Why The Judge Acquitted The Former Glaxo Lawyer
20 CommentsBy Ed Silverman // May 10th, 2011 // 3:39 pm
The decision this morning by US District Court Judge to toss the charges against former GlaxoSmithKline lawyer Lauren Stevens, who was indicted for obstructing an FDA probe into off-label marketing of the Wellbutrin SR antidepressant and making false statements to the agency, surprised many people who had been following the case.
Why did he do so? Courtesy of the court transcript, you can read his explanation….
“During the government’s case, which is now concluded, the Court heard extensive testimony of both FDA and GSK officials and, to put it mildly, a large volume of documentary evidence. Very significant portions of the documents placed before the Court were what would otherwise be privileged attorney-client documents. They were obtained by the United States as a result, as I’ve learned, of an order of a magistrate judge in the District of Massachusetts who ordered them produced under what’s known as the Crime Fraud Exception.
“There are, of course, profound implications for the free flow of communications between a lawyer and client when the privilege is abrogated, as it was in this case. The Crime Fraud Exception is designed to overcome the privilege only when the evidence establishes that the client intended to perpetrate a crime or fraud and the communications at issue between the attorney and the client were made in furtherance of such crime or fraud.
“The Crime Fraud Exception has been mentioned in some recent decisions in this circuit, including a recent decision from the District of South Carolina last montn in United States versus Giannini. And the Court there observed that the Crime Fraud Exception exists when, 1), the client was engaged in or planning a criminal or fraudulent scheme when he sought the advice of counsel to further the scheme and, 2), the documents containing the privileged materials bear a close relationship to the client’s existing or future scheme to commit a crime or fraud…
“With the 20/20 vision of hindsight, and that’s always the place to be in terms of wisdom, the Massachusetts Order was an unfortunate one, because I now have benefitted from a trial in which these documents that were ordered produced were paraded in front of me, and the prosecutors were permitted to forage through confidential files to support an argument for criminality of the conduct of the defendant.
“What those records demonstrate to the Court is, first of all, that access should not have been granted to them in the first place. But that’s not for me to decide. That’s already been decided by a magistrate judge in Massachusetts. But they also show that this was a client that was not engaged to assist a client to perpetrate a crime or fraud. Instead, the privileged documents in this case show a studied, thoughtful analysis of an extremely broad request from the Food and Drug Administration and an enormous effort to assemble information and respond on behalf of the client.
“The responses that were given by the defendant in this case may not have been perfect; they may not have satisfied the FDA. They were, however, sent to the FDA in the course of her bona fide legal representation of a client and in good faith reliance of both external and internal lawyers for GlaxoSmithKline.
“Now, what are the consequences of that? As to counts One and Two, the Safe Harbor Provision of Section 15(c) is an absolute bar. GlaxoSmithKline did not come to Ms. Stevens and say, assist us in committing a crime or fraud. It came to her for assistance in responding to a letter from the FDA. I conclude on the basis of this record that no reasonable juror could conclude otherwise beyond a reasonable doubt.
“As I included in my draft instructions that I had prepared in this case had it gone to the jury, on the role of lawyers and advice of counsel, the Safe Harbor Provision is designed specifically to protect an attorney who is acting in accordance with the obligation that every lawyer has to zealously represent his or her client and place their position in the most favorable possible light. That is the obligation of a lawyer as pointed out in the proceedings in Congress when 1515(c) was adopted. The Subcommittee on Criminal Justice had received complaints of prosecutors harassing members of the defense bar, and that vigorously and zealously representing a client is no a basis for charging an offense under the Obstruction of Justice chapter. That addresses the Safe Harbor Provisions which only pertains to counts One and Two.
“As to all counts relating to the question of advice of counsel, the evidence in this case can only support one conclusion, and that is that the defendant sought and obtained the advice and counsel of numerous lawyers. She made full disclosure to them. Every decision that she made and every letter she wrote waw done by a consensus. Now, even if some of these statements were not literally true, it is clear that they were made in good faith which would negate the requisite element required for all six of the crimes charged in this case.
“The government contends that some statements were false. For example, they point to the statement made by Ms. Stevens in a letter to the FDA in which she states that GlaxoSmithKline is not engaged in the promotion of Wellbutrin SR for weight loss. They seek to take that statement, however, in isolation, and the Court simply cannot do that and cannot permit a jury to do that.
“It is clear that while that statement was made, the same or other communications clearly disclosed to the FDA that there had been - speakers had been provided inadvertently with an off-label slide deck, that at least - that approximately 75 speaker presentations had off-label topics; that Dr. Wolkowitz had used the presentation that contained phrases and information about the effect of the drug on body weight that some may consider as outside the product’s approved indication.
