Day two kicked off with King & Spalding’s Andrew Bayman finalizing his points to the jury that he started yesterday. He told them that, in 2006, GSK told the FDA about Paxil’s increased suicide risks, he also told them that ‘Dear Doctor’ letters were sent out across the United States and that Stewart Dolin’s doctor was aware of this. According to Bayman, the FDA changed GSK’s warnings for all SSRIs and not just Paxil. Bayman also claimed that the FDA had told them (GSK) 4 times that they could not use their own wording in the label warning. Bayman also told the jury that GSK’s sales force (reps) have no influence in prescribing habits – at this point I had to hold in my laughter, given that they paid a $3 billion fine recently to the DOJ for doing just that! (See – “GlaxoSmithKline to Plead Guilty and Pay $3 Billion to Resolve Fraud.”)
More on King & Spalding’s Andrew Bayman later in this post.
Next up was Brent Wisner of Baum Hedlund who is representing Stewart Dolin’s, widow, Wendy Dolin.
Dolin presented the jury with three video depositions, the first being a May 2006 testimony from former GlaxoSmithKline CEO, JP Garnier. The depo was used in a previous case against GSK where Debra L. Tucker filed suit against them for the wrongful death of her brother, Rick, who, she alleged, killed himself after taking GSK’s Paxil.
In the 2006 testimony Garnier was asked…
“Would you agree that a reasonable and prudent pharmaceutical manufacturer has a duty to warn prescribers of serious adverse events?”
Garnier answered, “Yes, I would agree.”
It was also learned from Garnier’s deposition that there is a law in place to help pharmaceutical companies should they wish to change the labelling because of new evidence that may arise regarding serious adverse reactions. He was asked…
“You can change your label without even getting approval from the FDA, there’s a law that allows you to do that, correct?”
Garnier answered, “Yes, but in practice you don’t want to do that.”
He was then pressed, “Okay. But you can do it, if you want, the law allows that to occur?”
Garnier replied, “Yes, but you do want the FDA to agree with the changes you are going to propose because they have the power to correct what you just said the day before. You know, let’s say we decide to inform physicians of some new event affecting our drug, well, the next day the FDA might come back and say, well, we didn’t like the way you did this, you have to redo it. So it’s considerably disrupting, that’s why most companies go through the FDA first, in practice, but you are right, there is a legal right for us to go directly to the public.”
The above 2006 statement from Garnier kind of contradicts what King & Spalding’s attorney, Andrew Bayman, told the jury earlier in the day.
The next video deposition aired in court today was from John Christian Davies, a statistician from GSK. He confirmed that 8 of the 11 suicide attempts that have been previously mentioned in this trial were aged 30 or below, leaving 3 that were over the age of 30. GSK, in the Dolin trial, are denying that Paxil can cause suicide in adults. Hard to believe that a bunch of highly paid attorneys would think that anyone over the age of 30 are children or adolescents.
The final video deposition to be aired today was that of Geoffrey Charles Dunbar. Dunbar gave his testimony in September 2005, again it was in relation to another Paxil wrongful death lawsuit.
In 1987 Dunbar joined GSK, who were then known in the UK as Beecham Pharmaceuticals. He was given the role of director of CNS, a role whereby he oversaw Paxil clinical trials. Paxil, at this stage, was still in its infancy and hadn’t yet come to market.
In the 2005 video deposition Dunbar was asked about the contentious two placebo suicides that were wash-out and run-in suicides (Back story). He said that he was not aware of them, he added that he had only recently become aware of them (bear in mind that the video deposition was taken in 2005).
Dunbar was then pressed further…
“Whether it was through oversight or negligence or intent or whatever the reason, that publication of published data was invalid, wasn’t it?”
“Well, regardless of intent here, isn’t it true that public health on SSRIs for paroxetine was greatly misserved by your publications of this data in ’91 and ’92 and up through ’95 as being valid paroxetine figures not designated with an asterisk for wash-out and run-in? That was a misservice to public health, wasn’t it?”
Dunbar answered, “It was an error.”
Dunbar was then asked, “Okay. Are you inclined to do anything to correct the record, such as notifying GlaxoSmithKline that your authorship was incorrect?”
Dunbar answered that it wasn’t his intention to do so, on being asked why this was so? He answered…
“Because I think GlaxoSmithKline are very well aware of the issues we’re discussing now.”
Once the video depostions were played to those in attendance today, David Healy was then called to the witness stand…it was not without incident as King & Spalding made objections before Healy entered the courtroom, objections that saw King & Spalding attorney, Andrew Bayman, almost bursting a blood vessel as he tried to persuade the Judge not to allow certain lines of questioning from Baum Hedlund’s Brent Wisner.
The questions thrown at David Healy today, and his subsequent answers, will be covered in a blog post tomorrow. Suffice to say King & Spalding’s Andrew Bayman spent most of the day impersonating a Jack-In-The-Box as he stood from his seated position pleading objections to the Judge more times than I can count.
I personally think Bayman had an adverse reaction to the presence of Healy.
More on this tomorrow.