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Thursday, August 03, 2017

GSK Blame Stewart Dolin in Move for New Trial

One would have thought the case filed against GSK by Wendy Dolin was done and dusted. However, GSK has been adamant that the verdict handed down by the jury in Chicago last April is wrong. (Boo hoo)

Cry Me A River

GSK continues to cry its river of DeNile after being found responsible for Stewart Dolin's Paxil-induced death. Together with its King & Spalding lawyers, GSK now claims:

1)  U.S. District Judge William T. Hart did not properly instruct the jury

2) Dolin's doctor did not properly warn his patient that GSK's product increases suicidality and suicide

3) Ergo, when Dolin started suffering from Paxil-induced akathisia and psychosis, he should have noticed these adverse drug reactions (ADRs) before dying.

To most people, GSKs claims are ridiculous. But for GSK and other pharmaceutical companies, such outlandish claims are just business as usual.

GSK is essentially saying, "Yes, our drug and any generic version of it, has a propensity to cause someone to kill themselves. But we refute any responsibility because, together with the FDA, we wrote a vague warning about these risks. Further, doctors who prescribe our drug should communicate these risks to patients. Then, it is up to Paxil consumers to "choose" whether or not they want to kill themselves when suffering from Paxil-induced akathisia."

GSKs' claims are similar to ones they repeated for six-weeks during the Dolin vs. GSK trial. GSK blamed Stewart Dolin's death on his supposed "illness." GSK blamed Dolin's death on the doctor who prescribed their product. GSK blamed Dolin's death on the FDA. Now, GSK is blaming the judge for the jury's guilty verdict against GSK.

Don't Ya Just Love 'Em?

The jury ruled against GSK because the lackluster King & Spalding legal team couldn't defend the indefensible. Mounds of evidence piled up exposing GSKs greed and guilt. (The jury was likely also shocked to hear about the pile of bodies GSK tried to conceal--those innocent volunteers who died during Paxil's clinical trials.)

Not only did the jury find GSK responsible for Dolin's death; they also found GSK responsible for Dolin's pain and suffering. Therefore, they made two separate monetary awards.

GSK doesn't want to pay nor admit guilt. They are calling for a new trial and repeating their tactic of blaming everyone else for the ADRs their product causes. GSK states:

-  Its hands were tied because supposedly drug regulators would not allow GSK to use the specific warning language it wanted

- The jury instructions didn't entirely separate/7' different elements necessary for liability

- The doctor's testimony shows he was aware of the risk when prescribing paroxetine.

GSK's lackluster defense saw the jury rule in favor of Wendy Dolin and award her $2 million for wrongful death and $1 million for pain and suffering in the days before he took his life. She has yet to see a dime of that award because GSK are crying this river of denial. (De Nile)

Wendy Dolin, via her legal team, Baum Hedlund and Rapoport Law Offices PC, said Stewart's doctor testified that when he decided to prescribe the drug, he relied on the 2010 Paxil label. This Paxil label didn’t warn that Paxil could lead to suicidality in adults over age 24.  Furthermore, GSK failed to alert drug regulators that research showed an increased suicide risk among adults who take Paxil.

In 2007, GSK was invited by the FDA to discuss the inclusion of label language specific to adult suicidality. GSK then failed to meet with the FDA about this labeling issue. GSK did, however, have a duty to warn consumers even if the FDA decided not to. A 2006 video deposition played at trial shows GSK's former head, JP Garnier.

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

Garnier answered, "Yes, but in practice, you don't want to do that."

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

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

So, even Glaxo's own head was agreeing that GSK could have by-passed the FDA if it wanted to. The key phrase here is from Garnier's own mouth, "...there is a legal right for us to go directly to the public."

During the trial, it was revealed that there were 20 adult suicides in paroxetine clinical trials. Supposedly, there were no completed suicides in the paroxetine pediatric trials. (I say "supposedly" because one can never be certain if drug companies and regulators are telling the whole truth.) The clinical trial deaths beg the question: Why would GSK go to great lengths to confuse prescribing doctors with the warning about suicidality for patients under the age of 24?

GSK: A Forked-Tongue Monster 

Seeing GSK in court conjured up images of a forked-tongue monster speaking from both sides of its mouth. On opening day of the Dolin vs GSK trial, GSK's attorneys told jurors Paxil does not cause suicide.

Later, GSK lawyers claimed the company did everything in its power to show Stewart's doctor that Paxil increases the risk of suicidal thoughts and suicidal action among anyone who consumes it.

I'm reminded of a scene from the brilliant Fawlty Towers. Basil (John Cleese) returns to his hotel to discover that the building renovations haven't quite gone according to plan. We see "fault" here being passed around from pillar to post. Basil's reaction is priceless.

I suspect if Stewart Dolin was alive today, this would be his response.

Law 360 write about GSK's latest shenanigans here.

Bob Fiddaman

How the trial unfolded - a day-by-day account

Dolin v GSK - Opening Arguments

Dolin Vs GSK - Day Two - "Jack-In-The-Box"

Dolin vs GSK - Healy 'Rocks Da House'

Dolin Vs GSK - JP Garnier Video Deposition

Dolin Vs GSK - The Dunbar Tape

Dolin Vs GSK - Day 4 - Slam Dunk

Dolin Vs GSK - 8.9 Suicide Increase For Adult Paxil Users

Dolin Vs GSK - Day 6 - Ass Kicking Semantics

Dolin Vs GSK - Day 7 - Abraham Lincoln

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

Dolin Vs GSK - Glenmullen Nails It!

Dolin Vs GSK - "Babes"

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

Dolin Vs GSK - Robert "Bling Bling" Gibbons

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

Dolin Vs GSK: Jury shown List of the Dead in Paxil Clinical Trials

Dolin Vs GSK: Last Man Standing & The Return of Dr. Healy

Dolin Vs GSK: Closing Arguments

Dolin Vs GSK - The Verdict

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