“She also disclosed that the company became aware of certain activities that were inconsistent with the company’s policies; took its responsibilities seriously and instituted appropriate and necessary corrective actions to address these activities. The same applies to activities of Dr. Hudziak that were disclosed. So, this is not a statement that can be taken as being false when you consider it in the context in which it was given. 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.
“When a Rule 29 motion is made, she is not stripped of the presumption of innocence. And the government, while it gets the benefit of all inferences, they must be sufficient to overcome that presumption and permit a reasonable juror to find guilt beyond a reasonable doubt. I take my responsibility seriously. I practiced law for a long time and made a number of Rule 29 motions that - or in the state system equivalent of them. I don’t have a very good track record with those motions. In my seven and a half years as a jurist I have never granted one. There is, however, always a first.
“I conclude that I have an obligation when I find legally and sufficient evidence to sustain a conviction on any count that the motion must be granted. I believe that it would be a miscarriage of justice to permit this case to go to the jury. Moreover, there are serious implications for the practice of law generated by this prosecution. Lawyers can never assist a client in the commission of a crime or a fraud, and that’s well established. Lawyers do not get a free pass to commit crimes. I have presided over other trials of lawyers and have sent some to jail.
“I was affirmed by Fourth Circuit this year for having sent a lawyer who was in his 60s to jail for seven years for commission of - assisting a client in the commission of a fraudulent tax scheme. I have lawyers awaiting sentencing before me. Lawyers do not get a free pass in front of me. I’m more than happy to preside over their trials and where they’re convicted, as appropriate, give them jail sentences if that’s appropriate, and I wouldn’t hesitate to do that. However, a lawyer should never fear prosecution because of advice that he or she has given to a client who consults him or her, and a client should never fear that its confidences will be divulged unless its purpose in consulting the lawyer was for the purpose of committing a crime or a fraud.
“There is an enormous potential for abuse in allowing prosecution of an attorney for the giving of legal advice. I conclude that the defendant in this case should never have been prosecuted and she should be permitted to resume her career.
“The institutional problem that causes me a great concern is that while lawyers should not get a free pass, the Court should be vigilant to permit the practice of law to be carried on, to be engaged in, and to allow lawyers to do their job of zealously representing the interests of their client. Anything that interferes with that is something that the court system should not countenance. For those reasons, I am going to grant the defense’s motion for judgment of acquittal, and that will bring this case to an end.”
Here is the official transcript
Hat tip to White Collar Crime Prof blog
pic thx to walknboston on flickr
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Pretty pitiful decision Judge Titus! AS a former attorney you now know what Dante thinks of you too!
Batman
Pathetic as one attorney protects another. Sharks don’t eat their own - this is living modern day proof!
high plains drifter
This has to be a joke, I personally was given slides to hand deliver to local speakers by management. Do you think these 3-4 guys were all that were involved. GSK has 49,000 speakers. Stevens, it will show in a trial hopefully with a judge much more informed than TITUS, that yes indeed GSK used these “national thought leaders” to do one thing -promote off label. When Glaxo and Burroughs Wellcome merged in 1995 Webutrin was a dead drug, inefficient for depression and causing seizures. Glaxo resurrected this 15 year old failure into a success. How ? by creating a longer acting version — The SR form. They knew they could not sell it for depression effectively, so they started recruiting thousands of speakers to talk about weight loss, ADD, ADD,ADHD,sexual function, bipolar, anxiety and many other indications.
It became a multi billion dollar drug, right in front of Lauren Stevens and she knew why, MARKETING scams.
When the FDA asked about that she simply LIED and hid perinent information. She is responsible for Billions of taxpayer dollars wasted on an ineffective drug… because of only a FEW of the whores mentioned. Pradko, Hudziak, Montano, Croft, Wolsniski there were thousands of others but these were the ones who became millionaires…and Stevens was paid well to commit fraud, but TITUS would not allow that as evidence.
The chickens will come to roost when it is shown what Stevens ultimately was responsible for from 1995 to the present. 9 drugs, off label, kickbacks,lies, deaths, deformities….Paxil, Avandia, Lamictal,Lotronex and others. She is in fact a white collar killer, in a round about way.
How do I know all this and more ? I was there, given all the slides,ordered to get all of the above speakers to improve “market share”. This company as proven many times before in Court, including a 750 million dollar fine for adulterating and selling crummy drugs from Puerto Rico… Lying about best price and paying the fines…Hiding Paxil studies that killed kids, and still promoting it to kids…No compliance at all. If you reported issues you were fired.It went all the way to Bob Ingram COO and JP Garnier CEO through Stevens, who was the top dog fraud attorney.
