Tagged: Fiddaman Blog

The Fiddaman Blog…


http://fiddaman.blogspot.ie/2017/03/glaxo-dont-want-jury-to-see-paxils.html

Glaxo Don’t Want Jury To See Paxil’s “illegitimate” Suicide Figures

http://www.facebook.com/plugins/like.php?href=http://fiddaman.blogspot.ie/2017/03/glaxo-dont-want-jury-to-see-paxils.html&layout=button_count&show_faces=false&width=100&%20action=like&font=arial&colorscheme=light

Yet another objection by GlaxoSmithKline in the eagerly awaited Dolin Vs GlaxoSmithKline Paxil induced suicide trial, set to begin next Tuesday in Chicago.

GSK, it appears, are now bitchin’ about evidence submitted by Wendy Dolin, the widow of Stewart Dolin, that shows how (in a previous trial) the testimony of former FDA employee Dr. Martin Brecher showed that stopping or discontinuing Paxil led to undesirable side effects. (In re Paxil, Case No. CV-01 07937 MRP (C.D. Cal.))

GSK’s objection states…

“Permitting Plaintiff Wendy Dolin to introduce Dr. Brecher’s testimony would be highly and unfairly prejudicial because the jury would be left with the incorrect impression that FDA determined that GSK’s reporting of suicides and suicide attempts in the Paxil NDA was “scientifically illegitimate.”

During Brecher’s original deposition, taken almost 14 years ago, it was learned that Brecher, whilst employed at the FDA, told Glaxo (then SmithKline Beecham) officials that “Paxil was dangerously addictive.” (1)

Glaxo are also objecting to this evidence being submitted in the Dolin trial because, “…the prior case involved a different subject matter than this case.”

Brecher, whilst under oath was also questioned about the suicide figures relating to patients taking Paxil. Here’s part of that deposition. Keyword here is “illegitimate.”

You’ll note that GSK’s attorney’s cite the same thing when Brecher is being asked questions that forms part of their objection in the Dolin case, ergo “It has absolutely nothing to do with this litigation.”

Q (by Mr. Farber): Now, you had the NDA that was submitted in November of ’89 and you took over the job in January of ’90, correct. So you had had – this is prior to the Teicher article now in January by month at least and the NDA had been submitted two months earlier. That NDA had suicide tables and data; did it not?

A: Yes.

Q: And did you through a matter of course in your regular routine review that suicide data?

A: I believe I did.

[Objection and colloquy omitted]

Q: So the data on suicide that you had when the NDA – let’s basically — That will be Exhibit 15.
[Colloquy omitted]

Q: Take a look at that for a minute. Ready?

A: Uh-humm.

Q: Now this table Roman numeral 11.21 talks about attempted suicides and overdoses, Worldwide Data. And at the bottom it indicates the Par safety summary of 10 November of 1989. And you’ll notice up in the right-hand corner of the Worldwide Data that it has all the population that we talked about earlier that you believed I was telling you the truth and I am, the one that says 2,963 under Paroxetine, 1,151 and 554 respectively for placebo; do you see that?

A: Uh-humm.

Q: Okay. Now, here we have attempted suicides on the top line that are further broken down into drug overdose and I’ll save you the time by figuring this out and it’s to their benefit anyway, so the drug overdose category is within the top category, it’s not – it’s not in addition to, it’s a subset of attempted suicides. And my question is the asterisk of two overdoses during the placebo run-in, you see the asterisk on the side, and of the overdoses, attempted suicide, two were – occurred during the run-in period. Let me ask you this: Based on your procedures at FDA – first of all, let – let me back up a minute. Based on your procedures at the FDA, what is a run-in period?

A: Prior to randomization subjects are discontinued from their old medication and given placebo usually for about a week, sometimes shorter.

Q: And how about wash-out, same?

A: That — that period also washes out their previous medication.

Q: So the terms are effectively synonymous for the purposes of …

A: (No verbal response.)

Q: Okay, now, based on FDA procedure and I’ll even elevate that to scientific procedure that you understood scientific procedure to be when you were at the FDA, is it scientifically legitimate to count a suicidal act occurring during wash-out and run-in to the placebo count?

[GSK COUNSEL]: Object to the form of the question. It has absolutely nothing to do with this litigation.

MR. FARBER: You’re going to see a connection if you’re patient here.

A: No, because everybody got placebo.

Q: So it’s scientifically illegitimate way to count, correct?

A: Yeah.

So, it appears that the current crop of Glaxo attorneys involved in defending Paxil in a suicide trial don’t want this evidence seen by a jury, just as the old crop of Glaxo attorneys didn’t want the jury in a Paxil addiction case to see evidence of Paxil induced suicide.

Begs the question; what exactly do Glaxo want the jury to see, just their evidence? A case of having their cake and eating it, perhaps?

The Paxil addiction lawsuit was settled out of court, over 3,000 plaintiffs received a compensatory award (figure unknown)

In the UK, consumers of Paxil (known as Seroxat) have been waiting almost 10 years to find out if they can press ahead and sue GlaxoSmithKline with regard to severe adverse reactions caused by Seroxat. In a recent pre-trial judgment the UK Plaintiffs were told that the outcome of the class action in the USA has no relevance to the UK cases. Glaxo had previously objected that the UK Courts did not need to know this. (2)

A strange judgment given that the relevance is in the word ‘Withdrawal’. Nonetheless, the UK consumers still battle on.

Opening arguments in the Dolin trial commence Tues, March 14 in Chicago. I’ll be writing daily reports on the events.

Bob Fiddaman.

(1) “Paxil was dangerously addictive.”
(2) SANDRA BAILEY & OTHERS Vs GLAXOSMITHKLINE (UK) LIMITED 01/03/2017

Doin v GSK back stories.

Advertisements

Fiddaman Blog: GSK: Motions Denied in Paxil Suicide Case


http://fiddaman.blogspot.ie/2015/11/gsk-motions-denied-in-paxil-suicide-case.html


Saturday, November 21, 2015

GSK: Motions Denied in Paxil Suicide Case

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

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

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

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

GSK have been roundly trounced.

Judge James B. Zagel, in summary, said…

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

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

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

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

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

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

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

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

Bob Fiddaman