Editorial Note: This is a second post in the Change in Chicago Series looking at the Dolin trial and its verdict. There will be two more in the series.
Being cross-examined in a legal case involving Pharma is rarely fun. The lawyers will have done their homework in spades. As one of them put it to me once: Dr Healy, I have read everything you have ever written. Looking straight at him, I was quite prepared to believe this included every email I’d ever written. Between raking over an expert’s financial affairs, and private lives and any view ever expressed on anything, the assault on the expert can take any shape and rarely involves an engagement with the “science” of the issue. The results can be bloody.
In a deposition in the Dolin case two years previously that was supposed to be about the science of paroxetine, after a quick hour on the science, Dr Tamar Halpern and Bob Glanville for GSK spent nine hours instead picking over my relations with Betsi Cadwaladr University Health Board, my dealings with all sorts of people before finally producing several large binders containing every post on this and on the RxISK blog – something like 800,000 words and 500 blog posts, fishing fro statements to snag me on.
At trial, Andy Bayman, GSK’s lead lawyer made a show of presenting me with two huge binders of prior depositions and testimony. I didn’t have the wit to count up all the words and pages and hours of testimony but it was likely 10,000 plus pages, a million plus words and over 3000 hours worth of being grilled under oath. The usual tactic is to pick out a phrase deep in the folder and triumphantly present that to the Court as representative of “your views Dr Healy”.
This is where any prior use of irony, or jokes, or effort to take the views of those who have an opposite point of view to mine into account can become a liability.
One trick is just to ask: “Did I read that correctly Dr Healy” – and move quickly on. In Dolin I had what I thought was a minor triumph when Andy Bayman tried this and I had the wit to respond “No”. This was something he didn’t expect, particularly as he had all the words correct. I explained that he’d missed the note of irony.
Overall the cross in Dolin didn’t seem to be too bad. Mr Bayman was more than averagely pleasant – it seemed. He didn’t argue too much when I seemed to score points – as I thought. At the end some of those on the plaintiff’s team congratulated me on having done a good job – but they probably say that to all witnesses. Several people reading the transcript later commented on a job well done but they were supporters to begin with.
So, after the trial was over, I turned to the closing arguments from both sides with interest. What would Andy Bayman say? I was a little surprised to begin with. Surprise turned to consternation. What was this – it seemed like someone called David Healy was the prize witness for GSK. Again and again they quoted that nice Dr Healy as saying FDA knew of the problem decades previously. Dr Healy showed you that FDA saw exactly what GSK had done and you didn’t hear him mention any quibbles.
A lot of the points I thought I had scored with looked like own goals. No wonder Andy Bayman didn’t contest some of what I thought were my most effective shots. No wonder he was so nice.
The full transcripts and exhibits are available on the Baum Hedlund website and will be on SSRI stories.
In trials like the Dolin trial, the plaintiff’s team try to make sure the jury blames GSK rather than the man himself or his doctor. At the end of this trial, they thought they had done a good job and the jury might not be out for much more than a few hours. The jury was out for days. And when they came back it became clear they were wrestling on the issue of who to blame. But Stewart Dolin wasn’t in the frame. Nor was his doctor. The dilemma was whether FDA were more culpable than GSK.
This was like playing Go, where it can look like the black counters on the board have white encircled until white puts down one more piece and all of a sudden it wins.
As someone who knows Andy Bayman, I was interested to see what Andy Vickery would make of what had happened. Vickery is a Houston lawyer who in 2001 won the Tobin case – a first ever verdict against a pharmaceutical company for a behavioral effect of one of their drugs – which should have led to a Black Box Warning for Adults on Antidepressants. He might say he was “just a lil ol’ country lawyer, but momma Vickery didn’t raise no fools … But it would be tongue in cheek if he did.
In the end, the Jury got it right. They usually do. The citizens who decided the Dolin Paxil suicide case in Chicago last week held GSK accountable for the wrongful death of Stewart Dolin, by all accounts a very good man. And, although the verdict was only a fraction of the daily profits that GSK garnered from Paxil during its lengthy monopoly money patent protected marketing days, the verdict still holds the company that made those billions of dollars in profits — the company that had both the legal authority and moral responsibility to change the label — liable for damages.
But it was not easy. By all appearances, the Jury struggled at length with the beguiling arguments of GSK’s very talented lead counsel, Andy Bayman. He told them that the FDA were a “neutral group of scientists” who did not have a “dog in this fight.” And that the FDA had “spoken loudly” on the issue of SSRI induced suicide. It was excellent advocacy, but a sleight of hand.
The truth is that the FDA stuck its head in the sand on this issue when it was first raised regarding Prozac in 1990, and, with the exception of a minor nod for the protection of pediatric patients in 2004, it has kept its head in the sand. In this respect, I share Mr. Bayman’s perspective that the FDA has, indeed, “spoken through its silence.” The FDA’s abysmal abdication of its duty to protect patients was, indeed, another “proximate cause” of Stewart Dolin’s death. Its “silence” killed Stewart Dolin.
BUT, the FDA is immune from suit. To be sure, the FDA could argue that one of the reasons that it was silent is that GSK “cooked the books” on Paxil suicidality. There is ample evidence to support that. But the “whole truth” is that the FDA had plenty of information which should have caused it to act proactively and to protect the American populace, and it willfully neglected its duty to do so.
The issue first arose in 1989 in the wake of a scientific study by two highly credentialed Harvard neuropsychopharmacologists. They cited 6 cases in which Prozac was the likely precipitating cause in adult suicide attempts, and they posited a “biologically plausible” explanation for how and why that happened.
In response, the FDA assembled an ostensible “blue ribbon” panel to advise it. It was a total farce. Several of the panel members had to obtain “waivers” of their extensive ties to Big Pharma in order to serve at all, and the Chairman of the Committee wore a bullet-proof vest at the public hearing because he feared a family member of an SSRI suicide victim might shoot him!
When a citizen’s group petitioned the FDA to take action, to require warnings, it said, not now, but if ever there is a “court judgment” we will sit up and take notice. Our law firm provided that verdict in June of 2001 in the Tobin case in Wyoming. After hearing all of the scientific evidence from both sides, the Jury specifically found that “Paxil can cause some people to commit homicide and/or suicide,” that it had caused the four deaths in issue there, and that damages for those deaths were $8MM. Our principal expert was Dr. David Healy (who also testified on behalf of Mrs. Dolin, and who has been grossly and unfairly maligned by GSK for years).
In the wake of our 2001 verdict, the FDA could and should have required full, robust warnings. But they did not. Three years later they required “Black Box” warnings for pediatric patients, but, although the adult data was almost exactly the same, they permitted the drug companies to phrase the warnings as if to appear that they did not apply to adults over the age of 24.
Stewart Dolin was 57. And Mr. Bayman used the FDA’s “silence” and its pathetic endorsement of the “pediatric” only warning to good purpose. He argued effectively that the FDA has “never said” that Paxil causes suicide and that it had taken “no action” for the last 10 years (since it finally received all of the adult data regarding SSRI suicidality). In this, he was right. The FDA has taken “no action.” Shame on them! Andy Bayman was also on target when he said that Dr. Healy “laid the blame at the FDA’s feet.” He did so because the FDA was wrong all along!
Many, many good people have died because the FDA stuck its head in the sand on this issue. It should now pull its head out of the sand, and hang it in total shame.