Oh, but Stevens had all these expensive attorneys that she could afford. This judge says he just committed a lawyer to 7 years,in his 60’s –so what he probably should have been in prison in his 30’s….he just finally got caught. is that supposed to impress me. He is a fool at best.
This is an abomination and this Judge will soon see how far the corruption and fraud of Lauren Stevens ultimately goes….as she said everyone in the company is under a massive investigation. That includes her for many other misdeeds. She is a criminal to the core and any judge that lets her off the hook is no better. Titus’s argument is a joke, that will be corrected in the near future by the DOJ in Boston, according to Stevens herself.
Long story short,as a former employee I know what went on and next time, I will be coming forward. Titus will be proven to be the public menace that he actually is and Stevens and other executives will finally pay the price for GSK crimes. Take that to the bank. She is evil,as is the company.
Wait and see.
Paul
Thanks Ed, this is a great item to share. Clearly shows that the government in this case over-reached its privileges. I am convinced by the Judge’s discussion.
deafbutnotdumb
This Judge repeatedly claims attorney client privilege. It would seem to any normal juror that indeed the company did come to Lauren Stevens and say here take care of this. She did, she protected the off label promotion that GSK knew was not only nationwide, but
in fact a marketing plan. They had studies on weight loss, promoted it and Never sought an indication…they subverted FDA law for their own profit. They knew it was illegal,and it actually did not stop until the drug went off patent. They represented a few physicians as “rogue”,yet they knew what was going on all over the country-paid for and supplied the slides-which they then denied the FDA when requested to supply them.
THIS WOMAN WAS INDICTED BY NOT ONE, BUT DUE TO THE ACTIONS OF THE JUDGE– INDICTED BY TWO GRAND JURY PANELS. HE DID NOT LET THIS GET TO A THIRD JURY. WHY, WHO REALLY KNOWS…BUT SHE IS GUILTY AS HELL AND IF THE DOJ PURSUES HER FOR OTHER CRIMES WHILE SHE AT THE HELM IN GSK LEGAL, HOPEFULLY JUSTICE WILL BE DONE.
Attorney-client relationships have no privilege when both are scheming to commit continuing fraud on innocent patients, and the taxpayers. They knowingly subverted the very processes required by the FDA to sell a pharmaceutical product, and risked patient health and safety through kickbacks and fraud.
This trial was a travesty of justice,and when the whole truth is known this Judge will be shown to be an embarassment to the legal system. These jurors should have decided the matter, not KING TITUS,and for patient safety above-all hopefully this is the beginning, not the end of the investigation of Lauren Stevens.
anon
anyone who thinks that courts are not rigged against the rest of us desrves all that they get.
Been There
There was another issue that is not really being discussed - the egregious and overzealous conduct of the government lawyers. The judge was adamant about the impropriety of their conduct and it was a major contribution to his acquittal order. From an insider’s perspective, disagreements with the FDA are myriad and expected. However, just because their is a disagreement or that the FDA was not satisfied by a company’s response does not lead to inferences of criminal conduct. In some cases, both the FDA and the company can compound the problems with confounding factors such as lack of expertise, political maneuvering, and human shortcomings such as lack of time to understand the written communications or just the everday travails of working in an environment that is flooded with information and less gracious with time. The mental state needed for this crime was an intent, not negligence or recklessness or knowing. That’s a very high hurdle for a prosecution to prove. Had the governmetn pursued a criminal charge based on negligence or a strict liability crime that does not require showing a faulty mental state, then perhaps the case may have proceeded to a jury. However, that does not rectify the issues where the government over-reached on the indictment and then the trolling for attorney-client work product under bogus reasons. That was the essence of the judge’s diatribe in his order for acquittal.
MsPiggy
The message is clear: You can lie to Congress and the world about criminal activities if your a lawyer working for pharmaceutical corporation that spends millions in lobbying and campaign money.
This ruling is affirmed by appointed federal judge…juries can only be trusted if the government is going after regular folks..
Batman
I stand by my origial comment….the law benefits lawyers who lie and get in the way of legal subpoenas. If someone thinks that a subpoena can be ignored or falsely answered to as a privilege when it is the protection of the public interest that DOJ is seeking to bolster…then I stand aside and allow retars to walk into moving traffic.
In this case…after you Judge , I mean King Titus.
Condor
I’ll respect the able judge’s decision, and in the next breath, I will point out that if he felt “specific intent” evidence was lacking in his the criminal trial, the standard is not as high, in the North Carolina bar authorities hearings, should one be brought. That is. . . .
What STILL remains unsaid, in both the judge’s opinion, and the news coverage, is that there may well be a case for disciplinary proceedings, against Stevens, 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 fairly likely. She was practicing before a government agency, afterall — not an adversary court proceeding (where opposing counsel and judges buffer excessively zealous lawyering).
