Gary Douglas may have beat Merck in an important Fosamax trial last month, but can he beat sanctions for his behavior during closing arguments? The attorney, who helped Shirley Boles win $8 million in compensatory damages (back story here), was chastised in a stinging order by US District Court Judge John Keenan for a variety of alleged shenanigans during his recent summation.
"During the trial of this hard fought case, Mr. Douglas repeatedly acted in an inappropriate manner before the jury and made several improper and/or factually incorrect arguments in summation after having been admonished," Keenan writes in an order. Such as? Douglas claimed the FDA has an "incestuous" relationship with drugmakers, and offers cursory reviews and expedited approvals "in exchange" for funding, a reference to the user fees industry pays the agency.
Douglas also criticized the ability of the FDA to regulate drug safety "without a proper foundation in evidence," and compared its alleged shortcomings to the federal government's response to Hurricane Katrina. Keenan was also annoyed that he misstated a report submitted as evidence by Merck; mentioned punitive damages when he wasn't supposed to do so; improperly injected his own opinion concerning the evidence and improperly referred to adverse event reports.
Last, but not least, Keenan was angered at Douglas for "repeatedly disparaging defense witnesses and generally acting rudely to defense counsel in a manner that cannot be fully captured in the record: using sarcasm, gestures, imitations, mockery, singing, derogatory tones, laughing, and admittedly 'fooling around' and 'making fun.' " Unfortunately, Keenan doesn't mention which song Douglas belted out. Maybe it was 'The Winner Takes It All?'
pic thx to walknboston on flickr
9 Comments
Good one, Ed! [The pic of the preturbed jurist.]
I actually think this hurts Merck's chances of getting the verdict set aside -- en todo.
It seems Judge Keenan granted Merck almost all the relief Merck requested, to combat the one plaintiff-lawyer's shenanigans -- so the argument would run that (at least as to the trial verdict) the relief cured the perceived unfair advantage "won", by conduct unbecoming.
We'll see.
Namaste
As to the FDA having an
"incestuous relationship with pharmaceutical companies under which it gives cursory reviews and expedited approvals of new drug applications "in exchange" for funding"
I certainly would like to be able to testify.
On one occassion a company said "but we paid for an approval" and on another occassion a medical division director yelled at reviewers saying "our job is to approve drugs". Then promptly had reviewers on 2 different drugs removed from reviewing when they recommended nonapproval. (Both drugs were then approved in violation of the FD&CA.)
On another occassion a company simply said they'll call Bob Temple in order to have a requirement specified in the Food Drug and Cosmetics Act overturned, and that's what they did the very next day.
As for cursory reviews yes that definitely does happen. We even tell the companies to write our reviews for us and then we're told to copy and paste. I've even been told to accept whatever claims the company makes in their summary without any supporting data.
As for incentuous. How about hiring Industry VPs, having them or their assistants harass reviewers, and then putting the same ex-VPs in charge of the FDA's Culture of Safety self-investigation in response to the UCS and IOM reports. Of course some then left for Board positions with companys 6 months after they left.
Might Keenan also have benefited from pharma largesse?
Hello elmore -- federal judges are appointed for life -- not eleceted. He is very likely free from any form of conflict of interest.
It would be highly unlikely that he has (had) benefitted from pharma -- in the last 20 years (putting aside any of the "benefits" of taking any prescription drug). He is nearly 80 years old, and has been on the federal bench for decades -- perhaps since the 1980s -- but I didn't go double check that; certainly since the 1990s.
Moreover, any stockholdings of size in Merck, by Judge Keenan, would have been disclosed to the trial lawyers -- and would properly have been the basis for a recusal. [Many judges have blind trusts for all investment assets, this very reason.]
Federal judges are generally very sensitive to even an appearance of bias, or any other impropriety. Judge Keenan clearly hasn't worked in any pharma company in over 20 years. By federal rule, he cannot accept gifts from any person that may appear before him, in any matter.
In short, these are not back-water [elected] local county judges, sitting in some county-seat, or parish in Louisiana, Texas or Florida (or southern Illinois).
Namaste
BTW, I am sure there are many able judges in these above-mentioned locales -- but loal elections (for judges) do tend to create some inherent conflicts.
Namaste
The lawyer hired to represent the attorney in the original post has offered her client's explanation of these events. The entirety of these twin letters of explanation may be found as PDF files over at my site, but here is a portion of both letters:
On balance, a pretty good pair of letters, but I still think it more likely than not that some form of sanction will be entered against the lawyer, personally -- but not his client. It could likely be as mild as a stern admonishment -- or as severe as a disqualification from trying any additional Fosamax MDL cases. We'll see.In short -- in my view, without more, this is not likely to affect whether the verdict stands. I think it will.
Namaste
In fairness, I've also set the Merck trial counsel's letter of complaint -- to Judge Keenan (as a PDF file), at my place now.
A bit of it, here:
August 10 ought to be entertaining.Namaste
A $2,500 fine, an on the record scolding, and a reduced (but still mulit-million dollar) verdict.
Seems sane, just and equitable. Too bad the WSJ can't hire reporters who actually. . . read the English language.
Namaste
A follow-up post: even the reduced Boles II Fosamax® ONJ verdict might well imply a very large liability for Merck:
In fact -- at $1.8 billion, it would be just a little less than one tenth of the BP "Deepwater Horizon" oil spill claims fund reserve amount (at $20 billion).
The math, here: 1,200 times $1.5 million, equals $1.8 billion; bp's 2010 gulf oil spill fund currently equals $20 billion. Note that the Fosamax multiplication assumes no amount for Merck's own attorneys' fees -- in defending these matters. In fact, Merck has very-likely spent more than $30 million defending Boles I and Boles II, just on its own attorneys', and experts' fees. These costs will come down, on a per trial basis, as more and more are tried, but an on-going $5 million per full trial to verdict -- in attorneys' and experts' fess, is a good (perhaps even conservative) guess.
This item belongs in your Tuesday roundup, Ed -- it could be nearing $2 billion, when all the dust settles. . . .
Namaste