In a stunning blow to the federal government and its effort to hold some pharma execs accountable for breaking the law, a federal trial judge this morning threw out a closely watched case against former GlaxoSmithKline lawyer Lauren Stevens, who was accused of obstructing an FDA investigation into whether the drugmaker illegally marketed its Wellbutrin SR antidepressant as a diet drug.
US District Court Judge Roger Titus acquitted Stevens without sending the case to the jury, which he called a "first" in his seven and a half years on the bench, according to Dow Jones. "I conclude on the basis of the record before me that only with a jaundiced eye and with an inference of guilt that's inconsistent with the presumption of innocence could a reasonable jury ever convict this defendant," Titus said.
The surprise dismissal comes after the Stevens legal team succeeded in convincing Titus to toss the initial indictment from last November (see here). And after the trial began last week, the Stevens legal team argued she did not attempt to conceal information, but rather did not produce info in the absence of an FDA subpoena. They also maintained she did not make false statements, but that the government misconstrued her communications, and that she repeatedly received advice from the King & Spalding law firm that does work for the drugmaker (read her motion here).
wastebasket courtesy of l marie on flicker
15 Comments
Could be why the feds don't spend a lot of time prosecuting individuals, because it is expensive and takes up their limited time. Though it is getting pretty obvious big pharma does not have much fear for the law even when it endangers the safety of patients.
I am anti-pharma most of the time, but I am relieved to see this story.
To me it seemed like an individual was being "hung out to dry" for alleged group malfeasance.
Struck me as fundamentally unfair, though I do not purport to know all the details of this case.
And I seem to recall some individual comments here virtually guaranteeing that she would do jail time.
Hmmmm . . .
Yes there was a lot of chortling in these parts about the defendant's strategy once upon a time. Now there will be a lot of tut-tutting about the judge's decision, from people who surely possess more legal expertise than he does.
What remains unsaid, in both the judge's opinion, and the news coverage, is that there may well be pending disciplinary proceedings, at the state bar level.
Being acquitted of crime does not -- in any way -- rule out the possibility that she will ultimately be censured, suspended or disbarred.
That her conduct fell short of the ethical rules imposed upon lawyers, state by state, seems likely.
The obligation in this setting was candor -- before the FDA -- it seems probable even the judge's own opinion (acquitting her of a crime) today makes out a pretty clear case of less than candid behavior, before a governmental tribunal.
"Conduct unbecoming. . . ."
So, just wait for that other shoe to drop -- and to drop before too terribly long.
Namaste
"Although not my favorite lawyer, Reid Weingarten has chosen a brilliant strategy. “Intent to mislead the FDA”, an agency known for its share of misleading and obfuscation, especially by DDMAC, will be very difficult for the prosecutors to prove. I’m doing a 180. Unless the presecution completely blows its case, Stevens will walk."
Guess who made that brilliant prediction on these boards not long ago. Your one and only genuine industry insider. As I've said many times in many places, I'm extremely proud of my humility.
Have to agree that "intent to mislead the FDA" is a weak case at best. Just try finding something on its website (as compared to, say, Health Canada) and the word obfuscation comes right to mind. I suspect this was just a beginning; a trial balloon, and hope for a more intelligent case next time - one that does not involve a relative smallfry.
"...only with a jaundiced eye and with an inference of guilt that’s inconsistent with the presumption of innocence could a reasonable jury ever convict this defendant,”
So despite inside and knowing comments from many on this blog of presumed guilt, it looks like presumed innocence before a trial still is the law of our land. I am glad that we have a constitution that protects us all. I have no doubt that there are those in our industry that break the law and I hope those who do are identified and properly tried and convicted. But I hope we all withhold judgement and particularly character assasination until the legal process is complete.
The real travesty here is that taxpayer dollars were wasted on a trial in which the prosecutor had no case, was poorly prepared, and was able to present no witnesses with any real information or credibility. Absent that, any reasonable person who believes in our constituional rights would have to conclude that the prosecutor put her ego before the facts and that Lauren Stevens was innocent. Period. If the job of the DOJ is to protect the public and public interest, it failed miserably in the person of the prosecutor. Surely there must be some real criminals out there that she should have been spending our tax dollars and her time on. Maybe her job perforamce should be on trial.