The obligation in this setting was “candor, free of material omission” — 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, I’d wait for that other shoe to drop. . . .
Namaste
Guest
Batman: “the law benefits lawyers who lie and get in the way of legal subpoenas.”
Thanks for the legal analysis. Only problem is that there was no subpoena in this case (it was an administrative request) and the agency was not DOJ, but FDA.
Ms.Piggy: “The message is clear: You can lie to Congress and the world about criminal activities if your a lawyer working for pharmaceutical corporation that spends millions in lobbying and campaign money.”
Actually the message is that there was no criminal activity. That is why the case was dismissed. Did you read the part where Titus said ” . . . the privileged documents in this case show a studied, thoughtful analysis of an extremely broad request from the Food and Drug Administration and an enormous effort to assemble information and respond on behalf of the client.”
Also, both of the astute legal minds above claim that this case is an example of lawyers protecting lawyers. You must of missed the part where Titus discussed the other lawyers that he sent to jail recently and fail to account for the obvious fact that it was lawyers that charged the conduct and attempted to prosecute the case.
There may be good reasons for holding individuals responsible for conduct in the many recent off-label/kickback suits. But comments like this don’t strengthen the case. They make you look silly.
Salient point
It would be unethical for a judge to provide a jury final instructions if the only plausible decision he feels can be rendered is a not guilty verdict.
Batman
Guest,
Speak not of what you do not know. You are the type of poster who attacks those who have typos rather than content. This decision reads Republican all over it. Appointed Judge by George W Bush. Checkmate. Go back to the comics where you belong. Sorry, but you deserve this…
It is impossible to get multiple agencies to agree on anything. DOH rarely gets full buy in from the FDA or CMS and the judge took this to mean something was not right and that was just the beginning of the flawed legal analysis. This judge did not want to support a Democratic Presidential running and more effective DOJ. They have gotten more done in 3 yrs than the last 8 before because they are getting support from the White House to crack down on these types of white collar crime. Too bad the judge is one of “them” from the Bush era!
Salient point
Batman-So basically every person in the government not appointed by someone you voted for should be fired. The comics, or perhaps the cliff notes to the comics, are what you should be reading.
ROBIN
Wow, all the crazies are out this morrning, Batman!….and no, just this judge should be looked at for his behavior or is he lifetime appointed and bulletproof like some in the high court….love that too.
Salient point
Batman & ROBIN-Well the only crazy out this morning was me. Sorry about my comment. It was obnoxious.
The thing is, we can’t live in a society in which half the country believes everything about the other half is automatically wrong. This is a growing problem on both sides of the aisle. The difference when it comes to the judiciary is that the federal bench has largely been populated by the GOP, because it has dominated the White House for the last 30 years.
As for this case, it doesn’t serve anyone’s interests for a judge to allow a jury to reach a verdict that he has already decided is wrong as a matter of law. Judges are not just referees. There may be imperfections in who the judge is & how he got there, but the entire system breaks down if he doesn’t do the job he’s paid to do properly. And we have enough things breaking down as it is.
Canary
The problem is, with King Titus–He completely disregarded and condemned the decision of a Massachussetts Court to allow attorney client documents that they believed showed fraud on the part of both. There is no attorney client privilege if you are doing something criminal. Testimony showed they were committing a coverup of crimes. There is no doubt. The judge tossed out on his own, with no power to do so the information from the Mass. decision.
He thinks he knows more,yet no doubt the magistrate in Mass. studied this intently. The Judge is a clueless fool, and again as said before, this is not over. Stevens was in on a company conspiracy of criminal marketing. She will ultimately pay the price, for other drugs at some point.
Batman
Canary - Well said. I echo the Canary. Totally agree.
Observer
Well, the judge committed reversible error in at least one aspect: his reasoning was based on her giving advice to GSK. But that wasn’t what she was indicted for, was it? She was indicted FOR SIGNING HER OWN NAME TO STATEMENTS SHE KNEW WERE FALSE, and sending them to the FDA. And as the judge well knows, there were MANY documents produced that showed her scienter AND knowledge of the falsity. She became a PRINCIPAL in the fraud, not merely counsel. His reasoning was therefore specious, and clearly reversible. And all that dicta about whether the documents should have been produced or not? Gives the government a HUGE bargaining chip in getting this case in front of a different judge on remand.
Observer
Let’s also remember that Titus came stright to the bench - via a GW Bush nomination - from Venable, Baetjer & Howard, who have a 20-person Pharma section devoted to regulatory matter, solely representing pharma companies. He grants his first Rule 29 motion in a case of this importance?? Guess he was saving the big gunds for a big client…