process of filing a response.

On Friday, Dolin accused GSK of needlessly attempting to delay the trial after she and her attorneys had already accommodated an earlier request to bump the trial to late November.

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

GSK is represented by Alan S. Gilbert of Dentons, Andrew T. Bayman and Todd P. Davis of King & Spalding LLP. Mylan is represented by Robert E. Haley of Swanson Martin & Bell LLP and Clem C. Trischler and Jason M. Reefer of Pietragallo Gordon Alfano Bosick & Raspanti LLP.

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


I experienced Akathisa on Seroxat (Paxil) -Akathisa is the side effect which drive Stewart Dolin to kill himself on Paxil. I can only imagine how it feels for a child.. I wonder if the GSK’s lawyers in this case ever tried to imagine what it must feel like to experience it? Do they care that many thousands of kids (and adults) have been driven to suicide from Paxil? or is their pay check more important?

http://missd.co/


Are you suffering from akathisia?

Have you recently started taking a new medication for anxiety, depression, or any other mental health issue?

Akathisia: What to look for

Are you experiencing an increase in any of the following symptoms: anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, or physical/inner restlessness, which have in turn caused suicidal thoughts or feelings?

Perhaps a friend or loved-one, shortly after starting a new medication, has engaged in strange, unusual or violent behavior, or without warning has even taken his/her own life.

You or your loved-one may be suffering from akathisia.

Contact

If medication-induced suicide or akathisia has affected your life – or you would simply like to learn more – we would love to hear from you. To send us your stories, articles, questions or comments, please drop us a line:

share@missd.co

What is akathisia?

Akathisia is a disorder, induced by SSRI medications, which can cause a person to experience such intense inner restlessness that the sufferer is driven to violence and/or suicide.

Akathisia

Akathisia is a disorder, induced by SSRI medications, which can cause a person to experience such intense inner restlessness that the sufferer is driven to violence and/or suicide. It has been said, “Death can be a welcome result.” For reasons related to the strong political and lobbying power of pharmaceutical companies, akathisia is rarely explained as a possible side effect of SSRIs, and medical professionals and the general public know very little of the existence of this disorder.

In fact, the drug lobby would like you to believe that akathisia is simply “restless leg syndrome.” As a result, sufferers of akathisia, as well as the medical professionals with whom they consult, are not able to recognize the symptoms of akathisia and therefore take the steps necessary to stop it. This lack of knowledge has tragically resulted in akathisia sufferers taking their own lives, and leaving behind devastated loved ones.

MISSD is not anti-drug. We know that prescription drugs have been life-saving for so many individuals who struggle with mental health issues. We are for truth in disclosure, honesty in reporting and legitimate drug trials.

What should I do?

If you or someone you know is suffering from the symptoms of akathisia, you should tell the doctor who prescribed the drugs, call 911 or go to the nearest emergency room. MISSD does not give medical advice or counsel (see disclaimer).

According to the FDA:

Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication in patients whose depression is persistently worse, or who are experiencing emergent suicidality or symptoms that might be precursors to worsening depression or suicidality, especially if these symptoms are severe, abrupt in onset, or were not part of the patient’s presenting symptoms.

Stewart Dolin 1952-2010

About MISSD

Stewart Dolin had the perfect life. He was married to his high school sweetheart for 36 years. He was the father of two grown children with whom he had a very close and meaningful relationship. He was a senior partner of a large international law firm, managing hundreds of corporate lawyers. He enjoyed his work and derived satisfaction from cultivating relationships with his clients, as well as helping them achieve the results they desired. He enjoyed travel, skiing, dining, joking around with his family and friends and an occasional cigar. He was 57 years old, and high on life.

In the summer of 2010, Stewart developed some anxiety regarding work. He was prescribed Paxil (paroxetine), a selective serotonin reuptake inhibitor (“SSRI”). Stewart’s prescription was filled with a generic version of Paxil, manufactured by Mylan. Within days, Stewart’s anxiety became worse. He felt restless, had trouble sleeping, even asked his wife to listen to a meditation tape with him (hardly typical behavior). He kept saying, “I still feel so anxious.”

On July 15, 2010, (six days after beginning the medication), following a regular lunch with a business associate, Stewart left his office and walked to a nearby train platform. A registered nurse who was also on the platform later reported seeing Stewart pacing back and forth and looking very agitated. As a train approached, Stewart took his own life. This happy, funny, loving, wealthy, dedicated husband and father who loved life left no note and no logical reason why he would suddenly want to end it all. Neither Paxil nor the generic version listed suicidal behavior as a potential side effect for men of Stewart’s age.

We did not know it then, but Stewart was suffering from akathisia.

MISSD (The Medication-Induced Suicide Prevention and Education Foundation in Memory of Stewart Dolin) is a unique non-profit organization dedicated to honoring the memory of Stewart and other victims of akathisia by raising awareness and educating the public about the dangers of akathisia. MISSD aims to ensure that people suffering from akathisia’s symptoms are accurately diagnosed so that needless deaths are prevented. A website, the creation of educational materials and support of conferences such as Selling Sickness, will help to raise awareness and knowledge of akathisia and medication-induced suicides. Again, we feel it’s important to note that we are not anti-drug, and recognize that prescription drugs can be positive and life-saving for many individuals. We are for truth in disclosure, honesty in reporting and legitimate drug trials.