Where you there Mary? I was and the judge was clearly biased, and I am willing to concede that I am as well, because I have a friend who now has a seizure disorder due to this Pill. The Judge sustained 99.5% of all the defense objections, and overruled 100% of the prosecutions objections. He made it almost impossible for the Prosecution to ask any questions that would have impeached the string of "hostile" witnesses that were called! Almost all witnesses were current GSK employees that were prepped to save their jobs and Lauren. All at the same time. Lauren gets the Brass Ring Now! The fact that Judge Titus didn't allow the amount of money per year Ms. Stevens made into evidence, As it goes to motive, was blatantly biased! If she been a cocaine dealer he would have allowed it, but she is BIG PHARMA! And Cocaine Dealers don't have a Political Action Committee, However Big Pharma Does and pays for the influence!
PAC: Your friend's problems are about a company, not the behavior of an individual. get it straight. Titus followed the law. Read the documents.
Mary, Mary quite contrary...This inquiry from the FDA was given to GSK, THEY gave it to Stevens, she did her multimillion duty as lead counsel, she covered up documents requested, then she lied about it.
Stevens herself whines "Why me, GSK is under a massive investigation by a Grand Jury and has been in Boston since 2003". Why because this was a separate FDA issue. Hopefully the investigation in Boston is run by Susan Winkler. Lauren, you dodged the little bullet but the machine gun on 9 drugs you were in on for the same issues is coming. You are done, hopefully and there will be a competent Judge on the case.
As for the Judge, KING TITUS...he first had one Grand JURY indictment. Then he threw that out. Within a week, another jury indicted Stevens. This is unbelievable that 2 juries felt she was guilty--Yet KING TITUS would not let the final jury even rule. Dumb, corrupt and he will be made the fool he is when all of this is over.
This was always small potatoes. Stevens will be re-indicted on charges much more serious than the one she was facing. 9 drugs, 9 off label, 9 drugs with kickbacks. She better not be celebrating too long. GSK has killed 30 times more people than UBL.. add them up Paxil, Avandia, etc. mostly off label even Advair, people found dead clutching their inhaler due to Serevent component. Trust me this goes all the way to the top and this trial established 2 things:
1. GSK markets drugs without FDA approval. 2. GSK pay millions in kickbacks to physicians, all over the country to lie for them. Quid pro Quo to the max.
That is all the government needs to expand on and trust me, this time the witnesses will not be allowed to perjure themselves. This laid a great foundation for the case that Stevens says is on it's way.
Think about it Mary.
Simple fact is LAWYER acquitted LAWYER!
King TITUS will soon be known as the Court Jester. What Judge on earth would deny the right of a jury to hear the arguments, especially when 2 JURIES already thought she could be convicted. This Court Jester Titus seems he thinks he can overule a decision in Boston to let some attorney-client information out, because there was fraud involved. The testimony showed fraud was involved, also we needed to see what the defense had and how that held up under cross examination by the government. The prosecutor here, Sara Bloom is a national hero that has forced big pharma to pay billions in reparations for their crimes. It was not enough,it continued....now this will further encourage them.
Hey Court Jester, were you listening when testimony showed that an employee came to Compliance and Stevens in 2001 with allegations of many off label and kickback issue. The company retaliated and fired the employee, and demanded that he perform as ordered...criminally. Were you asleep ? Court Jester Titus should be impeached and go back with his pack of attorney friends. Love them don't you Jester.
Titus dismissed this case not because of any judicial principals but because he represents the pharma industry. The investigation of the US Attorney should now turn to Titus’s connections with Big Pharma and how he and his corrupt colleagues are profiting from his rulings. I have personal experience with Titus and can affirm he is corrupt, rude, dismissive and completely in the pay of defense counsel who represent Big Pharma. The US Attorney should investigate and put Titus in he jail cell he allowed the Glaxo attorney to escape. That would be a far better use of proscecutorial resources. I have plenty of evidence of his corruption I will share with any interested party. Titus needs to be prosecuted and removed from the bench.