If this could happen to Stewart, then it could happen to anyone. MISSD will make a difference.

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GSK Can’t Escape Suit Over Reed Smith Atty’s Suicide


http://www.law360.com/legalindustry/articles/515187/gsk-can-t-escape-suit-over-reed-smith-atty-s-suicide

By Greg Ryan0 Comments

Law360, New York (March 04, 2014, 5:06 PM ET) — In a groundbreaking ruling Friday, an Illinois federal judge determined that GlaxoSmithKline PLC can be held liable for a Reed Smith LLP corporate and securities partner’s suicide even though he took a generic version of the antidepressant Paxil, not the brand-name version made by the company.
The decision contradicts dozens of court rulings nationwide that brand-name drugmakers cannot be held liable for an injury caused by a generic drug. Only a handful of courts, including the Alabama Supreme Court, a California state appeals court and a Vermont federal court, have held otherwise.

The case appears to be the first time a court in the Seventh Circuit has considered the issue, according to the opinion by U.S. District Judge James Zagel.

The suit concerns the 2010 suicide of Stewart Dolin, the onetime chairman of Reed Smith’s corporate and securities group. Six days after he began taking paroxetine hydrochloride, a generic version of Paxil, to treat work-related anxiety and depression, he left his Chicago office and killed himself by jumping in front of an “L” train.

Dolin’s wife Wendy sued GSK and the manufacturer of the generic drug he took, Mylan Inc., claiming they failed to warn patients that adult users of paroxetine were at greater risk of suicidal behavior.

Judge Zagel dismissed Mylan from the suit but granted only part of GSK’s motion for summary judgment. While GSK cannot be held strictly liable for Dolin’s suicide, the company can be found negligent, he said.

The judge rejected GSK’s contention that the negligence claims were product liability claims in disguise, saying Illinois law did not require him to construe one as the other.

“The injury here did indeed occur in connection with a product. And GSK manufactures products. Yet plaintiff has not brought suit against GSK for tortious conduct committed strictly as a manufacturer of products. And, though GSK implicitly urges to the contrary, I see no reason why all suits brought against GSK must be brought against GSK qua manufacturer,” he said.

In order to determine whether a defendant owes a duty to a plaintiff even if they are not directly connected, Illinois courts are supposed to consider four factors, Judge Zagel said: the reasonable foreseeability of an injury, the injury’s likelihood, the burden of guarding against the injury and the consequences of putting that burden on the defendant.

The factors indicate GSK owed a duty to Dolin, according to the judge. GSK should have expected generics manufacturers would make paroxetine once the patent for Paxil expired, and it knew the companies would have to follow GSK’s label for the drug, he said. GSK failed to show that the likelihood of an injury was so remote that it eliminated its duty of care, he said.

To guard against the risk of suicide by someone like Dolin, GSK could have simply changed its warning label, Judge Zabel said. There is a danger of overwarning about a risk, but GSK did not argue that the danger outweighed the duty it owed to Dolin, he said.

“That GSK did not manufacture the pill Mr. Dolin ingested is largely immaterial on this point,” the judge said. “GSK will not be tasked with the burden of crafting one new warning label for Paxil, and then other discrete warnings for various generic iterations of the drug — that all of the iterations of paroxetine are bioequivalent and require the same warning is precisely the point.”

GSK “has been compensated for taking responsibility for paroxetine’s design and warning label” through the Hatch-Waxman Act, which extended brand-name makers’ exclusivity over sales of their drugs, according to Judge Zabel.

R. Brent Wisner of Baum Hedlund Aristei & Goldman PC, an attorney for Wendy Dolin, praised Judge Zagel for eliminating the “doughnut hole of liability” faced by Illinois generic-drug users seeking to hold a manufacturer accountable for their injury.

“If you create a drug and know that it poses serious risks, regardless of whether consumers use the brand-name or generic version of that drug, you have a duty to warn,” Wisner said in a statement.

GSK criticized the ruling, saying that nearly 90 other decisions, including all six federal appeals court decisions to date, have rejected brand-name maker liability for generic-drug injuries.

“Holding a branded manufacturer liable for its generic competitor’s product forces the branded manufacturer into the role of an insurer for the generic industry … [s]uch a result would chill research and innovation,” the drugmaker said in a statement.

A Reed Smith representative declined comment on the ruling, saying the case was not a firm matter. Reed Smith has represented GSK in other product liability matters.

Judge Zagel dismissed Mylan from the suit based on the U.S. Supreme Court‘s landmark Bartlett ruling last year, in which it held that federal law preempts design defect claims against generic-drug makers.

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

GSK is represented by Alan Gilbert and Melissa Economy of Dentons and Andrew Bayman, Todd Davis and Christopher Benson of King & Spalding LLP.

Mylan is represented by Robert Haley of Swanson Martin & Bell LLP and Clem Trischler and Jason Reefer of Pietragallo Gordon Alfano Bosick & Raspanti LLP.

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

–Editing by Andrew Park.

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